Result or Finding in Original Units
Findings/Adverse Events/CMs reported (reported in the diary)
Findings/Adverse Events/CMs reported; subject called back late because he was deeply asleep due to AEs.
Findings/Adverse Events/CMs reported, reported in the Diary (Malaise yesterday 1, today 0)
Other: local: tenderness, mild, resolved 06.09.2020
Other: Local: pain inj.site, mild, resolved (day 22)
Other: Local reaction mild, systemic resolved, lumbago not related, no conmed
Other: pain, tenderness local, mild resolved; arthralgia, mild resolved
Other: Malaise mild, resolved. Vomiting 1x; Nausea resolved. Headache mild ongoing, today resolved. 5 a.m. 500mg Paracetamol oral
Other: Moderate systemic reactions (Headache, loss of Appetite, Tiredness, Malaise) started 7h p.a.; one Paracetamol needed; all resolved 11.09.2020.
Other: Headache 26.08. resolved, mild; 1 Paracetamol 500 yesterday
Other: headache 26.08. mild, resolved; Paracetamol 500mg oral 26.08.
Other: swelling 2, resolved; pain, tenderness 1, resolved; 15.09.:38,6 Degree (Paracetamol Tbl); 16.09.: 38,10 Degree; Systemic headache 2, chills 3, resolved
Other: Headache 22.09., mild, 500 mg Paracetamol, resolved
Other: local pain 2, resolved; headache 2, resolved 2x500 mg Paracetamol
Other: Lab. d 2: CRP increased, suspect of urinary tract infection; no pain, no clinical equivalent. Volunteer was adviced to drink a Minimum of 2 L/d.
Other: Headache, mild, resolved, 22.09.2020 Paracetamol 500 mg
Findings/Adverse Events/CMs reported, \n \n other: Cystitis
Other: headache 1, resolved; local pain 1, resolved
headache, Malaise, Nausea 2 \n --> 500mg Paracetamol, resolved
Other: Joint pain 2, ongoing; headache 23.09., 2, resolved; Malaise 3, now 1, ongoing; tiredness 2 ongoing; Paracetamol 500 5 Tbl, last time = Ibu 400 12:10
tiredness 3, headache 2, myalgia 1, nausea 2, chills 2, loss of apetite, malaise 2; Paracetamol, paracetol 500 yesterday + Tbl. today resolved
Other: local pain, moderate, resolved; loss of Appetite, mild, ongoing
systemic reactions reported. \n will be entered in diary
systemic reactions reported, will be entered in diary
Other: tiredness + headache, mild, resolved
flu-like Symptoms (Fatigue, myalgia) starting 17Jun 2020, approx. 12:00, max.T. =36.8
still mild pain/tenderness at injetion site, mild fatigue 17Jun 2020
injection site reaction mild, ongoing, tiredness mild, documented in diary
injection site reaction mild (pain, tenderness) Temp. 37.7 no Fever, documented in diary
mild injection site reaction documented in diary
Arthralgia since 15.07.2020 07:00 moderate, injection site reaction mild since 15.07.2020 07:00, documented in diary
tiredness, headache, arthralgia, mild since 14Jul2020,,Injection site reactin (erythema)mild, both documented in diary
injection site reaction mild, documented in diary
flu-like Symptoms, headache -documented in diary
Findings/Adverse Events/CMs reported -> record on the AE/CM-Form
findings reported, no adverse events and no CMs reported
No new AE's or systemic reactions, mild local reaction ondoing
systemic reaction ongoing, no injection site reaction, swollen lymph node resolved
Findings/AEs/CMs reported: new reported systemic reaction, grade 2, resolved. no local reaction. no conmed intake. no fever.
headache mild (systemic reaction) on day 30Jul 2020entered in Diary, no co-med, no local-reaction
no findings or new AEs/CMs reported. no local or systemic reactions. no conmed intake. no fever.
no findings or new AEs/CMs reported. local reaction mild resolved. no systemic reaction. no conmed intake. no fever.
no findings or new AEs/CMs reported.no local or systemic reactions. no conmed intake. no fever.
Findings/AE/CMs reported: Skin Irritation perioral not related after wearing mouth-nose-mask. mild local reaction resolved. no systemic reaction. no conmed. no fever.
No systemic reactions reported, no new local reactions reported
no Findings/AE/CMs reported: mild local reaction 19Aug 2020 resolved.no systemic reaction. no conmed. no fever.

Result or Finding in Standard Format
Findings/Adverse Events/CMs reported (reported in the diary)
Findings/Adverse Events/CMs reported; subject called back late because he was deeply asleep due to AEs.
Findings/Adverse Events/CMs reported, reported in the Diary (Malaise yesterday 1, today 0)
Other: local: tenderness, mild, resolved 06.09.2020
Other: Local: pain inj.site, mild, resolved (day 22)
Other: Local reaction mild, systemic resolved, lumbago not related, no conmed
Other: pain, tenderness local, mild resolved; arthralgia, mild resolved
Other: Malaise mild, resolved. Vomiting 1x; Nausea resolved. Headache mild ongoing, today resolved. 5 a.m. 500mg Paracetamol oral
Other: Moderate systemic reactions (Headache, loss of Appetite, Tiredness, Malaise) started 7h p.a.; one Paracetamol needed; all resolved 11.09.2020.
Other: Headache 26.08. resolved, mild; 1 Paracetamol 500 yesterday
Other: headache 26.08. mild, resolved; Paracetamol 500mg oral 26.08.
Other: swelling 2, resolved; pain, tenderness 1, resolved; 15.09.:38,6 Degree (Paracetamol Tbl); 16.09.: 38,10 Degree; Systemic headache 2, chills 3, resolved
Other: Headache 22.09., mild, 500 mg Paracetamol, resolved
Other: local pain 2, resolved; headache 2, resolved 2x500 mg Paracetamol
Other: Lab. d 2: CRP increased, suspect of urinary tract infection; no pain, no clinical equivalent. Volunteer was adviced to drink a Minimum of 2 L/d.
Other: Headache, mild, resolved, 22.09.2020 Paracetamol 500 mg
Findings/Adverse Events/CMs reported, \n \n other: Cystitis
Other: headache 1, resolved; local pain 1, resolved
headache, Malaise, Nausea 2 \n --> 500mg Paracetamol, resolved
Other: Joint pain 2, ongoing; headache 23.09., 2, resolved; Malaise 3, now 1, ongoing; tiredness 2 ongoing; Paracetamol 500 5 Tbl, last time = Ibu 400 12:10
tiredness 3, headache 2, myalgia 1, nausea 2, chills 2, loss of apetite, malaise 2; Paracetamol, paracetol 500 yesterday + Tbl. today resolved
Other: local pain, moderate, resolved; loss of Appetite, mild, ongoing
systemic reactions reported. \n will be entered in diary
systemic reactions reported, will be entered in diary
Other: tiredness + headache, mild, resolved
flu-like Symptoms (Fatigue, myalgia) starting 17Jun 2020, approx. 12:00, max.T. =36.8
still mild pain/tenderness at injetion site, mild fatigue 17Jun 2020
injection site reaction mild, ongoing, tiredness mild, documented in diary
injection site reaction mild (pain, tenderness) Temp. 37.7 no Fever, documented in diary
mild injection site reaction documented in diary
Arthralgia since 15.07.2020 07:00 moderate, injection site reaction mild since 15.07.2020 07:00, documented in diary
tiredness, headache, arthralgia, mild since 14Jul2020,,Injection site reactin (erythema)mild, both documented in diary
injection site reaction mild, documented in diary
flu-like Symptoms, headache -documented in diary
Findings/Adverse Events/CMs reported -> record on the AE/CM-Form
findings reported, no adverse events and no CMs reported
No new AE's or systemic reactions, mild local reaction ondoing
systemic reaction ongoing, no injection site reaction, swollen lymph node resolved
Findings/AEs/CMs reported: new reported systemic reaction, grade 2, resolved. no local reaction. no conmed intake. no fever.
headache mild (systemic reaction) on day 30Jul 2020entered in Diary, no co-med, no local-reaction
no findings or new AEs/CMs reported. no local or systemic reactions. no conmed intake. no fever.
no findings or new AEs/CMs reported. local reaction mild resolved. no systemic reaction. no conmed intake. no fever.
no findings or new AEs/CMs reported.no local or systemic reactions. no conmed intake. no fever.
Findings/AE/CMs reported: Skin Irritation perioral not related after wearing mouth-nose-mask. mild local reaction resolved. no systemic reaction. no conmed. no fever.
No systemic reactions reported, no new local reactions reported
no Findings/AE/CMs reported: mild local reaction 19Aug 2020 resolved.no systemic reaction. no conmed. no fever.