chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Pain
Clinical narrative: severe burning in my spinal cord and described it as bad, as she was squirming; pain; This is a spontaneous report from a contactable consumer (patient) via medical information team. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), first dose via an unspecified route of administration on 05Mar2021 (lot number and expiration date were not reported) as single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient had the covid vaccine on 05Mar2021 and had a "severe burning in my spinal cord" and described it as bad, as she was squirming. The patient was in pain. The outcome of the events was unknown.   No follow-up attempts are completed; information about lot/batch number cannot be obtained
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: hives; This is a spontaneous report from a contactable nurse (patient). A 66-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EN6198), intramuscular, administered in left arm on 27Feb2021 11:00 as single dose for COVID-19 immunisation. Medical history included ongoing interstitial cystitis diagnosed 1.5yrs prior, ongoing idiopathic chronic pancreatitis diagnosed 2.5yrs ago, depression and heartburn. Ongoing concomitant medications included ibuprofen (ADVIL) taken for interstitial cystitis, bupropion hcl for depression, omeprazole (PRILOSEC) taken for heartburn, biotin and multivitamin gummies. The patient received first dose of bnt162b2 on 06Feb2021 for COVID-19 immunisation and experienced broke out in hives from her hands to the arches of her feet, and it was progressive. On 02Mar2021, 11:30, the patient experienced hives 3days after vaccine. Treatment for the event included 2 Benadryl 50 minutes apart. It was reported that benadryl was required for second dose to resolve, take Zyrtec before and after second dose prevented a second outbreak. (Also: no caffeine, Alcohol, exercise, and stress). The event was considered as important medical event. The patient had no other prior vaccination (within 4 weeks). Outcome of event was recovered on an unspecified date. The reporter considered the product had a casual effect to the adverse event.
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dysgeusia
Clinical narrative: Has metallic taste in her mouth; Cough; "This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number EL3247), via an unspecified route of administration in right arm on 23Jan2021 (at the age of 76-year-old) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took historical vaccine, first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL1284) in left arm on 03Jan2021, (at the age of 76-years-old) as a single dose for Covid-19 immunisation. The patient experienced cough on 29Jan2021, and has metallic taste in her mouth on an unknown date in Jan2021. The patient was hospitalised for the event has metallic taste in her mouth on an unknown date in 2021. The patient did not receive any treatment for the events. The outcome of the event Cough was not recovered and Has metallic taste in her mouth was recovered on an unknown date in 2021.  No follow-up attempts are needed. No further information is expected."
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Pharyngeal swelling
Clinical narrative: Felt very tired at two different intervals on day one; throat began swelling; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date unspecified), via an unspecified route of administration, administered in left arm on 10Mar2021 08:00 as single dose for COVID-19 immunisation. Medical history included known allergies to acidic foods, and several antibiotics (neomycin, tetracycline, etc.). It was reported that the patient was in good health. Concomitant medications included colecalciferol, ubidecarenone (COQ10 + D3), dhea and vitamin/minerals, which were medications in two weeks. On 10Mar2021 13:00, the patient experienced felt very tired at two different intervals on day one and 5 hours after shot, throat began swelling; patient waited 15 minutes then took 10 mg Loratadine and she wasn't better and after another 15 minutes, she took another 10 mg Loratadine. On day 2, after 8 hours, she felt normal. Therapy for the events included antihistamine. The patient had no covid prior vaccination and was not covid tested post vaccination. The patient had no other vaccine in 4 weeks. Outcome of events was recovered on an unspecified date.   Information about lot/batch number has been requested.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Both my partner and I tested positive for Covid-19 4 days after receiving our vaccines.; This is a spontaneous report from a contactable consumer (patient). The consumer reported same event for two patients. This is the first of two reports.  A 28-year-old female patient received bnt162b2 (Lot Number: EN6206), via an unspecified route of administration, administered in left arm on 10Mar2021 11:15 (at the age of 28-year-old) as single dose for COVID-19 immunization. The patient is not pregnant. Medical history was none. Concomitant medication included fluconazole. No known allergies. No covid prior vaccination. The patient and her partner both tested positive for covid-19 on 14Mar2021, 4 days after receiving the vaccines. The patient underwent lab tests and procedures which included Nasal Swab, Rapid and PCR on 14Mar2021 with positive result. No treatment was received for the event. The outcome of the event was not recovered.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021292125 same drug/event, different patient.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: tested positive for COVID-19; This is a spontaneous report from a contactable consumer (patient) via the medical information team. A 55-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot and expiry were not reported), via an unspecified route of administration on 06Mar2021 as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received the first dose of bnt162b2 on 06Mar2021. She started having symptoms of COVID-19 on 09Mar2021 and then tested positive for COVID-19 on 11Mar2021. She would like to know what she should do about receiving her second dose of bnt162b2. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Tested positive for COVID-19 infection; Tested positive for COVID-19 infection; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) on 26Feb2021 as a single dose, with route of administration unspecified, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 12Mar2021, two weeks after the first dose of vaccination, the patient had tested positive for COVID-19 infection. The outcome of the event was unknown. The patient was asking if the second dose of vaccination could be received as scheduled on 26Mar2021.  Follow-up attempts are completed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19, UNK
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 antibody test
Clinical narrative: vaccine did not protect patient from getting covid as covid test positive with CREON (PANCREATIN)/vaccine did not protect patient from getting covid as covid test positive.; COVID-19 virus test positive; This is a spontaneous report from a contactable consumer (patient) based on the information received by Pfizer from AbbVie, (Mfr. Control No.: 21K-163-3804517-00). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), intramuscular on an unspecified date (Batch/Lot number unknown, expiration date unknown) as SINGLE DOSE for covid-19 immunisation; pancreatin (CREON), oral from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at unspecified dose for an unspecified indication. The patient medical history was not reported. The patient's concomitant medications were not reported. This was a social media report by a consumer of a female with an event of non-serious COVID-19 vaccine did not protect patient from getting covid as covid test positive with CREON (PANCREATIN). There was no reported medical history. In 2021, the patient experienced covid-19 vaccine did not protect patient from getting covid (drug ineffective) as COVID test was positive on 28Feb2021. Thus, COVID-19 VACCINE was also considered suspect. Reporter causality not provided. The action taken in response to the event for pancreatin was unknown. The outcome of the events was unknown.  The reporter's causality for the event(s) of COVID-19 VACCINE DID NOT PROTECT PATIENT FROM GETTING COVID AS COVID TEST POSITIVE onset in 2021 and COVID-19 VACCINE DID NOT PROTECT PATIENT FROM GETTING COVID AS COVID TEST POSITIVE onset 28 Feb2021 was not provided.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: positive COVID-19 test; This is a spontaneous report from a contactable consumer(patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE,solution for injection, Lot Number: EN6206), administered in Arm Left on 10Mar2021 11:15 am as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. Concomitant medication(s) included fluconazole taken for an unspecified indication, start and stop date were not reported. The patient tested positive for covid-19 on 14Mar2021. The patient underwent lab tests and procedures which included Nasal swab, rapid and PCR were positive on 14-mar-2021.Patient did not have covid-19 prior vaccination. Patient did not received treatment adverse event and didn't have known allergies. The outcome of the event was not recovered.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021288981 same drug/event, different patient.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: got covid; got covid; This is a spontaneous report from a Pfizer Sponsored Program from a contactable consumer. A patient of unspecified age and gender received 1st dose of bnt162b2, via an unspecified route of administration in Feb2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient got covid on an unspecified date with outcome of unknown. The patient missed second dose due to covid. Patient would still like to receive second dose.   Information on the lot/batch number has been requested.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive to COVID-19 a few days after getting his first dose; tested positive to COVID-19 a few days after getting his first dose; This is a spontaneous report from a contactable Pharmacist. A male patient in his mid-thirties received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: unknown, Expiry Date: unknown) on an unknown date. A few days after getting his first dose of the vaccine, the patient was tested positive to covid 19. The reporter asked asked for the recommended interval between the infection and vaccination with the second dose. The outcome of the events was unknown.  Information about lot/ batch number has been requested.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events ___ and the suspect vaccine BNT162B2.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: received Pfizer's COVID vaccine on 04 Feb 2021 and tested positive with COVID on 08 Feb 2021; This is a spontaneous report from a contactable pharmacist.  A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: Unknown; Expiration Date: Unknown) via an unspecified route of administration on 04Feb2021 as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received pfizer's COVID vaccine on 04Feb2021 and tested positive with COVID on 08Feb2021. The patient underwent lab tests and procedures which included SARS-COV-2 test: positive on 08Feb2021. The outcome of event was unknown.  Information regarding lot/batch has been requested.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test positive
Clinical narrative: tested positive after the 1st dose; tested positive after the 1st dose; This is a spontaneous report received from a Pfizer-sponsored program. A contactable consumer (parent) reported on behalf of patient (her son). A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection), via an unspecified route of administration on 19Feb2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that the patient received his 1st dose of vaccine BNT162B2 on 19Feb2021 and was tested positive after first dose on an unspecified date. The patient was scheduled for second dose of vaccine BNT162B2 on 12Mar2021. Outcome of events was unknown.  Information about lot/batch number has been requested.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, Fatigue, Nasal congestion, Oropharyngeal pain
Clinical narrative: I tested positive; sore throat; fatigue; had a fever 100.8; runny nose; runny nose congestion symptoms; This is a spontaneous report received from contactable consumer (patient herself). A 35-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection) via an unspecified route of administration on 02Mar2021 at single dose for COVID-19 immunization. Patient medical history and concomitant medications were not reported. Patient received her first COVID vaccination 02Mar2021. She started experiencing runny nose congestion symptoms on Monday 08Mar2021, but thought were allergies. On Tuesday 09Mar2021 she had a fever 100.8 and her husband tested positive for COVID. Wednesday 09Mar2021 took PCR test and was negative. 13Mar2021 she tested positive symptoms of sore throat, runny nose and fatigue. Outcome of events was unknown.  information on about lot/batch number has been requested.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rhinorrhoea, SARS-CoV-2 test
Clinical narrative: I tested positive; sore throat; fatigue; had a fever 100.8; runny nose; runny nose congestion symptoms; This is a spontaneous report received from contactable consumer (patient herself). A 35-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection) via an unspecified route of administration on 02Mar2021 at single dose for COVID-19 immunization. Patient medical history and concomitant medications were not reported. Patient received her first COVID vaccination 02Mar2021. She started experiencing runny nose congestion symptoms on Monday 08Mar2021, but thought were allergies. On Tuesday 09Mar2021 she had a fever 100.8 and her husband tested positive for COVID. Wednesday 09Mar2021 took PCR test and was negative. 13Mar2021 she tested positive symptoms of sore throat, runny nose and fatigue. Outcome of events was unknown.  information on about lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: received first covax on 27Feb and then tested positive for virus; received first covax on 27Feb and then tested positive for virus; This is a spontaneous report from a contactable consumer via a Pfizer-sponsored program. A patient of unspecified age and gender received first dose of BNT162B2 (COVID-19 Vaccine, formulation: solution for injection), via an unspecified route of administration on 27Feb2021 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The consumer reported that the patient received first vax on 27Feb2021 and then tested positive for virus. The patient is supposed to get the second vax on 20Mar2021 and is asking how do they proceed. Outcome of events was unknown.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: was supposed to receive the 2nd dose this last Thursday but tested positive for Covid; was supposed to receive the 2nd dose this last Thursday but tested positive for Covid; This is a spontaneous report via a Pfizer-sponsored program Support from contactable consumer (patient). A male patient of unknown age received a first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via unknown route of administration on unknown date in Feb2021 as single dose for COVID-19 immunisation. Medical history and Concomitant medications were not reported. It was reported that the patient received the 1st dose of vaccine the end of Feb2021 and was supposed to receive the 2nd dose this last Thursday but tested positive for Covid in 2021. The outcome of events was unknown.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: His arm got sore; This is a spontaneous report from a contactable consumer (grandparent) via Pfizer sponsored program. A 19-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number and expiration date were not reported) via an unspecified route of administration, on unknown date as a single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Swap from first time caller asking for Grandson 19 yr. On an unknown date the patient took the first vaccine at store, but he thinks it was administered high up on shoulder and his arm got sore. He was not an HCP. The reporter was asking whether the patient should get another first vaccine. Read article. Provided number and transferred to medical information, hold que. Due to long hold times. Will fax to Pfizer from a Pfizer Sponsored program. CEP (Number) for AE. There were no unaddressed medical questions referred or forwarded to medical information. The outcome of the event was unknown.  Information on lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pain
Clinical narrative: chills; Fatigue; body & head aches; body & head aches; This is a spontaneous report received from a contactable consumer (patient) reported that a 73-year-old male patient receive second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient previously took BNT162B2 as first dose and experienced headache. The caller reported he and her wife experienced some headaches, chills, fatigue and body and headaches after second dose of vaccine. Outcome of the events was unknown.  No follow-up attempts possible. No further information expected. Information about the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: wife had CoronaVirus; wife had CoronaVirus; This is a spontaneous report received from a contactable consumer (husband) through Pfizer Sponsored Program COVAX US Support. A female patient of unknown age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via unknown route of administration on 22Feb2021 at single dose for COVID-19 immunisation. Medical history and Concomitant medications were not reported. Patient got the first dose 22Feb2021, after the first dose had Corona Virus in 2021. Patient has been okay since monday. Patient was scheduled for a second dose on 15Mar2021. The patient underwent labs and procedure included CoronaVirus test: positive in 2021. The outcome for the events was recovering.  Information on the lot/batch number has been requested.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Symptomatic COVID-19; tested positive on nasal swab tests (rapid antigen and PCR); Symptomatic COVID-19; tested positive on nasal swab tests (rapid antigen and PCR); This is a spontaneous report from a contactable healthcare professional (patient). A non-pregnant 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm, the first dose (Lot Number: E11284) on 30Dec2020 at 12:00 PM, then the second dose (Lot Number: EC1283) on 20Jan2021, both at a single dose, for COVID-19 immunization. The patient had no medical history and concomitant medications. The patient had no known allergies. No other vaccine was administered in four weeks. The most recent vaccine was administered in a nursing home or senior living facility. On 11Mar2021 at 08:00 PM, the patient started experiencing symptomatic COVID-19 and was confirmed as she tested positive on 15Mar2021. The adverse events resulted in doctor or other healthcare professional office or clinic visit. No treatment was administered for the events. The patient underwent COVID-19 nasal swab tests that was negative on 06Mar2021 (PCR), positive on 15Mar2021 (rapid antigen), and positive on 16Mar2021 (PCR). The patient was recovering from the events.; Sender's Comments: The patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 30Dec2020, then the second dose on 20Jan2021. On 11Mar2021, the patient started experiencing symptomatic COVID-19 and was confirmed as she tested positive on 15Mar2021.  Based on information available, vaccination failure with the suspected vaccine BNT162B2 in this patient cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Diarrhoea, Loss of consciousness
Clinical narrative: he passed out/fell out during court; covid-19; diarrhea; This is a spontaneous report received from a contactable consumer. A 61-year-old female consumer (patient) reported for herself that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route at a single dose for COVID-19 immunization. The patient had a history of shortness of breath often, had fatigue, muscle and body ache and headache, loss of taste and smell not that one. People had told her that so many people have died from it from blot clots. She also had a history of irritated bowel syndrome and had these side effects because she went through it anyways. She had a history of anxiety but had not had an attack in a long time. The patients niece broke out in hives (she did not know which vaccine). She had been high step and said that she was a hand washer at a restaurant and once she was done and got home and it started piling up at the end of the day when she layed down. She had heard that people were having heart attacks so must take a baby aspirin. The patients concomitant medications were not reported. After receiving the vaccine she passed out/fell out during court. Some people told her that some costumers died of covid 19 infection. On an unknown date she had covid-19 (she and her husband had covid and both got vaccinated with both shots) and had diarrhea for a month and got over. Someone had told her that they would chip her. The outcome of events was unknown for passed out and Covid-19 and recovered on unspecified date for diarrhea.  Information about the Lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Asymptomatic COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: had their first Pfizer vaccine 2 weeks ago and now have a positive PCR test; had their first Pfizer vaccine 2 weeks ago and now have a positive PCR test; This is a spontaneous report received from a contactable other healthcare professional. This other HCP reported similar events for 4 patients. This report is for 1st of 4 patients.  A patient of an unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number and Expiration Date was not reported), via an unspecified route of administration on an unspecified date in 2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medication was not reported. The reporter stated that, it is affecting 4 patients currently. They are totally asymptomatic. They had their first Pfizer vaccine 2 weeks ago and now have a positive PCR test. The outcome of the events was reported as unknown.  Information about lot/batch has been requested.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product BNT162B2 or comirnaty to the reported event Drug ineffective and covid-19 cannot be ruled out.,Linked Report(s) : US-PFIZER INC-2021307731 Different paitent, same drug, same event (split);US-PFIZER INC-2021307730 Different paitent, same drug, same event (split);US-PFIZER INC-2021307729 Different paitent, same drug, same event (split)
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: then tested positive for Covid-19 on Sunday; then tested positive for Covid-19 on Sunday; This is a spontaneous report from a non-contactable consumer (parent). An unspecified age female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via unspecified route of administration, on 08Mar2021, as a single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that patient received first dose of vaccine and undergone COVID-19 test and resulted in positive on an unknown date in Mar2021, Sunday (as reported). The patient concerned that she wanted to know what they should do about the 2nd dose. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Headache, Nasal congestion, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Tested positive for COVID-19; Tested positive for COVID-19 / mild cough and loss of taste/smell; Congestion; Headache; This is a spontaneous report from a contactable nurse (patient herself). A 29-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EN6202), via an unspecified route of administration in left arm on 25Feb2021 (at the age of 29-year-old) as a single dose for COVID-19 immunisation. The patient's medical history was none. No known allergies. Concomitant medications included levonorgestrel (MIRENA IUD). The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL9269) on 04Feb2021 (at the age of 29-year-old) as a single dose in left arm for COVID-19 immunisation. The patient did not receive other vaccine in four weeks. Prior vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient has been tested for COVID-19. It was reported that, patient received the second dosing of her Pfizer COVID-19 vaccination on 25Feb2021. On 19Mar2021, patient tested positive for COVID-19. Her symptoms include congestion, headache, mild cough, and loss of taste/smell on 19Mar2021. The adverse events resulted in emergency room/ department or urgent care. On 19Mar2021, the patient underwent lab test and procedure which included nasal swab / rapid COVID-19 swab: Positive, COVID-19 PCR: Positive. No treatment medications was received for the adverse events. The outcome of the events was recovering.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the vaccination failure cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for Covid 16Mar2021; tested positive for Covid 16Mar2021; This is a spontaneous report from a consumer (patient) from the Pfizer-sponsored program COVAX US Support. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via an unspecified route of administration on 28Feb2021 (Batch/Lot number was not reported) as single dose (dose 1) for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient got the first vaccine on 28Feb2021 and tested positive for COVID on 16Mar2021. She was in quarantine until 27Mar2021 but the second dose should be today, 21Mar2021. She cannot get her second dose today because of quarantining so she is now scheduled for 02Apr2021. The patient asked if the antibodies from COVID diminished the efficacy of the vaccine and if it will still be 95% effective. She stated her doctor said after 10 days of quarantine she has 42 days to get the second dose. The patient stated she is just going to get it and hope she gets the 94-95% efficacy. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Asymptomatic COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: had their first Pfizer vaccine 2 weeks ago and now have a positive PCR test; had their first Pfizer vaccine 2 weeks ago and now have a positive PCR test; This is a spontaneous report from a contactable other health care professional via a medical information team reported similar events for 4 patients. This is the 2nd (2nd patient) of 4 reports. A patient of an unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection lot number and expiration date unknown) via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunisation. Patient medical history and concomitant medications were not reported. It was stated that it was affecting 4 patients currently. They were totally asymptomatic. They had their first Pfizer vaccine 2 weeks ago and now have a positive PCR test on an unknown date in 2021. The outcome of the events was unknown.  Information on lot/batch number has been requested.; Sender's Comments: Considering a plausible temporal relationship and known product safety profile, a possible contributory role of suspect product Comirnaty to the reported 'COVID 19' cannot be completely excluded,Linked Report(s) : US-PFIZER INC-2021304208 Different paitent, same drug, same event (split)
Sex: U
Vaccine: COVID19
Symptoms: Asymptomatic COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: They are totally asymptomatic. They had their first Pfizer vaccine 2 weeks ago and now have a positive PCR test; They are totally asymptomatic. They had their first Pfizer vaccine 2 weeks ago and now have a positive PCR test; This is a spontaneous report received from a contactable other healthcare professional via Medical Information Team. This other HCP reported similar events for 4 patients. This report is for 4th of 4 patients.  A patient of an unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number and Expiration Date was not reported), via an unspecified route of administration on an unspecified date in 2021 as single dose for COVID-19 immunisation. The patient medical history and concomitant medication was not reported. The reporter stated that, it is affecting 4 patients currently. They are totally asymptomatic. They had their first Pfizer vaccine 2 weeks ago and now have a positive PCR test. The outcome of the events was reported as unknown.  Information about lot/batch has been requested.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events drug ineffective and asymptomatic COVID 19 and the suspect drug. ,Linked Report(s) : US-PFIZER INC-2021304208 Different paitent, same drug, same event (split)
Sex: M
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Exposure via breast milk
Clinical narrative: anaphylactic reaction; breastfeeding who had a baby with an anaphylactic reaction; This is a spontaneous report from a contactable pharmacist. This pharmacist reported information for both mother and baby. This is a baby report.   A 12-month-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), transmammary on an unspecified date (Batch/Lot number was not reported) as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient's mother received her first Pfizer vaccine and was breastfeeding, the baby (patient) had an anaphylactic reaction. The outcome of the event was unknown. The events were assessed as serious-medically significant.  Information about lot/batch number has been requested.; Sender's Comments: A contributory role of exposure to BNT162B2 via breastfeeding to the development of anaphylactic reaction cannot be excluded based on the product profile.,Linked Report(s) : US-PFIZER INC-2021305689 mother case
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Product dose omission issue, SARS-CoV-2 test
Clinical narrative: but in between we caught the virus; but in between we caught the virus; We never got the second one; This is a spontaneous report received from a non-contactable consumer (patient). A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), via an unspecified route of administration on Jan2021 as single dose for covid-19 immunization. The patient medical history and concomitant medication were not reported. Caller stated as I'm calling for me and my wife we both had first dose of the Pfizer-COVID-19 Vaccine in January, we would do a try to get the second one 3 weeks later, but in between we caught the virus, we were treated for the virus and we tested negative the last time we had a test. We never got the second one (second dose of the vaccine). The patient underwent lab tests and procedures which included sars-cov-2 test and tested negative last time. Outcome for COVID-19 was recovered on an unspecified date and remaining events were unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021314187 same reporter/drug/event different patient
Sex: F
Vaccine: COVID19
Symptoms: Gait inability, Influenza like illness
Clinical narrative: Flu-like symptoms; Unable to walk; This is a spontaneous report received from a contactable consumer or other non hcp. A 54-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) via an unspecified route of administration on 13Mar2021 as single dose for covid-19 immunisation. The patient medical history included multiple sclerosis. The concomitant medication included ongoing steroids. The patient experienced flu-like symptoms and she was unable to walk by the evening of 14Mar2021. She was hospitalized for several days. Therapeutic measures were taken as a result of flu-like symptoms and she was unable to walk and treatment included Solu-medrol. The outcome of the events was unknown.  Information about lot/ batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: I did a rapid test but it also shows me like a positive line; I did a rapid test but it also shows me like a positive line; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received 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 on an unknown date at a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient reported that "I did a rapid test, but it also shows me like a positive line" on an unspecified date. The outcome of the event was reported as unknown.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, International normalised ratio, SARS-CoV-2 test
Clinical narrative: the coach for the basketball team at got two doses of the Pfizer Covid 19 and tested positive for Covid 19; the coach for the basketball team got two doses of the Pfizer Covid 19 and tested positive for Covid 19; This is a spontaneous report from a contactable other hcp. A 64-years-old male patient received first dose and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE covid-19 immunisation. Medical history included dizziness (subsided) from an unknown date and unknown if ongoing on in unspecified date in Oct 2020 stroke and bleeding on the brain from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously took warfarin for blood clotting disorder. The patient previously took rabies vaccine on an unspecified date in Jul 2020, for rabies immunisation and experienced arms and legs were wea (subsided) and hypersensitivity/ eczema psoriasis. The patient experienced the coach for the basketball team got two doses of the Pfizer covid 19 and tested positive for covid 19 on an unspecified date. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on an unspecified date got two doses of the Pfizer Covid 19 and tested positive for Covid 19 and international normalised ratio: 3,5 on an unspecified date still threw a clot. The outcome of the events was reported as unknown.   Information about lot/batch number has been requested.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events Drug ineffective, COVID-19 and the suspect drug BNT162B2.
Sex: F
Vaccine: COVID19
Symptoms: Asymptomatic COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Few days after she got Covid but asymptomatic; Few days after she got Covid but asymptomatic; This is a spontaneous report received from a contactable reporter (daughter) reported that a female patient (mother) of an unspecified age (Age: 83; Unit: Unknown) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number: unknown) via an unspecified route of administration on 20Jan2021 as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. Reporter stated on behalf of her mother that few days after, she got Covid but asymptomatic in 2021. She went on quarantine at the facility for 2 weeks. Still remained positive in 2021 then another quarantine on their home. Took a swab test and turned negative in 2021. Reporter wanted to know the waiting time for her mother to have her 2nd dose, is it 90 days or none at all. The outcome of the event was recovered in 2021.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: 12Mar2021 caller reported the tested positive for COVID; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age (Age: 41; Unit: Unspecified) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on 02Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The reporter stated that he received first dose of vaccine 02Mar2021. On 08Mar2021 he began to have COVID symptoms. 12Mar2021 caller reports the tested positive for COVID. 22Mar2021 patient tested negative for COVID. Reporter would like to know if he can get his second dose tomorrow. The patient underwent lab tests and procedures which included covid-19: positive on 12Mar2021, covid-19: negative on 22Mar2021. The outcome of the event was recovered on 22Mar2021.  Information about lot/batch number has been requested.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Tested Positive for Covid19 after receiving first dose of the Covid Vaccine; Tested Positive for Covid19 after receiving first dose of the Covid Vaccine; This is a spontaneous report from a contactable physician (primary care doctor) and other healthcare professional. This physician reported similar events for two patients. This is 1st of 2 reports.  A 77-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, NDC number: 59267-1000-1, Expiry Date: 30Jun2021, Batch/lot number: EN6203) intramuscular in left arm on 28Feb2021 at 0.3mL single for COVID-19 immunisation. Medical history included ongoing diabetic years ago. Concomitant medication included ongoing allopurinol tablet at 300mg once a day. She takes tons of medications but nothing that interferes. She doesn't want to provide them all because she will be here all day. Reporter stated that a couple in their 70s received the Covid vaccine on 28Feb2021 and this past week, they came in here after a Covid exposure and they both tested positive for Covid19 after receiving first dose of the Covid Vaccine on 16Mar2021. They may have cold symptoms. Reporter asked if the couple could still get their second dose of the vaccination next week. The outcome of events was unknown.  Relatedness of drug to reaction(s)/event(s): Reaction assessed: Tested Positive for Covid19 after receiving first dose of the Covid Vaccine; Source of assessment: Primary Source Reporter; Method of assessment : Global Introspection; Drug result: Unrelated.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event COVID-19 and the suspect vaccine BNT162B2.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19 virus test positive; COVID-19 virus test positive; This is a spontaneous report from a contactable physician (primary care doctor) and a non-contactable other healthcare professional. This physician reported similar events for two patients. This is report 2 of 2.  A 74-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, NDC number: 59267-1000-1, Expiry Date: 30Jun2021, Batch/lot number: EN6203) intramuscular in left arm on 28Feb2021 at 0.3mL single for COVID-19 immunization. Medical history and concomitant medications were none. Reporter stated that a couple in their 70s received the Covid vaccine on 28Feb2021 and this past week, they came in here after a Covid exposure and they both tested positive for Covid19 after receiving first dose of the Covid Vaccine on 16Mar2021. They may have cold symptoms. Reporter asked if the couple could still get their second dose of the vaccination next week. Outcome of the event was unknown.  Relatedness of drug to reaction(s)/event(s): Reaction assessed: Tested Positive for Covid19 after receiving first dose of the Covid Vaccine; Source of assessment: Primary Source Reporter; Method of assessment: Global Introspection; Drug result: Unrelated.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on known drug safety profile, there is a reasonable possibility of causal association between the events drug ineffective and COVID 19 and the suspect drug.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: tested positive to COVID-19; This is a spontaneous report from a contactable pharmacist via Medical information team. A male patient of an unspecified age (reported as, age: 25; Units: unknown) received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration on 04Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient tested positive to COVID-19 on 11Mar2021 and will finish quarantine on 24Mar2021. The patient's second dose is scheduled for Thursday. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Asymptomatic COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for Covid 19; tested positive for Covid 19/ she is asymptomatic; This is a spontaneous report from a contactable consumer. A 63-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 04Mar2021 (Batch/Lot Number: EN6199) as a single dose for COVID-19 immunization. Medical history included exposed to someone with COVID 19. The patient's concomitant medications were not reported. The patient was due to receive the second dose on 25Mar2021. She tested positive for COVID 19 on 23Mar2021 after being exposed to someone with COVID 19. She was asymptomatic. She asked if she still get the second dose of the vaccine on 25Mar2021. Her rapid test was negative on an unspecified date but her 24 hour test on 23Mar2021 was positive. The outcome of the events was unknown. The events were assessed as serious-medically significant.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for covid; tested positive for covid; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported for daughter boyfriend (patient). A male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), Solution for injection, Lot number and Expiration date was not reported), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date 3 family were vaccinated last week Friday. Daughters boyfriend tested positive for covid. Now Daughter was tested on Wednesday was also tested positive. Wants to know when daughter can get 2nd dose or how this works with having covid. The outcome of the events was unknown.    Information about lot/batch number has been requested.