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: 1409856
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 06/18/2021
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: got his shot and ended up getting them anyway/Suspected vaccination failure; got his shot and ended up getting them anyway; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. Additional details were reported as follows: The case was reported by the patient's child. The age at vaccination was not reported. The patient had his Shingle shot and ended up getting shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation were unknown at the time of reporting. The follow up would not be possible as no contact details were available.

Other Meds:

Current Illness:

ID: 1409857
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 06/18/2021
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: had a bad nerves on my right arm; had tight right upper shoulder; headache; chill; very tired for 3 days then four days I felt great; This case was reported by a consumer via media and described the occurrence of peripheral neuropathy in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, less than 2 years after receiving Shingles vaccine, the patient experienced peripheral neuropathy (serious criteria GSK medically significant), stiffness shoulder, headache, chills and tiredness. On an unknown date, the outcome of the peripheral neuropathy was unknown and the outcome of the stiffness shoulder, headache, chills and tiredness were recovered/resolved. It was unknown if the reporter considered the peripheral neuropathy, stiffness shoulder, headache, chills and tiredness to be related to Shingles vaccine. Additional details were provided as follows: The patient was the reporter. The age at vaccination was not reported. The patient received Shingrix and had a bad nerve on right arm, tight right upper shoulder, headache, chill and was very tired for 3 days then four days felt great. The reporter mentioned that after second dose of shingles vaccine the patient felt strong fine.

Other Meds:

Current Illness:

ID: 1409858
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 06/18/2021
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: Got shingles shot.got shingals in my 30 s/ Suspected vaccination failure; Got shingles shot.got shingals in my 30 s; Got shingles shot.got shingals in my 30 s; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and inappropriate age at vaccine administration. On an unknown date, the outcome of the vaccination failure, shingles and inappropriate age at vaccine administration were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. Additional details were provided as follows: The case was reported by the patient. The age at vaccination was not reported. The reporter got Shingles shot and got shingles in his or her 30s, which led to inappropriate age at vaccine administration. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.

Other Meds:

Current Illness:

ID: 1409859
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 06/18/2021
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: got the vaccine and 6 months later got the shingles/ suspected vaccination failure; got the shingles; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, 6 months after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. Additional details were provided as follows: The case was reported by the patient's sibling. The age at vaccination was not reported. The reporter stated that, the patient got the vaccine and 6 months later got the shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory confirmation regarding shingles were unknown at the time of reporting.

Other Meds:

Current Illness:

ID: 1409861
Sex: F
Age:
State: CA

Vax Date:
Onset Date:
Rec V Date: 06/18/2021
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: had received Shingrix vaccine / afterward, pt had a shingles outbreak/ Suspected Vaccination failure; pt had a shingles outbreak; This case was reported by a physician via sales rep and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix. Additional details were reported as follows: The age at vaccination was not reported. The patient received the Shingrix and at some time afterward, had a shingles outbreak. The reporter could not remember anything else about patient/case. The reporter consented to follow-up. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.

Other Meds:

Current Illness:

ID: 1409862
Sex: U
Age:
State:

Vax Date: 06/04/2021
Onset Date: 06/01/2021
Rec V Date: 06/18/2021
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: 3 days later I got shingles in my one nasal passage; Received second dose / with adverse reactions ( swelling / at site); Received second dose / with adverse reactions ( / redness at site); This case was reported by a consumer and described the occurrence of shingles in a patient who received Herpes zoster (Shingrix) for prophylaxis. On 4th June 2021, the patient received the 2nd dose of Shingrix. In June 2021, 3 days after receiving Shingrix, the patient experienced shingles, injection site swelling and injection site erythema. On an unknown date, the outcome of the shingles, injection site swelling and injection site erythema were not recovered/not resolved. It was unknown if the reporter considered the shingles, injection site swelling and injection site erythema to be related to Shingrix. Additional details were reported as follows: This case was reported by patient herself/himself. The age at vaccination was not reported. After receiving 2nd dose of shingrix vaccine, the patient experienced injection site swelling ,injection site erythema and shingles. Shingles was happened 3 days after getting the 2nd dose of Shingrix vaccine. No further information was reported. Follow up was not possible as no contact details were provided.

Other Meds:

Current Illness:

ID: 1409864
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 06/18/2021
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: You got it from the Shot/ Suspected vaccination failure; You got it from the Shot; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown. The reporter considered the vaccination failure and shingles to be related to Shingles vaccine. Additional details were reported as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient received the Shingles vaccine and got shingles from it. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting. This case had been linked with US2021AMR100406 and US2021AMR100411, reported by same reporter.; Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR100406:Same reporter. US-GLAXOSMITHKLINE-US2021AMR100411:Same reporter.

Other Meds:

Current Illness:

ID: 1409865
Sex: U
Age:
State: FL

Vax Date:
Onset Date:
Rec V Date: 06/18/2021
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: redness; swelling; This case was reported by a other health professional via sales rep and described the occurrence of erythema in a patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced erythema and swelling. On an unknown date, the outcome of the erythema and swelling were unknown. It was unknown if the reporter considered the erythema and swelling to be related to Shingrix. Additional details were reported as follows: The age at vaccination was not reported. It was reported that a patient who received Shingrix experienced redness and swelling. No further information was reported. The reporter did not consent to follow up.

Other Meds:

Current Illness:

ID: 1409866
Sex: M
Age:
State:

Vax Date: 06/15/2021
Onset Date: 06/16/2021
Rec V Date: 06/18/2021
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: My husband had Shingrix yesterday. Fever today; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a male patient who received Herpes zoster (Shingrix) for prophylaxis. On 15th June 2021, the patient received Shingrix. On 16th June 2021, 1 days after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was not recovered/not resolved. It was unknown if the reporter considered the fever to be related to Shingrix. Additional details were reported as follows: The case was reported by the wife of the patient. The age at vaccination was not reported. The patient received dose of shingrix and experienced fever and the patient was asking how long it would usually last. Follow up was not possible as no contact details were provided.

Other Meds:

Current Illness:

ID: 1409867
Sex: M
Age: 67
State: PA

Vax Date: 06/10/2021
Onset Date: 06/10/2021
Rec V Date: 06/18/2021
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: first Shingrix dose 6/17/2020 / received his second dose 6/11/2121; This case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a 67-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received 1st dose of Shingrix on 17th June 2020). On 10th June 2021, the patient received the 2nd dose of Shingrix (intramuscular). On 10th June 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: This case was reported by patient himself. The patient received 2nd dose of Shingrix, more than recommended interval, which led to lengthening of vaccination schedule. At that time of 1st dose the pharmacist told him it would be a year before he needed his 2nd dose. The reporter also mentioned that, he should had gotten it within 2 to 6 months after the 1st dose and would like to know if he was ok, or should restart the series. The reporter consented to follow up.

Other Meds:

Current Illness:

ID: 1409868
Sex: F
Age: 67
State: MI

Vax Date: 06/11/2021
Onset Date: 06/12/2021
Rec V Date: 06/18/2021
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: Left armpit pain; Left armpit / swollen lymph nodes; This case was reported by a consumer via call center representative and described the occurrence of axillary pain in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Concurrent medical conditions included multiple myeloma. On 11th June 2021, the patient received the 1st dose of Shingrix (intramuscular). On 12th June 2021, 1 days after receiving Shingrix, the patient experienced axillary pain and axillary lymph nodes enlarged. On an unknown date, the outcome of the axillary pain and axillary lymph nodes enlarged were not recovered/not resolved. It was unknown if the reporter considered the axillary pain and axillary lymph nodes enlarged to be related to Shingrix. Additional details were provided as follows: Age at vaccination was not reported. The patient experienced left armpit pain and left swollen lymph nodes in the same location after receiving the Shingrix vaccine last Friday. The patient gave medical disclaimer and referred to health care professional. The reporter consented to follow up.

Other Meds:

Current Illness: Multiple myeloma

ID: 1409870
Sex: F
Age:
State: KS

Vax Date: 06/14/2021
Onset Date: 06/14/2021
Rec V Date: 06/18/2021
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: 3rd dose of bexsero was administered to a patient; This case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 18-year-old female patient who received Men B NVS (Bexsero) (batch number ABXB05BA, expiry date 31st March 2022) for prophylaxis. Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis. Previously administered products included Bexsero (received 1st dose on an unknown date) and Bexsero (received 2nd dose on an unknown date). On 14th June 2021, the patient received the 3rd dose of Bexsero and Bexsero Pre-Filled Syringe Device. On 14th June 2021, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered 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: Age at vaccination was not reported. The patient received 3rd dose of bexsero on 14th June 2021, which led to extra dose administered. The reporter would like to know any possible effect and any info on 3 doses. The reporter consented to follow up.

Other Meds:

Current Illness:

ID: 1409871
Sex: U
Age:
State: WI

Vax Date:
Onset Date:
Rec V Date: 06/18/2021
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 didn?t received Shingrix 2nd dose after one year since 1st dose; This case was reported by a pharmacist 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 2020, 1 year prior to reporting date). 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 reported 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 after one year since 1st dose administration, which led to incomplete course of vaccination.

Other Meds:

Current Illness:

ID: 1409873
Sex: F
Age: 70
State: GA

Vax Date: 04/01/2021
Onset Date: 04/01/2021
Rec V Date: 06/18/2021
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: first dose of Shingrix in 2018/ Two months ago (April 2021) she received the second dose; This case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received 1st dose of Shingrix on unknown date in 2018). In April 2021, the patient received the 2nd dose of Shingrix (intramuscular). In April 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 age at vaccination was not reported. The patient received 2nd dose of Shingrix, more than the recommended interval, which led to lenghtening of vaccination schedule. The patient asked the pharmacist to restart the series and to schedule her for a third vaccine, but the pharmacist refused to administer a third vaccine. The reporter consented to follow up.

Other Meds:

Current Illness:

ID: 1409876
Sex: M
Age:
State: IL

Vax Date:
Onset Date:
Rec V Date: 06/18/2021
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: received 1st dose of Shingrix / 03/10/2020/ did not receive 2nd shot yet.; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 75-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (1st dose received on 10th March 2020). 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 reported 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 Vaers details were provided for 1st dose of Shingrix. The reporter consented to follow-up. No further information was reported.

Other Meds:

Current Illness:

ID: 1409877
Sex: M
Age:
State: MO

Vax Date:
Onset Date: 04/13/2021
Rec V Date: 06/18/2021
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: FATIGUE; BODY ACHES; LOWER BACK PAIN ON LEFT SIDE/BACK PAIN; PAIN IN HIS WHOLE UPPER ARM (SHOULDER TO ELBOW) OF THE INJECTION SITE/LEFT ARM SORENESS; COLD CHILLS; INJECTION SITE PAIN; This spontaneous report received from a patient concerned a 50 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included headaches, blood pressure abnormal, iodine allergy, non-alcohol user, and non-smoker.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. Concomitant medications included losartan for blood pressure abnormal, and verapamil for headaches. On 13-APR-2021, the subject experienced body aches. On 13-APR-2021, the subject experienced lower back pain on left side/back pain. On 13-APR-2021, the subject experienced pain in his whole upper arm (shoulder to elbow) of the injection site/left arm soreness. On 13-APR-2021, the subject experienced cold chills. On 13-APR-2021, the subject experienced injection site pain. On 05-JUN-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, and cold chills on 15-APR-2021, lower back pain on left side/back pain, and fatigue on 06-JUN-2021, and injection site pain on APR-2021, and had not recovered from pain in his whole upper arm (shoulder to elbow) of the injection site/left arm soreness. This report was non-serious.

Other Meds: LOSARTAN; VERAPAMIL

Current Illness: Abstains from alcohol; Blood pressure abnormal; Headache; Iodine allergy; Non-smoker

ID: 1409878
Sex: F
Age:
State: TX

Vax Date:
Onset Date: 05/29/2021
Rec V Date: 06/18/2021
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: TROUBLE WITH HER VISION ON HER RIGHT SIDE; NUMBNESS IN RIGHT ARM AND LEG; TINGLING IN RIGHT ARM AND LEG; PRESSURE ON RIGHT SIDE OF HEAD; HEADACHE; PAINFUL ARM; This spontaneous report received from a patient concerned a 68 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetes, and pain very rarely in her left leg.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821286 expiry: 23-JUL-2021) dose was not reported, administered on 29-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 29-MAY-2021, the subject experienced painful arm. On 30-MAY-2021, the subject experienced tingling in right arm and leg. On 30-MAY-2021, the subject experienced pressure on right side of head. On 30-MAY-2021, the subject experienced headache. On 31-MAY-2021, the subject experienced numbness in right arm and leg. On an unspecified date, the subject experienced trouble with her vision on her right side. Treatment medications (dates unspecified) included: acetylsalicylic acid, and gabapentin. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from trouble with her vision on her right side, and painful arm on 29-MAY-2021, was recovering from headache, and pressure on right side of head, and had not recovered from numbness in right arm and leg, and tingling in right arm and leg. This report was non-serious.

Other Meds:

Current Illness: Diabetes; Leg pain

ID: 1409879
Sex: F
Age:
State:

Vax Date:
Onset Date: 06/11/2021
Rec V Date: 06/18/2021
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: LACK OF SLEEP; FEELING DRUGGY; FLU LIKE SYMPTOMS; SENSITIVITY; This spontaneous report received from a patient concerned a female 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: Unknown) dose was not reported, administered on 11-JUN-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow up to request batch number. No concomitant medications were reported. On 11-JUN-2021, the subject experienced lack of sleep. On 11-JUN-2021, the subject experienced feeling druggy. On 11-JUN-2021, the subject experienced flu like symptoms. On 11-JUN-2021, the subject experienced sensitivity. Laboratory data included: Body temperature (NR: not provided) 98.6 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the lack of sleep, feeling druggy, flu like symptoms and sensitivity was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1409881
Sex: F
Age:
State: CA

Vax Date:
Onset Date: 06/10/2021
Rec V Date: 06/18/2021
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: RED SPOTS UNDER SKIN ON CHEST AND ARMS; CHILLS; TOO TIRED; INJECTION SITE PAIN/ ARM AT INJECTION SITE HURTS; INJECTION SITE REDNESS; HEADACHE; FEVER; SHORTNESS OF BREATH; NERVE PAIN EVERYWHERE; PAIN IN LUNGS WHEN TALKING OR MOVING; This spontaneous report received from a patient concerned a 68 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid-19. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, expiry: UNKNOWN) dose was not reported, administered on 10-JUN-2021 for prophylactic vaccination. Concomitant medications included fluticasone furoate for covid-19. On 10-JUN-2021, the subject experienced shortness of breath. On 10-JUN-2021, the subject experienced nerve pain everywhere. On 10-JUN-2021, the subject experienced pain in lungs when talking or moving. On 10-JUN-2021, the subject experienced chills. On 10-JUN-2021, the subject experienced too tired. On 10-JUN-2021, the subject experienced injection site pain/ arm at injection site hurts. On 10-JUN-2021, the subject experienced injection site redness. On 10-JUN-2021, the subject experienced headache. On 10-JUN-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 101.3 F. On 14-JUN-2021, the subject experienced red spots under skin on chest and arms. Treatment medications (dates unspecified) included: salbutamol sulfate, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and fever on 11-JUN-2021, was recovering from shortness of breath, and injection site redness, had not recovered from nerve pain everywhere, injection site pain/ arm at injection site hurts, red spots under skin on chest and arms, and headache, and the outcome of pain in lungs when talking or moving and too tired was not reported. This report was non-serious.

Other Meds: FLUTICASONE FUROATE

Current Illness:

ID: 1409882
Sex: F
Age:
State: OH

Vax Date:
Onset Date: 03/01/2021
Rec V Date: 06/18/2021
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: NOSE BLEED; This spontaneous report received from a physician concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included polycythemia vera. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose was not reported, 1 total administered IN MAR-2021 for prophylactic vaccination. Batch number was not reported and has been requested. Non-company suspect drugs included: ruxolitinib phosphate (tablet, oral, batch number was not reported) 5 mg, 2 times every 1 total, from JUL-2020 for polycythemia vera. No concomitant medications were reported. In MAR-2021, the patient experienced nose bleed for 1 day and stopped. Then a week later, she had a nose bleed that lasted for 5 straight days. For the past 2 weeks before reporting, patient had only 1 nose bleed. Patient reported her nose bleed to physician, who suggested her to keep a watch on nose bleed. The patient had not experienced nose bleed until recently and wondered if receiving the vaccine and having nose bleed were related. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and dose of ruxolitinib phosphate was not changed. The outcome of nose bleed was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0;20210629648-covid-19 vaccine ad26.cov2.s -Nose bleeding. 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: MEDICAL HISTORY, UNDERLYING DISEASE

Other Meds:

Current Illness: Polycythemia vera

ID: 1409883
Sex: M
Age:
State:

Vax Date:
Onset Date: 06/13/2021
Rec V Date: 06/18/2021
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: CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown and expiry date: Unknown) dose was not reported, 1 total administered on 16-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 13-JUN-2021, Laboratory data included: Blood test (NR: not provided) Negative for Neutralizing Antibodies. Patient had confirmed immunological vaccine failure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint 90000182890. The suspected product quality complaint has been confirmed to be not voided based on the PQC evaluation/investigation performed.; Sender's Comments: V0 - 20210629741-COVID-19 VACCINE AD26.COV2.S -Confirmed Immunological 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: 1409884
Sex: F
Age:
State: WA

Vax Date:
Onset Date: 06/14/2021
Rec V Date: 06/18/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Unevaluable event

Symptoms: VACCINE WAS PUT IN SYRINGE AND LEFT AT ROOM TEMPERATURE; VACCINE ADMINISTERED OUTSIDE OF THE RECOMMENDED STORAGE CONDITIONS; .This spontaneous report received from a health care professional concerned a 63 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient was new at clinic and no medical history on file. the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, and batch number: 202A21A expiry: 07/AUG/2021) dose was not reported, administered on 14-JUN-2021 13:36 for prophylactic vaccination. No concomitant medications were reported. On 14-JUN-2021, the subject experienced vaccine was put in syringe and left at room temperature. On 14-JUN-2021, the subject experienced vaccine administered outside of the recommended storage conditions. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine administered outside of the recommended storage conditions and vaccine was put in syringe and left at room temperature was not reported. This report was non-serious. This case, from the same reporter is linked to 20210629846.

Other Meds:

Current Illness:

ID: 1409885
Sex: F
Age:
State: FL

Vax Date:
Onset Date:
Rec V Date: 06/18/2021
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: PAIN IN GROIN; PAIN IN ARM/PAIN IN THIGH; PAIN IN SHOULDER; This spontaneous report received from a patient concerned a female 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 APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced pain in groin, pain in arm/pain in thigh, and pain in shoulder. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain in arm/pain in thigh, pain in groin, and pain in shoulder. This report was non-serious.

Other Meds:

Current Illness:

ID: 1409886
Sex: F
Age:
State: AZ

Vax Date:
Onset Date: 06/09/2021
Rec V Date: 06/18/2021
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: ARMS ACHE; HIP ACHE; FATIGUE; This spontaneous report received from a patient concerned a female 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: 203A21A, expiry: UNKNOWN) dose was not reported, administered on 09-JUN-2021 11:00 for prophylactic vaccination. No concomitant medications were reported. On 09-JUN-2021, the subject experienced arms ache. On 09-JUN-2021, the subject experienced hip ache. On 09-JUN-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fatigue, arms ache and hip ache was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1409887
Sex: M
Age:
State: MA

Vax Date:
Onset Date: 06/15/2021
Rec V Date: 06/18/2021
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: DOSE OF VACCINE GIVEN TO PATIENT FROM A VIAL THAT HAD BEEN PUNCTURED PREVIOUS MORNING; This spontaneous report received from a pharmacist concerned a 71 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, expiry: 07-AUG-2021) dose was not reported, administered on 15-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 15-JUN-2021, the subject experienced dose of vaccine given to patient from a vial that had been punctured previous morning. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of dose of vaccine given to patient from a vial that had been punctured previous morning was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1409888
Sex: M
Age:
State: NV

Vax Date:
Onset Date: 03/26/2021
Rec V Date: 06/18/2021
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: FATIGUE; LEFT HAND CLENCHED INTO FIST FOR THE PAST TWO MONTHS AND A HALF; PREVIOUS RIGHT SIDED NUMBNESS WAS MORE INTENSE; DECREASED ENERGY; FEELING UNWELL; This spontaneous report received from a patient concerned a 63 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included sciatica, numbness of the right side, and environmental allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, expiry: UNKNOWN) dose was not reported, administered on 26-MAR-2021 10:00 for prophylactic vaccination. No concomitant medications were reported. On 26-MAR-2021, the subject experienced left hand clenched into fist for the past two months and a half. On 26-MAR-2021, the subject experienced previous right sided numbness was more intense. On 26-MAR-2021, the subject experienced decreased energy. On 26-MAR-2021, the subject experienced feeling unwell. On an unspecified date, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from left hand clenched into fist for the past two months and a half on 15-MAY-2021, had not recovered from decreased energy, feeling unwell, and previous right sided numbness was more intense, and the outcome of fatigue was not reported. This report was non-serious.

Other Meds:

Current Illness: Environmental allergy; Numbness; Sciatica

ID: 1409889
Sex: U
Age:
State: MI

Vax Date:
Onset Date: 06/10/2021
Rec V Date: 06/18/2021
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: PATIENT RECEIVED THE VACCINE 9.5 HOURS AFTER VIAL PUNCTURE; INCORRECT PRODUCT STORAGE; This spontaneous report received from a health care professional concerned multiple patients. 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: 042A21A, expiry: 05-AUG-2021) dose was not reported, administered on 10-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-JUN-2021, the patient experienced patient received the vaccine 9.5 hours after vial puncture. On 10-JUN-2021, the patient experienced incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the patient received the vaccine 9.5 hours after vial puncture and incorrect product storage was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1409890
Sex: F
Age: 71
State: CA

Vax Date: 03/12/2021
Onset Date: 03/12/2021
Rec V Date: 06/18/2021
Hospital: Y

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: Blood pressure was 195/96; Shortness of breath; Confusion; Weakness; Diarrhea; Speech was slurred; Additional rashes appeared; Chills; Tired; Headache; Joint pain; rashes that started to appear, itching, discomfort; Discomfort; Slept most of the night; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPERTENSION (Blood pressure was 195/96) and DYSPNOEA (Shortness of breath) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included VITAMINS NOS for an unknown indication. On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced SOMNOLENCE (Slept most of the night). On 15-Mar-2021, the patient experienced RASH PRURITIC (rashes that started to appear, itching, discomfort), DISCOMFORT (Discomfort) and ARTHRALGIA (Joint pain). On 16-Mar-2021, the patient experienced HYPERTENSION (Blood pressure was 195/96) (seriousness criterion hospitalization), DYSPNOEA (Shortness of breath) (seriousness criterion hospitalization), CONFUSIONAL STATE (Confusion), ASTHENIA (Weakness), DIARRHOEA (Diarrhea), DYSARTHRIA (Speech was slurred), RASH (Additional rashes appeared), CHILLS (Chills), FATIGUE (Tired) and HEADACHE (Headache). The patient was hospitalized from 16-Mar-2021 to 17-Mar-2021 due to DYSPNOEA and HYPERTENSION. The patient was treated with FLUTICASONE PROPIONATE (FLONAZE) (intravenous) at an unspecified dose and frequency; FAMOTIDINE at an unspecified dose and frequency and PREDNISONE at an unspecified dose and frequency. On 13-Mar-2021, SOMNOLENCE (Slept most of the night) had resolved. On 16-Mar-2021, HYPERTENSION (Blood pressure was 195/96), CONFUSIONAL STATE (Confusion) and DYSARTHRIA (Speech was slurred) had resolved. On 17-Mar-2021, RASH PRURITIC (rashes that started to appear, itching, discomfort), DIARRHOEA (Diarrhea) and RASH (Additional rashes appeared) had resolved. At the time of the report, DYSPNOEA (Shortness of breath) had not resolved and DISCOMFORT (Discomfort), ASTHENIA (Weakness), ARTHRALGIA (Joint pain), CHILLS (Chills), FATIGUE (Tired) and HEADACHE (Headache) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Mar-2021, Blood pressure measurement: 195/96 (High) units not provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds: VITAMINS NOS

Current Illness:

ID: 1409891
Sex: M
Age: 56
State: KY

Vax Date: 03/25/2021
Onset Date: 03/25/2021
Rec V Date: 06/18/2021
Hospital: Y

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: Can't even walk; Couldn't catch his breath; fatigue; Acute hypoxy respiratory failure; Pleuritic chest pain; Red ithcy eyes; HS pneumonitis; Decreased level of conciousness; ILD; non necrotizing granuloma; Flushing; Pulse ox reading in the 70's; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RESPIRATORY FAILURE (Acute hypoxy respiratory failure), CHEST PAIN (Pleuritic chest pain), OCULAR HYPERAEMIA (Red ithcy eyes), HYPERSENSITIVITY PNEUMONITIS (HS pneumonitis), DEPRESSED LEVEL OF CONSCIOUSNESS (Decreased level of conciousness), INTERSTITIAL LUNG DISEASE (ILD), PULMONARY GRANULOMA (non necrotizing granuloma), FLUSHING (Flushing), OXYGEN SATURATION DECREASED (Pulse ox reading in the 70's), GAIT INABILITY (Can't even walk), DYSPNOEA (Couldn't catch his breath) and FATIGUE (fatigue) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination. No adverse event reported. The patient's past medical history included Type 2 diabetes mellitus. Previously administered products included for an unreported indication: Accupril in 1996 and Accupril. Past adverse reactions to the above products included Ankle swelling with Accupril; and Knee swelling with Accupril. Concomitant products included HYDROCHLOROTHIAZIDE, LOSARTAN POTASSIUM (HYZAAR) for Blood pressure, METFORMIN, SERTRALINE, CYCLOBENZAPRINE HYDROCHLORIDE (FLEXERIL [CYCLOBENZAPRINE HYDROCHLORIDE]), IBUPROFEN, TADALAFIL (CIALIS), INSULIN LISPRO, CALCIUM, COLECALCIFEROL (CALCIUM VITAMIN D) and INSULIN GLARGINE (BASAGLAR KWIKPEN) for an unknown indication. On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced OXYGEN SATURATION DECREASED (Pulse ox reading in the 70's) (seriousness criterion medically significant), GAIT INABILITY (Can't even walk) (seriousness criterion hospitalization), DYSPNOEA (Couldn't catch his breath) (seriousness criterion hospitalization) and FATIGUE (fatigue) (seriousness criterion hospitalization). On an unknown date, the patient experienced RESPIRATORY FAILURE (Acute hypoxy respiratory failure) (seriousness criteria hospitalization and medically significant), CHEST PAIN (Pleuritic chest pain) (seriousness criterion hospitalization), OCULAR HYPERAEMIA (Red ithcy eyes) (seriousness criterion hospitalization), HYPERSENSITIVITY PNEUMONITIS (HS pneumonitis) (seriousness criteria hospitalization and medically significant), DEPRESSED LEVEL OF CONSCIOUSNESS (Decreased level of conciousness) (seriousness criteria hospitalization and medically significant), INTERSTITIAL LUNG DISEASE (ILD) (seriousness criteria hospitalization and medically significant), PULMONARY GRANULOMA (non necrotizing granuloma) (seriousness criterion hospitalization) and FLUSHING (Flushing) (seriousness criterion hospitalization). The patient was hospitalized from 27-Mar-2021 to 02-Apr-2021 due to CHEST PAIN, DEPRESSED LEVEL OF CONSCIOUSNESS, FLUSHING, HYPERSENSITIVITY PNEUMONITIS, INTERSTITIAL LUNG DISEASE, OCULAR HYPERAEMIA, PULMONARY GRANULOMA and RESPIRATORY FAILURE. At the time of the report, RESPIRATORY FAILURE (Acute hypoxy respiratory failure), CHEST PAIN (Pleuritic chest pain), OCULAR HYPERAEMIA (Red ithcy eyes), HYPERSENSITIVITY PNEUMONITIS (HS pneumonitis), DEPRESSED LEVEL OF CONSCIOUSNESS (Decreased level of conciousness), INTERSTITIAL LUNG DISEASE (ILD), PULMONARY GRANULOMA (non necrotizing granuloma), FLUSHING (Flushing), OXYGEN SATURATION DECREASED (Pulse ox reading in the 70's), GAIT INABILITY (Can't even walk), DYSPNOEA (Couldn't catch his breath) and FATIGUE (fatigue) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Glycosylated haemoglobin: 7.6. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Treatment While hospitalized, the consumer was started on 100mg Prednisone, now at 60mg of Prednisone, calcium, vitamin D, insulin lispro, protonix, bactrim, and is currently on oxygen. Concomitant medications Glucometer, Insullin pen and Lansets. Company Comment: Although a temporal association exists, provided information is not adequate to assess the causal association between the event and mRNA-1273. The detailed medical history and diagnostic report has not been provided. Causality is also confounded by the patient's comorbidities. Most recent FOLLOW-UP information incorporated above includes: On 09-Jun-2021: Follow-up received on 09/6/21: New event added: Acute hypoxy respiratory failure, Pleuritic chest pain, Red ithcy eyes, HS pneumonitis, Decreased level of consciousness, ILD, non necrotizing granuloma and Flushing.; Sender's Comments: Although a temporal association exists, provided information is not adequate to assess the causal association between the event and mRNA-1273. The detailed medical history and diagnostic report has not been provided. Causality is also confounded by the patient's comorbidities.

Other Meds: HYZAAR; METFORMIN; SERTRALINE; FLEXERIL [CYCLOBENZAPRINE HYDROCHLORIDE]; IBUPROFEN; CIALIS; INSULIN LISPRO; CALCIUM VITAMIN D; BASAGLAR KWIKPEN

Current Illness:

ID: 1409892
Sex: U
Age: 12
State: GA

Vax Date: 06/06/2021
Onset Date: 06/11/2021
Rec V Date: 06/18/2021
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: Vaccine vial was diluted with bacterialstatic sodium chloride 0.9%. Customer is aware and is no wanting t be revaccined.

Other Meds:

Current Illness:

ID: 1409893
Sex: M
Age: 26
State:

Vax Date: 06/11/2021
Onset Date: 06/17/2021
Rec V Date: 06/18/2021
Hospital:

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

Lab Data:

Allergies: No

Symptom List: Injection site pain

Symptoms: "vaccine arm" one week after first dose

Other Meds: Tylenol

Current Illness:

ID: 1409894
Sex: F
Age: 49
State: FL

Vax Date: 06/17/2021
Onset Date: 06/17/2021
Rec V Date: 06/18/2021
Hospital:

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

Lab Data:

Allergies: Prednisone

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

Symptoms: Pt. stated, "I felt dizzy 10 minutes after getting vaccinated." Vital signs within normal range. At 11:36am pt. stated, "I feel much better now." At 10:43am pt. stated, "I'm ok now, I can go home." Pt. went home at 10:44am.

Other Meds: none

Current Illness: none

ID: 1409895
Sex: M
Age: 33
State: FL

Vax Date: 06/17/2021
Onset Date: 06/17/2021
Rec V Date: 06/18/2021
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: No hay

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

Symptoms: Yesterday I finished the vaccination and now I have measles on my skin and itching. Is it an allergic reaction? Is this serious?

Other Meds: No

Current Illness: Rhinitis of the nose

ID: 1409896
Sex: M
Age: 30
State: TX

Vax Date: 06/17/2021
Onset Date: 06/18/2021
Rec V Date: 06/18/2021
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: None

Symptom List: Tremor

Symptoms: 2:30am cst I woke up in a lot of pain. My whole body was being racked by wave after wave of muscle soreness. Anything that touched my bed hurt. I tried sitting up, turning over side to side, and the pain continued. This was accompanied by a severe chill that caused my teeth to rattle. The apartment was set to 68 which is slightly warm to me. I got up to go to the restroom and my legs grew tired almost immediately. I?ve tried laying back down and getting back up 2 more times. The chill and the pain have continued now for 3 hours and 17 minutes, although the chill has diminished to a mild child instead of severe. No notable fever has been measured thus far.

Other Meds: None

Current Illness: None

ID: 1409897
Sex: F
Age: 34
State: TN

Vax Date: 05/27/2021
Onset Date: 05/27/2021
Rec V Date: 06/18/2021
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: Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)

Other Meds:

Current Illness:

ID: 1409898
Sex: F
Age: 20
State: CA

Vax Date: 06/17/2021
Onset Date: 06/17/2021
Rec V Date: 06/18/2021
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: Fainting / Unresponsive-Mild, Additional Details: Patient felt that he was about to pass out and almost fell from the chair. He then lied down on the floor. He was awake and alert, was able to breathe normally. EMS arrived and checked on him saying his heart rate and blood pressure were normal. He wanted to be taken to the hospital to get checked up.

Other Meds:

Current Illness:

ID: 1409899
Sex: F
Age: 32
State: NY

Vax Date: 06/16/2021
Onset Date: 06/16/2021
Rec V Date: 06/18/2021
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: Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypertension-Medium, Systemic: Nausea-Mild, Systemic: Shakiness-Medium, Systemic: Tachycardia-Medium, Additional Details: After 3 hours patient said feeling better.

Other Meds:

Current Illness:

ID: 1409900
Sex: F
Age: 41
State: RI

Vax Date: 05/20/2021
Onset Date: 05/20/2021
Rec V Date: 06/18/2021
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: Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, Additional Details: Upon awakening after the first moderna dose, patient discovered that her tongue felt swollen and raw. Foods such as A1 steak sauce became intolerably spicy and all other foods lost their taste. Patient had covid test prior a day prior to receiving the vaccine and had negative test results. Patient's tongue has not improved over the 28 days from the first dose. Has taken benadryll with no improvemet and is still mildly swollen. Upon evaluation by pharmacist, tongue lacked bright red color.

Other Meds:

Current Illness:

ID: 1409901
Sex: F
Age: 15
State: MA

Vax Date: 06/17/2021
Onset Date: 06/17/2021
Rec V Date: 06/18/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Error: Improper Storage (temperature)

Other Meds:

Current Illness:

ID: 1409902
Sex: F
Age: 29
State: MD

Vax Date: 03/10/2021
Onset Date: 03/11/2021
Rec V Date: 06/18/2021
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: NKDA

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

Symptoms: severe headache dizziness fatigue arm soreness muscle weakness myalgia moderate chest pain heart palpitations the dizziness appeared approximately 11 hours after the 2nd dose and the other symptoms appeared later in the day. the chest pain and heart palpitations also occurred with the first dose of the vaccine. symptoms resolved within 24 hours of onset.

Other Meds: Multivitamin Vitamin D

Current Illness: None

ID: 1409903
Sex: F
Age: 29
State: TX

Vax Date: 06/17/2021
Onset Date: 06/17/2021
Rec V Date: 06/18/2021
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: Error: Wrong Vaccine Formulation (ex. different manufacture. initial and booster)

Other Meds:

Current Illness:

ID: 1409904
Sex: M
Age: 16
State: VA

Vax Date: 06/17/2021
Onset Date: 06/17/2021
Rec V Date: 06/18/2021
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: Booster Given Too Early

Other Meds:

Current Illness:

ID: 1409905
Sex: F
Age: 32
State: VA

Vax Date: 05/16/2021
Onset Date: 05/17/2021
Rec V Date: 06/18/2021
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: None that I'm aware or

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

Symptoms: 24 hours after my second vaccine I started to get an ocular migraine which quickly progressed to speech slurring, numbness in right arm and left hand and confusion. I was unable to speak. I regained my vision the next afternoon after taking Butalbital every 4 hours. That next day I started my period despite being on birth control and taking my pill regularly. I had two other ocular migraines in the next 7 days.

Other Meds: Nikki birth control, spirolactone 50mg/day for hormonal acne

Current Illness: None

ID: 1409906
Sex: F
Age: 48
State: MI

Vax Date: 06/16/2021
Onset Date: 06/16/2021
Rec V Date: 06/18/2021
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: Systemic: Fainting / Unresponsive-Mild, Additional Details: EMS Called

Other Meds:

Current Illness:

ID: 1409907
Sex: F
Age: 35
State: CA

Vax Date: 05/27/2021
Onset Date: 06/03/2021
Rec V Date: 06/18/2021
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: Site: Pain at Injection Site-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Tachycardia-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)

Other Meds:

Current Illness:

ID: 1409908
Sex: F
Age: 47
State: PA

Vax Date: 06/04/2021
Onset Date: 06/07/2021
Rec V Date: 06/18/2021
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: Penicillin Sulfur

Symptom List: Headache, Limb discomfort, Nasal congestion

Symptoms: Rash on neck

Other Meds: Curcumin, glutathione

Current Illness:

ID: 1409909
Sex: F
Age: 14
State: IL

Vax Date: 06/17/2021
Onset Date: 06/17/2021
Rec V Date: 06/18/2021
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: Flushed / Sweating-Mild, Additional Details: Patient complaint of being feeling hot after the vaccination, gave her cold water to drink and made her lie down on the floor, fanned her, soon she was feeling better, got up and sat back on the chair, she was feeling good after wards and left.

Other Meds:

Current Illness:

ID: 1409910
Sex: F
Age: 59
State: CA

Vax Date: 06/17/2021
Onset Date: 06/17/2021
Rec V Date: 06/18/2021
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: Allergic: Rash Generalized-Medium, Additional Details: Patient experienced a mild rash after the first dose of Moderna on 5/13/2021, and she took Benadryl which helped but made her drowsy. So she didn't want to take Benadryl for the second dose. After 4 hours of receiving the second dose of Moderna on 6/17/2021, patient experienced the rash, and it was harsher than the first time. She still won't take the Benadryl since it makes her drowsy. Besides the rash, the patient states that she is fine when I asked her how she is feeling.

Other Meds:

Current Illness:

ID: 1409911
Sex: M
Age: 60
State: MA

Vax Date: 06/17/2021
Onset Date: 06/17/2021
Rec V Date: 06/18/2021
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: Systemic: Seizure-Severe

Other Meds:

Current Illness:

ID: 1409912
Sex: M
Age: 22
State: MO

Vax Date: 06/17/2021
Onset Date: 06/17/2021
Rec V Date: 06/18/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Hypotension-Medium

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 636,615

Page last modified: 03 October 2021 5:28pm