VAERS 2021 Database www.vaers.hhs.gov

Main Page | All 2021 Deaths | Videos
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: 1736198
Sex: M
Age:
State: WI

Vax Date:
Onset Date: 09/17/2021
Rec V Date: 09/27/2021
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: SHINGLES; This spontaneous report received from a patient concerned a 72 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: hypertension. The patient experienced drug allergy when treated with acetylsalicylic acid for drug used for unknown indication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982, and expiry: UNKNOWN) dose was not reported, administered on 03-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 17-SEP-2021, the patient experienced shingles. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from shingles. This report was non-serious.

Other Meds:

Current Illness: Hypertension

ID: 1736199
Sex: M
Age:
State:

Vax Date:
Onset Date: 09/23/2021
Rec V Date: 09/27/2021
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: DIZZINESS; This spontaneous report received from a consumer concerned a 52 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1816027, and expiry: UNKNOWN) dose was not reported, administered on 23-SEP-2021 13:30 for prophylactic vaccination. No concomitant medications were reported. On 23-SEP-2021, the patient experienced dizziness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from dizziness. This report was non-serious.

Other Meds:

Current Illness:

ID: 1736200
Sex: F
Age:
State: FL

Vax Date:
Onset Date: 09/01/2021
Rec V Date: 09/27/2021
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: EXPIRED VACCINE USED; This spontaneous report received from a health care professional concerned an adult female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: 19-SEP-2021) dose was not reported, administered on SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On SEP-2021, the patient experienced expired vaccine used. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine used was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1736201
Sex: M
Age:
State: OH

Vax Date:
Onset Date: 09/22/2021
Rec V Date: 09/27/2021
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: EXPIRED VACCINE USED; This spontaneous report received from a health care professional concerned a 60 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 202A21A, expiry: 21-SEP-2021) dose was not reported, administered on 22-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 22-SEP-2021, the patient experienced expired vaccine used. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine used was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1736202
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/27/2021
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 erythema, Injection site pruritus, Injection site swelling, Injection site warmth

Symptoms: your vaccine is injuring people; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (your vaccine is injuring people) in a patient of an unknown age and gender 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (your vaccine is injuring people). At the time of the report, VACCINATION COMPLICATION (your vaccine is injuring people) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medications were not reported. Treatment details not provided.

Other Meds:

Current Illness:

ID: 1736203
Sex: F
Age: 28
State: PA

Vax Date: 09/15/2021
Onset Date: 09/15/2021
Rec V Date: 09/27/2021
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: a pregnant patient was administered Fluzone, with no reported adverse event; Initial information received on 15-Sep-2021 regarding an unsolicited valid non-serious case from a consumer/non-health professional. This case involves a 28 years old female pregnant patient who was vaccinated with INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] [exposure during pregnancy]. Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The reported event occurred at 31 weeks of pregnancy and the patient was exposed to INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] at 31 weeks of pregnancy, during third pregnancy trimester for the vaccine. The date of last menstrual period was reported as 14-Feb-2021. The estimated due date was 08-Nov-2021. It was unknown if the patient had any medical history, concomitant disease or risk factor. The patient's past medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. On 15-Sep-2021, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number: UT7325QA; expiry date: 30-Jun-2021; Form: suspension for injection) via intramuscular route in unknown administration site for prophylactic vaccination. It was a case of vaccine exposure during pregnancy (same day latency). It was unknown if the patient experienced any additional symptoms/events. It was unknown if there were laboratory data/results available. At time of reporting, the outcome was unknown for the reported event. Additionally, at time of reporting, the outcome of the pregnancy was unknown.

Other Meds:

Current Illness:

ID: 1736205
Sex: F
Age:
State: WI

Vax Date: 09/16/2021
Onset Date: 09/16/2021
Rec V Date: 09/27/2021
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: A 6 month old patient was vaccinated with Fluzone High dose quadrivalent, with no AE; A 6 month old patient was vaccinated with Fluzone High dose quadrivalent, with no AE; Initial information regarding an unsolicited valid non-serious case was received from other health care professional via consumer/non-health care professional via Medical Information (Reference number- 00772888) and transmitted to Sanofi on 16-Sep-2021. This case involves a 6-month-old female patient who received INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (product administered to patient of inappropriate age and Accidental overdose). Medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. On 16-Sep-2021, the patient received a 0.7 ml dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ733AB, expiry: 30-Jun-2022) via unknown route in unknown administration site for prophylactic vaccination. It was a case of an actual medication error due to Inappropriate age at vaccine administration and Overdose accidental (latency same day). It was reported "Caller reported by accident, a FLUZONE HIGH-DOSE VACCINE was given to a 6 month old child. Caller wanted to know what she should do from here. Caller states that FLUZONE HIGH DOSE QUADRIVALENT 21-22was given to a six month old at a different location. "What should we watch for safety and side effects?" No adverse event was reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.

Other Meds:

Current Illness:

ID: 1736209
Sex: F
Age:
State: OH

Vax Date:
Onset Date:
Rec V Date: 09/27/2021
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: inadvertently given a dose of Fluzone Quadrivalent instead of Fluzone High-Dose with no adverse event; Initial information regarding an unsolicited valid non-serious case was received from Pharmacist via Medical Information (Reference number- 00774841) and transmitted to Sanofi on 17-Sep-2021. This case involves a 65 years old female patient who was inadvertently given a dose of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] instead of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (wrong product administered). The patient's medical history, past medical treatment(s), vaccination(s), concomitant medication and family history were not provided. On an unknown date, the patient received a 0.5 mL (once, total) dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number and expiry date were not reported) instead of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE via unknown route at an unknown administration site for prophylactic vaccination (wrong product administered). It was reported "He inquired whether the patient could receive a dose of Fluzone HD. Second: He requested the stability letter for Fluzone Quadrivalent, Fluzone High-Dose and Flublok." It was an actual medication error case due to wrong vaccine administered (latency: same day). At the time of reporting, the patient experienced no adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. There will be no information on the batch number for this case.

Other Meds:

Current Illness:

ID: 1736213
Sex: U
Age:
State: OH

Vax Date:
Onset Date:
Rec V Date: 09/27/2021
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: Abdominal pain, Chills, Sleep disorder

Symptoms: The caller stated that most of the medication came out of the syringe and did not go into the patient, with no adverse event; the medication came out of the syringe with no adverse event; Initial information received on 20-Sep-2021 regarding an unsolicited valid non-serious case from pharmacist and consumer/ non healthcare professional via Media Information (under reference 00776928). This case involves a patient (unknown age and gender) who was vaccinated with QUADRIVALENT INFLUENZA VACCINE (FLUZONE HIGH-DOSE QUADRIVALENT), but most of the medication came out of the syringe and did not go into the patient (underdose and syringe issue). The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. On an unknown date, the patient received a dose of suspect FLUZONE HIGH-DOSE QUADRIVALENT (lot number and expiration date were not reported) via unknown route in an unknown administration site for prophylactic vaccination. It was an actual medication error due to vaccine underdose and syringe leak (same day latency). It was reported "The caller stated that a call back on 21 SEP 2021 is okay as she is ending her shift for today. The caller stated that she administered a FLUZONE HIGH DOSE QUADRIVALENT injection to a patient today. The caller stated that most of the medication came out of the syringe and did not go into the patient. The caller would like to know if the patient must be revaccinated." At time of reporting, no adverse event was reported and the outcome was unknown for the reported event. There will be no information available on the batch number for this case. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.

Other Meds:

Current Illness:

ID: 1736216
Sex: F
Age: 16
State: OH

Vax Date: 09/17/2021
Onset Date: 09/17/2021
Rec V Date: 09/27/2021
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: 16 year old patient was inadvertently administered FLUBLOK QUADRIVALENT/ no AE; Initial information received on 21-Sep-2021 regarding an unsolicited valid non-serious case received from a pharmacist and consumer/non-healthcare professional via call center via Agency (Reference number- 00779084). This case involves a 16-year-old female patient who received INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (Product administered to patient of inappropriate age). The patient's medical history, past medical treatments, vaccinations, concomitant medication and family history were not provided. On 17-Sep-2021, the patient received a 0.5 mL dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot number: QFAA2103 and expiry date: 25-May-2022) via an intramuscular route at an unknown administration site for prophylactic vaccination. It was an actual medication error case due to inappropriate age at vaccine administration (latency: same day). It was reported "Call received from Pharmacist reporting a 16 year old patient was inadvertently administered FLUBLOK QUADRIVALENT. Caller with question on whether we have any safety information on administering FLUBLOK QUADRIVALENT to a pediatric patient." At the time of reporting, no adverse event was reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.

Other Meds:

Current Illness:

ID: 1736217
Sex: U
Age:
State: FL

Vax Date:
Onset Date:
Rec V Date: 09/27/2021
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: Fluzone Quad was given to a patient instead of the recommended Fluzone HD with no reported adverse event; Initial information received on 21-Sep-2021 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves elderly (patient was over the age of 65) and unknown gender for patient whom INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] was given to a patient instead of the recommended INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HD] (wrong product administered). The patient medical history, medical treatment(s), vaccination(s), concomitant medication, and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE [lot number and expiry date not reported] via an unknown route in unknown administration site prophylactic vaccination. On an unknown date, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [lot number and expiry date not reported] via an unknown route in unknown administration site prophylactic vaccination. It was case of actual medication error due to wrong product administered (Latency: on the same day). Details of laboratory data not reported. At the time of report no adverse event was reported. At time of reporting, the outcome was unknown for the event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. There will be no information available on the batch number for this case.

Other Meds:

Current Illness:

ID: 1736240
Sex: F
Age: 39
State: AR

Vax Date: 09/13/2021
Onset Date: 09/14/2021
Rec V Date: 09/27/2021
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: Light headed when standing, rapid heart beat ,short of breath; Light headed when standing, rapid heart beat ,short of breath; Light headed when standing, rapid heart beat ,short of breath; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Light headed when standing, rapid heart beat ,short of breath), DIZZINESS (Light headed when standing, rapid heart beat ,short of breath) and TACHYCARDIA (Light headed when standing, rapid heart beat ,short of breath) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Lumbar spondylosis, COPD and Migraine. On 13-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Sep-2021, the patient experienced DYSPNOEA (Light headed when standing, rapid heart beat ,short of breath), DIZZINESS (Light headed when standing, rapid heart beat ,short of breath) and TACHYCARDIA (Light headed when standing, rapid heart beat ,short of breath). At the time of the report, DYSPNOEA (Light headed when standing, rapid heart beat ,short of breath), DIZZINESS (Light headed when standing, rapid heart beat ,short of breath) and TACHYCARDIA (Light headed when standing, rapid heart beat ,short of breath) had not resolved. No concomitant medications were reported. Treatment information was not provided. The patient while standing heart races got light headed and experienced shortness of breath on walk. She was not sure whether the side effects were serious.

Other Meds:

Current Illness: COPD; Lumbar spondylosis; Migraine.

ID: 1736246
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/27/2021
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: got the shot but did get shingles/suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient got the Shingles shot but did get shingles, but not bad. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation for shingles were unknown at the time of reporting.

Other Meds:

Current Illness:

ID: 1736247
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/27/2021
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: suspected vaccination failure/have the vaccine but still got Shingles; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. Additional details provided were as follows: The case was reported by patient himself/herself. The age at vaccination was not reported. The patient received the shot of Shingles vaccine and still got hit will shingles. Follow-up would not be possible as no contact details available. The case is considered as suspected vaccination failure since the details regarding completion of vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.

Other Meds:

Current Illness:

ID: 1736252
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/27/2021
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: Heart rate decreased, Heart rate increased, Hypertension, Injection site pain, Musculoskeletal chest pain

Symptoms: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID 19 INFECTION; This spontaneous report received from a consumer via a company representative concerned a patient of unspecified age, sex, race, and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration, and batch number were not reported) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced suspected clinical vaccination failure, and suspected covid 19 infection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid 19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint.; Sender's Comments: V0: 20210945662-COVID-19 VACCINE AD26.COV2.S-Suspected clinical vaccination failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS

Other Meds:

Current Illness:

ID: 1736253
Sex: M
Age: 23
State: MO

Vax Date: 08/12/2021
Onset Date: 09/10/2021
Rec V Date: 09/27/2021
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: Nurse inadvertently injected a Moderna Covid-19 vaccine to a patient as a second dose who had received the Pfizer Vaccine as their first dose; This spontaneous case was reported by a nurse and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (Nurse inadvertently injected a Moderna Covid-19 vaccine to a patient as a second dose who had received the Pfizer Vaccine as their first dose) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016C21A) for COVID-19 vaccination. Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination. No Medical History information was reported. On 12-Aug-2021, the patient received first dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On 10-Sep-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 received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 10-Sep-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Nurse inadvertently injected a Moderna Covid-19 vaccine to a patient as a second dose who had received the Pfizer Vaccine as their first dose). On 10-Sep-2021, INTERCHANGE OF VACCINE PRODUCTS (Nurse inadvertently injected a Moderna Covid-19 vaccine to a patient as a second dose who had received the Pfizer Vaccine as their first dose) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments. No concomitant medications were reported. No treatment details were reported. Patient did not report any adverse events with both Pfizer and Moderna vaccine. Most recent FOLLOW-UP information incorporated above includes: On 15-Sep-2021: Follow up added- Pfizer start date was added.; Sender's Comments: This case concerns a 23 year-old male patient with no reported medical history, who experienced the unexpected event of Interchange of vaccine products. The event occurred on the same day as the first dose of Moderna COVID-19 vaccine, which followed a previous dose of Pfizer COVID-19 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.

Other Meds:

Current Illness:

ID: 1736254
Sex: F
Age:
State: PA

Vax Date: 02/01/2021
Onset Date:
Rec V Date: 09/27/2021
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: Giant lump pumped out from underneath arm, it was a lymph node/ Had a giant lymph node pop out under arm; Fever/ High fever; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Giant lump pumped out from underneath arm, it was a lymph node/ Had a giant lymph node pop out under arm) and PYREXIA (Fever/ High fever) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included COVID-19 (Recovered from COVID). In February 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 LYMPHADENOPATHY (Giant lump pumped out from underneath arm, it was a lymph node/ Had a giant lymph node pop out under arm) and PYREXIA (Fever/ High fever). At the time of the report, LYMPHADENOPATHY (Giant lump pumped out from underneath arm, it was a lymph node/ Had a giant lymph node pop out under arm) and PYREXIA (Fever/ High fever) had resolved. mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged. No concomitant medication was provided. No treatment medication was provided. The patient had fever and was close to be put in hospital and it got recovered. This case was linked to MOD-2021-052537, MOD-2021-325988 (Patient Link). Reporter did not allow further contact Most recent FOLLOW-UP information incorporated above includes: On 20-Sep-2021: Follow-up received: Patient demographic details (age and gender) and suspect start date was updated.

Other Meds:

Current Illness:

ID: 1736255
Sex: M
Age: 12
State: NC

Vax Date: 09/13/2021
Onset Date: 09/13/2021
Rec V Date: 09/27/2021
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: 12 year old patient receiving a dose of the Moderna COVID19 vaccine; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (12 year old patient receiving a dose of the Moderna COVID19 vaccine) in a 12-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 062e21a) for COVID-19 vaccination. No Medical History information was reported. On 13-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Sep-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (12 year old patient receiving a dose of the Moderna COVID19 vaccine). On 13-Sep-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (12 year old patient receiving a dose of the Moderna COVID19 vaccine) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medications were not reported by the reporter Treatment drugs were not reported by the reporter; Sender's Comments: This case concerns a 12 year-old male patient with no reported medical history, who experienced the unexpected event of Product administered to patient of inappropriate age. The event occurred on the day of the first dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.

Other Meds:

Current Illness:

ID: 1736256
Sex: U
Age:
State:

Vax Date: 05/01/2021
Onset Date:
Rec V Date: 09/27/2021
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: Missed second dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed second dose) 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. In 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 (Missed second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Missed second dose) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medication was not provided by the reporter. Treatment medication was not provided.; Sender's Comments: This case concerns a patient of unknown age or gender, with no reported medical history, who experienced the unexpected event of Product dose omission issue. The event occurred an unknown number of days after the first dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.

Other Meds:

Current Illness:

ID: 1736257
Sex: F
Age: 51
State: GA

Vax Date: 09/09/2021
Onset Date: 09/10/2021
Rec V Date: 09/27/2021
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: This spontaneous case reported by a consumer, describes the occurrence of pyrexia (fever) and dyspnea (difficulty breathing) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. Concomitant products included Eliquis (apixaban). On Sep 9, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Sep 10, 2021, patient experienced pyrexia (fever). On Sep 15, 2021, patient experienced dyspnea (difficulty breathing). On Sep 11, 2021, pyrexia (fever) resolved. At the time of the report, dyspnea (difficulty breathing) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No treatment medication reported.

Other Meds: Eliquis

Current Illness:

ID: 1736258
Sex: F
Age: 69
State: NC

Vax Date: 02/02/2021
Onset Date: 09/09/2021
Rec V Date: 09/27/2021
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: she was very faint; Diarrhea; weakness; had a fever of 100 degrees; headache; Nausea; Loss use of right hand; sore arm; it was very painful like some stepped on her right hand, hand started hurting and continued to get worse; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (it was very painful like some stepped on her right hand, hand started hurting and continued to get worse), DIZZINESS (she was very faint), MOTOR DYSFUNCTION (Loss use of right hand), DIARRHOEA (Diarrhea) and ASTHENIA (weakness) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014FZ1A, 012M20A and 003A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Penicillin allergy, Allergy to nuts, Fish allergy, Fruit allergy and Ulcerative colitis (In remission due to Entyvio infusions) since May 2019. Concomitant products included VEDOLIZUMAB (ENTYVIO), PREGNENOLONE, ESTROGEN NOS;TESTOSTERONE and PROGESTERONE for an unknown indication. On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Sep-2021 at 10:15 AM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Sep-2021, the patient experienced PAIN IN EXTREMITY (it was very painful like some stepped on her right hand, hand started hurting and continued to get worse) and VACCINATION SITE PAIN (sore arm). On 09-Sep-2021 at 4:00 PM, the patient experienced MOTOR DYSFUNCTION (Loss use of right hand). On an unknown date, the patient experienced DIZZINESS (she was very faint), DIARRHOEA (Diarrhea), ASTHENIA (weakness), PYREXIA (had a fever of 100 degrees), HEADACHE (headache) and NAUSEA (Nausea). On 10-Sep-2021, PAIN IN EXTREMITY (it was very painful like some stepped on her right hand, hand started hurting and continued to get worse), MOTOR DYSFUNCTION (Loss use of right hand) and VACCINATION SITE PAIN (sore arm) had resolved. At the time of the report, DIZZINESS (she was very faint), DIARRHOEA (Diarrhea), ASTHENIA (weakness), PYREXIA (had a fever of 100 degrees), HEADACHE (headache) and NAUSEA (Nausea) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medication included Thyroid, Desiccated taken daily orally started in year 2011 No treatment information was not provided. Patient reported to have taken an Entyvio infusion earlier that same week on 9/7/2021. Most recent FOLLOW-UP information incorporated above includes: On 21-Sep-2021: Follow up received on 21-09-2021 contains significant information: Event information, Concomitant medication, Patient history updated, Batch number updated

Other Meds: ENTYVIO; PREGNENOLONE; ESTROGEN NOS;TESTOSTERONE; PROGESTERONE

Current Illness: Allergy to nuts; Fish allergy; Fruit allergy; Penicillin allergy; Ulcerative colitis (In remission due to Entyvio infusions)

ID: 1736259
Sex: F
Age: 65
State: NC

Vax Date: 09/02/2021
Onset Date:
Rec V Date: 09/27/2021
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: hasn't felt very well; a knot on the arm which is swollen and red; a knot on the arm which is swollen; a knot on the arm which is swollen and red; a real bad headache; a fever; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (hasn't felt very well), SKIN MASS (a knot on the arm which is swollen and red), PERIPHERAL SWELLING (a knot on the arm which is swollen), ERYTHEMA (a knot on the arm which is swollen and red) and HEADACHE (a real bad headache) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 02-Sep-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 MALAISE (hasn't felt very well), SKIN MASS (a knot on the arm which is swollen and red), PERIPHERAL SWELLING (a knot on the arm which is swollen), ERYTHEMA (a knot on the arm which is swollen and red), HEADACHE (a real bad headache) and PYREXIA (a fever). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, MALAISE (hasn't felt very well), SKIN MASS (a knot on the arm which is swollen and red), PERIPHERAL SWELLING (a knot on the arm which is swollen), ERYTHEMA (a knot on the arm which is swollen and red), HEADACHE (a real bad headache) and PYREXIA (a fever) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication were reported. Patient had a Flu shot on her right arm. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1736260
Sex: U
Age: 28
State: GA

Vax Date: 06/09/2021
Onset Date:
Rec V Date: 09/27/2021
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: Received the first dose on 09JUN2021; This case was received via Regulatory Authority (Reference number: US-irms-MOD21-144332) on 16-Sep-2021 and was forwarded to Moderna on 16-Sep-2021. This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Received the first dose on 09JUN2021) in a 28-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020C21A) for COVID-19 vaccination. No Medical History information was reported. On 09-Jun-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 PRODUCT DOSE OMISSION ISSUE (Received the first dose on 09JUN2021). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Received the first dose on 09JUN2021) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medications was not reported. Treatment medications was not reported. Most recent FOLLOW-UP information incorporated above includes: On 20-Sep-2021: Follow up received confirms that patient did not experienced any adverse events so the case is invalid.

Other Meds:

Current Illness:

ID: 1736261
Sex: F
Age: 0
State: FL

Vax Date: 08/17/2021
Onset Date:
Rec V Date: 09/27/2021
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: Heat at the site of the vaccination; Itchiness at the site of the vaccination; Reddness at the site of the vaccination; Swelling at the site of the vaccination; Severe Pain at the site of the vaccination; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Heat at the site of the vaccination), VACCINATION SITE PRURITUS (Itchiness at the site of the vaccination), VACCINATION SITE ERYTHEMA (Reddness at the site of the vaccination), VACCINATION SITE SWELLING (Swelling at the site of the vaccination) and VACCINATION SITE PAIN (Severe Pain at the site of the vaccination) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 050E21A and 003C21A) for COVID-19 vaccination. Concurrent medical conditions included Hypothyroidism. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for Hypothyroidism. On 17-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Sep-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 VACCINATION SITE WARMTH (Heat at the site of the vaccination), VACCINATION SITE PRURITUS (Itchiness at the site of the vaccination), VACCINATION SITE ERYTHEMA (Reddness at the site of the vaccination), VACCINATION SITE SWELLING (Swelling at the site of the vaccination) and VACCINATION SITE PAIN (Severe Pain at the site of the vaccination). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (Heat at the site of the vaccination), VACCINATION SITE PRURITUS (Itchiness at the site of the vaccination), VACCINATION SITE ERYTHEMA (Reddness at the site of the vaccination), VACCINATION SITE SWELLING (Swelling at the site of the vaccination) and VACCINATION SITE PAIN (Severe Pain at the site of the vaccination) outcome was unknown. Treatment also included ice pack for adverse events. This case was linked to MOD-2021-322203 (Patient Link).

Other Meds: SYNTHROID.

Current Illness: Hypothyroidism.

ID: 1736262
Sex: F
Age: 69
State: FL

Vax Date: 01/07/2021
Onset Date:
Rec V Date: 09/27/2021
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: Injection site pain, Menorrhagia

Symptoms: headache; nausea; chills; sensitive eyes; slept for 3-4 hours.; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), NAUSEA (nausea), CHILLS (chills), PHOTOPHOBIA (sensitive eyes) and INSOMNIA (slept for 3-4 hours.) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination. Concomitant products included VERAPAMIL HYDROCHLORIDE for an unknown indication. On 07-Jan-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 (headache), NAUSEA (nausea), CHILLS (chills), PHOTOPHOBIA (sensitive eyes) and INSOMNIA (slept for 3-4 hours.). At the time of the report, HEADACHE (headache), NAUSEA (nausea), CHILLS (chills), PHOTOPHOBIA (sensitive eyes) and INSOMNIA (slept for 3-4 hours.) had resolved. 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. No treatment drug information was provided. This case was linked to MOD-2021-322601 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 18-Sep-2021: significant follow up ammended- Events added.

Other Meds: VERAPAMIL HYDROCHLORIDE.

Current Illness:

ID: 1736263
Sex: F
Age: 58
State: CA

Vax Date: 09/17/2021
Onset Date: 09/18/2021
Rec V Date: 09/27/2021
Hospital:

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

Lab Data: Test Date: 20210918; Test Name: Increase in white count; Result Unstructured Data: Increase in white count

Allergies:

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

Symptoms: Brain fog; Dizzy; Intense restriction of blood vessels; Could not sleep; Pain in shoulders; Whole body chills between breathing cycles; Headache; Nausea; Barfed; Numbing of pinky and ring finger on left hand; Entire left arm has tremor; Left and right side of body contracting from arm down to feet; Intense heat; Increase in white count; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Numbing of pinky and ring finger on left hand), TREMOR (Entire left arm has tremor), MUSCLE CONTRACTIONS INVOLUNTARY (Left and right side of body contracting from arm down to feet), FEELING HOT (Intense heat) and WHITE BLOOD CELL COUNT INCREASED (Increase in white count) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Myositis. On 17-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Sep-2021, the patient experienced WHITE BLOOD CELL COUNT INCREASED (Increase in white count). On an unknown date, the patient experienced HYPOAESTHESIA (Numbing of pinky and ring finger on left hand), TREMOR (Entire left arm has tremor), MUSCLE CONTRACTIONS INVOLUNTARY (Left and right side of body contracting from arm down to feet), FEELING HOT (Intense heat), FEELING ABNORMAL (Brain fog), DIZZINESS (Dizzy), ANGIOPATHY (Intense restriction of blood vessels), INSOMNIA (Could not sleep), ARTHRALGIA (Pain in shoulders), CHILLS (Whole body chills between breathing cycles), HEADACHE (Headache), NAUSEA (Nausea) and VOMITING (Barfed). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and ELECTROLYTES NOS at an unspecified dose and frequency. At the time of the report, HYPOAESTHESIA (Numbing of pinky and ring finger on left hand), TREMOR (Entire left arm has tremor), MUSCLE CONTRACTIONS INVOLUNTARY (Left and right side of body contracting from arm down to feet), FEELING HOT (Intense heat), WHITE BLOOD CELL COUNT INCREASED (Increase in white count), FEELING ABNORMAL (Brain fog), DIZZINESS (Dizzy), ANGIOPATHY (Intense restriction of blood vessels), INSOMNIA (Could not sleep), ARTHRALGIA (Pain in shoulders), CHILLS (Whole body chills between breathing cycles), HEADACHE (Headache), NAUSEA (Nausea) and VOMITING (Barfed) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Sep-2021, White blood cell count: increased (High) Increase in white count. No concomitant medications were provided. This case was linked to MOD-2021-322771, MOD-2021-322850 (Patient Link).

Other Meds:

Current Illness: Myositis

ID: 1736264
Sex: F
Age: 69
State: FL

Vax Date: 02/04/2021
Onset Date: 06/01/2021
Rec V Date: 09/27/2021
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: Nausea, Pain in extremity, Pyrexia

Symptoms: Severe itch/itchy; Little bumps; Heat; Red dots on my back; Hives; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Severe itch/itchy), SWELLING (Little bumps), TEMPERATURE INTOLERANCE (Heat), ERYTHEMA (Red dots on my back) and URTICARIA (Hives) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Blood pressure management. On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In June 2021, the patient experienced PRURITUS (Severe itch/itchy), SWELLING (Little bumps), TEMPERATURE INTOLERANCE (Heat), ERYTHEMA (Red dots on my back) and URTICARIA (Hives). The patient was treated with CETIRIZINE HYDROCHLORIDE (CETRIZINE) for Adverse event, at a dose of 5 milligram. At the time of the report, PRURITUS (Severe itch/itchy), SWELLING (Little bumps), TEMPERATURE INTOLERANCE (Heat) and ERYTHEMA (Red dots on my back) outcome was unknown and URTICARIA (Hives) had resolved. Concomitant drug included Low dose of blood pressure pill. Treatment medication included ice pack, 2 creams and 2 pills for allergy and the itch. It was reported as patient had no allergies.

Other Meds:

Current Illness: Blood pressure management.

ID: 1736265
Sex: M
Age: 89
State: CA

Vax Date: 01/26/2021
Onset Date: 01/26/2021
Rec V Date: 09/27/2021
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: Slight pain on the shoulder after the first dose; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Slight pain on the shoulder after the first dose) in an 89-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. Concomitant products included CALCIUM CARBONATE (ANTACID [CALCIUM CARBONATE]), ALLOPURINOL, GABAPENTIN, TESTOSTERONE, VITAMIN C [ASCORBIC ACID] and CALCIUM for an unknown indication. On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced ARTHRALGIA (Slight pain on the shoulder after the first dose). At the time of the report, ARTHRALGIA (Slight pain on the shoulder after the first dose) had resolved. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged. Concomitant products included prostate medication for an unknown indication. No treatment medications were reported. Patient he did not feel anything after the second dose. This case was linked to MOD-2021-322736 (Patient Link).

Other Meds: ANTACID [CALCIUM CARBONATE]; ALLOPURINOL; GABAPENTIN; TESTOSTERONE; VITAMIN C [ASCORBIC ACID]; CALCIUM.

Current Illness:

ID: 1736266
Sex: M
Age: 79
State: FL

Vax Date: 08/03/2021
Onset Date: 09/16/2021
Rec V Date: 09/27/2021
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: Nobody told me that I was going to have a hearing impairment.- Almost all my hearing is gone in my left ear; I have a little vertigo; But I already have a little imbalance thing already; second dose received on 16-Sep-2021, more than 35 days after 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of HYPOACUSIS (Nobody told me that I was going to have a hearing impairment.- Almost all my hearing is gone in my left ear), VERTIGO (I have a little vertigo), BALANCE DISORDER (But I already have a little imbalance thing already) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose received on 16-Sep-2021, more than 35 days after 1st dose) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014F21A and 040C21A) for COVID-19 vaccination. No Medical History information was reported. On 03-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Sep-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose received on 16-Sep-2021, more than 35 days after 1st dose). On 17-Sep-2021, the patient experienced HYPOACUSIS (Nobody told me that I was going to have a hearing impairment.- Almost all my hearing is gone in my left ear) and VERTIGO (I have a little vertigo). 17-Sep-2021, the patient experienced BALANCE DISORDER (But I already have a little imbalance thing already). At the time of the report, HYPOACUSIS (Nobody told me that I was going to have a hearing impairment.- Almost all my hearing is gone in my left ear), VERTIGO (I have a little vertigo), BALANCE DISORDER (But I already have a little imbalance thing already) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose received on 16-Sep-2021, more than 35 days after 1st dose) outcome was unknown. No concomitant medications and treatment information reported.

Other Meds:

Current Illness:

ID: 1736267
Sex: F
Age: 31
State: CA

Vax Date: 01/16/2021
Onset Date: 01/16/2021
Rec V Date: 09/27/2021
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: sweating; woke up with a severe headache; developed a fever; Acidic vomiting; Double vision; broke out in hives; bump on my right arm injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (bump on my right arm injection site), URTICARIA (broke out in hives), HYPERHIDROSIS (sweating), DIPLOPIA (Double vision) and HEADACHE (woke up with a severe headache) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. Concomitant products included PROPRANOLOL, PREDNISONE from 12-Aug-2021 to an unknown date and PYRIDOSTIGMINE BROMIDE (MESTINON) from 17-Sep-2021 to an unknown date for an unknown indication. On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE MASS (bump on my right arm injection site). On 22-Jan-2021, the patient experienced URTICARIA (broke out in hives). On 30-Jan-2021, the patient experienced DIPLOPIA (Double vision). On 31-Jan-2021, the patient experienced HYPERHIDROSIS (sweating), HEADACHE (woke up with a severe headache), PYREXIA (developed a fever) and VOMITING (Acidic vomiting). On 21-Jan-2021, VACCINATION SITE MASS (bump on my right arm injection site) had resolved. At the time of the report, URTICARIA (broke out in hives), HYPERHIDROSIS (sweating), DIPLOPIA (Double vision), HEADACHE (woke up with a severe headache), PYREXIA (developed a fever) and VOMITING (Acidic vomiting) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No Treatment Information were provided by the reporter This case was linked to MOD-2021-323941 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 20-Sep-2021: Followup received contains contact information like Address Updated

Other Meds: PROPRANOLOL; PREDNISONE; MESTINON.

Current Illness:

ID: 1736268
Sex: M
Age: 45
State: CA

Vax Date: 02/23/2021
Onset Date: 02/23/2021
Rec V Date: 09/27/2021
Hospital:

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

Lab Data:

Allergies: Allergy to animals (cat); pollen; seasonal allergy

Symptom List: Injection site pain

Symptoms: This spontaneous case reported by a consumer, describes the occurrence of severe chest pain (like a heart attack), gastrointestinal inflammation (inflammation of his gastrointestinal region noted) and esophagitis (inflammation of his esophageal region noted) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 022M20A and 042L20A) for COVID-19 immunization. Concurrent medical conditions included seasonal allergy, pollen allergy and allergy to animals (cat). On Jan 23, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Feb 23, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Feb 23, 2021, patient experienced severe chest pain (like a heart attack) and gastrointestinal inflammation (inflammation of his gastrointestinal region noted). Feb 23, 2021, patient experienced esophagitis (inflammation of his esophageal region noted). At the time of the report, severe chest pain (like a heart attack), gastrointestinal inflammation (inflammation of his gastrointestinal region noted) and esophagitis (inflammation of his esophageal region noted) outcome: unknown. No concomitant medications provided. Treatment: Patient prescribed acupuncture, antacids and gabapentin but he is not taking.

Other Meds:

Current Illness:

ID: 1736269
Sex: F
Age: 75
State: CA

Vax Date: 01/07/2021
Onset Date:
Rec V Date: 09/27/2021
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: 1st and 2nd dose: sore arm; This spontaneous case was reported by a physician and describes the occurrence of PAIN IN EXTREMITY (1st and 2nd dose: sore arm) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. Concurrent medical conditions included Asthma (Underlying Asthma which is usually in control) and Autoimmune disorder. Concomitant products included FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR) and GABAPENTIN for an unknown indication. On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (1st and 2nd dose: sore arm). The patient was treated with LEVALBUTEROL [LEVOSALBUTAMOL] (LEVALBUTEROL [LEVOSALBUTAMOL] NEBULISER) for Adverse event, at an unspecified dose and frequency; ITRACONAZOLE for Adverse event, at an unspecified dose and frequency; AZITHROMYCIN (ZITHROMAX) for Adverse event, at an unspecified dose and frequency and ANTIHISTAMINES for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (1st and 2nd dose: sore arm) 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. The patient used a box of Kleenex each day. The patient felt nauseated and vertigo after administration of gabapentin. This case was linked to MOD-2021-323634, MOD-2021-323635 (Patient Link).

Other Meds: ADVAIR; GABAPENTIN.

Current Illness: Asthma (Underlying Asthma which is usually in control); Autoimmune disorder.

ID: 1736270
Sex: F
Age: 69
State: WA

Vax Date: 02/11/2021
Onset Date: 02/11/2021
Rec V Date: 09/27/2021
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: Arm pain; Temp 102; Tiredness; Headache; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Arm pain), PYREXIA (Temp 102), FATIGUE (Tiredness) and HEADACHE (Headache) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination. Previously administered products included for an unreported indication: FLU VACCINE VII (Taken on 8/11/21 Intramuscular at Right Arm). Concurrent medical conditions included Allergy to antibiotic (Allergy to Vancomycin.), Asthma and Bronchiectasis. On 11-Feb-2021 at 11:00 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021 at 3:00 PM, the patient experienced PAIN IN EXTREMITY (Arm pain), PYREXIA (Temp 102), FATIGUE (Tiredness) and HEADACHE (Headache). On 13-Feb-2021, PAIN IN EXTREMITY (Arm pain), PYREXIA (Temp 102) and HEADACHE (Headache) had resolved. At the time of the report, FATIGUE (Tiredness) was resolving. Not Provided No concomitant medications were reported. No treatments were reported. This case was linked to MOD-2021-323610, MOD-2021-310473 (Patient Link).

Other Meds:

Current Illness: Allergy to antibiotic (Allergy to Vancomycin.); Asthma; Bronchiectasis.

ID: 1736271
Sex: M
Age: 30
State: CT

Vax Date: 09/14/2021
Onset Date: 09/14/2021
Rec V Date: 09/27/2021
Hospital:

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

Lab Data: Test Name: Heart beat; Result Unstructured Data: irregular heart beat

Allergies:

Symptom List: Tremor

Symptoms: Had a severe reaction; could not get up; an irregular heart beat; Got the 2 doses of the Pfizer vaccine. Then, last Tuesday 14-Sep-2021 got a dose of the Moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Had a severe reaction), MOBILITY DECREASED (could not get up), HEART RATE IRREGULAR (an irregular heart beat) and INTERCHANGE OF VACCINE PRODUCTS (Got the 2 doses of the Pfizer vaccine. Then, last Tuesday 14-Sep-2021 got a dose of the Moderna vaccine) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 14-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Sep-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Got the 2 doses of the Pfizer vaccine. Then, last Tuesday 14-Sep-2021 got a dose of the Moderna vaccine). On 15-Sep-2021, the patient experienced VACCINATION COMPLICATION (Had a severe reaction), MOBILITY DECREASED (could not get up) and HEART RATE IRREGULAR (an irregular heart beat). At the time of the report, VACCINATION COMPLICATION (Had a severe reaction), MOBILITY DECREASED (could not get up) and HEART RATE IRREGULAR (an irregular heart beat) outcome was unknown and INTERCHANGE OF VACCINE PRODUCTS (Got the 2 doses of the Pfizer vaccine. Then, last Tuesday 14-Sep-2021 got a dose of the Moderna vaccine) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: abnormal (abnormal) irregular heart beat. No concomitant medication were reported. No treatment information was provided by the reporter. Patient received first 2 doses of Pfizer vaccine the last one was around 4 months ago.patient does not take any medication regularly and that not aware of the patient having a previous diagnose of myocarditis or pericarditis and state the patient did not get covid-19.

Other Meds:

Current Illness:

ID: 1736272
Sex: F
Age: 68
State: HI

Vax Date: 08/16/2021
Onset Date: 08/16/2021
Rec V Date: 09/27/2021
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: bad watery diarrhea and 6 loose stools per day; sore right injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (bad watery diarrhea and 6 loose stools per day) and VACCINATION SITE PAIN (sore right injection site arm) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 16-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Aug-2021, the patient experienced DIARRHOEA (bad watery diarrhea and 6 loose stools per day) and VACCINATION SITE PAIN (sore right injection site arm). At the time of the report, DIARRHOEA (bad watery diarrhea and 6 loose stools per day) and VACCINATION SITE PAIN (sore right injection site arm) outcome was unknown. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged. No concomitant medications were provided. No treatment medications were provided. This case was linked to MOD-2021-323763 (Patient Link).

Other Meds:

Current Illness:

ID: 1736273
Sex: M
Age: 64
State: IL

Vax Date: 03/15/2021
Onset Date: 03/15/2021
Rec V Date: 09/27/2021
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: Brain fog; Headache; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Brain fog) and HEADACHE (Headache) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination. Concurrent medical conditions included Drug allergy (Meloxicam). Concomitant products included PREGABALIN (LYRICA) and INSULIN DEGLUDEC (TRESIBA) for an unknown indication. On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced FEELING ABNORMAL (Brain fog) and HEADACHE (Headache). At the time of the report, FEELING ABNORMAL (Brain fog) and HEADACHE (Headache) 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. Treatment medication include Lyrica . This case was linked to MOD-2021-315365 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 20-Sep-2021: Follow-up information no new information.

Other Meds: LYRICA; TRESIBA.

Current Illness: Drug allergy (Meloxicam.)

ID: 1736274
Sex: F
Age: 72
State: GA

Vax Date: 01/14/2021
Onset Date:
Rec V Date: 09/27/2021
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: red lump; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (red lump) and PAIN IN EXTREMITY (sore arm) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 30M20A and 026L20A) for COVID-19 vaccination. Concurrent medical conditions included Food allergy (Patient states being allergic to some food and medications but never experienced a reaction), Allergy to allopathic drugs (Patient states being allergic to some food and medications but never experienced a reaction), Blood pressure high, Osteoporosis and Hypothyroidism. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for Hypothyroidism, RALOXIFENE HYDROCHLORIDE (EVISTA) for Osteoporosis, MULTIVITAMINS [VITAMINS NOS] and VITAMIN D [VITAMIN D NOS] for an unknown indication. On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-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 ERYTHEMA (red lump) and PAIN IN EXTREMITY (sore arm). The patient was treated with FEXOFENADINE HYDROCHLORIDE (ALLEGRA) for No adverse event, at a dose of 1 dosage form once a day. At the time of the report, ERYTHEMA (red lump) and PAIN IN EXTREMITY (sore arm) had resolved. This case was linked to MOD-2021-323808 (Patient Link).

Other Meds: EVISTA; MULTIVITAMINS [VITAMINS NOS]; VITAMIN D [VITAMIN D NOS]; SYNTHROID.

Current Illness: Allergy to allopathic drugs (Patient states being allergic to some food and medications but never experienced a reaction); Blood pressure high; Food allergy (Patient states being allergic to some food and medications but never experienced a reaction); Hypothyroidism; Osteoporosis.

ID: 1736275
Sex: F
Age: 72
State: GA

Vax Date: 01/14/2021
Onset Date: 09/01/2021
Rec V Date: 09/27/2021
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: Rash on the chest that spread all the way to the back and neck; Sore; Joint hurt; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash on the chest that spread all the way to the back and neck), MYALGIA (Sore) and ARTHRALGIA (Joint hurt) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 005C21A, 026L20A and 30M20A) for COVID-19 vaccination. Concurrent medical conditions included Food allergy (Allergic to some food and medications) and Drug allergy (Allergic to some food and medications). Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for Hypothyroidism, RALOXIFENE HYDROCHLORIDE (EVISTA) for Osteoporosis, MULTIVITAMIN [VITAMINS NOS] and VITAMIN D [VITAMIN D NOS] for an unknown indication. On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In September 2021, the patient experienced MYALGIA (Sore) and ARTHRALGIA (Joint hurt). On 19-Sep-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced RASH (Rash on the chest that spread all the way to the back and neck). The patient was treated with FEXOFENADINE HYDROCHLORIDE (ALLEGRA) for Adverse event, at a dose of UNK UNK, qd. In September 2021, MYALGIA (Sore) and ARTHRALGIA (Joint hurt) had resolved. At the time of the report, RASH (Rash on the chest that spread all the way to the back and neck) outcome was unknown. The patient was also taking high blood pressure medication (unspecified) concomitantly. The patient was allergic to some food and medications but never experienced a reaction like this, the patient related rash to a possible reaction after taken third dose of the vaccine. The patient consulted to the physician for treatment medication. This case was linked to MOD-2021-323796 (Patient Link).

Other Meds: EVISTA; MULTIVITAMIN [VITAMINS NOS]; VITAMIN D [VITAMIN D NOS]; SYNTHROID.

Current Illness: Drug allergy (Allergic to some food and medications); Food allergy (Allergic to some food and medications.)

ID: 1736276
Sex: F
Age:
State: GA

Vax Date: 09/08/2021
Onset Date:
Rec V Date: 09/27/2021
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: Very sick for 3 days; she had a flu-like symptoms; fever temperature 99; nauseated / couldn't eat all day; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Very sick for 3 days), INFLUENZA LIKE ILLNESS (she had a flu-like symptoms), PYREXIA (fever temperature 99) and NAUSEA (nauseated / couldn't eat all day) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. Concurrent medical conditions included Arthritis. On 08-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (Very sick for 3 days), INFLUENZA LIKE ILLNESS (she had a flu-like symptoms), PYREXIA (fever temperature 99) and NAUSEA (nauseated / couldn't eat all day). At the time of the report, ILLNESS (Very sick for 3 days), INFLUENZA LIKE ILLNESS (she had a flu-like symptoms), PYREXIA (fever temperature 99) and NAUSEA (nauseated / couldn't eat all day) outcome was unknown. concomitant medications were not reported. treatment medications were not reported. This case was linked to MOD-2021-026932 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 22-Sep-2021: Non Significant followup received

Other Meds:

Current Illness:

ID: 1736277
Sex: F
Age: 61
State: MI

Vax Date: 03/19/2021
Onset Date: 05/01/2021
Rec V Date: 09/27/2021
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: felt kinda achy; 4mos now and it gotten worst in the joints/ Pain scale of 8-9/10 was noted every morning; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (felt kinda achy) and ARTHRALGIA (4mos now and it gotten worst in the joints/ Pain scale of 8-9/10 was noted every morning) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037K20A and 015M20A) for COVID-19 vaccination. Concurrent medical conditions included Seasonal allergy and Latex allergy. Concomitant products included MULTIVITAMINS [ASCORBIC ACID;ERGOCALCIFEROL;FOLIC ACID;NICOTINAMIDE;PANTHENOL;RETINOL;RIBOFLAVIN;THIAMINE HYDROCHLORIDE] for an unknown indication. On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-May-2021, the patient experienced MYALGIA (felt kinda achy) and ARTHRALGIA (4mos now and it gotten worst in the joints/ Pain scale of 8-9/10 was noted every morning). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) at a dose of 800mg. At the time of the report, MYALGIA (felt kinda achy) outcome was unknown and ARTHRALGIA (4mos now and it gotten worst in the joints/ Pain scale of 8-9/10 was noted every morning) had not resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medications include Cholesterol medications and multivitamins for an unknown indications.

Other Meds: MULTIVITAMINS [ASCORBIC ACID;ERGOCALCIFEROL;FOLIC ACID;NICOTINAMIDE;PANTHENOL;RETINOL;RIBOFLAVIN;THI.

Current Illness: Latex allergy; Seasonal allergy.

ID: 1736278
Sex: F
Age: 60
State: FL

Vax Date: 07/16/2021
Onset Date: 08/24/2021
Rec V Date: 09/27/2021
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: red area near the areola; tingling in the back of my head; lethargic; moved right arm more pain/ mobility issues in right shoulder, around joint of right shoulder; overall yucky; lump arise in my right breast, which caused a soreness and red area near the areola; Lump in breast; Pain in right arm/moved right arm more pain/ mobility issues in right shoulder, around joint of right shoulder; fever; fatigue; nausea; severe headache; chills; vomiting; This spontaneous case was reported by a consumer and describes the occurrence of JOINT RANGE OF MOTION DECREASED (moved right arm more pain/ mobility issues in right shoulder, around joint of right shoulder), PARAESTHESIA (tingling in the back of my head), LETHARGY (lethargic), ERYTHEMA (red area near the areola) and FEELING ABNORMAL (overall yucky) in a 60-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. Concurrent medical conditions included Rheumatoid arthritis since 1996, Cystitis interstitial since 2018 and Barrett's esophagus since 2017. Concomitant products included VITAMINS NOS for an unknown indication. On 16-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Aug-2021, the patient experienced JOINT RANGE OF MOTION DECREASED (moved right arm more pain/ mobility issues in right shoulder, around joint of right shoulder), LETHARGY (lethargic), FEELING ABNORMAL (overall yucky), BREAST PAIN (lump arise in my right breast, which caused a soreness and red area near the areola), BREAST MASS (Lump in breast), VACCINATION SITE PAIN (Pain in right arm/moved right arm more pain/ mobility issues in right shoulder, around joint of right shoulder), PYREXIA (fever), FATIGUE (fatigue), NAUSEA (nausea), HEADACHE (severe headache), CHILLS (chills) and VOMITING (vomiting). On an unknown date, the patient experienced PARAESTHESIA (tingling in the back of my head) and ERYTHEMA (red area near the areola). In September 2021, BREAST MASS (Lump in breast) had resolved. At the time of the report, JOINT RANGE OF MOTION DECREASED (moved right arm more pain/ mobility issues in right shoulder, around joint of right shoulder), VACCINATION SITE PAIN (Pain in right arm/moved right arm more pain/ mobility issues in right shoulder, around joint of right shoulder), PYREXIA (fever), FATIGUE (fatigue), NAUSEA (nausea), HEADACHE (severe headache), CHILLS (chills) and VOMITING (vomiting) had not resolved and PARAESTHESIA (tingling in the back of my head), LETHARGY (lethargic), ERYTHEMA (red area near the areola), FEELING ABNORMAL (overall yucky) and BREAST PAIN (lump arise in my right breast, which caused a soreness and red area near the areola) outcome was unknown. No treatment information was provided This case was linked to MOD-2021-269309 (Patient Link).

Other Meds: VITAMINS NOS.

Current Illness: Barrett's esophagus; Cystitis interstitial; Rheumatoid arthritis.

ID: 1736279
Sex: M
Age: 16
State: MO

Vax Date: 08/02/2021
Onset Date: 08/02/2021
Rec V Date: 09/27/2021
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: Adolescent received Moderna COVID-19 vaccine; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Adolescent received Moderna COVID-19 vaccine) in a 16-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) 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) (unknown route) 1 dosage form. On 02-Aug-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Adolescent received Moderna COVID-19 vaccine). On 02-Aug-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Adolescent received Moderna COVID-19 vaccine) 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 information was provided.

Other Meds:

Current Illness:

ID: 1736280
Sex: M
Age:
State:

Vax Date: 09/17/2021
Onset Date: 09/17/2021
Rec V Date: 09/27/2021
Hospital:

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

Lab Data: Test Date: 20210917; Test Name: Body temperature; Result Unstructured Data: Fever upto 102

Allergies:

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

Symptoms: Fever up to 102; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever up to 102) in a male 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 17-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Sep-2021, the patient experienced PYREXIA (Fever up to 102). At the time of the report, PYREXIA (Fever up to 102) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Sep-2021, Body temperature: 102 (High) Fever upto 102. No concomitant medication reported. No treatment medication reported. Reporter stated that patient was given booster dose and patient still had the event, fever even the next day morning.

Other Meds:

Current Illness:

ID: 1736281
Sex: M
Age: 24
State: MO

Vax Date: 09/19/2021
Onset Date: 09/19/2021
Rec V Date: 09/27/2021
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: Patient received an out-of-date Moderna vaccine / patient received a vial that was punctured 24-26 hours ago; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received an out-of-date Moderna vaccine / patient received a vial that was punctured 24-26 hours ago) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939902) for COVID-19 vaccination. No Medical History information was reported. On 19-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received an out-of-date Moderna vaccine / patient received a vial that was punctured 24-26 hours ago). On 19-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Patient received an out-of-date Moderna vaccine / patient received a vial that was punctured 24-26 hours ago) had resolved. 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 were reported. Treatment medication was not provided by the reporter. On 06-Sep-2021, the vial was initially stored in the refrigerator. Technician immunizer gave a second shot of a previous-date vial. The vial was punctured and exposed at room temperature range (8 degree to 25 degree C = 46 degree to 77 degree F), for more than 24 hours (between 24 and 26 hours), as it was first punctured on 18-Sep-2021 morning. The vial did not undergo any temperature excursions. There was no records of patient taking any regular medication. The pharmacist would like to know if the patient needs to get revaccinated or not. Or if there were any steps they need to take.

Other Meds:

Current Illness:

ID: 1736282
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/27/2021
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: This spontaneous case reported by a consumer, describes the occurrence of inflammation (head felt inflamed in different places), headache (painful, bad headache) and myalgia (body aches) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. Concurrent medical conditions included neurological disorder (NOS) and blood clot. Patient had neurological and blood clot concerns. In 2021, patient received first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. In 2021, patient experienced inflammation (head felt inflamed in different places), headache (painful, bad headache) and myalgia (body aches). At the time of the report, inflammation (head felt inflamed in different places), headache (painful, bad headache) and myalgia (body aches) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No concomitant medications or treatment information reported.

Other Meds:

Current Illness: Blood clot (neurological and blood clot concerns); neurological disorder (NOS)

ID: 1736283
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/27/2021
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: two arm plaques; This spontaneous case was reported by a physician and describes the occurrence of SKIN PLAQUE (two arm plaques) in a 73-year-old female patient 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 SKIN PLAQUE (two arm plaques). At the time of the report, SKIN PLAQUE (two arm plaques) outcome was unknown. Not Provided 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 were provided. No treatment medication were provided. This case was linked to MOD-2021-327033 (Patient Link). Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1736284
Sex: F
Age:
State: FL

Vax Date:
Onset Date:
Rec V Date: 09/27/2021
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: two arm plaques; This spontaneous case was reported by a physician and describes the occurrence of SKIN PLAQUE (two arm plaques) in a 26-year-old female patient 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 SKIN PLAQUE (two arm plaques). At the time of the report, SKIN PLAQUE (two arm plaques) 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 medication information was not provided by the reporter. Treatment information was not provided by the reporter. This case was linked to MOD-2021-327027, MOD-2021-327034 (Patient Link).

Other Meds:

Current Illness:

ID: 1736285
Sex: F
Age: 49
State: HI

Vax Date: 08/30/2021
Onset Date: 09/03/2021
Rec V Date: 09/27/2021
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: Non3

Symptom List: Injection site swelling, Limb discomfort

Symptoms: Hives all over my body starting at my arms now all over my stomach and legs. Seems to be getting worse everyday. Taking benadryl and zytrc to help with it. I am very worried please help someone check this for me. I do not have insurance and really want to get this checked and cured. I never had any issues like this before thr vaccine. Please help me I am really worried about this.

Other Meds: None

Current Illness: None

ID: 1736286
Sex: F
Age: 14
State: CA

Vax Date: 09/24/2021
Onset Date: 09/24/2021
Rec V Date: 09/27/2021
Hospital: Y

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

Lab Data: elevated, bilateral knee join effusions requiring tap- synovial fluid many wbc, no organism

Allergies: none

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

Symptoms: bilateral knee pain and swelling

Other Meds: none

Current Illness: none

ID: 1736287
Sex: F
Age: 61
State: PA

Vax Date: 08/22/2021
Onset Date: 08/22/2021
Rec V Date: 09/27/2021
Hospital:

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

Lab Data: N/A

Allergies: Yes

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

Symptoms: Approximately 1 hr after receiving the J&J COVID 19 vaccine SEVERE pruritus began over my entire body. It lasted for 1 1/2 days. I took 75mg of diphenhydramine every 4 hrs during that time.

Other Meds: Methadone baclofen duloxetine singulair trazadone melatonin Claritin diphenhydramine pseudafed

Current Illness: None

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am