chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Pain, Pyrexia, Vaccination site pain
Clinical narrative: Severe body aches; vomiting; fever; headache; Sore arm at injection site; This is a spontaneous report from a contactable consumer.  A 25-years-old female patient received dose 2 of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Lot number EL3247, via an unspecified route of administration in left arm on 09Feb2021 10:30 at SINGLE DOSE (at the age of 25 years) for covid-19 immunisation.  Historical vaccine included dose BNT162B2 Product COVID 19, Brand Pfizer- BioNTech, on 19Jan2021 Lot number EL3247, Administration date 19Jan2021 at 10:30, Left arm. Medical history was none.  There were no known allergies. The patient's concomitant medications were not reported.  The patient experienced fever 102 degree Fahrenheit on 09Feb2021 23:45 with outcome of recovered with sequelae, vomiting on 09Feb2021 23:45 with outcome of recovered with sequelae, severe body aches on 09Feb2021 23:45 with outcome of recovered with sequelae, sore arm at injection site on 09Feb2021 23:45 with outcome of recovered with sequelae, and headache on 09Feb2021 23:45 with outcome of recovered with sequelae.  The patient underwent lab tests and procedures which included body temperature 102-degree Fahrenheit on 09Feb2021.  No treatment was received.  No other vaccine given in four weeks.  No other medications were taken in two weeks. The patient did not have Covid prior vaccination.  The patient was not tested for Covid post vaccination.    No follow up attempts are possible. No further information is expected.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Severe body aches; vomiting; fever; headache; Sore arm at injection site; This is a spontaneous report from a contactable consumer.  A 25-years-old female patient received dose 2 of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Lot number EL3247, via an unspecified route of administration in left arm on 09Feb2021 10:30 at SINGLE DOSE (at the age of 25 years) for covid-19 immunisation.  Historical vaccine included dose BNT162B2 Product COVID 19, Brand Pfizer- BioNTech, on 19Jan2021 Lot number EL3247, Administration date 19Jan2021 at 10:30, Left arm. Medical history was none.  There were no known allergies. The patient's concomitant medications were not reported.  The patient experienced fever 102 degree Fahrenheit on 09Feb2021 23:45 with outcome of recovered with sequelae, vomiting on 09Feb2021 23:45 with outcome of recovered with sequelae, severe body aches on 09Feb2021 23:45 with outcome of recovered with sequelae, sore arm at injection site on 09Feb2021 23:45 with outcome of recovered with sequelae, and headache on 09Feb2021 23:45 with outcome of recovered with sequelae.  The patient underwent lab tests and procedures which included body temperature 102-degree Fahrenheit on 09Feb2021.  No treatment was received.  No other vaccine given in four weeks.  No other medications were taken in two weeks. The patient did not have Covid prior vaccination.  The patient was not tested for Covid post vaccination.    No follow up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Tested positive for COVID-19 test; This is a spontaneous report from a contactable consumer (patient) through the Pfizer-sponsored program. This consumer reported similar events for two patients. This is the first of the two reports.  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 20Jan2021 at a single dose, with route of administration unspecified, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 25Jan2021, the patient had tested positive for COVID-19 test. The outcome of the event, 'tested positive for COVID-19 test', was unknown. The patient had an appointment to get the second dose on 10Mar2021, and was asking if she should still get the second dose even though she had tested positive.  Information on the batch/lot number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021147922 same reporter/product/events, different patient
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: tested positive for Covid; This is a spontaneous report from a contactable consumer (patient's wife) through the Pfizer-sponsored program. This consumer reported similar events for two patients. This is the second of the two reports.  A male patient (reporter's husband) of an unspecified age received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number and expiry date unknown), via an unspecified route of administration on 20Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient and his wife got the first dose on 20Jan2021 and tested positive for COVID on 25Jan2021. The patient's wife wanted to know if it was okay for her and her husband to still get the vaccine as they are scheduled to get the second dose on 10Feb2021. The outcome of the event was unknown.   Information on the Batch/Lot number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021147921 same reporter/drug/event, different patient.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Got a diagnosis of COVID-19 between the two doses/In the mean time he has been diagnosed with COVID. He was diagnosed on either Monday or Tuesday of this week; This is a spontaneous report from a non-contactable consumer. This consumer reported for a 95-year-old male patient (father) who received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: Not Provided), via an unspecified route of administration on 29Jan2021 at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received the first dose of the Pfizer-BioNTech COVID-19 vaccine on 29Jan2021 and scheduled for second on 19Feb2021. In the mean time between the two doses he had been diagnosed with COVID. He was diagnosed on either Monday or Tuesday of this week (08Feb2021 or 09Feb2021). The reporter asked would the diagnosis of COVID affect the second dose of the vaccine and what to do from now. The patient underwent lab tests and procedures which included sars-cov-2 test: unknown result on an unspecified date. The outcome of event was unknown.   No follow-up attempts are possible: information about lot/batch number cannot be obtained.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: She received her first Pfizer COVID-19 Vaccine on 19Jan2021/ tested positive for the COVID-19 Virus on 08Feb2021/ been sneezing and has lost taste and smell; She received her first Pfizer COVID-19 Vaccine on 19Jan2021/ tested positive for the COVID-19 Virus on 08Feb2021/ been sneezing and has lost taste and smell; This is a spontaneous report from a Pfizer sponsored program Pfizer First Connect and COVAX US Support from a contactable consumer (patient). A 44-year-old female patient (also age at vaccination) received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3247), via an unspecified route of administration at the left arm on 19Jan2021 15:40 at SINGLE DOSE for covid-19 immunization. The patient was vaccinated at a hospital. Medical history was none and she has no prior health history. The patient has no history of all previous immunization with the Pfizer vaccine considered as suspect and no additional Vaccines Administered on Same Date of the Pfizer Suspect. No prior vaccinations within 4 weeks. For concomitant medications the patient has been taking vitamins, supplements, and iron for quite sometime. The patient received her first Pfizer COVID-19 Vaccine on 19Jan2021 (reported as 3 weeks ago). The patient stated that she has been sneezing and has lost taste and smell. She took a Covid test on Friday (05Feb2021: COVID-19 PCR test) and received negative results on Saturday (06Feb2021: COVID-19 PCR test). She said she tested positive for the COVID-19 Virus on 08Feb2021 (COVID-19 PCR test). She said she was supposed to go for the second COVID-19 Vaccine on 09Feb2021. She said she went to the COVID-19 Vaccine site that administered her first vaccine dose, and was told she couldn't get her second COVID-19 Vaccine dose/ missed appointment because she tested positive for the COVID-19 Virus. She said she was asked to call back this week to rescheduled her second COVID-19 Vaccine dose, but she hadn't done so because her father just passed away. She stated she required no treatment, and quarantined after the positive COVID-19 Virus test result. The patient did not require a visit to Emergency Room or Physician Office. The outcome of the events was unknown. The patient added she is "not sick at this time" and has no pre-existing conditions and seeking guidance on the next dose and wanted to know if she is eligible to get the second COVID-19 Vaccine dose, asking about the timing of the second if it would still be valid even if it is beyond the recommended 3 week period?
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for Covid 19; tested positive for Covid 19; This is a spontaneous report from a Pfizer-sponsored program, PFIZER FIRST CONNECT. A contactable pharmacist reported similar events for three patients. This is the second of the three reports.  A patient of unspecified age and gender received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 17Jan2021, for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date in 2021, after the first vaccination, the patient had COVID-19 confirmed by positive COVID-19 test and was put on isolation. The outcome of the event was unknown. The reporting pharmacist was wondering if there was a need to hold off the second dose of vaccination or if it could be administered on 07Feb2021.  Information on the lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product,  BNT162B2 vaccine, cannot be excluded for the reported events of COVID-19 and suspected LOE.  There is limited information provided in this report.  This case will be reassessed once additional information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2021148567 same drug and event, different patient;US-PFIZER INC-2021148508 same drug and event, different patient
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Body temperature decreased, Chills, Tremor, Vaccination site pain
Clinical narrative: low temperature (96.5); Chills; slight tremors; soreness at injection site; This is a spontaneous report from a non-contactable consumer (patient). A 77-years-old male patient received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3247), via an unspecified route of administration on 10Feb2021 08:15 at age of 77-years-old at arm left at single dose for COVID-19 immunisation. Medical history included bladder cancer, high blood pressure and no known allergies. Concomitant medication included allopurinol, amlodipine, valsartan, indapamide, atorvastatin (LIPITOR), pregabalin (LYRICA), metformin hydrochloride (MEDFORMIN), metoprolol succinate (TOPROL) and vitamin supplements. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The historical vaccine included the 1st dose of BNT162B2 on 18Jan2021 at age of 77-years-old for COVID-19 immunisation. The patient experienced chills, low temperature (96.5) and slight tremors, soreness at injection site on 10Feb2021 06:00 (as reported). No treatment was received for the adverse events. The events outcome was recovered on an unspecified date in Feb2021. No COVID prior vaccination, since the vaccination the patient hadn't been tested for COVID-19.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: dizzy; This is a spontaneous report from a Non contactable consumer via Pfizer-sponsored program.   A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose on an unspecified date for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient experienced dizzy on an unspecified date with outcome of unknown.    No follow-up attempts are possible; information about batch/ lot number cannot be obtained.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Tested positive after getting the first dose of covi-19 vaccine.; Tested positive after getting the first dose of covi-19 vaccine.; This is a spontaneous report from a Pfizer-sponsored program. A contactable male consumer ( patient) of unspecified age received his first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient tested positive after getting the first dose on an unspecified date. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood pressure measurement, COVID-19, Chills, Heart rate, Heart rate increased
Clinical narrative: Tested positive after getting the first dose of covi-19 vaccine.; Tested positive after getting the first dose of covi-19 vaccine.; This is a spontaneous report from a Pfizer-sponsored program. A contactable male consumer ( patient) of unspecified age received his first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient tested positive after getting the first dose on an unspecified date. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Oxygen saturation, SARS-CoV-2 test, Sinusitis
Clinical narrative: Tested positive after getting the first dose of covi-19 vaccine.; Tested positive after getting the first dose of covi-19 vaccine.; This is a spontaneous report from a Pfizer-sponsored program. A contactable male consumer ( patient) of unspecified age received his first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient tested positive after getting the first dose on an unspecified date. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Lymphadenopathy
Clinical narrative: swollen lymph nodes; tiredness; diarrhea; This is a spontaneous report from a contactable consumer (patient herself). A 60-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL3247), via an unspecified route of administration in left arm on 10Feb2021 09:15 at single dose for COVID-19 immunisation in workplace clinic. The patient's medical history included AFib, hypertension, known allergies: TB test (allergies to medications, food, or other products: TB test). Concomitant medications included apixaban, digoxin, metoprolol, enalapril; the patient received all the drugs within 2 weeks of vaccination. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL3247), in left arm on 20Jan2021 09:15 AM at single dose for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. On an unspecified date in 2021, the patient experienced swollen lymph nodes, tiredness, diarrhea. The events were considered as non-serious by the consumer. No treatment received for the adverse events. The outcome of the events was recovering.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Tested positive for Covid; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program, Pfizer First Connect. A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date unknown), via an unspecified route of administration on 21Jan2021 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient got the 1st shot on 21Jan2021, tested positive for Covid on 01Feb2021, 2nd round should be on Thursday. Asking if he needs to get the 2nd shot. The patient underwent lab tests and procedures which included Covid test: positive on 01Feb2021. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain, Pyrexia
Clinical narrative: fatigue; headache; body aches; fever; This is a spontaneous report from a contactable consumer (patient herself).  A 44-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: unknown), via an unspecified route of administration on 10Feb2021 08:15 (at age of 44-year-old) at single dose in left arm for COVID-19 immunisation. Medical history includes diabetes mellitus. There was no known allergies. No other vaccine was received in four weeks. Concomitant medication included empagliflozin (JARDIANCE), metformin for diabetes, semaglutide (OZEMPIC), atorvastatin (LIPITOR), sertraline. The patient experienced fatigue,  headache, body aches, and fever on 10Feb2021 14:00. No treatment was received for the events. There was no COVID prior vaccination or no COVID  tested post vaccination. The events did not result in emergency room visit or physician office visit. The outcome of events was resolving.  Information on the lot/batch number has been requested.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache
Clinical narrative: woke up at 1am with chills and a headache; woke up at 1am with chills and a headache/felt rundown with a lingering headache; This is a spontaneous report from a non-contactable consumer (patient).  A 31-year-old non-pregnant female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), at the age of 31-year-old via an unspecified route of administration on Left arm on 09Feb2021 09:00 (lot number=EN5318) at single dose for COVID-19 immunisation.  Medical history was none. There was no known allergies, no COVID prior vaccination or no COVID tested post vaccination. No other vaccine was received in four weeks. Concomitant medication included iron, ascorbic acid, betacarotene, calcium sulfate, colecalciferol, cyanocobalamin, ferrous fumarate, folic acid, nicotinamide, pyridoxine hydrochloride, retinol acetate, riboflavin, thiamine mononitrate, tocopheryl acetate, zinc oxide (PRENATAL VITAMINS). The patient previous took her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 31-year-old on Left arm on 16Jan2021 (lot number=EL3248) at single dose for COVID -19 immunisation. The patient felt fine all day, but woke up at 1am 10Feb2021 with chills and a headache (did not check temperature), took paracetamol (TYLENOL) and was able to get back to sleep. In the morning, felt rundown with a lingering headache, took ibuprofen. Around 1pm, symptoms were gone. The events did not result in emergency room or physician office visit. The outcome of the events was recovered on 10Feb2021 13:00.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Disturbance in attention, Dizziness, Headache, Nausea
Clinical narrative: nausea; dizzy; chills; body aches; headache; trouble concentrating; very sore arm; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 67-year-old non-pregnant female patient (Patient was not pregnant at the time of vaccination) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: E1823886, Expiry date: unknown), via an unspecified route of administration on 09Feb2021 at 10:00 (age at the time of vaccination was 67-year-old) on right arm at single dose for covid-19 immunisation. Medical history included allergy to Sulfa. Concomitant medication patient received within 2 weeks of vaccination included Hydrochloride, potassium chloride (K-DUR), vitamin d3, irbesartin. The patient experienced nausea, dizzy, chills, body aches, headache, trouble concentrating and very sore arm on 09Feb2021. The events were considered as non-serious. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No treatment was received for the adverse event. The patient was recovering from the events.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity
Clinical narrative: nausea; dizzy; chills; body aches; headache; trouble concentrating; very sore arm; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 67-year-old non-pregnant female patient (Patient was not pregnant at the time of vaccination) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: E1823886, Expiry date: unknown), via an unspecified route of administration on 09Feb2021 at 10:00 (age at the time of vaccination was 67-year-old) on right arm at single dose for covid-19 immunisation. Medical history included allergy to Sulfa. Concomitant medication patient received within 2 weeks of vaccination included Hydrochloride, potassium chloride (K-DUR), vitamin d3, irbesartin. The patient experienced nausea, dizzy, chills, body aches, headache, trouble concentrating and very sore arm on 09Feb2021. The events were considered as non-serious. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No treatment was received for the adverse event. The patient was recovering from the events.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Angioedema, Lymphadenopathy, Paraesthesia, Paraesthesia oral, Pruritus
Clinical narrative: angioedema; Face & tongue tingling; Face & tongue tingling; Itching all over; rash on limbs & chest; swollen lymph nodes; This is a spontaneous report from a contactable nurse (patient). A 64-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN9581), via an unspecified route of administration on 11Feb2021 11:15 (at the age of 64-year-old) at single dose in right arm for covid-19 immunisation. The patient other medical history included seizure disorder, hypertension, obesity, IBS (Irritable bowel syndrome), chronic rhinitis, atrial fibrillation. The patient had known allergies. No other vaccine in four weeks. The patient had received other medications in two weeks. The patient experienced face & tongue tingling. Itching all over, angioedema, rash on limbs & chest, swollen lymph nodes on 11Feb2021 12:00 PM. The patient received the treatment of events included diphenhydramine (BENADRYL). The outcome of the events was recovering.; Sender's Comments: The causal association between the reported event angioedema and BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: angioedema; Face & tongue tingling; Face & tongue tingling; Itching all over; rash on limbs & chest; swollen lymph nodes; This is a spontaneous report from a contactable nurse (patient). A 64-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN9581), via an unspecified route of administration on 11Feb2021 11:15 (at the age of 64-year-old) at single dose in right arm for covid-19 immunisation. The patient other medical history included seizure disorder, hypertension, obesity, IBS (Irritable bowel syndrome), chronic rhinitis, atrial fibrillation. The patient had known allergies. No other vaccine in four weeks. The patient had received other medications in two weeks. The patient experienced face & tongue tingling. Itching all over, angioedema, rash on limbs & chest, swollen lymph nodes on 11Feb2021 12:00 PM. The patient received the treatment of events included diphenhydramine (BENADRYL). The outcome of the events was recovering.; Sender's Comments: The causal association between the reported event angioedema and BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Toothache
Clinical narrative: toothache; This is a spontaneous report from a non-contactable consumer (the patient) from a Pfizer-sponsored program Pfizer First Connect. A female patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number not provided), via an unspecified route of administration on 08Feb2021 (age at vaccination unknown) as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had the second dose of vaccine yesterday. This morning (09Feb2021), she had a toothache. The doctor prescribed an antibiotic for the toothache. She inquired if her antibiotic would have an effect on the vaccine before taking. The clinical outcome of toothache was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Illness, SARS-CoV-2 test
Clinical narrative: 3 days later tested positive; got sick right after vaccine; This is a spontaneous report from a contactable consumer (the patient) via the Pfizer-sponsored program.  A female patient of unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 25Jan2021 as a single dose for COVID-19 vaccination. Medical history was not reported. Concomitant medications were not reported.  The patient stated that she got sick right after vaccine - 3 days later she tested positive. She also stated that "all symptoms are gone now."  Her second vaccine is on Monday and she is wondering if its okay to get the second dose on Monday. Lab data included a positive SARS-CoV-2 /COVID-19 test on 28Jan2021. The clinical outcomes of the events illness and COVID-19 were reported as resolved ("all symptoms are gone now") on an unspecified date.  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; tested positive for COVID-19; This is a spontaneous report from a contactable consumer, the patient, via the Pfizer-sponsored program. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date, the patient tested positive for COVID-19. The patient was scheduled for her second vaccination and asked if she still needed to receive the second dose. The clinical outcome of tested positive for COVID-19 was unknown.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Asymptomatic COVID-19, Chills, Drug ineffective, Headache, Influenza like illness
Clinical narrative: headache; nausea; chilling; generalized achiness; flu-like symptoms; positive COVID-19 test with no symptoms; positive COVID-19 test with no symptoms; This is a spontaneous report from a contactable consumer or other non hcp. A 67-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL8982) via an unspecified route of administration in left arm on 29Jan2021,16:15 at single dose for COVID-19 immunisation. Medical history included hypertension, osteoarthritis, prostate cancer, nephrolithiasis, glaucoma and drug hypersensitivity from an unknown date and unknown if ongoing. Concomitant medications were not reported. On 03Feb2021, the patient experienced headache, nausea, chilling, generalized achiness, flu-like symptoms. Adverse events: 12-24 hrs after the vaccine the patient experienced headache, nausea, chilling, and generalized achiness (basically flu-like symptoms). The symptoms resolved within 24 hrs. The patient never experienced any fever. Since he was having an OP surgery, he had to have a pre-op COVID-19 test (done 01Feb2021) which was positive. He was informed on 03Feb2021 that the COVID-19 test was positive and surgery and radiation had to be postponed. He was totally asymptomatic the entire time during his quarantine time, as well as since then. The outcome of the event COVID-19 test with no symptoms and drug ineffective was unknown and outcome of all other events was recovered on Feb2021.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pain, SARS-CoV-2 test
Clinical narrative: headache; nausea; chilling; generalized achiness; flu-like symptoms; positive COVID-19 test with no symptoms; positive COVID-19 test with no symptoms; This is a spontaneous report from a contactable consumer or other non hcp. A 67-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL8982) via an unspecified route of administration in left arm on 29Jan2021,16:15 at single dose for COVID-19 immunisation. Medical history included hypertension, osteoarthritis, prostate cancer, nephrolithiasis, glaucoma and drug hypersensitivity from an unknown date and unknown if ongoing. Concomitant medications were not reported. On 03Feb2021, the patient experienced headache, nausea, chilling, generalized achiness, flu-like symptoms. Adverse events: 12-24 hrs after the vaccine the patient experienced headache, nausea, chilling, and generalized achiness (basically flu-like symptoms). The symptoms resolved within 24 hrs. The patient never experienced any fever. Since he was having an OP surgery, he had to have a pre-op COVID-19 test (done 01Feb2021) which was positive. He was informed on 03Feb2021 that the COVID-19 test was positive and surgery and radiation had to be postponed. He was totally asymptomatic the entire time during his quarantine time, as well as since then. The outcome of the event COVID-19 test with no symptoms and drug ineffective was unknown and outcome of all other events was recovered on Feb2021.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Oral disorder
Clinical narrative: bad effect in the mouth; This is a spontaneous report from a contactable Other Health Professional.  A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced bad effect in the mouth per the dentist on an unspecified date with outcome of unknown. Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling of body temperature change, Headache, Pyrexia, Suspected COVID-19
Clinical narrative: COVID symptoms; extreme fatigue; headache; feverish; She would get hot and then very cold; This is a spontaneous report from a contactable consumer patient. A female patient of an unspecified age (reported as late 60's to early 70's) received BNT162B2, via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Hours later after received the vaccine, the patient experienced COVID symptoms. She felt extreme fatigue, headache and felt feverish but never took her temperature. She would get hot and then very cold. The outcome of events was unknown.  No follow-up attempts are possible, Information about batch/lot number cannot be obtained. No further information is expected.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rash, Urticaria, Urticaria thermal
Clinical narrative: Rash; Fever; Rash or hives are on her legs, thighs, neck, back, and head; Rash or hives are on her legs, thighs, neck, back, and head; This is a spontaneous report from a contactable nurse (patient husband). A 76-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: solution for injection, Lot Number: EL3247, Expiration date: 31May2021) via an unspecified route of administration in the right arm on 01Feb2021 (at the age of 76-year-old) as a single dose for COVID-19 immunisation. The patient relevant medical history included allergy. The concomitant medication was not reported. The patient previously took septra and experienced allergic to septra (she had taken many years ago. She took something and developed an allergy, but she hasn't used it in maybe 20 years). It was reported that patient received first dose of the Pfizer COVID-19 vaccine on Monday (01Feb2021) and she felt good, then late Tuesday she got a rash at 09:30 (about 30 hours after her injection) and a fever on (02Feb2021), which was listed on the brochure and was kind of expected, but he wanted to be reassured this was ok and not something like a severe allergic reaction. It was reported that patient second dose was scheduled for 22Feb2021. It was reported that patient has been taking Benadryl 25mg, 50mg total a day, 25mg one in the morning and then one in the evening by mouth. The reporter informed that the benadryl (Lot number: P119020, EXP: Feb2022) seems to calm the rash down, though it was more like hives than a rash. It was reported that patient had rash or hives are on her legs, thighs, neck, back, and head on an unknown date in Feb2021. The reporter told that the rash was not getting worse, and Benadryl seems to help it. The reporter told that the vaccine instructions they got said it was possible to get a rash or have a side effect, he just wanted to be reassured. Therapeutic measures were taken as a result of rash, rash or hives are on her legs, thighs, neck, back, and head. The outcome of the event fever was unknown while for other events was recovering.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous, Rash papular, Rash pruritic
Clinical narrative: Rash to anterior neck, 10x10 cm, raised, red, itching.; Rash to anterior neck, 10x10 cm, raised, red, itching.; Rash to anterior neck, 10x10 cm, raised, red, itching.; This is a spontaneous report from a contactable consumer (patient). A 56-year-old non-pregnant female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248), via an unspecified route of administration in the left arm on 30Jan2021 14:00 at a single dose for COVID-19 immunization. Medical history included ovarian cancer and chemotherapy; both  from 2018 to an unknown date. The patient's concomitant medications were not reported. The patient has not received other vaccine in four weeks. On 01Feb2021 10:00, patient experienced rash to anterior neck, 10x10 cm, raised, red, itching. Outcome of events was recovering. Therapeutic measures were taken as a result of events includes Claritin, steroid and antihistamine. Events resulted in doctor or other healthcare professional office/clinic visit. The patient was not diagnosed of covid prior vaccination and has not tested for covid post vaccination.
Age: 89.0
Sex: M
Vaccine: COVID19
Symptoms: Discomfort, Pruritus, Rash papular
Clinical narrative: body became very itchy and he was itchy all over; developing little red like pimples all different parts of his body; itchy bumps/ little tiny pimples on his skin and it was very uncomfortable; little tiny pimples on his skin and it was very uncomfortable; This is a spontaneous report from a contactable consumer (the patient). An 89-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3249, expiry date 31May2021), via an unspecified route of administration (injection) in the left arm on 22Jan2021 (at the age of 89-years-old) as a single dose for COVID-19 immunization. The patient's medical history was not reported. The patient was on unspecified concomitant medications. The patient stated he has been taking the same medications for several years, and he has had no problems with those. The patient did not receive any other vaccines on the same day. The patient had his first Pfizer COVID-19 shot on 22Jan2021. He was due for his second shot on 12Feb2021. After he had the first shot, his body got itchy all over and it was still itchy. He also had little tiny pimples on his skin, and it was very uncomfortable. He was wondering if this was a known reaction to the product. He had no idea what to do to relieve the itching. He got the vaccine on 22Jan2021, and the itching started either the next day or two days after getting the vaccine. His body became very itchy, and he was itchy all over. He was developing little red like pimples all different parts of his body; itchy bumps. The itching and pimples having continued through to now, and it seemed to get even more itchy in the evening at bedtime. Last night (unspecified date), he had it on the top of his feet down there, on the top and in between his toes. Those itchy bumps were all over, and he did not know if that was the Pfizer shot.  The patient tried different anti-itch creams on it, and that relieved it for a while, but then it came back. He used clobetasol propionate, but it had not worked. They stopped itch for a while but then it does not help. He tried some just plain anti-itch cream (clarified as Gold Bond Anti-Itch Cream) to stop the itching. It stopped itch for a while, but then it did not help. He did not have to use the cream until 3-4 days. It was some prescription from the doctor, but it was for his wife. He tried it, but it did not do anything. The patient stated the injection itself did not give him any problems. The patient was wondering whether he should take the second shot if this one gave him so much trouble. The clinical outcome of discomfort was unknown. The outcome of the other events was not recovered.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: woke up in the middle of the night (3AM) with a fever; This is a spontaneous report received from a non-contactable consumer (Patient herself). A 66-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection) vis an unspecified route of administration on 04Feb2021 10:00 at single dose for COVID-19 immunization. Patient medical history and concomitant medications were not reported. Patient previously took BNT162B2 in Jan2021. It was reported as patient was fine and engaged in physical activity during the day of second dose but woke up in the middle of the night (3AM) with a fever on 05Feb2021 03:00 and is currently recovering at home in bed. Patient did not receive any treatment for event. Outcome of event was recovering.  No follow-up attempts are Possible. Information on Lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal discomfort, Fatigue, Vaccination site pain
Clinical narrative: Extreme fatigue; Tenderness at injections site; Upset stomach; This is a spontaneous report from a contactable healthcare professional for a patient enrolled in Pfizer-sponsored program; this report is in regard to events reported in the patient medical history. A 60-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation.  The patient medical history and concomitant medications were not reported.  On an unspecified date the patient experienced extreme fatigue, tenderness at injections site and upset stomach that lingered for about a week. The patient got fatigue around 3:00 pm every day and took a nap which helped. The events were non-serious with outcome of unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue
Clinical narrative: Extreme fatigue; Tenderness at injections site; Upset stomach; This is a spontaneous report from a contactable healthcare professional for a patient enrolled in Pfizer-sponsored program; this report is in regard to events reported in the patient medical history. A 60-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation.  The patient medical history and concomitant medications were not reported.  On an unspecified date the patient experienced extreme fatigue, tenderness at injections site and upset stomach that lingered for about a week. The patient got fatigue around 3:00 pm every day and took a nap which helped. The events were non-serious with outcome of unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: they got the virus; This is a spontaneous report from a contactable consumer (patient's daughter). This consumer reported similar events for two patients. This is the second of two reports.  A female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date at SINGLE DOSE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The reporter reported that her parents received the first dose of bnt162b2 vaccine. Then, after a week, they got the virus on an unspecified date. The reporter said that they got it from the doctor's office. The reporter also mentioned that her parents are still recovering and are still on quarantine. The reporter wanted to know if they should still receive the 2nd dose of the vaccine. The reporter was also concerned because they were scheduled to receive the 2nd dose 3 days earlier than the recommended 3-week-interval, and wanted to know if that was acceptable. The patient was recovering from the event.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021130214 same reporter/drug, similar event, different patient
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea
Clinical narrative: Lot of stomach cramps; had a lot of diarrhea; This is a spontaneous report from a contactable consumer (patient).  A 76-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), (batch/lot number: EL8982, expiry: 30May2021) via an unspecified route of administration, on 31Jan2021 at a single dose, for covid-19 immunization. Medical history included neoplasm malignant (cancer), blood cholesterol ("cholesterol") and "blood pressure".  Patient's concomitant medications were unspecified. On 01Feb2021, patient had a lot of diarrhea and a lot of stomach cramps for a week. He got it from a week ago today and he has been experiencing this and couldn't go to work. The outcome of events was unknown.  Follow-up attempts are completed. Information about batch/lot number has been obtained.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Hypoaesthesia, Paraesthesia, Throat irritation, Urticaria
Clinical narrative: Numbness; itchy throat; tingling in face; trouble swallowing; hives on face and back; This 34- year-old female patient contactable consumer (reported for herself) received the second dose BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE lot En5318), via an unspecified route of administration, on 05Feb2021 at 01:30 PM (at the age of 34-years-old) as a single dose for COVID-19 immunization, in left arm. Historical Vaccine included first dose of BNT162B2 on 15Jan2021 at 10.45 (lot EL1484, expiry 30Apr2021), for COVID-19 immunization and experienced the onset of headache, intense arm pain at the injection site and mild joint pain. The patient's concomitant medications included The medical history included: Asthma, GERD, and obesity. Allergy to Sulfa. Historical Vaccine included first dose of BNT162B2 on 15Jan2021 (lot E63248), for COVID-19 immunization in left arm. The patient's concomitant medications included ALBUTEROL [SALBUTAMOL]. She has had no other vaccines in the past 4 weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 05Feb2021 13:45, she reported experiencing Numbness, tingling in face, trouble swallowing, itchy throat, hives on face and back. Patient received treatment of 3 doses of Benadryl. The outcome of the events Numbness, tingling in face, trouble swallowing, itchy throat, hives on face and back was recovering. It was reported that since the vaccination, the patient had not been tested for COVID-19.
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis
Clinical narrative: cold; This is a spontaneous report from a contactable consumer (reported for herself). A 67-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot/batch number and expiration date not provided), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On inbound call, patient stated she was taking her Pfizer second vaccine on Sunday and she had cold, asked if she would be able to take the second vaccine. The outcome of the event was unknown.  Information about lot/batch number has been requested.