VAERS 2021 Database www.vaers.hhs.gov

Main Page | All 2021 Deaths | Videos
VAERS Updated: 10/01/2021
** VAERS DATABASE Last updated: October 1, 2021**
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Manufacturers

Total Manufacturer
187,133MODERNA
33,878JANSSEN
2,321PFIZER\BIONTECH
1,091GLAXOSMITHKLINE BIOLOGICALS
983UNKNOWN MANUFACTURER
363MERCK & CO. INC.
229SEQIRUS, INC.
45DYNAVAX TECHNOLOGIES CORPORATION
41NOVARTIS VACCINES AND DIAGNOSTICS
29SANOFI PASTEUR
18EMERGENT BIOSOLUTIONS
8PAXVAX
7TEVA PHARMACEUTICALS
4PFIZER\WYETH
3BERNA BIOTECH, LTD.
2SMITHKLINE BEECHAM
2INTERCELL AG
2PROTEIN SCIENCES CORPORATION
1CSL LIMITED

Incidents per State

State Total
77,548
AK1,869
AL5,581
AR3,688
AS47
AZ14,288
CA61,984
CO11,665
CT8,149
DC1,663
DE1,807
FL37,749
FM5
GA15,058
GU120
HI2,453
IA4,625
ID2,692
IL20,334
IN24,007
KS4,615
KY7,696
LA4,887
MA14,654
MD12,514
ME3,129
MH11
MI18,739
MN12,528
MO9,710
MP29
MS2,790
MT2,375
NC16,368
ND1,356
NE2,880
NH3,100
NJ17,634
NM3,916
NV4,239
NY34,355
OH19,081
OK6,195
OR8,636
PA23,083
PR2,370
QM2
RI2,088
SC6,411
SD1,212
TN9,131
TX35,174
UT4,273
VA14,937
VI64
VT1,676
WA14,909
WI11,259
WV2,388
WY861
XB5
XL1
XV2

ID: 1556238
Sex: U
Age:
State: MD

Vax Date: 02/24/2021
Onset Date: 02/24/2021
Rec V Date: 08/14/2021
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: Accidentally administered 1.0 mL of the Moderna Covid-19 vaccine; A spontaneous report was received from a nurse concerning a patient who was accidentally administered 1.0 mLof the Moderna Covid-19 vaccine. The patient's medical history was not provided by reporter. Concomitant product use was not provided by the reporter. On 24-FEB-2021, the patient received their first of two planned doses of mRNA-1273 (Lot number unknown) intramuscularly for prophylaxis of COVID-19 infection. On 24-FEB-2021, vaccine was accidentally administered 1.0 mLof the Moderna Covid-19 vaccine. Treatment information was not provided. The outcome of the event, accidentally administered 1.0 mLof the Moderna Covid-19 vaccine, was considered resolved.; Reporter's Comments: This report refers to a case of accidental overdose for mRNA-1273 (lot # unknown) with no associated AEs reported.

Other Meds:

Current Illness:

ID: 1556239
Sex: F
Age: 63
State: FL

Vax Date: 02/19/2021
Onset Date: 02/19/2021
Rec V Date: 08/14/2021
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: Congestion; Covid virus; upper respiratory tightness; Flu like symptoms; Cough; fever; Headache; 36 days have passed since 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (36 days have passed since 1st dose), NASAL CONGESTION (Congestion), COVID-19 (Covid virus), RESPIRATORY DISORDER (upper respiratory tightness) and INFLUENZA LIKE ILLNESS (Flu like symptoms) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Bronchitis and Thyroid disorder. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for Thyroid disorder, FAMOTIDINE for an unknown indication. On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (36 days have passed since 1st dose), RESPIRATORY DISORDER (upper respiratory tightness), INFLUENZA LIKE ILLNESS (Flu like symptoms), COUGH (Cough), PYREXIA (fever) and HEADACHE (Headache). On 20-Feb-2021, the patient experienced NASAL CONGESTION (Congestion) and COVID-19 (Covid virus). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (36 days have passed since 1st dose) had resolved and NASAL CONGESTION (Congestion), COVID-19 (Covid virus), RESPIRATORY DISORDER (upper respiratory tightness), INFLUENZA LIKE ILLNESS (Flu like symptoms), COUGH (Cough), PYREXIA (fever) and HEADACHE (Headache) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Feb-2021, COVID-19: positive (Positive) positive.. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Treatment medications included Tylenol, an Inhaler, Steroid-Prednisone and Monoclonal Antibody treatment. Most recent FOLLOW-UP information incorporated above includes: On 16-Apr-2021: FU source document attached on 16th April and it contains Adverse event information On 14-Jun-2021: received; Sender's Comments: Although a temporal association exist between the product use and reported events. Patient was most-likely infected with COVID-19 prior to mRNA-1273 administration. Other events are likely symptoms of the infection. However, based on temporal association and known safety profile of the vaccine, the event of headache cannot be excluded.

Other Meds: SYNTHROID; FAMOTIDINE

Current Illness:

ID: 1556240
Sex: F
Age: 59
State: AL

Vax Date: 02/24/2021
Onset Date: 02/24/2021
Rec V Date: 08/14/2021
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: dizzy; Fever of 102.6; Headache; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizzy), PYREXIA (Fever of 102.6), HEADACHE (Headache) and NAUSEA (Nausea) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced DIZZINESS (dizzy), PYREXIA (Fever of 102.6), HEADACHE (Headache) and NAUSEA (Nausea). At the time of the report, DIZZINESS (dizzy), PYREXIA (Fever of 102.6), HEADACHE (Headache) and NAUSEA (Nausea) outcome was unknown. Not Provided DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Feb-2021, Body temperature: high (High) 102.6 High.. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant drugs were reported. No treatment information was reported. Patient wants to know why she cant take Tylenol for her symptoms.

Other Meds:

Current Illness:

ID: 1556241
Sex: M
Age:
State:

Vax Date: 01/28/2021
Onset Date: 02/24/2021
Rec V Date: 08/14/2021
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: Antibody test yesterday and was non-reactive; This spontaneous case was reported by a physician and describes the occurrence of ANTIBODY TEST ABNORMAL (Antibody test yesterday and was non-reactive) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concomitant products included ETANERCEPT (ENBREL) for an unknown indication. On 28-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, the patient experienced ANTIBODY TEST ABNORMAL (Antibody test yesterday and was non-reactive). At the time of the report, ANTIBODY TEST ABNORMAL (Antibody test yesterday and was non-reactive) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Feb-2021, Antibody test: non reactive (Negative) Non reactive. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported. Action taken with mRNA-1273 in response to the events was not Applicable.

Other Meds: ENBREL

Current Illness:

ID: 1556242
Sex: F
Age: 47
State: CA

Vax Date: 01/21/2021
Onset Date:
Rec V Date: 08/14/2021
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: Muscle cramps , and shaking ("like when you drink a lot of caffeine") which started with the first dose , got worse on second dose; Muscle cramps and shaking; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (Muscle cramps , and shaking ("like when you drink a lot of caffeine") which started with the first dose , got worse on second dose) and TREMOR (Muscle cramps and shaking) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042L20A and 022M20A) for COVID-19 vaccination. No Medical History information was reported. On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-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 MUSCLE SPASMS (Muscle cramps , and shaking ("like when you drink a lot of caffeine") which started with the first dose , got worse on second dose) and TREMOR (Muscle cramps and shaking). At the time of the report, MUSCLE SPASMS (Muscle cramps , and shaking ("like when you drink a lot of caffeine") which started with the first dose , got worse on second dose) and TREMOR (Muscle cramps and shaking) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant product use was not provided by the reporter. Treatment information was not provided.

Other Meds:

Current Illness:

ID: 1556243
Sex: F
Age: 47
State: CA

Vax Date: 01/21/2021
Onset Date:
Rec V Date: 08/14/2021
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: Muscle cramps and shaking worse; Muscle cramps and shaking worse; Condition aggravated; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (Muscle cramps and shaking worse), TREMOR (Muscle cramps and shaking worse) and CONDITION AGGRAVATED (Condition aggravated) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022M20A and 042L20A) for COVID-19 vaccination. No Medical History information was reported. On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-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 MUSCLE SPASMS (Muscle cramps and shaking worse), TREMOR (Muscle cramps and shaking worse) and CONDITION AGGRAVATED (Condition aggravated). At the time of the report, MUSCLE SPASMS (Muscle cramps and shaking worse), TREMOR (Muscle cramps and shaking worse) and CONDITION AGGRAVATED (Condition aggravated) outcome was unknown. The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable. Concomitant product use was not provided by the reporter. Treatment information was not provided.

Other Meds:

Current Illness:

ID: 1556244
Sex: F
Age:
State: CA

Vax Date: 02/13/2021
Onset Date:
Rec V Date: 08/14/2021
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: Since getting the vaccine she had a another episode a few days ago of rosacea and her provider prescribed her doxycycline; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ROSACEA (Since getting the vaccine she had a another episode a few days ago of rosacea and her provider prescribed her doxycycline) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included Rosacea (took antibiotics). On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ROSACEA (Since getting the vaccine she had a another episode a few days ago of rosacea and her provider prescribed her doxycycline). The patient was treated with DOXYCYCLINE for Rosacea, at an unspecified dose and frequency. At the time of the report, ROSACEA (Since getting the vaccine she had a another episode a few days ago of rosacea and her provider prescribed her doxycycline) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications were reported.

Other Meds:

Current Illness:

ID: 1556245
Sex: F
Age: 34
State: CA

Vax Date: 02/13/2021
Onset Date: 02/14/2021
Rec V Date: 08/14/2021
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: Headache; Chills; Fatigue; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HEADACHE (Headache), CHILLS (Chills) and FATIGUE (Fatigue) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination. No Medical History information was reported. On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021, the patient experienced HEADACHE (Headache), CHILLS (Chills) and FATIGUE (Fatigue). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 24-Feb-2021, HEADACHE (Headache), CHILLS (Chills) and FATIGUE (Fatigue) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative for COVID-19. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No relevant concomitant medications were reported. This case was linked to MOD-2021-027049, MOD-2021-026665 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 06-Aug-2021: Follow-up document received included no new information. NNI for daughter case

Other Meds:

Current Illness:

ID: 1556246
Sex: F
Age: 69
State: AZ

Vax Date: 01/29/2021
Onset Date: 02/21/2021
Rec V Date: 08/14/2021
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: Arm pain; Had a pulsating tingling feeling by side of head next to left eye; Cold sore on lip; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm pain), PARAESTHESIA (Had a pulsating tingling feeling by side of head next to left eye) and ORAL HERPES (Cold sore on lip) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination. The patient's past medical history included COVID-19 in 2020. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), ALENDRONATE SODIUM (FOSAMAX) and FAMOTIDINE (PEPCID AC) for an unknown indication. On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Feb-2021, the patient experienced PARAESTHESIA (Had a pulsating tingling feeling by side of head next to left eye) and ORAL HERPES (Cold sore on lip). On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm pain). The patient was treated with ACYCLOVIR [ACICLOVIR] ongoing since an unknown date for Cold sores, at a dose of 800 mg three times a day and PARACETAMOL (TYLENOL) for Pain in arm, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Arm pain), PARAESTHESIA (Had a pulsating tingling feeling by side of head next to left eye) and ORAL HERPES (Cold sore on lip) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.

Other Meds: SYNTHROID; FOSAMAX; PEPCID AC

Current Illness:

ID: 1556247
Sex: F
Age: 64
State: NJ

Vax Date: 02/06/2021
Onset Date: 02/20/2021
Rec V Date: 08/14/2021
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: tested positive for Covid-19; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (tested positive for Covid-19) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination. No Medical History information was reported. On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Feb-2021, the patient experienced SARS-COV-2 TEST POSITIVE (tested positive for Covid-19). At the time of the report, SARS-COV-2 TEST POSITIVE (tested positive for Covid-19) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications were reported Treatment medications was not provided

Other Meds:

Current Illness:

ID: 1556248
Sex: F
Age: 73
State: CA

Vax Date: 01/01/2021
Onset Date:
Rec V Date: 08/14/2021
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: Headaches and body aches; Redness on the arm; "A ball" on the arm; Headaches and body aches; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Headaches and body aches), ERYTHEMA (Redness on the arm), SWELLING ("A ball" on the arm), HEADACHE (Headaches and body aches) and CHILLS (Chills) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006M20A and 029L20A) for COVID-19 vaccination. No Medical History information was reported. On 01-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN (Headaches and body aches), ERYTHEMA (Redness on the arm), SWELLING ("A ball" on the arm), HEADACHE (Headaches and body aches) and CHILLS (Chills). At the time of the report, PAIN (Headaches and body aches), ERYTHEMA (Redness on the arm), SWELLING ("A ball" on the arm), HEADACHE (Headaches and body aches) and CHILLS (Chills) outcome was unknown. The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable. Concomitant product use was not provided by the reporter. Treatment information was not provided.

Other Meds:

Current Illness:

ID: 1556249
Sex: M
Age: 72
State: WA

Vax Date: 02/17/2021
Onset Date: 02/17/2021
Rec V Date: 08/14/2021
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: Chills; Headache; Chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of the first episode of CHILLS (Chills), the first episode of HEADACHE (Headache), the second episode of CHILLS (Chills) and the second episode of HEADACHE (Headache) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination. No Medical History information was reported. On 17-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced the first episode of CHILLS (Chills) and the first episode of HEADACHE (Headache). On 24-Feb-2021, the patient experienced the second episode of CHILLS (Chills) and the second episode of HEADACHE (Headache). At the time of the report, last episode of CHILLS (Chills) and the last episode of HEADACHE (Headache) outcome was unknown. Not Provided No Concomitant medication were reported. Treatment medication includes Coricidin.

Other Meds:

Current Illness:

ID: 1556250
Sex: F
Age:
State: FL

Vax Date:
Onset Date:
Rec V Date: 08/14/2021
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: Bump under injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE MASS (Bump under injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. unknown and unknown) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INJECTION SITE MASS (Bump under injection site). At the time of the report, INJECTION SITE MASS (Bump under injection site) outcome was unknown. Treatment was unknown Action taken with mRNA-1273 in response to the event was not applicable

Other Meds:

Current Illness:

ID: 1556251
Sex: F
Age:
State: FL

Vax Date: 02/16/2021
Onset Date:
Rec V Date: 08/14/2021
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: it is now worse compared to when she first got the vaccine; red; swollen; got a bruise the same day she got the shot; some of the bruising is turning different color /there is a horizontal line almost a centimeter and left of the inch long its is dark blue /it looks like she was tattooed; woke her up in the morning with pain /hurts; new hardness; hot; looked up and saw the vaccinator was pushing hard into her arm; sweat; new swelling about 4 inch diameter circling the top half of the shot; low grade fever; nausea/the consumer had experienced nausea; chills; This spontaneous case was reported by a consumer and describes the occurrence of CONDITION AGGRAVATED (it is now worse compared to when she first got the vaccine), ERYTHEMA (red), SWELLING (swollen), CONTUSION (got a bruise the same day she got the shot) and SKIN DISCOLOURATION (some of the bruising is turning different color /there is a horizontal line almost a centimeter and left of the inch long its is dark blue /it looks like she was tattooed) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CONDITION AGGRAVATED (it is now worse compared to when she first got the vaccine), ERYTHEMA (red), SWELLING (swollen), CONTUSION (got a bruise the same day she got the shot), SKIN DISCOLOURATION (some of the bruising is turning different color /there is a horizontal line almost a centimeter and left of the inch long its is dark blue /it looks like she was tattooed), PAIN (woke her up in the morning with pain /hurts), TENDERNESS (new hardness), FEELING HOT (hot), INCORRECT ROUTE OF PRODUCT ADMINISTRATION (looked up and saw the vaccinator was pushing hard into her arm), HYPERHIDROSIS (sweat), VACCINATION SITE SWELLING (new swelling about 4 inch diameter circling the top half of the shot), PYREXIA (low grade fever), NAUSEA (nausea/the consumer had experienced nausea) and CHILLS (chills). At the time of the report, CONDITION AGGRAVATED (it is now worse compared to when she first got the vaccine), ERYTHEMA (red), SWELLING (swollen), CONTUSION (got a bruise the same day she got the shot), SKIN DISCOLOURATION (some of the bruising is turning different color /there is a horizontal line almost a centimeter and left of the inch long its is dark blue /it looks like she was tattooed), PAIN (woke her up in the morning with pain /hurts), TENDERNESS (new hardness), FEELING HOT (hot), INCORRECT ROUTE OF PRODUCT ADMINISTRATION (looked up and saw the vaccinator was pushing hard into her arm), HYPERHIDROSIS (sweat), VACCINATION SITE SWELLING (new swelling about 4 inch diameter circling the top half of the shot), PYREXIA (low grade fever), NAUSEA (nausea/the consumer had experienced nausea) and CHILLS (chills) outcome was unknown. No treatment information was provided. No concomitant medication was provided. The patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in the event is not applicable Most recent FOLLOW-UP information incorporated above includes: On 16-Jun-2021: Follow up received on 16-Jun-2021 as 2nd dose details added.

Other Meds:

Current Illness:

ID: 1556252
Sex: F
Age: 88
State:

Vax Date: 02/12/2021
Onset Date: 02/20/2021
Rec V Date: 08/14/2021
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: rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination. Concomitant products included HYDROCORTISONE for an unknown indication. On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, the patient experienced RASH (rash). At the time of the report, RASH (rash) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment information was not provided.

Other Meds: HYDROCORTISONE

Current Illness:

ID: 1556253
Sex: F
Age: 66
State: NY

Vax Date: 01/15/2021
Onset Date: 02/02/2021
Rec V Date: 08/14/2021
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: Shortness of breath; Fever 103.0; Chills; Nausea; Body aches; Severe pain in left side of head; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of DYSPNOEA (Shortness of breath), PYREXIA (Fever 103.0), CHILLS (Chills), NAUSEA (Nausea) and MYALGIA (Body aches) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced DYSPNOEA (Shortness of breath), PYREXIA (Fever 103.0), CHILLS (Chills), NAUSEA (Nausea), MYALGIA (Body aches) and HEADACHE (Severe pain in left side of head). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, DYSPNOEA (Shortness of breath), PYREXIA (Fever 103.0), CHILLS (Chills), NAUSEA (Nausea), MYALGIA (Body aches) and HEADACHE (Severe pain in left side of head) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Feb-2021, Pyrexia: 103 High. On 03-Feb-2021, COVID-19: Negative. 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 concomitant medication was provided.

Other Meds:

Current Illness:

ID: 1556254
Sex: F
Age: 72
State: NC

Vax Date: 02/18/2021
Onset Date: 02/22/2021
Rec V Date: 08/14/2021
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: hoarseness; This spontaneous case was reported by a consumer and describes the occurrence of DYSPHONIA (hoarseness) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2021, the patient experienced DYSPHONIA (hoarseness). At the time of the report, DYSPHONIA (hoarseness) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications were reported. No treatment information was provided. Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: received on 14 JULY 2021 and 2nd dose details added without any AE . event outcome updated.

Other Meds:

Current Illness:

ID: 1556255
Sex: F
Age:
State: WA

Vax Date:
Onset Date:
Rec V Date: 08/14/2021
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: painful to use arm; left leg is not working; severe fatigue; attacked the muscle in upper arm and now locked; attacked left hip joint and pain is so intense; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (painful to use arm), LIMB DISCOMFORT (left leg is not working), FATIGUE (severe fatigue), MYALGIA (attacked the muscle in upper arm and now locked) and ARTHRALGIA (attacked left hip joint and pain is so intense) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (painful to use arm), LIMB DISCOMFORT (left leg is not working), FATIGUE (severe fatigue), MYALGIA (attacked the muscle in upper arm and now locked) and ARTHRALGIA (attacked left hip joint and pain is so intense). On 29-Jan-2021, FATIGUE (severe fatigue) had resolved. On 30-Jan-2021, PAIN IN EXTREMITY (painful to use arm) and MYALGIA (attacked the muscle in upper arm and now locked) had resolved. On 31-Jan-2021, LIMB DISCOMFORT (left leg is not working) and ARTHRALGIA (attacked left hip joint and pain is so intense) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment information included topical Product, hot/cold compress and injection (steroid or pain killer) administered by orthopedic doctor. No concomitant medication was provided. This case was linked to MOD-2021-090574 (Patient Link).

Other Meds:

Current Illness:

ID: 1556256
Sex: F
Age: 60
State: MO

Vax Date: 02/16/2021
Onset Date: 02/20/2021
Rec V Date: 08/14/2021
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: Wasnt feeling good; Headache; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Wasnt feeling good), HEADACHE (Headache) and NAUSEA (Nausea) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. No Medical History information was reported. On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, the patient experienced FEELING ABNORMAL (Wasnt feeling good), HEADACHE (Headache) and NAUSEA (Nausea). At the time of the report, FEELING ABNORMAL (Wasnt feeling good), HEADACHE (Headache) and NAUSEA (Nausea) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported.No treatment information was provided.

Other Meds:

Current Illness:

ID: 1556257
Sex: F
Age:
State: TX

Vax Date: 02/23/2021
Onset Date:
Rec V Date: 08/14/2021
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: Numb mouth and tongue; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA ORAL (Numb mouth and tongue) and FATIGUE (Tiredness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination. No Medical History information was reported. On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HYPOAESTHESIA ORAL (Numb mouth and tongue) and FATIGUE (Tiredness). At the time of the report, HYPOAESTHESIA ORAL (Numb mouth and tongue) and FATIGUE (Tiredness) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment information was provided. No concomitant medication was provided. Most recent FOLLOW-UP information incorporated above includes: On 15-Jul-2021: TCR form received on 15-JUL-2021. Patient does not consent to further contact.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. However, details including the medical history, concomitant medications, diagnostics/ treatment administered is required for further analysis.

Other Meds:

Current Illness:

ID: 1556258
Sex: F
Age:
State: MI

Vax Date: 01/30/2021
Onset Date: 01/30/2021
Rec V Date: 08/14/2021
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: Feeling unwell; Slept for 13 hours; Felt like she was beaten with a stick, Aching, whole body aching , body ache; Cant get her breathe; Dizzy; Havent gotten better; So weak; Feeling tired, Fatigued, Cant be up more than 10 minutes; Headaches; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Feeling unwell), HYPERSOMNIA (Slept for 13 hours), PAIN (Felt like she was beaten with a stick, Aching, whole body aching , body ache), DYSPNOEA (Cant get her breathe) and DIZZINESS (Dizzy) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included HYDROCODONE for Pain, INSULIN LISPRO (HUMALOG), LOSARTAN, DULOXETINE, LEVOTHYROXINE, GABAPENTIN, VITAMIN D3, VITAMIN B12 NOS, SIMVASTATIN, HYDROCHLOROTHIAZIDE and FLUOCINONIDE for an unknown indication. On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, the patient experienced MALAISE (Feeling unwell), HYPERSOMNIA (Slept for 13 hours), PAIN (Felt like she was beaten with a stick, Aching, whole body aching , body ache), DYSPNOEA (Cant get her breathe), DIZZINESS (Dizzy), FEELING ABNORMAL (Havent gotten better), ASTHENIA (So weak), FATIGUE (Feeling tired, Fatigued, Cant be up more than 10 minutes) and HEADACHE (Headaches). At the time of the report, MALAISE (Feeling unwell), HYPERSOMNIA (Slept for 13 hours), PAIN (Felt like she was beaten with a stick, Aching, whole body aching , body ache), DYSPNOEA (Cant get her breathe), DIZZINESS (Dizzy), FEELING ABNORMAL (Havent gotten better), ASTHENIA (So weak), FATIGUE (Feeling tired, Fatigued, Cant be up more than 10 minutes) and HEADACHE (Headaches) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment medications were provided by the reporter. Most recent FOLLOW-UP information incorporated above includes: On 16-Feb-2021: Follow up received: Reporter's address was updated, Con-meds and treatment medication updated. On 12-Jul-2021: Non significant FU_Received

Other Meds: HUMALOG; LOSARTAN; DULOXETINE; LEVOTHYROXINE; GABAPENTIN; VITAMIN D3; VITAMIN B12 NOS; SIMVASTATIN; HYDROCODONE; HYDROCHLOROTHIAZIDE; FLUOCINONIDE

Current Illness:

ID: 1556259
Sex: F
Age: 59
State: TX

Vax Date: 02/03/2021
Onset Date: 02/25/2021
Rec V Date: 08/14/2021
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: administration error (vaccine brands interchanged for 1st and 2nd doses); A spontaneous report was received from a physician concerning, a 59-year-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced administration error as the vaccine brands interchanged for 1st and 2nd doses. The patient's medical history was not provided by the reporter. Concomitant product use was not provided by the reporter. On 03 Feb 2021, the patient received the first of two planned doses of mRNA-1273 (Lot number: unknown) for prophylaxis of COVID-19 infection at a different site. On 25 Feb 2021, the patient was given the Pfizer vaccine for their second dose at the pharmacy in the reporter's facility. Treatment information for the event was not provided by the reporter. Action taken with mRNA-1273 in response to the event was unknown. On 25 Feb 2021, the outcome of the event administration error as the vaccine brands interchanged for 1st and 2nd doses was considered resolved.; Reporter's Comments: This report refers to a case of wrong vaccine administered for mRNA-1273, lot # unknown with no associated AEs.

Other Meds:

Current Illness:

ID: 1556260
Sex: F
Age: 75
State: PA

Vax Date: 01/27/2021
Onset Date: 02/25/2021
Rec V Date: 08/14/2021
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: Frequent urination; This spontaneous case was reported by a consumer and describes the occurrence of POLLAKIURIA (Frequent urination) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20A and 014M20A) for COVID-19 vaccination. The patient's past medical history included Cystitis interstitial. On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Feb-2021, the patient experienced POLLAKIURIA (Frequent urination). The patient was treated with IBUPROFEN at a dose of UNK dosage form. At the time of the report, POLLAKIURIA (Frequent urination) outcome was unknown. No concomitant medication was provided. Action taken with mRNA-1273 in response to the event was not applicable.

Other Meds:

Current Illness:

ID: 1556261
Sex: M
Age: 65
State: NJ

Vax Date: 02/23/2021
Onset Date: 02/23/2021
Rec V Date: 08/14/2021
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: felt a little woozy; severe fatigue; a little nausea; could not see straight; This spontaneous case was reported by a physician and describes the occurrence of VISUAL IMPAIRMENT (could not see straight), DIZZINESS (felt a little woozy), FATIGUE (severe fatigue) and NAUSEA (a little nausea) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination. No Medical History information was reported. On 23-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, the patient experienced VISUAL IMPAIRMENT (could not see straight), FATIGUE (severe fatigue) and NAUSEA (a little nausea). On 24-Feb-2021, the patient experienced DIZZINESS (felt a little woozy). On 25-Feb-2021, VISUAL IMPAIRMENT (could not see straight), DIZZINESS (felt a little woozy), FATIGUE (severe fatigue) and NAUSEA (a little nausea) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were reported.No treatment information was provided.Action taken with mRNA-1273 in response to the events was not applicable.

Other Meds:

Current Illness:

ID: 1556262
Sex: M
Age: 65
State: MI

Vax Date: 01/21/2021
Onset Date: 01/24/2021
Rec V Date: 08/14/2021
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: severe cramps; chiils; headache; body ache; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (severe cramps), CHILLS (chiils), HEADACHE (headache) and MYALGIA (body ache) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L2EA) for COVID-19 vaccination. No Medical History information was reported. On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jan-2021, the patient experienced MUSCLE SPASMS (severe cramps), CHILLS (chiils), HEADACHE (headache) and MYALGIA (body ache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, MUSCLE SPASMS (severe cramps), CHILLS (chiils), HEADACHE (headache) and MYALGIA (body ache) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medication was provided.

Other Meds:

Current Illness:

ID: 1556263
Sex: F
Age: 71
State: NY

Vax Date: 01/28/2021
Onset Date: 01/29/2021
Rec V Date: 08/14/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: itchy sensation near injection site; Injection site rash; swelling (hardness) near injection site; Painful arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Painful arm), VACCINATION SITE PRURITUS (itchy sensation near injection site), VACCINATION SITE RASH (Injection site rash) and VACCINATION SITE SWELLING (swelling (hardness) near injection site) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination. No medical history was provided by the reporter. On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced PAIN IN EXTREMITY (Painful arm). On 04-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (itchy sensation near injection site), VACCINATION SITE RASH (Injection site rash) and VACCINATION SITE SWELLING (swelling (hardness) near injection site). The patient was treated with CORTISONE at a dose of 1 dosage form. On 31-Jan-2021, PAIN IN EXTREMITY (Painful arm) had resolved. At the time of the report, VACCINATION SITE PRURITUS (itchy sensation near injection site), VACCINATION SITE RASH (Injection site rash) and VACCINATION SITE SWELLING (swelling (hardness) near injection site) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No relevant concomitant medications reported.

Other Meds:

Current Illness:

ID: 1556264
Sex: F
Age:
State: NJ

Vax Date: 01/27/2021
Onset Date: 02/07/2021
Rec V Date: 08/14/2021
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: pain; injection site rash; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (pain) and VACCINATION SITE RASH (injection site rash) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination. Concomitant products included ACETYLSALICYLIC ACID and VITAMIN D [VITAMIN D NOS] for an unknown indication. On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Feb-2021, the patient experienced PAIN (pain) and VACCINATION SITE RASH (injection site rash). At the time of the report, PAIN (pain) and VACCINATION SITE RASH (injection site rash) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Treatment information was not provided. Most recent FOLLOW-UP information incorporated above includes: On 08-Feb-2021: follow up received on 08-feb-2021,Email address updated, 1st shot on 21-jan-2021 updated, batch no of drug updated , concomitant medication baby aspirin, vitamin d updated ,event rash from forage to forage of left arm site of injection on 7-feb-2021 updated On 09-Feb-2021: follow up recived on 9-feb-2021,Caller called to provide the correct date of vaccine administration which is 27Jan2021 instead of 21-jan-2021, On 21-Apr-2021: followup received on 21-apr-2021,Contact information updated

Other Meds: ACETYLSALICYLIC ACID; VITAMIN D [VITAMIN D NOS]

Current Illness:

ID: 1556265
Sex: M
Age:
State: CA

Vax Date: 01/13/2021
Onset Date:
Rec V Date: 08/14/2021
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: pain that goes up his neck; pain which went into his left shoulder in the joint; mild fever; gives a mild headache; sore at the injection site; muscle ache; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (pain that goes up his neck), ARTHRALGIA (pain which went into his left shoulder in the joint), PYREXIA (mild fever), HEADACHE (gives a mild headache) and VACCINATION SITE PAIN (sore at the injection site) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was provided by the reporter. Concomitant products included ATENOLOL, MULTIVITAMIN & MINERAL, FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR), Albuterol Inhaler, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) and ASCORBIC ACID, ROSA CANINA FRUIT (VITAMIN C & ROSEHIP) for an unknown indication. On 13-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 NECK PAIN (pain that goes up his neck), ARTHRALGIA (pain which went into his left shoulder in the joint), PYREXIA (mild fever), HEADACHE (gives a mild headache), VACCINATION SITE PAIN (sore at the injection site) and MYALGIA (muscle ache). At the time of the report, NECK PAIN (pain that goes up his neck), ARTHRALGIA (pain which went into his left shoulder in the joint), PYREXIA (mild fever), HEADACHE (gives a mild headache), VACCINATION SITE PAIN (sore at the injection site) and MYALGIA (muscle ache) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds: ATENOLOL; MULTIVITAMIN & MINERAL; ADVAIR; Albuterol Inhaler; ASPIRIN (E.C.); VITAMIN D 2000; VITAMIN C & ROSEHIP

Current Illness:

ID: 1556266
Sex: F
Age: 65
State:

Vax Date: 02/02/2021
Onset Date: 02/02/2021
Rec V Date: 08/14/2021
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: Flu like symptoms; Chills; Joint pain; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms), CHILLS (Chills) and ARTHRALGIA (Joint pain) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms), CHILLS (Chills) and ARTHRALGIA (Joint pain). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms), CHILLS (Chills) and ARTHRALGIA (Joint pain) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication reported. No treatment was provided.

Other Meds:

Current Illness:

ID: 1556267
Sex: U
Age:
State: IL

Vax Date:
Onset Date:
Rec V Date: 08/14/2021
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: Teeth chattering; Fever of 103 Degree Fahrenheit; 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 CHILLS (Teeth chattering) and PYREXIA (Fever of 103 Degree Fahrenheit) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CHILLS (Teeth chattering) and PYREXIA (Fever of 103 Degree Fahrenheit). At the time of the report, CHILLS (Teeth chattering) and PYREXIA (Fever of 103 Degree Fahrenheit) outcome was unknown. Not Provided DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Pyrexia: 103 Fever 103 Degrees Fahrenheit. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment information was provided. No concomitant medication was provided.

Other Meds:

Current Illness:

ID: 1556268
Sex: F
Age:
State: NE

Vax Date: 02/19/2021
Onset Date: 02/19/2021
Rec V Date: 08/14/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site pain

Symptoms: patients received the vaccine and were sick; This spontaneous case was reported by a consumer and describes the occurrence of in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 19-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. 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 assessment. No concomitant medications were reported Treatment information was not provided.

Other Meds:

Current Illness:

ID: 1556269
Sex: F
Age: 90
State: IL

Vax Date: 02/12/2021
Onset Date:
Rec V Date: 08/14/2021
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: turned red for a while; itches; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itches) and ERYTHEMA (turned red for a while) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination. No Medical History information was reported. On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRURITUS (itches) and ERYTHEMA (turned red for a while). At the time of the report, PRURITUS (itches) and ERYTHEMA (turned red for a while) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment information was provided. No concomitant medication was provided.

Other Meds:

Current Illness:

ID: 1556270
Sex: F
Age: 52
State: VA

Vax Date: 01/29/2021
Onset Date: 02/07/2021
Rec V Date: 08/14/2021
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: This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of PRURITUS (itchy), ERYTHEMA (red) and URTICARIA (hives) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. No Medical History information was reported. On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Feb-2021, the patient experienced PRURITUS (itchy), ERYTHEMA (red) and URTICARIA (hives). The patient was treated with ISOPROPANOL (RUBBING ALCOHOL) for Itching, at an unspecified dose and frequency and CORTISONE for Itching, at an unspecified dose and frequency. At the time of the report, PRURITUS (itchy) was resolving and ERYTHEMA (red) and URTICARIA (hives) had not resolved. Not Provided 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 concomitant medication was provided.

Other Meds:

Current Illness:

ID: 1556271
Sex: F
Age: 78
State: VA

Vax Date: 01/27/2021
Onset Date: 01/27/2021
Rec V Date: 08/14/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Tremor

Symptoms: big rash; sore; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN (sore) and RASH (big rash) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concomitant products included APIXABAN (ELIQUIS), VALSARTAN, ROSUVASTATIN, DULOXETINE, ZINC, PROBIOTIC 10, UBIQUINOL and VITAMIN D2 for an unknown indication. On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced PAIN (sore). On 03-Feb-2021, the patient experienced RASH (big rash). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Antihistamine therapy, at an unspecified dose and frequency. On 28-Jan-2021, PAIN (sore) had resolved. At the time of the report, RASH (big rash) had not resolved. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.

Other Meds: ELIQUIS; VALSARTAN; ROSUVASTATIN; DULOXETINE; ZINC; PROBIOTIC 10; UBIQUINOL; VITAMIN D2

Current Illness:

ID: 1556272
Sex: M
Age: 61
State: CA

Vax Date: 01/12/2021
Onset Date: 01/19/2021
Rec V Date: 08/14/2021
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: Lot of gas; Bloating; Very nauseus; Lost appetite; This spontaneous case was reported by a physician and describes the occurrence of DECREASED APPETITE (Lost appetite), FLATULENCE (Lot of gas), ABDOMINAL DISTENSION (Bloating) and NAUSEA (Very nauseus) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concomitant products included TAMSULOSIN HYDROCHLORIDE (FLOMAX [TAMSULOSIN HYDROCHLORIDE]) and OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]) for an unknown indication. On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced DECREASED APPETITE (Lost appetite) and NAUSEA (Very nauseus). On 25-Jan-2021, the patient experienced FLATULENCE (Lot of gas) and ABDOMINAL DISTENSION (Bloating). At the time of the report, DECREASED APPETITE (Lost appetite), FLATULENCE (Lot of gas), ABDOMINAL DISTENSION (Bloating) and NAUSEA (Very nauseus) 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. No treatment information was provided.

Other Meds: FLOMAX [TAMSULOSIN HYDROCHLORIDE]; PRILOSEC [OMEPRAZOLE]

Current Illness:

ID: 1556273
Sex: F
Age: 40
State: AZ

Vax Date: 02/12/2021
Onset Date: 02/12/2021
Rec V Date: 08/14/2021
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: Lump; Huge Red Welt; Super itchy; Tender; Super Red; This spontaneous case was reported by a consumer and describes the occurrence of AXILLARY MASS (Lump), URTICARIA (Huge Red Welt), VACCINATION SITE ERYTHEMA (Super Red), VACCINATION SITE PRURITUS (Super itchy) and VACCINATION SITE PAIN (Tender) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination. No Medical History information was reported. On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (Super Red) and VACCINATION SITE PAIN (Tender). On an unknown date, the patient experienced AXILLARY MASS (Lump), URTICARIA (Huge Red Welt) and VACCINATION SITE PRURITUS (Super itchy). At the time of the report, AXILLARY MASS (Lump), URTICARIA (Huge Red Welt), VACCINATION SITE ERYTHEMA (Super Red), VACCINATION SITE PRURITUS (Super itchy) and VACCINATION SITE PAIN (Tender) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment information was provided. No concomitant medication was provided.

Other Meds:

Current Illness:

ID: 1556274
Sex: M
Age: 82
State: IA

Vax Date: 01/26/2021
Onset Date: 01/26/2021
Rec V Date: 08/14/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: A little bit of sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (A little bit of sore arm) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination. The patient's past medical history included No adverse event (No medical history reported). Concomitant products included PARACETAMOL (TYLENOL) 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 PAIN IN EXTREMITY (A little bit of sore arm). At the time of the report, PAIN IN EXTREMITY (A little bit of sore arm) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds: TYLENOL

Current Illness:

ID: 1556275
Sex: M
Age: 56
State: WV

Vax Date: 02/05/2021
Onset Date: 02/05/2021
Rec V Date: 08/14/2021
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: Physical aches; Just felt miserable; Extreme fatigue worse than COVID-19 just felt miserable; Higher fever 100.8; Some fatigue; Low grade fever 99.4; General ache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (General ache), PAIN (Physical aches), FEELING ABNORMAL (Just felt miserable), PYREXIA (Low grade fever 99.4) and FATIGUE (Extreme fatigue worse than COVID-19 just felt miserable) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COVID-19 virus test positive (On 14Dec21 he tested positive for COVID 19.) on 14-Dec-2020. On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced PAIN (General ache), PYREXIA (Low grade fever 99.4) and FATIGUE (Some fatigue). On 06-Feb-2021, the patient experienced PAIN (Physical aches), FEELING ABNORMAL (Just felt miserable), FATIGUE (Extreme fatigue worse than COVID-19 just felt miserable) and PYREXIA (Higher fever 100.8). On 07-Feb-2021, PAIN (General ache), PAIN (Physical aches), FEELING ABNORMAL (Just felt miserable), PYREXIA (Low grade fever 99.4), FATIGUE (Extreme fatigue worse than COVID-19 just felt miserable), PYREXIA (Higher fever 100.8) and FATIGUE (Some fatigue) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Feb-2020, Body temperature: 99.4 ?F (High) Low grade fever. On 06-Feb-2021, Body temperature: 100.8 ?F (High) High grade fever. On 14-Dec-2021, SARS-CoV-2 test: positive (Positive) Positive. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were provided. Treatment medications were unknown.

Other Meds:

Current Illness:

ID: 1556276
Sex: F
Age: 83
State:

Vax Date: 02/19/2021
Onset Date: 02/20/2021
Rec V Date: 08/14/2021
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: blood pressue 240; hand and foot wouldn't move; weakness; very sick nauseous; mass of diarrhea; bad headache; very dizzy; very cold; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (mass of diarrhea) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination. Concomitant products included ERGOCALCIFEROL, RETINOL PALMITATE (VITAMINS A & D), ACETYLSALICYLIC ACID (BABY ASPIRIN), LORAZEPAM, PROBIOTICS NOS, OMEPRAZOLE, METOPROLOL TARTRATE (LOPRESSOR) and ATORVASTATIN CALCIUM (LIPITOR) for an unknown indication. On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, the patient experienced DIARRHOEA (mass of diarrhea). At the time of the report, DIARRHOEA (mass of diarrhea) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment medications were unknown.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.

Other Meds: VITAMINS A & D; BABY ASPIRIN; LORAZEPAM; PROBIOTICS NOS; OMEPRAZOLE; LOPRESSOR; LIPITOR

Current Illness:

ID: 1556277
Sex: F
Age: 24
State: TX

Vax Date: 03/09/2021
Onset Date: 07/15/2021
Rec V Date: 08/14/2021
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: Vantin

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

Symptoms: Skin rash all over body, followed by dry peeling skin, now acne on face

Other Meds: Sprintec

Current Illness:

ID: 1556278
Sex: F
Age: 58
State: AZ

Vax Date: 07/25/2021
Onset Date: 07/26/2021
Rec V Date: 08/14/2021
Hospital:

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

Lab Data:

Allergies: Vicodin

Symptom List: Pain in extremity

Symptoms: Nausea vomiting couldn't hardly walk hip pain legs ache n head pounding puking dehydration wheezing

Other Meds: Budesonide Ventolin HFA

Current Illness:

ID: 1556279
Sex: F
Age: 73
State: GA

Vax Date: 01/18/2021
Onset Date: 01/25/2021
Rec V Date: 08/14/2021
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: INJECTION SITE ITCHING; rash around the injection site, getting worse, around 3-4 inches in size; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PRURITUS (INJECTION SITE ITCHING) and INJECTION SITE RASH (rash around the injection site, getting worse, around 3-4 inches in size) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination. Concurrent medical conditions included Allergy. Concomitant products included TIOTROPIUM BROMIDE (SPIRIVA HANDIHALER), LEVOTHYROXINE SODIUM (SYNTHROID), FAMOTIDINE, CLONIDINE, MACROGOL 3350 (MIRALAX), ACETYLSALICYLIC ACID (BABY ASPIRIN) and CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) for an unknown indication. On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jan-2021, the patient experienced INJECTION SITE PRURITUS (INJECTION SITE ITCHING) and INJECTION SITE RASH (rash around the injection site, getting worse, around 3-4 inches in size). At the time of the report, INJECTION SITE PRURITUS (INJECTION SITE ITCHING) and INJECTION SITE RASH (rash around the injection site, getting worse, around 3-4 inches in size) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Treatment details included Benadryl ointment

Other Meds: SPIRIVA HANDIHALER; SYNTHROID; FAMOTIDINE; CLONIDINE; MIRALAX; BABY ASPIRIN; VITAMIN D 2000

Current Illness: Allergy

ID: 1556280
Sex: F
Age: 76
State: AL

Vax Date: 01/12/2021
Onset Date: 01/12/2021
Rec V Date: 08/14/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: rash at the injection site; injection site hard; injection site swelling; a bump at the injection site; itching at the injection site; arm hurt; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm hurt), VACCINATION SITE RASH (rash at the injection site), VACCINATION SITE INDURATION (injection site hard), INJECTION SITE SWELLING (injection site swelling) and VACCINATION SITE MASS (a bump at the injection site) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included OMEPRAZOLE, SIMVASTATIN, ROPINIROLE and TRAMADOL for an unknown indication. On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On 12-Jan-2021, the patient experienced PAIN IN EXTREMITY (arm hurt). On an unknown date, the patient experienced VACCINATION SITE RASH (rash at the injection site), VACCINATION SITE INDURATION (injection site hard), INJECTION SITE SWELLING (injection site swelling), VACCINATION SITE MASS (a bump at the injection site) and INJECTION SITE PRURITUS (itching at the injection site). On 15-Jan-2021, PAIN IN EXTREMITY (arm hurt) had resolved. At the time of the report, VACCINATION SITE RASH (rash at the injection site), VACCINATION SITE INDURATION (injection site hard), INJECTION SITE SWELLING (injection site swelling), VACCINATION SITE MASS (a bump at the injection site) and INJECTION SITE PRURITUS (itching at the injection site) had not 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. Treatment reported- Aleve for the symptoms Other concomitant medications included- medicine for constipation as needed and medicine for reflux. Most recent FOLLOW-UP information incorporated above includes: On 14-May-2021: TCR: 2 reactions from shot, call back.

Other Meds: OMEPRAZOLE; SIMVASTATIN; ROPINIROLE; TRAMADOL

Current Illness:

ID: 1556281
Sex: M
Age:
State: CA

Vax Date: 02/01/2021
Onset Date: 02/01/2021
Rec V Date: 08/14/2021
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: pain on the injection site; more tired than normally do; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (pain on the injection site) and FATIGUE (more tired than normally do) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. No Medical History information was reported. On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced VACCINATION SITE PAIN (pain on the injection site) and FATIGUE (more tired than normally do). On 01-Feb-2021, VACCINATION SITE PAIN (pain on the injection site) and FATIGUE (more tired than normally do) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No relevant concomitant medications were reported. No treatment information was provided.

Other Meds:

Current Illness:

ID: 1556282
Sex: F
Age: 80
State: AZ

Vax Date: 01/15/2021
Onset Date: 01/22/2021
Rec V Date: 08/14/2021
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: area where vaccine was administered stareted to itch; VERY RED; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (area where vaccine was administered stareted to itch) and VACCINATION SITE ERYTHEMA (VERY RED) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The patient's past medical history included Mastectomy (Mastectomy and Lymph nodes removal (Left.). Concurrent medical conditions included Drug allergy (Allergic to Sulfas, Penicillin, codeine, Iodine, Tetracycline) and Allergy (Dust and Sprouts). On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (area where vaccine was administered stareted to itch) and VACCINATION SITE ERYTHEMA (VERY RED). The patient was treated with DIPHENHYDRAMINE, PARACETAMOL, PHENYLPROPANOLAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE;PARACETAMOL;PHENYLPROPANOLAMINE HYDROCHLORIDE]) (oral) at an unspecified dose and frequency and CAMPHOR, DIPHENHYDRAMINE HYDROCHLORIDE, ZINC OXIDE (BENADRYL SKIN ALLERGY RELIEF) (topical) at an unspecified dose and frequency. On 22-Jan-2021, VACCINATION SITE PRURITUS (area where vaccine was administered stareted to itch) had resolved and VACCINATION SITE ERYTHEMA (VERY RED) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were provided.. The treatment Benadryl Skin Allergy was applied topically via spay.

Other Meds:

Current Illness:

ID: 1556283
Sex: F
Age: 68
State: TX

Vax Date: 01/27/2021
Onset Date: 01/27/2021
Rec V Date: 08/14/2021
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: extremally dizzy; all of sudden felt down; felt icky; No energy; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (extremally dizzy), FALL (all of sudden felt down), FEELING ABNORMAL (felt icky) and ASTHENIA (No energy) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M20A and 012A21A) for COVID-19 vaccination. Concomitant products included CALCIUM, MAGNESIUM and ZINC for an unknown indication. On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Jan-2021, the patient experienced DIZZINESS (extremally dizzy), FALL (all of sudden felt down), FEELING ABNORMAL (felt icky) and ASTHENIA (No energy). At the time of the report, DIZZINESS (extremally dizzy) and FALL (all of sudden felt down) had resolved and FEELING ABNORMAL (felt icky) and ASTHENIA (No energy) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Additional concomitant medication included Vitamin C for an unknown indication. Follow up received on April 30 included additional events of feeling abnormal(feeling icky) and asthenia (low energy) and dose 2 events which will be reported in a separate report with case # MOD-2021-100848. Action taken with mRNA-1273 in response to the events was not Applicable. This case was linked to MOD-2021-100848 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: Follow up was received on 30 Apr 2021 included New AE added

Other Meds: CALCIUM; MAGNESIUM; ZINC

Current Illness:

ID: 1556284
Sex: F
Age:
State: CA

Vax Date: 02/03/2021
Onset Date: 02/03/2021
Rec V Date: 08/14/2021
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: Tenderness; Pupil contracted to almost nothing; Arm hurting little bit; This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (Tenderness), MIOSIS (Pupil contracted to almost nothing) and PAIN IN EXTREMITY (Arm hurting little bit) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination. No Medical History information was reported. On 03-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced TENDERNESS (Tenderness), MIOSIS (Pupil contracted to almost nothing) and PAIN IN EXTREMITY (Arm hurting little bit). On 04-Feb-2021, TENDERNESS (Tenderness), MIOSIS (Pupil contracted to almost nothing) and PAIN IN EXTREMITY (Arm hurting little bit) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were provided. Treatment medications were unknown.

Other Meds:

Current Illness:

ID: 1556285
Sex: F
Age:
State: AR

Vax Date: 01/28/2021
Onset Date: 01/28/2021
Rec V Date: 08/14/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site swelling, Limb discomfort

Symptoms: mildly painful to move her arm; hard in areas underneath; a lot more itchy; hot; huge area of redness; it was bumpy; nauseated; a little bit of redness/erythema; arm was itchy at the injection site; irritating; muscle aches; chills; fatigue; painful to move arm around shoulder; injection site was warm and hot to touch, swollen, hard, bumpy, itching.; injection site was warm and hot to touch, swollen, hard, bumpy, itching.; injection site was warm and hot to touch, swollen, hard, bumpy, itching.; redness, swelling, pain at the site; redness, swelling, pain at the site; redness, swelling, pain at the site; This spontaneous case was reported by a nurse and describes the occurrence of PAIN IN EXTREMITY (mildly painful to move her arm), INDURATION (hard in areas underneath), PRURITUS (a lot more itchy), FEELING HOT (hot) and SKIN IRRITATION (irritating) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, the patient experienced VACCINATION SITE SWELLING (redness, swelling, pain at the site), VACCINATION SITE ERYTHEMA (redness, swelling, pain at the site) and VACCINATION SITE PAIN (redness, swelling, pain at the site). On 29-Jan-2021, the patient experienced MYALGIA (muscle aches), CHILLS (chills), FATIGUE (fatigue), ARTHRALGIA (painful to move arm around shoulder), VACCINATION SITE WARMTH (injection site was warm and hot to touch, swollen, hard, bumpy, itching.) and VACCINATION SITE INDURATION (injection site was warm and hot to touch, swollen, hard, bumpy, itching.). 29-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (injection site was warm and hot to touch, swollen, hard, bumpy, itching.). On 31-Jan-2021, the patient experienced SKIN IRRITATION (irritating). On 04-Feb-2021, the patient experienced ERYTHEMA (a little bit of redness/erythema) and VACCINATION SITE PRURITUS (arm was itchy at the injection site). On 05-Feb-2021, the patient experienced PAIN IN EXTREMITY (mildly painful to move her arm), INDURATION (hard in areas underneath), PRURITUS (a lot more itchy), FEELING HOT (hot), ERYTHEMA (huge area of redness), SKIN MASS (it was bumpy) and NAUSEA (nauseated). At the time of the report, PAIN IN EXTREMITY (mildly painful to move her arm), PRURITUS (a lot more itchy), FEELING HOT (hot), SKIN IRRITATION (irritating), ERYTHEMA (a little bit of redness/erythema), ERYTHEMA (huge area of redness), VACCINATION SITE SWELLING (redness, swelling, pain at the site), VACCINATION SITE PAIN (redness, swelling, pain at the site), MYALGIA (muscle aches), CHILLS (chills) and VACCINATION SITE WARMTH (injection site was warm and hot to touch, swollen, hard, bumpy, itching.) had resolved and INDURATION (hard in areas underneath), SKIN MASS (it was bumpy), VACCINATION SITE ERYTHEMA (redness, swelling, pain at the site), FATIGUE (fatigue), ARTHRALGIA (painful to move arm around shoulder), VACCINATION SITE PRURITUS (arm was itchy at the injection site) and NAUSEA (nauseated) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments. Treatment for the event was triamcinolone cream, Keflex, warm compresses, Tylenol. It has gotten better. The second dose of mRNA-1273 was temporarily withheld in response to the event.

Other Meds:

Current Illness:

ID: 1556286
Sex: U
Age:
State: TX

Vax Date:
Onset Date:
Rec V Date: 08/14/2021
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: Chills, Diarrhoea, Fatigue, Feeling abnormal, Headache

Symptoms: vaccination site rash; vaccination site pain; vaccination site pruritus; vaccination site warmth; vaccination site swelling; A report was received from a consumer concerning a patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and who experienced rash at the injection site, pain at the injection site, itching at the injection site, warmth at the injection site and swelling at the injection site. The patient's medical history was not reported . Concomitant medications were not reported. On 08-Jan-2021, the patient received their first of two planned doses of mRNA-1273 intramuscularly for COVID-19 prophylaxis. On an undisclosed date, the patient experienced rash at the injection site, pain at the injection site, itching at the injection site, warmth at the injection site and swelling at the injection site and went to the Dermatologist. The treatment given was not reported. Action taken with mRNA-1273 in response to the event(s) was not reported. The outcome of the event was unknown. Patient consented to follow-up.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.Further information has been requested.

Other Meds:

Current Illness:

ID: 1556287
Sex: F
Age: 70
State: ME

Vax Date: 02/24/2021
Onset Date: 02/24/2021
Rec V Date: 08/14/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: their upper arm was painful.; achy on the arm of the vaccine, their upper arm was painful.; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (their upper arm was painful.) and VACCINATION SITE PAIN (achy on the arm of the vaccine, their upper arm was painful.) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination. Concomitant products included METFORMIN, DILTIAZEM, LOSARTAN, ROSUVASTATIN, OMEPRAZOLE, LISINOPRIL, ACETYLSALICYLIC ACID (BABY ASPIRIN), FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR) and ISOSORBIDE MONONITRATE (ISOSORBIDE MONONITE) for an unknown indication. On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, the patient experienced PAIN IN EXTREMITY (their upper arm was painful.) and VACCINATION SITE PAIN (achy on the arm of the vaccine, their upper arm was painful.). At the time of the report, PAIN IN EXTREMITY (their upper arm was painful.) and VACCINATION SITE PAIN (achy on the arm of the vaccine, their upper arm was painful.) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Treatment medications were not provided.

Other Meds: METFORMIN; DILTIAZEM; LOSARTAN; ROSUVASTATIN; OMEPRAZOLE; LISINOPRIL; BABY ASPIRIN; ADVAIR; ISOSORBIDE MONONITE

Current Illness:

Total 2021 VAERS Injuries: 636,615

Page last modified: 03 October 2021 5:28pm