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

Incidents per State

State Total
72,296
AK1,638
AL5,339
AR3,412
AS44
AZ13,316
CA58,147
CO11,002
CT7,824
DC1,626
DE1,670
FL36,235
FM3
GA13,429
GU82
HI2,195
IA4,332
ID2,473
IL19,261
IN22,568
KS4,284
KY6,945
LA4,714
MA13,886
MD11,901
ME2,997
MH8
MI17,865
MN11,345
MO8,919
MP30
MS2,676
MT2,147
NC15,401
ND1,273
NE2,732
NH2,859
NJ17,232
NM3,702
NV4,071
NY32,763
OH18,072
OK5,940
OR7,954
PA22,457
PR2,104
QM2
RI1,911
SC6,055
SD1,133
TN8,691
TX34,122
UT4,023
VA13,944
VI49
VT1,661
WA13,811
WI10,395
WV2,220
WY805
XB5
XL1
XV2

ID: 1514230
Sex: F
Age: 48
State: AZ

Vax Date: 01/01/2021
Onset Date: 03/28/2021
Rec V Date: 07/30/2021
Hospital: Y

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies: PCN

Symptom List:

Symptoms: Obstructed kidney stone causing 4 day hospitalization, stent placement, 2 lithotripsies.

Other Meds: Zyrtec Prilosec

Current Illness: None

ID: 1514232
Sex: F
Age: 19
State: OK

Vax Date: 06/24/2021
Onset Date: 06/26/2021
Rec V Date: 07/30/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies: None

Symptom List:

Symptoms: Severe headaches from two days after the first shot to present. Never had headache issues before. Abdominal Pain started day after first shot and has continued since. Extreme fatigue started 2 days after vaccine and is still present. Muscle twitching started the day after 2nd shot. Skin feels like it is burning. Started the day after second shot.

Other Meds: None

Current Illness: None

ID: 1514234
Sex: M
Age: 31
State: TX

Vax Date: 07/29/2021
Onset Date: 07/29/2021
Rec V Date: 07/30/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies: Tylenol

Symptom List:

Symptoms: Twenty minutes after I received the vaccine, I was home and started to feel dizzy, light headed, and numb. My body felt extremely cold and I had to sit in the car with the doors closed to feel hotter under the weather. I probably stayed in the car close to 10 minutes. Then, I went into the house and I started feeling waves of cold so I immediately went and sat in the yard for another 15 minutes. This was one of the worst times. I could not move my face, arms, fingers, or legs and I was literally crying and trying to breathe. There was a numbing sensation that stretched from my finger tips to my arms, legs, toes, and across the chest (like a "u" shape). I told my dad at the time to get the phone ready to dial 911 just in case. This was very similar but slightly worse reaction when compared to the first vaccine I got 28 days earlier. I moved back into the house and had to be under blankets for the next 10 minutes. It was very difficult because my entire body was numb, like it was locked up in one posture. After another 15 minutes, it started getting better but it felt like my heart had taken a pounding. Later this evening, I started feeling chills again with my teeth clattering. I had to go under blankets. I had my watch on and it said my HR was 80. I used my dad's oxygen device and it said 97%. My heart felt heavy again, as if it had done a lot of work.

Other Meds: None.

Current Illness: None

ID: 1514236
Sex: M
Age: 37
State: CA

Vax Date: 12/18/2020
Onset Date: 01/04/2021
Rec V Date: 07/30/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies: None

Symptom List:

Symptoms: Constant tinnitus alternating in both ears, varying in intensity, the sound is whining. Started on 4/28/2021 upon waking up.

Other Meds: Lisinopril-Hctz since 2005, Metformin since 2014

Current Illness:

ID: 1514237
Sex: F
Age: 41
State: CA

Vax Date: 01/11/2021
Onset Date: 01/11/2021
Rec V Date: 07/30/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies: None

Symptom List:

Symptoms: Heart palpitations daily and frequently occurred very recently after the second dose. I began having mild chest pain approx. 2 months after, progressive to intermittently moderately several times weekly, has now progressed to daily mild to moderate L sided chest pain, with one episode of severe on 7/27/21. The mild to moderate pain has continued almost constantly since then.

Other Meds: None

Current Illness: None

ID: 1514238
Sex: F
Age: 34
State: VA

Vax Date: 03/10/2021
Onset Date: 03/10/2021
Rec V Date: 07/30/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies: Amoxicillin

Symptom List:

Symptoms: I had a severe headache and muscle soreness after the vaccine. I was 6 months pregnant with my second child. They were born full term on May 30th, normal, healthy, weighing 8lbs 15oz.

Other Meds: Prenatal vitamins; Iron

Current Illness:

ID: 1514240
Sex: F
Age: 50
State: TX

Vax Date: 07/29/2021
Onset Date: 07/29/2021
Rec V Date: 07/30/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies: Pork

Symptom List:

Symptoms: Hives, anxiety, sore throat, redness, weakness,

Other Meds: B12 shot. Lisinopril.

Current Illness: N/A

ID: 1514241
Sex: F
Age: 30
State: AL

Vax Date: 07/30/2021
Onset Date: 07/30/2021
Rec V Date: 07/30/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: Grand mal seizure took place about 10 minutes after administration. Paramedics arrived on scene after seizure had ended. Upon examining the patient, EMT determined the pt was fit to go home

Other Meds:

Current Illness:

ID: 1514363
Sex: U
Age:
State: TX

Vax Date:
Onset Date: 06/28/2021
Rec V Date: 07/30/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: VARlVAX had a temperature excursion and was administered; Additional AE's were reported; This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies, concurrent condition and concomitant medication were not provided. On an unknown date, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (lot# T028306 has been verified to be a valid lot number, expiration date was reported as 20-AUG-2022; strength and route were not reported) 5 ml once for prophylaxis. The vaccine was stored under 4 Fahrenheit (F) for 24 hours. There was no previous temperature excursion. On 28-JUN-2021, the patient experienced unspecified adverse event. The outcome of the event was unknown. The causality assessment between the event and varicella virus vaccine live (oka/merck) (VARIVAX) was not reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-2107USA000237:01957083 US-009507513-2107USA000111:01957080 US-009507513-2107USA000236:01957053 US-009507513-2107USA000238:01957079

Other Meds:

Current Illness:

ID: 1514364
Sex: F
Age: 1
State: WV

Vax Date: 07/07/2021
Onset Date: 07/07/2021
Rec V Date: 07/30/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
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Lab Data:

Allergies:

Symptom List:

Symptoms: No additional AE; Patient was administered expired MMRll on 07/07/2021; This spontaneous report was received from an office manager referring to a patient of unknown age and gender. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided. On 07-JUL-2021, the patient was vaccinated with an expire dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA)(M-M-R II) lot number S020162 has been verified to be a valid lot number, expiration date 30-JUN-2021 (dosage regimen and route of administration were not reported) for prophylaxis. No adverse event was reported. The vaccine had not had temperature excursions. This is a non-valid case due to the lack of patient identifiers. Follow-up information has been received from the office manager on 21-JUL-2021. The patient was a 12-month-old female. Her address was provided. The patient did not have allergies. It was reported that "active problems" included maternal history of hepatitis C and Coombs test. She had no history of an adverse event following previous vaccinations nor other illnesses at the time of vaccination. Birth weight was 7 lb 13 oz. She was vaccinated with the first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA)(M-M-R II) administered subcutaneously in the left thigh. On the same date, she was vaccinated with pneumococcal vaccine conj 13v (crm197) (PREVENAR 13) and hepatitis a vaccine inact (HAVRIX). It was reported that the patient tolerated the adverse event well. It was a single use vaccine/ vaccine-device and it was used according to the instruction leaflet. The operator of the device was a healthcare professional and they were trained. The vaccine was available for return/evaluation. The adverse event was reported to a doctor.

Other Meds: PREVENAR 13; HAVRIX

Current Illness: Coombs test; Hepatitis C; Prophylaxis

ID: 1514365
Sex: U
Age:
State: MO

Vax Date: 07/12/2021
Onset Date: 07/12/2021
Rec V Date: 07/30/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
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Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: no other AE occurred; dose of ROT ATEQ that was administered after the expiration date.; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided. On 12-JUL-2021, the patient was vaccinated with expired dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # 1691140, expiration date: 10-JUL-2021, dose reported as 1 dose, orally (dose number and exact dose were not reported) for prophylaxis. No adverse event occurred.

Other Meds:

Current Illness:

ID: 1514366
Sex: F
Age: 0
State: CA

Vax Date: 07/16/2021
Onset Date: 07/16/2021
Rec V Date: 07/30/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: No additional adverse events reported; administered on 07/16/2021 after it had expired on 07/11/2021; This spontaneous report was received from a licensed vocational nurse and refers to a 9-week-old female patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 16-JUL-2021, the patient was vaccinated with expired dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) injection, 0.5 milliliter, lot # R027327, expiration date 11-JUL-2021 (route of administration and injection site were not reported) for prophylaxis. No temperature excursion had occurred. No additional adverse events were reported.

Other Meds:

Current Illness:

ID: 1514367
Sex: U
Age:
State: IL

Vax Date: 07/08/2021
Onset Date: 07/08/2021
Rec V Date: 07/30/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
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Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: temperature excursion for PNEUMOVAX 23; This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concomitant medications or concurrent conditions was provided. On 08-JUL-2021, the patient was vaccinated with an improperly stored dose of Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) lot # T034630 was confirmed to be valid, expiration date 22-JUN-2022 (dose, route and site of administration were not reported), for prophylaxis. The administered dose was exposed to the temperature of 75 degrees Fahrenheit (F) for 960 hours. It was reported that the call was not because of a digital data logger and there was no previous temperature excursion.

Other Meds: PNEUMOVAX23 SYRINGE (DEVICE)

Current Illness:

ID: 1514370
Sex: F
Age:
State: OK

Vax Date: 04/01/2021
Onset Date:
Rec V Date: 07/30/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: tore the muscle / went to the hospital and has been in PT since; arm got so inflamed / went to the hospital and has been in PT since; arm / infected / went to the hospital and has been in PT since; This case was reported by a pharmacist via sales rep and described the occurrence of torn muscle in a female patient who received Herpes zoster (Shingrix) for prophylaxis. In April 2021, the patient received the 1st dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced torn muscle (serious criteria GSK medically significant), inflammation localized and arm infection. On an unknown date, the outcome of the torn muscle, inflammation localized and arm infection were unknown. It was unknown if the reporter considered the torn muscle, inflammation localized and arm infection to be related to Shingrix. Additional details were provided as follows: The age at vaccination was not reported. The patient stated that she received the 1st dose of Shingrix and less than 4 months after the vaccination she experienced inflamed arm and it got infected and tore the muscle. The patient went to the hospital and had been in PT (Physical therapy) since after 1st dose. The reporter stated that they called the patient to schedule 2nd Shingrix dose.

Other Meds:

Current Illness:

ID: 1514372
Sex: M
Age:
State: NC

Vax Date:
Onset Date:
Rec V Date: 07/30/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
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Lab Data:

Allergies:

Symptom List:

Symptoms: Pediatric patients be given Havrix Adult Dose; Pediatric patients be given Havrix Adult Dose; This case was reported by a other health professional via sales rep and described the occurrence of overdose in a 18-year-old male patient who received HAV (Havrix adult) (batch number EK59B, expiry date 20th November 2020) for prophylaxis. Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis. On an unknown date, the patient received Havrix adult and Havrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Havrix adult and Havrix Pre-Filled Syringe Device, the patient experienced overdose and adult product administered to child. On an unknown date, the outcome of the overdose and adult product administered to child 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 age at vaccination was not reported. The reporter stated that, the pediatric patient received Havrix adult dose, which led to overdose and adult product administered to child. The reporter consented to follow up. This was 3 of 4 linked cases, reported by same reporter for different patients.; Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR159012:Same reporter US-GLAXOSMITHKLINE-US2021AMR159011:Same reporter US-GLAXOSMITHKLINE-US2021AMR158998:Same reporter

Other Meds:

Current Illness:

ID: 1514373
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 07/30/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: suspected vaccination failure; corneal shingles in my right eye; very painful.; 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. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis and COVID 19 VACCINE for prophylaxis. Previously administered products included Covid vaccine (received 1st dose on an unknown date). On an unknown date, the patient received the 2nd dose of Shingles vaccine, the 1st dose of Shingles vaccine and the 2nd dose of COVID 19 VACCINE. On an unknown date, several years after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria medically significant), ophthalmic herpes zoster (serious criteria medically significant) and pain. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the ophthalmic herpes zoster and pain were not recovered/not resolved. It was unknown if the reporter considered the vaccination failure, ophthalmic herpes zoster and pain to be related to Shingles vaccine and Shingles vaccine. Additional details were provided as follows: The patient had reported for him/herself. The age at vaccination was not reported. The patient received both the doses of Shingles vaccine several years ago from the date of reporting. After receiving Shingles vaccine and 2nd dose of Covid vaccine, the patient got corneal shingles in his/her right eye. The patient reported that, it was very painful. It was unknown if the reporter considered the ophthalmic herpes zoster and pain to be probably related to Covid vaccine. This case was considered as suspected vaccination failure, since the details regarding laboratory confirmation were not provided.

Other Meds:

Current Illness:

ID: 1514375
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 07/30/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: Got shingles from the shingle shot/ Suspect vaccination failure; Got shingles from the shingle shot; 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, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown. The reporter considered the vaccination failure and shingles to be related to Shingles vaccine. Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The patient got shingles from the shingle shot and was suffering beyond explanation. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization for shingles, time to onset for event and laboratory confirmation for shingles were not provided.

Other Meds:

Current Illness:

ID: 1514376
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 07/30/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: had the shot and have gotten the shingles twice/Suspected Vaccination failure; have gotten the shingles twice; 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, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient after vaccination, gotten the shingles twice. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation were unknown at the time of reporting. No contact details were provided.

Other Meds:

Current Illness:

ID: 1514379
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 07/30/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: suspected vaccination failure; had them 3 times; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. The patient's past medical history included shingles. On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. Additional details were provided are as follows: The age at vaccination was not reported. The patient received Shingles vaccination and had shingles 3 times, once before vaccination and twice after vaccination. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.

Other Meds:

Current Illness:

ID: 1514380
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 07/30/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: I know 6 people that got the shot and then got shingles /Suspected vaccination failure; I know 6 people that got the shot and then got shingles; 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, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. Additional details were provided as follows; The age at vaccination was not reported. The reporter stated that, the patient got the shot and then got shingles. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization for shingles, time to onset for event and laboratory confirmation for shingles were not provided. This case was 1 of 6 linked cases reported by same reporter for different patient.; Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR161278:Same reporter. Pt 2/6 US-GLAXOSMITHKLINE-US2021AMR161279:Same reporter. Pt. 3/6 US-GLAXOSMITHKLINE-US2021AMR161280:Same reporter. Pt 4/6 US-GLAXOSMITHKLINE-US2021AMR161281:Same reporter. Pt 5/6 US-GLAXOSMITHKLINE-US2021AMR161282:Same reporter. Pt 6/6

Other Meds:

Current Illness:

ID: 1514381
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 07/30/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: almost died; convulsions; turned to blue; This case was reported by a consumer via interactive digital media and described the occurrence of near death experience in a patient who received DTP (A or W not known) (DTP vaccine) for prophylaxis. On an unknown date, the patient received DTP vaccine. On an unknown date, unknown after receiving DTP vaccine, the patient experienced near death experience (serious criteria GSK medically significant and life threatening), convulsion (serious criteria GSK medically significant and life threatening) and cyanosis (serious criteria life threatening). On an unknown date, the outcome of the near death experience, convulsion and cyanosis were unknown. It was unknown if the reporter considered the near death experience, convulsion and cyanosis to be related to DTP vaccine. Additional details were provided as follows: The patient had reported for him/herself. The age at vaccination was not reported. When the patient was baby, he/she almost died from the DTP shot. The patient slipped into convulsions and turned to blue. After that, pertussis part of the shot had left out because, that was protocol. The patient stated that, not everyone should get the pertussis part of the shot.

Other Meds:

Current Illness:

ID: 1514382
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 07/30/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: fainted; sweats; fever; sustained injury; This case was reported by a other health professional via sales rep and described the occurrence of faint in a female patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 1 day after receiving Shingrix, the patient experienced faint (serious criteria GSK medically significant), sweating, fever and injury. On an unknown date, the outcome of the faint, sweating, fever and injury were unknown. It was unknown if the reporter considered the faint, sweating, fever and injury to be related to Shingrix. Additional details were provided as follows: The reporter was the patient's daughter. The age at vaccination was not reported. After receiving Shingrix, the patient had sweats and fever and next day, she fainted and sustained injury.

Other Meds:

Current Illness:

ID: 1514383
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 07/30/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: suspected vaccination failure; have gotten shingles; 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 (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix. Additional details were provided as follows: This case was reported by patient him/herself. The age at vaccination was not reported. After receiving Shingrix, the patient got shingles, 3 times in the year of reporting. The patient asked, if he/she could get the vaccine again. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation of shingles were not provided.

Other Meds:

Current Illness:

ID: 1514384
Sex: F
Age:
State: PA

Vax Date:
Onset Date:
Rec V Date: 07/30/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

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Allergies:

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Symptoms: severe allergic reaction; This case was reported by a consumer via call center representative and described the occurrence of allergic reaction in a female patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent) (batch number AFLLA175AA, expiry date 30th June 2009) for prophylaxis. On an unknown date, the patient received FluLaval Quadrivalent. On an unknown date, unknown after receiving FluLaval Quadrivalent, the patient experienced allergic reaction. On an unknown date, the outcome of the allergic reaction was recovered/resolved. The reporter considered the allergic reaction to be related to FluLaval Quadrivalent. Additional details were provided as follows: This case was reported by patient herself. The age at vaccination was not reported. The patient reported that she had severe allergic reaction to Flulaval 2008-2009 season. The patient did not gave her email address or age or birth date. The patient thought that the adverse event was already reported. No further information was provided.

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Current Illness:

ID: 1514385
Sex: M
Age:
State: CA

Vax Date:
Onset Date: 05/01/2021
Rec V Date: 07/30/2021
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Symptoms: he had both Shingrix vaccine/ Shingles episode on mid-May of this year 2021.; Shingles / shingles outbreak; an unusual very mild rash/rash was on the back-left side of the torso; itched/ itching at the left side of the face; pain on the left trigeminal nerve; Shingles nerve problems; still pain on the face; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Zostavax. On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. In May 2021, more than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, rash, pruritus facial, trigeminal neuralgia, neurological disorder nos and facial pain. The patient was treated with gabapentin. On an unknown date, the outcome of the vaccination failure, rash, pruritus facial and trigeminal neuralgia were unknown and the outcome of the shingles was recovered/resolved and the outcome of the neurological disorder nos and facial pain were not recovered/not resolved. It was unknown if the reporter considered the vaccination failure, shingles, rash, pruritus facial, trigeminal neuralgia, neurological disorder nos and facial pain to be related to Shingrix and Shingrix. Additional detaails were provided as follows: The reporter was the patient. The patient received both Shingrix shot as soon as the vaccine was available around 2017. The patient had the Zostavax vaccine before getting both doses of Shingrix. The patient had Shingles episode on mid-May of this year 2021. The reporter stated that, had an unusual very mild rash that he thought it was bug bites and it itched not painful. The patient reported the shingles rash was on the back-left side of the torso, itching at the left side of the face with pain on the trigeminal nerve, with no visible rash, only itching. The patient stated that the outbreak of the Shingles rash happened simultaneously at the same time the itching and pain on the left trigeminal nerve started. This trigeminal left nerve was never an issue before. The patient reported, had been prescribed Gabapentin and will be starting a new anti-seizures medication. The reporter stated that, did not have Shingles now and only had shingles nerve problems and still pain on the face. The reporter stated that, no pain in the torso area. Not all information was available. Both dates of vaccination were unknown. Lot and expiration dates were unknown. The reporter consented to follow up.

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Current Illness:

ID: 1514386
Sex: M
Age: 77
State: CA

Vax Date: 01/10/2020
Onset Date: 01/13/2020
Rec V Date: 07/30/2021
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Symptoms: received a cardiac catheterization; has not had his second dose; was diagnosed with / pericarditis; was diagnosed with minimal coronary disease; trouble breathing; sever chest pain; This case was reported by a nurse and described the occurrence of pericarditis in a 78-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. Concurrent medical conditions included pericarditis, coronary disease, chronic lymphocytic leukemia and shingles. On 10th January 2020, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, the patient received the 2nd dose of Shingrix. On 13th January 2020, 3 days after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced pericarditis (serious criteria GSK medically significant), coronary disease, difficulty breathing and chest pain. On an unknown date, the patient experienced cardiac catheterization and incomplete course of vaccination. On an unknown date, the outcome of the pericarditis, chest pain and incomplete course of vaccination were not recovered/not resolved and the outcome of the coronary disease, difficulty breathing and cardiac catheterization were unknown. It was unknown if the reporter considered the pericarditis, coronary disease, difficulty breathing, chest pain and cardiac catheterization to be related to Shingrix. Additional details were reported as follows: The case was reported by the patient's wife. The age at vaccination was not applicable for 2nd dose reported. The patient received the 1st dose of Shingrix and 3 days later he had severe chest pain and trouble breathing. The patient went to the emergency department at that time, received a cardiac catheterization, was diagnosed with minimal coronary disease and pericarditis. The patient had not received his 2nd dose of Shingrix till the time of reporting which led to incomplete course of vaccination. The reporter consented to follow up.

Other Meds:

Current Illness: Chronic lymphocytic leukemia; Coronary disease; Pericarditis; Shingles

ID: 1514390
Sex: F
Age:
State: CO

Vax Date: 07/23/2021
Onset Date: 07/23/2021
Rec V Date: 07/30/2021
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Symptoms: received Hiberix / dose expired; received Hiberix/ patient?s age/ 72; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 72-year-old female patient who received Hib (Hiberix) (batch number G4XX7, expiry date 20th May 2021) for prophylaxis. On 23rd July 2021, the patient received Hiberix. On 23rd July 2021, unknown after receiving Hiberix, the patient experienced expired vaccine used and inappropriate age at vaccine administration. On an unknown date, the outcome of the expired vaccine used and inappropriate age at vaccine administration were unknown. Additional details were provided as follows: The age at vaccination was not reported. The pharmacist stated that, the patient received already expired vaccine at the age of 72 years old, which led to expired vaccine used and inappropriate age at vaccine administration. The health care professional was not sure about the patient's age, mentioned it was 72, although it was explained that that was not the recommended age for the use of the vaccine. The reporter consented to follow up.

Other Meds:

Current Illness:

ID: 1514391
Sex: F
Age:
State: IA

Vax Date: 06/18/2021
Onset Date: 06/18/2021
Rec V Date: 07/30/2021
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Symptoms: Kinrix was administrated instead of Boostrix to a 14 years old; Kinrix was administrated instead of Boostrix; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 14-year-old female patient who received DTPa-IPV (Kinrix) (batch number hb7l7, expiry date 31st August 2021) for prophylaxis. Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis. On 18th June 2021, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 18th June 2021, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and wrong vaccine administered. The action taken with Kinrix Pre-Filled Syringe Device was unknown. On an unknown date, the outcome of the inappropriate age at vaccine administration and wrong vaccine administered 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 medical assistance reported that, Kinrix was administrated instead of Boostrix to a 14 years old patient, which led to inappropriate age at vaccine administration and wrong vaccine administered. No adverse event was reported. The reporter consented to follow up.

Other Meds:

Current Illness:

ID: 1514392
Sex: M
Age: 66
State: TN

Vax Date: 11/10/2019
Onset Date: 07/23/2021
Rec V Date: 07/30/2021
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Symptoms: Suspected Vaccination failure; HCP confirmed Shingles / Developed shingles; Red spot on his right back / spread under his right armpit to his stomach; The redness has formed blisters on his stomach area; Spot gave him a burning sensation; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a 67-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. On 10th November 2019, the patient received the 2nd dose of Shingrix (intramuscular). On an unknown date, the patient received the 1st dose of Shingrix. On 23rd July 2021, 621 days after receiving Shingrix, unknown after receiving Shingrix and an unknown time after starting Valtrex, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, red rash, blister and burning sensation. The patient was treated with valaciclovir hydrochloride (Valtrex) and analgesic, nos (Pain Medication). On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles, red rash, blister and burning sensation were not recovered/not resolved. It was unknown if the reporter considered the vaccination failure, shingles, red rash, blister and burning sensation to be related to Shingrix and Shingrix. Additional details were provided as follows: The case was reported by the patient himself. The patient received the two doses of Shingrix and patient had shingles. The patient stated that on last friday before reporting date he noticed a red spot on his right back about the size of a silver dollar,the patient was working in yard so he thought he was bitten by an insect. On 25th July 2021,the red spot grew to the size of a basketball and spread under his right armpit to his stomach. The patient went to the HCP and the HCP confirmed it as Shingles. At the day of reporting the redness had formed blisters on his stomach area. The HCP started on patient valtrex and pain medications for treatment. The reporter stated that he developed shingles even though he received both doses of the Shingrix. The reporter did not consent to follow up. The reporter did not give permission to contact HCP. This case was considered as suspected vaccination failure since the details regarding laboratory test confirming shingles were unknown at the time of reporting.

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Current Illness:

ID: 1514393
Sex: M
Age:
State: NC

Vax Date: 04/03/2021
Onset Date:
Rec V Date: 07/30/2021
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Symptoms: prostate cancer; This case was reported by a pharmacist via call center representative and described the occurrence of prostate cancer in a 83-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. On 3rd April 2021, the patient received the 1st dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced prostate cancer (serious criteria GSK medically significant). The patient was treated with non-drug therapy (Radio Therapy). On an unknown date, the outcome of the prostate cancer was unknown. It was unknown if the reporter considered the prostate cancer to be related to Shingrix. Additional details were provided as follows: The age at vaccination was not reported. The pharmacist reported that the patient received the 1st dose of Shingrix and less than 4 months after the vaccination the patient experienced prostate cancer. The patient was on radio therapy as treatment. The reporter consented to follow up. The pharmacist only knew that it was a new diagnosis for the patient. No further details provided. The pharmacist consented to follow up via letter in the mail.

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Current Illness:

ID: 1514394
Sex: M
Age: 7
State: TX

Vax Date: 07/26/2021
Onset Date: 07/26/2021
Rec V Date: 07/30/2021
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Symptoms: Kinrix given to a 7 years old patient; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 7-year-old male patient who received DTPa-IPV (Kinrix) (batch number JP55J5, expiry date 13th September 2022) for prophylaxis. Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis. On 26th July 2021, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 26th July 2021, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional details were provided as follows: The 7 years old patient received Kinrix, which led to inappropriate age at vaccine administration. The reporter wanted to know if this dose was valid or if needs to re done it. The reporter consented to follow up. This case was linked with case US2021160427, reported by same reporter for different patient. .; Sender's Comments: US-GLAXOSMITHKLINE-US2021160427:Same reporter.

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Current Illness:

ID: 1514397
Sex: F
Age:
State: TX

Vax Date:
Onset Date: 06/05/2021
Rec V Date: 07/30/2021
Hospital: Y

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Symptoms: CEREBRAL ARTERY OCCLUSION; CEREBROVASCULAR ACCIDENT; ATRIAL SEPTAL DEFECT; THROMBECTOMY; CONFIRMED COVID-19 INFECTION; SARS-COV-2 TEST POSITIVE; CHILLS; FATIGUE; HEADACHE; CONFIRMED CLINICAL VACCINATION FAILURE; This spontaneous report received from a health care professional via a Regulatory Authority Vaccine Adverse Event Reporting System (VAERS ID: 1463769), concerned a 35 year old female patient of unspecified race and ethnic origin. The patient's height, and weight were not reported. The patient's concurrent condition included antiphospholipid syndrome. The patient had no allergies reported. On 14-JAN-2021, the patient was tested positive for coronavirus disease (COVID-19) via the COVID-19 polymerase chain reaction (PCR) test. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration was not reported, batch number: 201A21A and expiry: unknown) dose was not reported, 1 total, administered on 08-APR-2021 for prophylactic vaccination. Concomitant medication included Xarelto (rivaroxaban). On 05-JUN-2021, the patient experienced onset of chills, fatigue, headache and was tested positive for COVID-19 via COVID-19 PCR test [severe acute respiratory syndrome coronavirus 2 (SARS-COV-2) test positive, confirmed covid-19 infection and confirmed clinical vaccination failure]. The patient went to emergency room visit and was hospitalized (date unspecified in report). On 05-JUN-2021, she had acute right middle cerebral artery (R MCA) ischemic stroke (cerebrovascular accident), 2/2 M1 occlusion (cerebral artery occlusion) status post (S/P) thrombectomy '(HCC)' (as reported), and had atrial septal defect [patent foramen ovale (PFO)]. On 12-JUN-2021, she was discharged to inpatient rehabilitation. The patient was hospitalized for 8 days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the atrial septal defect, cerebral artery occlusion, cerebrovascular accident, chills, confirmed covid-19 infection, fatigue, headache, thrombectomy, SARS-COV-2 test positive and confirmed clinical vaccination failure was not reported. This report was serious (Hospitalization Caused / Prolonged, Other Medically Important Condition, Life Threatening, and Disability Or Permanent Damage). This report was associated with product quality complaint : 90000187446. Version created to amend previously reported information on 23-JUL-2021. Upon review following information amended. Event chills, fatigue and headache were updated from labeled to unlabeled. Additional information received from Consumer Complaint Vigilance Organization on 27-JUL-2021. The following information updated and incorporated into the case narrative. product quality complaint number was added.; Sender's Comments: V1: Follow-up information updates the labeling and adds a product quality complaint number; this does not change the previous assessment. This spontaneous report received from a Regulatory Authority [VAERS ID: 1463769] concerns a 35-year-old female patient of unspecified ethnicity who had an acute right middle cerebral artery (R MCA) ischemic stroke with cerebral artery occlusion and was hospitalized 58 days after receiving the Janssen Covid-19 vaccine. Concurrent condition included antiphospholipid syndrome. The patient was previously COVID-19 polymerase chain reaction (PCR) test positive 3 month prior to vaccination. On the day of hospitalization, the patient noted chills, fatigue, headache; COVID-19 PCR test was positive. The patient underwent thrombectomy "HCC"; atrial septal defect was noted. The subject's anti-phospholipid syndrome and SARS-COV-2 infection may have increased the risk for the events to occur. However, considering the temporal relationship with vaccination, a relationship with Janssen Covid-19 vaccine cannot be ruled out. Therefore, the relationship is considered indeterminate.

Other Meds: XARELTO

Current Illness: Antiphospholipid syndrome

ID: 1514398
Sex: F
Age:
State: MN

Vax Date:
Onset Date: 04/16/2021
Rec V Date: 07/30/2021
Hospital: Y

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Symptoms: GUILLAIN BARRE SYNDROME; LEFT AND RIGHT SIDE OF THE FACE - BELL'S PALSY; TWITCHES; NERVE PAIN IN BILATERAL FEET AND HAND; TINGLING OF FEET AND HANDS; LOWER AND MIDDLE BACK PAIN; This spontaneous report received from a patient concerned a 46 year old female. The patient's weight was 175 pounds, and height was 61 centimeters. The patient's was a non smoker, non drinker, allergies included bee allergy (she carries an Epipen), environmental and dust mite allergy. There was no history of drug abuse or illicit drug use. The patient did not have any current medical conditions. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805029) on 31-MAR-2021 for prophylactic vaccination. Concomitant medications included ergocalciferol, lactobacillus acidophilus, and vitamins nos. On 16-APR-2021 the patient started experiencing a constant ache in her lower back near the sacrum, with a 4/10 on a the pain scale. At night the pain worsened and also included a stabbing middle back pain, with a 9-10/10 on the pain scale. She couldn't sleep, couldn't stand or sit. There was no relief even after taking Tylenol and ibuprofen. On 21-APR-2021, she developed Bell's Palsy on the left side of her face. She was drinking water and it fell out of the side of her mouth. She went to the hospital for evaluation and the doctors suspected that she had been bitten by a tick. Blood work was done to assess for a tick bite as well as a computerised tomogram (CT) scan of the head to rule out a stroke. Both results came back normal and additional blood work was sent to a larger facility for further tick bite testing. She was discharged home from the Emergency Room (ER) with prescriptions for prednisone for 1 week, 10 day course of penicillin, and tramadol every 4-6 hours for the pain as needed. On 22-APR-2021 or 23-APR-2021 she attended the hospital again. This time the right side of her face was affected with Bell's palsy in addition to the left side. Blood work was performed which came back normal. The doctors believed the symptoms were related to a tick bite. She received an injection for the back pain which she believed was tramadol but did not provide any relief. She was discharged home with a prescription for hydrocodone to be taken for pain as needed. She received the same follow-up advice and was advised to continue with the steroid, antibiotic and pain medications. The left sided Bell's palsy resolved on 25-APR-2021 or 26-APR-2021. On 24-APR-2021 or 25-APR-2021 the patient visited hospital due to back pain, the severity of which had prevented her from sleeping for days. She arrived at 3:00 am and was discharged by 9:00 am. She received Intravenous morphine and a ketamine infusion for 1 hour. This provided instant relief and she was able to sleep. Blood work was done and was normal. Upon discharge she was advised to stop the tramadol and she instead received a prescription for oxycodone. She was advised to take the oxycodone if the hydrocodone didn't work. The patient stated that at this time, she felt great and hopeful that entire day until the back pain retuned at night. On 26-APR-2021 she retuned to hospital due to the severity of the back pain. Middle and lower back pain had returned at a 9-10/10 pain level. She received an injection of tramadol which didn't provide relief. She was discharged home and the ER doctor suggested physiotherapy. She as seen by her primary care provided the same day, a nurse practitioner (NP). The NP prescribed 10 morphine pills. At this point the Bell's palsy was resolving. On 28-APR-2021 or 29-APR-2021, she visited the hospital again for back pain and received a shot of morphine and was then discharged home. The ER physician recommended a neurologist. On 29-APR-2021, the patient noticed that her hand writing was messier and she had a hard time writing. She began dragging her right foot when walking and on 30-APR-2021 she was unable to step onto a curb and couldn't drag either leg when getting into the car. She lost sensation and movement in both legs from the knee down. Initially her right leg was worse than the left but eventually they were the same. On 01-MAY-202 she fell because her left leg "gave out". The same day she underwent a magnetic resonance imaging (MRI) scan on her head/back. Right sided Bell's palsy resolved on 01-MAY-2021 or 02-MAY-2021. On 03-MAY-2021 the patient spoke to her NP and discussed her concerns that her symptoms may be Guillain-Barre syndrome. She was advised to go to the ER. She was admitted to hospital and she received an intravenous injection for pain. A neurologist tested her reflexes; she was told her reflexes were absent from the knees down in both legs. This was tested on either the 03-MAY-2021 or 04-MAY-2021 and worsened on 04-MAY-2021. A lumbar puncture (Spinal tap) was performed on 04-MAY-2021 which confirmed Guillain-Barre syndrome (GBS) and a 5 day course of treatment (unspecified) was started. On 04-MAY-2021 she experienced the worst back pain, during hospitalisation she received intravenous hydromorphone hydrochoride (Dilaudid) every 6 hours and intravenous hydrocodone every 4 hours. she had some relief after the first day and gained some mobility back but had the same back pain. During the 5 days of treatment, she noticed relief. By the time she was discharged, on 09-MAY-2021, she was able to walk again with the help of a cane. She received physiotherapy whilst in hospital and has continued with treatments since discharge. The stabbing pain in the middle of the back resolved during the 5 days of treatment, approximately 06-MAY-2021 but she stated that her lower back is still achy but physiotherapy has helped. Her lower back pain comes and goes at 2-3/10 pain level and she currently takes ibuprofen as needed for prevention before periods of activity. The reported developing nerve pain on an unspecified date, in both feet describing the feeling like "when you sit on your foot for too long then the feeling returns initially". The pain started during the 5 days of treatment once feeling and mobility returned to her legs. The pain has improved over time but both feet remain tingly with the left foot feeling worse. Her movement is still impaired but she can still get around the house despite feeling shaky when using the stairs. She also experienced nerve pain in her hands during the treatment which she believes may have started sooner when her hand writing appeared messy. Her hands have improved and the nerve pain "comes and goes in stages" The pain has resolved but her hands feel tingly and a "little asleep". She also noticed her thumb and finger grip is weaker. The patient also experienced twitches in bilateral hands and legs, her face and "all over". Onset date was unspecified. The twitches "come and go" and occur 1 to 20 times per day. The patient stopped using a cane on 09-JUN-2021. The patient did not have a plan for follow-up with a neurologist. She did not see the neurologist in July. The neurologist in the hospital said that follow-up is not needed unless issues arise. The pain doctor that the patient was seeing wanted to keep an eye on the back pain in case it was not related to GBS, or if the GBS had exacerbated a previous condition. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from left and right side of the face - bell's palsy on 02-MAY-2021, was recovering from Guillain-Barre syndrome; nerve pain in bilateral feet and hand, tingling of feet and hands, and lower and middle back pain, and the outcome of twitches was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V0: This spontaneous report from a patient concerns a 46-year-old female who developed Guillain-Barre Syndrome (GBS) which was diagnosed 34 days after receiving the Janssen COVID-19 vaccine. Symptom of lower back pain began 16 days post-vaccine which became severe and intractable over 13 days; she then developed bilateral Bell's palsy 21 days post-vaccine and lost sensation and movement below her knees 30 days post-

Other Meds: MULTIVITAMIN [VITAMINS NOS]; VITAMIN D [ERGOCALCIFEROL]; LACTOBACILLUS ACIDOPHILUS

Current Illness: Allergic reaction to bee sting (carries an Epipen because she was "covered in hives" many years ago after being stung.); House dust mite allergy; Non-smoker

ID: 1514399
Sex: U
Age:
State:

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Onset Date:
Rec V Date: 07/30/2021
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Symptoms: PHOTOPHOBIA; This spontaneous report received from a patient concerned multiple patients. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 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 number. No concomitant medications were reported. On an unspecified date, the subject experienced photophobia. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of photophobia was not reported. This report was non-serious.; Sender's Comments: V0: Medical Assessment Comment not required as per standard procedure as case assessed as non-serious.

Other Meds:

Current Illness:

ID: 1514400
Sex: M
Age:
State: CA

Vax Date:
Onset Date:
Rec V Date: 07/30/2021
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Symptoms: RAPID AND SEVERE WORSENING OF DIABETES AFTER THE J&J COVID VACCINE ADMINISTRATION; SEVERE HYPERGLYCEMIA; ANOREXIA; FLU LIKE SYMPTOMS\FELT WARM WITHOUT FEVER; INSOMNIA; ANXIOUS; MILD HYPONATREMIA; HYPOCHLOREMIA; WEAK; This spontaneous report was received from literature: Rapid and severe worsening of diabetes in a heart transplant recipient after Johnson & Johnson's Janssen COVID-19 vaccine administration. Medicine. 2021 Jun 19;101-104. This report concerned a 55 year old male. The patient's weight was 53.6 kilograms, and height was not reported. The patient's past medical history included developed ventricular tachycardia at age 35, congestive heart failure at age 42. He was found to have normal coronary arteries during the heart transplant evaluation. He received an orthotopic heart transplant at age 49 (transplanted heart functioned well). Histology of the native heart showed non ischemic cardiomyopathy and myofibrillar myopathy due to c.571 G C mutation in the MYOT gene, and concurrent conditions included ventricular tachycardia, and controlled mild diabetes, and other pre-existing medical conditions included the patient had no known diabetic complications and patient had family (siblings) history of diabetes. The patient was previously treated with prednisone for transplant immunosuppression. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) 1 total, dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included metformin for controlled mild diabetes, mycophenolate mofetil for transplant immunosuppression, tacrolimus for transplant immunosuppression, acetylsalicylic acid, gabapentin, magnesium oxide, mexiletine, and rosuvastatin. On an unspecified date, the patient visited the endocrine clinic urgently for severe hyperglycemia. Four weeks before presentation, the patient had received the vaccine. A few days later, he developed flu-like symptoms, he felt warm without fever, weak, sleepy, and anorexic and he had to sleep most of the day. These symptoms lasted for a few days then abated. Most of the same symptoms recurred a few days later, in addition he developed insomnia even though he was tired, polyuria, and thirst, and lost 9 lbs. The patient's fasting glucose readings had ranged between 130-150 mg/dL (normal 65-99) before he received the vaccine. The fasting glucose rose to 200 mg/dL one day after the vaccine administration and gradually rose to 400 over the next few weeks. On the morning of the presentation, a routine blood test showed fasting glucose of 422 mg/dL. The patient was asked to go to the endocrine clinic immediately for advice. The patient had developed ventricular tachycardia at age 35 and congestive heart failure at age 42. He was found to have normal coronary arteries during the heart transplant evaluation. He received an orthotopic heart transplant at age 49, six years before the current presentation. Histology of the native heart showed nonischemic cardiomyopathy. His immunosuppression regimen initially consisted of prednisone, mycophenolate, and tacrolimus but prednisone was tapered off several months later. The transplanted heart functioned well. The patient had normal hemoglobin A1c (5.2, normal C mutation in the MYOT gene. The patient's medications at the current presentation included aspirin 81 mg daily, gabapentin 300 mg twice daily, mexiletine 150 mg twice daily, rosuvastatin 5 mg tablet three times weekly, magnesium oxide 400 mg twice daily, metformin 500 mg twice daily, mycophenolate 250 mg twice daily, and tacrolimus 3 mg twice daily. At the endocrine clinic, the patient appeared anxious and thin but was in no acute distress. The patient denied abdominal pain. The patient's temperature was 36.5 ?C (97.7 ?F), blood pressure 114/80 mmHg, heart rate 104 beats/minute, weight 53.6 kg, and body mass index (BMI) 19.67 kg/m?. He had moist mucosa. Auscultation revealed tachycardia and clear lungs. The patient had no lower extremity edema. Point-of-care glucose was 382 mg/dL and A1c 13.0. The same blood specimen which showed glucose of 422 mg/dL also showed mild hyponatremia and hypochloremia but normal creatinine, bicarbonate, and anion gap. Additional tests were added to the existing blood specimen collected earlier that day. Amylase and lipase levels were normal; insulin and C-peptide levels were in the low normal range, which showed ? cell function deficiency in the face of severe hyperglycemia. ? cell autoantibodies including those against glutamic acid decarboxylase-65, ICA-512, and insulin were tested but the results were not immediately available. The patient was deemed stable enough to be managed as an outpatient. Insulin glargine 10 units daily and insulin lispro 5 units before each meal were started and metformin was held. In two days, Insulin glargine dose was raised to 15 units daily and insulin lispro to 7 units. A week later, he was seen at the endocrine clinic again. He felt much better and regained 1-2 lbs. ? cell autoantibodies were all negative. Fasting glucose levels were 137-150 mg/dL and daytime glucose 273 to 330 mg/dL. Insulin glargine dose was raised to 18 units daily and insulin lispro to 10 units. On the last follow-up 16 days after the urgent endocrine clinic visit, his glycemia was well controlled with insulin glargine 30 units daily and insulin lispro 10 units before each meal. The patient felt that he had been back to his baseline health before receiving the vaccine. Laboratory data (dates unspecified) included: Amylase (NR: 31 - 124) 56 U/L, Anion gap (NR: 8 - 19) 12 mmol/L, 13 mmol/L, Anti-glutamic acid decarboxylase antibody (NR: 0.0 - 5.0) less than 5.0 IU/mL, Anti-insulin antibody (NR: 0.0 - 0.4) less than 0.4 U/mL, Anti-islet cell antibody (NR: 0.0 - 7.4) less than 5.4 U/mL, Auscultation (NR: not provided) revealed tachycardia and clear lungs, Autoantibody test (NR: not provided) negative, Bicarbonate (NR: 20 - 30) 27 mmol/L, 24 mmol/L, Blood glucose (NR: not provided) 382 mg/dL, Blood pressure (NR: not provided) 114/80 mmHg, Blood urea nitrogen (NR: 7 - 22) 17 mg/dL, 29 mg/dL, Body mass index (NR: not provided) 19.67 kg/m2, Body temperature (NR: not provided) 36.5 C, Calcium (NR: 8.6 - 10.4) 9.3 mg/dL, 9.5 mg/dL, Chloride (NR: 96 - 106) 95 mmol/L, 102 mmol/L, Creatinine (NR: 0.60 - 1.30) 0.97 mg/dL, 0.89 mg/dL, Fasting blood glucose 130-150 mg/dL, 200 mg/dL, 400 mg/dL, 422 mg/dL, Fasting blood glucose (NR: not provided) 137-150 mg/dL, 113-145 mg/dL, Glucose (NR: not provided) 273 to 330 mg/dL, Glucose (NR: 65 - 99) 422 mg/dL, 145 mg/dL, HbA1C (NR: 5.2 - 5.7) 6.6 %, 5.9-7.6 %, 6.5 %, 13.0 %, 6.7 %, 6.7 %, 6.1 %, 8.4 %, normal, Heart rate (NR: not provided) 104 beats/minute, Insulin (NR: 3 - 25) 6 uU/mL, Insulin C-peptide (NR: 1.1 - 4.3) 2.3 ng/mL, Lipase (NR: 9 - 63) 49 U/L, Magnesium (NR: 1.4 - 1.9) 1.6 mEq/L, 1.6 mEq/L, Postprandial hyperglycemia (NR: not provided) 200-300 mg/dL, Potassium (NR: 3.6 - 5.3) 4.6 mmol/L, 5.3 mmol/L, Sodium (NR: 135 - 146) 139 mmol/L, 134 mmol/L, Weight (NR: not provided) 53.6 kg, and (NR: not provided) regained 1-2 lb. Treatment medications (dates unspecified) included: insulin glargine, and insulin lispro. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from mild hyponatremia, and hypochloremia, was recovering from severe hyperglycemia, and the outcome of flu like symptoms\felt warm without fever, anorexia, rapid and severe worsening of diabetes after the j&j covid vaccine administration, weak, insomnia and anxious was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210754168-Covid-19 vaccine ad26.cov2.s - Rapid and severe worsening of diabetes after the J&J covid vaccine administration, severe hyperglycemia. 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: GABAPENTIN; METFORMIN; ASPRIN; MEXILETINE; ROSUVASTATIN; MAGNESIUM OXIDE; MYCOPHENOLATE; TACROLIMUS

Current Illness: Diabetes

ID: 1514401
Sex: U
Age:
State:

Vax Date:
Onset Date: 07/23/2021
Rec V Date: 07/30/2021
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Symptoms: COVID TEST POSITIVE; 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 23-JUL-2021, the subject experienced covid test positive. Laboratory data included: COVID-19 virus test (NR: not provided) positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid test positive was not reported. This report was non-serious. This report was associated with product quality complaint: 90000187245 The suspected product quality complaint has been confirmed to be voided (no PQC was identified within the time period when complaint was reported) based on the PQC evaluation/investigation performed.; Sender's Comments: Medical assessment comment not required as per standard procedure as the case assessed non-serious

Other Meds:

Current Illness:

ID: 1514402
Sex: M
Age:
State: NJ

Vax Date:
Onset Date: 05/01/2021
Rec V Date: 07/30/2021
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Symptoms: SHORT-TERM MEMORY LOSS; FEELS LIKE GOING SENILE; CAN'T STAY AWAKE; FELT IN A FOG/FELT LIKE SYMPTOMS HIT LIKE A BRICK WALL; FEAR OF DRIVING; NAUSEATED; This spontaneous report received from a patient concerned a 54 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included type 2 diabetes, and other pre-existing medical conditions included patient described himself as healthy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 206A21A, and expiry: UNKNOWN) dose was not reported, administered on 26-APR-2021 for prophylactic vaccination. Concomitant medications included metformin for type 2 diabetes. On MAY-2021, the subject experienced feels like going senile. On MAY-2021, the subject experienced short-term memory loss. On MAY-2021, the subject experienced can't stay awake. On MAY-2021, the subject experienced felt in a fog/felt like symptoms hit like a brick wall. On MAY-2021, the subject experienced fear of driving. On MAY-2021, the subject experienced nauseated. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from short-term memory loss, nauseated, can't stay awake, feels like going senile, felt in a fog/felt like symptoms hit like a brick wall, and fear of driving. This report was non-serious. This case, from the same reporter is linked to 20210754945.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.

Other Meds: METFORMIN

Current Illness: Type II diabetes mellitus ("mild" type 2 diabetes)

ID: 1514403
Sex: F
Age:
State: FL

Vax Date:
Onset Date: 05/16/2021
Rec V Date: 07/30/2021
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Symptoms: WEIRD SPINNING; SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION/FEVER/SPLITTING HEADACHE/SINUS PRESSURE/COUGH/CONGESTION/FEELING SICK; FELT ROTTEN AFTER THE SHOT/FELT LIKE BRAIN WAS FLOATING IN HOT WATER; This spontaneous report received from a patient concerned a 51 year old female. Initial information was processed along with the additional information received on 26-JUL-2021 The patient's height, and weight were not reported. The patient's past medical history included Lyme disease, and concurrent conditions included non-smoker, alcohol user (Occasional glass of wine), and penicillin allergy. The patient was not pregnant at the time of reporting. The patient had 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: 205A21A, and expiry: 07-AUG-2021) dose was not reported, 1 total administered to left arm on 16-MAY-2021 for prophylactic vaccination. Concomitant medications included vitamins nos. On 16-MAY-2021, after the vaccination, the patient felt rotten for a day and a half but no other side effects. On 23-JUL-2021, the patient started experiencing fever, splitting headache and sinus pressure. On 24-JUL-2021, the patient went to get a rapid covid-19 test and result came as positive to Covid-19 (suspected covid-19 infection and suspected clinical vaccination failure). The patient also had symptoms such as congestion, headache, and cough which was present at the time of reporting. It was reported that, the patient's symptoms were like waves sometimes she felt better then she felt sick. The patient stated that her fever was 99 F and not more than 100 F. The patient also stated that she felt like her brain was floating in hot water and felt weird spinning. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt rotten after the shot/felt like brain was floating in hot water on MAY-2021, had not recovered from suspected covid-19 infection/fever/splitting headache/sinus pressure/cough/congestion/feeling sick, and the outcome of suspected clinical vaccination failure and weird spinning was not reported. This report was serious (Other Medically Important Condition). This report was associated with product complaint number 90000187262. The suspected product quality complaint has been confirmed to be not voided (meet PQC) based on the PQC evaluation/investigation performed.; Sender's Comments: V0: 20210755349-COVID-19 VACCINE AD26.COV2.S-Suspected clinical vaccination failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS

Other Meds: VITAMINS NOS

Current Illness: Alcohol use (Occasional glass of wine); Non-smoker; Penicillin allergy

ID: 1514404
Sex: F
Age:
State: OH

Vax Date:
Onset Date:
Rec V Date: 07/30/2021
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Symptoms: PANIC ATTACKS; LONG-TERM DIZZINESS; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, 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 panic attacks, and long-term dizziness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the long-term dizziness and panic attacks was not reported. This report was non-serious. This case, from the same reporter is linked to 20210754977 and 20210759716.; Sender's Comments: V0 : Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.

Other Meds:

Current Illness:

ID: 1514405
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 07/30/2021
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Symptoms: TINNITUS; EAR DISCOMFORT, EAR PRESSURE, EAR FULLNESS; 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 tinnitus, and ear discomfort, ear pressure, ear fullness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the tinnitus and ear discomfort, ear pressure, ear fullness was not reported. This report was non-serious. This case, from the same reporter is linked to 20210758691 and 20210758713.; Sender's Comments: V0: Medical assessment comments not required as per the standard procedure as the case is assessed as non-serious.

Other Meds:

Current Illness:

ID: 1514406
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 07/30/2021
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Symptoms: SKIN FALLS OFF; This spontaneous report received from a consumer 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. 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 skin falls off. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of skin falls off 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:

ID: 1514407
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 07/30/2021
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Symptoms: JAUNDICE; VACCINE EXPOSURE VIA BREAST MILK; This spontaneous report received from a patient by a Business partner (Pfizer Inc.) on 23-JUL-2021 was received on 23-JUL-2021 and concerned an infant of unspecified sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient's parent 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 jaundice, and vaccine exposure via breast milk. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the jaundice and vaccine exposure via breast milk 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:

ID: 1514408
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 07/30/2021
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Symptoms: ANAPHYLAXIS; INAPPROPRIATE AGE AT VACCINE ADMINISTRATION; OFF LABEL USE; This spontaneous report received from a consumer via other company (Pfizer Inc.) concerned 4 patients. No past medical history or concurrent conditions were reported. The patients received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) 1 total, dose, start therapy date were not reported for prophylactic vaccination. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, patients experienced anaphylaxis, inappropriate age at vaccine administration, and off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the anaphylaxis, inappropriate age at vaccine administration and off label use was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 ;20210756606-JANSSEN COVID-19 VACCINE-Anaphylaxis. This event(s) is labeled per RSI and is therefore considered potentially related.

Other Meds:

Current Illness:

ID: 1514409
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 07/30/2021
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Symptoms: VARICELLA ZOSTER VIRUS MENINGITIS; ACHES; RIGHT LEG (L5 DERMATOME) INVOLVEMENT WITH VESICULAR SKIN LESIONS; FEVER; This spontaneous report received from a patient by a Business partner (Pfizer Inc.) was received on 23-Jul-2021 and concerned a 34-year-old female with unspecified race and ethnicity. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient had no past medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: Unknown) dose not reported, 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. It was reported that 2 weeks after vaccination on an unspecified date, the patient experienced significant immunological response like fever and ache to the vaccine. On an unspecified date, the patient had right leg (L5 dermatome) involvement with vesicular skin lesions and headache with eventual diagnosis of varicella zoster virus meningitis (VZV meningitis). Laboratory data (dates unspecified) included: Absolute lymphocyte count (NR: not provided) Normal, and HIV antigen (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, aches, varicella zoster virus meningitis and right leg (l5 dermatome) involvement with vesicular skin lesions was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210756694-covid-19 vaccine ad26.cov2-varicella zoster virus meningitis. 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: 1514411
Sex: M
Age:
State: MI

Vax Date:
Onset Date:
Rec V Date: 07/30/2021
Hospital:

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Symptoms: PRURITUS THROUGHOUT THE BODY ALTERNATES IN DIFFERENT AREAS OF THE BODY/ ITCHINESS (BACK OF LEFT ANKLE, BACK OF BOTH ARMS, SIDE OF LEFT LEG ON CALF AREA AND WAIST AREA,LEFT HAND),ITCHY AREAS WITH RED MINOR BUMPS SIZE OF A QUARTER TO HALF-A DOLLAR LIKE; This spontaneous report received from a patient concerned a 68 year old male. The patient's weight was 262 pounds, and height was 69 inches. The patient's past medical history included rheumatic fever in childhood, and concurrent conditions included alcohol user, and non smoker, 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, batch number: 042A21A, and expiry: UNKNOWN) dose was not reported, administered on 08-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced pruritus throughout the body alternates in different areas of the body/ itchiness (back of left ankle, back of both arms, side of left leg on calf area and waist area, left hand), itchy areas with red minor bumps size of a quarter to half-a dollar like mosquito bites. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pruritus throughout the body alternates in different areas of the body/ itchiness (back of left ankle, back of both arms, side of left leg on calf area and waist area,left hand),itchy areas with red minor bumps size of a quarter to half-a dollar like mosquito bites. This report was non-serious.

Other Meds:

Current Illness: Alcohol use (1-2/week); Non-smoker

ID: 1514412
Sex: M
Age:
State: MI

Vax Date:
Onset Date: 04/16/2021
Rec V Date: 07/30/2021
Hospital:

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Symptoms: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 53 year old male. Initial information was processed along with the additional information received on 28-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: 180525 expiry: UNKNOWN) dose was not reported, 1 total administered to right arm on 17-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 16-APR-2021, the patient experienced COVID-19 which was suspected vaccination failure and suspected covid-19 infection. On 26-JUL-2021 the patient experienced tickle in his throat. On 27-JUL-2021 the patient experienced cold like symptoms (no fever or tiredness), cough, raspy voice and stuffy nose. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection, and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a Product Quality Complaint: 90000187393.; Sender's Comments: V0: 20210757719-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: 1514414
Sex: F
Age:
State: FL

Vax Date:
Onset Date: 04/09/2021
Rec V Date: 07/30/2021
Hospital:

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Symptoms: CONFIRMED IMMUNOLOGICAL VACCINATION FAILURE; FELT LIKE HIT A WALL; SUDDENLY FELT VERY EXHAUSTED; This spontaneous report received from a patient concerned a 57 year old female of unknown race, and ethnic origin. The patient's height, and weight were not reported. The patient's concurrent conditions included many environmental allergies, alcohol user, non smoker, Hashimoto's disease, vitiligo, and autoimmune disease, and the patient had no known allergies. The patient had no history of drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1808982, and expiry: unknown) dose was not reported, 1 total, administered on 08-APR-2021 at 14:30 to right arm for prophylactic vaccination. Concomitant medications included thyroid replacement medications [both triiodothyronine (T4) and tetraiodothyronine (T3) replacement]. On 09-APR-2021, almost exactly 24 hours after receiving the vaccine, the patient felt like she hit a wall, suddenly felt very exhausted and went to sleep immediately. The patient noted no unusual effects during sleep. On 10-APR-2021, in the morning, the patient felt fine and back to normal. The patient saw her physician quarterly routinely & her physician did bloodwork routinely at each quarterly exam. Her second quarterly routine examination of the year was on 11-JUN-2021 and bloodwork was done. The patient's physician reported that she had no antibodies post covid-19 vaccine ad26.cov2.s. The patient did not know what type of serological test was done to make that determination, although she did know that it was not the one for T-cell (T lymphocyte) testing and that the testing was carried out at diagnostics center. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt like hit a wall, and suddenly felt very exhausted on 10-APR-2021, and the outcome of confirmed immunological vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000187497.; Sender's Comments: V0:20210757925-COVID-19 VACCINE AD26.COV2.S-Confirmed immunological 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: Alcohol use (1 drink occasionally); Autoimmune disorder; Environmental allergy (Many environmental allergies.); Hashimoto's disease; Non-smoker; Vitiligo

ID: 1514415
Sex: M
Age:
State: MI

Vax Date:
Onset Date: 05/07/2021
Rec V Date: 07/30/2021
Hospital:

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Symptoms: ON AND OFF SHAKING HANDS; This spontaneous report received from a consumer concerned a 66 year old male. The patient's weight was 208 pounds, and height was 173 centimeters. The patient's past medical history included heart stent placement surgery, and concurrent conditions included high blood pressure, and cholesterol. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, expiry: 23/JUN/2021) dose was not reported, administered on 30-APR-2021 for prophylactic vaccination. Concomitant medications included clopidogrel bisulfate for cholesterol. On 07-MAY-2021, the subject experienced on and off shaking hands. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from on and off shaking hands. This report was non-serious.

Other Meds: PLAVIX

Current Illness: Blood pressure high; Cholesterol

ID: 1514416
Sex: M
Age:
State: MD

Vax Date:
Onset Date: 05/09/2021
Rec V Date: 07/30/2021
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Symptoms: RASHES (HIVES) ALL OVER THE BODY; This spontaneous report received from a patient concerned a 62 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included non-alcohol user, non-smoker, and crohn's disease, 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 received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A214, expiry: UNKNOWN) dose was not reported, administered on 02-MAY-2021 for prophylactic vaccination. Concomitant medications included mesalazine for crohn's disease. On 09-MAY-2021, the subject experienced rashes (hives) all over the body. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from rashes (hives) all over the body. 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: MESALAMINE

Current Illness: Abstains from alcohol; Crohn's disease; Non-smoker

ID: 1514417
Sex: F
Age:
State: LA

Vax Date:
Onset Date: 07/22/2021
Rec V Date: 07/30/2021
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Symptoms: SUSPECTED CLINICAL VACCINE FAILURE; LOSS OF HEARING; SWOLLEN TONSILS; LOSS OF APPETITE; TIREDNESS; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a parent concerned a 25 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient was not pregnant at the time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total administered on MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Reporter unaware about the exact date on which the patient got the COVID-19 vaccine. No concomitant medications were reported. On unspecified date patient experienced tiredness. On 22-JUL-2021, the patient experienced suspected covid-19 infection. According to reporter patient got COVID because patient was exposed to it. The patient did not take any medications for the tiredness nor report it to Health care professional (HCP). In regards to testing positive for COVID-19, HCP was aware of this but had not been given any treatments for COVID-19 symptoms. Laboratory data included: COVID-19 virus test (NR: not provided) Positive. On an unspecified date, the patient experienced suspected clinical vaccine failure, loss of hearing, swollen tonsils, and loss of appetite. Patient was at home isolating without medical treatment. Reporter did not have lot information but will have daughter call to provide further information on this report. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from loss of hearing, and tiredness, had not recovered from suspected covid-19 infection, swollen tonsils, and loss of appetite, and the outcome of suspected clinical vaccine failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210758347-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 20210758347-covid-19 vaccine ad26.cov2.s- suspected covid-19 infection, loss of hearing. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).

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Current Illness:

Total 2021 VAERS Injuries: 599,999

Page last modified: 03 October 2021 5:28pm