VAERS 2021 Database www.vaers.hhs.gov

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VAERS Updated: 11/12/2021
** VAERS DATABASE Last updated: November 12, 2021**
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Manufacturers

Total Manufacturer
199,106MODERNA
36,710JANSSEN
5,381PFIZER\BIONTECH
2,555GLAXOSMITHKLINE BIOLOGICALS
1,469UNKNOWN MANUFACTURER
897MERCK & CO. INC.
627SEQIRUS, INC.
112DYNAVAX TECHNOLOGIES CORPORATION
91SANOFI PASTEUR
75NOVARTIS VACCINES AND DIAGNOSTICS
40EMERGENT BIOSOLUTIONS
14PAXVAX
12TEVA PHARMACEUTICALS
12PROTEIN SCIENCES CORPORATION
9PFIZER\WYETH
4BERNA BIOTECH, LTD.
4SMITHKLINE BEECHAM
3INTERCELL AG
1MEDIMMUNE VACCINES, INC.
1CSL LIMITED

COVID19 Lot Number

VAX LOT Total
2S9CL7,949
7,473
2,547
1,506
1,187
1,051
1,049
s0294561,043
866
IMM209861
816
UT7065MA766
657
579
U62828AA563
557
538
U6737AA516
515
S034636506
4F472471
458
P100253275449
444
276563436
429
418
4BH32414
MENVEO404
PP9L5362
UJ446AA337
319
306
290
271
49TM3270
R1B252M253
4F472179
933622147
C5763AA144
CW3116134
3Y7NL126
UNK114
113
ARBA141A105
104
103
96
300057A90
79
1F4EB73
R1B743M62
56
UJ090AA55
51
UH894AB46
45
UNK44
UNK42
42
EJ168638
Unknown36
35
34
32
32
26
el128424
24
A115A22
22
EN620222
21
UNK20
20
19
Z127A19
19
17
JEV18K95E15
12
111798PI12
10
A739088
No batch number8
3333324181078
6
6
TAR356
5
5
U6935AA5
UNK5
4
unknown4
3
2
55RB72
2
2
2
2
2
U7124AA2
JEV18A68E2
2
ABYB05BA1
1
1
1
1
AMVA436A1
1
1
TJ3521
A130A; VIS give1
1
U7140BB1
1
1
SP UP016AA1
1
1808P08802/ESV01
037K20A300,947
EL1284288,578
57,766
1,432

Incidents per State

State Total
82,750
CA62,821
FL38,209
TX36,512
NY34,921
PA23,646
IN23,622
IL20,597
MI19,590
OH19,426
NJ18,413
NC16,769
GA15,932
WA15,351
VA15,234
MA14,876
AZ14,206
MN12,940
MD12,656
CO11,908
WI11,425
MO10,240
TN9,685
OR8,768
KY8,437
CT8,300
SC6,700
OK6,293
AL5,692
LA5,025
IA4,825
KS4,821
UT4,637
NV4,374
NM3,967
AR3,807
ME3,161
NH3,096
NE2,918
MS2,859
ID2,785
WV2,469
HI2,459
PR2,417
MT2,414
RI2,076
DE1,868
AK1,830
VT1,734
DC1,715
ND1,388
SD1,269
WY866
GU118
VI69
AS47
MP29
MH8
XB6
FM4
QM3
XV2
XL1

ID: 1755807
Sex: F
Age: 58
State: AZ

Vax Date: 09/21/2021
Onset Date:
Rec V Date: 10/02/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 037K20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Dysphagia, Epiglottitis

Symptoms: vial punctured for more than 12 hours; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vial punctured for more than 12 hours) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006D21A) for COVID-19 vaccination. No Medical History information was reported. On 21-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (vial punctured for more than 12 hours). At the time of the report, EXPIRED PRODUCT ADMINISTERED (vial punctured for more than 12 hours) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were not reported. No treatment medications were not provided.

Other Meds:

Current Illness:

ID: 1755808
Sex: F
Age: 77
State: NY

Vax Date: 02/05/2021
Onset Date:
Rec V Date: 10/02/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025L20A
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Anxiety, Dyspnoea

Symptoms: just a little bit of a sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (just a little bit of a sore arm) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination. No Medical History information was reported. On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (just a little bit of a sore arm). At the time of the report, PAIN IN EXTREMITY (just a little bit of a sore arm) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medications were not provided. Treatment information was not provided. This case was linked to MOD-2021-329129 (Patient Link).

Other Meds:

Current Illness:

ID: 1755809
Sex: F
Age:
State: PA

Vax Date: 08/20/2021
Onset Date: 08/20/2021
Rec V Date: 10/02/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot: EL1284
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Chest discomfort, Dysphagia, Pain in extremity, Visual impairment

Symptoms: first dose to a 16 year old; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (first dose to a 16 year old) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939902) for COVID-19 vaccination. No Medical History information was reported. On 20-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Aug-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (first dose to a 16 year old). On 20-Aug-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (first dose to a 16 year old) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported. No treatment medications were reported.

Other Meds:

Current Illness:

ID: 1755810
Sex: F
Age:
State: NY

Vax Date: 01/20/2021
Onset Date:
Rec V Date: 10/02/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: unknown
Dose Series: UNK
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Dizziness, Fatigue, Mobility decreased

Symptoms: when she stood up, she fainted; Increased urination for a few days/got up in the morning, she urinated; Stayed in bed all day because was so sleepy; Very tired; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (when she stood up, she fainted) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20-2A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced SYNCOPE (when she stood up, she fainted) (seriousness criterion medically significant), POLLAKIURIA (Increased urination for a few days/got up in the morning, she urinated), SOMNOLENCE (Stayed in bed all day because was so sleepy) and FATIGUE (Very tired). At the time of the report, SYNCOPE (when she stood up, she fainted), POLLAKIURIA (Increased urination for a few days/got up in the morning, she urinated), SOMNOLENCE (Stayed in bed all day because was so sleepy) and FATIGUE (Very tired) had resolved. No concomitant medication information was reported. No treatment information was reported. Company comment: This case concerns a 83-year-old, female patient with no relevant medical history, who experienced the unexpected event of Syncope. The event occurred unspecified date after the second dose of Moderna Covid-19 Vaccine. The rechallenge was not applicable as event occurred after administration of second dose. The benefit-risk relationship of Moderna Covid-19 Vaccine is not affected by this report.; Sender's Comments: This case concerns a 83-year-old, female patient with no relevant medical history, who experienced the unexpected event of Syncope. The event occurred unspecified date after the second dose of Moderna Covid-19 Vaccine. The rechallenge was not applicable as event occurred after administration of second dose. The benefit-risk relationship of Moderna Covid-19 Vaccine is not affected by this report.

Other Meds:

Current Illness:

ID: 1755811
Sex: F
Age:
State: FL

Vax Date:
Onset Date: 09/23/2021
Rec V Date: 10/02/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data: Test Date: 20210923; Test Name: Antibody test; Result Unstructured Data: Low

Allergies:

Symptom List: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth

Symptoms: swollen arm; It itched, it was like a bee sting; it hurt at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swollen arm), VACCINATION SITE PRURITUS (It itched, it was like a bee sting) and VACCINATION SITE PAIN (it hurt at the injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Sep-2021, the patient experienced PERIPHERAL SWELLING (swollen arm), VACCINATION SITE PRURITUS (It itched, it was like a bee sting) and VACCINATION SITE PAIN (it hurt at the injection site). At the time of the report, PERIPHERAL SWELLING (swollen arm), VACCINATION SITE PRURITUS (It itched, it was like a bee sting) and VACCINATION SITE PAIN (it hurt at the injection site) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Sep-2021, Antibody test: low (Low) Low. No concomitant medication was provided. The first dose was fine. After second dose the patient had a swollen arm, it hurt at the injection site, and it itched, it was like a bee sting. No treatment information was provided.

Other Meds:

Current Illness:

ID: 1755812
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/02/2021
Hospital:

Vax Type: FLUC4
Manufacturer: SEQIRUS, INC.
Vax Name: INFLUENZA (SEASONAL) (FLUCELVAX QUADRIVALENT)
Lot: 276563
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Chills, Confusional state, Eye inflammation, Headache, Laboratory test

Symptoms: depression; feel horrible; repulsion; This spontaneous case was reported by a consumer and describes the occurrence of DEPRESSION (depression), FEELING ABNORMAL (feel horrible) and ANXIETY (repulsion) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DEPRESSION (depression), FEELING ABNORMAL (feel horrible) and ANXIETY (repulsion). At the time of the report, DEPRESSION (depression), FEELING ABNORMAL (feel horrible) and ANXIETY (repulsion) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitants were provided. No treatment medications was reported. After introduction of vaccination, the patient was in a little bit of guilt, repulsion and depression with horrible feeling (reported in a crosslinked case). The vaccine should get to everybody and that the formula should be shared. Reporter did not allow further contact Most recent FOLLOW-UP information incorporated above includes: On 22-Sep-2021: Non significant follow up received on 22-sep-2021

Other Meds:

Current Illness:

ID: 1755813
Sex: F
Age: 77
State: FL

Vax Date: 01/25/2021
Onset Date: 01/25/2021
Rec V Date: 10/02/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011J20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Pyrexia, White blood cell count decreased

Symptoms: This spontaneous case reported by a consumer, describes the occurrence of vaccination site pain (sore arm at the injection site) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 030L20A) for COVID-19 immunization. No medical history reported. On Jan 25, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Jan 25, 2021, patient experienced vaccination site pain (sore arm at the injection site). At the time of the report, vaccination site pain (sore arm at the injection site) outcome unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. The reporter did not provide any causality assessments, concomitant medication or treatment information. This case linked to MOD-2021-328755 (patient link).

Other Meds:

Current Illness:

ID: 1755814
Sex: F
Age: 32
State: PA

Vax Date: 09/22/2021
Onset Date:
Rec V Date: 10/02/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: UNK
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Pharyngeal swelling

Symptoms: Feels muscle weakness from her collar bone to her elbow/ radiating from her elbow down to her radius; Injection site feels cool; Injection site white in appearance; Feels atrophied; Injection site firm; Pain is now "migrating to the elbow and it feels atrophied"; Injection site was sore afterwards/ tender; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULAR WEAKNESS (Feels muscle weakness from her collar bone to her elbow/ radiating from her elbow down to her radius), VACCINATION SITE COLDNESS (Injection site feels cool), VACCINATION SITE DISCOLOURATION (Injection site white in appearance), MUSCLE ATROPHY (Feels atrophied) and VACCINATION SITE REACTION (Injection site firm) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 22-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MUSCULAR WEAKNESS (Feels muscle weakness from her collar bone to her elbow/ radiating from her elbow down to her radius), VACCINATION SITE COLDNESS (Injection site feels cool), VACCINATION SITE DISCOLOURATION (Injection site white in appearance), MUSCLE ATROPHY (Feels atrophied), VACCINATION SITE REACTION (Injection site firm), ARTHRALGIA (Pain is now "migrating to the elbow and it feels atrophied") and VACCINATION SITE PAIN (Injection site was sore afterwards/ tender). The patient was treated with EMERGEN C at an unspecified dose and frequency and IBUPROFEN (MOTRIN [IBUPROFEN]) at a dose of Three 800 mg. At the time of the report, MUSCULAR WEAKNESS (Feels muscle weakness from her collar bone to her elbow/ radiating from her elbow down to her radius), VACCINATION SITE COLDNESS (Injection site feels cool), VACCINATION SITE DISCOLOURATION (Injection site white in appearance), MUSCLE ATROPHY (Feels atrophied), VACCINATION SITE REACTION (Injection site firm), ARTHRALGIA (Pain is now "migrating to the elbow and it feels atrophied") and VACCINATION SITE PAIN (Injection site was sore afterwards/ tender) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No relevant concomitant medications were reported. Treatment information also included drinking plenty of water and cool and warm compresses.

Other Meds:

Current Illness:

ID: 1755815
Sex: F
Age: 51
State: NY

Vax Date: 12/26/2020
Onset Date: 01/02/2021
Rec V Date: 10/02/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data: Test Date: 20210118; Test Name: Colonoscopy; Test Result: Inconclusive ; Result Unstructured Data: There was no bleeding, just polyps.

Allergies:

Symptom List: Abdominal pain, Chills, Sleep disorder

Symptoms: rectal bleeding; irregular cycle with heavy bleeding and blood clots; irregular cycle with heavy bleeding and blood clots; polyps; This spontaneous case was reported by an other health care professional and describes the occurrence of RECTAL HAEMORRHAGE (rectal bleeding) and THROMBOSIS (irregular cycle with heavy bleeding and blood clots) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025J20A and 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 26-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Jan-2021, the patient experienced RECTAL HAEMORRHAGE (rectal bleeding) (seriousness criterion medically significant), THROMBOSIS (irregular cycle with heavy bleeding and blood clots) (seriousness criterion medically significant), MENOMETRORRHAGIA (irregular cycle with heavy bleeding and blood clots) and POLYP (polyps). At the time of the report, RECTAL HAEMORRHAGE (rectal bleeding) had not resolved and THROMBOSIS (irregular cycle with heavy bleeding and blood clots), MENOMETRORRHAGIA (irregular cycle with heavy bleeding and blood clots) and POLYP (polyps) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Jan-2021, Colonoscopy: there was no bleeding, just polyps (Inconclusive) There was no bleeding, just polyps.. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication was provided by the reporter. No treatment information was provided by the reporter. It was reported that Patient visited her OBGYN in January who did a PAP on her. In May Patient did a biopsy which was benign, but Patient's uterus was swollen. They can see that is probably where it (the bleeding) is coming from. Patient had to do a sonogram or xray for her uterus. Now it's (the bleeding) still getting worse. Patient's OBGYN has scheduled a DNC procedure to clear out all the blood clots for next month. Patient has been visiting her OBGYN every month, but not this month since there is a plan for the procedure. Patient has not had any previous medications or treatments. Patient is relatively healthy, takes no regular medications, and has no history of diabetes or high blood pressure. This case concerns a 51-year-old, female patient with no relevant medical history, who experienced the unexpected events of Rectal bleeding and menometrorrhagia. The events occurred approximately 8 days after the first dose of Moderna Covid-19 vaccine. The rechallenge was not applicable, as the event happened after the first dose. However, the reported polyps (?cervical polyps) remains a contributory factor. The benefit-risk relationship of Spikevax is not affected by this report. This case was linked to MOD-2021-328732 (Patient Link). Reporter did not allow further contact; Sender's Comments: This case concerns a 51-year-old, female patient with no relevant medical history, who experienced the unexpected events of Rectal bleeding and menometrorrhagia. The events occurred approximately 8 days after the first dose of Moderna Covid-19 vaccine. The rechallenge was not applicable, as the event happened after the first dose. However, the reported polyps (?cervical polyps) remains a contributory factor. The benefit-risk relationship of Spikevax is not affected by this report.

Other Meds:

Current Illness:

ID: 1755816
Sex: U
Age:
State: TX

Vax Date:
Onset Date:
Rec V Date: 10/02/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011J201A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Diarrhoea, Nasal congestion

Symptoms: Past the 30 day beyond use date; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Past the 30 day beyond use date) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Past the 30 day beyond use date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Past the 30 day beyond use date) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. The vials did not undergone previous temperature excursion. The vials were removed from the freezer on 03-Sep-2021 and 17-Sep-2021. Date of administration (if applicable) 03-Sept-2021 and 17-Sept-2021. No concomitant medications were provided. No treatment information was reported.

Other Meds:

Current Illness:

ID: 1755817
Sex: M
Age: 54
State: AR

Vax Date: 08/02/2021
Onset Date: 09/23/2021
Rec V Date: 10/02/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling

Symptoms: expired vaccine administered to patients; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired vaccine administered to patients) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 062E21A and 088D21A) for COVID-19 vaccination. No Medical History information was reported. On 02-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Sep-2021 at 9:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vaccine administered to patients). On 23-Sep-2021, EXPIRED PRODUCT ADMINISTERED (expired vaccine administered to patients) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were provided. No treatment medications were provided. The vial was stored in refrigerator on 14 Sep 2021 and vial was punctured on 22 Sep 2021 at 6 am . The vial did not undergo any temperature excursions. The person who pre - draw the doses took around 6- 10 min, then the syringes were stored in the fridge. This case was linked to MOD-2021-328726 (Patient Link).

Other Meds:

Current Illness:

ID: 1755818
Sex: F
Age:
State: FL

Vax Date:
Onset Date: 09/23/2021
Rec V Date: 10/02/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 039k20a
Dose Series: 1
Vax Route: SYR
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Rash, Urticaria

Symptoms: My sister looked like she's having seizures after she got the 2nd dose of the Moderna Covid-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (My sister looked like she's having seizures after she got the 2nd dose of the Moderna Covid-19 vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Sep-2021, the patient experienced SEIZURE (My sister looked like she's having seizures after she got the 2nd dose of the Moderna Covid-19 vaccine) (seriousness criterion medically significant). At the time of the report, SEIZURE (My sister looked like she's having seizures after she got the 2nd dose of the Moderna Covid-19 vaccine) outcome was unknown. Concomitant medications was not reported. Treatment history was not reported. Patient's vascular surgeon told her that showed that it worked. company Comment: This case concerns a female patient of an unknown age with no previous relevant medical reported, who experienced the unexpected event of seizure. The events occurred on an unknown number of days after the second dose of mRNA-1273. The rechallenge was not applicable since the events happened after the second dose. The benefit-risk relationship of mRNA-1273 is not affected by this report. Further information was requested.; Sender's Comments: This case concerns a female patient of an unknown age with no previous relevant medical reported, who experienced the unexpected event of seizure. The events occurred on an unknown number of days after the second dose of mRNA-1273. The rechallenge was not applicable since the events happened after the second dose. The benefit-risk relationship of mRNA-1273 is not affected by this report. Further information was requested.

Other Meds:

Current Illness:

ID: 1755819
Sex: M
Age: 27
State: AR

Vax Date: 08/02/2021
Onset Date: 09/23/2021
Rec V Date: 10/02/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Blood pressure decreased, Chest pain, Chills, Confusional state, Decreased appetite

Symptoms: Patients were administered "expired vaccines"/ the vial was punctured for more than 24 hours; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients were administered "expired vaccines"/ the vial was punctured for more than 24 hours) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 062E21A and 088D21A) for COVID-19 vaccination. No Medical History information was reported. On 02-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients were administered "expired vaccines"/ the vial was punctured for more than 24 hours). On 23-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Patients were administered "expired vaccines"/ the vial was punctured for more than 24 hours) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were provided. No treatment medications were reported. Date the vial was initially stored in the refrigerator:14Sep2021. Date(s) of administration of vaccine when applicable: 23Sep2021. This case was linked to MOD-2021-328710 (Patient Link).

Other Meds:

Current Illness:

ID: 1755820
Sex: M
Age: 64
State: NJ

Vax Date: 03/18/2021
Onset Date:
Rec V Date: 10/02/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025J20-2A
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Dyspnoea, Fatigue, Feeling abnormal, Head discomfort, Headache

Symptoms: developed some nodules under his arm; afraid of these "nodules"; probably muscle pain; When he touched under his arm, it hurt; This spontaneous case was reported by a consumer and describes the occurrence of NODULE (developed some nodules under his arm), TENSION (afraid of these "nodules"), MYALGIA (probably muscle pain) and AXILLARY PAIN (When he touched under his arm, it hurt) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination. No Medical History information was reported. On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced NODULE (developed some nodules under his arm), TENSION (afraid of these "nodules"), MYALGIA (probably muscle pain) and AXILLARY PAIN (When he touched under his arm, it hurt). At the time of the report, NODULE (developed some nodules under his arm), TENSION (afraid of these "nodules"), MYALGIA (probably muscle pain) and AXILLARY PAIN (When he touched under his arm, it hurt) outcome was unknown. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged. No concomitant medications was reported. No treatment drug details was reported. This case was linked to MOD-2021-328758 (Patient Link).

Other Meds:

Current Illness:

ID: 1755821
Sex: F
Age: 77
State: FL

Vax Date: 01/25/2021
Onset Date: 02/23/2021
Rec V Date: 10/02/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011J20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data: Test Date: 20210223; Test Name: Blood pressure; Result Unstructured Data: blood pressure went up to about 160 over something; Test Date: 20210223; Test Name: Body temperature; Result Unstructured Data: 102?F

Allergies:

Symptom List: Heart rate decreased, Heart rate increased, Hypertension, Injection site pain, Musculoskeletal chest pain

Symptoms: I passed out; my legs were uncontrollable; They were weak; They were shaking; my blood pressure went up to about 160 over something; I had a fever of 102?F; I began vomiting; my body was sore; I had a sore arm at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (I passed out) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 030L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Feb-2021, the patient experienced LOSS OF CONSCIOUSNESS (I passed out) (seriousness criterion medically significant), LIMB DISCOMFORT (my legs were uncontrollable), MUSCULAR WEAKNESS (They were weak), TREMOR (They were shaking), BLOOD PRESSURE INCREASED (my blood pressure went up to about 160 over something), PYREXIA (I had a fever of 102?F), VOMITING (I began vomiting), MYALGIA (my body was sore) and VACCINATION SITE PAIN (I had a sore arm at the injection site). At the time of the report, LOSS OF CONSCIOUSNESS (I passed out), LIMB DISCOMFORT (my legs were uncontrollable), MUSCULAR WEAKNESS (They were weak), TREMOR (They were shaking), BLOOD PRESSURE INCREASED (my blood pressure went up to about 160 over something), PYREXIA (I had a fever of 102?F), VOMITING (I began vomiting), MYALGIA (my body was sore) and VACCINATION SITE PAIN (I had a sore arm at the injection site) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Feb-2021, Blood pressure measurement: went up to about 160 (High) blood pressure went up to about 160 over something. On 23-Feb-2021, Body temperature: 102 (High) 102?F. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications reported by reporter No treatment medications provided by the reporter. 22Feb2021: I got the 2nd dose of the Moderna Covid-19 vaccine around 8p. Company comment:This case concerns a 77-year-old, female patient with no relevant medical history, who experienced the unexpected event of Loss of consciousness. The event occurred approximately 2 days after the second dose of Moderna Covid-19 vaccine. The rechallenge was not applicable as event occurred after the second dose of Moderna COvid-19 vaccine. The benefit-risk relationship of Moderna Covid-19 vaccine is not affected by this report. This case was linked to MOD-2021-328683 (Patient Link).; Sender's Comments: This case concerns a 77-year-old, female patient with no relevant medical history, who experienced the unexpected event of Loss of consciousness. The event occurred approximately 2 days after the second dose of Moderna Covid-19 vaccine. The rechallenge was not applicable as event occurred after the second dose of Moderna COvid-19 vaccine. The benefit-risk relationship of Moderna Covid-19 vaccine is not affected by this report.

Other Meds:

Current Illness:

ID: 1755822
Sex: M
Age: 64
State: NJ

Vax Date: 03/18/2021
Onset Date: 05/01/2021
Rec V Date: 10/02/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025J20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Nausea, Pain, Pain in extremity, Paraesthesia oral, Pyrexia

Symptoms: More than 36 days after the first dose without receiving the second dose, finally got the injection on 06May2021; pain in the injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (pain in the injection site) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 36 days after the first dose without receiving the second dose, finally got the injection on 06May2021) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004C21A. and 038A21A) for COVID-19 vaccination. No Medical History information was reported. On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 36 days after the first dose without receiving the second dose, finally got the injection on 06May2021). In May 2021, the patient experienced INJECTION SITE PAIN (pain in the injection site). At the time of the report, INJECTION SITE PAIN (pain in the injection site) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 36 days after the first dose without receiving the second dose,finally got the injection on 06May2021) had resolved. no concomitant medications are provided. treatment to the events not reported. This case was linked to MOD-2021-328736 (Patient Link).

Other Meds:

Current Illness:

ID: 1755823
Sex: U
Age:
State: MA

Vax Date:
Onset Date:
Rec V Date: 10/02/2021
Hospital:

Vax Type: DTAPHEPBIP
Manufacturer: GLAXOSMITHKLINE BIOLOGICALS
Vax Name: DTAP + HEPB + IPV (PEDIARIX)
Lot:
Dose Series: UNK
Vax Route:
Vax Site: LG

Lab Data:

Allergies:

Symptom List: SARS-CoV-2 antibody test, SARS-CoV-2 test negative

Symptoms: 7 people who turned up with appendicitis; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of APPENDICITIS (7 people who turned up with appendicitis) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced APPENDICITIS (7 people who turned up with appendicitis) (seriousness criterion medically significant). At the time of the report, APPENDICITIS (7 people who turned up with appendicitis) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Reporter also mentioned that there was 7 people who turned up with appendicitis in a research group who received the vaccine (unknown which vaccine). Concomitant product use was not provided by reporter. Treatment information was not provided. Company Comment - This case concerns a patient of unknown age and gender who experienced the serious unexpected event of Appendicitis. The event occurred an unknown time after a COVID-19 vaccine of unknown manufacturer. Re-challenge is unknown as no information about the dose(s) is reported. The Benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report. This case was linked to MOD-2021-313517 (Patient Link).; Sender's Comments: This case concerns a patient of unknown age and gender who experienced the serious unexpected event of Appendicitis. The event occurred an unknown time after a COVID-19 vaccine of unknown manufacturer. Re-challenge is unknown as no information about the dose(s) is reported. The Benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report.

Other Meds:

Current Illness:

ID: 1755824
Sex: F
Age: 42
State: TN

Vax Date: 08/12/2021
Onset Date:
Rec V Date: 10/02/2021
Hospital:

Vax Type: HIBV
Manufacturer: MERCK & CO. INC.
Vax Name: HIB (PEDVAXHIB)
Lot:
Dose Series: UNK
Vax Route:
Vax Site: LG

Lab Data:

Allergies:

Symptom List: Ear pain, Hypoaesthesia

Symptoms: Covid-19 Arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Covid-19 Arm) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006D21A) for COVID-19 vaccination. No Medical History information was reported. On 12-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (Covid-19 Arm). At the time of the report, VACCINATION SITE REACTION (Covid-19 Arm) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported. No treatment medications were reported. This case was linked to MOD-2021-328572 (Patient Link).

Other Meds:

Current Illness:

ID: 1755825
Sex: M
Age: 54
State: NC

Vax Date: 02/26/2021
Onset Date: 07/01/2021
Rec V Date: 10/02/2021
Hospital:

Vax Type: PNC13
Manufacturer: PFIZER\WYETH
Vax Name: PNEUMO (PREVNAR13)
Lot:
Dose Series: UNK
Vax Route:
Vax Site: LG

Lab Data:

Allergies:

Symptom List: Abdominal pain upper, Dizziness, Dysgeusia

Symptoms: Neurological symptoms; slurred speech; possible myasthenia gravis; drooping right eye lid/ then progressively had whole right side of face drooped; having issues with his left side; double vision; his eczema was aggravated; This spontaneous case was reported by a pharmacist and describes the occurrence of MYASTHENIA GRAVIS (possible myasthenia gravis) and FACIAL PARALYSIS (drooping right eye lid/ then progressively had whole right side of face drooped) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In July 2021, the patient experienced ECZEMA (his eczema was aggravated). In September 2021, the patient experienced DISCOMFORT (having issues with his left side) and DIPLOPIA (double vision). On an unknown date, the patient experienced MYASTHENIA GRAVIS (possible myasthenia gravis) (seriousness criterion medically significant), FACIAL PARALYSIS (drooping right eye lid/ then progressively had whole right side of face drooped) (seriousness criterion medically significant), NEUROLOGICAL SYMPTOM (Neurological symptoms) and DYSARTHRIA (slurred speech). The patient was treated with PYRIDOSTIGMINE BROMIDE at an unspecified dose and frequency and PREDNISONE at an unspecified dose and frequency. At the time of the report, MYASTHENIA GRAVIS (possible myasthenia gravis), ECZEMA (his eczema was aggravated), NEUROLOGICAL SYMPTOM (Neurological symptoms), DISCOMFORT (having issues with his left side) and DIPLOPIA (double vision) outcome was unknown, FACIAL PARALYSIS (drooping right eye lid/ then progressively had whole right side of face drooped) had not resolved and DYSARTHRIA (slurred speech) was resolving. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant product was not provided by the reporter. Patient reported that he experienced Eczema, he visited to dermatologist 10 weeks ago due to eczema was aggravated. Six weeks ago he experienced neurological symptoms drooping eye lid, progressively had whole right side of face drooped and slurred speech. He experiencing issues with his left side, eyelid droop was intermittently better, then worse, double vision. His slurred speech had improved. Patient done with on 07-Sep-2021 laboratory test computed tomography scan of the chest/neck area to check his thymus results were not provided. Company comment: This case concerns a 55-year-old male patient with no reported medical history, who experienced the unexpected event of nyastenia gravis-like reaction and facial paralysis. The events occurred on an unknown date after the second dose of mRNA-1273 (Moderna COVID-19 Vaccine). The rechallenge was unknown as information pertaining to the first dose and date of second dose were not disclosed. Causality for the reported event was not provided by the reporter. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.; Sender's Comments: This case concerns a 55-year-old male patient with no reported medical history, who experienced the unexpected event of nyastenia gravis-like reaction and facial paralysis. The events occurred on an unknown date after the second dose of mRNA-1273 (Moderna COVID-19 Vaccine). The rechallenge was unknown as information pertaining to the first dose and date of second dose were not disclosed. Causality for the reported event was not provided by the reporter. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.

Other Meds:

Current Illness:

ID: 1755826
Sex: M
Age: 40
State: CA

Vax Date: 05/27/2021
Onset Date:
Rec V Date: 10/02/2021
Hospital:

Vax Type: RV1
Manufacturer: GLAXOSMITHKLINE BIOLOGICALS
Vax Name: ROTAVIRUS (ROTARIX)
Lot:
Dose Series: 1
Vax Route: PO
Vax Site: MO

Lab Data:

Allergies:

Symptom List: Blood pressure increased, Chest discomfort, Heart rate increased

Symptoms: Patient received his 1st dose and now wants to take his 2nd dose 90 days later; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Patient received his 1st dose and now wants to take his 2nd dose 90 days later) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027C21A) for COVID-19 vaccination. No Medical History information was reported. On 27-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient received his 1st dose and now wants to take his 2nd dose 90 days later). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Patient received his 1st dose and now wants to take his 2nd dose 90 days later) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. The patient wanted to take his 2nd Moderna vaccine 90 days later. No concomitant and treatment medication was reported by the reporter.

Other Meds:

Current Illness:

ID: 1755827
Sex: F
Age: 65
State: GA

Vax Date: 09/18/2021
Onset Date: 09/19/2021
Rec V Date: 10/02/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot: Eh9899
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site erythema, Injection site pruritus, Injection site swelling, Lymph node pain, Lymphadenopathy

Symptoms: internal burning sensation all over her body; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (internal burning sensation all over her body) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination. No Medical History information was reported. On 18-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Sep-2021, the patient experienced BURNING SENSATION (internal burning sensation all over her body). On 19-Sep-2021, BURNING SENSATION (internal burning sensation all over her body) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication was provided. No treatment medication was provided.

Other Meds:

Current Illness:

ID: 1755828
Sex: M
Age:
State: OR

Vax Date: 09/23/2021
Onset Date: 09/23/2021
Rec V Date: 10/02/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Unevaluable event

Symptoms: headaches; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headaches) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination. No Medical History information was reported. On 23-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Sep-2021, the patient experienced HEADACHE (headaches). At the time of the report, HEADACHE (headaches) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant and treatment information were reported by the reporter. Patient had called to report that he had headaches few hours after taking the Moderna vaccine.

Other Meds:

Current Illness:

ID: 1755829
Sex: U
Age:
State: AR

Vax Date: 09/17/2021
Onset Date: 09/17/2021
Rec V Date: 10/02/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Chills, Dizziness, Injection site pain, Myalgia, Pyrexia

Symptoms: Doses administered beyond expiration date; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses administered beyond expiration date) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 17-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses administered beyond expiration date). On 17-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Doses administered beyond expiration date) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medication of the patient was not reported. No treatment information was provided by the reporter. All 4 were second doses and/or third ones. No first doses. The vials were expired while being stored in the freezer. It was unknown if the vial undergo any temperature excursions.

Other Meds:

Current Illness:

ID: 1755830
Sex: F
Age: 43
State: ME

Vax Date: 09/14/2021
Onset Date: 09/14/2021
Rec V Date: 10/02/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011L20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site pain, Pain

Symptoms: Had a tingling cold sensation in the left ear to the left side of her neck; Had a tingling cold sensation in the left ear to the left side of her neck; Pain from elbowto wrist and hand/Pain from elbowto wrist; Sore arm; This spontaneous case was reported by a pharmacist and describes the occurrence of PARAESTHESIA (Had a tingling cold sensation in the left ear to the left side of her neck), FEELING COLD (Had a tingling cold sensation in the left ear to the left side of her neck), PAIN IN EXTREMITY (Pain from elbowto wrist and hand/Pain from elbowto wrist) and PAIN IN EXTREMITY (Sore arm) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination. No Medical History information was reported. On 14-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Sep-2021, the patient experienced PARAESTHESIA (Had a tingling cold sensation in the left ear to the left side of her neck), FEELING COLD (Had a tingling cold sensation in the left ear to the left side of her neck), PAIN IN EXTREMITY (Pain from elbowto wrist and hand/Pain from elbowto wrist) and PAIN IN EXTREMITY (Sore arm). On 16-Sep-2021, PAIN IN EXTREMITY (Sore arm) had resolved. At the time of the report, PARAESTHESIA (Had a tingling cold sensation in the left ear to the left side of her neck), FEELING COLD (Had a tingling cold sensation in the left ear to the left side of her neck) and PAIN IN EXTREMITY (Pain from elbowto wrist and hand/Pain from elbowto wrist) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No relevant concomitant medications were reported. No treatment information was provided.

Other Meds:

Current Illness:

ID: 1755831
Sex: F
Age: 63
State: MI

Vax Date: 03/12/2021
Onset Date:
Rec V Date: 10/02/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data: Test Name: SARS-CoV-2 test; Test Result: Negative ; Result Unstructured Data: Negative

Allergies:

Symptom List: Injection site pain, Menorrhagia

Symptoms: weakened/second shot (it) knocked her out for a month; very bad cough; every bone hurt; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weakened/second shot (it) knocked her out for a month), COUGH (very bad cough) and BONE PAIN (every bone hurt) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037AZ1B and 040A21A) for COVID-19 vaccination. Concurrent medical conditions included Cancer (Stage 4 Cancer) since 2019. On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ASTHENIA (weakened/second shot (it) knocked her out for a month), COUGH (very bad cough) and BONE PAIN (every bone hurt). At the time of the report, ASTHENIA (weakened/second shot (it) knocked her out for a month) had resolved and COUGH (very bad cough) and BONE PAIN (every bone hurt) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medication include chemotherapy. Treatment medication include medication for chest relief to get the mucous out. Patient's cancer spread to kidney ,then to stomach , then to brain around the end of 2020 and beginning of 2021. Now patient is able to walk and got some strength.

Other Meds:

Current Illness: Cancer (Stage 4 Cancer)

ID: 1755832
Sex: F
Age: 59
State: NC

Vax Date: 04/08/2021
Onset Date: 04/08/2021
Rec V Date: 10/02/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025J20A
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Arthralgia, Chills, Headache, Mobility decreased, Myalgia

Symptoms: After 1st dose, she had body aches.; She also had headaches; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (After 1st dose, she had body aches.) and HEADACHE (She also had headaches) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination. Concomitant products included CARVEDILOL (COREG) and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for an unknown indication. On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 08-Apr-2021, the patient experienced MYALGIA (After 1st dose, she had body aches.) and HEADACHE (She also had headaches). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, MYALGIA (After 1st dose, she had body aches.) and HEADACHE (She also had headaches) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. This case was linked to MOD-2021-329004 (Patient Link).; Sender's Comments: This case concerns a 59-year-old, female patient with no relevant medical history, who experienced the expected non-serious events of headache and myalgia. The events occurred on the same day after the first dose of Spikevax (Moderna COVID-19 vaccine). The rechallenge was unknown since the outcome of the events of myalgia and headache is unknown (no specific information if they were resolved after the second dose according to source document narrative). The events are consistent with the current understanding of the mechanism of action of the study medication. The benefit-risk relationship of Spikevax (Moderna COVID-19 vaccine) is not affected by this report.

Other Meds: COREG; ZYRTEC [CETIRIZINE HYDROCHLORIDE]

Current Illness:

ID: 1755833
Sex: F
Age: 61
State: LA

Vax Date: 03/30/2021
Onset Date:
Rec V Date: 10/02/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data: Test Name: COVID-19 virus test; Test Result: Positive ; Result Unstructured Data: Positive

Allergies:

Symptom List: Nausea, Pain in extremity, Pyrexia

Symptoms: mildly sore arm; Positive for Covid-19; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (mildly sore arm) and COVID-19 (Positive for Covid-19) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A21A and 030B21A) for COVID-19 vaccination. The patient's past medical history included Ex-smoker (smoked 35 years), Open heart surgery and Triple vessel bypass graft. Concurrent medical conditions included Amputee, Diabetes and High cholesterol. On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (mildly sore arm) and COVID-19 (Positive for Covid-19). At the time of the report, PAIN IN EXTREMITY (mildly sore arm) and COVID-19 (Positive for Covid-19) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive. She did not experience any side effects except for a mildly sore arm. She recently tested positive for COVID-19 but was completely asymptomatic. She attributed her lack of problems from COVID-19 to vaccine. No concomitant medications were reported. No treatment information was reported.; Sender's Comments: This report concerns a 62 year old female patient with relevant medical history of open heart surgery, diabetes and a past history of smoking who experienced unexpected non-serious events of pain in extremity and COVID-19. It was reported that the patient tested positive for COVID-19, however was asymptomatic. The events occurred after an unknown duration following vaccination with mRNA-1273. The benefit-risk relationship of mRNA-1273 is not affected by this report.

Other Meds:

Current Illness: Amputee; Diabetes; High cholesterol

ID: 1755834
Sex: F
Age:
State:

Vax Date: 03/03/2021
Onset Date: 04/02/2021
Rec V Date: 10/02/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: UNK
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Chills, Fatigue, Headache, Myalgia

Symptoms: Inflammation; now I'm not able to do it; Mainly on the back and lower muscles/Back down; Sometimes in neck and lower part of head; Head pain; my body aches so bad; lower part of head; Extreme muscle pain; Extremely exhausted and fatigued; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 22-Sep-2021 and was forwarded to Moderna on 22-Sep-2021. This spontaneous case was reported by a consumer and describes the occurrence of INFLAMMATION (Inflammation), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (now I'm not able to do it), BACK PAIN (Mainly on the back and lower muscles/Back down), NECK PAIN (Sometimes in neck and lower part of head) and HEADACHE (Head pain) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039A21A and 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Apr-2021, the patient experienced FATIGUE (Extremely exhausted and fatigued). In July 2021, the patient experienced MYALGIA (Extreme muscle pain). On an unknown date, the patient experienced INFLAMMATION (Inflammation), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (now I'm not able to do it), BACK PAIN (Mainly on the back and lower muscles/Back down), NECK PAIN (Sometimes in neck and lower part of head), HEADACHE (Head pain), PAIN (my body aches so bad) and HEADACHE (lower part of head). The patient was treated with IBUPROFEN for Back pain, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) for Back pain, at an unspecified dose and frequency. On 02-Apr-2021, FATIGUE (Extremely exhausted and fatigued) had resolved. At the time of the report, INFLAMMATION (Inflammation) and HEADACHE (Head pain) outcome was unknown and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (now I'm not able to do it), BACK PAIN (Mainly on the back and lower muscles/Back down), NECK PAIN (Sometimes in neck and lower part of head), PAIN (my body aches so bad), HEADACHE (lower part of head) and MYALGIA (Extreme muscle pain) had not resolved. Concomitant and Treatment was not specified. Doctor told patient to take Ibuprofen or Tylenol for the pain, but patient didn't like taking medication. This case was linked to MOD-2021-329014 (Patient Link).

Other Meds:

Current Illness:

ID: 1755835
Sex: M
Age:
State: TX

Vax Date: 09/09/2021
Onset Date: 09/09/2021
Rec V Date: 10/02/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Headache, Heart rate increased, Injection site erythema, Injection site pain, Injection site swelling

Symptoms: Inappropriate schedule of vaccine administered; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 09-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Sep-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On 21-Sep-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No relevant concomitant medications was reported. Treatment information was not provided. Patient was claiming that he was not given a vaccine so another pharmacist gave another dose.

Other Meds:

Current Illness:

ID: 1755836
Sex: M
Age: 22
State: VA

Vax Date: 06/02/2021
Onset Date:
Rec V Date: 10/02/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Nausea

Symptoms: hallucinations; hearing voices; Psychosis\mental problems; paranoia; This spontaneous case was reported by a consumer and describes the occurrence of HALLUCINATION (hallucinations) and HALLUCINATION, AUDITORY (hearing voices) in a 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 02-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HALLUCINATION (hallucinations) (seriousness criterion medically significant), HALLUCINATION, AUDITORY (hearing voices) (seriousness criterion medically significant), PSYCHOTIC DISORDER (Psychosis\mental problems) and PARANOIA (paranoia). At the time of the report, HALLUCINATION (hallucinations), HALLUCINATION, AUDITORY (hearing voices), PSYCHOTIC DISORDER (Psychosis\mental problems) and PARANOIA (paranoia) outcome was unknown. No concomitant and treatment drugs were provided. Company comment: This case concerns a 22 -year-old male patient with no medical history, who experienced the unexpected events of Hallucination, hallucination auditory, Psychotic disorder, Acoustic stimulation tests abnormal and Paranoia. The events occurred after the second dose of mRNA-1273, Moderna COVID-19 Vaccine. Event seriousness assessed as per Regulatory Authority reporting. The rechallenge was not applicable. The reporter did not provide a causality assessment. The benefit-risk relationship of mRNA-1273, Moderna COVID-19 Vaccine is not affected by this report. This case was linked to MOD-2021-329076 (Patient Link).; Sender's Comments: This case concerns a 22 -year-old male patient with no medical history, who experienced the unexpected events of Hallucination, hallucination auditory, Psychotic disorder, Acoustic stimulation tests abnormal and Paranoia. The events occurred after the second dose of mRNA-1273, Moderna COVID-19 Vaccine. Event seriousness assessed as per Regulatory Authority reporting. The rechallenge was not applicable. The reporter did not provide a causality assessment. The benefit-risk relationship of mRNA-1273, Moderna COVID-19 Vaccine is not affected by this report.

Other Meds:

Current Illness:

ID: 1755837
Sex: F
Age: 47
State: VA

Vax Date: 09/13/2021
Onset Date: 09/13/2021
Rec V Date: 10/02/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: UNK
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site pain

Symptoms: COVID arm; injection site hot to the touch; injection site really hard; big round red rash on her injection arm; injection arm itches crazy; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (COVID arm), VACCINATION SITE WARMTH (injection site hot to the touch), VACCINATION SITE INDURATION (injection site really hard), VACCINATION SITE RASH (big round red rash on her injection arm) and VACCINATION SITE PRURITUS (injection arm itches crazy) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 13-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Sep-2021, the patient experienced VACCINATION SITE REACTION (COVID arm), VACCINATION SITE WARMTH (injection site hot to the touch), VACCINATION SITE INDURATION (injection site really hard), VACCINATION SITE RASH (big round red rash on her injection arm) and VACCINATION SITE PRURITUS (injection arm itches crazy). At the time of the report, VACCINATION SITE REACTION (COVID arm) had not resolved and VACCINATION SITE WARMTH (injection site hot to the touch), VACCINATION SITE INDURATION (injection site really hard), VACCINATION SITE RASH (big round red rash on her injection arm) and VACCINATION SITE PRURITUS (injection arm itches crazy) outcome was unknown. No concomitant medications were provided. The patient received both doses of the Moderna COVID-19 vaccine. The patient developed what is called COVID arm. It happened after the second dose and still has it. It was a big round red rash on injection arm that itches crazy, was hot to the touch and really hard. The red mark appeared almost immediately after the second dose. No treatment medications were provided.

Other Meds:

Current Illness:

ID: 1755838
Sex: F
Age:
State: KS

Vax Date: 09/17/2021
Onset Date: 09/01/2021
Rec V Date: 10/02/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site induration, Injection site pruritus, Injection site swelling, Injection site warmth

Symptoms: tingling in fingers/ 3 fingers of right hand; numb/only 3 fingers of right hand; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (tingling in fingers/ 3 fingers of right hand) and HYPOAESTHESIA (numb/only 3 fingers of right hand) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001C21A) for COVID-19 vaccination. No Medical History information was reported. On 17-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In September 2021, the patient experienced PARAESTHESIA (tingling in fingers/ 3 fingers of right hand) and HYPOAESTHESIA (numb/only 3 fingers of right hand). At the time of the report, PARAESTHESIA (tingling in fingers/ 3 fingers of right hand) and HYPOAESTHESIA (numb/only 3 fingers of right hand) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported No treatment information was provided

Other Meds:

Current Illness:

ID: 1755839
Sex: M
Age: 22
State: VA

Vax Date: 06/29/2021
Onset Date: 06/29/2021
Rec V Date: 10/02/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011j20a
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Chills, Dizziness, Nausea, Pain, Tachycardia

Symptoms: Hallucinations; Hearing voices; Paranoia/Paranoid; Psychosis\some mental problems after the first dose but it became worse after the second dose; This spontaneous case was reported by a consumer and describes the occurrence of HALLUCINATION (Hallucinations) and HALLUCINATION, AUDITORY (Hearing voices) in a 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 29-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jun-2021, the patient experienced HALLUCINATION (Hallucinations) (seriousness criterion medically significant), HALLUCINATION, AUDITORY (Hearing voices) (seriousness criterion medically significant), PARANOIA (Paranoia/Paranoid) and PSYCHOTIC DISORDER (Psychosis\some mental problems after the first dose but it became worse after the second dose). At the time of the report, HALLUCINATION (Hallucinations), HALLUCINATION, AUDITORY (Hearing voices), PARANOIA (Paranoia/Paranoid) and PSYCHOTIC DISORDER (Psychosis\some mental problems after the first dose but it became worse after the second dose) outcome was unknown. No concomitant medication was reported. Treatment information was not provided by reporter. It was reported patient will be taken into twenty four hour crisis center on 23Sep2021 for testing to check whether he has Schizophrenia. Company Comment : This case concerns a 22-year-old, male patient with no relevant medical history, who experienced the unexpected events of Psychosis, Hallucination, auditory hallucination and paranoia. The events occurred the same day after the second dose of Spikevax. The rechallenge is positive since the reported stated the patient had some mental problems after the first dose and it became worse after the second dose. The reporter assessed the events as related to the product. The benefit-risk relationship of Spikevax is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a persistent or permanent incapacity This case was linked to MOD-2021-329052 (Patient Link).; Sender's Comments: This case concerns a 22-year-old, male patient with no relevant medical history, who experienced the unexpected events of Psychosis, Hallucination, auditory hallucination and paranoia. The events occurred the same day after the second dose of Spikevax. The rechallenge is positive since the reported stated the patient had some mental problems after the first dose and it became worse after the second dose. The reporter assessed the events as related to the product. The benefit-risk relationship of Spikevax is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a persistent or permanent incapacity

Other Meds:

Current Illness:

ID: 1755840
Sex: U
Age:
State: WI

Vax Date: 09/23/2021
Onset Date: 09/23/2021
Rec V Date: 10/02/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 039K20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Tremor

Symptoms: Administered dose more than 12 hours after vial puncture; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered dose more than 12 hours after vial puncture) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination. No Medical History information was reported. On 23-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered dose more than 12 hours after vial puncture). On 23-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Administered dose more than 12 hours after vial puncture) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant drugs were reported. No treatment drugs were reported. Most recent FOLLOW-UP information incorporated above includes: On 23-Sep-2021: New reporter added.

Other Meds:

Current Illness:

ID: 1755841
Sex: F
Age: 52
State: PA

Vax Date: 02/01/2021
Onset Date:
Rec V Date: 10/02/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025J20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Erythema, Pruritus

Symptoms: flu like symptoms; slight body ache; slight fever; slight chills; This spontaneous case was reported by an other health care professional and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms), MYALGIA (slight body ache), PYREXIA (slight fever) and CHILLS (slight chills) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms), MYALGIA (slight body ache), PYREXIA (slight fever) and CHILLS (slight chills). At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms), MYALGIA (slight body ache), PYREXIA (slight fever) and CHILLS (slight chills) outcome was unknown. mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant product included blood pressure medication and diabetic medication the patient chose not to disclose the names of the medications. No treatment medication information was provided This case was linked to MOD-2021-329305, MOD-2021-329306 (Patient Link).

Other Meds:

Current Illness:

ID: 1755842
Sex: M
Age:
State: OH

Vax Date: 08/13/2021
Onset Date:
Rec V Date: 10/02/2021
Hospital:

Vax Type: UNK
Manufacturer: UNKNOWN MANUFACTURER
Vax Name: VACCINE NOT SPECIFIED (NO BRAND NAME)
Lot:
Dose Series: UNK
Vax Route: SYR
Vax Site: UN

Lab Data:

Allergies:

Symptom List: Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling, Myalgia

Symptoms: at first declined having any side effects then said a headache that resolved on its own; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (at first declined having any side effects then said a headache that resolved on its own) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 13-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEADACHE (at first declined having any side effects then said a headache that resolved on its own). At the time of the report, HEADACHE (at first declined having any side effects then said a headache that resolved on its own) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medication of the patient was not reported. No treatment information was provided by the reporter. This case was linked to MOD-2021-328744 (Patient Link).

Other Meds:

Current Illness:

ID: 1755843
Sex: F
Age: 37
State: IN

Vax Date: 09/23/2021
Onset Date: 09/01/2021
Rec V Date: 10/02/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011J20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Cough, Limb discomfort, Pain, SARS-CoV-2 test positive

Symptoms: A patient received a Moderna vaccine this am from a vial that was punctured at 3pm on 22Sep2021; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A patient received a Moderna vaccine this am from a vial that was punctured at 3pm on 22Sep2021) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 062E21A) for COVID-19 vaccination. No Medical History information was reported. On 23-Sep-2021 at 9:52 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In September 2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (A patient received a Moderna vaccine this am from a vial that was punctured at 3pm on 22Sep2021). In September 2021, EXPIRED PRODUCT ADMINISTERED (A patient received a Moderna vaccine this am from a vial that was punctured at 3pm on 22Sep2021) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication was provided by reporter. No treatment information was provided by reporter. Most recent FOLLOW-UP information incorporated above includes: On 28-Sep-2021: Significant followup received & updated patient demographics and updated suspect details

Other Meds:

Current Illness:

ID: 1755844
Sex: F
Age: 73
State: TX

Vax Date: 01/15/2021
Onset Date: 02/13/2021
Rec V Date: 10/02/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 039K20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Asthenia, Chills, Headache, Myalgia

Symptoms: yappy feeling; felt lousy/not feeling good; headaches; This spontaneous case was reported by a consumer and describes the occurrence of LOGORRHOEA (yappy feeling), MALAISE (felt lousy/not feeling good) and HEADACHE (headaches) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 041L20A) for COVID-19 vaccination. No medical history was provided by the reporter. Concomitant products included ATORVASTATIN, ASPIRIN [ACETYLSALICYLIC ACID], CALCIUM, DILTIAZEM, DULOXETINE, GABAPENTIN, LETROZOLE, LEVOTHYROXINE, MODAFINIL, MELATONIN, INSULIN ASPART (NOVOLOG), OLMESARTAN MEDOXOMIL (BENICAR), OMEPRAZOLE, OXYCODONE, INSULIN GLARGINE (TOUJEO), EICOSAPENTAENOIC ACID ETHYL ESTER (VASCEPA), LIRAGLUTIDE (VICTOZA) and RIVAROXABAN (XARELTO) for an unknown indication. On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Feb-2021, the patient experienced MALAISE (felt lousy/not feeling good) and HEADACHE (headaches). On an unknown date, the patient experienced LOGORRHOEA (yappy feeling). On 13-Feb-2021, MALAISE (felt lousy/not feeling good) and HEADACHE (headaches) had resolved. At the time of the report, LOGORRHOEA (yappy feeling) outcome was unknown. Other concomitant medications include over-the-counter fiber supplement, over-the-counter multivitamin. No treatment medications were reported. This case was linked to MOD-2021-329130 (Patient Link).

Other Meds: ATORVASTATIN; ASPIRIN [ACETYLSALICYLIC ACID]; CALCIUM; DILTIAZEM; DULOXETINE; GABAPENTIN; LETROZOLE; LEVOTHYROXINE; MODAFINIL; MELATONIN; NOVOLOG; BENICAR; OMEPRAZOLE; OXYCODONE; TOUJEO; VASCEPA; VICTOZA; XARELTO

Current Illness:

ID: 1755845
Sex: M
Age: 13
State: HI

Vax Date: 09/23/2021
Onset Date: 09/23/2021
Rec V Date: 10/02/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011J20A
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site erythema, Injection site pain, Injection site swelling

Symptoms: Inappropriate age at vaccine administration; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inappropriate age at vaccine administration) in a 13-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination. No Medical History information was reported. On 23-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Sep-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inappropriate age at vaccine administration). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inappropriate age at vaccine administration) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant and Treatment was not specified.

Other Meds:

Current Illness:

ID: 1755846
Sex: U
Age:
State: CA

Vax Date:
Onset Date:
Rec V Date: 10/02/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot: EK9231
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Chills, Feeling cold, Feeling hot, Myalgia, Pain

Symptoms: 2 other people had the same pain on the side of the breast where they got the shot; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of AXILLARY PAIN (2 other people had the same pain on the side of the breast where they got the shot) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced AXILLARY PAIN (2 other people had the same pain on the side of the breast where they got the shot). At the time of the report, AXILLARY PAIN (2 other people had the same pain on the side of the breast where they got the shot) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. No treatment information was provided.

Other Meds:

Current Illness:

ID: 1755847
Sex: F
Age: 77
State: NY

Vax Date: 03/05/2021
Onset Date: 03/05/2021
Rec V Date: 10/02/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Pain in extremity

Symptoms: colapsed to the ground; it was very serious / very serious reaction; just a little bit of a sore arm / just a tiny tiny of a sore arm; passed out cold with no warning / suddenly she blacked out; Myalgia; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (passed out cold with no warning / suddenly she blacked out), FALL (colapsed to the ground), VACCINATION COMPLICATION (it was very serious / very serious reaction), PAIN IN EXTREMITY (just a little bit of a sore arm / just a tiny tiny of a sore arm) and MYALGIA (Myalgia) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. No Medical History information was reported. On 05-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, the patient experienced MYALGIA (Myalgia). On 06-Mar-2021, the patient experienced LOSS OF CONSCIOUSNESS (passed out cold with no warning / suddenly she blacked out). On an unknown date, the patient experienced FALL (colapsed to the ground), VACCINATION COMPLICATION (it was very serious / very serious reaction) and PAIN IN EXTREMITY (just a little bit of a sore arm / just a tiny tiny of a sore arm). At the time of the report, LOSS OF CONSCIOUSNESS (passed out cold with no warning / suddenly she blacked out), FALL (colapsed to the ground), VACCINATION COMPLICATION (it was very serious / very serious reaction), PAIN IN EXTREMITY (just a little bit of a sore arm / just a tiny tiny of a sore arm) and MYALGIA (Myalgia) outcome was unknown. No concomitant medication was reported. No treatment medication use was reported. This case was linked to MOD-2021-328631.; Sender's Comments: This case concerns a 77-year-old, female patient with no relevant medical history, who experienced the unexpected non-serious event of loss of consciousness among other non-serious adverse events. The event occurred on the same day after the second dose of Spikevax (Moderna COVID-19 vaccine). The rechallenge was not applicable since the event occurred exclusively after the second dose. The age of the patient could be a potential confounder to the event. The benefit-risk relationship of Spikevax (Moderna COVID-19 vaccine) is not affected by this report. Case seriousness downgraded due to lack of evidence of seriousness from a regulatory or clinical standpoint according to source document

Other Meds:

Current Illness:

ID: 1755848
Sex: U
Age:
State: NY

Vax Date:
Onset Date:
Rec V Date: 10/02/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot:
Dose Series: 2
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Abdominal pain upper, Abnormal behaviour, Adverse reaction, Anger, Asthma

Symptoms: adverse event; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a health care professional and describes the occurrence of ADVERSE EVENT (adverse event) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE EVENT (adverse event). At the time of the report, ADVERSE EVENT (adverse event) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant drug information was provided. No treatment information was reported. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1755849
Sex: M
Age: 60
State: WI

Vax Date: 09/20/2021
Onset Date: 09/20/2021
Rec V Date: 10/02/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 039K20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Consciousness fluctuating, Crying, Dry skin, Epistaxis, Headache

Symptoms: Administered dose more than 12 hours after vial puncture; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered dose more than 12 hours after vial puncture) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination. No Medical History information was reported. On 20-Sep-2021 at 3:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Sep-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered dose more than 12 hours after vial puncture). On 20-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Administered dose more than 12 hours after vial puncture) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Patient is taking unknown concomitant medication. Treatment medication was not reported. The vial was initially punctured on Friday 17-Sep-2021 at 8:00 AM. The patient received vaccine 67 hours after the 12 hours expiry. Therefore, the patient received the vaccine 79 hours after the vials was punctured. The vaccine did had any particulates or discoloration. The accumulative time the vaccine was at room temperature was 15 minutes. Most recent FOLLOW-UP information incorporated above includes: On 23-Sep-2021: New reporter added. On 24-Sep-2021: Patient demographics added, added information in I narrative.

Other Meds:

Current Illness:

ID: 1755850
Sex: F
Age:
State: CA

Vax Date:
Onset Date:
Rec V Date: 10/02/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025J20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Hypotonia, Lethargy, Respiratory rate decreased, Screaming, Skin warm

Symptoms: down her arm, and her whole left arm; she had discomfort in the back of her skull; in the back of her neck, she had to go for medical treatment, she is still going through physical therapy; This spontaneous case was reported by a nurse and describes the occurrence of LIMB DISCOMFORT (down her arm, and her whole left arm), HEAD DISCOMFORT (she had discomfort in the back of her skull) and MUSCULOSKELETAL DISCOMFORT (in the back of her neck, she had to go for medical treatment, she is still going through physical therapy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LIMB DISCOMFORT (down her arm, and her whole left arm), HEAD DISCOMFORT (she had discomfort in the back of her skull) and MUSCULOSKELETAL DISCOMFORT (in the back of her neck, she had to go for medical treatment, she is still going through physical therapy). The patient was treated with Physical therapy for Musculoskeletal discomfort. At the time of the report, LIMB DISCOMFORT (down her arm, and her whole left arm), HEAD DISCOMFORT (she had discomfort in the back of her skull) and MUSCULOSKELETAL DISCOMFORT (in the back of her neck, she had to go for medical treatment, she is still going through physical therapy) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications reported. No treatment medications reported. This case was linked to MOD-2021-329313 (Patient Link).

Other Meds:

Current Illness:

ID: 1755851
Sex: F
Age:
State: TN

Vax Date: 03/09/2021
Onset Date:
Rec V Date: 10/02/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 026LZOA
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Vomiting

Symptoms: Covid symptoms; after second vaccine patient had fever for about a week; This spontaneous case was reported by a consumer and describes the occurrence of SUSPECTED COVID-19 (Covid symptoms) and PYREXIA (after second vaccine patient had fever for about a week) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037A21B and 010A21A) for COVID-19 vaccination. The patient's past medical history included Bullous disorder and Acid reflux (esophageal). Concurrent medical conditions included COPD and Emphysema. Concomitant products included ALBUTEROL [SALBUTAMOL] for an unknown indication. On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SUSPECTED COVID-19 (Covid symptoms) and PYREXIA (after second vaccine patient had fever for about a week). At the time of the report, SUSPECTED COVID-19 (Covid symptoms) outcome was unknown and PYREXIA (after second vaccine patient had fever for about a week) had resolved. Concomitant medication also include trilogy once daily. Treatment includes antibiotics and steroid pack Patient also had both lungs altered, a third of each was taken out. Patient stated that her doctor said to her that she had the same Covid symptoms as the doctor had, when the doctor had Covid. The patient had two Covid tests done on 06June2021. Patient stated results were that she had no antibodies.; Sender's Comments: This case concerns a female patient with relevant medical history of COPD, Emphysema, Bullous disorder and Acid reflux (esophageal)., who experienced the unexpected event of suspected COVID 19 and expected event of pyrexia. The event of suspected COVID 19 occurred on an unknown date while pyrexia occurred after the second dose of Moderna COVID-19 Vaccine. Patient stated that her doctor said to her that she had the same Covid symptoms as the doctor had, when the doctor had Covid. The patient had two Covid tests done and results were that she had no antibodies. The rechallenge was not applicable. Based on the current available information, the mRNA-1273 does not contain a virus capable of causing COVID-19 infection after vaccination. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.

Other Meds: ALBUTEROL [SALBUTAMOL]

Current Illness:

ID: 1755852
Sex: U
Age:
State: FL

Vax Date:
Onset Date:
Rec V Date: 10/02/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 037K20A
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Headache, Limb discomfort, Nasal congestion

Symptoms: Reactions within 1-2 days; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of VACCINATION COMPLICATION (Reactions within 1-2 days) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Reactions within 1-2 days). At the time of the report, VACCINATION COMPLICATION (Reactions within 1-2 days) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant and treatment medications were reported.

Other Meds:

Current Illness:

ID: 1755853
Sex: M
Age: 70
State: WA

Vax Date: 07/29/2021
Onset Date:
Rec V Date: 10/02/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Back pain, Cold sweat, Headache, Nausea, Vomiting

Symptoms: Shortly after receiving 2nd dose, his lungs cleared up, He doesnt need to use stabilizer,doing good with lungs,could breathee really gooddoesnt have any gurgling in lungs; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (Shortly after receiving 2nd dose, his lungs cleared up, He doesnt need to use stabilizer,doing good with lungs,could breathee really gooddoesnt have any gurgling in lungs) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 062E21A and 059E21A) for COVID-19 vaccination. No Medical History information was reported. Concomitant products included MIRABEGRON (MYRBETRIQ) and SERTRALINE for an unknown indication. On 29-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (Shortly after receiving 2nd dose, his lungs cleared up, He doesnt need to use stabilizer,doing good with lungs,could breathee really gooddoesnt have any gurgling in lungs). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (Shortly after receiving 2nd dose, his lungs cleared up, He doesnt need to use stabilizer,doing good with lungs,could breathee really gooddoesnt have any gurgling in lungs) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No treatment medication was reported.

Other Meds: MYRBETRIQ; SERTRALINE

Current Illness:

ID: 1755854
Sex: M
Age: 65
State: CO

Vax Date: 03/10/2021
Onset Date: 03/01/2021
Rec V Date: 10/02/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025j20-2A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site swelling, Limb discomfort

Symptoms: patient was mentally foggy/mental fogginess; patient experienced headaches; chills; patient experienced fever; uncomfortable flu-like symptoms; patient started to feel off; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (uncomfortable flu-like symptoms), DEPRESSED MOOD (patient started to feel off), FEELING ABNORMAL (patient was mentally foggy/mental fogginess), HEADACHE (patient experienced headaches) and CHILLS (chills) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 10-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (uncomfortable flu-like symptoms), FEELING ABNORMAL (patient was mentally foggy/mental fogginess), HEADACHE (patient experienced headaches), CHILLS (chills) and PYREXIA (patient experienced fever). In March 2021, the patient experienced DEPRESSED MOOD (patient started to feel off). In March 2021, INFLUENZA LIKE ILLNESS (uncomfortable flu-like symptoms), DEPRESSED MOOD (patient started to feel off), FEELING ABNORMAL (patient was mentally foggy/mental fogginess), HEADACHE (patient experienced headaches), CHILLS (chills) and PYREXIA (patient experienced fever) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. no concomitant medications are provided. treatment to the events not reported. Patient gave a more detailed description: second shot was administered at 9 o'clock. By 11 o'clock patient started to feel off, by 12 o'clock patient had a headache, by 1 o'clock patient had chills, headache, and uncomfortable flu-like symptoms. As patient said, these lasted around 36 hours, and the mental fogginess for 8 hours more. This case was linked to MOD-2021-329486 (Patient Link).

Other Meds:

Current Illness:

ID: 1755855
Sex: M
Age: 72
State: MD

Vax Date: 01/25/2021
Onset Date: 09/01/2021
Rec V Date: 10/02/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Patient tested negative 3 times.

Allergies:

Symptom List: Chills, Diarrhoea, Fatigue, Feeling abnormal, Headache

Symptoms: sore arm; low grade fever; fatigue; chest congestion; This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (chest congestion), VACCINATION SITE PAIN (sore arm), PYREXIA (low grade fever) and FATIGUE (fatigue) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 050E21A, 013L20A and 025J20A) for COVID-19 vaccination. No Medical History information was reported. On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Sep-2021, the patient experienced VACCINATION SITE PAIN (sore arm). In September 2021, the patient experienced CHEST DISCOMFORT (chest congestion), PYREXIA (low grade fever) and FATIGUE (fatigue). At the time of the report, CHEST DISCOMFORT (chest congestion), VACCINATION SITE PAIN (sore arm), PYREXIA (low grade fever) and FATIGUE (fatigue) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Patient tested negative 3 times.. The patient was immunocompromised. No concomitant medications were provided. No treatment medications were provided.

Other Meds:

Current Illness:

ID: 1755856
Sex: F
Age: 35
State: SC

Vax Date: 09/17/2021
Onset Date: 09/17/2021
Rec V Date: 10/02/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 037K20A
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Hot flush, Myalgia, Nausea, Tension headache

Symptoms: nauseous; her entire body is very itchy; left arm (where the vaccine was administered) became very itchy/entire body; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (left arm (where the vaccine was administered) became very itchy/entire body) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 17-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Sep-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PRURITUS (left arm (where the vaccine was administered) became very itchy/entire body) (seriousness criterion medically significant). On 20-Sep-2021, the patient experienced NAUSEA (nauseous) and PRURITUS (her entire body is very itchy). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Vaccination site pruritus, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PRURITUS (left arm (where the vaccine was administered) became very itchy/entire body), NAUSEA (nauseous) and PRURITUS (her entire body is very itchy) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication information was provided. It was reported that within 3 minutes after the administration of the vaccine, the patient's left arm (where the vaccine was administered) became very itchy. She was advised by the pharmacist to go tot the emergency room (ER) where she was given Benadryl shot and was advised to continue Benadryl. As of today, her entire body is very itchy and she is still nauseous (started last 20Sep2021). The patient wants to know if she should proceed with the 2nd dose because her pharmacist told her not to get the 2nd dose while the ER doctor told her to have it. Company comment: This case concerns a 35-year-old, female patient with no previous relevant medical history, who experienced the unexpected event of vaccination site pruritus. The event occurred on the same day after the first dose of mRNA-1273 (Moderna COVID-19 Vaccine). The rechallenge was not applicable since only information about the first dose was disclosed. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.; Sender's Comments: This case concerns a 35-year-old, female patient with no previous relevant medical history, who experienced the unexpected event of vaccination site pruritus. The event occurred on the same day after the first dose of mRNA-1273 (Moderna COVID-19 Vaccine). The rechallenge was not applicable since only information about the first dose was disclosed. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am