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
73,371
AK1,645
AL5,407
AR3,439
AS44
AZ13,409
CA58,650
CO11,073
CT7,906
DC1,639
DE1,686
FL36,676
FM3
GA13,546
GU82
HI2,206
IA4,345
ID2,486
IL19,535
IN22,656
KS4,309
KY6,984
LA4,756
MA14,019
MD12,004
ME3,013
MH8
MI18,049
MN11,418
MO8,983
MP30
MS2,697
MT2,153
NC15,523
ND1,276
NE2,749
NH2,878
NJ17,457
NM3,726
NV4,119
NY33,075
OH18,225
OK5,976
OR8,032
PA22,677
PR2,123
QM2
RI1,920
SC6,121
SD1,139
TN8,763
TX34,511
UT4,060
VA14,038
VI50
VT1,677
WA13,913
WI10,462
WV2,233
WY810
XB5
XL1
XV2

ID: 1528232
Sex: F
Age:
State: IA

Vax Date: 03/23/2021
Onset Date: 03/23/2021
Rec V Date: 08/05/2021
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Symptoms: All Left side - Face numbness; mild inner mouth swelling; Very heavy legs; Inappropriate schedule of vaccine administered; This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient received the first dose of BNT162B2 (PFIZER COVID-19 VACCINE, lot number: EN6208), at the age of 41 years old, in left arm on 23Mar2021 at 08:30 at single dose for COVID-19 immunisation. The patient also received the second dose of BNT162B2 (lot number: ER781), at the age of 41 years old, in right arm on 23Mar2021 (same date) at single dose for COVID-19 immunisation. Medical history included high blood pressure (BP) and penicillin allergy. The patient was not pregnant at time of vaccination. The patient had no COVID prior vaccination. Concomitant medications included hydroxyzine hydrochloride (HYDROXIZINE) and losartan (htcz, unspecified). The patient did not receive any other vaccine in four weeks of vaccination. The patient experienced all left side - face numbness, mild inner mouth swelling on 06May2021 at 08:00. The events resulted in emergency room (ER) visit and went away after 2 weeks. The patient also experienced very heavy legs on 06May2021 at 08:00. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, life threatening illness (immediate risk of death from the event) and disability or permanent damage. The patient underwent lab tests and procedures which included COVID-19 test (nasal swab): negative on 11Jul2021. The patient had been tested for COVID-19 post vaccination. It was unknown if the treatment received. The outcome of the events face numbness and mouth swelling was recovered on May2021. The outcome of the event very heavy legs was not recovered. The outcome of the event inappropriate schedule of vaccine administered was unknown.

Other Meds: HYDROXIZINE; LOSARTAN

Current Illness:

ID: 1528233
Sex: F
Age:
State: IA

Vax Date: 03/23/2021
Onset Date: 05/06/2021
Rec V Date: 08/05/2021
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Symptoms: Mild anaphylactic throat swelling at clinic; Mild anaphylactic throat swelling at clinic; left side head nerve inflammation; ear muffled- no infection; head twitching/spasm, dull, burning, sharp, neddle; head twitching/spasm, dull, burning, sharp, neddle; head twitching/spasm, dull, burning, sharp, neddle/head pressure; head twitching/spasm, dull, burning, sharp, neddle/head pressure; head twitching/spasm, dull, burning, sharp, neddle; migraine line pains; sinus pressure; tinnitus; heightened anxiety; nerve zaps in brain, toes and tooth; dizziness; bdain fog; speech problem; mini stroke like symptoms; insomnia; base skull feels swollen; High inflammation markers; This is a spontaneous report from a contactable consumer (patient). This 41-year-old female patient received bnt162b2 (Brand: Pfizer), dose 2 via an unspecified route of administration, administered in arm right on 23Mar2021 (Batch/Lot Number: ER781) as dose 2, single at the age of 41-year-old for covid-19 immunisation. Medical history included high bp and known allergies penicillin. Concomitant medications included hydroxyzine hydrochloride (HYDROXIZINE) taken for an unspecified indication, start and stop date were not reported; hydrochlorothiazide, losartan potassium (LOSARTAN HCTZ) taken for an unspecified indication, start and stop date were not reported. No other vaccine in four weeks. Facility where the most recent COVID-19 vaccine was administered: Other. First dose was received on 23Mar2021 08:30 am in arm left at the age of 41-year-old with Batch/lot number: EN6208 and experienced all Left side - Face numbness, mild inner mouth swelling, ER visit, went away after 2 weeks, and very heavy legs. Adverse event 2nd dose: mild anaphylactic throat swelling at clinic, doubled on hydroxyzine per nurse. 10 days post (as reported): left side head nerve inflammation, ear muffled- no infection, head twitching/spasm, dull, burning, sharp needle, migraine line pains, sinus pressure, head pressure, tinnitus, heightened anxiety, nerve zaps in brain, toes and tooth, dizziness, brain fog, speech problem, mini stroke like symptoms, insomnia, base skull feels swollen. ER, primary doc, neurons and physical therapists being seen. No treatments avail...VAX reaction confirmed. High inflammation markers. Adverse event start date reported as 06May2021 08:00 am. Events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Life threatening illness (immediate risk of death from the event), Disability or permanent damage. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. Covid test post vaccination covid test type post vaccination: Nasal Swab on 11Jul2021: Negative. Treatment was unknown. The patient was not recovered.

Other Meds: HYDROXIZINE; LOSARTAN HCTZ

Current Illness:

ID: 1528234
Sex: F
Age:
State:

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Rec V Date: 08/05/2021
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Symptoms: Thyroiditis subacute; This is a spontaneous report from a non-contactable consumer or other non-healthcare professional. This is 21 of 29 reports. A 41-years-old female patient received second dose of bnt162b2 (PFIZER-BIOTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunization. No medical history and no concomitant medications were not reported. The patient previously took first dose of BNT162B2 (Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as single dose for covid-19 immunization. Article refers to 29 cases that can be found in table 1 in the article. Up to 8 June 2021. Cases were mostly classified as non-serious (62%). In the 11 serious cases, two reported caused or prolonged hospitalization and the other nine medically important conditions as the seriousness criteria. Information on the dose number was available in 19 cases. In 11 cases the SAT occurred after administration of the first dose and in nine cases after the second dose. Time-to-onset (TTO) was observed to be in median three days after the second dose (ranging from 0 to 60 days) compared to a median TTO of six days after the first dose (ranging from 0 to 26 days). In one case (case 8), reporting the SAT onset after the second dose, it was mentioned that the patient experienced SAT already after the first dose and that symptoms recurred with the second (positive rechallenge). TTO in this case was reported as one day after vaccination with the second dose. Furthermore, this patient seemed to have an underlying thyroid disorder. It was reported that the symptoms of SAT resolved when she stopped her "thyroid medication". Since it was not specified what kind of medication the patient was taking, it is not possible to conclude whether it was underlying hyper- or hypothyroidism. Patients experiencing SAT following vaccination were mainly female (n=24 83%) and five patients were male (17%). Patients age was reported in 28 cases resulting in a median age of 45 years (range 18 to 67 years). The most frequently co-reported terms were pyrexia (n=7), lymphadenopathy and neck pain (each n=4), and blood TSH decreased, headache, hyperthyroidism, iodine uptake decreased, tachycardia, and thyroxine free decreased (each n=3). The radioactive iodine uptake (RAIU) test is a reliable test to differentiate between causes of hyperthyroidism. Low uptake suggests thyroiditis and high uptake suggests Grave's disease6. In the current case series, RAIU was performed in three cases confirming the diagnosis of SAT (cases 5, 23, and 26). Patients experiencing SAT following vaccination were mainly female (n=24 83%) In six of the cases corticosteroids (prednisone or dexamethasone) were used to treat SAT and in the remaining case the patient was planned to start antibiotic therapy. Information about the outcome was available in five of these cases. In two cases the patients were reported to have recovered, in one case the patient was recovering at the time of reporting and in the remaining two cases the outcome was reported as not recovered at the time of reporting, but in one of those cases (case 16) the patient was reported to respond to prednisone treatment. Furthermore, in the recent scientific literature a series of case reports of patients developing SAT associated with COVID-19 infections was published14 to 21. Six of the eight published reports concern female patients14 to 16,19 to 21. In the current case series, three of the 16 authorized COVID-19 vaccines were reported as suspected. However, one case (case 18) reported a viral thyroiditis without further specification. The only available information was that the patient was not tested positive for COVID-19. Another two cases may represent confounders: the patient in case 16 was reported to receive concomitant eculizumab treatment in course of a clinical trial. Eculizumab potentially increases the risk for infections favoring the occurrence of SAT. Subacute thyroiditis (SAT) is an inflammatory disease of the thyroid caused by viral infections or autoimmune reactions. Its reported incidence was 12.1 cases/100,000 person years in the USA with a higher incidence in females than males (19.1 vs 4.1 cases/100,000 person years) between 1970 and 19971. However, no recent information about SATs incidence is available. Two of the cases reported the occurrence of SAT in young female patients (25 and 28 years old) following seasonal influenza vaccination10,11. The fourth case report described a previously healthy 36-year-old female patient who presented with clinical symptoms of thyrotoxicosis after having received H1N1 influenza vaccination one month prior to presentation13. Though there is not much evidence of SAT following immunization in general, a series of case reports on patients developing SAT in association with COVID-19 infection can be found in the recent scientific literature14 to 21. Inflammatory response, apoptosis, and local damage, direct viral replication, interaction with thyroidal ACE2 receptors, and a potential central mechanism with low TSH level possibly secondary to hypothalamus-pituitary dysfunction have been discussed as potential mechanisms for COVID-19- induced SAT20. In case number 21 reaction was reported as Thyroiditis subacute. Calculated TTO: 1 months. The patient's hospitalization was prolonged as a result of thyroiditis subacute/viral thyroiditis. The outcome was reported as resolved on an unspecified date. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected

Other Meds:

Current Illness:

ID: 1528235
Sex: M
Age:
State: CO

Vax Date: 04/15/2021
Onset Date: 07/14/2021
Rec V Date: 08/05/2021
Hospital: Y

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Symptoms: On July 15 I had surgery to remove significant blood clots from my heart and lungs as a result from a saddle pulmonary embolism. I have done testing to eliminate Cancer, Hereditary and red blood cells; On July 15 I had surgery to remove significant blood clots from my heart and lungs as a result from a saddle pulmonary embolism. I have done testing to eliminate Cancer, Hereditary and red blood cells; This is a spontaneous report from a contactable consumer (patient). A 59-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EW0153; Expiry date: unknown) via an unspecified route of administration, administered in arm right on 15Apr2021 13:00 (at age of 59-year-old) as dose 2, single for COVID-19 immunization. Medical history included chronic low back pain from multiple back surgeries and allergy to sulfa from an unknown date and unknown if ongoing. Concomitant medications included magnesium sulfate, Vitamin D Nos taken for an unspecified indication. The patient had previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EN6207; Expiry date: unknown) on 25Mar2021 at 13:00 (at age of 59-year-old) as dose 1 single for COVID-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. It was reported that, on July 15 patient had surgery to remove significant blood clots from his heart and lungs as a result from a saddle pulmonary embolism which was reported on 14Jul2021 (at 04:00). patient had done testing to eliminate cancer, hereditary and red blood cells for as a cause 8 days. The adverse event resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The patient was hospitalized due to adverse event. Therapeutic measures were taken as a result of adverse event as patient underwent surgery (to remove significant blood clots from heart and lungs as a result from a saddle pulmonary embolism) on 15Jul2021 and unspecified medication. The outcome of events was resolving.

Other Meds: MAGNESIUM SULFATE; VITAMIN D NOS

Current Illness:

ID: 1528236
Sex: M
Age:
State: SC

Vax Date: 01/26/2021
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Rec V Date: 08/05/2021
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Symptoms: My sister and brother-in-law both contracted COVID-19 after receiving their first dose of the Pfizer Covid-19 Vaccine; My sister and brother-in-law both contracted COVID-19 after receiving their first dose of the Pfizer Covid-19 Vaccine; This is a spontaneous report from a contactable consumer. This consumer reported for a patient (reporter's brother-in-law). A 91-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on 26Jan2021 (age at vaccination: 91 years), as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter reported that my sister and brother-in-law both contracted COVID-19 after receiving their first dose of the Pfizer Covid-19 Vaccine on an unspecified date in 2021. The reporter would like to know if they could receive their second dose or would they need to repeat the series. The patient underwent lab test and procedure included Covid 19 with positive result on an unspecified date in 2021. There was a Product Complaint. Description of Product Complaint included Pfizer Covid 19 vaccine: Tested positive after getting first dose of Pfizer Covid 19 vaccine. Product strength and count size dispensed: Is a sample of the product available to be returned, if requested (Y/N): Packaging sealed and intact? Outcome of the events was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

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ID: 1528237
Sex: F
Age:
State: NC

Vax Date: 07/02/2021
Onset Date: 07/01/2021
Rec V Date: 08/05/2021
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Symptoms: It was like I had a COVID; It was like I had a COVID; It made me sick; Headache; I ran a fever; This is a spontaneous report from a contactable consumer or other non health professional (patient) via Pfizer sponsored program. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot Number: AWO198) via an unspecified route of administration on 02Jul2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. She has not done her second one because she said, she had a reaction and she did not tell me what that reaction was and her question was can she still get the second vaccine, she does have the medical information phone number. She stated they got that in the system, it was all there, she called in and reported it. On an unspecified date in Jul2021, it made her sick, it made her have a headache, she ran a fever. It was like she had a COVID. The outcome of the events was reported as unknown. Follow-up attempts are completed. No further information is expected.

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Current Illness:

Date Died: 07/01/2021

ID: 1528238
Sex: F
Age:
State: AZ

Vax Date: 06/23/2021
Onset Date: 06/28/2021
Rec V Date: 08/05/2021
Hospital: Y

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Symptoms: Heart attack and lungs filled with water; Heart attack and lungs filled with water; Stopped breating; This is a spontaneous report from a contactable consumer. A 52-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in left arm on 23Jun2021 (Batch/Lot number was not reported) as dose 2, single for covid-19 immunisation. Medical history included stroke occurred 20 years ago, kidney problems, heart attack eight years ago, patient had 7 stents around her heart, her capillaries were small, The veins to her heart were small, asthma, schizophrenia, stated lungs were bad, had a stroke 20 years ago and it affected her emotions. She could only laugh or be mad. Concomitant drug were unspecified. Patient was on a lot of them. The patient had first shot of BNT162B2 on 31May2021 in left arm for COVID-19 Immunization and she started crying. The patient experienced heart attack and lungs filled with water (death, hospitalization) on Jul2021 with fatal outcome, stopped breating (hospitalization) on 28Jun2021 with outcome of unknown. The patient was hospitalized for 3 days. The patient died in Jul2021. It was unknown whether autopsy done. The clinical course was reported as follows: Caller on the line who mentioned he was a PCA, clarified as a patient care attendant for his wife. He is calling about the Pfizer Shot, the vaccination, clarified as to prevent COVID, the COVID Shot. He stated his wife died due to the shot. He mentioned he has no avenue to go down. No direction. He stated he is upset no research has been done form people who died from the shot, or information from it causing one to have a heart attack, lungs filling with water, or weakening the immune system. He later clarified this is what happened to his wife. Caller stated he feels that his wife died from the COVID shot, but he is not a scientist and has no way of proving that. He wants someone to call him and tell him. Caller clarified the patient's cause of death. He stated the death certificate has she passed away due to heart attack due to lungs filling with water and she could not be resuscitated. They tried for two hours. Caller stated he does not know the exact date patient passed away, it is all packed up. It was either 02Jul 2021 or 03Jul2021. He confirmed the heart attack and lungs filling with water occurred on the date she passed away. Caller explained, he wanted to explain what he saw. After she first got the shot she started crying. He mentioned his wife had a stroke 20 years ago and it affected her emotions. She could only laugh or be mad. Patient's mother and father had passed away within three months of each other and she could not even cry then. Caller stated after patient got the shot she started crying and did not know what was going on. He mentioned she was close to menopause and he thought it was just menopause going on. It was all day, every day, she was crying. Then after the second shot a few days later patient stopped breathing. The paramedics were called who provided a breathing treatment. Patient was taken to the hospital and was there for three days. They could not figure out what was wrong. They did work-ups. Patient was in ICU. Then she crashed. They started CPR. Patient's lungs filled up with water, patient had a heart attack, and she stopped breathing. Caller clarified patient had the issues with breathing and stopped breathing initially like on 28Jun2021. Then patient was taken to the hospital. Stated patient's health was never like us. However, he kept her not sick. He was good at his job. However, when patient was sick he would take patient to the hospital or the doctor's to find out what is going on. When sick she was in the hospital, when she was fine she was home. No vaccines administered on same date of the pfizer suspect. Confirmed none were given on the same date. The paramedics were called, patient was taken to hospital and was admitted to ICU due to patient stopped breathing. Information on the lot/batch number has been requested.; Reported Cause(s) of Death: Heart attack; Lungs filled with water

Other Meds:

Current Illness:

ID: 1528239
Sex: F
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Rec V Date: 08/05/2021
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Symptoms: patient was fully vaccinated with Pfizer vaccine, had tested, through a PCR test, positive for COVID; patient was fully vaccinated with Pfizer vaccine, had tested, through a PCR test, positive for COVID; This is a spontaneous report from a contactable consumer. A 16-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot number and expiration date: not provided) via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number and expiration date: not provided) via unspecified route of administration on an unspecified date as DOSE 2, SINGLE both for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, patient was fully vaccinated with Pfizer vaccine, had tested, through a PCR test, positive for COVID. Symptoms were mild including runny nose, stuffed up and were getting better. The patient underwent lab tests and procedure which included SARS-CoV-2 test/ PCR test was positive on an unspecified date. The events outcome was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

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Current Illness:

ID: 1528240
Sex: M
Age:
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Rec V Date: 08/05/2021
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Symptoms: Tested positive for the COVID Delta variant after being vaccinated; Tested positive for the COVID Delta variant after being vaccinated; He mentioned he is not feeling well.; This is a spontaneous report from a contactable consumer. This consumer reported for unknown male patient. A male patient of an unspecified age received bnt162b2 (COVID-19 VACCINE - manufacturer unknown; Solution for injection, Lot number: unknown, Expiry date: unknown), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. No medical and concomitant medication history were reported. The patient experienced tested positive for the COVID delta variant after being vaccinated and not feeling well. Reporter was unsure of which vaccine was administered (only info is that it was a 2-dose version, so Moderna or Pfizer). There were no adverse reactions, only actively symptomatic. The patient underwent lab tests and procedures which included SARS-CoV-2 test positive on an unspecified date. The outcome of the events were unknown. Information about lot/batch number cannot be obtained. Information on the lot/batch number has been requested.

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Current Illness:

ID: 1528241
Sex: U
Age:
State:

Vax Date: 03/16/2021
Onset Date: 06/01/2021
Rec V Date: 08/05/2021
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Symptoms: Problems with my thigh started about 6 weeks ago and finally they are getting worse; Something is going on with the back of my thigh it's difficult to walk; This is a spontaneous report from two contactable consumers (Patient and another consumer). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot Number: EN6207), dose 2 via an unspecified route of administration, in Right arm on 16Mar2021 at 13:00 as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection; Lot number: EL9267), dose 1 via an unspecified route of administration in right arm on 23Feb2021 at 13:00 for COVID-19 immunization. Patient did not receive prior vaccination within 4 weeks. On an unspecified date in 2021, Consumer stated that consumer was having side effects from the Pfizer vaccine. Consumer read online some of the problems were in your thighs and consumer thought consumer had formed hamstring in both thighs and consumer just went to have an x-ray in hamstrings were fine but there was something was going on with the back of thigh it's difficult to walk. The problems with thigh started about 6 weeks ago and finally they were getting worse on an unspecified date in Jun2021 and consumer went to doctor 3 days ago. Patient did not receive any treatment for side effects. The patient underwent lab tests and procedures on an unspecified date in 2021 which included x-ray: fine (x-ray in my hamstrings are fine). The outcome of events was unknown. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1528242
Sex: U
Age:
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Vax Date:
Onset Date: 07/28/2021
Rec V Date: 08/05/2021
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Symptoms: positive for Covid19; positive for Covid19; fever; lost his sense of taste and smell; lost his sense of taste and smell; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: not reported), dose 1 via an unspecified route of administration on an unspecified date as a single dose and dose 2 via an unspecified route of administration on an unspecified date as single dose for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. On 28Jul2021, the patient tested positive for Covid19, has a low grade fever, lost his sense of taste and smell. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 28Jul2021. The outcome of all the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

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Current Illness:

ID: 1528243
Sex: F
Age:
State:

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Rec V Date: 08/05/2021
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Symptoms: passed out in her car and got into a car accident; passed out in her car and got into a car accident; This is a spontaneous report from a contactable consumer (patient). A 36-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot number: not reported) via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced as, passed out in her car and got into a car accident on an unspecified date. Reported as, after receiving the Pfizer COVID-19 vaccine, she passed out in her car and got into a car accident. Her doctor confirmed that it was a result of the vaccine. She stated that it happened right after she left the doctor's office where she received the Pfizer COVID-19 vaccine. She waited 20 minutes and immediately passed out. She got into an accident and was rushed to the emergency room. Outcome of the events were unknown. Information on the lot/ batch number has been requested.

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Current Illness:

ID: 1528244
Sex: M
Age:
State: TX

Vax Date:
Onset Date: 07/01/2021
Rec V Date: 08/05/2021
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Symptoms: positive for COVID; positive for COVID; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received second dose of bnt162b2 (BNT162B2, solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on an unspecified date as dose 2, single, dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications was not reported. Caller states my cousin and his wife also got diagnosed a couple days earlier than I did. Especially when I found out my cousin and his wife had both doses and tested positive. The patient was positive for covid on Jul2021 considered as medically significant. The clinical outcome of the event was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1528245
Sex: F
Age:
State: TX

Vax Date:
Onset Date: 07/01/2021
Rec V Date: 08/05/2021
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Symptoms: tested positive for COVID; tested positive for COVID; This is a spontaneous report from a contactable consumer. A female patient (Cousin's wife) of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) and received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient pregnant information was unknown. The patient was tested positive for covid in Jul2021. Reporter stated my cousin and his wife also got diagnosed a couple days earlier than I did. I just wanted to make sure this got reported because I know you were still trying to figure all this out. Especially when I found out my cousin and his wife had both doses and tested positive. Reporter asked, "is there any more information about this". The patient underwent lab tests and procedures which included COVID-19 as positive on Jul2021. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1528246
Sex: F
Age:
State:

Vax Date: 04/01/2021
Onset Date: 07/01/2021
Rec V Date: 08/05/2021
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Symptoms: Caller has since contracted COVID-19 as a "break through case" last week; Caller has since contracted COVID-19 as a "break through case" last week; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unknown date in Apr2021 as dose 1, single; and later received second dose of BNT162B2 (Batch/Lot number was not reported) via an unspecified route of administration on an unknown date in Apr2021 as dose 2, single; both for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unknown date in Jul2021 (reported as last week), the patient experienced contracted covid-19 as a "break through case". Batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.

Other Meds:

Current Illness:

ID: 1528247
Sex: M
Age:
State: CA

Vax Date: 07/15/2021
Onset Date: 07/01/2021
Rec V Date: 08/05/2021
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Symptoms: Heart attack; Caller states that he has been having a weird chest pain and tightening of the chest and does know if it is related to the vaccine or to his heart.; Caller states that he has been having a weird chest pain and tightening of the chest and does know if it is related to the vaccine or to his heart./He states its a pressure in his chest; Scared; he wasn't feeling well and needed to lie down; Sore arm; Tiredness; This is a spontaneous report from a contactable consumer. A 56-year-old male consumer (patient) reported that patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation was Solution for injection, Lot Number: not reported), dose 1 via unspecified route on 15Jul2021, as single dose for COVID-19 immunization (age at time of vaccination 56 years). The patient medical history and concomitant medications were not reported. On an unspecified date in Jul2021 the patient experienced Heart attack, he did not want to die of Corona or Delta virus. He wanted to know what he should do. He did not know if he was gone to die of a heart attack, he had been having a weird chest pain and tightening of the chest and does know if it was related to the vaccine or to his heart, Sore arm, and Tiredness. He was scared to get the second dose and is looking for guidance. agent states that the caller declined to fill out safety report because he stated he was not feeling well and needed to lie down. He had these chest pains for the last 3 or 4 days this week. He states that it seems like it is getting a little bit worse. All he could link it to is the vaccine, several people told him including his mailman that if you have a heart condition not to get the vaccine. He was questioning if he wants to get his second shot because it is a little scary what he is going through right now. It was unknown especially when it comes to your heart. He states when he gets off this phone call, he was gone to call his doctor. He states he did not know what to do but he is just concerned about his chest pain. He had been taking baby aspirin, twice a day one in the morning and one at night and that seems to be helping a little bit. He forgot to take it last night and all the sudden he felt the chest pain, he states he just took it a little while ago and he knows it takes time for it to kick in. He did not know. It was a pressure in his chest, so he was not sure if it could be his heart, he states the pain seems to be between the center and the right versus the left side. The outcome of event Scared was unknown, and rest of all events was not recovered. The lot number for the vaccine, [BNT162B2] was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1528248
Sex: M
Age:
State: NC

Vax Date: 02/22/2021
Onset Date: 07/26/2021
Rec V Date: 08/05/2021
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Symptoms: Positive COVID test with symptoms; Positive COVID test with symptoms; This is a spontaneous report from a contactable consumer (patient). A 55-year-old male patient of received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), on 22Feb2021 (batch/lot number: EL3247) as dose 1, single; on 15Mar2021 (batch/lot number: EL-3247, at the age of 54-year-old) as dose 2, single, both via an unspecified route of administration, administered in arm left for COVID-19 immunization. Medical history included T1 DM (type 1 diabetes mellitus), the patient was Known allergies to PCN and CDN. Prior to vaccination, the patient was no diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. Concomitant medications included insulin aspart (FIASP) and desvenlafaxine succinate monohydrate (PRISTIQ); both drugs received within 2 weeks of vaccination. The COVID-19 vaccine was administered at workplace clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 26Jul2021, the patient experienced Positive Covid test with symptoms. The events was resulted at Doctor or other healthcare professional office/clinic visit. The patient underwent lab data and procedures included on 26Jul2021; he was tested Nasal swab with positive results. The events did not required hospitalization prolonged. The patient did not take the treatment for the events. The outcome of the event was recovering.

Other Meds: FIASP; PRISTIQ

Current Illness:

ID: 1528249
Sex: F
Age:
State:

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Rec V Date: 08/05/2021
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Symptoms: Patient had Pfizer Covid vaccine and contracted Covid-19.; Sars-Cov-2 infection; This is a spontaneous report form a contactable consumer (patient) via regulatory authority. A 20-year-old female patient received unspecified dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot number and Expiry date was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date patient had Pfizer covid vaccine and contracted covid-19. Event took place after use of product. The outcome of the event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1528250
Sex: F
Age:
State:

Vax Date: 05/19/2021
Onset Date: 05/22/2021
Rec V Date: 08/05/2021
Hospital: Y

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Symptoms: blood clot in spleen; This is a spontaneous report from a non-contactable consumer (patient reported for herself). An 82-year-old female patient received bnt162b2 (BNT162B2, formulation: Solution for injection, Lot Number: EW0177), dose 2 via an unspecified route of administration, administered in Arm Right on 19May2021 (at the age of 82-year-old) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included high blood pressure. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. There were no concomitant medications. The patient previously received her first dose of (BNT162B2, formulation: Solution for injection, Lot Number: EW0172), via an unspecified route of administration, administered on 28Apr2021 (at the age of 82-year-old) as DOSE 1, SINGLE for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Since the vaccination, the patient had not been tested for COVID-19. On 22May2021, a few days after 2nd dose of Pfizer vaccine, the patient was hospitalized with a blood clot in spleen. It was reported that the patient had no prior medical history. The seriousness criteria of the event reported as hospitalization. The outcome of the event was resolved on an unspecified date in 2021. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1528251
Sex: F
Age:
State:

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Rec V Date: 08/05/2021
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Symptoms: Blood Clots in the Wrist; This is a spontaneous report from a contactable consumer. A female patient of unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: unknown), via an unspecified route of administration, on an unknown date, as dose number unknown, single, for COVID-19 Immunisation. Medical history and concomitant medications were not reported. On an unknown date, the patient experienced blood clots in the wrist. The outcome of the event was unknown. Follow-up attempts completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1528252
Sex: F
Age:
State:

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Rec V Date: 08/05/2021
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Symptoms: Blood clot in the brain; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number and expiry date were not reported) via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. Medical history included lupus. The patient's concomitant medications were not reported. The patient experienced blood clot in the brain on an unspecified date. It was reported that, consumer stated she had not an adverse reaction. Her sister in law had an adverse reaction, she had lupus and she was not sure if that had caused the blood clot in her brain. She enquired how did she find out if adverse reactions have been reported about this or not. She also enquired had anyone reported the reaction with lupus or lupus cerebritis or not. Cerebritis means that it was affecting the brain. The outcome of event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

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Current Illness:

ID: 1528253
Sex: F
Age:
State: MN

Vax Date:
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Rec V Date: 08/05/2021
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Symptoms: Covid vaccine and she tested positive for covid afterwards; Covid vaccine and she tested positive for covid afterwards; This is a spontaneous report from a contactable consumer. This is the second of three reports A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: not reported) via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. Medical history and concomitant medications were not reported. The reporter mentioned his wife's co-worker (patient) also got the Covid vaccine and she tested positive for covid afterwards on an unspecified date, this was shortly after getting the vaccine. On an unspecified date, the patient underwent COVID-19 test with result positive. The outcome of the event was unknown. The lot number for the vaccine [BNT162B2] was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202100971123 same reporter/drug, different patients/AE

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Current Illness:

Date Died: 04/29/2021

ID: 1528254
Sex: M
Age:
State: OR

Vax Date: 03/23/2021
Onset Date: 03/24/2021
Rec V Date: 08/05/2021
Hospital: Y

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Symptoms: Post-vaccine auto-immune reaction, organ failure (DRESS syndrome); This is a spontaneous report from a contactable consumer. An 81-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date not provide) on 23Mar2021 12:00 at age of 81 years old as single dose on left arm via an unspecified route of administration for COVID-19 immunization. Relevant medical history included hypertension, temporomandibular joint syndrome, tinnitus and joint discomfort. On 02Mar2021 at 12:00 PM at 81 years old, on Left arm the patient received first dose of BNT162B2 for COVID-19 immunization. Concomitant medications included hydrochlorothiazide, valsartan (CO-DIOVAN), vitamin D3, ginkgo biloba, collagen and melatonin. It was informed that on 29Apr2021 the patient died after developing a severe allergic auto-immune reaction, diagnosed as DRESS Syndrome, started on 24Mar2021 09:00. The adverse event result in emergency room visit and physician office visit. It was mentioned that patient was hospitalized 13 days due to the event and was treated with high-dose of cortico-steorids, antibiotics. It was also informed that It took a lot of effort by several doctors, and ultimately the intervention of a premiere infectious disease expert in another location, on 18Apr2021, to make a definitive diagnosis and to confirm it was a reaction to the Pfizer COVID vaccine. (as reported). The doctors tried but failed to save him, and he died on 29Apr2021 (as reported). The patient underwent a SARS-CoV-2 test (Blood test) on 28Apr2021 which resulted negative. An autopsy was not performed. Serious criteria was fatal, life-threatening and hospitalization. The event [Post-vaccine auto-immune reaction, organ failure (DRESS syndrome)] occurred in a country different from that of the reporter. This may be a duplicate report if another reporter from the country where the event occurred has submitted the same information to his/her local agency. Information on the lot/batch number has been requested. Follow-up (20May2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected. Amendment: This follow-up report is being submitted to amend previously reported information: updated the reporter's country.; Reported Cause(s) of Death: Post-vaccine auto-immune reaction, organ failure (DRESS syndrome)

Other Meds: CO-DIOVAN; VITAMIN D3; GINKGO BILOBA; COLLAGEN; MELATONIN

Current Illness:

Date Died:

ID: 1528255
Sex: F
Age:
State: ID

Vax Date:
Onset Date:
Rec V Date: 08/05/2021
Hospital: Y

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Symptoms: blood clots in her lungs; This is a spontaneous report from a contactable consumer or other non hcp from a Pfizer sponsored program. A 86-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), dose unknown via an unspecified route of administration on an unspecified date in 2020 (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunisation; tofacitinib citrate (XELJANZ), route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication. The patient medical history and concomitant medications were not reported. The reporter stated that his neighbor was taking Xeljanz and got the COVID 19 vaccine (unknown manufacturer) and died from blood clots in her lungs. She died on an unspecified date and the family was blaming Xeljanz. The patient was diagnosis with blood clots about a month ago. She got COVID Vaccine around Christmas 2020. She was in hospital for 5 days with blood clots. The reporter inquired if vaccine cause blood clots. Seriousness of the event was reported as death and hospitalization. The action taken in response to the event for tofacitinib citrate was not applicable. The outcome of the event was fatal. It was not reported if an autopsy was performed. Follow-up attempts are needed. Information on the lot/batch number is expected.; Reported Cause(s) of Death: unknown cause of death

Other Meds: Xeljanz

Current Illness:

ID: 1528256
Sex: F
Age:
State:

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Rec V Date: 08/05/2021
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Symptoms: patient states over the years she has had to hold medication various times due to neutropenia, a biopsy, both covid vaccines.; patient states over the years she has had to hold medication various times due to neutropenia, a biopsy, both covid vaccines.; This is a spontaneous report from a Pfizer-sponsored program received from a contactable Healthcare professional. A 50-years-old female patient received the first and the second dose of bnt162b2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN), via an unspecified route of administration on an unspecified dates, at 50 years of age, (Batch/Lot numbers was not reported for both doses) as single doses, for COVID-19 immunization and palbociclib (IBRANCE), oral from 2018 (over 3 years) (Batch/Lot number was not reported) and ongoing, at starting dose of 125 mg for breast cancer, then decreased after few cycles to 75 mg daily for 21 of 28 days due to neutropenia. Medical history included mouth sores, fatigue, joint pain, hair thinning, constipation, nausea and neutropenia, all ongoing at the time of the report. Concomitant medication included letrozole taken for an unspecified indication since an unknown date. The patient stated that over the years she has had to hold medication various times due to neutropenia, a biopsy and both COVID-19 vaccines. She reports her side effects did not go away while she was off medication. Neutropenia onset date was reported as 2021 and it was assessed as medically significant. The patient underwent lab tests and procedures which included biopsy: unknown results and lab test which showed neutropenia. The action taken with palbociclib in response to the event was unknown. At the time of the report the event outcome was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported event of neutropenia due to temporal relationship. However, concomitant therapy with palbociclib represents an alternative explanation for the neutropenia. In addition, the patent has medical history of recurrent neutropenia. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics including baseline CBC with differential, counteractive treatment measures and concomitant medications. This case will be reassessed once additional 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: LETROZOLE

Current Illness: Constipation; Fatigue; Hair thinning; Joint pain; Nausea; Neutropenia; Sore mouth

ID: 1528257
Sex: M
Age:
State:

Vax Date:
Onset Date: 07/01/2021
Rec V Date: 08/05/2021
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Symptoms: Symptomatic of COVID infection despite vaccination; no test to confirm; Symptomatic of COVID infection despite vaccination; no test to confirm; This is a spontaneous report from a contactable consumer or other non health care professional. A male patient of unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection; Batch/Lot Number: Unknown), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. It was unknown if the patient tested COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. On an unspecified date in Jul2021, the patient was symptomatic of covid infection despite vaccination; no test to confirm. Patient did not receive treatment for the events. The outcome the events was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1528258
Sex: F
Age:
State: NY

Vax Date:
Onset Date: 07/29/2021
Rec V Date: 08/05/2021
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Symptoms: Caller tested positive for COVID-19 with a "1287" result of antibodies on her test; Caller tested positive for COVID-19 with a "1287" result of antibodies on her test; a urinary tract infection; This is a spontaneous report from a contactable consumer or other non-health care professional (patient) via medical information team. A 70-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: unknown, Expiration date not reported), via an unspecified route of administration, administered on an unspecified date in Feb2021(at the age of 70-year- old) as single dose and first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: unknown, Expiration date not reported), via an unspecified route of administration, administered on unspecified date (at the age of 70 years old) for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Caller wants to know if the high COVID-19 antibody levels that she presented on her physical test could be due to a urinary tract infection that she developed recently. Caller and her husband received the second dose of the Pfizer COVID-19 vaccine on Feb, shortly after receiving the vaccine caller had no antibodies against COVID-19 and now a year later she resulted with a high level of antibodies relatively closely after experiencing a urinary infection. Caller will have a new medical test performed on Sep. As far as she knows she never had COVID-19. Caller heard that the type O blood is more protective with the vaccine. Caller also read that according to Pfizer withheld after 6 months of receiving the second dose of the vaccine patients have less immunity. E-transmitting neglected probable lack of efficacy. The patient tested positive for covid-19 with a 1287 result of antibodies on her test on 29Jul2021, and a urinary tract infection in 2021. The outcome of event urinary tract infection was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1528259
Sex: M
Age:
State: IL

Vax Date: 03/03/2021
Onset Date: 07/29/2021
Rec V Date: 08/05/2021
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Symptoms: took COVID test and it came back positive; took COVID test and it came back positive; This is a spontaneous report from a contactable consumer (patient). A 50-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection Batch/Lot number: EJ1685, Expiration Date was not reported), via an unspecified route of administration, administered in left arm like the shoulder on 03Mar2021 (at the age of 50-years-old) as dose 1, single and received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection Batch/Lot number: EK5730, Expiration Date was not reported), via an unspecified route of administration, administered in left arm like the shoulder on 24Mar2021(at the age of 50-years-old) as dose 2, single for covid-19 immunisation at vaccination clinic. The patient medical history was none. There were no concomitant medications. It was reported that, the patient had the vaccine in Mar. He was a little stuffy this week and had mild symptoms. Down the street has COVID test. He took COVID test and it came back positive. Patient clarified yesterday, 29Jul2021, he had rapid COVID test and it was positive. PCR test was also done, but he hasn't gotten the PCR results, that will take a couple of days. He took the test yesterday morning between 11:00AM or 11:30AM. His awareness date of testing COVID positive was yesterday, 29Jul2021. Patient states that he was stuffy, had a little cough, and didn't feel right on Sunday 25Jul2021. He went to a drive up testing site. He was feeling off and had a cough. The patient underwent lab tests and procedures which included PCR test: unknown results on 29Jul2021, Rapid COVID Test: positive on 29Jul2021. The outcome of the events was unknown. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1528260
Sex: F
Age:
State: CA

Vax Date: 02/01/2021
Onset Date:
Rec V Date: 08/05/2021
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Symptoms: Prolonged arrhythmia episodes starting after 1st dose; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), intramuscular, administered in arm left in Feb2021 12:00 (Batch/Lot Number: EL3247) (at the age of 67-years-old) as dose 1, single for covid-19 immunisation. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Facility where the most recent COVID-19 vaccine was administered in a hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and did not receive any other medications within 2 weeks of vaccination. Medical history included thyroiditis, non-specified atopic dermatitis and allergies: fragrances used in cosmetics/cleaning products. There were no concomitant medications. The patient previously took melaleuca alternifolia oil (TEA TREE OIL) and experienced allergies: tea tree oil. The patient experienced prolonged arrhythmia episodes starting after first dose on 12Mar2021. It was unknown if this will be permanent. The patient considered the report as serious. Did not results in death, not medically significant, not life threatening, did not cause/prolong hospitalization, not disabling/incapacitating, no intervention required and no congenital anomaly/birth defect. There was no treatment for the event. The outcome of the event was not recovered. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1528261
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/05/2021
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Symptoms: He may have had a stroke; His left hand, he had no control over it; Slurred speech; This is a spontaneous report from a contactable consumer. A male patient (Father) of an unspecified age received BNT162B2 (BNT162B2, formulation: Solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single for covid-19 immunization. The patient's medical history and concomitant medications was not reported. Reporter was calling on behalf of his/her father, patient took the Pfizer vaccine on Monday, his first shot and sounds like he may have had a stroke (event captured as per verbatim) the next day. He won't go to the doctor, he woke up 'next' morning and his left hand, he had no control over it on an unspecified date. On an unspecified date, he had slurred speech, reporter didn't notice, reporter just found this out today and reporter didn't even know that he has got the shot. The symptoms have gone better, and he didn't go to the doctor. So, one, he never goes to the doctor hardly ever and two, he was researching it online and said that, he thought that maybe those were symptoms like the side effects of getting the vaccine but reporter was concerned that maybe it was a stroke. Reporter have been trying to get him go to the hospital but since the symptoms have got better, he was not going. When asked for LOT of first shot reporter stated, that reporter don't know what that was he/she don't have that reporter can get that from him but he/she was not at his house right now. The outcome of the events was unknown. Follow-up activities are closed. Batch/lot number is not available

Other Meds:

Current Illness:

ID: 1528262
Sex: M
Age:
State: LA

Vax Date:
Onset Date:
Rec V Date: 08/05/2021
Hospital:

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Symptoms: contracted covid; contracted covid; He still has the impaired sense of taste and smell unfortunately; He still has the impaired sense of taste and smell unfortunately; This is a spontaneous report from contactable consumer (patient) and from a Pfizer sponsored program. A 32-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot Number: not reported) via an unspecified route of administration on an unspecified date (at the age of 32-years-old) as DOSE 1, SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, patient contracted COVID after the first dose of COVID-19 vaccine. He had been negative for a week now (at the time of report). He still had the impaired sense of taste and smell unfortunately. He has had that for 2 weeks. According to PCR test he was negative on an unspecified date. He had heard conflicting information about getting the second dose straight away or waiting 30 days. Outcome of the event impaired sense of taste and smell was not resolved and while contracted covid was resolved on an unknown date and drug ineffective was unknown. The lot number for the vaccine, (BNT162B2), was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1528263
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/05/2021
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Symptoms: My son received a first dose of Pfzer vaccine and developed a blood clot.; This is a spontaneous report from a contactable consumer. The patient participated in patient assistance. This consumer (patient's parent) reported for a male patient (reporter's son) of an unspecified age received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, Solution for injection,Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as DOSE 1, Single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received a first dose of Pfzer vaccine and developed a blood clot on an unspecified date .Event was considered to be medically significant. The patient underwent lab test included ct scan, ultrasounds and hematology report. Based on the findings, it was concluding that since there was no anatomical or genetic issue, blood clot was caused by vaccine and the clinical outcome of event was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1528264
Sex: F
Age:
State: CT

Vax Date:
Onset Date: 06/02/2021
Rec V Date: 08/05/2021
Hospital:

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Symptoms: Patient was fully vaccinated and got COVID after Memorial Day; Patient was fully vaccinated and got COVID after Memorial Day; This is a spontaneous report from a contactable consumer received via a Pfizer sales representative. A 61-year-old female patient received doses 1 and 2 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via unspecified routes of administration on unspecified dates (at the age of 61-years-old) as single doses for COVID-19 immunization. Medical history was unknown. It was unknown if the patient received any other vaccines prior to the vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications were not reported. It was unknown if the patient had any allergies. On 02Jun2021, the patient was fully vaccinated and got COVID-19 after Memorial Day. The event was reported as non-serious. The patient was not hospitalized for the event. It was unknown if the patient received treatment for the event. The outcome of COVID-19 was recovered. It was unknown if the patient was tested for COVID-19 after the vaccination.

Other Meds:

Current Illness:

ID: 1528265
Sex: M
Age:
State: NJ

Vax Date: 05/01/2021
Onset Date: 07/01/2021
Rec V Date: 08/05/2021
Hospital:

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Symptoms: Patient tested positive for COVID; Patient tested positive for COVID; This is a spontaneous report from a contactable consumer. A 27-year-old male patient received the first and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), on Apr2021 (Lot: EW0179) and May2021 (Lot: EW0161), respectively, at the age of 27-years-old, intramuscular as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were none. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. On Jul2021, the patient tested positive for COVID. Laboratory tests included COVID test post vaccination (nasal swab) in Jul2021: positive. The patient was not treated for the event. The clinical outcome of the event was resolved on Jul2021. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1528266
Sex: M
Age:
State: NY

Vax Date: 02/19/2021
Onset Date: 02/19/2021
Rec V Date: 08/05/2021
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Symptoms: Bit anemic; Low on iron; His white cell count was high; Joint pains; Night sweats; Hot flashes; Loss of appetite and taste buds/he has not been eating very well; Loss of appetite and taste buds; Feeling meh; Sick; He had pain in his arm; He had pain in his back and left shoulder where he had the shot; Bad pains; He had pain in his back and left shoulder where he had the shot; he is down to 150lbs, he has not been eating very well; Cough; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Lot Number: EN6201; Expiration Date: Jun2021), dose 2 intramuscular, administered in Arm Left on 19Feb2021 18:15 as a single dose for covid-19 immunization (age at vaccination: 63-year-old). The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Lot Number: EL9263, Expiration Date: May2021), dose 1 intramuscular administered in Arm Left on 29Jan2021 18:15 as a single dose for covid-19 immunization. The patient had no reactions to the first vaccine. The patient medical history was not reported. There were no concomitant medications. The patient had no other vaccine within four weeks and no other medications received within 2 weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19 by nasal swab on 07Mar2021 and the covid test result was negative. The patient did not have any allergies. No adverse event reported prior to vaccination. On 19Feb2021 23:00, The patient experienced night sweats/hot flashes, loss of appetite and taste buds, Feeling meh, joint pains. The patient received his second Pfizer COVID shot four weeks ago and has been sick every day since 19Feb2021. The patient knew it (bnt162b2) was not a live vaccine like a flu shot, but he has been having a lot of reactions that one would have if they had COVID. The patient believes he was down to 150 lbs, he has not been eating very well since an unknown date in 2021. He mentions he was getting a little better, especially compared to the first few nights after receiving the vaccine. Twice, he has had bad pains on an unknown date in 2021. The very first night (19Feb2021), he had pain in his arm then it went away. A week or two later, on an unknown date in 2021, he had pain in his back and left shoulder where he had the shot. He clarifies he was only seen in the ER and was not admitted into the hospital. He has been in contact with his doctor. The patient reported that 10 vials of blood were taken and a urine sample on 28Feb2021. From the results, the patient stated that he may be a little bit anaemic, low on iron. His white cell count was high but has come down a little bit. He confirms he had testing done on 28Feb2021 and the following Sunday, 07Mar2021, he went to the ER. He states if he could get his taste buds and appetite back 100% that would be huge. He often has night sweats, hot flashes. On an unknown date in 2021, he had a cough. Often, it's just a "meh" feeling. He has been trying to contact someone who can offer some kind of treatment. He states they now want him to take iron pills and a multivitamin to help. Prior to that, they kept pushing Tylenol or Advil several times of day. He makes the comment "let me just hit a light". Tylenol 500mg: Lot: WJ27520, Expiry date: Jun2023. The adverse event resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care visit. The patient had received treatment. The patient underwent lab tests and procedures which included on 28Feb2021 - blood test: little bit anaemic, urine analysis: unknown result, weight: 150 lbs he is down to 150lbs, he has not been eating very well, blood iron: low, white blood cell count: high- but has come down a little bit and sars-cov-2 test: negative on 07Mar2021. Outcome of the event Night sweats/hot flashes, loss of appetite and taste buds. Feeling meh, joint pains was not recovered; pain in his arm was recovered; white cell count was high was recovering and all other events was unknown. There is a Product Complaint. Description of complaint: The caller received his second Pfizer COVID shot four weeks ago and has been sick every day since. The caller states he knows its not a live vaccine like a flu shot, but he has having a lot of reactions that one would have if they had COVID. No follow-up attempts are possible. No further information is expected. No further details were provided or obtained.

Other Meds:

Current Illness:

ID: 1528267
Sex: F
Age:
State: WV

Vax Date: 03/08/2021
Onset Date: 03/08/2021
Rec V Date: 08/05/2021
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Symptoms: Pressure had dropped to 158/108 and I told you before it was extremely high; Before it was up around 190/180 something like that; Nausea; Throat and mouth started by getting very dry; Throat and mouth started by getting very dry; Rapid heartbeat; Light-headed; Sick on stomach; Blood pressure went through the roof; Heart skipping beats; This is a spontaneous report from a contactable consumer or other non hcp. A 69-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN6198), dose 1 via Intramuscular in arm left on 08Mar2021 (at the age of 69-years-old) as dose 1, single for covid-19 immunisation. Medical history included Acid reflux, and Anxiety. Concomitant medication included omeprazole 40 mg tablet, Orally once a day for Acid reflux. On 08Mar2021, the patient experienced throat and mouth started by getting very dry, rapid heartbeat, light-headed, sick on stomach, blood pressure went through the roof, heart skipping beats, nausea, pressure had dropped to 158/108 and i told you before it was extremely high; before it was up around 190/180 something like that. The patient underwent lab tests and procedures which included blood pressure measurement: 190/180 mmhg, it was up around 190/180 something , blood pressure measurement: 158/108 mmhg. Pressure had dropped to 158/108 , heart rate increased: rapid on 08Mar2021 and EKG with result unknown. Patient have Anxiety occasionally. She reported It's there since she was a child. It was years ago. Patient reported the injection did not hurt. After the vaccination, the patient was given a number to contact in case of emergency. She had a reaction and I call. She was taken out by an ambulance. Her throat and mouth started by getting very dry and she developed rapid heartbeat, extremely rapid and her blood pressure went through the roof. She do not have high blood pressure. She was advised by my doctor and 2 emergency room doctor, not to take the second shot. Everything within 10 minutes started, she got little lightheaded and was sick on her stomach but she did not throw up. The second dose was supposed to be on 29Mar but she was advised by 3 doctors that she should not take it. The patient reported that she had no laboratory test but she reported she had routine blood check. When probed if consumer is still experiencing the events, the consumer stated No. In the past when they were checking on her they kept on saying she was skipping beats. She received treatment for nausea. They took her blood for EKG and then at the end before they let her go home the pressure had dropped to 158/108 and she was extremely high, because it was 158/108 they gave her 2 shot and she thought it was Ativan (Consumer was unsure) to relax her. To see if it could go down any further. Before it was up around 190/180 something like that. When probed about the dosage of the treatment, consumer stated, "No, because at that time I was flipping, I wasn't out of my mind but my heart kept flipping and skipping." The patient asked can the first dose alone give her any protection as she cannot take the second dose as per medical consultation. Outcome of the events were unknown. No follow-up attempts are possible. No further information is expected.

Other Meds: OMEPRAZOLE

Current Illness:

ID: 1528268
Sex: F
Age:
State: CA

Vax Date: 04/09/2021
Onset Date: 04/01/2021
Rec V Date: 08/05/2021
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Symptoms: Pins and needles for 11 weeks/left side of face tingling/left arm started tingling and also left leg; Ringing in my ears; Cherry angiomas type marks all over body; This is a spontaneous report received from a contactable consumer (patient). A 40-year-old non pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot #: ER8729) via an unspecified route of administration on 09Apr2021 at 10:45 (at the age of 40-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history was reported as none. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported; however, it was reported that there were no other medications taken within two weeks of the COVID-19 vaccine. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 09Apr2021, the patient experienced pins and needles for 11 weeks/left side of face tingling/left arm started tingling and also left leg and on an unspecified date in Apr2021, the patient experienced ringing in my ears and cherry angiomas type marks all over body. The events were reported as serious for disability or permanent damage. The clinical course was reported as follows: The patient's left side of face started tingling within 15 minutes of getting the shot. On the next day, her left arm started tingling and also left leg. She also had ringing in her ears. The patient also stated that she has had pins and needles for 11 weeks post vaccine. The adverse events resulted in a doctor or other healthcare professional office/clinic visit. Treatment was received for the adverse events and was unspecified. The patient was tested for COVID-19 post vaccination on Jul2021 (nasal swab; PCR) which was negative. The clinical outcomes of the events pins and needles for 11 weeks/left side of face tingling/left arm started tingling and also left leg, ringing in my ears and cherry angiomas type marks all over body were not recovered/ not resolved.

Other Meds:

Current Illness:

ID: 1528269
Sex: M
Age:
State: FL

Vax Date: 07/19/2021
Onset Date: 07/01/2021
Rec V Date: 08/05/2021
Hospital: Y

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Symptoms: His Adam's apple area is very swollen; currently in the hospital without the ability to swallow/not able to swallow; Does he have to start over from scratch with the second vaccine dose since it has ben over 6 weeks from the first?/it has been over 42 days; Does he have to start over from scratch with the second vaccine dose since it has ben over 6 weeks from the first?"/He received the second dose, 4 days ago, on 19uly2021; doctors think he has an infection, his lungs have pneumonia; his lungs are full; This is a spontaneous report from a contactable consumer (patient's spouse). An 82-years-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number EW0181), via an unspecified route of administration on 19Jul2021 (82-years-old at the time of vaccination) as single dose for COVID-19 immunization. Medical history included Tested positive for COVID-19 on 05Mar2021, after receiving the first dose of the vaccine on 07Feb2021 (Lot# EN5818). The patient's concomitant medications were not reported. The patient previously took bnt162b2 for COVID-19 immunisation and experienced High temperature (hospitalized from 05Mar2021 to 07Apr2021), No taste or smell -all events were reported as resolved. Patient's wife reported that her 82 years spouse who received his first vaccine on 07Feb2021 and who then tested positive for Covid on 05Mar2021 (also reported he had COVID in Apr2021), had been hospitalized twice with a high fever. Patient wife told it has been over 42 days, that's why the delay in the second vaccine dose, weren't sure if they should get one or not, so does he start all over again or does he just take the second shot? She states she has asked every medical person in town and no one knows, so she is calling the source. As of 23Jul2021 it was further reported that the patient received his second vaccine shot on Sunday [19Jul2021] and 2 days later [21Jul2021] he was not able to swallow. His Adam's apple area was very swollen since 21Jul2021 and he was being in the hospital for 4 days due to swollen Adam's apple, with inability to swallow. He was in emergency for several days and he was getting worse. The patient was currently in hospital. The doctors put their heads together and they can't figure out what is wrong with him; the reporter think's it's a reaction to the vaccine. The doctors think "he has an infection, his lungs have pneumonia, his lungs are full". No follow-up attempts are needed; information about lot/batch number cannot be obtained. Follow-up (23Jul2021): New information reported from the same contactable consumer (patient's wife) includes: additional events "inability to swallow", "Adam's apple area is very swollen", "Infection / his lungs have pneumonia", "his lungs are full", all assessed as serious, second vaccine dose date and Lot#. Case upgraded to serious. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1528270
Sex: F
Age:
State: NJ

Vax Date: 05/11/2021
Onset Date: 05/12/2021
Rec V Date: 08/05/2021
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Symptoms: Fevers; Body aches; Severe migraines; Severe vomiting; Headaches; Diarrhea; The initial case was assessed as non-serious. Upon receipt of follow-up information on 27Jul2021, this case now contains all required information to be upgraded to serious. This is a spontaneous report from a contactable consumer (patient). A non-pregnant 35-year-old female patient received the first and second doses of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), both intramuscular in left arm, on 11May2021 at 06:15 PM (18:15; at the age of 35 years) (Lot Number: EW0168, Expiration Date: Aug2021), as dose 1, single, and then on 01Jun2021 at 18:00 (06:00 PM; at the age of 35 years) (Lot Number: EW0180), as dose 2, single, for COVID-19 immunization. The patient had no medical history and concomitant medications. The patient had no known allergies. The patient was not diagnosed with COVID-19 prior vaccination. No other vaccine was administered in four weeks. The vaccine was administered in a pharmacy or drug store facility. Both doses caused extreme reactions including fevers, body aches, severe migraines, severe vomiting, headaches, and diarrhea on 12May2021 and then again on 02Jun2021. The events required visit to the physician office. The events were considered serious due to persistent or significant disability or incapacity (severe and incapacitating). The patient took medicine as treatment for migraine. The other events did not require the initiation of new medication, other treatment, or procedure. The patient was not tested for COVID-19 post vaccination. The patient was recovering from "Severe migraines". The outcome of "Headaches" and "Diarrhea" was unknown. The patient recovered with lasting effects (with sequel) from "Fever" in 2021; and recovered from the remaining events (without sequel) in 2021.

Other Meds:

Current Illness:

ID: 1528271
Sex: F
Age: 25
State: TX

Vax Date: 08/04/2021
Onset Date: 08/05/2021
Rec V Date: 08/05/2021
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Allergies: N/a

Symptom List:

Symptoms: I woke up from sleeping around 2:00 am on 8/5 (approx 12 hours after my vaccine) to difficulty breathing and a sore throat. I felt like there was pressure on my chest and although I could still take deep breaths, it was difficult.

Other Meds: Zinc - 1 tablet Advil 200mg - 2 tablets

Current Illness: N/a

ID: 1528272
Sex: F
Age: 75
State: WA

Vax Date: 01/25/2021
Onset Date: 02/13/2021
Rec V Date: 08/05/2021
Hospital: Y

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Allergies: Remicade

Symptom List:

Symptoms: Noticed pain in back on 02-13-1921 that patient thought was a kidney infection. Treated at hospital emergency room on 02-18-1921 for infection and water retention and sent home. Returned to hospital on 02-19-1921 and was diagnosed with a blood clot in her left lung and heart in A-Fib. Was in Medical Center for 5 days. Treated with Warfarin.

Other Meds: Oxygen , Prednisone , Pramipexole , Symbicort 160-4.5 MCG/ACT Aero, Diltiazem XR 240, Losartan Potassium , Tylenol and Vitamin C.

Current Illness: Listed in #12 below.

ID: 1528273
Sex: F
Age: 52
State: HI

Vax Date: 05/07/2021
Onset Date: 07/31/2021
Rec V Date: 08/05/2021
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Symptoms: patient was exposed to COVID on 07/24, she is asymptomatic, tested positive for COVID on 7/31/2021

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Current Illness:

ID: 1528274
Sex: F
Age: 63
State: TX

Vax Date: 01/15/2021
Onset Date: 01/25/2021
Rec V Date: 08/05/2021
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Allergies: None

Symptom List:

Symptoms: Bruising, extreme low platelet count (2000) Platelet infusion, IVIG ( multiple doses), Rituxin Treatment course still underway Diagnosed June 21, 2021- under care of doctor, multiple doctor visits including emergency room

Other Meds: Vitamin D Meloxicam

Current Illness: None

ID: 1528275
Sex: F
Age: 43
State: HI

Vax Date: 03/24/2021
Onset Date: 08/03/2021
Rec V Date: 08/05/2021
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Symptoms: patient was exposed to someone with COVID, asymptomatic, tested positive for COVID on 8/3/2021

Other Meds:

Current Illness:

ID: 1528276
Sex: M
Age: 57
State: FL

Vax Date: 05/20/2021
Onset Date: 07/01/2021
Rec V Date: 08/05/2021
Hospital: Y

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Lab Data:

Allergies: Penicillin

Symptom List:

Symptoms: Enlarged and weak heart. Shortness of breath. Very high heart rate 200 plus .all these affects started happening after 2nd shot . heart needed to be shocked to get correct heartbeat. Extreme fatigue. Very weak and short of breath.

Other Meds: None

Current Illness: None

ID: 1528277
Sex: F
Age: 16
State: CA

Vax Date: 07/19/2021
Onset Date: 07/19/2021
Rec V Date: 08/05/2021
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Symptoms: Vaccine was exposed to 80.6 degree Fahrenheit for 14 hours 15 minutes/ no AE; Initial information was received on 28-Jul-2021 regarding an unsolicited valid non-serious case received from an Other health professional via Medical Information (Reference number- 00700812) and transmitted to Sanofi on 28-Jul-2021. This case involves a 16-year-old female patient reported that MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] was exposed to 80.6-degree Fahrenheit for 14 hours 15 minutes with no adverse event (Product storage error) and the patient administered the vaccine after the temperature excursion with no adverse event (Poor quality product administered). Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided. On 19-Jul-2021, the patient received a 0.5 ml (once) dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [lot U6877BA and expiry date 28-Feb-2022] via intramuscular route in left deltoid for prophylactic vaccination. It was a case of actual medication error due to incorrect product storage and poor-quality vaccine administered (latency was on same day). It was reported that, " MA calling to report a temperature excursion caused by a fridge malfunction that lasted for 14 hours 15 minutes with a high temperature of 80.6?F. Medical Assistant reporting on behalf of a 16-year-old female receiving a Menactra dose after the Menactra was exposed to a temperature excursion that made the vaccine not suitable for use. The caller reported that the temperature excursion was on 25Jun2021 and the vaccine was administered on 19Jul2021 and she wants to know if anything needs to be done in regard to this. Vaccines. Product used: Used. Still using product: No". At the time of reporting, patient had no adverse event. 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 guidelines. 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: 1528278
Sex: U
Age:
State: GA

Vax Date:
Onset Date:
Rec V Date: 08/05/2021
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Symptoms: Hib portion was reconstituted with normal saline and the DTap-IPV portion was not given/ no AE; Initial information was received on 28-Jul-2021 regarding an unsolicited valid non-serious case received from a Nurse via Agency (Reference number- 00701210) and transmitted to Sanofi on 28-Jul-2021. This case involves a patient (unknown age and unknown gender) reported that while being treated with DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] Hib portion was reconstituted with normal saline and the DTap-IPV portion was not given with no adverse event (product preparation error). Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided. On an unknown date, the patient received a 0.5 ml (total) dose (once) of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [lot number not reported, and expiry date not provided] via unknown route in unknown administration site for prophylactic vaccination. It was reported that, "A Nurse reporting a medication error for Pentacel described as the Hib portion was reconstituted with normal saline and the DTap-IPV portion was not given. The caller reported that information is limited for this report do to not knowing all the facts; that she believes the Hib portion was given with normal saline; that the DTap-IPV portion was not given. PENTACEL blue top was given with just normal saline instead of green top. Is this dose suitable or does it need to be repeated? Product used: Used Still using product : No". It was a case of actual medication error due to active ingredient not added to diluent (latency was on same day). At the time of reporting, patient had no adverse event. There will be no information available on batch number for this case. 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.

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Current Illness:

ID: 1528279
Sex: M
Age:
State: CA

Vax Date: 07/28/2021
Onset Date: 07/28/2021
Rec V Date: 08/05/2021
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Symptoms: A patient received a expired vaccine, no AE; Initial information regarding an unsolicited valid non-serious case was received from other healthcare professional via Medical Information (Reference number- 00701286) and transmitted to Sanofi on 28-Jul-2021. This case involves a 16-month-old male patient who received an expired HIB (PRP/T) VACCINE [ACT-HIB] (expired product administered). The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DAPTACEL) and PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for prophylactic vaccination. On 28-Jul-2021, the patient received 0.5 mL dose of expired suspect HIB (PRP/T) VACCINE (lot UJ358AAB and expiry date: 27-Jul-2021) via an intramuscular route in the right thigh for prophylactic vaccination (expired product administered). This was a case of actual medication error due to Expired vaccine used (latency same day). At time of reporting, no adverse events were 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: DAPTACEL; PREVNAR 13

Current Illness:

ID: 1528280
Sex: M
Age: 18
State: IN

Vax Date: 07/28/2021
Onset Date: 07/28/2021
Rec V Date: 08/05/2021
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Symptoms: receiving an extra dose with no reported adverse event; Initial information received on 29-Jul-2021 regarding an unsolicited valid non-serious case received from a other health professional via Media Information (under the reference). This case involved a 18 years old male patient who had an extra dose with no reported adverse event (extra dose administered) after receiving MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (MENACTRA). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included MENINGOCOCCAL VACCINE B RFHBPA/FHBPB (TRUMENBA) for Immunisation. On 28-Jul-2021, the patient received a dose 3 of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (o.5 ml, solution for injection, lot U6921AA and expiration date: 17-apr-2021) via intramuscular route in the right deltoid for prophylactic vaccination. On 28-JUL-2021 the patient developed a non-serious receiving an extra dose with no reported adverse event (extra dose administered) following the administration vaccine. It was an actual medication error due to extra dose administered. It was not reported if the patient received a corrective treatment for the event (receiving an extra dose with no reported adverse event). No laboratory data reported. At time of reporting, the outcome was Unknown for the reported event. 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 guidelines. 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: TRUMENBA

Current Illness:

ID: 1528281
Sex: M
Age: 3
State: WV

Vax Date: 07/29/2021
Onset Date: 07/29/2021
Rec V Date: 08/05/2021
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Symptoms: patient received an expired dose of ACTHIB with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from the other health care professional via medical information (Reference number- 00702980) and transmitted to Sanofi on 29-Jul-2021. This case involves a 3-year-old male patient received an expired dose of suspect HIB (PRP/T) VACCINE [ACT-HIB] (expired product administered). Concomitant medications included HEPATITIS A VACCINE (HEPATITIS A), PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVENAR 13) and DIPHTHERIA VACCINE TOXOID, HEPATITIS B VACCINE RHBSAG (YEAST), PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID (PEDIARIX). Medical history, medical treatment, vaccination and family history were not provided. On 29-Jul-2021, the patient received a 0.5 mL first dose of suspect HIB (PRP/T) VACCINE [total, once, strength: standard, UJ358AA, expiry date: 27-Jul-2021] via an intramuscular route at the right thigh for prophylactic vaccination (expired product administered). (Latency: on the same day) It was a case of actual medication error due to expired vaccine use. It was reported that, "nurse practitioner asked for information regarding administration of expired dose". At the time of report, no adverse event 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: HEPATITIS A; PREVENAR 13; PEDIARIX

Current Illness:

Total 2021 VAERS Injuries: 605,812

Page last modified: 03 October 2021 5:28pm