VAERS 2021 Database www.vaers.hhs.gov

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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: 1313167
Sex: M
Age: 46
State:

Vax Date: 09/29/2020
Onset Date: 09/29/2020
Rec V Date: 05/13/2021
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: Patient under 65 received Fluad QIV; Aches; Injection site pain; Chills; Muscle soreness; This spontaneous case received on 05-Nov-2020 from other health professional (nurse) via Agency (reference number: SEQW20-04830) and concerned a 46-year-old, male patient. The patient had no relevant medical history. The patient's concomitant medications were not reported. On 29-Sep-2020, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, MF59, dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid) (explicitly coded as 'Inappropriate age at vaccine administration') for influenza prophylaxis. The batch number reported was 286592. On an unspecified date in 2020, unknown time after receiving Fluad Quadrivalent, the patient experienced injection site pain, muscle soreness, aches and chills. The patient's corrective treatment associated with the events included Tylenol (paracetamol), ibuprofen and Sudafed (xylometazoline hydrochloride). The outcome of the events was not reported. The reporter did not provide a causality assessment. The case was assessed as non-serious. The case is linked to the cases 202004845, 202006068, 202006069, 202006072, 202006074, 202006080, 202006081, 202006084, 202006085, 202006086, 202006087, 202006089, 202006090, 202006091, 202006092, 202006095, 202006097 and 202006098 (the same reporter). Company comment: A 46-year-old, male patient was vaccinated with Fluad Quadrivalent. An unknown amount of time after receiving Fluad Quadrivalent, the patient developed pain, chills, myalgia and vaccination site pain. With information available, causal role of the suspect vaccine is assessed as possibly related. Product administered to patient of inappropriate age is assessed as not related, per company's conventions.; Sender's Comments: A 46-year-old, male patient was vaccinated with Fluad Quadrivalent. An unknown amount of time after receiving Fluad Quadrivalent, the patient developed pain, chills, myalgia and vaccination site pain. With information available, causal role of the suspect vaccine is assessed as possibly related. Product administered to patient of inappropriate age is assessed as not related, per company's conventions.

Other Meds:

Current Illness:

ID: 1313168
Sex: F
Age: 33
State:

Vax Date: 09/29/2020
Onset Date: 09/29/2020
Rec V Date: 05/13/2021
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: Patient under 65 received Fluad QIV; Soreness in the arm; Fever; This spontaneous case received on 05-Nov-2020 from other health professional (nurse) via Agency (reference number: SEQW20-04815) and concerned a 33-year-old, female patient. The patient had no relevant medical history. The patient's concomitant medications were not reprorted. On 29-Sep-2020, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, MF59, dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid) (explicitly coded as 'Inappropriate age at vaccine administration') for influneza prophylaxis. The batch number reported was 286592. . On an unspecified date in 2020, unknown time after receiving Fluad Quadrivalent, the patient experienced soreness in the arm and fever. There was no corrective treatment The outcome of the events was not reported. The reporter did not provide a causality assessment. The case was assessed as non-serious. The case is linked to the cases 202004845, 202006068, 202006069, 202006072, 202006074, 202006077, 202006080, 202006081, 202006084, 202006085, 202006086, 202006087, 202006089, 202006090, 202006091, 202006092, 202006095, 202006097 and 202006098 (the same reporter). Company comment: A 33-year-old, female patient was vaccinated with Fluad Quadrivalent. An unknown amount of time after receiving Fluad Quadrivalent, the patient experienced pain in extremity and pyrexia. With information available, causal role of the suspect vaccine is assessed as possibly related. Product administered to patient of inappropriate age is assessed as not related, per company's conventions.; Sender's Comments: A 33-year-old, female patient was vaccinated with Fluad Quadrivalent. An unknown amount of time after receiving Fluad Quadrivalent, the patient experienced pain in extremity and pyrexia. With information available, causal role of the suspect vaccine is assessed as possibly related. Product administered to patient of inappropriate age is assessed as not related, per company's conventions.

Other Meds:

Current Illness:

ID: 1313169
Sex: F
Age: 41
State:

Vax Date: 09/29/2020
Onset Date: 09/29/2020
Rec V Date: 05/13/2021
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: Very sore; Immediately hot at the injection site; Patient under 65 received Fluad QIV; This spontaneous case received on 05-Nov-2020 from other health professional (nurse) via Agency (reference number: SEQW20-04783) and concerned a 41-year-old, female patient. The patient had no relevant medical history. The patient's concomitant medications were not reported. On 29-Sep-2020, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, MF59, dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid) (explicitly coded as 'Inappropriate age at vaccine administration') for influenza prophylaxis. The batch number reported was 286592. On the same day, immediately after receiving Fluad Quadrivalent, the patient felt very sore and hot at the injection site. The patient did not receive any corrective treatment. The outcome of the events was not reported. The reporter did not provide a causality assessment. The case was assessed as non-serious. The case is linked to the cases 202004845, 202006068, 202006069, 202006072, 202006074, 202006077, 202006080, 202006084, 202006085, 202006086, 202006087, 202006089, 202006090, 202006091, 202006092, 202006095, 202006097 and 202006098 (the same reporter). Company comment: A 41-year-old, female patient was vaccinated with Fluad Quadrivalent. On the same day, immediately after receiving Fluad Quadrivalent, the patient developed pain and vaccination site warmth. With information available, causal role of the suspect vaccine is assessed as possibly related. Product administered to patient of inappropriate age is assessed as not related, per company's conventions.; Sender's Comments: A 41-year-old, female patient was vaccinated with Fluad Quadrivalent. On the same day, immediately after receiving Fluad Quadrivalent, the patient developed pain and vaccination site warmth. With information available, causal role of the suspect vaccine is assessed as possibly related. Product administered to patient of inappropriate age is assessed as not related, per company's conventions.

Other Meds:

Current Illness:

ID: 1313170
Sex: M
Age: 38
State:

Vax Date: 09/29/2020
Onset Date: 09/29/2020
Rec V Date: 05/13/2021
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: Patient under 65 received Fluad QIV; Very sore arm; Headache; This spontaneous case received on 05-Nov-2020 from other health professional (nurse) via Agency (reference number: SEQW20-04842) and concerned a 38-year-old, male patient. The patient had no relevant medical history. The patient's concomitant medications were not reprorted. On 29-Sep-2020, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, MF59, dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid) (explicitly coded as 'Inappropriate age at vaccine administration') for influenza prophylaxis. The batch number reported was 286592. On an unknown date in 2020, an unspecified amount of time after receiving Fluad Quadrivalent, the patient experienced very sore arm and headache. The patient was treated with ibuprofen. The outcome of events 'painful arm' and headache was not reported. The reporter did not provide causality assessment. The case was assessed as non-serious. The case is linked to the cases 202004845, 202006068, 202006069, 202006072, 202006074, 202006077, 202006080, 202006081, 202006085, 202006086, 202006087, 202006089, 202006090, 202006091, 202006092, 202006095, 202006097 and 202006098 (the same reporter). Company comment: A 38-year-old, male patient was vaccinated with Fluad Quadrivalent. An unknown amount of time after receiving Fluad Quadrivalent, the patient developed pain in extremity and headache. With information available, causal role of the suspect vaccine is assessed as possibly related. Product administered to patient of inappropriate age is assessed as not related, per company's conventions.; Sender's Comments: A 38-year-old, male patient was vaccinated with Fluad Quadrivalent. An unknown amount of time after receiving Fluad Quadrivalent, the patient developed pain in extremity and headache. With information available, causal role of the suspect vaccine is assessed as possibly related. Product administered to patient of inappropriate age is assessed as not related, per company's conventions.

Other Meds:

Current Illness:

ID: 1313171
Sex: F
Age: 40
State:

Vax Date: 09/29/2020
Onset Date: 09/29/2020
Rec V Date: 05/13/2021
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: Patient under 65 received Fluad QIV; Sore arm for 3 days; Chills; Low grade fever; This spontaneous case was received on 05-Nov-2020 from other health professional (nurse) via Agency (reference number: SEQW20-04805) and concerned a 40-year-old, female patient. The patient had no relevant medical history. The patient's concomitant medications were not reported. On 29-Sep-2020, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, MF59, dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid) (explicitly coded as 'Inappropriate age at vaccine administration') for influenza prophylaxis. The batch number reported was 286592. On an unspecified date in 2020, an unknown amount of time after receiving Fluad Quadrivalent, the patient experienced low grade fever and chills, and she developed sore arm . The patient was treated with Tylenol (paracetamol). On an unspecified date in 2020, three days after the onset, the patient recovered from the event of sore arm. The outcome of the events fever and chills was not reported. The reporter did not provide a causality assessment. The case was assessed as non-serious. The case is linked to the cases 202004845, 202006068, 202006069, 202006072, 202006074, 202006077, 202006080, 202006081, 202006084, 202006086, 202006087, 202006089, 202006090, 202006091, 202006092, 202006095, 202006097 and 202006098 (the same reporter). Company comment: A 40-year-old, female patient was vaccinated with Fluad Quadrivalent. An unknown amount of time after receiving Fluad Quadrivalent, the patient developed chills, pyrexia and pain in extremity. With information available, causal role of the suspect vaccine is assessed as possibly related. Product administered to patient of inappropriate age is assessed as not related, per company's conventions.; Sender's Comments: A 40-year-old, female patient was vaccinated with Fluad Quadrivalent. An unknown amount of time after receiving Fluad Quadrivalent, the patient developed chills, pyrexia and pain in extremity. With information available, causal role of the suspect vaccine is assessed as possibly related. Product administered to patient of inappropriate age is assessed as not related, per company's conventions.

Other Meds:

Current Illness:

ID: 1313172
Sex: F
Age: 51
State:

Vax Date: 09/29/2020
Onset Date: 09/29/2020
Rec V Date: 05/13/2021
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: Patient under 65 received Fluad QIV; Rash of both arms and hands with blisters on L hand side (injected arm); Rash of both arms and hands with blisters on L hand side (injected arm); This spontaneous case received on 05-Nov-2020 from other health professional (nurse) via Agency (reference number: SEQW20-04837) and concerned a 51-year-old, female patient. The patient's medical history included psoriasis. The patient's concomitant medications were not reported. On 29-Sep-2020, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, MF59, dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid) (explicitly coded as 'Inappropriate age at vaccine administration') for an influenza prophylaxis. The batch number reported was 286592. On an unspecified date in 2020, an unknown time after receiving Fluad Quadrivalent, the patient experienced rash of both arms and hands with blisters on left (L) hand side of injected arm. The patient visited dermatologist, who stated it could have been from the flu shot. The patient did not receive any corrective treatment. The outcome of the events was not reported. The reporter assessed all events as related to Fluad Quadrivalent. The case was assessed as non-serious. The case is linked to the cases 202004845, 202006068, 202006069, 202006072, 202006074, 202006077, 202006080, 202006081, 202006084, 202006085, 202006087, 202006089, 202006090, 202006091, 202006092, 202006095, 202006097 and 202006098 (the same reporter). Company comment: A 51-year-old, female patient was vaccinated with Fluad Quadrivalent. An unknown amount of time after receiving Fluad Quadrivalent, the patient developed rash and blister. With information available, causal role of the suspect vaccine is assessed as possibly related. Product administered to patient of inappropriate age is assessed as not related, per company's conventions.; Reporter's Comments: The reporter stated that the events could have been from the flu shot.; Sender's Comments: A 51-year-old, female patient was vaccinated with Fluad Quadrivalent. An unknown amount of time after receiving Fluad Quadrivalent, the patient developed rash and blister. With information available, causal role of the suspect vaccine is assessed as possibly related. Product administered to patient of inappropriate age is assessed as not related, per company's conventions.

Other Meds:

Current Illness: Psoriasis

ID: 1313173
Sex: F
Age: 28
State:

Vax Date: 09/29/2020
Onset Date: 09/29/2020
Rec V Date: 05/13/2021
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: Patient under 65 received Fluad QIV; Sore throat; Injection site pain; Headache; This spontaneous case was received on 05-Nov-2020 from other health professional (nurse) via Agency (reference number: SEQW20-04820) and concerned a 28-year-old, female patient. The patient had no relevant medical history. The patient's concomitant medications were not reported. On 29-Sep-2020, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, MF59, dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid) (explicitly coded as 'Inappropriate age at vaccine administration') for influenza prophylaxis. The batch number reported was 286592. On an unknown date in 2020, an unknown amount of time after receiving Fluad Quadrivalent, the patient experienced injection site pain, headache and sore throat. The patient started treatment with Tylenol (paracetamol). The outcome of the events was not reported. The reporter did not provide a causality assessment. The case was assessed as non-serious. The case is linked to the cases 202004845, 202006068, 202006069, 202006072, 202006074, 202006077, 202006080, 202006081, 202006084, 202006085, 202006086, 202006089, 202006090, 202006091, 202006092, 202006095, 202006097, 202006098 (the same reporter). Company comment: A 28-year-old, female patient was vaccinated with Fluad Quadrivalent. An unknown amount of time after receiving Fluad Quadrivalent, the patient developed oropharyngeal pain, headache and vaccination site pain. With information available, causal role of the suspect vaccine is assessed as possibly related. Product administered to patient of inappropriate age is assessed as not related, per company's conventions.; Sender's Comments: A 28-year-old, female patient was vaccinated with Fluad Quadrivalent. An unknown amount of time after receiving Fluad Quadrivalent, the patient developed oropharyngeal pain, headache and vaccination site pain. With information available, causal role of the suspect vaccine is assessed as possibly related. Product administered to patient of inappropriate age is assessed as not related, per company's conventions.

Other Meds:

Current Illness:

ID: 1313174
Sex: F
Age: 28
State:

Vax Date: 09/29/2020
Onset Date: 09/29/2020
Rec V Date: 05/13/2021
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: Patient under 65 received Fluad QIV; Injection site was very sore; Headache; This spontaneous case was received on 05-Nov-2020 from other health professional (nurse) via Agency (reference number: SEQW20-04838) and concerned a 28-year-old, female patient. The patient's concurrent conditions included carcinoma (reported as 'CA') and asthma. The patient's concomitant medications were not reported. On 29-Sep-2020, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, MF59, dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid) (explicitly coded as 'Inappropriate age at vaccine administration') for influenza prophylaxis. The batch number reported was 286592. On an unknown date in 2020, an unknown amount of time after receiving Fluad Quadrivalent, the patient's injection site was very sore, and she had a headache. The patient started treatment with Tylenol (paracetamol). The outcome of the events was not reported. The reporter did not provide a causality assessment. The case was assessed as non-serious. The case is linked to the cases 202004845, 202006068, 202006069, 202006072, 202006074, 202006077, 202006080, 202006081, 202006084, 202006085, 202006086, 202006087, 202006090, 202006091, 202006092, 202006095, 202006097, 202006098 (the same reporter). Company comment: The events of headache and 'vaccination site pain' are assessed as related to Fluad Quadrivalent, while the event of 'Inappropriate age at vaccine administration' is assessed as not related.; Sender's Comments: The events of headache and 'vaccination site pain' are assessed as related to Fluad Quadrivalent, while the event of 'Inappropriate age at vaccine administration' is assessed as not related.

Other Meds:

Current Illness: Asthma; Carcinoma

ID: 1313175
Sex: F
Age: 58
State:

Vax Date: 09/29/2020
Onset Date: 09/29/2020
Rec V Date: 05/13/2021
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: Patient under 65 received Fluad QIV; Hot and red knot; Hot and red knot; Swollen arm; This spontaneous case received on 05-Nov-2020 from other health professional (nurse) via Agency (reference number: SEQW20-04816) and concerned a 58-year-old, female patient. The patient's medical history included hypothyroidism. The patient's concomitant medications were not reprorted. On 29-Sep-2020, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, MF59, dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid) (explicitly coded as 'Inappropriate age at vaccine administration') for influneza prophylaxis. The batch number reported was 286592. On an unspecified date in 2020, unknown time after receiving Fluad Quadrivalent, the patient developed hot and red knot, swollen arm. The patient was treated with Tylenol (paracetamol). The outcome of the events was not reported. The reporter did not provide a causality assessment. The case was assessed as non-serious. The case is linked to the cases 202004845, 202006068, 202006069, 202006072, 202006074, 202006077, 202006080, 202006081, 202006084, 202006085, 202006086, 202006087, 202006089, 202006091, 202006092, 202006095, 202006097 and 202006098 (the same reporter). Company comment: A 58-year-old, female patient was vaccinated with Fluad Quadrivalent. An unknown amount of time after receiving Fluad Quadrivalent, the patient developed peripheral swelling, nodule and feeling hot (hot and red knot). With information available, causal role of the suspect vaccine is assessed as possibly related. Product administered to patient of inappropriate age is assessed as not related, per company's conventions.; Sender's Comments: A 58-year-old, female patient was vaccinated with Fluad Quadrivalent. An unknown amount of time after receiving Fluad Quadrivalent, the patient developed peripheral swelling, nodule and feeling hot (hot and red knot). With information available, causal role of the suspect vaccine is assessed as possibly related. Product administered to patient of inappropriate age is assessed as not related, per company's conventions.

Other Meds:

Current Illness: Hypothyroidism

ID: 1313176
Sex: F
Age: 38
State:

Vax Date: 09/29/2020
Onset Date: 09/29/2020
Rec V Date: 05/13/2021
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: Patient under 65 received Fluad QIV; Feeling cold; Generalized malaise; Joint pain; Muscle ache; This spontaneous case received on 05-Nov-2020 from other health professional (nurse) via Agency (reference number: SEQW20-04825) and concerned a 38-year-old, female patient. The patient had no relevant medical history. The patient's concomitant medications were not reported. On 29-Sep-2020, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, MF59; dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid) (explicitly coded as 'Inappropriate age at vaccine administration') for influenza prophylaxis. The batch number reported was 286592. On an unspecified date, an unknown amount of time after receiving Fluad Quadrivalent, the patient experienced generalized malaise, joint pain, muscle aches, and was feeling cold. The patient started treatment with Tylenol (paracetamol). The outcome of the events was not reported. The reporter did not provide causality assessment. The reporter assessed the case as non-serious. This case is linked with the cases 202004845, 202006067, 202006068, 202006069, 202006072, 202006074, 202006077, 202006078, 202006079, 202006080, 202006081, 202006084, 202006085, 202006086, 202006087, 202006088, 202006089, 202006090, 202006092, 202006093, 202006095, 202006096, 202006097, 202006099 (the same reporter). Company comment: A 38-year-old, female patient was vaccinated with Fluad Quadrivalent. An unknown amount of time after receiving Fluad Quadrivalent, the patient experienced malaise, arthralgia, myalgia and was feeling cold. With information available, causal role of the suspect vaccine is assessed as possibly. Product administered to patient of inappropriate age is assessed as not related, per company's conventions.; Sender's Comments: A 38-year-old, female patient was vaccinated with Fluad Quadrivalent. An unknown amount of time after receiving Fluad Quadrivalent, the patient experienced malaise, arthralgia, myalgia and was feeling cold. With information available, causal role of the suspect vaccine is assessed as possibly. Product administered to patient of inappropriate age is assessed as not related, per company's conventions.

Other Meds:

Current Illness:

ID: 1313177
Sex: F
Age: 52
State:

Vax Date: 09/29/2020
Onset Date: 09/29/2020
Rec V Date: 05/13/2021
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: Patient under 65 received Fluad QIV; Soreness; Left arm with numb fingers; Headache; This spontaneous case was received on 05-Nov-2020 from other health professional (nurse) via Agency (reference number: SEQW20-04803) and concerned a 52-year-old, female patient. The patient had no relevant medical history. The patient's concomitant medications were not reprorted. On 29-Sep-2020, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, MF59, dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid) (explicitly coded as 'Inappropriate age at vaccine administration') for influenza prophylaxis. The batch number reported was 286592. On an unspecified date in 2020, an unknown amount of time after receiving Fluad Quadrivalent, the patient experienced severe soreness, left arm with number fingers and headache. The patient was treated with Tylenol (paracetamol) and Aleve (naproxen). The outcome of events was not reported. The reporter did not provide causality assessment. The case was assessed as non-serious. The case is linked to the cases 202004845, 202006068, 202006069, 202006072, 202006074, 202006077, 202006080, 202006081, 202006084, 202006085, 202006086, 202006087, 202006089, 202006090, 202006091, 202006095, 202006097 and 202006098 (the same reporter). Company comment: A 52-year-old, female patient was vaccinated with Fluad Quadrivalent. An unknown amount of time after receiving Fluad Quadrivalent, the patient experienced pain, headache and hypoaesthesia. With information available, causal role of the suspect vaccine is assessed as possibly related. Product administered to patient of inappropriate age is assessed as not related, per company's conventions.; Sender's Comments: A 52-year-old, female patient was vaccinated with Fluad Quadrivalent. An unknown amount of time after receiving Fluad Quadrivalent, the patient experienced pain, headache and hypoaesthesia. With information available, causal role of the suspect vaccine is assessed as possibly related. Product administered to patient of inappropriate age is assessed as not related, per company's conventions.

Other Meds:

Current Illness:

ID: 1313178
Sex: M
Age: 57
State:

Vax Date: 09/29/2020
Onset Date: 09/29/2020
Rec V Date: 05/13/2021
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: Patient under 65 received Fluad QIV; Site pain for 3 days; Headache; Fatigue for 48h; This spontaneous case was received on 05-Nov-2020 from other health professional (nurse) via Agency (reference number: SEQW20-04836) and concerned a 57-year-old, male patient. The patient's concurrent conditions included hypertension (HTN). The patient's concomitant medications were not reported. On 29-Sep-2020, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, MF59, dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid) (explicitly coded as 'Inappropriate age at vaccine administration') for influenza prophylaxis. The batch number reported was 286592. On an unspecified date in 2020, an unknown amount of time after receiving Fluad Quadrivalent, the patient experienced site pain for three days, headache and fatigue for 48h. The patient was treated with Tylenol (paracetamol). On an unknown date in 2020, the patient recovered from the events of 'vaccination site pain' and fatigue. The outcome of the event of headache was not reported. The reporter did not provide a causality assessment. The case was assessed as non-serious. The case is linked to the cases 202004845, 202006068, 202006069, 202006072, 202006074, 202006077, 202006080, 202006081, 202006084, 202006085, 202006086, 202006087, 202006089, 202006090, 202006091, 202006092, 202006097, 202006098 (the same reporter). Company comment: The events of headache, 'vaccination site pain' and fatigue are considered as related to Fluad Quadrivalent, while the event of 'Inappropriate age at vaccine administration' is considered as not related to Fluad Quadrivalent.; Sender's Comments: The events of headache, 'vaccination site pain' and fatigue are considered as related to Fluad Quadrivalent, while the event of 'Inappropriate age at vaccine administration' is considered as not related to Fluad Quadrivalent.

Other Meds:

Current Illness: Hypertension

ID: 1313179
Sex: F
Age: 53
State:

Vax Date: 09/29/2020
Onset Date: 09/29/2020
Rec V Date: 05/13/2021
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: Patient under 65 received Fluad QIV; Arm pain; Injection site redness; This spontaneous case was received on 05-Nov-2020 from other health professional (nurse) via Agency (reference number: SEQW20-04834) and concerned a 53-year-old, female patient. The patient had no relevant medical history. The patient's concomitant medications were not reported. On 29-Sep-2020, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, MF59, dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid) (explicitly coded as 'Inappropriate age at vaccine administration') for influenza prophylaxis. The batch number reported was 286592. On an unspecified date in 2020, an unknown amount of time after receiving Fluad Quadrivalent, the patient developed injection site redness and arm pain. No corrective treatment was given for the events. The outcome of the events was not reported. The reporter did not provide a causality assessment. The case was assessed as non-serious. The case is linked to the cases 202004845, 202006068, 202006069, 202006072, 202006074, 202006077, 202006080, 202006081, 202006084, 202006085, 202006086, 202006087, 202006089, 202006090, 202006091, 202006092, 202006095 and 202006098 (the same reporter). Company comment: A 53-year-old, female patient was vaccinated with Fluad Quadrivalent. An unknown amount of time after receiving Fluad Quadrivalent, the patient experienced pain in extremity and vaccination site erythema. With information available, causal role of the suspect vaccine is assessed as possibly. Product administered to patient of inappropriate age is assessed as not related, per company's conventions.; Sender's Comments: A 53-year-old, female patient was vaccinated with Fluad Quadrivalent. An unknown amount of time after receiving Fluad Quadrivalent, the patient experienced pain in extremity and vaccination site erythema. With information available, causal role of the suspect vaccine is assessed as possibly. Product administered to patient of inappropriate age is assessed as not related, per company's conventions.

Other Meds:

Current Illness:

ID: 1313180
Sex: F
Age: 50
State:

Vax Date: 09/29/2020
Onset Date: 09/29/2020
Rec V Date: 05/13/2021
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: Patient under 65 received Fluad QIV; Body aches; Fever; Injection site soreness; This spontaneous case from the was received on 05-Nov-2020 from other health professional (nurse) via The Agency (reference number: SEQW20-04824) and concerned a 50-year-old, female patient. The patient's relevant medical history included heart disease and hypertension (HTN). The patient's concomitant medications were not reported. On 29-Sep-2020, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, MF59; dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid) (explicitly coded as 'Inappropriate age at vaccine administration') for influenza prophylaxis. The batch number reported was 286592. On an unspecified date in 2020, an unknown amount of time after receiving Fluad Quadrivalent, the patient experienced fever, body aches and injection site soreness. The patient was treated with ibuprofen. The outcome of the events was not reported. The reporter did not provide causality assessment. The reporter assessed the case as non-serious. The case is linked to the cases 202004845, 202006068, 202006069, 202006072, 202006074, 202006077, 202006080, 202006081, 202006084, 202006085, 202006086, 202006087, 202006089, 202006090, 202006091, 202006092, 202006095 and 202006097 (the same reporter). Company comment: The patient experienced pain (reported as 'body ache'), pyrexia and vaccination site pain on an unspecified date after administration of Fluad Quadrivalent. Causality is assessed as possibly related for vaccination site pain (due to anatomical plausibility) and unassessable for pyrexia and pain (temporal association is unclarified, and the patient also suffers from unspecified heart disease). Patient under 65 received Fluad QIV- product administration error is assessed as unrelated per company conventions.; Sender's Comments: Company comment: The patient experienced pain (reported as 'body ache'), pyrexia and vaccination site pain on an unspecified date after administration of Fluad Quadrivalent. Causality is assessed as possibly related for vaccination site pain (due to anatomical plausibility) and unassessable for pyrexia and pain (temporal association is unclarified, and the patient also suffers from unspecified heart disease). Patient under 65 received Fluad QIV- product administration error is assessed as unrelated per company conventions.

Other Meds:

Current Illness: Heart disease, unspecified; Hypertension

ID: 1313181
Sex: M
Age:
State: NJ

Vax Date: 09/26/2020
Onset Date: 09/26/2020
Rec V Date: 05/13/2021
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: The patient requested the high dose vaccine several times and FLD QUAD was administered; Very upset; This spontaneous case from was received on 10-Nov-2020 from other non-health professional (consumer) via The Agency (reference number: SEQW20-04960) and concerned a 72-year-old, male patient. The patient's medical history and concomitant medications were not reported. On 26-Sep-2020, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, MF59, dose: 0.5 mL, route of administration: intramuscular, anatomical location: deltoid) for flu prophylaxis. The batch number was not reported. The patient requested the high dose vaccine, and in the pharmacy, they confirmed that Fluad Quadrivalent was a high dose vaccine. Later the patient was advised that Fluad Quadrivalent was a standard dose vaccine (explicitly coded as 'Wrong vaccine administered'). On an unspecified date in 2020, after receiving Fluad Quadrivalent, the patient was very upset that Fluad Quadrivalent was being marketed by the pharmacy as a high dose vaccine. The outcome of the event was not reported. The reporter did not provide causality assessment. The case was assessed as non-serious. Company comment: The patient experienced emotional distress on an unspecified date after administration of Fluad Quadrivalent. Reportedly, the patient requested the high dose vaccine several times and FLD QUAD. Wrong product administered is assessed as unrelated per company conventions and emotional distress is also assessed as unrelated. There is no suggestion that the product produced this event. Temporal association is unclarified and there is no biological background for this association.; Sender's Comments: The patient experienced emotional distress on an unspecified date after administration of Fluad Quadrivalent. Reportedly, the patient requested the high dose vaccine several times and FLD QUAD. Wrong product administered is assessed as unrelated per company conventions and emotional distress is also assessed as unrelated. There is no suggestion that the product produced this event. Temporal association is unclarified and there is no biological background for this association.

Other Meds:

Current Illness:

ID: 1313182
Sex: M
Age: 65
State:

Vax Date: 11/20/2020
Onset Date: 11/20/2020
Rec V Date: 05/13/2021
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: Cough; On and off dizziness; Heavy sweating; This spontaneous case from the was received on 23-Nov-2020 from other health professional via The Agency (reference number: SEQW20-05390) and concerned a 65-year-old, male patient. The patient's medical history and concomitant medications were not reported. On 20-Nov-2020, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59; dose: 0.5 ml, route of administration: intramuscular and anatomical location: left arm) for influenza prophylaxis. The batch number reported was 279812 and expiry date was 30-Jun-2021. On the same day, 30 minutes after receiving Fluad Quadrivalent, the patient developed heavy sweating. The patient also had on and off dizziness. On 23-Nov-2020, sweating returned as well as a cough. At the time of initial reporting on 23-Nov-2020, the patient had not recovered from the events, reported as not improved. The reporter did not provide a causality assessment. The reporter assessed the case as non-serious. Company comment: A 65-year-old patient was vaccinated with Fluad Quadrivalent. On the same day, 30 minutes after receiving Fluad Quadrivalent, the patient developed hyperhidrosis and dizziness. Three days later the patient also experienced cough. Causality is assessed as possibly related for all events. Causal role of the suspect vaccine is assessed as possibly related for all events.; Sender's Comments: A 65-year-old patient was vaccinated with Fluad Quadrivalent. On the same day, 30 minutes after receiving Fluad Quadrivalent, the patient developed hyperhidrosis and dizziness. Three days later the patient also experienced cough. Causality is assessed as possibly related for all events. Causal role of the suspect vaccine is assessed as possibly related for all events.

Other Meds:

Current Illness:

ID: 1313183
Sex: M
Age:
State:

Vax Date: 11/01/2020
Onset Date: 11/01/2020
Rec V Date: 05/13/2021
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: Pain at injection site; This spontaneous case was received on 27-Nov-2020 from other non-health professional (consumer) via Agency (reference number: SEQW20-05445) and concerned a 83-year-old, male patient. The patient's medical history and concomitant medications were not reported. The patient stated he was very healthy. On an unspecified date in Nov-2020, reported as a week ago, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59; dose, route of administration and anatomical location: not reported) for influenza prophylaxis. The batch number was not reported. On an unspecified date in Nov-2020, unknown amount of time after receiving Fluad Quadrivalent, the patient has not had any response only developed mild pain at the injection site. The outcome of the event was not reported. The reporter did not provide a causality assessment. The reporter assessed the case as non-serious. This case is linked to 202007428 due to same patient and reporter. Company comment: The event of 'vaccination site pain' is considered as related to Fluad Quadrivalent.; Sender's Comments: The event of 'vaccination site pain' is considered as related to Fluad Quadrivalent.

Other Meds:

Current Illness:

ID: 1313184
Sex: F
Age: 84
State: TX

Vax Date: 09/08/2020
Onset Date: 09/10/2020
Rec V Date: 05/13/2021
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: Pain in her upper arm/shoulder/ pain in her left arm/tender and hurts at night; Pain in her upper arm/shoulder/ pain in her left arm/ tender and hurts at night; Pain in her upper arm/shoulder/ pain in her left arm/ tender and hurts at night; This spontaneous case from the was received on 07-Dec-2020 from other non-health professional (consumer) via The agency (reference number: SEQW20-05636) and concerned an 84-year-old female patient. The patient's medical history included blood pressure abnormal, blood cholesterol abnormal and fibroid. The patient's concomitant medications included blood pressure, cholesterol medications and fibroid pill. The patient's historical vaccine included influenza vaccines, after which her arm was sore and painful, but not for long period of time as in this report. On 08-Sep-2020, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59; dose: 0.5 ml; anatomical location: left arm; route of administration: not reported) for prevention of seasonal influenza. The batch number was not reported. On 10-Sep-2020, two days after receiving Fluad Quadrivalent, the patient experienced pain in her upper arm and shoulder, it was tender and hurt at night. The patient also had difficulty dressing. On an unknown date in 2020, the patient went to doctor, and was provided a prescription for meloxicam, but she was still experiencing pain and soreness in her arm. At the time of initial reporting on 07-Dec-2020, the patient had not recovered from the events, as she was still experiencing pain in her left arm three months after the injection. The reporter did not provide a causality assessment. This case is linked with case 202007548 (the same patient and reporter). Company comment: A 84-year-old patient was vaccinated with Fluad Quadrivalent. Two days after receiving Fluad Quadrivalent, the patient experienced pain in extremity, arthralgia and tenderness. Causality is assessed as possibly related for all events.; Sender's Comments: A 84-year-old patient was vaccinated with Fluad Quadrivalent. Two days after receiving Fluad Quadrivalent, the patient experienced pain in extremity, arthralgia and tenderness. Causality is assessed as possibly related for all events.

Other Meds:

Current Illness: Blood cholesterol abnormal; Blood pressure abnormal; Fibroids

ID: 1313185
Sex: F
Age:
State:

Vax Date: 10/16/2020
Onset Date:
Rec V Date: 05/13/2021
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: Pain and heat at injection site; Sick to her stomach; Feeling weak; Had to stay in bed; Arm was swollen; Couldn't eat anything; Nauseous; Fever; Pain and heat at injection site; This spontaneous case from the was received on 11-Dec-2020 from other non-health professional via The agency (reference number: SEQW20-05716) and concerned a 70-year-old female patient. The patient's medical history and concomitant medications were not reported. On 16-Oct-2020, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59, dose, route of administration and anatomical location: not reported) for influenza prophylaxis. The batch number was not reported. On an unspecified date in 2020, an unknown amount of time after receiving Fluad Quadrivalent, the patient experienced pain and heat at injection site for several days, fever for three to four days, was sick to her stomach and could not eat anything. She was also nauseous, felt weak, her arm was swollen and she had to stay in bed. On an unspecified date in 2020, the patient recovered from events of 'vaccination site warmth', fever and 'vaccination site pain'. At the time of initial reporting on 11-Dec-2020, the patient was recovering from events 'stomach discomfort', 'weakness', 'bedridden', 'appetite lost', 'swollen arm' and nauseous, as she had improved. The reporter did not provide a causality assessment. The reporter assessed the events as non-serious. Company comment: A 70-year-old patient was administered Fluad Quadrivalent. An unknown amount of time after receiving Fluad Quadrivalent, the patient experienced pain and heat at injection site for several days, fever for three to four days, was sick to her stomach and could not eat anything. She was also nauseous, felt weak, her arm was swollen and she had to stay in bed. No alternative aetiology was provided. Causality is assessed as possibly related for vaccination site pain, vaccination site warmth, nausea, pyrexia, abdominal discomfort, decreased appetite, asthenia, bedridden and peripheral swelling.; Sender's Comments: A 70-year-old patient was administered Fluad Quadrivalent. An unknown amount of time after receiving Fluad Quadrivalent, the patient experienced pain and heat at injection site for several days, fever for three to four days, was sick to her stomach and could not eat anything. She was also nauseous, felt weak, her arm was swollen and she had to stay in bed. No alternative aetiology was provided. Causality is assessed as possibly related for vaccination site pain, vaccination site warmth, nausea, pyrexia, abdominal discomfort, decreased appetite, asthenia, bedridden and peripheral swelling.

Other Meds:

Current Illness:

ID: 1313186
Sex: U
Age:
State:

Vax Date: 08/19/2020
Onset Date:
Rec V Date: 05/13/2021
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: Worried; This spontaneous case from the was received on 14-Dec-2020 from other non-health professional (consumer) via the agency (reference number: SEQW20-05741) on 14-Dec-2020, and concerned an elderly, female patient. The patient's medical history and concomitant medications were not reported. It was reported that the patient typically got vaccinated in late September and early October. On 19-Aug-2020, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, MF59; anatomical location, dose, indication, route of administration: not reported). The batch number was not reported. On an unspecified date in 2020, unknown amount of time after receiving Fluad Quadrivalent, the patient became worried that she would not have effective coverage through to April. At the time of initial reporting on 14-Dec-2020, the patient had not recovered from the event. The reporter did not provide causality assessment to Fluad (TIV). Company comment:The patient developed anxiety unknown amount of time after receiving the suspect product, Fluad Quadrivalent. Reportedly, the patient was worried that she would not have effective coverage through to April. The patient's medical history and concomitant medications were not reported. Causality is assessed as not related due to biological implausibility.; Sender's Comments: The patient developed anxiety unknown amount of time after receiving the suspect product, Fluad Quadrivalent. Reportedly, the patient was worried that she would not have effective coverage through to April. The patient's medical history and concomitant medications were not reported. Causality is assessed as not related due to biological implausibility.

Other Meds:

Current Illness:

ID: 1313187
Sex: F
Age: 46
State: AZ

Vax Date: 03/27/2021
Onset Date: 04/18/2021
Rec V Date: 05/13/2021
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: heart racing above 100 for over 10 minutes when inactive. coughing.

Other Meds:

Current Illness:

ID: 1313188
Sex: F
Age: 41
State: KY

Vax Date: 05/12/2021
Onset Date: 05/12/2021
Rec V Date: 05/13/2021
Hospital:

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

Lab Data:

Allergies: None

Symptom List: Unevaluable event

Symptoms: Insomnia, joint aches, low-grade fever

Other Meds: None

Current Illness: None

ID: 1313189
Sex: M
Age: 60
State: AZ

Vax Date: 05/12/2021
Onset Date: 05/12/2021
Rec V Date: 05/13/2021
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: PATIENT RECIEVED A 3RD DOSE

Other Meds:

Current Illness:

ID: 1313190
Sex: F
Age: 28
State: HI

Vax Date: 05/12/2021
Onset Date: 05/12/2021
Rec V Date: 05/13/2021
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: none

Symptom List: Injection site pain, Pain

Symptoms: Patient received second covid shot from technician certified to vaccinate. Tech knocked on door, because when patient went to stand she felt like putting her head between her legs and fainting. I went in there and it looked like previous episodes of fainting I have seen so I tried to calm her and have her breath while patient was getting the blood pressure machine. Patient then fainted again a little more intensely, but still not alarming me that much. She came to and again I was talking with her to try to keep her alert. I asked her how she was feeling. She said she was extremely hot (she kept repeating this), that she had a headache, and asked for water. I told her we couldn't give her food or water until she felt better. We now had blood pressure monitor on her and it wouldn't read her pressure or pulse it kept saying error. I just used it on another patient with high blood pressure and it had been functional. I had been manually holding her pulse and it was strong and normal. Then she fainted again and started shaking. the shaking quickly stopped. She woke up and said that she couldn't see. I asked tech to call 911, while I stayed with her and kept assessing her. Tech got the headset got 911 on the phone and turned the phone over to me. I asked her to grab another blood pressure monitor. We tried again and at 3:55pm it was 88/50 and pulse of 66. I was talking 911 and responding to all questions over the phone. I had to ask the patient for the responses (many COVID related questions). I told the lady her blood pressure and the lady said I don't need to know any of that. She wanted me to keep asking the patient questions. The blood pressure was 87/49 and pulse of 65 at 3:58. Now the EMT had arrived and assessed her. They said she fainted and she said she did not want to go with them. So they left. The patient remained at pharmacy for 45 to 90 min more until she was sure she felt okay enough to catch an uber home. I called her at 8:43pm and she said she feels much better, has eaten, and is with her boyfriend in case she experiences anymore ADRS. Upon asking who her primary physician is she said she last saw a doctor in another country. She said her md only speaks another language. I asked her to call her MD and report to her in a different language what happened since I am unable to speak with her.

Other Meds: none

Current Illness: none

ID: 1313191
Sex: F
Age: 17
State: AZ

Vax Date: 05/12/2021
Onset Date: 05/12/2021
Rec V Date: 05/13/2021
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: PATIENT UNDERAGE

Other Meds:

Current Illness:

ID: 1313192
Sex: F
Age: 47
State: CA

Vax Date: 05/10/2021
Onset Date: 05/12/2021
Rec V Date: 05/13/2021
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: Penicillin, mild dairy allergy, various plants, trees and animals

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

Symptoms: Both of my legs developed an itchy red rash approx 60 hours after the vaccine. Hives/bumps and patchy redness on both both calves and thighs. My neck also feels itchy but not severe and no hives or red itchy rash. I took two benedryl and used an OTC anti-itch cream tonight and will see my doctor it it persists.

Other Meds: Lexipro, adderall

Current Illness: None (seasonal allergies)

ID: 1313193
Sex: M
Age: 59
State: CA

Vax Date: 04/27/2021
Onset Date: 05/11/2021
Rec V Date: 05/13/2021
Hospital: Y

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: ITP with wet purpura and platelet count <10. No ICH at the time of admission.

Other Meds: Amlodipine

Current Illness: Recent prostate surgery and possible prostatitis

ID: 1313194
Sex: F
Age: 20
State: DE

Vax Date: 05/12/2021
Onset Date: 05/12/2021
Rec V Date: 05/13/2021
Hospital:

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

Lab Data:

Allergies: None

Symptom List: Chills, Fatigue, Headache, Myalgia

Symptoms: Sore arm, dizzy, feeling tired, muscle aches, shaking, takes a lot of effort to stand, slight headache

Other Meds: Vitamin D, hair, skin and nail vitamins, birth control, generic zyrtec

Current Illness: None

ID: 1313195
Sex: F
Age: 26
State: PA

Vax Date: 05/12/2021
Onset Date: 05/12/2021
Rec V Date: 05/13/2021
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: Aspirin and penicillin

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

Symptoms: Fever of 102.3, severe body and muscle aches aches, throat pain, chills, confusion, headache, fatigue

Other Meds: None

Current Illness: None

ID: 1313196
Sex: F
Age: 23
State: NY

Vax Date: 05/10/2021
Onset Date: 05/11/2021
Rec V Date: 05/13/2021
Hospital:

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

Lab Data:

Allergies: none

Symptom List: Nausea

Symptoms: Throat tightening, hoarseness starting 12 hours after and progressing.

Other Meds: none

Current Illness: no

ID: 1313197
Sex: F
Age: 63
State: OH

Vax Date: 04/17/2021
Onset Date: 04/21/2021
Rec V Date: 05/13/2021
Hospital:

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

Lab Data:

Allergies: Slight rash once when taking a Sulfa prescription

Symptom List: Injection site pain

Symptoms: After four days with no noticeable side effects or problems, I laid down for the night & noticed that my heart seemed to be struggling a great deal as in it seemed to be pounding hard, racing, & along with arrhythmia. This continued with a severe & continuous struggle around the clock, but more extreme throughout the night. I at first thought maybe I had some dehydration, but this did not seem to be the case. I was diagnosed with light Tachycardia in 1987, but have never experienced anything like what has happened since the COVID-19 vaccine. I searched the internet & noticed there are reports of other people suffering with the same issue & that a country has opened an investigation related to these heart struggles resulting in Myocarditis following the vaccine. I am under the care of a cardio Dr. in a city who prescribed Metoprolol ER Succinate 50 mg 1 x daily, ordered a 30 day event monitor which just arrived in the mail, & has ordered an MRI, along with some lab work.

Other Meds: Bumetanide 0.5 mg 2 x daily, Potassium CL Micro10 MEQ ER 2 x daily, Losartan 50 mg 1 x daily, B12 over the counter 500 mcg daily, store brand Women's Multi-Vitamin Gummies daily, Ezetimibe 10 mg 1 x daily, Deva Vegan Coenz

Current Illness: Fibromyalgia, OA, Rheumatoid Arthritis, Sjogren's Syndrome, Raynaud's Syndrome, Polymyositis, Tachycardia (since 1987 very mild case), Obesity

ID: 1313198
Sex: F
Age: 31
State: HI

Vax Date: 05/06/2021
Onset Date: 05/08/2021
Rec V Date: 05/13/2021
Hospital:

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

Lab Data:

Allergies: shellfish

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

Symptoms: On monday morning may 10, we went to emergency at 1am in the morning. My wife started to get red spots on her front chest, lower abdomen, and back on may 8. Over a couple days it got more red and more dots. The morning of may 10 it got ichy so she couldn't sleep and found there were more red dots so we went to emergency. Doctor checked on it and said her experience is it will go away after a week. It has been a few days and there are less dots and they are slightly less red. Hopefully it will completely go away. At the hospital she was given one pill of benadryl and a liquid steroid. she was prescribed benadryl but she didn't want to take it.

Other Meds: none

Current Illness: none

ID: 1313199
Sex: F
Age: 49
State: OR

Vax Date: 03/14/2021
Onset Date: 03/28/2021
Rec V Date: 05/13/2021
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: Penicillin Mango (contact dermatitis not true food allergy)

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

Symptoms: I developed a herpes sore on my top lip 2 weeks post injection for both doses. Treated topically at home with OTC Abreva cream, resolved about 1 week later. I also experienced oral discomfort on my hard palate and tongue about 24-48 following both injections. It was similar to a chemo side effect but not as severe, tenderness, kind of raw/burning sensation. Resolved on its own after several days

Other Meds: Anastrozole, omega 3, vit D, multi vit, magnesium

Current Illness: None

ID: 1313200
Sex: F
Age: 83
State: HI

Vax Date: 02/16/2021
Onset Date: 04/20/2021
Rec V Date: 05/13/2021
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: Penicillin family, zithromycin family,

Symptom List: Tremor

Symptoms: Severe unrelenting muscle cramps in right thigh

Other Meds: Warfarin, Losartin, hydrodiuril, creon, vitamin D3, mucinex

Current Illness:

ID: 1313201
Sex: F
Age: 19
State: IL

Vax Date: 05/11/2021
Onset Date: 05/11/2021
Rec V Date: 05/13/2021
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: About 6-7 hours after receiving the vaccine, I started to develop hives around my body, including on feet, stomach, ears, face, back, and legs. I had fever and chills, muscle aches, joint pain, headaches, and nausea later that night as well. The next morning, my left eye was swollen, left side of tongue completely swollen, lips swollen, and left side of throat closed (anaphylaxis). I took prednisone, Benadryl, and Tylenol to relieve the symptoms, and the swelling around my left eye, tongue, throat, and lips went away. Throughout the day, more hives have developed around my body and face, including my right eye. I am continuing to take Benadryl and Tylenol and finish doses of prednisone. The fever and chills, muscles aches, joint pains, hives, headache, and nausea are still present.

Other Meds:

Current Illness: Slight cold

ID: 1313202
Sex: F
Age: 34
State:

Vax Date: 04/13/2021
Onset Date: 04/13/2021
Rec V Date: 05/13/2021
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: Hydrocodone, poison ivy

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

Symptoms: Injection site muscle tenderness/soreness shortly after injection. Swollen lymph node on the same side as injection 3-4 days after vaccine. Redness at injection site that appeared 7 days after vaccine and lasted for about a day; visited the doctor regarding the lymph node and redness since it was a delayed symptom.

Other Meds: Women's daily vitamin, Vitamin D, Loratidine 10mg

Current Illness: n/a

ID: 1313203
Sex: F
Age: 25
State: MA

Vax Date: 05/11/2021
Onset Date: 05/11/2021
Rec V Date: 05/13/2021
Hospital: Y

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

Lab Data:

Allergies: None

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

Symptoms: Patient reported symptomatic heart palpitations after receiving the 2nd dose of the Pfizer SARS-CoV2 mRNA vaccine on 5/11/2021 at 1pm which lasted a few hours. She then presented to her urgent care clinic around 3pm and was transferred to the Hospital ED. She was found to be in sinus tachycardia to HR 140s-150s. Work-up as described below was largely unrevealing. Plan for TTE on this hospital admission. Overall believe that severe anxiety is a the driving factor behind her sinus tachycardia, and that the SARS-CoV2 vaccination was just coincidental in time course.

Other Meds: Melatonin as needed for sleep

Current Illness: Severe anxiety

ID: 1313204
Sex: M
Age: 41
State:

Vax Date: 05/07/2021
Onset Date: 05/07/2021
Rec V Date: 05/13/2021
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: Severe headaches immediately after vaccination, followed by dizziness and continued headaches

Other Meds:

Current Illness:

ID: 1313205
Sex: F
Age: 27
State: FL

Vax Date: 05/05/2021
Onset Date: 05/12/2021
Rec V Date: 05/13/2021
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: Penicillin

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

Symptoms: Pain and red rash 1 week after injection

Other Meds:

Current Illness:

ID: 1313206
Sex: M
Age: 60
State: FL

Vax Date: 03/23/2021
Onset Date: 03/25/2021
Rec V Date: 05/13/2021
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: Soy, sulfa

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

Symptoms: Headache in the back of head with nausea

Other Meds: Sever headache in the back of my head, with low grade nausea. It became almost chronic, and it still persists 2 months later. No medication helps, with exception of Exedrin. I cannot take Exedrin due to colitis. Please help!!!

Current Illness: None

ID: 1313207
Sex: F
Age: 42
State: CA

Vax Date: 04/22/2021
Onset Date: 04/30/2021
Rec V Date: 05/13/2021
Hospital:

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

Lab Data:

Allergies: Codeine/Vicodin (full body rash), MRI Contrast (rash on chest and short of breath, Onions (major digestive upset/pain

Symptom List: Pain in extremity

Symptoms: 8 days after first shot in The Pfizer Covid vaccine series, I developed very horrible tinnitus. Had not been around any loud sounds. Just woke up with it roaring in my ears. Never had COVID.

Other Meds: Gabapentin, Buspirone, Famotidine, Dexilant, Citracel, Colace, Evening Primerose Oil, Vitamin D, Prenatal Vitamin, Melatonin, Advil (or Advil PM), Magnesium, occasional Tylenol

Current Illness: None

ID: 1313208
Sex: M
Age: 56
State: MI

Vax Date: 04/15/2021
Onset Date: 04/22/2021
Rec V Date: 05/13/2021
Hospital:

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

Lab Data:

Allergies: None

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

Symptoms: Tinnitus has become worse

Other Meds: Rosuvastatin, Ezetimibe, Losartan, Centrum 50, fish oil, turmeric

Current Illness: None

ID: 1313209
Sex: F
Age: 42
State: NY

Vax Date: 04/20/2021
Onset Date: 04/28/2021
Rec V Date: 05/13/2021
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: Menstrual irregularity. I cramped and bled for 15 days which has never before happened in my life. Cycle is normally 5-7 days with 2-3 heavy flow days in the middle and intermittent cramping. Also experienced Mild nausea and sleepiness.

Other Meds: Levothyroxine Wellbutrin

Current Illness:

ID: 1313210
Sex: F
Age: 61
State: FL

Vax Date: 05/11/2021
Onset Date: 05/11/2021
Rec V Date: 05/13/2021
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: NKDA

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

Symptoms: Client began to feel anxious and shaky after receiving the vaccine. Fire Rescue at the scene to evaluate client. Clients BP was elevated but all other vitals stable. Client states hx of high BP and did not take BP meds this morning. Client began to feel much better and blood pressure came down. Per Fire Rescue no further evaluation needed. Client exited park at 2:30pm.

Other Meds: Losactan

Current Illness: none

ID: 1313223
Sex: U
Age: 0
State: OH

Vax Date: 04/21/2021
Onset Date: 04/21/2021
Rec V Date: 05/13/2021
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: Patient had no reported side effects; an expired dose of ROTATEQ was administered; This spontaneous report was received from a nurse referring to a 4-month-old infant of unknown gender. The patient's pertinent medical history, concomitant drugs and drug allergies were not reported. On 31-MAR-2021, the vaccine of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was stored in 46 degrees Fahrenheit for 6 hours. At 15:30, on 21-APR-2021, the patient was administered with the expired dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot #: 1676327, expiration date: 19-APR-2021, dose: 2 milliliter (ml), strength was not reported) orally for prophylaxis. The patient had no reported side effects.

Other Meds:

Current Illness:

ID: 1313224
Sex: U
Age:
State: MD

Vax Date: 04/14/2021
Onset Date: 04/14/2021
Rec V Date: 05/13/2021
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: Confirmed with the caller no other AE; a 13 year old patiant inadvertently received a dose of PROQUAD; This spontaneous report was received from a medical assistant referring to a 13-year-old patient of unknown gender. The patient's pertinent medical history, concomitant drugs and drug allergies were not reported. On 14-APR-2021, the patient was inadvertently vaccinated with a dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (albumin status recombinant Human albumin (rHA) (lot #: t0281391, expiration date: 15-FEB-2022, 1 dosage form, strength and route were not reported) for prophylaxis (inappropriate age at vaccine administration). It was confirmed that no other adverse event reported.

Other Meds:

Current Illness:

ID: 1313225
Sex: U
Age:
State: UT

Vax Date: 05/07/2021
Onset Date: 05/07/2021
Rec V Date: 05/13/2021
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: no further AEs reported; a patient was given an expired dose of MMR II vaccine; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. Information about pertinent medical history, drug reaction/allergy and concomitant medication was not provided. On 07-MAY-2021, the patient was vaccinated with an expired dose measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (dose was reported as 1 injection, lot# S013683, expiration date 05-MAY-2021; strength, route of administration, anatomical location were not reported) for prophylaxis (expired product administered). No further adverse events (AEs) were reported (no adverse event). No product quality complaint (PQC) was involved.

Other Meds:

Current Illness:

ID: 1313226
Sex: F
Age:
State:

Vax Date: 05/10/2021
Onset Date: 05/10/2021
Rec V Date: 05/13/2021
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: No additional AE reported; Customer called to report that PROQUAD and V ARlV AX were inadvertently administered to a 12-month old female consumer; This spontaneous report was received from a consumer referring to a 12 months old female patient. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported. On 10-MAY-2021, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) and varicella virus vaccine live (oka/merck) (VARIVAX) (strength, dose, route, lot# and expiration date were not provided) for prophylaxis (inappropriate schedule of product administration). No additional adverse event was reported.

Other Meds:

Current Illness:

ID: 1313232
Sex: U
Age:
State: AL

Vax Date:
Onset Date:
Rec V Date: 05/13/2021
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: Havrix being given to a 2 month old; This case was reported by a other health professional via sales rep and described the occurrence of inappropriate age at vaccine administration in a 2-month-old patient who received HAV (Havrix) for prophylaxis. Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis. On an unknown date, the patient received Havrix and Havrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional details were provided as follows: The reporter reported that Havrix being given to a 2 month old patient, which led to inappropriate age at vaccine administration. No other details was given. The reporter consented to follow up.

Other Meds:

Current Illness:

ID: 1313234
Sex: M
Age:
State:

Vax Date:
Onset Date: 04/08/2021
Rec V Date: 05/13/2021
Hospital: Y

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: STEMI HEART ATTACK; This spontaneous report received from a consumer concerned a 31 year old male. The patients height, and weight were not reported. The patients concurrent conditions included elevated cholesterol, and other pre-existing medical conditions included patient was not having a family history of heart issues.May be patient was genetically more prone to heart attacks. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, frequency 1 total, administered on APR-2021 for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported. On 08-APR-2021 in the morning, the patient experienced stemi heart attack (life-threatening), patient was rushed to Emergency Room at 3:00AM in morning and the patient was hospitalized. The patient experienced permanent heart damage and patient received angiogram and stent in artery was performed for the diagnosis. Laboratory data (dates unspecified) included: Angiogram (NR: not provided) not provided. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the stemi heart attack was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210504947-COVID-19 VACCINE AD26.COV2.S-STEMI Heart Attack . This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).

Other Meds:

Current Illness: Cholesterol high

Total 2021 VAERS Injuries: 636,615

Page last modified: 03 October 2021 5:28pm