chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Dyspnoea, Headache, Heart rate, Heart rate increased
Clinical narrative: difficulty breathing; Difficulty swallowing ( felt as if my throat was closing); rapid heart beat; severe headache; This is a spontaneous report from a contactable consumer (patient).   A 35-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: Ff8839, Expiry Date: Not Reported), via an unspecified route of administration, administered in Arm Left on 29Sep2021 (at the age of 35-year-old) at 16:30 as dose 2, single for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The medical history included seizure. There were no concomitant medications. The patient historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: Fc3182, Expiry Date: Not reported) via an unspecified route of administration, administered in Arm Left on 08Sep2021 (at the age of 35-year-old) at 16:15 as dose 1, single for covid-19 immunisation. No other vaccine in four weeks. No other medications in two weeks. No covid prior vaccination. No covid tested post vaccination. The patient did not have any known allergies. On 30Sep2021, the patient experienced, difficulty swallowing (felt as if my throat was closing), rapid heartbeat, severe headache, difficulty breathing. Lasted about 20 or 30 mins. The patient underwent lab tests and procedures which included heart rate: rapid on 30Sep2021. The AE resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for reported event. Outcome of the events was not recovered.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Swelling face
Clinical narrative: facial numbness/numbness in her left arm; swelling on the left side of her face; This is a spontaneous report from a contactable consumer reported for her daughter (patient). A 23-years-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 07Oct2021 at age of 23-years-old as dose number unknown, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.  The patient received the vaccine, and now was suffering from numbness. The patient had the Pfizer vaccine this morning at 10 and she was getting worse with facial numbness and swelling on the left side of her face and numbness in her left arm and she was very concerned. This wasn't showing up or listed as a side effect. Reporter stated they reached out to the doctor but they didn't want her in the ER because of Covid and said to go tomorrow if it gets worse. The outcome of the events was unknown.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: His wife tested positive; His wife tested positive; This is a spontaneous report from a Pfizer-sponsored program with Regulatory Authority Support. A contactable consumer reported for a 71-year-old female patient (wife) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EL9262, Expiry date: unknown) via an unspecified route of administration, administered in Arm Left on 04Feb2021 (at the age of 70 years old) as dose 1, single and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EN6200, Expiry date: unknown) via an unspecified route of administration, administered in Arm Left on 25Feb2021 as dose 2, single COVID-19 immunization. Medical history included urinary tract infection and had treatment for UTI. Caller's wife stated that she had treatment with a Z-Pak. She was prescribed, an antibiotic, and she had treatment for UTI, so that was a different type of antibiotic. She says that the packages for those antibiotics were discarded when they were done with them, she doesn't remember the dosages and doesn't have NDC/LOT/EXP to provide for his Z-pak or her unspecified antibiotic. Caller's wife's outcome of having COVID queried, but not provided. The patient's concomitant therapy was not reported. The reporter stated that his wife did get both doses of the Pfizer COVID-19 vaccine, and she also popped positive for a COVID test on 26Aug2021. He says the good thing was that they were in a group at a family reunion of 25 so maybe 30 people get together for a week in Aug, and of course all of them were vaccinated so they thought they were safe, then he found out he wasn't, so they immediately left the group and nobody else had positive tests, just him and his wife. She says that they had pretty sloppy handwriting, and no NDC/EXP were provided on the handwritten vaccine card. She says she tested positive for COVID on 26Aug2021, then clarifies her first positive was 29Aug2021, using the home test Ellume, which they are having problems with that test it has been on the news. She says she tested negative on 27Aug2021, so she doesn't know. The reporter assessed as non-serious. The patient underwent lab tests and procedures which included sars-cov-2 test negative on 27Aug2021 More information available: No, sars-cov-2 test: positive on 29Aug2021. The outcome of the events was unknown. Follow up attempts are completed. No further information was expected. Sender's Comments: Linked Report(s): US-PFIZER INC-202101332905 same reporter/drug/event, different patients.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Fatigue, Vaccination failure
Clinical narrative: Tested positive for Covid 19; Tested positive for Covid 19; fatigue; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 55-Year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in Arm Right on 15Mar2021 12:00 (at the age of 54-Year-old, Lot Number: EL3247) as dose 2, single, dose 1 via an unspecified route of administration, administered in Arm Right on 22Feb2021 12:00 (at the age of 54-Years-old, Lot Number: EL3247) as dose 1, single for covid-19 immunisation. Patient received both the doses at clinic. The patient's medical history was reported as none. The patient's concomitant medications were not reported. Past medication included flu vaccine received on 06Oct2021. Patient did not have, NDC, Lot Number, or Expiry Date for this flu vaccine. She received it at the clinic. Patient's family history was reported as none. Patient denied any other medications, medical conditions, labs, testing, or treatments relevant to these events. On 07Oct2021, the patient tested positive for covid 19 and had breakthrough case of covid 19 which showed vaccination failure. On an unknown date in 2021, patient experienced fatigue after the Pfizer Covid Vaccines. Events were considered as medically significant except fatigue. The patient underwent lab tests and procedures which included sars-cov-2 test and showed positive results on 07Oct2021. Additional Vaccines Administered on Same Date of the Pfizer Suspect If applicable, list all vaccines administered on same date with the Pfizer vaccine considered as suspect was reported as None. Any other vaccinations within four weeks prior to the first administration date of the suspect vaccine was reported as None. The outcome of event tested positive for covid 19 was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Syncope
Clinical narrative: passed out (fainted); Prolonged trouble breathing; extreme long-term dizziness; This is a spontaneous report from a contactable consumer (Patient). A 20-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6206) via an unspecified route of administration, administered in left arm on 22Mar2021 14:30 (at the age of 20-years-old) as dose 2, single for covid-19 immunization. Patient was not pregnant at the time of vaccination. The patient medical history included chronic pain and moderate asthma. Patient previously took amoxicillin and experienced allergy. Patient was known allergic to Penicillin and Shellfish. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6202) via an unspecified route of administration, administered in left arm on 01Mar2021 03:45 (at the age of 20-years-old) as dose 1, single for covid-19 immunization and experienced prolonged trouble breathing. The patient concomitant medications included bupropion hydrochloride (WELLBUTRIN) 150mg and YAz birth control (within two weeks of vaccination). Patient received other vaccine on the same date (Pfizer vaccine date) 04Oct2021. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. Patient had not received any other vaccines within 4 weeks. On 22Mar2021, the patient experienced Prolonged trouble breathing, extreme long-term dizziness, passed out (fainted) within a few hours after receiving the second dose. It was reported that the adverse events resulted in doctor or other healthcare professional office/clinic visit. It was unknown if the patient had received treatment for the events. The patient also received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EW0202) via an unspecified route of administration, administered in right arm on 04Oct2021 02:30 PM as dose 3, single for covid-19 immunization and experienced prolonged trouble breathing, prolonged swollen axillary lymph nodes after booster dose. Outcome of the events was recovering.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Breast pain, Chest pain, Migraine, Neck pain
Clinical narrative: Left breast pain close to arm pit radiation shooting pain to my chest; Left breast pain close to arm pit radiation shooting pain to my chest; Neck/back pain; Neck/back pain; severe migraine; blurry vision in left eye; This is a spontaneous report from a contactable consumer (patient). A 31-year-old female patient received third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: Ff2587) via an unspecified route of administration, administered in left arm on 06Oct2021 13:45 (at the age of 31-year-old) as dose 3 (booster), single for covid-19 immunisation. Patient was not pregnant at the time of vaccination. Medical history included asthma and obese from an unknown date and unknown if ongoing and known allergies from coconut and latex from an unknown date and unknown if ongoing. Concomitant medications in two weeks included Buspirone, Bupropion. Patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL0142) administered in right arm on 22Jan2021 10:00 and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL8982) in left arm on 12Feb2021 10:00 for covid-19 immunisation. Patient did not receive other vaccine in four weeks. Patient had no Covid prior vaccination. Patient not tested for covid post vaccination. On 07Oct2021 12:00, the patient experienced left breast pain close to arm pit radiation shooting pain to my chest, neck/back pain, severe migraine, blurry vision in left eye. No treatment taken for adverse events. Outcome of the events was not recovered at the time of reporting.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: Left breast pain close to arm pit radiation shooting pain to my chest; Left breast pain close to arm pit radiation shooting pain to my chest; Neck/back pain; Neck/back pain; severe migraine; blurry vision in left eye; This is a spontaneous report from a contactable consumer (patient). A 31-year-old female patient received third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: Ff2587) via an unspecified route of administration, administered in left arm on 06Oct2021 13:45 (at the age of 31-year-old) as dose 3 (booster), single for covid-19 immunisation. Patient was not pregnant at the time of vaccination. Medical history included asthma and obese from an unknown date and unknown if ongoing and known allergies from coconut and latex from an unknown date and unknown if ongoing. Concomitant medications in two weeks included Buspirone, Bupropion. Patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL0142) administered in right arm on 22Jan2021 10:00 and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL8982) in left arm on 12Feb2021 10:00 for covid-19 immunisation. Patient did not receive other vaccine in four weeks. Patient had no Covid prior vaccination. Patient not tested for covid post vaccination. On 07Oct2021 12:00, the patient experienced left breast pain close to arm pit radiation shooting pain to my chest, neck/back pain, severe migraine, blurry vision in left eye. No treatment taken for adverse events. Outcome of the events was not recovered at the time of reporting.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate irregular, Immunisation, Lymphadenitis, Off label use
Clinical narrative: Heart rate up to 204 within minutes of receiving the vaccine; heart rate fluctuated between 104-114 fifteen minutes later, eventually normalized after 30 minutes; severe lymph node inflamed under armpit the following day; dose number=3; dose number=3; This is a spontaneous report from a contactable consumer (patient).   A 38-years-old non-pregnant female patient received booster dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: FF2587, expiration date not reported), via an unspecified route of administration, administered in right arm on 05Oct2021 17:00 (at the age of 38 years) as dose 3 (booster), single for COVID-19 immunization. Medical history included allergies to penicillin and sulfa from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Patient previously received first dose of bnt162b2 (Lot Number: EL3249) as dose 1, single and second dose of bnt162b2 (Lot number: EN9581) as dose 2 single, both via an unspecified route of administration on an unspecified date for COVID-19 immunization. Patient was not pregnant at the time of vaccination. No other vaccine in four weeks. No covid prior vaccination and not COVID tested post vaccination. On 05Oct2021 17:15, the patient experienced heart rate up to 204 within minutes of receiving the vaccine; heart rate fluctuated between 104-114 fifteen minutes later, and eventually normalized after 30 minutes. Patient also had severe lymph node inflamed under armpit the following day (same arm as injection site) on 05Oct2021 17:15. Events resulted in doctor or other healthcare professional office/clinic visit. Treatment received for events was unknown. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Heart rate, Heart rate increased, Nausea, Near death experience
Clinical narrative: i thought i was going to die; horrible body aches; piled a fast heart rate; i had forty-two hours of severe nausea during which i could not even hold down a drop of water; massive headache; This is a spontaneous report from a non-contactable consumer(patient). A 61-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number and expiration date was not reported) via an unspecified route of administration, administered on 21Apr2021 as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications was not reported. Historical vaccination included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number and expiration date was not reported) via an unspecified route of administration, administered an unknown date as dose 1, single for COVID-19 immunization. The patient reported that she had forty two hours of severe nausea during which she could not even hold down a drop of water in addition to a massive headache and horrible body aches and piled a fast heart rate, she thought she was going to die. The patient underwent lab tests and procedures which included heart rate and reported as fast on an unknown date. The outcome of the events was reported as unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: i thought i was going to die; horrible body aches; piled a fast heart rate; i had forty-two hours of severe nausea during which i could not even hold down a drop of water; massive headache; This is a spontaneous report from a non-contactable consumer(patient). A 61-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number and expiration date was not reported) via an unspecified route of administration, administered on 21Apr2021 as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications was not reported. Historical vaccination included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number and expiration date was not reported) via an unspecified route of administration, administered an unknown date as dose 1, single for COVID-19 immunization. The patient reported that she had forty two hours of severe nausea during which she could not even hold down a drop of water in addition to a massive headache and horrible body aches and piled a fast heart rate, she thought she was going to die. The patient underwent lab tests and procedures which included heart rate and reported as fast on an unknown date. The outcome of the events was reported as unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Cardiac arrest, Dizziness, Nausea, Seizure
Clinical narrative: seizure; cardiac arrest; nauseous; dizzy; This is a spontaneous report from a contactable consumer (parent) reported for patient (son). A 16-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on Jun2021 as dose 2, single for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported. He has had no prior health issues. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) in May2021 at age of 16-years-old for COVID-19 immunization. On 19Jul2021 upon arriving to a friend's house, the patient suffered a seizure than cardiac arrest. He was resuscitated 3x prior to arriving at the hospital, thankfully getting his pulse back. If he was not where he was reporter would be writing you a very different email as thankfully the house he was at was able to administer CPR. He was airlifted to a hospital where testing began to try to find out what happen. It was ruled his event was cardiac related, not neurological. Prior to the event he was nauseous, and dizzy. He was tested for myocarditis which came back negative. A defibrillator was now in his chest, and her son will never play sports again. For a 14-year-old (as reported), this was a huge hit mentally. She read so much about the effect of the vaccine. The nausea, the dizziness, the cardiac arrest. All signs point to that a child wouls have had chest pains, and that these symptoms occur a certain amount of time ater vaccination. The fact that he was working out after the vaccine too, and an athelet by nature, just make her even more curious. With her son, it happened about 5 weeks post vaccination and no myocarditis that thay have seen to date. The signs and symptoms are so spot on for what happened to him. He could have died, in fact on paer, he did and was resuscitated. The outcome of the events was unknown.  The lot number for BNT162B2 was not provided and will be requested during follow-up.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Headache, Malaise
Clinical narrative: Fatigue; fever; chills; extreme dizziness/nausea; extreme dizziness/nausea; headache; malaise; This is a spontaneous report from a contactable other hcp.   A patient of unspecified age and gen-der received third booster dose bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number: not reported), dose 3 via an unspecified route of administration on an unspecified date as dose 3 (BOOSTER), Single for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. Historical vaccine received second dose bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection,), via an unspecified route of administration on an unspecified date Single, received first dose bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection,), via an unspecified route of administration on an unspecified date Single for covid-19 immunisation. Fatigue, fever, chills, extreme dizziness/nausea, headache, malaise for 18 hours which started 12 hours third shot (8 months after second shot).The patient experienced fatigue, fever, chills, extreme dizziness/nausea, headache, malaise.  The outcome of events was unknown.  The lot number for the vaccine, [BNT162B2] was not provided and will be requested during follow-up.
Sex: U
Vaccine: COVID19
Symptoms: Nausea, Pyrexia
Clinical narrative: Fatigue; fever; chills; extreme dizziness/nausea; extreme dizziness/nausea; headache; malaise; This is a spontaneous report from a contactable other hcp.   A patient of unspecified age and gen-der received third booster dose bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number: not reported), dose 3 via an unspecified route of administration on an unspecified date as dose 3 (BOOSTER), Single for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. Historical vaccine received second dose bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection,), via an unspecified route of administration on an unspecified date Single, received first dose bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection,), via an unspecified route of administration on an unspecified date Single for covid-19 immunisation. Fatigue, fever, chills, extreme dizziness/nausea, headache, malaise for 18 hours which started 12 hours third shot (8 months after second shot).The patient experienced fatigue, fever, chills, extreme dizziness/nausea, headache, malaise.  The outcome of events was unknown.  The lot number for the vaccine, [BNT162B2] was not provided and will be requested during follow-up.
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: passed away; This is a spontaneous report from a Regulatory Authority from a contactable consumer reported for a patient (friend). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization.  Medical history included staph infections. The patient's concomitant medications were not reported.  The patient had a couple staph infections before, received the Pfizer BioNTech COVID-19 Vaccine and 2 days later, had passed away. The patient died on an unspecified date. The outcome of the event was fatal. It was not reported if an autopsy was performed.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Reported Cause(s) of Death: passed away
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Death, Laboratory test, Swelling, Syncope, Urinary retention
Clinical narrative: death/died; Couldn''t even urinate, collapsed with kicking by Mess, like to trauma unit.; swelling from the waist down; collapsed with kicking by Mess, like to trauma unit; This is a spontaneous report from a non-contactable consumer. A 62-year-old male patient (Uncle) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 23Jun2021 (at the age of 62 years old) (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient's medical history included hospitalization. Patient had had multiple hospitalization. No Other Medical Conditions, not even cold, no diabetes, no cancer. The patient's concomitant medications were not reported. The patient declared death and died on 24Jun2021 from the Pfizer vaccine. He died because he was forced to get the shot to keep his job and died within 24 hour and that was in the report. He died in the trauma unit of the hospital. It was unknown if an autopsy was performed. He experienced swelling from the waist down immediately after his 2nd shot and by that evening, couldn't even urinate, collapsed with kicking by Mess, like to trauma unit and died next morning and doctor declared, It's a vaccine injury. For Height and Weight, Reporter Stated, "Probably 6 foot may be 175 (not clarify, hence not captured in tab). For Other Medications, Reporter Stated, "Not that I am aware of. They are not take any medications". The patient was hospitalized on the 23rd, that evening he admitted, 23rd June (23Jun2021). Seriousness for He died in the trauma unit of the hospital was Hospitalization, Death. The patient underwent lab tests and procedures which included lab test with unknown results on an unspecified date. The outcome of the event death/died was fatal, of the other events was unknown.   No follow-up attempts are possible; information about lot/batch cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101335055 same reporter/drug, different patient/event.;US-PFIZER INC-202101335048 same reporter/drug, different patient/event.; Reported Cause(s) of Death: death/died
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Cough, Diarrhoea, Headache
Clinical narrative: I ran a low grade fever of 100.3 for 2 days; had a severe headache; joint pain; nausea; diarrhea; body aches; runny nose; dry cough; This is a spontaneous report from a contactable other hcp (patient herself).   A 45-years-old female patient received bnt162b2 (BNT162B2, formulation: solution for injection , lot number: 301308A, expiration date: not reported), via an unspecified route of administration, administered in Arm Left on 15Sep2021 19:30 (at the age of 45 years) as dose 1, single for COVID-19 immunization. Medical history included Known allergies from Flu vaccine, Eggs, Coconut, Seafood and Lyrica. Patient had no COVID prior vaccination. Concomitant medication(s) included ibuprofen (IBUPROFEN) taken for an unspecified indication, start and stop date were not reported; paracetamol (TYLENOL) taken for an unspecified indication, start and stop date were not reported. On 16Sep2021 at 06:00, the patient ran a low grade fever of 100.3 for 2 days, had a severe headache, joint pain, nausea, diarrhea, body aches, runny nose, dry cough. Patient had Covid test type post vaccination: Nasal swab on 27Sep2021 and results were Negative. Patient did not receive any treatment. Clinical outcome of the event was reported as recovered in Sep-2021.  Follow-Up (14Oct2021): Follow-up attempts are completed. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Pyrexia, Rhinorrhoea, SARS-CoV-2 test
Clinical narrative: I ran a low grade fever of 100.3 for 2 days; had a severe headache; joint pain; nausea; diarrhea; body aches; runny nose; dry cough; This is a spontaneous report from a contactable other hcp (patient herself).   A 45-years-old female patient received bnt162b2 (BNT162B2, formulation: solution for injection , lot number: 301308A, expiration date: not reported), via an unspecified route of administration, administered in Arm Left on 15Sep2021 19:30 (at the age of 45 years) as dose 1, single for COVID-19 immunization. Medical history included Known allergies from Flu vaccine, Eggs, Coconut, Seafood and Lyrica. Patient had no COVID prior vaccination. Concomitant medication(s) included ibuprofen (IBUPROFEN) taken for an unspecified indication, start and stop date were not reported; paracetamol (TYLENOL) taken for an unspecified indication, start and stop date were not reported. On 16Sep2021 at 06:00, the patient ran a low grade fever of 100.3 for 2 days, had a severe headache, joint pain, nausea, diarrhea, body aches, runny nose, dry cough. Patient had Covid test type post vaccination: Nasal swab on 27Sep2021 and results were Negative. Patient did not receive any treatment. Clinical outcome of the event was reported as recovered in Sep-2021.  Follow-Up (14Oct2021): Follow-up attempts are completed. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Pain in extremity, Pyrexia
Clinical narrative: The next day (06Oct), I could barely walk as my limbs were very sore; I experienced extreme exhaustion-enough to keep me in bed; On the afternoon (5Oct)that I received the booster dose (#3) of the Pfizer vaccine, I developed fever (102); shivering. The shivering was very intense--more like shaking.; The shivering was very intense-more like shaking.; This is a spontaneous report from a contactable consumer(patient herself). A 69 years non-pregnant old female patient received dose 3 BNT162B2 PFIZER BIONTECH COVID 19 VACCINE mRNA, lot number:3015581A) via unspecified route of administration in Left arm administered on 05 Oct2021 at 10:00AM. Patient medical history include glaucoma and elevated cholesterol from unspecified date. Patient's other medications in two weeks included multivit, fishoil, magnesium, C, D, Bilberry. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: EN6205) via an unspecified route of administration, administered in arm left on 06Mar2021 as dose 2, single and dose 1 of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: EL9264) via an unspecified route of administration, administered in arm left on 13Feb2021 as dose 1, single for covid-19 immunisation. Patient received vaccine at Pharmacy or Drug Store. Patient had not received any other vaccine in 4 weeks. Patient did not have covid prior vaccination. The patient did not tested covid post vaccination. On 05 Oct2021 the in afternoon patient received the booster dose (#3) of the Pfizer vaccine, developed fever (102) and shivering. The shivering was very intense-more like shaking. Patient took Tylenol but the shivering/shaking continued. The next day (06Oct) patient could barely walk as my limbs were very sore. Patient experienced extreme exhaustion-enough to keep me in bed. In the evening, the fever remained at 102.2. The next day (07Oct), the shivering has decreased and the fever came down to almost normal but the body aches and exhaustion continue. Patient had not received treatment for events. The patient underwent body temperature measurement results was 102 on 05Oct2021 and 102.2 on 06Oct2021. The outcome of events were recovering.   Follow-Up (14Oct2021): Follow-up attempts are completed. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: The next day (06Oct), I could barely walk as my limbs were very sore; I experienced extreme exhaustion-enough to keep me in bed; On the afternoon (5Oct)that I received the booster dose (#3) of the Pfizer vaccine, I developed fever (102); shivering. The shivering was very intense--more like shaking.; The shivering was very intense-more like shaking.; This is a spontaneous report from a contactable consumer(patient herself). A 69 years non-pregnant old female patient received dose 3 BNT162B2 PFIZER BIONTECH COVID 19 VACCINE mRNA, lot number:3015581A) via unspecified route of administration in Left arm administered on 05 Oct2021 at 10:00AM. Patient medical history include glaucoma and elevated cholesterol from unspecified date. Patient's other medications in two weeks included multivit, fishoil, magnesium, C, D, Bilberry. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: EN6205) via an unspecified route of administration, administered in arm left on 06Mar2021 as dose 2, single and dose 1 of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: EL9264) via an unspecified route of administration, administered in arm left on 13Feb2021 as dose 1, single for covid-19 immunisation. Patient received vaccine at Pharmacy or Drug Store. Patient had not received any other vaccine in 4 weeks. Patient did not have covid prior vaccination. The patient did not tested covid post vaccination. On 05 Oct2021 the in afternoon patient received the booster dose (#3) of the Pfizer vaccine, developed fever (102) and shivering. The shivering was very intense-more like shaking. Patient took Tylenol but the shivering/shaking continued. The next day (06Oct) patient could barely walk as my limbs were very sore. Patient experienced extreme exhaustion-enough to keep me in bed. In the evening, the fever remained at 102.2. The next day (07Oct), the shivering has decreased and the fever came down to almost normal but the body aches and exhaustion continue. Patient had not received treatment for events. The patient underwent body temperature measurement results was 102 on 05Oct2021 and 102.2 on 06Oct2021. The outcome of events were recovering.   Follow-Up (14Oct2021): Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Rash, SARS-CoV-2 test
Clinical narrative: I developed significant pain; swelling under my right arm; I developed a significant visible lump-like swelling extending from my right arm pit to my right Pectoralis & Teres Minor muscles.; The swelling was about 3" in diameter, discolored with a rash-like pinkish tone; The swelling was about 3" in diameter, discolored with a rash-like pinkish tone; This is a spontaneous report from a contactable consumer or other non hcp (Patient).  A 64 year-old adult female (Non pregnant) patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch number: not reported/Lot Number: 3013I8A), dose 3 via an unspecified route of administration, administered in Arm Right on 29Sep2021, at 15:30 as dose 3(BOOSTER), single for covid-19 immunisation. The patient previously received second dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch number: not reported/Lot Number: EP7534 & 3013I8A), via an unspecified route of administration, administered in Arm Right on 18Mar2021, at 09:00 AM (Age at the vaccination 64 years), as dose 2, single and first dose via an unspecified route of administration, administered in Arm Right on 26Feb2021, at 03:30 PM (Age at the vaccination 64 years), as dose 1, single for Covid-19 Immunization. Medical history included Grave's Disease, Celiac Disease, Raynaud's Disease from an unknown date and unknown if ongoing. Concomitant medications included methimazole (METHIMAZOLE) and olopatadine hydrochloride (PATADAY) taken for an unspecified indication, start and stop date were not reported. Patient did not receive other vaccine in four weeks. Patient did not received treatment as a result of AE. Patient not had covid prior to vaccination. On 30Sep2021, at 08:00 the patient developed significant pain, swelling under her right arm, developed a significant visible lump-like swelling extending from her right arm pit to her right Pectoralis & Teres Minor muscles, the swelling was about 3" in diameter, discolored with a rash-like pinkish tone. Timeframe between vaccination and starting of symptoms was 16 hrs 30 min. The patient underwent lab tests and procedures which included sars-cov-2 test (Nasal Swab) was negative on 04Oct2021. The outcome of the events was recovered.   Follow-Up (14Oct2021): Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: I developed significant pain; swelling under my right arm; I developed a significant visible lump-like swelling extending from my right arm pit to my right Pectoralis & Teres Minor muscles.; The swelling was about 3" in diameter, discolored with a rash-like pinkish tone; The swelling was about 3" in diameter, discolored with a rash-like pinkish tone; This is a spontaneous report from a contactable consumer or other non hcp (Patient).  A 64 year-old adult female (Non pregnant) patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch number: not reported/Lot Number: 3013I8A), dose 3 via an unspecified route of administration, administered in Arm Right on 29Sep2021, at 15:30 as dose 3(BOOSTER), single for covid-19 immunisation. The patient previously received second dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch number: not reported/Lot Number: EP7534 & 3013I8A), via an unspecified route of administration, administered in Arm Right on 18Mar2021, at 09:00 AM (Age at the vaccination 64 years), as dose 2, single and first dose via an unspecified route of administration, administered in Arm Right on 26Feb2021, at 03:30 PM (Age at the vaccination 64 years), as dose 1, single for Covid-19 Immunization. Medical history included Grave's Disease, Celiac Disease, Raynaud's Disease from an unknown date and unknown if ongoing. Concomitant medications included methimazole (METHIMAZOLE) and olopatadine hydrochloride (PATADAY) taken for an unspecified indication, start and stop date were not reported. Patient did not receive other vaccine in four weeks. Patient did not received treatment as a result of AE. Patient not had covid prior to vaccination. On 30Sep2021, at 08:00 the patient developed significant pain, swelling under her right arm, developed a significant visible lump-like swelling extending from her right arm pit to her right Pectoralis & Teres Minor muscles, the swelling was about 3" in diameter, discolored with a rash-like pinkish tone. Timeframe between vaccination and starting of symptoms was 16 hrs 30 min. The patient underwent lab tests and procedures which included sars-cov-2 test (Nasal Swab) was negative on 04Oct2021. The outcome of the events was recovered.   Follow-Up (14Oct2021): Follow-up attempts are completed. No further information is expected.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Deep vein thrombosis, Immunisation, Off label use, SARS-CoV-2 test
Clinical narrative: DVT in left leg 4 weeks after 2 nd doseRecurrent DVT in left leg 2 weeks after 3rd dose; Received dose 3; Received dose 3; This is a spontaneous report from a contactable physician (patient). This 52-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 intramuscular, administered in Arm Left on 06Jan2021 08:00 at age of 51-year-old as dose 2, single, dose 3 intramuscular, administered in Arm Left on 20Sep2021 13:00 at age of 51-year-old as dose 3 (booster), single for COVID-19 immunization.  Medical history included Factor V leiden, hypertension (HTN). No known allergies. Concomitant medications included cetirizine hydrochloride (ZYRTEC); lisinopril. No other vaccine in four weeks. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on 18Dec2020 03:00 PM in Arm Left at age of 51-year-old as dose 1, single for Covid-19 immunization. The patient experienced DVT in left leg 4 weeks after 2nd dose Recurrent DVT in left leg 2 weeks after 3rd dose on 04Oct2021 08:00. The event resulted in doctor or other healthcare professional office/clinic visit, Life threatening illness (immediate risk of death from the event). The patient underwent lab tests and procedures which included covid test: negative on 24Sep2021 (Nasal Swab).  Therapeutic measures were taken as a result of the event. The outcome of event DVT of legs was recovering, of other events was unknown.   The lot number for BNT162B2 was not provided and will be requested during follow-up.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event Deep vein thrombosis and BNT162B2. 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.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyskinesia, Fall, Magnetic resonance imaging, Weight
Clinical narrative: I fell twice, couldn''t figure out why I didn''t have no control over my body; I couldn''t stop myself from going down, I have got hit the floor twice; I have been dizzy, I was dizzy when I get up; I get up I''d feel dizzy; I fell twice, couldn''t figure out why I didn''t have no control over my body; I couldn''t stop myself from going down, I have got hit the floor twice; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 73-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: FF2589) via an unspecified route of administration, administered in arm left on 16Sep2021 (at age of 73 years old) as dose 1, single for COVID-19 immunization. Medical history included cerebrovascular accident from an unknown date and unknown if ongoing, hypertension from an unknown date and unknown if ongoing. Concomitant medications included escitalopram oxalate (LEXAPRO) taken for an unspecified indication from an unspecified start date and ongoing; metoprolol taken for hypertension, cerebrovascular accident from an unspecified start date and ongoing; famotidine taken for an unspecified indication, start and stop date were not reported; calcium taken for an unspecified indication, start and stop date were not reported. On an unspecified date patient stated that she was supposed to have the second dose today (date unspecified) unfortunately the healthcare provider didn't came to her house, she stated I fell twice, couldn't figure out why I didn't have no control over my body; I couldn't stop myself from going down, I have got hit the floor twice (fall), I have been dizzy, I was dizzy when I get up; I get up and feel dizzy, I fell twice, couldn't figure out why I didn't have no control over my body; I couldn't stop myself from going down, have got hit the floor twice. Consumer stated, "They can call me maybe they are going to come after they call, I don't know. It's two guys came the first time but they didn't tell me that this Pfizer will cause the dizziness and I have been dizzy, I fell twice I had to go to hospital last time and I couldn't figure out why I didn't have no control over my body. This related to study programme. The COVID-19 Vaccine was a Pfizer product. Patient did not any received any treatment. Consumer stated, "I am on a lot of medications, and they said that I shouldn't have got it if I was on blood thinner, I said I gave you all my pills, consumer stated, "There is a whole lot, I take a stool softener. The patient underwent lab tests and procedures which included magnetic resonance imaging: unknown result on they did a MRI of my brain to see if I had another stroke and weight: 152 lbs on 152 Pounds. The outcome for the events was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Deafness unilateral, Kearns-Sayre syndrome, Narcolepsy
Clinical narrative: his hearing is gone in one ear/can't hear; narcolepsy has intensified by a thousand percent/sleepy; has Kearns syndrome and the vaccine has made his eye fall more; has Kearns syndrome and the vaccine has made his eye fall more; This is a spontaneous report from a contactable consumer (patient's wife). A 54-year-old male patient (reporter's husband) received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), via an unspecified route of administration on 2021 (lot number was not reported) as dose 1, single for COVID-19 immunization.  Medical history included ongoing Kearns syndrome and ongoing narcolepsy both from unknown dates. The patient's concomitant medications were not reported. The patient was reported to be having severe side effects from the shot on unknown dates in 2021. The patient is a dentist and since he got the vaccine, his eye has fallen more, his hearing is gone in one ear, and his narcolepsy has intensified by a thousand percent. The reporter clarified that the patient has Kearns syndrome and the vaccine has made his eye fall more. He has been home for 3 weeks. The reporter stated that she should have already filed a claim with Pfizer's safety department. This is the reporter's fifth time calling. Someone keeps calling her and she keeps calling back and leaving a message but she doesn't hear back. The reporter stated that the patient cannot work unless he has his second shot. She wanted to know if her husband should take a chance on getting his second shot of the COVID vaccine after having that experience. The patient can't hear and that's why he can't be on the phone. It's frustrating for him. The patient was losing a guaranteed salary because he can't work. The patient can no longer work and if he can't drive back, the patient's wife (reporter) is going to have to go pick him up if he's too sleepy. The reporter wanted to know if the events will eventually go away. The outcome of the events was unknown.   The lot number for the vaccine, BNT162B2 was not provided and will be requested during follow-up.
Sex: F
Vaccine: COVID19
Symptoms: Acoustic stimulation tests, Acoustic stimulation tests abnormal, Jaundice neonatal
Clinical narrative: Failed hearing test twice; Jaundice; This is a spontaneous report from a contactable consumer (patient's mother) reporting information for herself and her baby. This is the baby report. A 33-days-old female patient was exposure via transplacental from the 2nd trimester to BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), administered intramuscularly to the mother on 25Mar2021 at 09:00 AM at the age of 32 years old (Batch/Lot number: ER8727, Expiration date: unknown) as dose 1, single and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), administered intramuscularly to the mother on 15Apr2021 at 09:00 at the age of 32 years old (Batch/Lot Number: EP7533, Expiration date: unknown) as dose 2, single, for COVID-19 immunization. Mother medical history included ongoing Sjogrens with onset date of 2007, but was diagnosed in 2016; ongoing dysautonomia with an unsure onset date and included postural tachycardia syndrome (POTS) and orthostatic hypotension; ongoing transformative migraines, hemiplegic in nature from 2007; functional movement disorder; connective tissue condition; ongoing narcolepsy with cataplexy with onset date of 2009, but was diagnosed in 2018; and lactose, which caused problems, but no known allergies beyond that; pain; and allergies. Mother concomitant medications included diphenhydramine hydrochloride (BENADRYL), cetirizine hydrochloride (ZYRTEC ALLERGY), paracetamol (TYLENOL) and acetylsalicylic acid (ASPIRIN (E.C.)). On an unknown dat the baby experienced jaundice (treated with phototherapy) and she failed hearing test twice. The outcome of the jaundice was not recovered, the outcome of the other event was unknown.   Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021423841 same reporter/drug, different event/patient