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: 1489488
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 07/21/2021
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: Have had the shingles 7 times; This case was reported by a consumer via interactive digital media and described the occurrence of shingles 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, unknown after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to Shingles vaccine. Additional details were reported as follows: The case was reported by patient. Age at vaccination was not reported. The patient had one shot and had the shingles 7 times.

Other Meds:

Current Illness:

ID: 1489489
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 07/21/2021
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: I know more than one person that took the shingles shot only to get shingles a month or two later / Suspect vaccination failure; I know more than one person that took the shingles shot only to get shingles a month or two later; your immune system is weakened; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, between 1 and 3 months after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and decreased immune responsiveness. On an unknown date, the outcome of the vaccination failure, shingles and decreased immune responsiveness were unknown. The reporter considered the vaccination failure, shingles and decreased immune responsiveness to be related to Shingles vaccine. Additional details were provided as follows: The age at vaccination was not applicable for this report. The reporter stated that shingles were something you got after you took the shot and your immune system was weakened. The reporter know more than one person that took the shingles shot only to get shingles a month or two later. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule and laboratory test confirming shingles were unknown at the time of reporting. Follow-up would not be possible, as no contact details were available.

Other Meds:

Current Illness:

ID: 1489490
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 07/21/2021
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: I felt bad for about 3 or 4 days; This case was reported by a consumer via interactive digital media and described the occurrence of feeling bad 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 feeling bad. On an unknown date, the outcome of the feeling bad was recovered/resolved. It was unknown if the reporter considered the feeling bad to be related to Shingles vaccine. Additional information was provided as follows: The case was reported by patient himself/herself. The age at vaccination was not reported. The patient felt bad for about 3 or 4 days after vaccination. No other information was reported.

Other Meds:

Current Illness:

ID: 1489491
Sex: U
Age:
State: GA

Vax Date:
Onset Date:
Rec V Date: 07/21/2021
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: lowest temperature reached was 1.6 dregrees Celsius / total time out of range was 2 hours and 30 minutes / wasn't a consecutive time frame / patients received the vaccines involved in the excursion; This case was reported by a nurse via other manufacturer and described the occurrence of incorrect storage of drug in a patient who received HBV (Engerix B) (batch number J7H4D, expiry date unknown) for prophylaxis. Co-suspect products included HPV 16-18 (HPV vaccine) (batch number 1659422, expiry date unknown) for prophylaxis, PNEUMOCOCCAL 13 VALENT CONJUGATE VACCINE (PREVNAR 13) (batch number DR7158, expiry date unknown) for prophylaxis and MENACTRA (batch number U6919AA, expiry date unknown) for prophylaxis. On an unknown date, the patient received Engerix B, HPV vaccine, PREVNAR 13 and MENACTRA. On an unknown date, unknown after receiving Engerix B and HPV vaccine, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown. Additional details were reported as follows: This case was reported by a nurse. The age at vaccination was not reported. The nurse reported that the patient received Engerix B,HPV Vaccine,Prevnar 13 and Menactra. Caller stated about temperature excursion with a vaccine. Also stated that it dropped bellows 2 degrees for 2 hours and 30 minutes and that it wasn't consecutive. The agend said the only number that showed up when the caller stated was the caller confirmed the details provided by the transfer agent. Caller confirmed she was calling to obtain stability details. The caller clarified the lowest temperature reached was 1.6 degrees Celsius. She confirmed that the total time out of range was 2 hours and 30 minutes. It wasn't a consecutive time frame. She said patients received the vaccines involved in excursion. The caller does not have any patients information with her to provide. Nurse clarified that patient received 4 different vaccines that given that day so just provided lot or batch numbers.

Other Meds:

Current Illness:

ID: 1489494
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 07/21/2021
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: Would it be harmful if a patient received an extra Menveo vaccination?; This case was reported by a other health professional via interactive digital media and described the occurrence of extra dose administered in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis. On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown. Additional details were provided as follows: The age at vaccination was not reported. The patient received extra dose of Menveo vaccine. Health care professional enquired that would it be harmful if patient received extra Menveo vaccination. No other information was provided.

Other Meds:

Current Illness:

ID: 1489497
Sex: U
Age:
State: MO

Vax Date:
Onset Date:
Rec V Date: 07/21/2021
Hospital: Y

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: psychiatric issues; This case was reported by a nurse via sales rep and described the occurrence of psychiatric symptom in a child patient who received Men B NVS (Meningococcal B vaccine) for prophylaxis. On an unknown date, the patient received Meningococcal B vaccine. On an unknown date, unknown after receiving Meningococcal B vaccine, the patient experienced psychiatric symptom (serious criteria hospitalization). On an unknown date, the outcome of the psychiatric symptom was unknown. It was unknown if the reporter considered the psychiatric symptom to be related to Meningococcal B vaccine. Additional details were reported as follows: The age at vaccination was not reported. The patient received a Men B vaccination unsure if Bexsero or Tumenba and soon after the patient had psychiatric issues and was admitted to a hospital for those. That was all the information that the reporter had but did speak to MSL about this. The reporter did not consent to follow up.

Other Meds:

Current Illness:

ID: 1489498
Sex: U
Age:
State: CA

Vax Date:
Onset Date:
Rec V Date: 07/21/2021
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: Dose given without powder mixed; Dose given without powder mixed; This case was reported by a nurse via sales rep and described the occurrence of inappropriate preparation of medication in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis. On an unknown date, the patient received Menveo. On an unknown date, 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 age at vaccination was not reported. The Menveo vaccine was mixed improperly dose given without powder mixed, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter did not consent to follow up.

Other Meds:

Current Illness:

ID: 1489499
Sex: U
Age:
State: IN

Vax Date: 07/12/2021
Onset Date: 07/01/2021
Rec V Date: 07/21/2021
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: Kinrix vaccine in an unknown thigh; cellulitis; This case was reported by a other health professional via sales rep and described the occurrence of cellulitis in a patient who received DTPa-IPV (Kinrix) (batch number D24G7, expiry date 4th June 2022) for prophylaxis. Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis. On 12th July 2021, the patient received Kinrix (intramuscular) and Kinrix Pre-Filled Syringe Device. On 12th July 2021, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced vaccine administered at inappropriate site. In July 2021, the patient experienced cellulitis (serious criteria GSK medically significant). On an unknown date, the outcome of the cellulitis and vaccine administered at inappropriate site were unknown. It was unknown if the reporter considered the cellulitis to be related to Kinrix and Kinrix Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional details were provided as follows: The age at vaccination was not reported. The pediatric patient received Kinrix in an unknown thigh which led to vaccine administered at inappropriate site. Less than a week after receiving Kinrix, the patient developed cellulitis. The reporter consented to follow up. The reporter and healthcare professional gave permission to contact them for further information. No other information was shared. This was 1 of 4 linked cases reported by the same reporter.; Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR154891:Same reporter US-GLAXOSMITHKLINE-US2021153977:Same reporter US-GLAXOSMITHKLINE-US2021AMR154892:same reporter

Other Meds:

Current Illness:

ID: 1489507
Sex: F
Age: 42
State: OH

Vax Date: 07/13/2021
Onset Date: 07/13/2021
Rec V Date: 07/21/2021
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: given one pediatric dose of Engerix-B / (0.5ML); given one pediatric dose of Engerix-B; This case was reported by a nurse via call center representative and described the occurrence of underdose in a 42-year-old female patient who received HBV (Engerix B pediatric) (batch number 73H93, expiry date 10th January 2022) for prophylaxis. On 13th July 2021, the patient received Engerix B pediatric .5 ml. On 13th 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 reported as follows: The reporter drawn a titer, that an adult was given one pediatric dose of Engerix-B as a booster dose, which led to underdose and adult use of a child product. The reporter consented to follow up.

Other Meds:

Current Illness:

ID: 1489508
Sex: U
Age: 56
State: MA

Vax Date: 05/11/2021
Onset Date: 05/11/2021
Rec V Date: 07/21/2021
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: administration of 1-adult dose of Havrix followed by 1-pediatric dose of Havrix; Adult use of child product; This case was reported by a pharmacist via call center representative and described the occurrence of underdose in a 56-year-old patient who received HAV (Havrix 720) for prophylaxis. Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis. Previously administered products included Havrix 1440 adult (1st dose received on 4th November 2020). On 11th May 2021, the patient received the 2nd dose of Havrix 720 and Havrix Pre-Filled Syringe Device. On 11th May 2021, unknown after receiving Havrix 720 and Havrix Pre-Filled Syringe Device, 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. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional details were provided as follows: The reporter stated, the administration of 1 adult dose of Havrix followed by 1 pediatric dose of Havrix with patient, which led to underdose and adult use of a child product. The reporter did not consent to follow up. This case was linked with case US2021152082, reported by same reporter for different patient.; Sender's Comments: US-GLAXOSMITHKLINE-US2021152082:Same reporter

Other Meds: HAVRIX Pre-Filled Syringe Device

Current Illness:

ID: 1489510
Sex: M
Age: 11
State: NY

Vax Date: 07/14/2021
Onset Date: 07/15/2021
Rec V Date: 07/21/2021
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: hives/ on the right deltoid at the injection site; mild edema/ on the right deltoid at the injection site; mild erythema/ on the right deltoid at the injection site; itching/ on the right deltoid at the injection site; This case was reported by a physician via call center representative and described the occurrence of injection site hives in a 11-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number F3NL3, expiry date 7th May 2023) for prophylaxis. Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis. On 14th July 2021, the patient received Boostrix and Boostrix Pre-Filled Syringe Device. On 15th July 2021, 1 days after receiving Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced injection site hives, injection site edema, injection site erythema and injection site itching. The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the injection site hives, injection site edema, injection site erythema and injection site itching were not recovered/not resolved. It was unknown if the reporter considered the injection site hives, injection site edema, injection site erythema and injection site itching to be related to Boostrix and Boostrix Pre-Filled Syringe Device. 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 reported as follows: The patient received Boostrix on 14th July 2021, in the right deltoid. HCP (healthcare professional ) stated that, the next day on 15th July 2021, the patient began to experiencing itching, mild erythema, mild edema, and hives on the right deltoid at the injection site. The patient had received Benadryl for side effects. The reporter consented to follow up.

Other Meds: Boostrix Pre-Filled Syringe Device

Current Illness:

ID: 1489514
Sex: M
Age: 9
State: IL

Vax Date: 07/16/2021
Onset Date: 07/16/2021
Rec V Date: 07/21/2021
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: Havrix adult dose administered to a 9 y/o child; Havrix adult dose administered to a 9 y/o child; HPV vaccine administered at the same time; This case was reported by a other health professional via call center representative and described the occurrence of overdose in a 9-year-old male patient who received HAV (Havrix adult) (batch number E9G4E, expiry date 29th December 2021) for prophylaxis. Co-suspect products included hepatitis A vaccine pre-filled syringe device injection syringe for prophylaxis and HPV 16-18 (HPV vaccine) for prophylaxis. On 16th July 2021, the patient received Havrix adult (intramuscular), hepatitis A vaccine pre-filled syringe device and HPV vaccine. On 16th July 2021, unknown after receiving Havrix adult and hepatitis A vaccine pre-filled syringe device and not applicable after receiving HPV vaccine, the patient experienced overdose, adult product administered to child and product use in unapproved population. On an unknown date, the outcome of the overdose, adult product administered to child and product use in unapproved population were 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 reported as follows: The healthcare professional reported administered Havrix adult dose to a child, which led to overdose and adult product administered to child and the HPV vaccine administered at the same time to male patient, which led to product use in unapproved population. The reporter consented to follow up. This case had been linked with US2021075972, reported by same reporter.; Sender's Comments: US-GLAXOSMITHKLINE-US2021075972:Same reporter

Other Meds:

Current Illness:

ID: 1489516
Sex: F
Age:
State: LA

Vax Date:
Onset Date: 03/10/2021
Rec V Date: 07/21/2021
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: CHEST X-RAY; ELECTROCARDIOGRAM; NUMBNESS IN RIGHT ARM; TINGLING IN RIGHT ARM; COMPUTERISED TOMOGRAM; ULTRASOUND SCAN ABNORMAL; HYPERTENSION; SKIN SENSITISATION; ARTHRALGIA; PAIN; FATIGUE; PERIPHERAL SWELLING; DEEP VEIN THROMBOSIS; PULMONARY EMBOLISM; GAIT DISTURBANCE; FEELING ABNORMAL; DYSPNOEA; INFLUENZA LIKE ILLNESS; MALAISE; This spontaneous report received from a patient via a Regulatory Authority Vaccine Adverse Event Reporting System (VAERS) (ID: 1331063) concerned a 60-year-old female. The patient's height, and weight were not reported. The patient's past medical history included degenerative disc disease (neck surgery (four discs repaired), and knee replacement, and concurrent conditions included fibromyalgia, and arthritis. The patient had no known allergy and current illness at the time of vaccination. The patient received covid-19 vaccine ad26.cov2. s (suspension for injection, route of admin not reported, batch number: 1802072, and expiry: UNKNOWN) dose was not reported, 1 total administered on 08-MAR-2021 15:00 at right arm for prophylactic vaccination. Concomitant medications included diclofenac, ibuprofen, oxycodone hydrochloride/paracetamol. The patient woke up and felt like she was hit by a train (feeling abnormal) and felt crappy for next 3-5 days, everything was hurting (malaise), even taking a step. She experienced gait disturbance, patient felt bad, tired like the flu (influenza like illness) but does not had respiratory issues. On 12-MAR-2021, she had dyspnea. Patient started symptoms shortness of breath, could not walk without SOB (Shortness of Breath), her legs started to swell (Peripheral swelling/edema), joints were sore/pain (arthralgia), she felt tired (fatigue). On 23-MAR-2021, she visited doctor with high blood pressure (hypertension) and edema, she was prescribed medication for blood pressure and fluid pills (unspecified). Four days later, her legs were swollen bigger, and the PCP switched the medication. It hurt to brush against the skin on her calf (skin sensitization). The patient was diagnosed 4 blood clots (thrombosis) in left calf by ultrasound scan. She ended up in the emergency room the following day, and Computerized tomogram scans were performed and they found pulmonary embolisms in the lower lobes of both lungs. The patient was also diagnosed with electrocardiogram, computerized tomogram, Blood test and chest x-ray. Laboratory data included: Computerized tomogram (NR: not provided) pulmonary embolisms in the lower lobes of both lungs, and Ultrasound scan (NR: not provided) 4 clot on left calf (abnormal). She has been taking Xarelto ever since. In JUN-2021, she said that she began feeling tingling numbness in her right arm, from her elbow to her fingertips. It tingles most of the day and wakes her up at night. Patient was on blood thinners. Laboratory data (dates unspecified) included: Blood test (NR: not provided) unspecified, Chest X-ray (NR: not provided) Not reported, and Electrocardiogram (NR: not provided) not reported. Treatment medications (dates unspecified) included: rivaroxaban. The action taken with covid-19 vaccine ad26.cov2. s was not applicable. The patient recovered from feeling abnormal, had not recovered from deep vein thrombosis, skin sensitization, peripheral swelling, pain, malaise, influenza like illness, hypertension, gait disturbance, fatigue, dyspnea, arthralgia, chest x-ray, computerized tomogram, electrocardiogram, and ultrasound scan abnormal, and the outcome of pulmonary embolism, numbness in right arm and tingling in right arm was not reported. This report was serious (Other Medically Important Condition). This case is a duplicate of 20210538232. Additional information was received from patient on 13-JUL-2021. The following information was updated and incorporated into the case narrative: reporter details (first and last name, address, city, zip code, office, email address), Updated disease start date (degenerative disc disease and knee replacement), Events added (pulmonary embolism, numbness in right arm and tingling in right arm), updated event (thrombosis to deep vein thrombosis), Updated event onset date (deep vein thrombosis, ultrasound scan and computerized tomogram) updated lab dates(ultrasound scan and computerized tomogram), updated lab result(computerized tomogram), Added vaccination time and treatment drug(Xarelto) and vaccine facility details (vaccine facility name, city and military information) Upon review following information was amended: Removed partial date (2021) of event Electrocardiogram and lab test (chest x-ray, electrocardiogram and blood test). Additional information was received from patient on 13-JUL-2021. It was determined that (20210538232) was a duplicate of this case. All relevant information regarding this case will be submitted under (20210556305); Sender's Comments: V1-20210556305-Covid-19 vaccine ad26.cov2.s-PULMONARY EMBOLISM and DEEP VEIN THROMBOSIS. Follow-up received regarding Other Information: reporter details, disease start date, Events added, updated event (thrombosis to deep vein thrombosis), event onset date ,lab dates,lab result, vaccination time , treatment drug and vaccine facility details . This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). 20210556305-covid-19 vaccine ad26.cov2.s-Thrombosis, ultrasound scan abnormal. This events are considered unassessable. The events has a compatible/suggestive temporal relationship, are unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the events.

Other Meds: PERCOCET [OXYCODONE HYDROCHLORIDE;PARACETAMOL]; ADVIL [IBUPROFEN]; DICLOFENAC

Current Illness: Arthritis; Fibromyalgia

ID: 1489517
Sex: F
Age:
State: OR

Vax Date:
Onset Date: 04/17/2021
Rec V Date: 07/21/2021
Hospital: Y

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 CLINICAL VACCINATION FAILURE; PULMONARY THROMBOSIS; MENTAL IMPAIRMENT; COVID-19; COMPUTERISED TOMOGRAM THORAX ABNORMAL; COUGH; DYSPNOEA; NASOPHARYNGITIS; PAIN; PAINFUL RESPIRATION; ANTICOAGULANT THERAPY; ELECTROCARDIOGRAM; FIBRIN D DIMER; INTENSIVE CARE; SARS-COV-2 TEST POSITIVE; CHILLS; MALAISE; ASTHENIA; This spontaneous report received from a patient via a Regulatory Authority VAERS (Vaccine Adverse Event Reporting System) (VAERS ID: 1421473) concerned a 75 year old female of unknown race and ethnic origin. The patient's height, and weight were not reported. The patient's past medical history included osteoarthritis, seasonal allergies, and hypothyroidism, and concurrent conditions included mild cold, and Gastroesophageal reflux disease (GERD). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number:1808078, and expiry: UNKNOWN) frequency 1 total, dose was not reported, administered on 03-APR-2021 to left arm for prophylactic vaccination. Concomitant medications included ascorbic acid, colecalciferol, compounded hormones, esomeprazole magnesium, fexofenadine hydrochloride, fluorometholone, fluticasone propionate, thyroid, vitamins nos, and zinc. On 17-APR-2021, patient had COVID symptoms of cold like symptoms, then a night of chills and coughing, followed by aches then weeks of what patient thought may be allergies, but patient was not feeling good. Patient continued to cough, but thought it was attributed to GERD. Patient wasn't thinking it could be COVID because patient had been vaccinated. Patient experienced pulmonary thrombosis, nasopharyngitis, and mental impairment and was hospitalized on unspecified day. By 18-MAY-2021, patient was having trouble breathing as it was painful to inhale. Patient thought patient might be having a heart attack so went into the emergency room at Hospital. Patient was tested positive in emergency room (ER). Patient had no heart problem. There were also at least 5 blood clots found in patient's lungs. Patient felt like what patient imagine it would feel like if patient's ribs were broken and patient was trying to take a deep breath. On 18-MAY-2021, patient experienced suspected clinical vaccination failure. Patient continued to have difficulty inhaling because of the pain of doing so into the next day 19-MAY-2021 and part of the 20-MAY-2021. Patient was administered oxygen and pain meds for the first day. Patient was put on Eliquis, which patient was ordered to take for 6 more months. Patient was released from ICU on the 20-MAY-2021. Patient still have no energy, lack of clarity of thought, and easily out of breath a month later. In the hospital, patient had no fever. Patient thought that the only time patient thought was on 19-APR-2021 when patient had the chills and cough. patient was hospitalized for 3 days. Laboratory data included: Computerised tomogram thorax abnormal (NR: not provided) Not Reported, Electrocardiogram (NR: not provided) Not reported, Fibrin D dimer (NR: not provided) Not reported. On 18-MAY-2021, laboratory test included, SARS-CoV-2 test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the covid-19, asthenia, chills, computerised tomogram thorax abnormal, cough, dyspnoea, malaise, mental impairment, nasopharyngitis, pain, painful respiration, pulmonary thrombosis, anticoagulant therapy, electrocardiogram, fibrin d dimer, intensive care, sars-cov-2 test positive and suspected clinical vaccination failure was not reported. This report was serious (Hospitalization Caused / Prolonged and Life Threatening). This report was associated with product quality complaint: 90000185984. The suspected product quality complaint has been confirmed to be not voided. The reported allegation could not be confirmed, a manufacturing related root cause could not be identified, based on the PQC evaluation/investigation performed. Additional information was received from Consumer Complaint Vigilance Organization on 16-JUL-2021. The following information was updated and incorporated into the case narrative: Investigation result added.; Sender's Comments: V3: In this version following information was updated and incorporated into the case narrative: Investigation result. This updated information does not alter the causality of the previously assessed events. 20210705031-COVID-19 VACCINE AD26.COV2.S -19- Pulmonary Thrombosis, Mental Impairment, Covid-19, Asthenia, Chills, Cough, Dyspnoea, Malaise, Nasopharyngitis, Pain, Painful Respiration. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). V0: 20210705031-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 20210705031-COVID-19 VACCINE AD26.COV2.S -19- Computerised Tomogram Thorax Abnormal, Anticoagulant Therapy, Electrocardiogram, Fibrin D Dimer, Intensive Care And Sars-Cov-2 Test Positive . This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).

Other Meds: NEXIUM [ESOMEPRAZOLE MAGNESIUM]; VITAMINS NOS; THYROID; FLUOROMETHOLONE; VITA D3; ZINC; VITA C [ASCORBIC ACID]; ALLEGRA; FLONASE [FLUTICASONE PROPIONATE]; ELIQUIS

Current Illness: Cold; GERD

ID: 1489518
Sex: F
Age:
State: AZ

Vax Date:
Onset Date: 05/18/2021
Rec V Date: 07/21/2021
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: PERIPHERAL SWELLING; JOINT SWELLING; LABORATORY TEST; PAIN IN EXTREMITY; RASH; RHEUMATOID ARTHRITIS; This spontaneous report received from a patient via a Regulatory Authority Vaccine Adverse Event Reporting System (VAERS) (reference number 1437585) concerned a 52 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetic. The patient experienced drug allergy when treated with levothyroxine, and lisinopril. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 204A21A, expiry: UNKNOWN) dose was not reported, 1 total administered on 04-MAY-2021 to left arm for prophylactic vaccination. Concomitant medications included acetylsalicylic acid (aspirin low dose), atorvastatin, estradiol, gemfibrozil, insulin glargine (Lantus Solo star Pen), levothyroxine sodium(Synthroid), metformin, and omeprazole. On 18-MAY-2021, the patient experienced Left arm sore (pain in extremity) for about 9days and the patient's right finger had started to swell at the joint (joint swelling), On the same day the patient experienced rash, undergone laboratory test and was diagnosed with rheumatoid arthritis. By 21-MAY-2021, the patient's finger pain went through hand and had painful bumps on elbows and fingers. On 28-MAY-2021, the patient both hands and left foot were swollen (peripheral swelling). It was reported that the patient had follow up appointment with doctor on 29-JUN-2021 and by then both the feet, hands and left knee were swollen. The patient's laboratory data included: Laboratory test (NR: not provided) Lupus, autoimmune negative and the patient was diagnosed with Rheumatoid arthritis based on symptoms. The patient visited physician office. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from rheumatoid arthritis, pain in extremity, peripheral swelling, rash, joint swelling, and laboratory test. This report was serious (Other Medically Important Condition). version created to amend previously reported information on 09-JUL-2021. Upon review, the following information was amended: onset date of rheumatoid arthritis, pain in extremity, laboratory test captured as 18-MAY-2021, narrative updated.; Sender's Comments: V1 - This version created to amend previously reported information on 09-JUL-2021 regarding : onset date of rheumatoid arthritis, pain in extremity, laboratory test captured as 18-MAY-2021. This does not change causality of previously reported events. 20210722011-covid-19 vaccine ad26.cov2.s-Rheumatoid Arthritis. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).

Other Meds: METFORMIN; GEMFIBROZIL; SYNTHROID; INSULIN GLARGINE; ASPRIN; ESTRADIOL; OMEPRAZOLE; ATORVASTATIN

Current Illness: Diabetic

ID: 1489519
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 07/21/2021
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: SICK; This spontaneous report received from a patient by a Business partner (Pfizer Inc.) on 09-JUL-2021 was received on 12-JUL-2021 and concerned 8 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: unknown) dose, 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 subject experienced sick. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of sick was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1489520
Sex: F
Age:
State:

Vax Date:
Onset Date: 03/14/2021
Rec V Date: 07/21/2021
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: MATERNAL EXPOSURE DURING PREGNANCY; SORE ARM; CHILLS; FEELING UNWELL; FEVER 100.8 FAHRENHEIT (F); FATIGUE; HEADACHE; MUSCLE PAIN; NAUSEA; This solicited pregnancy report received from a health care professional concerned a 34 year old female. The patient was enrolled in a non-company sponsored study C-VIPER: COVID 19 Vaccines International Pregnancy Exposure Registryt number: C00060). The patient's weight was 52.15 kilograms, and height was not reported. The patient's past medical history included multigravida. The patient initiated treatment with covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose was not reported, administered on 14-MAR-2021 for prevention covid-19. 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 14-MAR-2021, the patient experienced maternal exposure during pregnancy. On 14-MAR-2021, the patient experienced sore arm. On 14-MAR-2021, the patient experienced chills. On 14-MAR-2021, the patient experienced feeling unwell. On 14-MAR-2021, the patient experienced fever 100.8 fahrenheit (f). On 14-MAR-2021, the patient experienced fatigue. On 14-MAR-2021, the patient experienced headache. On 14-MAR-2021, the patient experienced muscle pain. On 14-MAR-2021, the patient experienced nausea. Laboratory data included: Body temperature (NR: not provided) 100.8 Fahrenheit. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, fatigue, feeling unwell, fever 100.8 fahrenheit (f), headache, muscle pain, nausea, sore arm and maternal exposure during pregnancy was not reported. The reporter provided no causality assessment. Company causality between covid-19 vaccine ad26.cov2.s, and maternal exposure during pregnancy was not related, and between covid-19 vaccine ad26.cov2.s, and sore arm, chills, feeling unwell, fever 100.8 fahrenheit (f), fatigue, headache, muscle pain, and nausea was related. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.

Other Meds:

Current Illness:

ID: 1489521
Sex: M
Age:
State: NC

Vax Date:
Onset Date: 04/01/2021
Rec V Date: 07/21/2021
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: SHORTNESS OF BREATH; FELT LIKE I WAS GOING TO DIE; ALLERGIC REACTION; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included non smoker, and alcohol user, and other pre-existing medical conditions included the patient had no pertinent medical history. the patient was a healthy person and had not been to an emergency room in years. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A 21A, and expiry: 05-AUG-2021) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced allergic reaction. On 12-APR-2021, the subject experienced shortness of breath. On 12-APR-2021, the subject experienced felt like i was going to die. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the shortness of breath, felt like i was going to die and allergic reaction was not reported. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.

Other Meds:

Current Illness: Alcohol use; Non-smoker

ID: 1489522
Sex: F
Age:
State: NY

Vax Date:
Onset Date: 03/11/2021
Rec V Date: 07/21/2021
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: SHINGLES; FLU LIKE SYMPTOMS; This spontaneous report received from a patient concerned a 63 year old female. The patient's weight was 87 pounds, and height was 60 inches. The patient's past medical history included hives, and concurrent conditions included lymphedema in left leg, bronchiectasis, abstain from alcohol, and non smoker, and other pre-existing medical conditions included the patient had no drug abuse or illicit drug usage. The patient experienced drug allergy when treated with amoxicillin/clavulanic acid, clarithromycin, and doxycycline. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 10-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 11-MAR-2021, the subject experienced flu like symptoms. On 09-JUN-2021, the subject experienced shingles. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu like symptoms on 12-MAR-2021, and had not recovered from shingles. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required per standard procedure as the case assessed as non-serious.

Other Meds:

Current Illness: Abstains from alcohol; Bronchiectasis (Diagnosed 1995.); Lymphedema (unknown cause of disease.); Non-smoker

ID: 1489523
Sex: F
Age:
State: LA

Vax Date:
Onset Date: 04/10/2021
Rec V Date: 07/21/2021
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: FEELING NUMBNESS IN THE PALM OF HER RIGHT HAND AND IN RIGHT LEG AND FOOT; DIFFICULT TO MOVE FOR ABOUT 4 DAYS; FELT SEVERE PAIN IN BOTH THE HANDS, LEGS, AND ARMS; ABNORMAL HEART BEAT; HIGH BLOOD PRESSURE; FELT WEAK; SLIGHT HEADACHE; PAIN ON INJECTION SITE; LOSS OF APPETITE; SLIGHT CHILLS; This spontaneous report received from a patient concerned a 26 year old , female. The patient's height, and weight were not reported. The patient's concurrent conditions included nonsmoker, non alcohol use, and blood pressure, and other pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1808980 expiry: UNKNOWN) dose was not reported, 1 total administered on 10-APR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the patient experienced loss of appetite, slight chills, weakness, slight headache and pain on injection site. After 2-3 weeks after receiving vaccine, on 01-MAY-2021, the patient experienced sever pain in hands, legs and arms and it was very difficult to move for about 4 days. Patient went to the clinic in May to seek help for her pain and new heart side effects. Patient noticed that her heart was beating abnormally, It would beat hard 10 minutes and then stop. On MAY-2021, Laboratory data included: Scan (NR: not provided) No abnormalities with heart. In clinic they also checked blood pressure and Laboratory data included: Blood pressure (NR: not provided) Abnormally high, Heart rate (NR: not provided) normal, Patient did an Magnetic resonance imaging (MRI) 3 days after the clinic appointment and had No abnormalities, results came normal. On 11-JUL-2021, the patient experienced feeling numbness in the palm of right hand and in right leg and foot and Patient said it's not serious but had been dealing with the symptoms continuously. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from difficult to move for about 4 days, and loss of appetite, slight chills, weakness, slight headache, and pain on injection site on 11-APR-2021, had not recovered from felt severe pain in both the hands, legs, and arms, abnormal heart beat, and feeling numbness in the palm of right hand and in right leg and foot, and the outcome of high blood pressure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0.20210730598-covid-19 vaccine ad26.cov2.s -Abnormal heart beat. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).

Other Meds:

Current Illness: Abstains from alcohol; Low blood pressure (always had low blood pressure); Nonsmoker

ID: 1489524
Sex: F
Age:
State: NY

Vax Date:
Onset Date: 04/06/2021
Rec V Date: 07/21/2021
Hospital: Y

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: NON-ISCHEMIC CARDIOMYOPATHY; CONGESTIVE HEART FAILURE (TROUBLE BREATHING, FLUID RETENTION, SWOLLEN HANDS, ABDOMEN EXTREMELY DISTENDED, ACUTE SYSTOLIC HEART FAILURE, HEART WAS EXTREMELY ENLARGED); PREMATURE HEARTBEAT; BLOOD CLOT; KIDNEY STONES; SORENESS IN THE LEFT ARM; PAROXYSMAL ATRIAL FIBRILLATION (SYNCOPE, COLLAPSE); This spontaneous report received from a patient concerned a 52 year old female. The patient's weight was 240 pounds and height was 174 centimeters. The patient had no known allergies and no heart condition before the vaccine administration. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 42A21A and expiry: unknown) dose was not reported, 1 total administered on 06-APR-2021 around 11:30 on the left arm for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, right after the administration, the patient experienced soreness in the left arm, but nothing patient could not handle. Since 06-APR-2021, the patient experienced syncope/ collapse episode and was in detox several times, had to have a loop monitor inserted into her chest. Patient was diagnosed with paroxysmal atrial fibrillation. On 17-APR-2021, around 09:00 patient had trouble breathing, abdomen was getting distended, by 15:00 patient was looking like 9 months pregnant, patient's hands were very swollen, abdomen extremely distended. Patient was admitted to the emergency room (ER) and was made stabilized. Patient had a computerised tomogram (CAT) scan and all sort of testing and it was determined that patient had fluid retention. Patient was treated with Lasix (furosemide) to get the fluid off. On 19-APR-2021, patient underwent an echocardiogram and was diagnosed with congestive heart failure, non-ischemic cardiomyopathy, acute systolic heart failure (with ejection fraction= 25%). Patient was sent to another hospital with a cardiac center, where was told that arteries were clean but heart was extremely enlarged. Then patient was hospitalized for 4 more days and sent back home. Cardiac team put patient on high blood pressure medicine because they wanted patient's blood pressure to be around 90/60. Treatment medications were started which included metoprolol 25 mg 3 times a day, then lowered to 25 mg twice a day. Patient was also started with Xarelto (rivaroxaban) 20 mg once a day. On MAY-2021, the patient had kidney stones. On 28-JUN-2021, the patient had first blood clot under the blood thinner. Patient had shortness of breath (extremely painful, like someone was stabbing). From that patient was taking Lovenox 110 U twice a day and was told that would need to take that for the rest of her life. Patient had second blood clot six days after the first one, it was smaller than the first one but extremely painful too. On an unspecified date, the patient had premature heartbeat. Laboratory data showed elevated troponins. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the soreness in the left arm, blood clot, paroxysmal atrial fibrillation (syncope, collapse), premature heartbeat, kidney stones, congestive heart failure (trouble breathing, fluid retention, swollen hands, abdomen extremely distended, acute systolic heart failure, heart was extremely enlarged) and non-ischemic cardiomyopathy was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V0: 20210730842-covid-19 vaccine ad26.cov2.s-blood clot, congestive heart failure (trouble breathing, fluid retention, swollen hands, abdomen extremely distended, acute systolic heart failure, heart was extremely enlarged), non-ischemic cardiomyopathy, paroxysmal atrial fibrillation (syncope, collapse), kidney stones. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).

Other Meds:

Current Illness:

ID: 1489525
Sex: M
Age:
State: KY

Vax Date:
Onset Date: 05/05/2021
Rec V Date: 07/21/2021
Hospital: Y

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: COULD NOT MOVE LEGS, ARMS AND UPPER BODY; LOSS OF APPETITE; CHILLS; This spontaneous report received from a consumer concerned a 66 year old male. The patient's height, and weight were not reported. The patient's past medical history included aneurysm in 2012 (rupture killed the nerve with one leg), the aneurysm changed the way he was walking and problems walking and concurrent conditions included ex-alcohol user (Stopped drinking 2 years ago), non-smoker, rheumatoid arthritis, and blood thinner. The patient had no known allergies. The patient had no history of drug abuse or illicit drug use. The patient was previously treated with prednisone. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025, expiry: UNKNOWN) dose was not reported, 1 total, administered on 03-MAR-2021 in left deltoid for prophylactic vaccination. Concomitant medications included infliximab for rheumatoid arthritis. The last dose of infliximab was in FEB-2021. The patient did not discuss getting the vaccine with rheumatoid arthritis doctor. On 05-MAY-2021, the patient had more limited movement until could not move legs and was not walking good. It went up from legs to arms, upper body (coded as could not move legs, arms and upper body). The patient went to emergency room at hospital and stayed in hospital for 1 week. The patient went to rehabilitation one week after for physical therapy. The patient was about ninety percentage back to where he was before the vaccine. The patient also experienced chills and loss of appetite. The symptoms lasted 3 weeks and went away. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from loss of appetite, and chills, and was recovering from could not move legs, arms and upper body. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210730947-JANSSEN COVID-19 VACCINE Ad26.COV2.S- Could not move legs, arms and upper body. 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: MEDICAL HISTORY, UNDERLYING DISEASE.

Other Meds: REMICADE

Current Illness: Anticoagulant therapy; Ex-alcohol user (did not use any more. Stopped drinking 2 years ago.); Non-smoker; Rheumatoid arthritis

ID: 1489526
Sex: M
Age:
State: TX

Vax Date:
Onset Date: 06/15/2021
Rec V Date: 07/21/2021
Hospital: Y

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

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

Symptoms: POSSIBLE OCULAR MYASTHENIA GRAVIS; POSSIBLE FOURTH CRANIAL NERVE PALSY; SINUS INFECTION; ALLERGIC REACTION; SLIGHT DIFFERENCE IN EAR PRESSURES; This spontaneous report received from a patient concerned a 46 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included marginally high blood pressure, and the patient had no allergies to medications, food, or other products. The patient had no other illnesses at the time of vaccination and up to one month prior, and no prior medical history or neurological history in the family. The patient had no adverse event following any previous vaccine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, expiry: UNKNOWN) dose was not reported, administered on 09-MAR-2021 at 11:00 to left arm for prophylactic vaccination. Concomitant medications included ascorbic acid (Vitamin C), Multivitamins, cod-liver oil, Vitamin D, and lisinopril. On an unspecified date in MAY-2021, the patient had some vision issues/seeing double, but did not think much about it . The patient went to his Primary Care Physician (PCP) for annual physical exam where bloodwork and everything was done and it came back normal except Cholesterol, which was marginally higher. The issue was not causing much discomfort for the patient, and it sort of went away, the best the patient could recall or couldn't recall. On 14-JUN-2021, the patient started having trouble focusing with his eyes again. It was causing him more discomfort than before so he visited his PCP, on 15-JUN-2021.doctor mentioned there was slight difference in ear pressures and maybe it was that. Not totally satisfied with that, the patient visited his Optometrist the next day and he suspected 4th nerve Palsy and asked the patient to make an appointment with the Eye Center with a specialist. The patient went and saw doctor at the eye Centre, On 17-JUN-2021 and he also suspected 4th nerve Palsy. Doctor ordered Magnetic Resonance Imaging (MRI) of the brain and Orbit which the patient completed on 22-JUN-2021 (later to come back normal). As the patient waited for the results that week, his condition was slightly deteriorating whereby he had to close his right eye to walk and go up and down the stairs. Just to rule out any Ear, Nose, And Throat (ENT) issues, the patient went and saw his ENT doctor on 21-JUN-2021. His hearing was normal and he conducted a Computed Tomography (CT) scan of the sinuses and he saw some infection but did not think it was in an area which would have caused any issues with the patient's right eye. The doctor, however, did prescribe antibiotics which the patient had started. The first dose and the patient started having an allergic reaction even though he had taken it before and not had any reaction (the patient had never had any reaction to any medication prior to that in his life). So the doctor changed the antibiotic and the patient started taking the other medication. On 27-JUN-2021, when the patient woke up, he noticed his right eye to be half closed, he thought maybe he had overworked his right eye and it might get better. However, on 28-JUN-2021, when the patient woke up, it had got worse. The patient decided to visit doctor that day itself at the Eye institute. Doctor, after his examination and consulting with another neurologist, said that he suspected Cranial nerve Palsy and possible Myasthenia Gravis. doctor suggested that if the patient wanted answers right away, then check into the Emergency Room (ER). The patient did check himself that same day and the neurologists and the ER doctors immediately admitted him to the hospital and conducted multiple tests. Laboratory data included: Antibody test (NR: not provided) Unknown, Carotid angiogram (Magnetic resonance angiography-MRA) (NR: not provided) Unknown, Chest X-ray (NR: not provided) Unknown, Electromyogram (NR: not provided) Unknown, and Lumbar puncture (NR: not provided) Unknown. The patient was at the hospital till 03-JUL-2021, and released with medications and possible diagnosis of cranial nerve palsy/Ocular Myasthenia Gravis. The patient was hospitalized for 6 days. The patient was waiting for a call back from the neurologists for a follow-up appointment and further treatment, if any. The patient's symptoms of droopy eyes persist on his right eye, and both his eyes cannot focus together. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from suspected fourth cranial nerve palsy/right eye half closed/vision issues, seeing double/closes right eye to walk and go up and down the stairs, possible ocular myasthenia gravis, sinus infection, slight difference in ear pressures, and allergic reaction. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0:20210731014-Covid-19 vaccine ad26.cov2.s -Possible ocular myasthenia gravis, IVth nerve paralysis. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).

Other Meds: LISINOPRIL; COD LIVER OIL; VITAMIN D [ERGOCALCIFEROL]; VITAMIN C [ASCORBIC ACID]; MULTIVITAMIN

Current Illness: Blood pressure high

ID: 1489527
Sex: F
Age:
State: UT

Vax Date:
Onset Date: 06/19/2021
Rec V Date: 07/21/2021
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: PLATELET COUNT DECREASE; WHITE BLOOD CELL COUNT DECREASE; VERTIGO; HEART PALPITATIONS; CHEST PAIN ON THE LEFT SIDE OF THE HEART; MIGRAINE; A FEELING OF ROCKING LIKE ON A BOAT; This spontaneous report received from a patient concerned a 53 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol use, and non-smoker, and other pre-existing medical conditions included the patient had no known allergies. the patient had no history of drug abuse or illicit drug use. the patient was not pregnant at the time of report. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A and expiry: UNKNOWN) dose was not reported, administered on 26-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 19-JUN-2021, the subject experienced vertigo. On 19-JUN-2021, the subject experienced heart palpitations. On 19-JUN-2021, the subject experienced chest pain on the left side of the heart. On 19-JUN-2021, the subject experienced migraine. On 19-JUN-2021, the subject experienced a feeling of rocking like on a boat. On 23-JUN-2021, the subject experienced platelet count decrease. On 23-JUN-2021, the subject experienced white blood cell count decrease. Laboratory data included: Lab test (NR: not provided) Unknown, Platelet count (NR: not provided) Decreased, and White blood cell count (NR: not provided) Decreased. On 01-JUL-2021, Laboratory data included: Platelet count (NR: not provided) Normal, and White blood cell count (NR: not provided) Normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from platelet count decrease, and white blood cell count decrease on 01-JUL-2021, vertigo, heart palpitations, and migraine on 29-JUN-2021, and chest pain on the left side of the heart, and had not recovered from a feeling of rocking like on a boat. This report was non-serious.; Sender's Comments: V0: Medical Assessment Comment not required as per standard procedure as the case assessed as non-serious.

Other Meds:

Current Illness: Non-smoker; Social alcohol drinker (A couple of glasses of wine per week.)

ID: 1489528
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 07/21/2021
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: EMERGENCY SURGERY; HEALTH/ AUTOIMMUNE ISSUES; This spontaneous report received from a patient concerned a patient of an unspecified age, sex, race, and ethnic origin. 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: unknown) dose, start therapy date were not reported, frequency time was 1 total administered for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced health/ autoimmune issues ever since received vaccine and had emergency surgery. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the emergency surgery and health/ autoimmune issues was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210731463-Covid-19 vaccine ad26.cov2.s -Emergency Surgery. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).

Other Meds:

Current Illness:

Date Died: 05/02/2021

ID: 1489529
Sex: F
Age:
State:

Vax Date:
Onset Date: 04/01/2021
Rec V Date: 07/21/2021
Hospital: Y

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: PATIENT PLACED ON VENTILATOR; DEATH; COVID PNEUMONIA; This spontaneous report received from a consumer via a company representative via social media concerned a 49 year old female of unspecified race and ethnic origin. The patient's height, and weight were not reported. The patient had no health problems. 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, administered in late APR-2021 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. In late APR-2021, on the night of vaccination, the patient experienced flu like symptoms. She was hospitalized and was in intensive care unit (ICU) (date unspecified), she never got better from flu like symptoms. It was claimed that the patient had Covid pneumonia. On an unspecified date, patient experienced sever lung damage and lung complications, and the patient was placed on ventilator. On 02-MAY-2021, the patient died from unknown cause of death It was unknown if the autopsy was performed. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient died of death on 02-MAY-2021, and the outcome of covid pneumonia and patient placed on ventilator was not reported. This report was serious (Death, Hospitalization Caused / Prolonged, and Life Threatening).; Sender's Comments: V0 -20210731688-Covid-19 vaccine ad26.cov2.s-Death, Covid Pneumonia, Patient placed on ventilator. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH

Other Meds:

Current Illness:

Date Died:

ID: 1489530
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 07/21/2021
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: PASSED AWAY; This spontaneous report received from a consumer via a company representative via social media concerned a 5 decade 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: not reported, expiry date: unknown) 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 passed away due to vaccination. The cause of death was unknown. It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0: 20210732113-COVID-19 VACCINE AD26.COV2.S-Death. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH

Other Meds:

Current Illness:

ID: 1489531
Sex: M
Age:
State: MO

Vax Date:
Onset Date:
Rec V Date: 07/21/2021
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: SUSPECTED CLINICAL VACCINATION FAILURE; COVID-19; This spontaneous report received from a consumer concerned a male of unspecified age. Initial information was processed along with the additional information received on 16-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, start therapy date were not reported 1 total administered for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date the patient (reporter's sister-in-law's husband ) got COVID-19 after getting vaccinated (suspected clinical vaccination failure). The action taken with COVID-19 vaccine ad26.cov2.s was not applicable. The outcome of the COVID-19 and suspected vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint 90000186312.; Sender's Comments: V0: 20210732319-COVID-19 vaccine ad26.cov2.s-suspected clinical vaccination 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: 1489532
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 07/21/2021
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: SUSPECTED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. Initial information was processed with the additional information received on 16-JUL-2021. The patient's height, and weight were not reported. The patient's past medical history included organ transplant. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1820095) dose was not reported, 1 total, administered on JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient did not show antibodies (suspected immunological vaccine failure). Laboratory data (dates unspecified) included: Antibody test (NR: not provided) No antibody found. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of suspected immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000186131.; Sender's Comments: V0: 20210733429-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:

ID: 1489533
Sex: M
Age:
State: DC

Vax Date:
Onset Date: 07/05/2021
Rec V Date: 07/21/2021
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: CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; SLIGHT FEVER; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. Initial information was processed along with the additional information received on 16-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 and expiry: Unknown), 1 total, dose was not reported, administered on 06-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 05-JUL-2021, the patient experienced slight fever. Laboratory data included: body temperature (NR: not provided) 98.9 to 100.1. On 08-JUL-2021, the patient went to doctor office for slight fever over 3 days and wanted to be sure that he was not affected with COVID-19. Assistant of physician conducted three tests. Laboratory data included: COVID-19 antibody test and SARS-CoV-2 rapid diagnostic test which showed negative and unspecified test to evaluate immunity to COVID-19 however, unspecified immunity test showed negative results (captured as confirmed immunological vaccine failure) and the patient had no signs of antibody in his system. It was reported that, patients physician did not have any recommendation due to the limited data and information on this matter, and he will contacting them to have a recommendation. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the confirmed immunological vaccine failure and slight fever was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint:90000186307.; Sender's Comments: V0:20210733506-Covid-19 vaccine ad26.cov2.s -Confirmed 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:

ID: 1489534
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 07/21/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site pain

Symptoms: UNABLE TO TURN NECK; PAIN; WEAKNESS; This spontaneous report received from a patient 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, 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 subject experienced unable to turn neck, pain, and weakness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the weakness, unable to turn neck and pain was not reported. This report was non-serious. This report was associated with product quality complaint: 90000186099. The suspected product quality complaint has been confirmed to be voided (did not meet PQC criteria) based on the PQC evaluation/investigation performed. This case, from the same reporter is linked to 20210733608.

Other Meds:

Current Illness:

ID: 1489535
Sex: F
Age:
State: CA

Vax Date:
Onset Date: 04/01/2021
Rec V Date: 07/21/2021
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: MEDICATION ERROR; LOWER BACK PAIN; CRAMPING IN ARM; BLURRED VISION; CAN NOT DRIVE; CAN NOT WORK; NEED HELP FROM OTHERS TO CARE FOR CHILDREN; BOTH LEG PAIN; This spontaneous report received from a parent concerned a 40 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included shrimp allergy, non-smoker, and non alcohol user, and other pre-existing medical conditions included the patient was not pregnant at the time of reporting. no medical conditions as per patient and no medications.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1809887 expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. Concomitant medications included bnt 162 for prophylactic vaccination. On APR-2021, the subject experienced lower back pain. On APR-2021, the subject experienced cramping in arm. On APR-2021, the subject experienced blurred vision. On APR-2021, the subject experienced can not drive. On APR-2021, the subject experienced can not work. On APR-2021, the subject experienced need help from others to care for children. On APR-2021, the subject experienced both leg pain. On 10-APR-2021, the subject experienced medication error. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from lower back pain, cramping in arm, both leg pain, and blurred vision, and the outcome of medication error, can not drive, can not work and need help from others to care for children was not reported. This report was non-serious.

Other Meds: BNT 162

Current Illness: Abstains from alcohol; Food allergy; Non-smoker

ID: 1489536
Sex: F
Age:
State: TX

Vax Date:
Onset Date: 06/30/2021
Rec V Date: 07/21/2021
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: INCREASED APPETITE; FATIGUE; SLEPT FOR 14 TO 16 HOURS; STRESS; 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, and batch number were not reported) dose was not reported, administered on 30-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 30-JUN-2021, the subject experienced sleepiness (slept for 14 to 16 hours). On 30-JUN-2021, the subject experienced stress. On an unspecified date, the subject experienced increased appetite, and fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fatigue, increased appetite, sleepiness (slept for 14 to 16 hours) and stress was not reported. This report was non-serious.

Other Meds:

Current Illness:

Date Died:

ID: 1489537
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 07/21/2021
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: DEATH; This spontaneous report received from a consumer concerned a 5 decade old male of unknown 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, and batch number were not reported, UNKNOWN expiry) dose, 1 total, 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 died from unknown cause of death. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death). It was unknown whether the Autopsy was performed.; Sender's Comments: V0: 20210733844-covid-19 vaccine ad26.cov2.s-Death. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s); Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH

Other Meds:

Current Illness:

ID: 1489538
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 07/21/2021
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: GUILLAIN-BARRE SYNDROME; This spontaneous report received from a health care professional via social media via company representative concerned a male patient 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, and batch number were not reported) dose, start therapy date were not reported for an unspecified indication. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. On an unspecified date, the subject experienced Guillain-Barre syndrome. The reporter had a patient last week who now had this syndrome four weeks after taking the vaccine and can barely walk or 'hold in anything" This report was serious (Other Medically Important Condition).; Sender's Comments: V0: This spontaneous report received via social media post concerns a male patient of unspecified age and ethnicity who had Guillain-Barre syndrome 4 weeks after receiving the Janssen Covid-19 vaccine. The patient was reported as "can barely walk" or ?hold in anything". No other pertinent details reported. The information available precludes a complete and meaningful assessment. Based on the information available, and the occurrence of GBS could represent background incidence of such events in the general population. However, a relationship with Janssen Covid-19 vaccine cannot be ruled out and thus the relationship is considered indeterminate.

Other Meds:

Current Illness:

ID: 1489539
Sex: U
Age:
State:

Vax Date:
Onset Date: 07/14/2021
Rec V Date: 07/21/2021
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: UPSET STOMACH/SLIGHT BUTTERFLY PAIN; AREA OF PAIN AROUND THE INJECTION SITE; This spontaneous report received from a patient 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, administered on 14-JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 14-JUL-2021, the subject experienced upset stomach/slight butterfly pain. On 14-JUL-2021, the subject experienced area of pain around the injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from upset stomach/slight butterfly pain, and area of pain around the injection site on 14-JUL-2021. This report was non-serious.

Other Meds:

Current Illness:

ID: 1489540
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 07/21/2021
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: PATIENT HAD NO MORE INDIGESTION AFTER TAKING VACCINE (UNEXPECTED THERAPEUTIC EFFECT); This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's past medical history included indigestion. The patient was previously treated with famotidine for indigestion. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported 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 subject had no more indigestion after taking vaccine (unexpected therapeutic effect). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of patient had no more indigestion after taking vaccine (unexpected therapeutic effect) was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1489541
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 07/21/2021
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: CAN'T PEE; CAN'T CRAP; IN BED ALL THE TIME; EYES ACHE/HURT IN EYES; FEELING REALLY SICK; 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: Unknown and expiry: Unknown) dose was not reported, 1 total, administered on 15-MAY-2021 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 can't pee, can't crap, in bed all the time, eyes ache/hurt in eyes, and was feeling really sick. The patient's doctor would be coming on 16-JUL-2021. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the can't pee, can't crap, in bed all the time, eyes ache/hurt in eyes and feeling really sick was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0-20210734547-Covid-19 vaccine ad26.cov2.s - CAN'T PEE. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).

Other Meds:

Current Illness:

ID: 1489542
Sex: U
Age:
State:

Vax Date:
Onset Date: 07/01/2021
Rec V Date: 07/21/2021
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: SO SO SO ACHEY; SHIVERS; MASSIVE FEVER; This spontaneous report received from a patient via a company representative 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 was not reported, administered on JUL-2021 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 JUL-2021, the subject experienced so so so achey. On JUL-2021, the subject experienced shivers. On JUL-2021, the subject experienced massive fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the massive fever, shivers and so so so achey was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1489543
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 07/21/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot: EK9231
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

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

Symptoms: TERRIBLE BODY PAINS; VOMITING; SOME FLU; DIDN'T SLEEP WELL; TERRIBLE HEADACHE; This spontaneous report received from a patient via a company representative 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, 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 subject experienced terrible body pains, vomiting, some flu, didn't sleep well, and terrible headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the terrible body pains, terrible headache, vomiting, some flu and didn't sleep well was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1489544
Sex: M
Age:
State: CA

Vax Date:
Onset Date: 04/03/2021
Rec V Date: 07/21/2021
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: VERY LETHARGIC; ACHES; This spontaneous report received from a patient concerned a 51 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: Unknown) dose was not reported, administered on 03-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 03-APR-2021, the subject experienced very lethargic. On 03-APR-2021, the subject experienced aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from very lethargic on 06-APR-2021, and the outcome of aches was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1489545
Sex: M
Age:
State: SC

Vax Date:
Onset Date: 07/01/2021
Rec V Date: 07/21/2021
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: PAIN AS FEELING LIKE A BUBBLE OF FLUID; PAIN FEELS LIKE A DEEP, SOFT TISSUE INJURY; INJECTION SITE SWOLLEN; PRESSURE UNDER THE MUSCLE; INJECTION SITE ARM PAIN AND TENDER; SPACEY; This spontaneous report received from a patient concerned a 37 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: 204A21A, and expiry: UNKNOWN) dose was not reported, administered on 01-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 01-JUL-2021, the subject experienced spacey. On 01-JUL-2021, the subject experienced injection site arm pain and tender. On 16-JUL-2021, the subject experienced pain as feeling like a bubble of fluid. On 16-JUL-2021, the subject experienced pain feels like a deep, soft tissue injury. On 16-JUL-2021, the subject experienced injection site swollen. On 16-JUL-2021, the subject experienced pressure under the muscle. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from spacey on 01-JUL-2021, and had not recovered from injection site arm pain and tender, pain as feeling like a bubble of fluid, injection site swollen, pressure under the muscle, and pain feels like a deep, soft tissue injury. This report was non-serious.

Other Meds:

Current Illness:

ID: 1489546
Sex: M
Age:
State: FL

Vax Date:
Onset Date: 04/18/2021
Rec V Date: 07/21/2021
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: PLATELET COUNT WENT DOWN TO 96; NEUROLOGICAL SYMPTOMS; ANXIETY; DIMINISHED QUALITY OF LIFE; LOSING INTEREST IN LIFE; DIFFICULTY IN WALKING/ DIFFICULTY GETTING OUT OF THE CAR; GENERALIZED HEAVY MUSCLE PAIN ALL OVER THE BODY ESPECIALLY ON ARMS AND HANDS; FEELING OF ELECTRIC SHOCK ON LEFT SIDE OF BODY ESPECIALLY UNDERNEATH THE LEFT FEET AND LEFT INDEX FINGER; SEVERE HEADACHE MOSTLY ON LEFT SIDE AND TOP PART OF HEAD; This spontaneous report received from a patient concerned a 49 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure, pre-diabetes which the patient controls with exercise and diet and no medications, alcohol user (had been drinking vodka for the past few weeks), and non-smoker. The patient had no known allergies and no history of drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029 expiry: UNKNOWN) dose was not reported, 1 total administered to left arm on 27-MAR-2021 for prophylactic vaccination. Concomitant medications included olmesartan for blood pressure. On an unspecified date before vaccination the laboratory data (dates unspecified) included: Platelet count (NR: not provided) 160. On 18-APR-2021 (3 weeks after vaccination), the patient experienced severe headache mostly on left side and top part of head and ended up in the emergency room at 01:00 AM in the morning. In the emergency room, the patient had a brain scan and he was told that the brain scan showed no blood clot and that his platelet counts were good. After these tests the patient was sent back home. On 27-JUN-2021 (for the past 2 weeks prior to this report), the patient experienced generalized heavy muscle pain all over the body especially on arms and hands and difficulty in walking and getting out of the car. On an unspecified date in JUN-2021, the patient experienced feeling of electric shock on left side of body especially underneath the left feet and left index finger. On an unspecified date, patient reported that his platelet count went down to 96 after the vaccination, had anxiety and had been drinking vodka every night because his quality of life was diminished and he refused to go back to the emergency room. The patient was irritated and he was losing interest in life. The patient had not experienced any fever or nausea. The patient had scheduled an appointment with the physician on 26-JUL-2021 due to his concern about the neurological symptoms. It was reported that, the emergency services were called and informed about the patient. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from severe headache mostly on left side and top part of head, platelet count went down to 96, generalized heavy muscle pain all over the body especially on arms and hands, difficulty in walking/ difficulty getting out of the car, anxiety, losing interest in life, feeling of electric shock on left side of body especially underneath the left feet and left index finger, diminished quality of life, and neurological symptoms. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210738395-Covid-19 vaccine ad26.cov2.s-Platelet count went down to 96. 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: MEDICAL HISTORY

Other Meds: OLMESARTAN

Current Illness: Alcohol use (Occasionally has been drinking for the past few weeks, vodka.); Blood pressure high; Non-smoker; Pre-diabetes (does not take medication. Only controls with exercise and diet.)

ID: 1489547
Sex: F
Age:
State: GA

Vax Date:
Onset Date:
Rec V Date: 07/21/2021
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: SEVERE SIDE EFFECTS AT NIGHT; SHAKING/MOVING; COULD NOT GET OUT OF BED; CHILLS; HIGH FEVER; FATIGUED/TIRED; WEAKNESS; This spontaneous report received from a patient via a company representative concerned a 60 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose, start therapy date were not reported 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 severe side effects at night, shaking/moving, could not get out of bed, chills, high fever, fatigued/tired, and weakness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fatigued/tired, and weakness, and the outcome of severe side effects at night, chills, shaking/moving, could not get out of bed and high fever was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1489548
Sex: F
Age:
State: TX

Vax Date:
Onset Date: 07/12/2021
Rec V Date: 07/21/2021
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: CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 61 year old female of unknown race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025 and expiry date: 09-Jul-2021) dose was not reported, 1 total administered on 07-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-JUL-2021, the patient started getting slight coughs, chills, slight fever, runny nose and extremely tired. On 14-JUL-2021 the patient tested for PCR COVID test which resulted positive on 15-JUL-2021 with confirmed covid-19 test and confirmed clinical vaccination failure. The patient is worried about how she got COVID as she was using a mask everywhere she went, didn't go out much, and social distanced. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from confirmed covid-19 infection as of 16-JUL-2021, she still had all the same symptoms but was feeing less tired and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210738448-COVID-19 VACCINE AD26.COV2.S-Confirmed 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: 1489549
Sex: M
Age:
State: CT

Vax Date:
Onset Date: 07/15/2021
Rec V Date: 07/21/2021
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: STAY ASLEEP / REST LONGER; INJECTION SITE ARM PAIN; FEELING TIRED; LOSS OF ENERGY; This spontaneous report received from a patient concerned a 74 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure, and other pre-existing medical conditions included patient had no known drug allergies. patient was taking multivitamins and multivitamins for the eye. The patient was previously treated with lisinopril for high blood pressure, and amlodipine for high blood pressure. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 180978 expiry: UNKNOWN) dose was not reported, administered on 27-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 15-JUL-2021, the subject experienced stay asleep / rest longer. On 15-JUL-2021, the subject experienced injection site arm pain. On 15-JUL-2021, the subject experienced feeling tired. On 15-JUL-2021, the subject experienced loss of energy. Treatment medications (dates unspecified) included: menthol/methyl salicylate. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from injection site arm pain on 16-JUL-2021, and the outcome of feeling tired, loss of energy and stay asleep / rest longer was not reported. This report was non-serious.

Other Meds:

Current Illness: Blood pressure high

ID: 1489550
Sex: F
Age:
State: MA

Vax Date:
Onset Date: 04/06/2021
Rec V Date: 07/21/2021
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: MIGRAINE; CHEST PAIN; PAIN AT THE INJECTION SITE; This spontaneous report received from a parent concerned a 20 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient have no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: OU3A21A expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced pain at the injection site. On 19-APR-2021, the subject experienced migraine. On 19-APR-2021, the subject experienced chest pain. On 20-APR-2021, Laboratory data included: EKG (NR: not provided) Normal, and X-ray (NR: not provided) Normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from migraine on 23-APR-2021, chest pain on 22-APR-2021, and pain at the injection site. This report was non-serious.

Other Meds:

Current Illness:

ID: 1489551
Sex: M
Age:
State: NY

Vax Date:
Onset Date: 07/17/2021
Rec V Date: 07/21/2021
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: ADMINISTERED PRE-FILLED SYRINGE THAT WAS 10 MINUTES PAST ITS 6 HOUR MAXIMUM IN THE REFRIGERATOR; STORED PRE-FILLED SYRINGE THAT WAS 10 MINUTES PAST ITS 6 HOUR MAXIMUM IN THE REFRIGERATOR; This spontaneous report received from a physician concerned a 57 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: 1808982, expiry: 07-AUG-2021) dose was not reported, administered on 17-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 17-JUL-2021, the subject experienced administered pre-filled syringe that was 10 minutes past its 6 hour maximum in the refrigerator. On 17-JUL-2021, the subject experienced stored pre-filled syringe that was 10 minutes past its 6 hour maximum in the refrigerator. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administered pre-filled syringe that was 10 minutes past its 6 hour maximum in the refrigerator and stored pre-filled syringe that was 10 minutes past its 6 hour maximum in the refrigerator was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1489552
Sex: F
Age:
State: SC

Vax Date:
Onset Date:
Rec V Date: 07/21/2021
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: AFFECTING MOVEMENT IN ELBOW AND SHOULDER OF INJECTION ARM; UNABLE TO STRAIGHTEN ELBOW WITHOUT BEING IN PAIN; HAVING PAIN IN THE INJECTION ARM; This spontaneous report received from a patient via a company representative 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, start therapy date were not reported 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 affecting movement in elbow and shoulder of injection arm, unable to straighten elbow without being in pain, and having pain in the injection arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from having pain in the injection arm, unable to straighten elbow without being in pain, and affecting movement in elbow and shoulder of injection arm. This report was non-serious.

Other Meds:

Current Illness:

ID: 1489553
Sex: M
Age:
State: MA

Vax Date:
Onset Date: 07/02/2021
Rec V Date: 07/21/2021
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: ACHY; INJECTION SITE PAIN; This spontaneous report received from a consumer concerned a 23 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included shellfish allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1821281 expiry: UNKNOWN) dose was not reported, administered on 02-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-JUL-2021, the subject experienced achy. On 02-JUL-2021, the subject experienced injection site pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from achy, and injection site pain on 03-JUL-2021. This report was non-serious. This case, from the same reporter is linked to 20210738857.

Other Meds:

Current Illness: Shellfish allergy

Total 2021 VAERS Injuries: 636,615

Page last modified: 03 October 2021 5:28pm