chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Paraesthesia oral, SARS-CoV-2 test, Tinnitus, Tremor
Clinical narrative: Debilitating headache; nausea; vomiting; ringing in the ears; L eye drooping; numbness and tingling of lips; numbness and tingling of lips; trembling of R side of body; abnormal/change in gait; change in vision; hypertension; This is a spontaneous report from a contactable nurse (patient herself). A 39-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/lot number and Expiration date was unknown), first dose via an unspecified route of administration on an unspecified date, second dose via intramuscularly in right arm on 16Jan2021 15:30; both at single dose for COVID-19 immunisation in workplace clinic. The patient's medical history included depression, MTHFR (methylenetetrahydrofolate reductase), latex allergy. Concomitant medications included venlafaxine, L-methylfolate; the patient received both the drugs within 2 weeks of vaccination. The patient previously took fluoxetine, citalopram and experienced known allergies for both the drugs. 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 been tested for COVID-19 since the vaccination. The patient experienced debilitating headache, nausea, vomiting, ringing in the ears, L eye drooping, numbness and tingling of lips, trembling of R side of body, abnormal/change in gait, change in vision, hypertension on 25Jan2021 06:00. On 01Feb2021, the patient underwent lab test and procedure included nasal swab/ COVID-19 by PCR: Negative. The adverse events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient was treated with IV Dexamethazone, Diphenhydramine, ketorolac, promethazine for all the events. The outcome of the events was not recovered.  Information on the Lot/Batch number has been requested.; Sender's Comments: On the basis of the available information, the reported events debilitating headache, nausea, vomiting, ringing in the ears, L eye drooping, numbness and tingling of lips, trembling of R side of body, abnormal/change in gait, change in vision, hypertension would seem most likely related to intercurrent and/or underlying medical condition and concomitant medication, which is not related to bnt162b2. This case will be reassessed when additional information becomes available. This 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 to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Visual impairment, Vomiting
Clinical narrative: Debilitating headache; nausea; vomiting; ringing in the ears; L eye drooping; numbness and tingling of lips; numbness and tingling of lips; trembling of R side of body; abnormal/change in gait; change in vision; hypertension; This is a spontaneous report from a contactable nurse (patient herself). A 39-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/lot number and Expiration date was unknown), first dose via an unspecified route of administration on an unspecified date, second dose via intramuscularly in right arm on 16Jan2021 15:30; both at single dose for COVID-19 immunisation in workplace clinic. The patient's medical history included depression, MTHFR (methylenetetrahydrofolate reductase), latex allergy. Concomitant medications included venlafaxine, L-methylfolate; the patient received both the drugs within 2 weeks of vaccination. The patient previously took fluoxetine, citalopram and experienced known allergies for both the drugs. 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 been tested for COVID-19 since the vaccination. The patient experienced debilitating headache, nausea, vomiting, ringing in the ears, L eye drooping, numbness and tingling of lips, trembling of R side of body, abnormal/change in gait, change in vision, hypertension on 25Jan2021 06:00. On 01Feb2021, the patient underwent lab test and procedure included nasal swab/ COVID-19 by PCR: Negative. The adverse events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient was treated with IV Dexamethazone, Diphenhydramine, ketorolac, promethazine for all the events. The outcome of the events was not recovered.  Information on the Lot/Batch number has been requested.; Sender's Comments: On the basis of the available information, the reported events debilitating headache, nausea, vomiting, ringing in the ears, L eye drooping, numbness and tingling of lips, trembling of R side of body, abnormal/change in gait, change in vision, hypertension would seem most likely related to intercurrent and/or underlying medical condition and concomitant medication, which is not related to bnt162b2. This case will be reassessed when additional information becomes available. This 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 to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Myalgia, SARS-CoV-2 test, Tenderness
Clinical narrative: left arm was tender; Cramping feeling and feels like spasms; muscles were sore on the left side; This is a spontaneous report from a contactable consumer.  This consumer (patient) reported that a 42-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN5318) at the age of 42-years, via an unspecified route of administration in left arm on 31Jan2021 at single dose for COVID-19 immunization, in workplace clinic. Medical history included shell-fish allergy. No other vaccine in four weeks, no COVID-19 prior vaccination. Patient was tested negative for COVID-19 virus test (Nasal Swab) on 25Jan2021. No other medications in two weeks. At 00:00 on 17Feb2021 (16Feb2021 12:00 PM), the patient experienced left arm was tender and muscles were sore on the left side. Cramping feeling and feels like spasms. Patient went to the hospital cause of pain. The adverse events resulted in emergency room/department or urgent care. No treatment. On an unspecified date, COVID-19 was tested post vaccination with unknown results. Outcome of the events was unknown.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Asthenia, Chills, Cough, Decreased appetite
Clinical narrative: RA; no energy/weak; OA; coughing; chilling; diarrhea; headache; we are not hungry but food is tasteless/no taste; fibro; no taste/food was tasteless; She did not feel very well; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar events for her husband and herself. This is the first of two reports for herself. Only this case is serious. A 72-year-old (non-pregnant) female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot # EN6201, via an unspecified route of administration on 10Feb2021 17:15 as single dose for covid-19 immunisation.  The patient medical history was not reported. Concomitant medications included unspecified products in two weeks. There was no other vaccine in four weeks.The patient experienced coughing, weak, no taste, chilling, diarrhea, no energy, headache all on 11Feb2021. She did not feel very well on the day she took her shot on 10Feb2021 but did not have a fever. She was not hungry but food was tasteless.It was also reported that "she had RA OA and fibro. and take thyroid medicine besides medicine for the others. Adverse event start date: 11Feb2021". No treatment was received for all events and events outcome was not resolved.The patient did not have COVID prior vaccination and no COVID tested post vaccination.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021207100 same reporter/product, similar events, different patient
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fibromyalgia, Headache, Malaise, Osteoarthritis
Clinical narrative: RA; no energy/weak; OA; coughing; chilling; diarrhea; headache; we are not hungry but food is tasteless/no taste; fibro; no taste/food was tasteless; She did not feel very well; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar events for her husband and herself. This is the first of two reports for herself. Only this case is serious. A 72-year-old (non-pregnant) female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot # EN6201, via an unspecified route of administration on 10Feb2021 17:15 as single dose for covid-19 immunisation.  The patient medical history was not reported. Concomitant medications included unspecified products in two weeks. There was no other vaccine in four weeks.The patient experienced coughing, weak, no taste, chilling, diarrhea, no energy, headache all on 11Feb2021. She did not feel very well on the day she took her shot on 10Feb2021 but did not have a fever. She was not hungry but food was tasteless.It was also reported that "she had RA OA and fibro. and take thyroid medicine besides medicine for the others. Adverse event start date: 11Feb2021". No treatment was received for all events and events outcome was not resolved.The patient did not have COVID prior vaccination and no COVID tested post vaccination.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021207100 same reporter/product, similar events, different patient
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Rheumatoid arthritis
Clinical narrative: RA; no energy/weak; OA; coughing; chilling; diarrhea; headache; we are not hungry but food is tasteless/no taste; fibro; no taste/food was tasteless; She did not feel very well; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar events for her husband and herself. This is the first of two reports for herself. Only this case is serious. A 72-year-old (non-pregnant) female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot # EN6201, via an unspecified route of administration on 10Feb2021 17:15 as single dose for covid-19 immunisation.  The patient medical history was not reported. Concomitant medications included unspecified products in two weeks. There was no other vaccine in four weeks.The patient experienced coughing, weak, no taste, chilling, diarrhea, no energy, headache all on 11Feb2021. She did not feel very well on the day she took her shot on 10Feb2021 but did not have a fever. She was not hungry but food was tasteless.It was also reported that "she had RA OA and fibro. and take thyroid medicine besides medicine for the others. Adverse event start date: 11Feb2021". No treatment was received for all events and events outcome was not resolved.The patient did not have COVID prior vaccination and no COVID tested post vaccination.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021207100 same reporter/product, similar events, different patient
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 COVAX US Support from a contactable consumer (patient). A male patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number unknown), via an unspecified route of administration on 19Jan2021 at single dose for COVID-19 immunization. He tested positive for COVID-19 on unknown date. The second dose was rescheduled for 18Feb2021. Outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Feeling cold, Loss of consciousness, Pallor, Syncope
Clinical narrative: Fainted; unresponsive; Chills; cool; pale; This is a spontaneous report from a contactable consumer (patient). A 66-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EN9581), via an unspecified route of administration, administered in right arm on 11Feb2021 at 01:30 AM (at age of 66 years old) at a single dose for COVID-19 immunization. Medical history included elevated cholesterols, prostate cancer-low-Gleason scale-7. Known allergies: Seasonal allergy, pollen. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: 3L3247), via an unspecified route of administration, administered in right arm on 21Jan2021 at 02:30 PM (at age of 66 years old) at a single dose for COVID-19 immunization. The patient did not had Covid prior vaccination, also not did Covid tested post vaccination. Concomitant medications included atorvastatin calcium and tamsulosin. On 12Feb2021 at 12:30 AM, the patient experienced chills, cool, pale, moist skin. Fainted 22 hours' after received the second dose of vaccination. Was unresponsive about 30-40 seconds. After getting cold compress on the neck and face splashed with cold water, was able to answer basic question to EMS team who was called by patient's wife at 12:28 PM. EMS advise to drink a lot of fluids with/electrolytes also took 500 mg Tylenol rapid release gels and 4 hours later Aspirin 325 mg as Tylenol did not help. Stay warm in bad until next day. The events resulted in Doctor or other healthcare professional office/clinic visit. The outcome of the events was recovered in Feb2021.  Information on the lot/batch number has been requested.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Productive cough
Clinical narrative: cough; coughing up yellow chuncks; This is a spontaneous report from a contactable Nurse. A non-pregnant 55-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration, on an unspecified date (at the age of 55 years) as a single dose for COVID-19 immunization. Medical history included asthma, narcolepsy, allergy multiple. Concomitant medications were not reported. On an unspecified date, the patient experienced cough. The clinical course was as follows: The patient reported, "I have asthma, and I just received the Covid shot. I have been coughing more this last week, and coughing up yellow chuncks. I am a Dr. and I put myself on a z-pak, and I am going to do an x-ray. I will see MD next week when I see him". The prescriber was not aware. Therapeutic measures were taken as a result of cough. The clinical outcome of the cough and coughing up yellow chuncks was not recovered.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: I was in the hospital on Thursday and Friday for a mini stroke; This is a spontaneous report from a Pfizer Sponsored Program. A contactable consumer (patient) reported that a female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL3246), via an unspecified route of administration in Jan2021 at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient was scheduled to get her second shot tomorrow (16Feb2021). She had the first one 3 weeks ago and was looking at the paper work just to make sure that she did not miss anything and it said tell the vaccination provider about medical conditions including if you were on a blood thinner. The patient stated that she was hospitalized last 4 days ago, she had a blood disorder, blood thinner. The patient was in the hospital on Thursday (11Feb2021) and Friday (12Feb2021) for a mini stroke and was prescribed a blood thinner (Treatment) that she took one Saturday morning one Sunday morning and one this morning (15Feb2021). The outcome of event was unknown.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, Dyspnoea, Investigation, Oxygen saturation
Clinical narrative: RA; Substernal CP; mild SOB; CP / pressure 5/10 radiating to neck; This is a spontaneous report from a contactable Nurse. A 73-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly in Right Arm on 19Feb2021 14:15 (Lot Number: EL9262) as single dose for covid-19 immunisation. Medical history included enlarged prostate and asthma. Concomitant medications in two weeks included salbutamol (ALBUTEROL); fluticasone furoate, umeclidinium bromide, vilanterol trifenatate (TRELEGY, reported as triogy); morniflumate (FLOMAX, reported as flowmax). If other vaccine in four weeks: No. If covid prior vaccination: No. If covid tested post vaccination: No. Known allergies: No. Facility type vaccine Other (as reported). The patient experienced RA (rheumatoid arthritis), substernal cp (chest pain), mild SOB (Shortness of breath), CP/pressure 5/10 radiating to neck, all on 19Feb2021 14:15 with outcome of unknown.  The patient underwent lab tests and procedures which included chest pressure: 5/10 on 19Feb2021, oxygen saturation: 97% on 19Feb2021. Clinical course: Substernal CP (Chest pain) approx 10 min post vaccine with mild SOB. Patient denied scratchy throat or throat swelling no swelling noted patient speaking in full sentences O2 sats 97 %, RA, no hives noted, no rash, no difficulty swallowing. Patient reported CP / pressure 5/10 radiating to neck. No pain on palpation lungs clr bi laterally EMS called patient care transfered to paramedics. The events resulted in Emergency room or department or urgent care. No treatment received for the events.; Sender's Comments: The reported RA (rheumatoid arthritis) was more likely an intercurrent disease, and less likely causally related to the use of  first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE).  This case will be reassessed should additional information become 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.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Rheumatoid arthritis
Clinical narrative: RA; Substernal CP; mild SOB; CP / pressure 5/10 radiating to neck; This is a spontaneous report from a contactable Nurse. A 73-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly in Right Arm on 19Feb2021 14:15 (Lot Number: EL9262) as single dose for covid-19 immunisation. Medical history included enlarged prostate and asthma. Concomitant medications in two weeks included salbutamol (ALBUTEROL); fluticasone furoate, umeclidinium bromide, vilanterol trifenatate (TRELEGY, reported as triogy); morniflumate (FLOMAX, reported as flowmax). If other vaccine in four weeks: No. If covid prior vaccination: No. If covid tested post vaccination: No. Known allergies: No. Facility type vaccine Other (as reported). The patient experienced RA (rheumatoid arthritis), substernal cp (chest pain), mild SOB (Shortness of breath), CP/pressure 5/10 radiating to neck, all on 19Feb2021 14:15 with outcome of unknown.  The patient underwent lab tests and procedures which included chest pressure: 5/10 on 19Feb2021, oxygen saturation: 97% on 19Feb2021. Clinical course: Substernal CP (Chest pain) approx 10 min post vaccine with mild SOB. Patient denied scratchy throat or throat swelling no swelling noted patient speaking in full sentences O2 sats 97 %, RA, no hives noted, no rash, no difficulty swallowing. Patient reported CP / pressure 5/10 radiating to neck. No pain on palpation lungs clr bi laterally EMS called patient care transfered to paramedics. The events resulted in Emergency room or department or urgent care. No treatment received for the events.; Sender's Comments: The reported RA (rheumatoid arthritis) was more likely an intercurrent disease, and less likely causally related to the use of  first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE).  This case will be reassessed should additional information become 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.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This is a spontaneous report from a contactable consumer (Patient's husband) via a sponsored program. An 82-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNONW), the patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNONW), both via an unspecified route of administration on unspecified dates (at the age of 82 years); both as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The husband reported on behalf of his wife who got the first and the second dose of the vaccine, and she experienced sore arms after the vaccine. The clinical outcome of sore arm was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: Not feeling well; This is a spontaneous report from a contactable consumer, the patient, via the 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 was not feeling well after the first vaccination. The patient wanted to confirm if this was an effect of the vaccine or if this was because she was exposed to her friend who felt COVID symptoms. The clinical outcome of not feeling well was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Multiple sclerosis, Vertigo
Clinical narrative: Multiple sclerosis; The room started spinning; This is a spontaneous report received from Pfizer. A contactable consumer (patient herself) reported that a female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection) via an unspecified route of administration on 11Feb2021 at SINGLE DOSE for covid-19 immunization. The patient medical history and concomitant medications were not reported. A few days after receiving the 1st dose, in Feb2021, the patient experienced with multiple sclerosis and the room started spinning for 10 min a few days. The event multiple sclerosis was considered as medically significant. Outcome of the events was unknown.  Information about batch/lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Vertigo
Clinical narrative: dizziness; vertigo; This is a spontaneous report from a sponsored program. A contactable consumer (patient's grandchild) reported that a female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Calling on behalf of her grandmother who experienced dizziness and vertigo after the 1st dose of the vaccine. The outcome of the events was unknown.   Information about the 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 dose of covid vaccine and Tested positive; Received first dose of covid vaccine and Tested positive; This is a spontaneous report from a contactable consumer from the Pfizer-sponsored program.   A patient of 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 immunization. The patient's medical history and concomitant medications were not reported. The reporter called in and wanted to know the time interval between Remdesivir and BNT162B2. It was reported that the patient received the first dose of BNT162B2 and tested positive and was treated with Remdesivir and wanted the second dose. The outcome of the event was unknown.   Information on the batch/lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Swelling face, Urticaria
Clinical narrative: swollen face and hives; swollen face and hives; This is a spontaneous report from a contactable consumer from a sponsored program. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration on 12Feb2021 (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. On 13Feb2021, the patient experienced swollen face and hives (non-serious).  The clinical outcome of the events was unknown.  The batch/lot numbers for the vaccine, bnt162b2, were not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive, Vaccination failure
Clinical narrative: COVID positive after testing after second dose; COVID positive after testing after second dose; This is a spontaneous report from Pfizer, received from a contactable consumer (patient). A female patient of an unspecified age received the first and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on unspecified dates (Batch/Lot number was not reported) as single doses for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. After the second dose, patient was COVID positive after testing after second dose. Outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Sinusitis
Clinical narrative: sinus infection; This is a spontaneous report from a sponsored program. A contactable consumer (patient) reported that a female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Caller called to ask if it was okay to get the second dose of Covid-19 vaccine scheduled tomorrow if she was currently on antibiotic due to sinus infection. Therapeutic measures were taken as a result of sinus infection. The outcome of the event was unknown.  Information on the lot/ batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles; This is a spontaneous report from a non-contactable consumer (daughter). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration in Jan2021 (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 the first Pfizer vaccines the very end of Jan and he's due for the second vaccine this Saturday and he's developed shingles in 2021. The reporter wanted to know if the patient can get the second vaccine. The outcome of the event was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, SARS-CoV-2 antibody test negative
Clinical narrative: he went and had an antibody test because he had no side effects and the results were negative; This is a spontaneous report from a contactable consumer (patient).  A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date unspecified), via an unspecified route of administration on 06Jan2021 (first dose) at single dose; and via unspecified route of administration on 27Jan2021 (second dose) at single dose; for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported.  The patient reported that he went and had an antibody test because he had no side effects to the vaccine and the results were negative on an unspecified date. He was asking what that means. His wife who was a health worker had side effects of chills and swollen arm. Outcome of event was unknown.  Information about lot/ batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: nauseous; This is a spontaneous report from a contactable consumer (the patient) from a sponsored program. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number not provided), via an unspecified route of administration on an unspecified date (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 still had symptoms after the vaccine; she was feeling nauseous. The clinical outcome of nauseous was not recovered.  Information about lot/ batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Appetite disorder, Decreased appetite, Fatigue
Clinical narrative: Unable to eat/loss of appetite; Unable to eat/loss of appetite; tired; This is a spontaneous report from a sponsored program from a contactable consumer. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was unable to eat/loss of appetite and was tired on an unspecified date. There was no fever. The outcome of unable to eat/loss of appetite and tired was unknown.     The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
Sex: F
Vaccine: COVID19
Symptoms: Cough
Clinical narrative: coughing; This is a spontaneous report from a contactable consumer (patient) from a sponsored program. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration on 15Jan2021 (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. On an unspecified date, the patient experienced coughing (non-serious). The clinical course was reported as follows: The patient received the first dose on 15Jan2021, and the second dose was supposedly scheduled for 05Feb2021. The patient, however, missed receiving the second dose because the nurse on duty told her to go to her doctor as she was coughing at that time. The clinical outcome of the event was unknown.  The batch/lot numbers for the vaccine, bnt162b2, were not provided and will be requested during follow up.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This is a spontaneous report from a contactable consumer (patient).   A 75-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported), (at the age of 75-year-old) as SINGLE DOSE for covid-19 immunisation.  Medical history included High Blood Pressure, osteoporosis, Overactive bladder.  The patient received second shot on the 06Feb (not clarified). After the first shot, the patient had no symptoms except for sore arm. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Injection site ached a little bit; This is a spontaneous report from a contactable consumer. The consumer reported similar events for 2 patients (himself and wife). This is second of two reports. This consumer reported for a 83 year old female patient (wife). An 83-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 13Feb2021 (at the age of 83 years old) as a single dose for COVID-19 vaccination. Medical history and concomitant medications were not reported. Past vaccination history included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on an unspecified date. On an unspecified date in Feb2021, the patient experienced  injection site ached a little bit (duration about 12 hours). The clinical outcome of injection site ached a little bit  was unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.  ; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021194850 same reporter/drug/AE, different patient
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: He got a fever and he had other symptoms; This is a spontaneous report from a contactable other healthcare professional.   A male patient of an unspecified age received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported.  The reporter stated she was calling because her boyfriend is getting the vaccine (Unspecified vaccine) and do not understand a lot of conflicting news articles and basically the last time he got the first dose, he got a fever and he had other symptoms. So, the reporter stayed away. He was afraid he might give the reporter something. Right now he is getting his second dose today. The reporter was asking if it was actually true that you put the Covid flu into the vaccine? So, like the reporter being exposed to it if she was around the patient. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Age: 76.0
Sex: F
Vaccine: COVID19, UNK, UNK
Symptoms: Oedema
Clinical narrative: a little bit of Edema; This is a spontaneous report from a contactable consumer (patient).  A 76-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Right on 09Feb2021 (Batch/Lot Number: EN6201), at the age of 76-year-old at the time of vaccination, as SINGLE DOSE for COVID-19 immunization, fulvestrant (FASLODEX), route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication; denosumab (XGEVA), route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication. Medical history included bone cancer from Jun2020 (Stage IV Bone Cancer), breast cancer. Concomitant medication included palbociclib (IBRANCE) taken for an unspecified indication from Jul2020; ascorbic acid, ergocalciferol, folic acid, retinol, tocopherol, vitamin b nos (MULTIPLE VITAMINS) taken for an unspecified indication, start and stop date were not reported. On 12Feb2021, the patient experienced a little bit of Edema which was also stated as not bad with outcome of unknown. No treatment was received for the event.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Left arm hurt for 2-3 days then resolved on its own; This is a spontaneous report from a contactable consumer.   A 69-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number was not reported), via an unspecified route of administration on 12Feb2021  as single dose for covid-19 immunization.  The patient's medical history and concomitant medications were not reported.  On 12Feb2021, at 15:00 patient experienced left arm hurt for 2-3 days then resolved on its own. No covid test post vaccination was snoted.  The outcome of event was recovered in Feb2021, with no treatment given.  The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up .
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis, Pain in extremity
Clinical narrative: Cold; Sore left arm; This is a spontaneous report from a contactable consumer, the patient.  A 69-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number LC3302), via an unspecified route of administration in the left arm on 12Feb2021 at 17:15 (at the age of 69-years-old) as a single dose for COVID-19 immunisation.  Relevant medical history included diabetes (diagnosed 4-5 years ago). The patient did not have any relevant family medical history. Concomitant medications included echinacea and vitamins, both from an unknown date at an unknown dose for an unknown indication and unspecified medications for diabetes, cholesterol and thyroid, all started prior to the vaccine. The patient previously received a shingles shot (unspecified product) for immunization and experienced injection site soreness.  The patient did not receive any other vaccines on same date of the BNT162B2 vaccine and no prior vaccinations within 4 weeks of the vaccine.  On 12Feb2021 the patient experienced a cold approximately five hours after the vaccination (reported as 21:30 - 22:00) which was a little worse on Saturday but started to get better and a sore left arm within a few hours of receiving the vaccine (exact time unknown).  The events did not require a visit to ER or physician's office and there were no relevant tests performed. The patient stated they have not had a cold in over a year and would like to know if it is a symptom of the vaccine. The patient reported she is taking echinacea liquid and it usually helps within 36 hours and now this is her third day. It has gotten better because she takes echinacea and vitamins as well. The patient stated her left arm was sore, but not bad. She first stated it was 3-4 inches above elbow and later stated it was about 4 inches from shoulder and she did not think it was in the muscle. The patient has an appointment for her second dose in 4 weeks, the patient inquired if there will be an issue with her receiving second dose in 4 weeks instead of 3 weeks. The clinical outcome of the cold and sore left arm was recovering.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Decreased appetite, Fatigue, Headache
Clinical narrative: extreme congestion; Loss of appetite; nausea; fever; chills; headache; fatigue; dry cough; injection site pain; pain; This is a spontaneous report from a contactable consumer (patient). A 64-year-old non-pregnant female received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6201, Expiry date: unknown), via an unspecified route of administration on 09Feb2021 at 03:00 PM (at the age of 64-year-old) on Left arm at single dose for covid-19 immunisation. The patient's medical history was not reported. Patient had unspecified other medications in two weeks. The patient previously took first dose of BNT162B2 (Lot number: EL9262) on 22Jan2021 at 02:30 PM on Left arm at single dose for covid-19 immunisation and had vancomycin and experienced drug allergy. The patient experienced Loss of appetite, nausea, fever, chills, headache, fatigue, dry cough, extreme congestion, pain at injection site and aches on 10Feb2021. 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.  No follow-up attempts are possible. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Pulmonary congestion, Pyrexia, Vaccination site pain
Clinical narrative: extreme congestion; Loss of appetite; nausea; fever; chills; headache; fatigue; dry cough; injection site pain; pain; This is a spontaneous report from a contactable consumer (patient). A 64-year-old non-pregnant female received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6201, Expiry date: unknown), via an unspecified route of administration on 09Feb2021 at 03:00 PM (at the age of 64-year-old) on Left arm at single dose for covid-19 immunisation. The patient's medical history was not reported. Patient had unspecified other medications in two weeks. The patient previously took first dose of BNT162B2 (Lot number: EL9262) on 22Jan2021 at 02:30 PM on Left arm at single dose for covid-19 immunisation and had vancomycin and experienced drug allergy. The patient experienced Loss of appetite, nausea, fever, chills, headache, fatigue, dry cough, extreme congestion, pain at injection site and aches on 10Feb2021. 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.  No follow-up attempts are possible. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Headache, Malaise, Pyrexia
Clinical narrative: High Fever with Chills; Tiredness; Headache; Patient was not feeling well; This is a spontaneous report from a contactable other healthcare professional. A 37-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EL3247), intramuscular administered in the left arm on 12Feb2021, 14:45, as a single dose for covid-19 immunization. The patient has no medical history. The patient has no known allergies. There were no concomitant medications. On 13Feb2021 at 04:00, the patient experienced high fever with chills and tiredness and headache. Patient has no treatment for the events. The patient underwent lab tests and procedures which included body temperature: high. The outcome of the events was recovering. The patient has not had Covid prior to vaccination and was not tested positive for Covid-19 post vaccination.  Follow-up (15Feb2021): New information received in response to the query sent regarding to confirm "First Pfizer Awareness Date" for this Adverse event, and provide the true reporter who reported this adverse event to you, includes: confirmation reported my symptoms on 15Feb2021 and they started on 13Feb2021. Patient's symptoms started very late on 13Feb and I was in high fever on the 14Feb. I was not feeling well and also want to wait to see if I will have any other symptoms so that I can report all of them. I reported on 15th early morning with in 24 hours of my symptoms.
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report from a contactable consumer.   A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number was not reported), dose 2 via an unspecified route of administration on 14Feb2021 as single dose as for covid-19 immunization.  The patient's medical history and concomitant medications were not reported.  The patient previously received BNT162B2  for covid-19 immunization  as dose 1 on an unspecified date. The patient experienced sore arm on an unspecified date.  The patient underwent lab tests and procedures which included blood work which was good on an unspecified date.  The outcome of sore arm was recovered on an unspecified date.   The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: first Pfizer shot on 06Feb2021/had a mini version of COVID after that; This is a spontaneous report received from a contactable consumer (patient). A patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration, on 06Feb2021, as single dose, for COVID-19 immunisation. Medical history included COVID-19 on 01Jan2021 and finally tested negative on 26Jan2021. The patient's concomitant medications were not reported. It was reported that the patient received the first dose on 06Feb2021 and had a mini version of COVID after that, in Feb2021. It was also reported that the patient had a very strong reaction (unspecified, pending clarification). The patient wanted to know if it was advisable to get a COVID test and if it comes back positive, is it okay to still get the second shot. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Considerable pain for 2-3 days; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as a single dose for COVID-19 immunization. The patient's medical history included hypochondriasis from an unknown date and unknown if ongoing. Concomitant medications were not reported. The patient previously received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) for COVID-19 immunization on an unknown date and had "no trouble." On an unspecified date, the patient experienced considerable pain for 2-3 days (non-serious).  The clinical course was reported as follows: The reporter stated he had a family member (sister) who received the second vaccination in a different state. The patient had no trouble with the first dose of the COVID-19 vaccine and had considerable pain for 2-3 days with the second dose. The reporter stated there was nothing serious or to be concerned about. The reporter stated that the patient had been a hypochondriac. The clinical outcome of the event was unknown.  The batch/lot numbers for the vaccine, bnt162b2, were not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Nausea
Clinical narrative: tired; dizzy; nauseous; This is a spontaneous report from a contactable consumer. An adult non-pregnant female patient of unspecified age received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 12Feb2021, for COVID-19 immunisation. Medical history included COVID-19 on an unknown date prior to vaccination. Concomitant medications were not reported. On 13Feb2021 the patient experienced being tired, dizzy and nauseous. It was unknown if a treatment was received. Events outcome was unknown. Information about lot/batch number has been requested.