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: 1497680
Sex: F
Age: 21
State: CA

Vax Date: 07/14/2021
Onset Date: 07/14/2021
Rec V Date: 07/23/2021
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: Administration of a pediatric dose of Engerix-B to an adult patient; Administration of a pediatric dose of Engerix-B to an adult patient; This case was reported by a other health professional via call center representative and described the occurrence of underdose in a 21-year-old female patient who received HBV (Engerix B pediatric) (batch number LP724, expiry date 18th May 2023) for prophylaxis. On 14th July 2021, the patient received Engerix B pediatric. On 14th July 2021, unknown after receiving Engerix B pediatric, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product were unknown. Additional details were provided as follows: The adult patient received pediatric dose of Engerix-B, which led to underdose and adult use of a child product. The reporter consented to follow up.

Other Meds:

Current Illness:

ID: 1497681
Sex: F
Age:
State: IN

Vax Date: 06/21/2021
Onset Date: 06/21/2021
Rec V Date: 07/23/2021
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: A powder vial left in the box and not sure which patient didn't receive / they believe that a 16 year old patient; A powder vial left in the box and not sure which patient didn't receive / they believe that a 16 year old patient; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 16-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMXA437A, expiry date unknown) for prophylaxis. On 21st June 2021, the patient received the 2nd dose of Menveo. On 21st June 2021, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown. Additional details were provided as follows: The reporter stated that, they believe that a 16-year-old patient received a single dose but only received the diluent portion of the vaccine for the booster dose, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter asked that would it be harmful if a patient received an extra Menveo vaccination, as they were not sure if she received the 2nd dose. The reporter stated that, there were 3 patients that day that it was ordered but not sure which patient did not receive, there was a powder vial left in the box, but the reporter was going to offer them to come in and get another dose but not sure if it would be a 3rd dose. The reporter inquired about a 3rd dose. The reporter consented to follow up via email.

Other Meds:

Current Illness:

ID: 1497682
Sex: M
Age: 59
State: NC

Vax Date: 07/09/2021
Onset Date: 07/09/2021
Rec V Date: 07/23/2021
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: it was improper administration technique / needle leaked during administration of shingrix; needle leaked during administration unknown dose got it and rest leaked; This case was reported by a pharmacist via call center representative and described the occurrence of wrong technique in product usage process in a 59-year-old male patient who received Herpes zoster (Shingrix) (batch number ap545, expiry date 25th January 2023) for prophylaxis. On 9th July 2021, the patient received the 2nd dose of Shingrix. On 9th July 2021, unknown after receiving Shingrix, the patient experienced wrong technique in product usage process and incomplete dose administered. On an unknown date, the outcome of the wrong technique in product usage process and incomplete dose administered were unknown. Additional details were provided as follows: The reporter stated that, needle leaked during administration of Shingrix, unknown number of vaccine dose got in and rest leaked, which led to incomplete dose administered and no product complain it was improper administration technique, which led to wrong technique in product usage process. The reporter consented to follow up.

Other Meds:

Current Illness:

ID: 1497683
Sex: F
Age: 57
State: TX

Vax Date: 03/04/2021
Onset Date: 03/04/2021
Rec V Date: 07/23/2021
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: non-raised red spots on/ top of both legs/ top of both feet to her toes/ top of both arms /are currently on /lower arms, torso, face and tongue; spots are itchy; vision is blurry currently.; spots are currently on her /tongue; she is allergic to the ingredients in the vaccine; sweating; chills; fever; This case was reported by a consumer via call center representative and described the occurrence of sweating in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Concurrent medical conditions included eczema. On 4th March 2021, the patient received the 1st dose of Shingrix (intramuscular). On 4th March 2021, less than a day after receiving Shingrix, the patient experienced sweating, chills and fever. On 11th March 2021, the patient experienced red spotty rash, pruritus, blurred vision, rash tongue and allergy to vaccine. The patient was treated with prednisone and antihistamine. On 7th March 2021, the outcome of the sweating, chills and fever were recovered/resolved. On an unknown date, the outcome of the red spotty rash, pruritus, blurred vision and rash tongue were not recovered/not resolved and the outcome of the allergy to vaccine was unknown. The reporter considered the sweating, chills, fever, red spotty rash, pruritus, blurred vision, rash tongue and allergy to vaccine to be related to Shingrix. Additional details were provided as follows: The reporter reported after receiving her Shingrix vaccine she experienced sweating, chills, and fever that resolved in 3 days (did not share how soon they began after the vaccine). The reporter stated that, on 11th March 2021, she began to break out in non-raised red spots on the top of both legs, the top of both feet to her toes, and the top of both arms. The reporter's HCP had put her on Prednisone dose packs which she had been on and off since 11th March 2021. The reporter was currently maintained on Prednisone 10mg daily to keep the spots at bay. The spots were itchy and the prednisone helped with that and in addition to Prednisone she was taking an antihistamine. The reporter also stated that, the spots went away when she was on the Prednisone dose pack, but when she finished the medication the spots reappeared in a different area. The spots were currently on her lower arms, torso, face and tongue. The reporter stated her vision was blurry currently and she had been to her Healthcare professional, a dermatologist and an allergist. The dermatologist performed a punch test and it came back as eczema was the cause of the rashes. The reporter does not think this was eczema. The allergist and Healthcare professional, said that this was a super auto immune response to the Shingrix vaccine. The Healthcare professional did not recommend getting the second dose of Shingrix. The caller felt she was allergic to the ingredients in the vaccine. The reporter did not consent to follow up.

Other Meds:

Current Illness: Eczema

ID: 1497684
Sex: F
Age: 61
State: CT

Vax Date: 01/29/2021
Onset Date: 01/29/2021
Rec V Date: 07/23/2021
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: First dose was given on 17Feb2021 / second dose on 29Jan2021; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 61-year-old female patient who received Herpes zoster (Shingrix) (batch number 295S7, expiry date 9th October 2022) for prophylaxis. Previously administered products included Shingrix (1st dose receive on 17th February 2020, batch number KS43H, expiry date -unknown). On 29th January 2021, the patient received the 2nd dose of Shingrix. On 29th January 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown. Additional details were provided as follows: The reporter called for information regarding validity of the administration of a second dose of Shingrix after almost 1 year since first dose. The patient received 2nd dose late than the recommended time interval, which led to lengthening of vaccination schedule. The reporter was not sure about sharing too much patient information and only provided date of birth and gender. The reporter consented to follow up.

Other Meds:

Current Illness:

ID: 1497685
Sex: F
Age:
State: FL

Vax Date:
Onset Date:
Rec V Date: 07/23/2021
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 age 50 and was prescribed / intentionally / Shingrix; This case was reported by a consumer via call center representative and described the occurrence of product prescribing error in a 49-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included scoliosis. Concurrent medical conditions included shingles. Concomitant products included valaciclovir (Valacyclovir). On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced product prescribing error. On an unknown date, the outcome of the product prescribing error was unknown. Additional details were provided as follows: This case was reported by the patient herself. The patient medical history included scoliosis and shingles. The patient was negative for rheumatoid arthritis. The age at vaccination was not reported but the patient was under 50 years of age. The patient was prescribed Shingrix intentionally because she had active outbreaks of shingles and wanted to prevent further outbreaks of shingles because she did not want to spread shingles to a family member who was immunocompromised, which led to product prescribing error. The patient also took valacyclovir blue pills made by pharmaceuticals. She stated that she always had those same blue pills and never had/used brand name Valtrex. She also reported the unexpected benefit of not having a cold while on valacyclovir. She thought that being on an antiviral protected her from the common cold virus. The reporter consented to follow up.

Other Meds: VALACYCLOVIR

Current Illness: Shingles

ID: 1497686
Sex: U
Age:
State: VA

Vax Date:
Onset Date:
Rec V Date: 07/23/2021
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: is past due for dose two of Shingrix / received dose one in September of 2019; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (1st dose received in September 2019). On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown. Additional detaails were provided as follows: The age at vaccination was not applicable for this report. The health care professional did not provide any patient demographics. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The health care professional did not provide complete address, lot number or expiration date of product. The health care professional did not specify what type of health care professional they were. The health care professional left web form and AE data collected from the submitted web form.

Other Meds:

Current Illness:

ID: 1497687
Sex: F
Age:
State: CA

Vax Date: 07/17/2021
Onset Date: 07/17/2021
Rec V Date: 07/23/2021
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: Subcutaneously instead of Intramuscularly; This case was reported by a pharmacist via call center representative and described the occurrence of intramuscular formulation administered by other route in a 58-year-old female patient who received Herpes zoster (Shingrix) (batch number 27pa5, expiry date unknown) for prophylaxis. On 17th July 2021, the patient received the 1st dose of Shingrix (subcutaneous). On 17th July 2021, unknown after receiving Shingrix, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the intramuscular formulation administered by other route was unknown. Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, the patient patient was administered shingrix Subcutaneously instead of Intramuscularly, which led to intramuscular formulation administered by other route. The reporter consented to follow up. This case was linked with case US2021137216, reported by same reporter for different patient.; Sender's Comments: US-GLAXOSMITHKLINE-US2021137216:Same reporter

Other Meds:

Current Illness:

ID: 1497688
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 07/23/2021
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: dose 1 of Shngrix on 09/24/2018 and no 2nd dose yet; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (1st dose received on 24th September 2018). On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown. Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter stated that, no lot number or expiry date available at the moment. The reporter consented to follow up.

Other Meds:

Current Illness:

ID: 1497689
Sex: F
Age:
State: OK

Vax Date: 07/21/2021
Onset Date: 07/21/2021
Rec V Date: 07/23/2021
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: vaccinated /with an expired Shingrix vaccine.; This case was reported by a physician via call center representative and described the occurrence of expired vaccine used in a 51-year-old female patient who received Herpes zoster (Shingrix) (batch number N72HC, expiry date 9th June 2021) for prophylaxis. On 21st July 2021, the patient received Shingrix. On 21st July 2021, unknown after receiving Shingrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown. Additional details were provided as follows: The physician reported that the patient was vaccinated with Shingrix which was already expired on 9th June 2021, which led to expired vaccine used. The reporter consent to follow up.

Other Meds:

Current Illness:

ID: 1497690
Sex: M
Age:
State: NJ

Vax Date:
Onset Date: 05/01/2021
Rec V Date: 07/23/2021
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: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a consumer via a company representative from social media (news media) concerned a male of unspecified age. initial information was processed along with additional information received on 19-JUL-2021. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry; unknown) dose was not reported, 1 total, administered on 07-APR-2021 for prophylactic vaccination. The batch number was not reported per procedure no follow up will be requested. No concomitant medications were reported. In early MAY-2021, the patient tested positive for the virus (suspected covid-19 infection and suspected clinical vaccination failure). Laboratory data included: COVID-19 virus test (NR: not provided) positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210735412, 20210735269, 20210735400, 20210735569 and 20210526031. This report was associated with product quality complaint number: 90000186228, 90000179542.; Sender's Comments: V0. 20210735691-covid-19 vaccine ad26.cov2.s-Suspected clinical vaccination failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS

Other Meds:

Current Illness:

ID: 1497691
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 07/23/2021
Hospital: Y

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: UNSPECIFIED SIDE EFFECTS; This spontaneous report received from a patient via a company representative concerned a male of unspecified age, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, total 1 dose administered, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced unspecified side effects. He was hospitalized on an unspecified date for 1 week. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of unspecified side effects was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0- 20210740887-Covid-19 vaccine ad26.cov2.S Unspecified side effects. This event is considered unassessable. The event 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.

Other Meds:

Current Illness:

Date Died:

ID: 1497692
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 07/23/2021
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: DEATH; STROKE; This spontaneous report received from other health professional via a company representative from social media concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, frequency 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced stroke. On an unspecified date, the patient died from unknown cause of death. It was unknown if autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of stroke was not reported. This report was serious (Death, and Other Medically Important Condition). This case, from the same reporter is linked to 20210740986 and 20210740726.; Sender's Comments: V0: This social media received cased concerns a patient of unspecified age, gender, and ethnicity who had a "stroke" and died from an unspecified cause on unspecified date after receiving. No other pertinent details reported. Information is very limited in this case. The information available precludes a complete and meaningful assessment; hence, the causality is considered unclassifiable due to insufficient information.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH

Other Meds:

Current Illness:

ID: 1497693
Sex: M
Age:
State:

Vax Date:
Onset Date: 07/14/2021
Rec V Date: 07/23/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: SUSPECTED VACCINE FAILURE; SUSPECTED COVID 19; ALLERGY SYMPTOMS; This spontaneous report received from a patient concerned a male of unspecified age, race and ethnic origin. Initial information was processed with additional information received on 20-Jul-2021. The patient's height, and weight were not reported. The patient's past medical history included hernia surgery. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) .5 ml, 1 total, administered on 07-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Patient had concomitant therapy of other therapeutic products unspecified. Patient thought that he had allergy symptoms which started on 14-JUL-2021. He also had hernia surgery on 16-JUL-2021. He lost taste and smell on 19-JUL-2021. On 19-JUL-2021, he was tested was positive for COVID. Laboratory data included: COVID-19 virus test (NR: not provided) Positive. Patient had suspected clinical vaccination failure and suspected covid-19 infection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected clinical vaccination failure, suspected covid-19 infection and allergy symptoms was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210741495. This report was associated with product quality complaint: 90000186465. .; Sender's Comments: 20210742023-COVID-19 VACCINE AD26.COV2.S-suspected clinical vaccine failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS

Other Meds:

Current Illness:

ID: 1497694
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 07/23/2021
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: SEVERE NERVE DAMAGE IN UPPER EXTREMITIES; This spontaneous report received from a patient via a company representative via social media concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced severe nerve damage in upper extremities and only had 20% use of left arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of severe nerve damage in upper extremities was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210744528- Covid-19 vaccine ad26.cov2.s- Severe nerve damage in upper extremities. This event(s) is considered unassessable. The event(s) has an unknown/unclear 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:

ID: 1497695
Sex: M
Age:
State:

Vax Date:
Onset Date: 07/01/2021
Rec V Date: 07/23/2021
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: FEVER; INFLAMMATION IN RECTAL MUSCLE; VERY SORE; MUSCLE PAIN; HEADACHE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 11-JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On JUL-2021, the subject experienced inflammation in rectal muscle. On JUL-2021, the subject experienced very sore. On JUL-2021, the subject experienced muscle pain. On JUL-2021, the subject experienced headache. On 18-JUL-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 37.4?C. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from muscle pain, headache, and fever, and the outcome of inflammation in rectal muscle and very sore was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1497696
Sex: F
Age: 47
State: NJ

Vax Date: 03/29/2021
Onset Date: 04/26/2021
Rec V Date: 07/23/2021
Hospital: Y

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: Unruptured brain aneurysm; feeling non stop Vibrating/buzzing pins and needles on head and foot; Tremor; Lip swelling; terrible pain on my right wrist and elbow on my right side; arthritis type of pain; This spontaneous case was reported by a consumer and describes the occurrence of ANEURYSM (Unruptured brain aneurysm), PARAESTHESIA (feeling non stop Vibrating/buzzing pins and needles on head and foot) and TREMOR (Tremor) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014C21A and 028A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Cold sores and Clipping intracerebral aneurysm on 02-Jun-2021. Concomitant products included BUDESONIDE (PULMICORT) from 05-Jan-2014 to an unknown date for Allergic asthma, ALBUTEROL [SALBUTAMOL] from 05-Jan-2014 to an unknown date for Asthma. On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Apr-2021, the patient experienced TREMOR (Tremor) (seriousness criterion hospitalization). On 29-Apr-2021, the patient experienced LIP SWELLING (Lip swelling). On 09-May-2021, the patient experienced PARAESTHESIA (feeling non stop Vibrating/buzzing pins and needles on head and foot) (seriousness criterion hospitalization). On an unknown date, the patient experienced ANEURYSM (Unruptured brain aneurysm) (seriousness criterion hospitalization) and PAIN IN EXTREMITY (terrible pain on my right wrist and elbow on my right side; arthritis type of pain). The patient was hospitalized from 09-May-2021 to 11-May-2021 due to ANEURYSM, PARAESTHESIA and TREMOR. On 03-May-2021, LIP SWELLING (Lip swelling) had resolved. On 16-May-2021, PAIN IN EXTREMITY (terrible pain on my right wrist and elbow on my right side; arthritis type of pain) had resolved. At the time of the report, ANEURYSM (Unruptured brain aneurysm) was resolving and PARAESTHESIA (feeling non stop Vibrating/buzzing pins and needles on head and foot) and TREMOR (Tremor) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-May-2021, Blood pressure measurement: over 200 (High) high. On 09-May-2021, Computerised tomogram: abnormal (abnormal) unruptured brain aneurysm. On an unknown date, Angiogram: inconclusive (Inconclusive) Aneurysm 7mm. Patient's primary care physician advised her that her lip swelling was a cold sore, but the patient stated she did not get any blister nor pain. It was reported that the vibration, pins and needle got much better but came back on 10-Jul-2021. The vibration/ tremor is on both sides but mainly on the left. Treatment included acupuncture. Patient is currently recovering at home. She is scheduled to see a neurologist on 04-Aug-2021 to seek help for the internal tremor/ vibration on her feet. Company comment: Based on the current available information and temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: ADR Received.Significant FU-Case is upgraded to serious. Events, labs and medical history added.; Sender's Comments: Based on the current available information and temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded.

Other Meds: PULMICORT; ALBUTEROL [SALBUTAMOL]

Current Illness:

ID: 1497697
Sex: M
Age:
State: HI

Vax Date: 01/25/2021
Onset Date: 03/01/2021
Rec V Date: 07/23/2021
Hospital: Y

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: Pneumonia; flu like symptoms; Night Sweats; Malaise/fatigue; occasional cough or two; Malaise/ fatigue; intermittent Chills; This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA (Pneumonia) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 031M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In March 2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms), NIGHT SWEATS (Night Sweats), MALAISE (Malaise/fatigue), COUGH (occasional cough or two), FATIGUE (Malaise/ fatigue) and CHILLS (intermittent Chills). On an unknown date, the patient experienced PNEUMONIA (Pneumonia) (seriousness criteria hospitalization and medically significant). The patient was hospitalized for 3 days due to PNEUMONIA. At the time of the report, PNEUMONIA (Pneumonia), INFLUENZA LIKE ILLNESS (flu like symptoms), NIGHT SWEATS (Night Sweats), MALAISE (Malaise/fatigue), COUGH (occasional cough or two), FATIGUE (Malaise/ fatigue) and CHILLS (intermittent Chills) had resolved. No concomitant medications were reported. No treatment medications were reported. As per report in the month March 2021 patient started experiencing flu like symptoms and On the 06May2021 and currently he is feeling the same flu like symptoms. Company Comment: 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. Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: Added new event added. This case is upgraded as serious as event pneumonia is added.; 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:

Current Illness:

ID: 1497698
Sex: U
Age:
State: AL

Vax Date:
Onset Date:
Rec V Date: 07/23/2021
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: She went to put the needle on the hub to give the dose, and she tried to unscrew the cap when the whole hub broke off at the neck.; She went to put the needle on the hub to give the dose, and she tried to unscrew the cap when the whole hub broke off at the neck.; This is a spontaneous report from a contactable nurse. A patient of unspecified age and gender received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13, Pfizer), via an unspecified route of administration on an unspecified date (Lot Number: DX8301; Expiration Date: 31Jan2023, NDC number: 0005197101, 05 ml) as 0.5mL, single for immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, one of the clinic nurses was taking the vaccine out of the fridge. She went to put the needle on the hub to give the dose, and she tried to unscrew the cap when the whole hub broke off at the neck. There was exposed glass so it was unable to be given. The nurse was wanting to report a quality issue with Prevnar and wanting credit for it. The sample of the product was available to be returned. Packaging was sealed and intact. Investigation results: Description of Complaint: Description of complaint: There is a nurse on the line reporting a PQC for Prevnar 13. Product-Description: Prevnar 13V PFS Suspension 0.5mlX10, Injectable, Lot: DX8301, expiration: 31Jan2023, NDC Number: 0005197101. Brief Complaint Description: She went to put the needle on the hub to give the dose, and she tried to unscrew the cap when the whole hub broke off at the neck. There was exposed glass so it was unable to be given. Product strength and count size dispensed: 0.5mL, 1 vial. The sample of the product was available to be returned. Packaging was sealed and intact. Reasonably Suggest Device Malfunction: Yes. Severity of Harm: S3. Process Related was No. Final Confirmation Status was Not Confirmed. Vendor Related was No. Root Cause Analysis/Identif: The withheld investigation could not indicate a probable root cause for the complaint to be related to the production process of the involved batch. All reviewed records for the involved batch indicated that the batch met the established requirements at time of release. However, without complaint sample and based on the available information it is not possible to perform a more profound investigation and/or root cause analysis. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation, stability and patient safety. PGS withheld concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. No evidence was found to indicate that manufacturing activities at contributed to the reported complaint. In the absence of a returned complaint sample, a definitive root cause was not identified for the reported complaint. Note: The most likely root cause is attributed to the failure of the glass due to residual thermal stress resulting from the syringe manufacturing process when the tips were formed, and stress was introduced as the glass cooled. Such stress is inherent to the forming process, and while subsequent annealing should mitigate this stress, it may remain present at low levels. Following investigation, no evidence was found to indicate that manufacturing activities at contributed to the defect reported in this complaint. Impact Analysis: Following review of the investigation results based on the final scope, there is no evidence that manufacturing activities. Corrective / Preventive Action: No corrective or preventive actions were identified as all reviewed records for the involved batch indicated that the batch met the established requirements at time of release, therefore no corrective and preventative actions were identified. This complaint reported a broken syringe tip. The correct classification and priority were assigned to this complaint. Summary of Investigation: The initial scope of the withheld investigation is limited to the lots documented in the related lots grid. An NTM is raised by Pfizer withheld; Refer to PR withheld, after assessment of the complaint it was determined that a withheld is required. The findings of the withheld investigation are as follows; Batch /Process Record Review: No Findings in relation to the reported complaint. Reserve Sample Evaluation: No defects were observed related to the reported complaint. Complaint Sample Evaluation: A sample/photo were not returned for the complaint at the time of report completion. Trend/Complaint History: A lot specific trend was not identified For the Fill Lot and associated syringe barrel lots. The final scope was limited to the GC Fill Lot (refer to related lots grid) as no evidence was found to indicate that manufacturing activities at withheld contributed to the reported complaint. Conclusion: The complaint for hub broke off at the neck of Prevnar 13V Injectable was investigated. The investigation included reviewing the involved batch records, deviation investigation, evaluation of retain sample(s), an analysis of the complaint history for the reported lot and product type and Annual Product (Quality) Review. The final scope was determined to be the associated lot(s) of the reported lot DX8301. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation, stability and patient safety. withheld concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The NTM process determined that a regulatory notification (withheld)was required. The reported defect could not be confirmed on the evaluation of the retain sample. No root cause or CAPA were identified as the complaint was not confirmed. This complaint reported broken syringe tip for a Prevnar 13V syringe. The Fill Lot is DJ2750. Following investigation, the final scope was limited to the withheld Fill Lot as a trend was not identified and no evidence was found to indicate that manufacturing activities at withheld contributed to the reported complaint. The investigation included a review of; batch and process records, a lot history review and reserve review for the lot in scope. An evaluation of the complaint history confirms that this is the first complaint reported for the Fill Lot for this complaint subclass. A lot specific trend was not identified, and a trend was not identified for the associated syringe barrel lots. The complaint sample/ photo was not returned at the time of report completion, the reported complaint was not confirmed. Broken syringe tip may be attributed to the failure of the glass due to residual thermal stress resulting from the syringe manufacturing process when the tips were formed, and stress was introduced as the glass cooled. Such stress is inherent to the forming process, and while subsequent annealing should mitigate this stress, it may remain present at low levels. There are controls in place at Pfizer withheld to prevent/detect this defect; the withheld inspection machine detects a missing tip cap, cracks in the barrel and underfill / empty syringes. There were no issues identified during the investigation impacting product quality. A process related root cause was not identified at withheld and no corrective/preventative actions are required. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1497699
Sex: F
Age: 64
State: NC

Vax Date: 05/12/2021
Onset Date: 05/12/2021
Rec V Date: 07/23/2021
Hospital:

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

Lab Data:

Allergies: Levofloxacin, Thimerosal, cyclobenzaprine, hydroxyzine, wheat, zolpidem

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

Symptoms: Patient reported "stroke-like" symptoms about 1 hour after getting the 2nd Pfizer vaccine. She described issues with coordination, weakness in hands, dystonia in her hands. Numbness L side of her face, lips tingling, eyes felt strange with a burning sensation. Very mild shortness of breath

Other Meds: No Medications

Current Illness: None

ID: 1497700
Sex: M
Age: 50
State: WA

Vax Date: 02/28/2021
Onset Date: 04/01/2021
Rec V Date: 07/23/2021
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: None

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

Symptoms: Good

Other Meds: None

Current Illness: None

ID: 1497701
Sex: M
Age: 48
State: MI

Vax Date: 03/04/2021
Onset Date: 03/25/2021
Rec V Date: 07/23/2021
Hospital:

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

Lab Data:

Allergies: no

Symptom List: Unevaluable event

Symptoms: Swelling in feet, abdomen and hands.

Other Meds: none

Current Illness: none

ID: 1497702
Sex: F
Age: 39
State: LA

Vax Date: 04/06/2021
Onset Date: 06/11/2021
Rec V Date: 07/23/2021
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: N/A

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

Symptoms: Tingling in my hands & feet, horrible pain in my neck and shoulders, bad headaches

Other Meds: Hair, skin and nails-GNC Blood Builder Iron tablets

Current Illness: N/A

ID: 1497703
Sex: M
Age: 55
State: OK

Vax Date: 03/31/2021
Onset Date: 04/02/2021
Rec V Date: 07/23/2021
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: My entire legs (both, but mostly the left) will cramp anywhere from hip to toe, 4-8 times a night. Sometmes it's the whole leg, but it normally jumps around from side of foot or hamstring or shin or calf or toes or anywhere. Normal standing and stretching doesn't work effectively. I have found nothing that will make the cramps go aways immediately. It takes me usssually 30 minutes of stretching an rubbing to get the cramps to reside enough to go back to bed. The cramping has been constant since the first of April (4 months now). My doctor has had me try muscle relaxers with no help. He's had me back of on certain meds. I've had blood work and magnesium and potaWssum is normal. I'm staying hydrated, drank pickle juic

Other Meds: Metformin, Lyrica, Carvedilol, Levemir, Trulicity, More..

Current Illness:

ID: 1497704
Sex: F
Age: 15
State: RI

Vax Date: 04/24/2021
Onset Date: 04/24/2021
Rec V Date: 07/23/2021
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: Error: Patient Too Young for Vaccine Administered-

Other Meds:

Current Illness:

ID: 1497705
Sex: M
Age: 17
State: NY

Vax Date: 05/12/2021
Onset Date: 05/12/2021
Rec V Date: 07/23/2021
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: Error: Patient Too Young for Vaccine Administered-

Other Meds:

Current Illness:

ID: 1497706
Sex: M
Age: 54
State: FL

Vax Date: 07/10/2021
Onset Date: 07/10/2021
Rec V Date: 07/23/2021
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: Systemic: Joint Pain-Severe, Additional Details: Patient's wife reports that pt experienced muscle pain in shoulders, chest, back, and arm after 30 mins of administration. Later that evening, pt was unconscious and went to the emergency room where he was transferred to the ICU. He has since progressed positively and currently in rehab.

Other Meds:

Current Illness:

ID: 1497707
Sex: F
Age: 48
State: MA

Vax Date: 07/22/2021
Onset Date: 07/22/2021
Rec V Date: 07/23/2021
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: Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Hypertension-Mild, Systemic: Tingling (specify: facial area, extemities)-Severe, Systemic: Weakness-Medium

Other Meds:

Current Illness:

ID: 1497708
Sex: M
Age: 22
State: VT

Vax Date: 07/22/2021
Onset Date: 07/22/2021
Rec V Date: 07/23/2021
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: Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: shot 1t 1256pm, pt began coughing 105pm, had sweating and extrem cough/brionchospasms, benadryl and water 106pm, called 911, emt came 125pm and cleared 145 pm

Other Meds:

Current Illness:

ID: 1497709
Sex: M
Age: 44
State: CA

Vax Date: 07/21/2021
Onset Date: 07/21/2021
Rec V Date: 07/23/2021
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: Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Hypotension-Mild, Additional Details: Pt received first shot setting down. When advised to move to obseration area and pharmacist walked back to pharmacy, pt fainted. Pt was hot, sweaty, and has low BP. EMT was called and pt was resolved and alert after several minutes. Pt was evaluated by EMT and cleared and left on his own.

Other Meds:

Current Illness:

ID: 1497710
Sex: F
Age: 40
State: PA

Vax Date: 03/15/2021
Onset Date: 03/01/2021
Rec V Date: 07/23/2021
Hospital:

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

Lab Data:

Allergies: None

Symptom List: Injection site pain

Symptoms: Onset of Raynaud?s syndrome with 3-5 days. Severe joint pain beginning in hands and later moving through the body. Fatigue. Nausea. Headaches. Diagnosis of Sj?gren?s syndrome. On April 8th following nerve tests and several blood tests.

Other Meds: None

Current Illness: None

ID: 1497711
Sex: F
Age: 34
State: WI

Vax Date: 07/22/2021
Onset Date: 07/22/2021
Rec V Date: 07/23/2021
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: Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Chills-Mild, Systemic: Dizziness / Lightheadness-Mild

Other Meds:

Current Illness:

ID: 1497712
Sex: M
Age: 57
State: CA

Vax Date: 06/12/2021
Onset Date: 06/12/2021
Rec V Date: 07/23/2021
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: Error: Wrong Vaccine Formulation (ex. different manufact. initial and booster)-

Other Meds:

Current Illness:

ID: 1497713
Sex: F
Age: 33
State: IL

Vax Date: 07/20/2021
Onset Date: 07/21/2021
Rec V Date: 07/23/2021
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: Site: Itching at Injection Site-Medium, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Itch Generalized-Medium, Systemic: Weakness-Mild, Additional Details: warm to touch

Other Meds:

Current Illness:

ID: 1497714
Sex: F
Age: 33
State: IL

Vax Date: 07/20/2021
Onset Date: 07/21/2021
Rec V Date: 07/23/2021
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: Site: Itching at Injection Site-Mild, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Itch Generalized-Medium, Additional Details: warm to the touch. redness size of half dollar

Other Meds:

Current Illness:

ID: 1497715
Sex: F
Age: 59
State: NY

Vax Date: 06/02/2021
Onset Date: 06/03/2021
Rec V Date: 07/23/2021
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: Systemic: Tingling (specify: facial area, extemities)-Medium

Other Meds:

Current Illness:

ID: 1497716
Sex: F
Age: 59
State: NY

Vax Date: 06/02/2021
Onset Date: 06/03/2021
Rec V Date: 07/23/2021
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: Systemic: Numbness (specify: facial area, extremities)-Medium

Other Meds:

Current Illness:

ID: 1497717
Sex: F
Age: 17
State: NY

Vax Date: 05/11/2021
Onset Date: 05/11/2021
Rec V Date: 07/23/2021
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: Error: Patient Too Young for Vaccine Administered-

Other Meds:

Current Illness:

ID: 1497718
Sex: M
Age: 76
State: FL

Vax Date: 01/29/2021
Onset Date: 06/10/2021
Rec V Date: 07/23/2021
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: Right side of face became paralized,

Other Meds: AMD-Areds2

Current Illness: Macular degeneration

ID: 1497719
Sex: M
Age: 72
State: OH

Vax Date: 07/20/2021
Onset Date: 07/21/2021
Rec V Date: 07/23/2021
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: None

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

Symptoms: 24 hours of fever of 101, body aches, weakness, chills, loss of appetite. Soreness at injection site lasting three days.

Other Meds: Lipitor, Losartan, Glipizide, Januvia, Pregabalin, Verapamil, Aleve

Current Illness: None

ID: 1497720
Sex: M
Age: 20
State: CA

Vax Date: 07/22/2021
Onset Date: 07/22/2021
Rec V Date: 07/23/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Pain in extremity

Symptoms: Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Hypotension-Mild, Additional Details: pt fainted after receiving second dose of vaccine; lack of food in stomach plus cannabis inhalation earlier in the morning

Other Meds:

Current Illness:

ID: 1497721
Sex: M
Age: 17
State: CA

Vax Date: 07/22/2021
Onset Date: 07/22/2021
Rec V Date: 07/23/2021
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: Error: Patient Too Young for Vaccine Administered-

Other Meds:

Current Illness:

ID: 1497722
Sex: M
Age: 49
State: NJ

Vax Date: 05/04/2021
Onset Date: 05/04/2021
Rec V Date: 07/23/2021
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: Systemic: Dizziness / Lightheadness-Mild, Additional Details: Patient's wife called 7/22/21 saying they believe the 2nd covid vaccine caused her husband's vertigo. This occurs whenever he lays on his right side. She states it began exactly the day that he received the 2nd dose, on 5/4/21.

Other Meds:

Current Illness:

ID: 1497723
Sex: M
Age: 15
State: CT

Vax Date: 05/02/2021
Onset Date: 05/02/2021
Rec V Date: 07/23/2021
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: Error: Patient Too Young for Vaccine Administered-

Other Meds:

Current Illness:

ID: 1497724
Sex: F
Age: 21
State: PA

Vax Date: 07/22/2021
Onset Date: 07/22/2021
Rec V Date: 07/23/2021
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: Systemic: Hyperventilation-Mild, Systemic: Numbness (specify: facial area, extremities)-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Systemic: Weakness-Mild, Additional Details: Patient asked about possible side effects from vaccine. They were discussed with her. She asked about why she needed to stay15 minutes after vaccination which was stated to assess for possible allergic reaction. Pt reported she had severe panic attacks in the past and that she was then concerned about allergic reaction. She stated she had numbness at her hand which went away after 30 minutes. she was assessed for 30 minutes. Her anxiety deminished and she wanted to leave.

Other Meds:

Current Illness:

ID: 1497725
Sex: F
Age: 15
State: GA

Vax Date: 07/21/2021
Onset Date: 07/21/2021
Rec V Date: 07/23/2021
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: Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Shakiness-Medium, Systemic: Weakness-Medium, Additional Details: 5 minutes after 1st covid vaccine, patient became lightheaded, pale and fainted. While unconcious, patient was shaking (not sure if it was a seizure or due to fainting) for about 1 minute. We called 911 and patient regained consiousness shortly after. She was confused and was weak. EMS arrived and took vitals but all vitals were within normal range. EMS thinks patient had a vaso-vagal response and cleared patient to leave. After 20 minutes, patient said she felt okay and left the building.

Other Meds:

Current Illness:

ID: 1497726
Sex: M
Age: 33
State: CO

Vax Date: 07/21/2021
Onset Date: 07/21/2021
Rec V Date: 07/23/2021
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: Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Hypotension-Mild

Other Meds:

Current Illness:

ID: 1497727
Sex: F
Age: 35
State: AL

Vax Date: 07/22/2021
Onset Date: 07/22/2021
Rec V Date: 07/23/2021
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: Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Headache-Mild, Additional Details: patient stated she was feeling a little strange after injection, stated her head was hurting and felt like it had pressure in it

Other Meds:

Current Illness:

ID: 1497728
Sex: F
Age:
State:

Vax Date:
Onset Date: 06/28/2021
Rec V Date: 07/23/2021
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: SUSPECTED IMMUNOLOGICAL VACCINE FAILURE; DIFFICULTY SPEAKING; SLEEPY; BLURRED VISION 80 PERCENT OF THE TIME; CONFUSION; DIZZINESS; PROBLEM CONCENTRATING; JETLAGGED; CAN'T BE ON FEET FOR MORE THAN 20 MIN; TIREDNESS; FEELING SICK; This spontaneous report received from a patient concerned a 46 year white and Hispanic or Latino old female. The patient's height, and weight were not reported. The patient's concurrent conditions included hashimoto disease. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, and expiry: UNKNOWN) dose was not reported, frequency was 1 total administered on 24-JUN-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 05-JUL-2021, Laboratory data included: PCR (NR: not provided) negative. On 08-JUL-2021, Laboratory data included: PCR (NR: not provided) negative. On 9 Jul 2021, the patient started to feel very tired as if she is Jetlagged. Her eye lid would close from being so tired even after 11 hours of sleeping. She is having difficulty speaking, concentrating and she is feeling dizzy and confused. On 19 Jul 2021, she felt well and better, but she still had problem concentrating and blurred vision 80 percent of the time. She can't be on her feet for more than 20 min. On 19-Jul-2021 (for 10 days), she could not go to work or take care of her kids. Her doctor was suspecting she may have Covid infection during her visit and those symptoms were post Covid syndrome. She suffered from hypothyroidism due to Hashimoto disease. She started taking anti-inflammatory medication and omega 3 as suggested by her Doctor. She was worried as she heard that she may be getting a swelling of the brain. On 13-JUL-2021, Laboratory data included: Laboratory test (NR: not provided) high levels of ATPO which are the antibodies against thyroid gland but normal TSH and T3. On 17-JUL-2021, Laboratory data included: Laboratory test (NR: not provided) high levels of ATPO which are the antibodies against the thyroid gland but normal TSH and T3. MRI (NR: not provided) neurological functions are fine, and PCR (NR: not provided) negative. On 18-JUL-2021, Laboratory data included: IgG normal (NR: not provided) negative. On 28-JUN-2021, she experienced feeling sick. On an unspecified date, the patient experienced suspected immunological vaccine failure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from feeling sick, had not recovered from dizziness, difficulty speaking, tiredness, sleepy, blurred vision 80 percent of the time, confusion, and problem concentrating, and the outcome of jetlagged, can't be on feet for more than 20 min, and suspected immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210741759-COVID-19 VACCINE AD26.COV2.S-Suspected immunological vaccine failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS

Other Meds:

Current Illness: Hashimoto's disease

ID: 1497906
Sex: M
Age: 58
State: NY

Vax Date: 05/07/2021
Onset Date: 05/07/2021
Rec V Date: 07/23/2021
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: No known allergies

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

Symptoms: 2 days after the mRNA vaccine 2nd dose, patient developed a severe acute onset of inflammatory polyarthritis involving PIPs, MCPs, wrists, knees, ankles, and MTPs with joint swelling. He also had myalgias (muscle pain diffusely). He had progressively worsening symptoms and was hospitalized at Allen-NY Presbyterian in July 2021 and was found to have very high Rheumatoid factor (>650) and high ESR (100s). It was thought that patient had a dormant rheumatoid arthritis, which was triggered by the natural immune response to the vaccine. He was treated with Solumedrol 30mg IV twice a day in the hospital and symptoms resolved in 24 hours. He was discharged with a prednisone taper of 40mg/day tapered off over 1 month, and will be followed in the Rheumatology clinic. To see if he has develops chronic Rheumatoid arthritis, or if this a temporary and treatable Reactive arthritis to the vaccine.

Other Meds: Methadone

Current Illness: COPD-well controlled, Opiod abuse history--well controlled on Methadone

Total 2021 VAERS Injuries: 636,615

Page last modified: 03 October 2021 5:28pm