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
84,516
AK1,766
AL5,965
AR3,877
AS44
AZ14,206
CA63,086
CO11,868
CT8,525
DC1,714
DE1,819
FL40,375
FM3
GA14,928
GU90
HI2,396
IA4,638
ID2,667
IL20,962
IN23,378
KS4,659
KY8,015
LA5,184
MA14,972
MD12,830
ME3,208
MH8
MI19,585
MN12,450
MO9,803
MP30
MS2,978
MT2,321
NC16,918
ND1,407
NE2,968
NH3,071
NJ19,001
NM4,008
NV4,494
NY35,559
OH19,636
OK6,376
OR8,683
PA24,435
PR2,362
QM2
RI2,049
SC6,750
SD1,212
TN9,677
TX37,633
UT4,364
VA15,090
VI61
VT1,758
WA15,069
WI11,278
WV2,393
WY877
XB5
XL1
XV2

ID: 1398571
Sex: F
Age:
State: WA

Vax Date: 05/14/2021
Onset Date: 05/15/2021
Rec V Date: 06/15/2021
Hospital: Y

Vax Type:
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Symptom List:

Symptoms: having a stroke or heart attack; high BP/Blood Pressure shot up to 210/110; back, shoulder and chest pain in the middle; had back pain; right shoulder pain; pain behind her neck; Vertigo so bad she had to hang on or stay close to things so she didn't feel like she was flipping over; big flare up of the vertigo; nausea/wave of nausea, very nauseous; felt like energy pressure up in her from the waist up; feeling cold and clammy; Cold and Clammy; This is spontaneous report from contactable consumer (reporting for self). A 68-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, Batch/Lot Number: EW0186-H; Expiration Date: 31Aug2021), via an unspecified route of administration, administered in arm right on 14May2021 at 14:35 as 1st dose, single dose for COVID-19 immunization (at the age of 68-years-old). The patient's medical history included ongoing underactive thyroid started 5-6 years ago and family history included relatives have had cancer. Concomitant medication included levothyroxine (LEVOTHYROXINE, 125mcg once a day) taken for hypothyroidism from an unspecified start date (started 5-6 years ago) and was ongoing. It was reported by the patient that on 14May2021, she received first dose of vaccine and the day after her vaccine on 15May2021, when she woke up, early in the morning when she takes her thyroid medication and she usually takes it at 07:00am every day and she keeps on schedule, but her stomach felt like it was going to flip, like she was going to vomit and she started experiencing vertigo and nausea and mentioned that vertigo was so bad she had to hang on or stay close to things, so she did not feel like she was flipping over and mentioned that states it had lessened a little bit, but not much and stated that a week after that, she had a big flare up of the vertigo, and she had to sit down in her wooden rocking chair with big arms and further stated that on 20May2021 it was night-time at 22:30 pm she got a very big wave of nausea and vertigo and her Blood Pressure shot up to 210/110, she had chest pain in the middle, not on the heart but the middle of chest, she was very nauseous, had back pain, right shoulder pain and pain behind her neck and she thought she was having a stroke and mentioned that she felt like energy pressure up in her from the waist up and she got cold and clammy. The patient further stated that she had her son call the paramedic at 23:00 pm and they took her to the hospital on the night of 20May2021 i.e., into the morning of 21May2021 because they thought she was having a stroke or heart attack and she was hospitalized, and they did tests for a couple of days. She reported that she has not gotten the second vaccine and she was not going to get her second vaccine at this time because she was still having the vertigo. She mentioned that she never had problems with high blood pressure, and she thought this might be one of the side effects. She was asking if there is a window of time that she has to get the second dose of vaccine and stated that the back and neck pain started to subside in route to the hospital and she had two more flare ups of chest pain in the hospital but everything besides the nausea and vertigo recovered by the time she was discharged, and they were taking her blood pressure every 15 minutes. The patient stated that she was hospitalized for three Days from 21May2021 to 23May2021. Therapeutic measures were taken to treat event was Nitro and Baby Aspirin and Blood Pressure Pill, Stress Test and went in and checked her heart. Stress Test was IV and Cat Scan or MRI to check her heart, cholesterol was excellent 90 but states they put her on a cholesterol medication to help her heart. Caller mentioned that they said that if anything was to happen, that helps the heart in a stressful condition, and it was a good thing to have on board. On an unspecified date in May-2021, the patient underwent lab tests and procedures which included Coronary angiogram which result showed no signs of obstruction, Cholesterol was 90 (units not provided) and stress test which result showed some Ischemia and on 20May2021 blood pressure was 210/110 (units not provided). The patient was recovered from vertigo on an unspecified date and on 21May2021 patient was recovered from the events of heart attack, back pain, shoulder pain and neck pain and on 23May2021 from hypertension, chest pain, feeling cold, clammy and felt like energy pressure up in her from the waist up and on 02Jun2021 from nausea. Follow-up attempts are possible, further information is expected.

Other Meds: LEVOTHYROXINE

Current Illness: Hypothyroidism (: Started 5-6 years ago)

ID: 1398572
Sex: F
Age:
State: CT

Vax Date: 04/21/2021
Onset Date: 04/01/2021
Rec V Date: 06/15/2021
Hospital:

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Symptoms: sore arm; Hands tingled like they were asleep; she hasn't been walk a lot; woke up in the middle of the night gasping for air and stopped breathing; woke up in the middle of the night gasping for air and stopped breathing; hands get cold very easily; fingers feel funky, when she went to do anything her hands hurt and were swollen; This is a spontaneous report from a contactable consumer. This 65-years-old female consumer (patient) reported that she received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EW0170; Expiration Date: 31Aug2021) via an unspecified route of administration on 21Apr2021 08:41, as a single dose on left arm for COVID-19 immunization. Medical history of the patient was reported as none. The concomitant medications were reported as multivitamins: (Start: Unknown Stop: Ongoing), he mentioned he was taking it from 40 years ago, does not always take, does not always remember. They were one a day gummies. It was mentioned that history of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available), vaccines administered on same date of the pfizer suspect if applicable, list all vaccines administered on same date with the Pfizer vaccine considered as suspect and relevant tests were reported as none. The patient did not visit the emergency room. She went to physician office, but doctor did not want to see her. On 21Apr2021, the same day the patient reported that she woke up in the middle of the night gasping for air and stopped breathing. One day later, on 22Apr2021, the patient had slightly swollen balls of feet, hurts when walks, she had not been walking a lot, had sore arm, her hands tingled like they were asleep. fingertips hurt when typing and slightly swollen balls of feet, hurts when walks. On an unknown date in Apr2021 the patient was out gardening, it was hot out, her hands were cold, hurt and felt swollen. She was fighting through this, kept fighting and digging and hoeing, thought it would go away and did not, when she went to do anything her hands hurt and were swollen. She uses a mouse and 3D apocolate, a workstation on a 3D computer. She does not know if this aggravates it. She works from home, that can aggravate it, and her fingers still feel funky. She works at a computer all day, moves around a lot, but tingling, and writing too, her hands start to bother her. She was not doing much computer work, she was busy talking because she could not do much on the computer. The outcome of woke up in the middle of the night gasping for air and stopped breathing was recovered on 21Apr2021, the outcome of slightly swollen balls of feet, hurts when walks, she has not been walking a lot was unknown. The event of sore arm recovered on 23Apr2021. The event of hands tingled like they were asleep and slightly swollen balls of feet, hurts when walks were recovering. The event of hands get cold very easily and fingertips hurt when typing, fingers feel funky, when she went to do anything her hands hurt and were swollen had not recovered. The caller mentioned that she wanted to be able to travel, wanted to return to work, when asked, she felt it was a responsible thing to do. She got it to protect herself and others. But, with the reaction she had she is afraid to get second one. Comment: When she called her doctor, the doctor said to call the CDC. They couldnt help her. Thats how they worded it. Information on Lot/Batch number was available. Additional information has been requested.

Other Meds:

Current Illness:

ID: 1398573
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 06/15/2021
Hospital:

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Symptoms: Experienced appendicitis and had to remove appendix; This is a spontaneous report from a contactable reporter. A consumer reported for the female patient (reporter's granddaughter). A female patient of an unspecified age received BNT162B2, (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number and expiration date was not reported), via an unspecified route of administration on an unspecified date as 1st dose, single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced appendicitis and had to remove appendix on an unspecified date. The reporter was curious about what to do with her granddaughter (consumer), 3 weeks is today, after she got her first Covid vaccination (Covid Vaccine) and she experienced appendicitis and she had to have her appendix removed. Today is exactly three weeks. The reporter want to know, when is it safe for her to get her second shot, and she is at home and it's been full 3 weeks." Reporter was informed about Pfizer Medical Information Department. The outcome of the event was unknown. Information about batch/lot number has been requested.

Other Meds:

Current Illness:

ID: 1398574
Sex: U
Age:
State: CA

Vax Date:
Onset Date: 05/06/2021
Rec V Date: 06/15/2021
Hospital:

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Symptoms: Two ER doctors saw it and they said it Bell's palsy; This is a spontaneous report from a contactable nurse. This nurse reported for a patient. The patient of an unspecified age and gender received BNT162B2 (Solution for injection, Lot number: unknown) via an unspecified route of administration on an unknown date, as a single dose for Covid-19 immunization. Medical history and concomitant medications were not reported. The patient stated that, she talked to Pfizer. She had to gone to ER on 06MAY2021. She woke up actually on the 04MAY2021 and she was going to go. She got up at 7 and was going to go to the grocery store. She got dressed and she was going to her brush teeth and everything. She looked in mirror and the right side of her face was flaccid and muscles weren't moving and she said her lips were numb. Right side of her face was flaccid: Attempted to clarify seriousness criteria with caller. She stated it was disfiguring initially then said it was disabling. She stated it was a slight improvement. When she got this she called online doctor visit where you talk to a doctor. She wanted to know if it was one of her medications that could cause this. Doctor said she take's Topamax because she has a very fine essential hand tremor so they wanted to try that in her right hand. MD said that if it was that medication they would stop it and in a few days it would go away and it persisted and her eye closed. Muscles weren't moving : treatment ? On 06MAY2021 she went to the ER. She had her friend take her there. Two ER doctors saw it and they said it Bell's palsy. She has some other symptoms that have occurred about 2.5 to 3 weeks ago with the right side of your face she had severe pain. Severe pain: The pain was terrible it is ongoing. Her right forehead temporal all the way down the jaw line to her right ear. It is disabling you can't imagine. Why did she get this. The pain was still persisting day and night. Treatment - Her primary doctor ordered physical therapy she hasn't started treatment. Its not until 08JUN2021 she guesses they are going to do ultrasound she will get an evaluation with the ultrasound to see if they can reduce the inflammation to all those areas where her face isn't moving, the muscle. She thinks it is important to add that coffee or any liquids drips out of her mouth and onto her top. She has to bend over the kitchen table she can't chew her food on the right side and the food goes up to the gum line and doesn't go anywhere. The inside of her cheek muscles aren't moving. It was stated that on 06May2021, they diagnosed four other patients with Bell's palsy who received Pfizer. They did her medication they gave her prednisone 60 mg a day for a week. And the other one was acyclovir an anti-viral 1 gram 3 times a day for a week. The evet was medically significant. The patient was visited to emergency room. Vaccination Facility Type: Hospital. Prior Vaccinations patient did not take any other medication or vaccination within 4 weeks and No adverse events following prior vaccinations The outcome of the event of Bell's palsy was unknown. Information on Lot/Batch number had been requested Follow-up attempts not completed; information about lot/batch number cannot be obtained. No further information expected.; Sender's Comments: Based on current information available event bell's palsy was considered related to suspect drug based on compatable temporal association and known safety profile of the drug. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2021662119 same reporter/product/event, different patient

Other Meds:

Current Illness:

ID: 1398575
Sex: F
Age:
State: NY

Vax Date: 06/03/2021
Onset Date: 06/01/2021
Rec V Date: 06/15/2021
Hospital:

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Symptoms: Muscular and joint pain; Muscular and joint pain; Lethargic; Looks like she is under anesthesia; Feeling exceedingly drained/tiredness; Her entire body is in pain; Dizziness; Jabbing pains under the arms and in her head; Jabbing pains under the arms and in her head; Weakness; Experienced swollen glands/glands got swollen; Swelling in her armpits; This is a spontaneous report from a contactable consumer. This consumer reported for 19-year-old female patient (reporter's daughter) that: A 19-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EW0185 and expiry date: 31Aug2021), second dose via an unspecified route of administration on 03Jun2021 in her upper left arm, as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration on 13May2021 (Lot Number: EW0168/EJ6795 and expiry date: 31Aug2021) in her upper left arm, single dose for COVID-19 immunisation. The patient experienced swelling in her armpits in Jun2021. On 03Jun2021 (started almost on the onset of injection), experienced weakness. In Jun2021 (started probably 2 days ago on 04Jun2021 or 05Jun2021), experienced swollen glands. On 05Jun2021, jabbing pains under the arms in her gland and inside of her head (took Tylenol and it dissipated but it was worse now than in the beginning). On 06Jun2021, feeling exceedingly drained, tiredness, dizziness and entire body was in pain. Reporter stated like this was muscular and joint pain and her daughter was very lethargic. It was informed that the last night was the hardest and her daughter describes this pain feeling like she has an elephant on top of her. On 07Jun2021 (around 3am), looks like she was under anaesthesia. The patient was experiencing pain, weakness, and tiredness which made her look like she belongs in the hospital. Reporter stated her daughter has no fever or vomiting but she has made sure her daughter has stayed on tylenol products, and fully hydrated with pedialyte. The patient taking normal medications along with Tylenol with a little bit of codeine. She had consulted briefly with her pharmacist but not taken Motrin as per pharmacist instruction. She had been drinking 3 full pedialytes per day. Now she was down for the count again and it looks like she just got the shot again and now it was the 7th day and she kind of predicted it would go on for 3 to 4 days. When patient got the vaccine she was right smack in the middle of her menstrual cycle which was rough enough on her but now her cycle was over and she was still down for the count. Reporter had concerned as her daughter takes other medications. Nothing changed her daughter and had been on the same medication for other things and it has been standard and has been on them for a year. The patient had no fever, she just took it 5 minutes ago and it was normal. The outcome of the events muscular and joint pain, lethargic were unknown rest all were not recovered.

Other Meds:

Current Illness:

ID: 1398576
Sex: F
Age:
State:

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

Vax Type:
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Symptoms: Receiving the second dose due to heavy bleeding; This is a spontaneous report from a contactable consumer (patient's friend). A female patient of unspecified age received the second dose of BNT162B2 (COVID-19 Vaccine - Manufacturer Unknown, Lot Number and Expiry Date were not reported) via an unspecified route of administration on an unspecified date as 2nd dose, single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient took historical vaccine dose 1 of BNT162B2 on an unknown date for Covid-19 immunisation. It was reported that on an unknown date patient experienced heavy bleeding or extended periods. Patient was hospitalized after receiving the second dose due to heavy bleeding. Reporter asked that was there any data or studies relating to this issue. The outcome of the event was unknown. Information on lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1398577
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 06/15/2021
Hospital:

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Symptoms: COVID-19 positive after vaccination.; COVID-19 positive after vaccination.; Had a clot and thrombectomy; This is a spontaneous report from contactable other-HCP (patient). A patient of an unspecified age and gender received bnt162b2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Lot Number: Unknown) via an unspecified route of administration on unspecified as a single dose for COVID-19 immunization. Patient's medical history included thrombectomy and concomitant medication was not reported. On an unspecified date, patient had COVID-19 positive after vaccination and had a clot and thrombectomy. Treated with Xaralto and had another clot. Event took place after use of product. The outcome of events was unknown. Information about lot/batch number has been requested.; Sender's Comments: Based on the limited information currently provided the lack of efficacy of the administered vaccine BNT162B2 and also the causal association between the reported event clot with the usage of the vaccine cannot be excluded. The contributory role of the patient's medical history needs to be taken into consideration. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.

Other Meds:

Current Illness:

ID: 1398578
Sex: U
Age:
State: CA

Vax Date:
Onset Date:
Rec V Date: 06/15/2021
Hospital:

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Symptoms: 3 people that were fully vaccinated with the Pfizer covid 19 vaccine and have contracted covid.; 3 people that were fully vaccinated with the Pfizer covid 19 vaccine and have contracted covid.; This is a spontaneous report from a contactable pharmacist. A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: en5318), via an unspecified route of administration on an unspecified date and second dose of bnt162b2 (BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: el8982), via an unspecified route of administration on an unspecified date as SINGLE DOSE, for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that, on unspecified date, the reporter had 3 people that were fully vaccinated with the Pfizer covid 19 vaccine and had contracted covid. He asked if there were any issues with specific lot numbers: el8982, en5318. He did not have any information to provide for the people. The seriousness of the events reported as non-serious by reporter. The outcome of the events was reported as unknown.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events and the suspect vaccine,Linked Report(s) : US-PFIZER INC-2021669273 same reporter/drug/event, different patient;US-PFIZER INC-2021665561 same reporter/drug/event, different patient

Other Meds:

Current Illness:

ID: 1398579
Sex: F
Age:
State: DE

Vax Date: 05/01/2021
Onset Date: 06/04/2021
Rec V Date: 06/15/2021
Hospital:

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Symptoms: Light-headed/Dizzy; Fatigue; tested positive for Covid-19; tested positive for Covid-19; This is a spontaneous report from a contactable consumer or other non hcp. A 58-year-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection, Batch/Lot Number: EW0172, Expiry date: unknown), via an unspecified route of administration on 01May2021 as 2nd dose, single dose for covid-19 immunisation. Patient historical vaccine included received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection, Batch/Lot Number: ER8731), via left upper arm in the muscle on 10Apr2021 as 1st dose, single dose for covid-19 immunisation. Patient medical history included influenza from 2019 to an unknown date went back in 2019, last year in January, they said she had influenza and sent her home and the patient's concomitant medications were not reported. The patient experienced tested positive for covid-19 on 04Jun2021, light-headed on an unspecified date, dizzy on an unspecified date, fatigue on an unspecified date. The patient underwent lab tests and procedures which included sars-cov-2 test it was positive on 04Jun2021 positive for Covid-19. Outcome of the event was unknown. Follow-up attempts are needed. Further information is requested.

Other Meds:

Current Illness:

ID: 1398580
Sex: F
Age:
State:

Vax Date: 04/01/2021
Onset Date: 04/01/2021
Rec V Date: 06/15/2021
Hospital:

Vax Type:
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Symptoms: rheumatoid arthritis flares after both covid vaccines; This is a spontaneous report received from Pfizer sponsored program. A contactable other HCP and consumer reported that a 57-year-old female patient received first and second doses of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: unknown) via an unspecified route of administration, on an unknown date in Apr2021 as a single dose for COVID-19 immunization. Medical history included ongoing rheumatoid arthritis. The patient's concomitant medications were not reported. On an unknown date in Apr2021 patient's rheumatoid arthritis flares, after both COVID vaccines, with some improvement noted. Patient required oral steroids post first COVID vaccine and MD administered steroid injection post second COVID injection. The outcome of event was recovering. Information on the Lot/Batch number has been requested.; Sender's Comments: As there is limited information in the case provided, the causal association between the event "Rheumatoid arthritis flare up " and the suspected vaccine BNT162B2 cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Other Meds:

Current Illness: Rheumatoid arthritis (Verbatim: Rheumatoid arthritis)

ID: 1398581
Sex: F
Age:
State:

Vax Date: 06/08/2021
Onset Date:
Rec V Date: 06/15/2021
Hospital:

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Symptoms: herpes on her eye 8 hours; This is a spontaneous report from a contactable consumer (Patient) via Medical Information Team. A 31-year-old female patient received first dose of BNT162B2 (PFIZER- BIONTECH COVID- 19 VACCINE, Solution for injection, lot number was not reported), via an unspecified route of administration on 08Jun2021 as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that, the patient experienced herpes on her eye 8 hours after getting the first dose of the vaccine. Patient stated that she had no medical information question and was calling in just to report the adverse event. The outcome of the event was unknown. Information about lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1398583
Sex: U
Age:
State: NJ

Vax Date: 03/19/2021
Onset Date:
Rec V Date: 06/15/2021
Hospital:

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Symptoms: got the virus before I receive the second dose; got the virus before I receive the second dose; This is a spontaneous report from a contactable consumer. A 68-years-old patient of unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EN6208), dose 2 via an unspecified route of administration on 19Mar2021 (at 68-years age) as 2ND DOSE, SINGLE DOSE for covid-19 immunizations. Patient medical history was not reported. Family history includes death of mother and father, mother had breast cancer and father had liver cancer. The patient's concomitant medications were not reported. Patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EM9809), dose 1 via an unspecified route of administration on 05Feb2021 at 14:00 PM as 1st dose, single dose for covid-19 immunizations. The patient got the virus before patient receive the second dose. After the Quarantine patient received the Second Dose. Patient was ok now (unspecified). No treatment received for reported adverse event. The outcome of the events was unknown.

Other Meds:

Current Illness:

ID: 1398584
Sex: M
Age:
State: WI

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

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Symptoms: My left armpit swelled up to a baseball cut in half size. Very painful to the touch at times.; My left armpit swelled up to a baseball; Second dose on 07Jun2021, first dose received on 24May2021; This is a spontaneous report from a contactable consumer (patient). A 29-year-old-male patient received second dose of bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Right on 07Jun2021 14:00 (Inappropriate schedule) (Lot Number: Ew0179) as single dose (at age of 29-year-old) for covid-19 immunisation. Medical history was not reported. Concomitant medications included paracetamol (TYLENOL); celecoxib (CELEBREX). The patient previously took gabapentin and experienced hypersensitivity, pregabalin (LYRICA) and experienced hypersensitivity. First dose of bnt162b2 (BNT162B2) was administered on 24May2021 at 13:00 (at age of 29-year-old) in Left arm for covid-19 immunisation, lot number: Ew0179. The patient did not receive any other vaccines within four weeks prior to the vaccination. Patient did not have COVID prior vaccination and also patient was not tested for COVID since the vaccination. Patient stated that on 08Jun2021 08:00 his left armpit swelled up to a baseball cut in half size. Very painful to the touch at times. No treatment was received. Events resulted in Emergency room/department or urgent care. Patient had not recovered from the events.

Other Meds: TYLENOL; CELEBREX

Current Illness:

ID: 1398585
Sex: F
Age:
State:

Vax Date: 06/02/2021
Onset Date: 06/03/2021
Rec V Date: 06/15/2021
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Symptoms: spike on her blood pressure for the past 2 days reaching a maximum of 205/125; fever later on the evening and the whole next day reaching 100.1F; body aches; chills; wakes up in the evening with a cold sweat; face was flushing bright red and goes away after a while; This is a spontaneous report from a contactable consumer (patient). A 45-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Lot number: EW0182, Expiration date: Unknown), via an unspecified route on 02Jun2021 as a single dose for covid-19 immunization. Medical history included hypertension for which she has taken intracranial hypertension medication Diamox, 250mg, twice a day for over a year now to lower her blood pressure, tubal ligation in 2015 and since then she is on a low dose birth control because she was suffering from migraines in the past and was getting shots and then was taken off of that and put on hormonal continuous treatment. She now has no periods and doesn't suffer from migraines. Also, she has COVID back in Mar2021 and had a severe case. The patient concomitant medications were not reported. On 02Jun2021, patient experienced a fever later on the evening and the whole next day reaching 100.1F (03Jun2021), she complained about body aches and for the next 2 days up until today she experienced chills and wakes up in the evening with a cold sweat ("clothing are wet because of the sweat") and the chills are also experienced during daytime (ongoing), her face was flushing bright red and goes away after a while. She knows for a fact that this is not hormonal because she is on a low dose birth control pill since she had a tubal ligation in 2015. So, she knows it is not pre- menstrual. She has had a spike in her blood pressure within the last 2 days with the highest reached being 205/125 (ongoing). She said her main concern was with the hypertension and she figured that all of her other side effects were normal, but it made her nervous with her hypertension and how her blood pressure shot up so high because her medication keep her blood pressure normal and it has never gone above normal on this medication other than two days ago when she had the spike and it has been high since then. She has been trying to keep it down and her diastolic keeps going above 90 and her doctor wants her below that. She has been trying to get in touch with the neurologist who prescribed her that medication and he is usually very busy. She has been on her medication for intracranial hypertension for over a year now and confirmed that she wasn't started on it due to the side effects from the COVID vaccine. The patient underwent lab test and procedure which included body temperature reading of 100.1F on 03Jun2021 and blood pressure measurement of 205/125. Patient wanted to know if the adverse events that she experienced are included in the most commonly reported AEs after getting the Pfizer BioNTech Covid-19 Vaccine shot, how long the adverse events usually last after getting the first dose and if the side effects that she experienced after getting the first shot would be a contraindication in getting the 2nd dose of the vaccine. The clinical outcome of the event her blood pressure keeps going up down to today, she does not have a fever anymore, but she is still getting chills and she feels like she gets flushing in her cheeks throughout the nighttime but she is still going on with no fever. One night she may wake up with sweats and another night she wont, and outcome of body ache was unknown. Follow-up (10Jun2021): New information received from a same contactable 45-year-old female consumer (patient) included: events information updated, date for had ran a fever of 101 degrees updated, lot number updated, treatment taken as a result of events updated, medical history added, and clinical outcome of the events updated. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1398586
Sex: M
Age:
State:

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Rec V Date: 06/15/2021
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Symptoms: Heart attack; This is a spontaneous report from a non-contactable other HCP via Medical Information Team. A 58-year-old male patient received received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: not reported), via an unspecified route of administration on unspecified date as an Unknown, Single Dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter stated that another person had a heart attack on the freeway with less than a month of getting the Pfizer vaccine. The reporter stated this patient was a 58-year-old male. The reporter stated, he would never get another one, he hopes to God his son never gets one either, he was telling everyone they should take Loroquine (reporter does not had spelling), not even sure if available. The outcome of the event was unknown.; Sender's Comments: As there is limited information in the case provided, the causal association between the event and the suspect drug cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Other Meds:

Current Illness:

ID: 1398587
Sex: U
Age:
State:

Vax Date: 05/28/2021
Onset Date: 05/28/2021
Rec V Date: 06/15/2021
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Symptoms: patient was given expired IPOL/ NO AE; Initial information received on 28-May-2021 regarding an unsolicited valid non-serious case received from a other health professional. This case involves pediatric patient who received expired IPV (VERO) [IPOL] (batch number not reported and expiry date: 13-Mar-2021) on 28-May-2021 (expired product administered) for prophylactic vaccination by nurse. The patient's past medical treatment, vaccination, concomitant medication and family history were not provided. It is unknown if the patient had any medical history, concomitant disease or risk factor. It was an potential medication error case due to expired vaccine used (latency: same day). It was unknown if there were lab data/results available. It is unknown if the patient experienced any additional symptoms/events. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. There will be no information available on the batch number for this case.

Other Meds:

Current Illness:

ID: 1398588
Sex: M
Age:
State: VA

Vax Date: 05/28/2021
Onset Date: 05/28/2021
Rec V Date: 06/15/2021
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Symptoms: patient received an expired dose of Pentacel with no adverse event reported; Initial information received on 03-Jun-2021 regarding an unsolicited valid non-serious case received from a other health professional via Medical Information (Reference number- 00627057). This case involves a 6 month-old male patient who was vaccinated with 0.5 mL (once, standard) expired dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] (batch number UJ227AA-for HIB component and expiry date 23-Apr-21) via an intramuscular route at the left thigh on 28-May-21 for prophylactic vaccination (expired product administered). The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) for prophylactic vaccination. It was a case of an actual medication error due to expired vaccine used (latency was on same day). At the time of report, no adverse event reported. Result of assessment was not reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. There will be no information available on batch number for this case.

Other Meds: PREVNAR

Current Illness:

ID: 1398589
Sex: M
Age: 0
State: MI

Vax Date: 05/24/2021
Onset Date: 05/24/2021
Rec V Date: 06/15/2021
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Symptoms: ACTHIB was reconstituted with sterile water diluent instead of 0.4% saline with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from a other health care professional via physician via the Medical Information (Reference number- 00628765) and transmitted to Sanofi on 04-Jun-2021. This case involves a 4 months old male patient who received 0.5 ml second dose of HIB (PRP/T) VACCINE [ACT-HIB] reconstituted with sterile water diluent instead of 0.4% saline (lot UJ426AAB, expiry: 03-Jul-2022, Injection) via intramuscular route in the right thigh for prophylactic vaccination on 24-May-2021 (Product preparation error) Medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13), ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) and DIPHTHERIA VACCINE TOXOID, HEPATITIS B VACCINE RHBSAG (YEAST), PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID (PEDIARIX) for prophylactic vaccination. It was a case of an actual medication error due to Wrong diluent used (latency same day) At the time of report, no adverse event was reported The caller reported that he was reviewing their vaccine log and noted that on 24-May-2021, a male child was administered a dose of ACT-HIB incorrectly. The caller wanted to know what to do now. The vaccine will be repeated. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.

Other Meds: PREVNAR 13; ROTAVIRUS VACCINE; PEDIARIX

Current Illness:

ID: 1398590
Sex: F
Age: 51
State: NC

Vax Date: 05/11/2021
Onset Date: 05/11/2021
Rec V Date: 06/15/2021
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Symptoms: Patient was administered with an expired 0.5ml dose of Typhim VI with no AE; Initial information regarding an unsolicited valid non-serious case was received from a other health care professional via Medical Information (Reference number- 00631153) and transmitted to Sanofi on 07-Jun-2021. This case involves a 51 years old female patient who received a 0.5 mL expired dose of suspect TYPHOID VI POLYSACCHARIDE VACCINE [TYPHIM VI] (batch number: R1B741M and expiry date : 23-Mar-2021) via unknown route in left deltoid (expired product administered) for prophylactic vaccination on 11-May-2021. The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided. It was an actual medication error case due to expired vaccine used (latency: same day). The patient received no other medications or vaccinations on that visit. At the time of reporting, no adverse event was reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.

Other Meds:

Current Illness:

ID: 1398592
Sex: F
Age: 41
State: MD

Vax Date: 06/14/2021
Onset Date: 06/14/2021
Rec V Date: 06/15/2021
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Symptoms: Headache for the past 11 hours; severe chills for at least 5 hours (went to sleep and chills were gone); feeling dehydrated since I got the shot; fatigue and restlessness

Other Meds:

Current Illness:

ID: 1398593
Sex: M
Age: 23
State:

Vax Date: 05/17/2021
Onset Date: 06/01/2021
Rec V Date: 06/15/2021
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Allergies: NKA

Symptom List:

Symptoms: Pt c/o chest pain starting on 01 or 02 JUN; he came in today 15JUN when he realized the chest pain was not resolving; symptoms were classic pericarditis with worse with laying down and resolved with leaning forward; ecg confirms pericarditis; he was sent directly to cardiology from primary care

Other Meds: Vitamin d 50,000 iu po daily

Current Illness: kidney stones; elevated blood pressure;

ID: 1398594
Sex: F
Age: 33
State: TX

Vax Date: 06/14/2021
Onset Date: 06/14/2021
Rec V Date: 06/15/2021
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Allergies: No

Symptom List:

Symptoms: Itching all over

Other Meds: Zoloft, prenatal

Current Illness: No

ID: 1398627
Sex: U
Age:
State: TN

Vax Date:
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Rec V Date: 06/15/2021
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Symptoms: a temperature excursion for PROQUAD, VARlVAX, and MMR II; products may have been administered; No additional AE's/PQC's noted.; This spontaneous report as received from an other reporter and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients might have been vaccinated with improperly stored doses of: - Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) lot # U002540, expiration date 24-JUL-2022, - Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), lot # S020161, expiration date 30-JUN-2021, albumin status rHA and lot # T007230, expiration date 27-FEB-2022, albumin status rHA, - varicella virus vaccine live (Oka/Merck) (VARIVAX) lot # S033953, expiration date 24-OCT-2021 and lot # T027305, expiration date 12-AUG-2022. Doses and routes of administration were not reported. There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 9 to 25 (13.1) degrees Celsius for 4 hours and 26 minutes. There was no previous excursion of -10 to 8 (8.1) degrees Celsius for 1 hour and 37 minutes reported. Data logger was involved.

Other Meds:

Current Illness:

ID: 1398628
Sex: U
Age:
State: IA

Vax Date:
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Rec V Date: 06/15/2021
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Symptoms: ROTATEQ "given more than 10 weeks later" from initial dose; This spontaneous report was received from a nurse prescriber via company representative and refers to an infant patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally (exact dose, lot # and expiration date were not reported). On an unknown date (reported as "more than 10 weeks later from initial dose"), the patient received second dose of with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally (exact dose, lot # and expiration date were not reported) (inappropriate schedule of vaccine administered). Both vaccines were administered for prophylaxis.

Other Meds:

Current Illness:

ID: 1398629
Sex: F
Age: 0
State: MD

Vax Date: 05/20/2021
Onset Date: 05/20/2021
Rec V Date: 06/15/2021
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Symptoms: No other AE; a temperature excursion and the ROTATEQ had been administered.; This spontaneous report was received from a medical assistant referring to a 2 months old female patient. The patient's pertinent medical history, drug reactions/ allergies and concomitant medication were not reported. On 20-MAY-2021, the patient was vaccinated with a temperature excursion Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) (lot# 1691303, expiration date 21-DEC-2021; dose, strength, frequency and route unknown) for prophylaxis (Incorrect product storage). The vaccine was stored at a temperature excursion of 34.9 Fahrenheit (F) for 2 hours. The date of excursion was 13-MAY-2021. There was no previous temperature excursion. Data logger was involved. No product quality complaint was involved. No adverse effect reported.

Other Meds:

Current Illness:

ID: 1398630
Sex: U
Age:
State:

Vax Date: 06/04/2021
Onset Date: 06/05/2021
Rec V Date: 06/15/2021
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Symptoms: injection site became swollen,; injection site became/ inflamed; injection site became /sore; redness has spread down the arm to about an inch above the elbow; This case was reported by a consumer via interactive digital media and described the occurrence of injection site swelling in a patient who received Herpes zoster (Shingrix) for prophylaxis. On 4th June 2021, the patient received the 1st dose of Shingrix. On 5th June 2021, 1 days after receiving Shingrix, the patient experienced injection site swelling, injection site inflammation, injection site pain and erythema of extremities. On an unknown date, the outcome of the injection site swelling, injection site inflammation and injection site pain were unknown and the outcome of the erythema of extremities was not recovered/not resolved. It was unknown if the reporter considered the injection site swelling, injection site inflammation, injection site pain and erythema of extremities to be related to Shingrix. Additional details were provided as follows: The patient had reported the case for himself/herself. The age at vaccination was not reported. The patient received Shingrix last Friday from the reporting date and next day injection site became swollen, inflamed and sore. Since then the redness has spread down the arm to about an inch above the elbow. The reporter asked, was it possible that he/she had some shingles. The follow-up would be not possible, as no contact details were available.

Other Meds:

Current Illness:

ID: 1398631
Sex: U
Age:
State:

Vax Date:
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Rec V Date: 06/15/2021
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Symptoms: got the vaccine, but still got shingles/Suspected vaccination failure; shingles; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown. 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 patient received Shingrix and had Shingles. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization for shingles and laboratory confirmation for herpes zoster were not provided.

Other Meds:

Current Illness:

ID: 1398632
Sex: U
Age:
State:

Vax Date: 06/08/2021
Onset Date: 06/01/2021
Rec V Date: 06/15/2021
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Symptoms: injection site is still red; injection site/ warm to the touch; injection site/ very tender; This case was reported by a consumer via interactive digital media and described the occurrence of injection site erythema in a patient who received Herpes zoster (Shingrix) for prophylaxis. On 8th June 2021, the patient received the 2nd dose of Shingrix. In June 2021, less than a day after receiving Shingrix, the patient experienced injection site erythema, injection site warmth and injection site tenderness. On an unknown date, the outcome of the injection site erythema, injection site warmth and injection site tenderness were not recovered/not resolved. It was unknown if the reporter considered the injection site erythema, injection site warmth and injection site tenderness to be related to Shingrix. Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The patient received 2nd dose of Shingrix a little over 24 hours ago and experienced injection site redness, was warm to the touch, and very tender. The reporter asked how long should expect this to last.

Other Meds:

Current Illness:

ID: 1398633
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 06/15/2021
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Symptoms: What risk if miss second dose of Bexsero?; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Men B NVS (Bexsero) for prophylaxis. Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis. Previously administered products included Bexsero (1st dose received on an unknown date). On an unknown date, the patient received the 2nd dose of Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination 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 age at vaccination was not applicable for this report. Till the time of reporting patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The patient was asking what was risk if missed second dose of Bexsero.

Other Meds:

Current Illness:

ID: 1398634
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 06/15/2021
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Symptoms: got the shot then got shingles/suspected vaccination failure; got shingles; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown. 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 patient received Shingrix and had Shingles. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization for shingles and laboratory confirmation for herpes zoster were not provided. This case linked with US2021AMR127128, reported by same reporter.; Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR127128:Same reporter

Other Meds:

Current Illness:

ID: 1398635
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 06/15/2021
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Symptoms: You can get it from the vaccination! That's how I got it./Suspected vaccination failure; You can get it from the vaccination! That's how I got it.; This case was reported by a consumer via media and described the occurrence of Suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. Additional details were provided as follows: The case was reported by patient itself. The age at vaccination was not reported. The patient got Shingles after vaccination. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, laboratory confirmation, time to onset of shingles were unknown at the time of reporting.

Other Meds:

Current Illness:

ID: 1398636
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 06/15/2021
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Symptoms: who has received one of the shingles vaccines has gotten shingles / have a friend with it right now/ Suspected Vaccination failure; have a friend with it right now / she is in agony!; she is in agony!; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles and pain were not recovered/not resolved. It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine. Additional details were reported as follows: This case was reported by patient's friend. The age at vaccination was not reported. The patient received Shingles vaccine and at the time of reporting, she had shingles and was in agony. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting. This case had been linked with US2021AMR127615, reported by same reporter.; Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR127615:Same reporter

Other Meds:

Current Illness:

ID: 1398637
Sex: F
Age:
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Rec V Date: 06/15/2021
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Symptoms: My mom got shingles shot and still got it 8 months later/ Suspected vaccination failure; Got shingles shot and still got it; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, 8 months after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. Additional details were reported as follows: The patient was reporter's mother. The age at vaccination was not reported. The patient received the Shingles vaccine and still got shingles 8 months later of vaccination. The reporter stated that the shots did not always prevent you from getting whatever your trying to prevent getting, unless the doctor lied about patient had Shingles. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory test confirming herpes zoster were unknown at the time of reporting.

Other Meds:

Current Illness:

ID: 1398638
Sex: U
Age:
State:

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Onset Date:
Rec V Date: 06/15/2021
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Symptoms: Had the vaccine --had shingles/ Suspected vaccination failure; Shingles; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. Additional details were reported as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient received the Shingles vaccine and had shingles. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.

Other Meds:

Current Illness:

ID: 1398639
Sex: U
Age:
State:

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Rec V Date: 06/15/2021
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Symptoms: Got Shingles despite the 2 Doses of Shingrex/ Suspected vaccination failure; Shingles; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and 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 and Shingrix. Additional details were reported as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient received 2 doses of Shinglrix and got shingles. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.

Other Meds:

Current Illness:

ID: 1398640
Sex: M
Age:
State:

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Rec V Date: 06/15/2021
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Symptoms: received the 1st dose / May 2019 / has not received dose 2 as of yet; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a 53-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received the 1st dose in May 2019). On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown. Additional information was provided as follow: The age at vaccination was not applicable for this report. Till the time of reporting patient did not receive 2nd dose of Shingrix vaccine, which led to incomplete course of vaccination. No adverse events reported. The reporter did not consented to follow up. The VAERS details pertains to 1st dose of Shingrix.

Other Meds:

Current Illness:

ID: 1398641
Sex: F
Age: 18
State: NM

Vax Date: 06/10/2021
Onset Date: 06/10/2021
Rec V Date: 06/15/2021
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Symptoms: administration of an expired first dose of Bexsero; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 18-year-old female patient who received Men B NVS (Bexsero) (batch number ABXA32AB, expiry date 31st May 2021) for prophylaxis. Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis. On 10th June 2021, the patient received the 1st dose of Bexsero and Bexsero Pre-Filled Syringe Device. On 10th June 2021, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used 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 patient received expired first dose of Bexsero, which led to experienced expired vaccine used. No further events were reported. The reporter consent to follow up.

Other Meds:

Current Illness:

ID: 1398642
Sex: F
Age:
State: TN

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Rec V Date: 06/15/2021
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Symptoms: first dose on Feb 8th 2019 and she never received second dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (1st dose received on 8th February 2019). On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown. Additional case details were reported as follows: The age at vaccination was not applicable for this report. Till the time of reporting, patient did not receive 2nd dose of vaccine, which led to incomplete course of vaccination. The reporter was looking for information about timing on Shingrix schedule. No data available about lot number and expiration date at the time of reporting. The reporter consented to follow up.

Other Meds:

Current Illness:

ID: 1398643
Sex: F
Age:
State: NC

Vax Date:
Onset Date:
Rec V Date: 06/15/2021
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Symptoms: first dose of Shingrix in March of 2019./ not yet received the second dose.; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (1st dose received in March 2019). On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown. Additional case details were reported as follows: The patient reported case for herself. The age at vaccination was not applicable for this report. Till the time of reporting patient did not receive 2nd dose of vaccine, which led to incomplete course of vaccination. The reporter did not consent to follow up.

Other Meds:

Current Illness:

ID: 1398644
Sex: M
Age:
State: MA

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Rec V Date: 06/15/2021
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Symptoms: WORSENED IMMUNE THROMBOCYTOPENIA; This spontaneous report was received from literature: Exacerbation of immune thrombocytopenia following Covid-19 vaccination. This report concerned a 60 year old male patient of unspecified race and ethnic origin. The objective of this study was prospective analysis of all of immune thrombocytopenia (ITP) patients after 12-JAN-2021 to assess the frequency of worsening ITP symptoms and exacerbation of thrombocytopenia in those who chose to receive COVID-19 vaccination. The duration period of study was between 12-JAN-2021 and 01-MAY-2021. In the study, 52 consecutive patients who received COVID-19 vaccination were identified and followed. The patients were advised to obtain platelet counts 1-7 days before and 3-14 days after vaccination and assessed for exacerbation of their thrombocytopenia and clinical signs of bleeding after vaccination. The patient's height, and weight were not reported. The patient's past medical history included splenectomy (had multiple courses of rituximab), and concurrent conditions included immune thrombocytopenia (had since 16 years). The patient had multiple prior severe relapses every 3-5 years often lasted for months. The patient experienced severe relapse of immune thrombocytopenia when treated with meningococcal vaccine for prophylactic vaccination in past. The patient was in complete remission for 3 years. The patient's platelet count prior to vaccination was 270 X 10*9/L. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) 1 total, 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. Five days after the vaccination, the patient experienced a worsened immune thrombocytopenia. The patient had petechiae, ecchymoses, epistaxis and oral blood blisters. Five days after vaccine, platelets were 7 X 10*9/L with epistaxis. The lowest platelet count after the vaccination was 1 X 10*9/L. The patient was treated with prednisone, intravenous immunoglobulin, rituximab and romiplostim. It had been 33 days until platelet count were greater than 30 X 10*9/L. Laboratory data (dates unspecified) included: Platelet count (NR: not provided) 1 X 10*9/L, 7 X 10*9/L, greater than 30 X 10*9/L, 270 10*9/L. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of worsened immune thrombocytopenia was not reported. In conclusion, the results of the study suggested that some patients with ITP might have a transient exacerbation of their thrombocytopenia, some with symptoms, within 1 week of their COVID-19 vaccination. It was recommended that ITP patients should still undergo at least the initial vaccination for COVID-19. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: This spontaneous report from a literature concerns a 60-year-old male patient of unknown ethnicity, with concurrent immune thrombocytopenia (ITP) and splenectomy, who was noted to have worsening of ITP 5 days after vaccination, with platelet count of 1 to 7x10*9/L. Signs and symptoms reported was petechiae, ecchymoses, epistaxis, and oral blood blisters. Platelet count prior to vaccination was 270x10*9/L. There were reported prior relapses every 3-5 years that lasted for months and one "severe" relapse after meningococcal vaccination. Thirty-three days post vaccination the platelet count was 30x10*9/L. No other details reported. The event was confounded by the underlying ITP with history of relapses. However, considering the temporal association of the decline in platelet count after vaccination, the prior exacerbation after meningococcal vaccination, and recently evolving theories in the literature about COVID infections and vaccinations, the potential vaccine contribution cannot be excluded.

Other Meds:

Current Illness: Immune thrombocytopenia (since 16 years. The patient had multiple prior severe relapses every 3-5 years often lasted for months. The patient was in complete remission for 3 years.)

ID: 1398645
Sex: F
Age:
State: MI

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

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Symptoms: BLOOD CLOTS; This spontaneous report received from a patient concerned a female of unspecified age, 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: 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 no. No concomitant medications were reported. On an unspecified date, the patient experienced blood clots, and was hospitalized (date unspecified) for 3 to 4 weeks. Treatment medications (dates unspecified) included: Xarelto (Rivaroxaban). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood clots was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0 20210614970-COVID-19 VACCINE AD26.COV2.S-blood clots. 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: 1398646
Sex: F
Age:
State: NJ

Vax Date:
Onset Date: 04/11/2021
Rec V Date: 06/15/2021
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Symptoms: PAIN TO RIGHT SIDE OF THE NECK; NUMBNESS OF RIGHT ARM/RIGHT SIDE OF NECK/RIGHT EAR; RIGHT ARM TINGLING; PAIN TO RIGHT EAR; PAIN TO RIGHT SIDE OF GROIN; RIGHT LEG PAIN/RIGHT ARM PAIN/EXCRUCIATING PAIN THAT FELT LIKE AN INTENSE CHARLIE HORSE; HEADACHE; QUEASY FEELING THAT FELT LIKE DID 100 SIT-UPS; STOMACH PAIN; LOWER BACK PAIN; This spontaneous report received from a patient concerned a 55 year old female. The patient's weight was 135 pounds, and height was 65 inches. The patient's past medical history included thyroidectomy, and concurrent conditions included thyroid replacement medication, non alcoholic, and non smoker, and other pre-existing medical conditions included the patient was not pregnant at the time of reporting and had uses. the patient did not have any history of drug abuse or illicit drug use. the patient had no drug or non-drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, and batch number: 205A21A expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-APR-2021, the subject experienced stomach pain. On 11-APR-2021, the subject experienced lower back pain. On 11-APR-2021, the subject experienced headache. On 11-APR-2021, the subject experienced queasy feeling that felt like did 100 sit-ups. Laboratory data included: Pain scale (NR: not provided) 5/10, 3/10, 1/10. On 15-APR-2021, the subject experienced right leg pain/right arm pain/excruciating pain that felt like an intense charlie horse. On 24-APR-2021, the subject experienced pain to right side of the neck. On 24-APR-2021, the subject experienced numbness of right arm/right side of neck/right ear. On 24-APR-2021, the subject experienced right arm tingling. On 24-APR-2021, the subject experienced pain to right ear. On 24-APR-2021, the subject experienced pain to right side of groin. On 25-APR-2021, Laboratory data included: Basic metabolic panel (NR: not provided) Normal, CBC (NR: not provided) Normal, Creatinine (NR: not provided) Normal, Laboratory test (NR: not provided) Normal, and Thyroid function test (NR: not provided) Normal. On 26-APR-2021, Laboratory data included: ECG (NR: not provided) Normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from stomach pain, lower back pain, headache, and queasy feeling that felt like did 100 sit-ups on 20-APR-2021, and pain to right side of the neck, numbness of right arm/right side of neck/right ear, right arm tingling, pain to right ear, pain to right side of groin, and right leg pain/right arm pain/excruciating pain that felt like an intense charlie horse on 05-MAY-2021. This report was non-serious.

Other Meds:

Current Illness: Abstains from alcohol; Non-smoker; Thyroid hormone replacement therapy (Thyroid replacement medication Inhaler.)

ID: 1398647
Sex: F
Age:
State: CA

Vax Date:
Onset Date: 05/06/2021
Rec V Date: 06/15/2021
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Symptoms: FELT LIKE IMMUNE SYSTEM TAXED; COLD SORE; LARGE SCABS ON NOSE; TIRED; EXTREMELY HEAVY PERIOD; DIARRHEA/ STOOL WAS LIQUID; CLAMMINESS; SHORTNESS OF BREATH; FEVER; STOMACH PAIN; NAUSEA; AREA BELOW EYES ALL THE WAY DOWN TO HER CHEST BECAME NUMB; GENERALLY UNWELL; HEART SLOWED DOWN; EXTREME DROWSINESS; SPEECH SLOWED DOWN; ITCHINESS SPREAD TO THE ENTIRE BODY/ ITCHINESS IN HER EYES AND NOSE; NIGHT SWEATS; WEIRD DREAMS; This spontaneous report received from a patient concerned a 51 year old female. The patient's weight was 175 pounds, and height was 69 inches. The patient's concurrent conditions included allergic to cats, allergic to pollen, alcohol use, and cigarette smoker, and other pre-existing medical conditions included the patient had no drug abuse or illicit drug usage. the patient was healthy and not pregnant at the time of the reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, expiry: UNKNOWN) dose was not reported, administered on 06-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-MAY-2021, the subject experienced heart slowed down. On 06-MAY-2021, the subject experienced extreme drowsiness. On 06-MAY-2021, the subject experienced speech slowed down. On 06-MAY-2021, the subject experienced itchiness spread to the entire body/ itchiness in her eyes and nose. On 06-MAY-2021, the subject experienced night sweats. On 06-MAY-2021, the subject experienced weird dreams. On 06-MAY-2021, the subject experienced area below eyes all the way down to her chest became numb. On 06-MAY-2021, the subject experienced generally unwell. On 07-MAY-2021, the subject experienced stomach pain. On 07-MAY-2021, the subject experienced nausea. On 07-MAY-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 101-102 F, and Pain scale (NR: not provided) 8/10 (unit not reported). On 10-MAY-2021, the subject experienced clamminess. On 10-MAY-2021, the subject experienced shortness of breath. On 10-MAY-2021, the subject experienced diarrhea/ stool was liquid. Laboratory data included: Body temperature (NR: not provided) 99 -100 F. On 11-MAY-2021, the subject experienced extremely heavy period. On 12-MAY-2021, the subject experienced tired. On 03-JUN-2021, the subject experienced cold sore. On 03-JUN-2021, the subject experienced large scabs on nose. On an unspecified date, the subject experienced felt like immune system taxed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from extreme drowsiness, and area below eyes all the way down to her chest became numb on 06-MAY-2021, itchiness spread to the entire body/ itchiness in her eyes and nose on 07-MAY-2021, weird dreams, and diarrhea/ stool was liquid on 14-MAY-2021, stomach pain on 08-MAY-2021, clamminess, shortness of breath, and nausea on 12-MAY-2021, and tired on 17-MAY-2021, was recovering from fever, cold sore, large scabs on nose, and felt like immune system taxed, had not recovered from night sweats, and generally unwell, and the outcome of extremely heavy period, heart slowed down and speech slowed down was not reported. 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: Alcohol use (The patient was a minimal drinker and did not drink even once a month.); Allergic to cats; Cigarette smoker (The patient had remote smoking history in her 20's with alcohol consumption.); Pollen allergy

ID: 1398648
Sex: M
Age:
State: FL

Vax Date:
Onset Date: 05/01/2021
Rec V Date: 06/15/2021
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Symptoms: DISCOMFORT IN CHEST; SLIGHT COUGH; EXTREME FATIGUE FOR 2 WEEKS; FELT OFF; 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, and batch number were not reported) dose was not reported, administered on MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAY-2021, the subject experienced felt off. On MAY-2021, the subject experienced extreme fatigue for 2 weeks. On JUN-2021, the subject experienced discomfort in chest. On JUN-2021, the subject experienced slight cough. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from extreme fatigue for 2 weeks, and was recovering from felt off, discomfort in chest, and slight cough. This report was non-serious.

Other Meds:

Current Illness:

ID: 1398649
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 06/15/2021
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Symptoms: SHOULDER SORE; 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 was not reported, administered on 10-APR-2021 for prophylactic vaccination. The batch number was not-reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced shoulder sore. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from shoulder sore. This report was non-serious.

Other Meds:

Current Illness:

ID: 1398650
Sex: M
Age:
State: VA

Vax Date:
Onset Date: 04/13/2021
Rec V Date: 06/15/2021
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Symptoms: MILD STROKE; This spontaneous report received from a patient concerned a 56 year old white, Hispanic or Latino 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: 1808609, expiry: unknown) dose was not reported, one total administered on 06-APR-2021 for prophylactic vaccination. Patient could not remembered which arm received the vaccine and thought it was upper right arm. No concomitant medications were reported. On 13-APR-2021, patient waked up with a very sharp headache pain on the right side of brain and had a blurry vision for entire day and much of next day. Since then until now patient still had a low and mild headache that comes and go and very mild nausea that comes and goes. On 01-JUN-2021, patient had an Magnetic resonance imaging (MRI) which showed result that patient had a mild stroke. On 09-JUN-2021, patient had an Magnetic resonance angiography (MRA) that revealed no plaque. Patient Stated that he had another MRV scheduled on day of reporting. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from mild stroke. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210626713-COVID-19 VACCINE AD26.COV2.S-Mild Stroke. 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: 1398651
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 06/15/2021
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Symptoms: ACHES; CHILLS; FATIGUE; 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. 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 aches, felt like kicked my ass, chills, and fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, aches, fatigue and felt like kicked my ass was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1398652
Sex: F
Age:
State: CA

Vax Date:
Onset Date: 04/01/2021
Rec V Date: 06/15/2021
Hospital:

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Symptom List:

Symptoms: STIFFNESS IN ARM KIND OF HARD TO OPEN AND CLOSE THEM; BLURRY VISION THAT COMES AND GOES; PAIN THAT FEELS LIKE INFLAMMATION; JOINT PAIN THAT FEELS LIKE ARTHRITIS PAIN; SHARP PAIN IN HEAD; STRANGE BRUISES ON HANDS AND LEGS; TINNITED (RINGING IN EARS) AND HAVING DIFFICULT IN SLEEPING BECAUSE OF RINGING; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included lung disease, and other pre-existing medical conditions included patient has taken anti-inflammatory medication in the past for lung disease. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031 expiry: UNKNOWN) dose was not reported, administered on 13-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced strange bruises on hands and legs. On APR-2021, the subject experienced tinnited (ringing in ears) and having difficult in sleeping because of ringing. On an unspecified date, the subject experienced stiffness in arm kind of hard to open and close them, blurry vision that comes and goes, pain that feels like inflammation, joint pain that feels like arthritis pain, and sharp pain in head. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tinnited (ringing in ears) and having difficult in sleeping because of ringing, and the outcome of strange bruises on hands and legs, sharp pain in head, joint pain that feels like arthritis pain, stiffness in arm kind of hard to open and close them, blurry vision that comes and goes and pain that feels like inflammation was not reported. This report was non-serious.

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Current Illness:

ID: 1398653
Sex: M
Age: 50
State: MN

Vax Date: 03/04/2021
Onset Date:
Rec V Date: 06/15/2021
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Symptoms: Had a light fluttering; Heart palpitations, flet like he had butterfiles in his chest; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC FLUTTER (Had a light fluttering) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022m20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Palpitations. Concomitant products included GABAPENTIN, MIRTAZAPINE, CLONAZEPAM and ESOMEPRAZOLE SODIUM (NEXIUM [ESOMEPRAZOLE SODIUM]) for an unknown indication. On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CARDIAC FLUTTER (Had a light fluttering) (seriousness criterion medically significant) and PALPITATIONS (Heart palpitations, flet like he had butterfiles in his chest). At the time of the report, CARDIAC FLUTTER (Had a light fluttering) and PALPITATIONS (Heart palpitations, flet like he had butterfiles in his chest) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment information was not provided by the reporter. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded

Other Meds: GABAPENTIN; MIRTAZAPINE; CLONAZEPAM; NEXIUM [ESOMEPRAZOLE SODIUM]

Current Illness: Palpitations

ID: 1398654
Sex: M
Age: 39
State: OK

Vax Date: 04/08/2021
Onset Date: 06/03/2021
Rec V Date: 06/15/2021
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Symptoms: had an operation; got the first dose on 08Apr2021 and then got the second dose on 03Jun2021; This spontaneous case was reported by a consumer and describes the occurrence of SURGERY (had an operation) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 048B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Jun-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (got the first dose on 08Apr2021 and then got the second dose on 03Jun2021). On an unknown date, the patient experienced SURGERY (had an operation) (seriousness criterion medically significant). At the time of the report, SURGERY (had an operation) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (got the first dose on 08Apr2021 and then got the second dose on 03Jun2021) outcome was unknown. No concomitant medication information provided. Patient got the first dose on 08Apr2021. Patient missed the appointment for second dose due to an operation he had and he got it on 3jun2021. Limited information regarding the events has been provided at this time and is insufficient for causality assessment. Further information has been requested.; Sender's Comments: Limited information regarding the events has been provided at this time and is insufficient for causality assessment. Further information has been requested.

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Current Illness:

Total 2021 VAERS Injuries: 660,048

Page last modified: 03 October 2021 5:28pm