chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: she had increased pain; This is a spontaneous report received from a contactable health care professional and a consumer. A 70-year-old female patient received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 01Feb2021 at single dose for COVID-19 immunization. Medical history included rheumatoid arthritis. Concomitant medications were unknown. The patient previously received tofacitinib citrate (XELJANZ) for rheumatoid arthritis, hydroxychloroquine (PLAQUENIL), celebrex. The patient reported skipping three days of medication when she got her covid-19 vaccine on 01Feb2021. After missing three days, she had increased pain in 2021, which was so bad that she could not function, and lasted for about 1.5 weeks before returning back to normal. MD not aware. When she stopped taking xeljanz for her covid-19 vaccine, she also stopped taking her plaquenil and celebrex. She planned on getting the second vaccine on wednesday and was only holding the medication the day before because she did not want to experience the pain again. MD not aware. The patient was advised to talk with md first. Outcome of the event was unknown.   Information about lot/batch number has been requested.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Decreased appetite, Dysstasia, Gait inability
Clinical narrative: very sick/Horrible; very painful muscles; very painful joints/The pain in all of her joints and muscles was a total nightmare; extreme weakness; very weak hand grip strength; Anorexia; unable to walk, stand up or sit down without max assist; unable to walk, stand up or sit down without max assist; Headache; This is a spontaneous report from a contactable nurse (patient). A 62-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: BL9264) via an unspecified route of administration, administered in arm right on 10Feb2021 12:30 as single dose for covid-19 immunisation. The patient medical history was not reported. Patient has no COVID prior to vaccination. Patient is not pregnant. No Known allergies. There were no concomitant medications.  Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EL9261) via an unspecified route of administration, administered in arm left on 21Jan2021 11:00 AM for covid-19 immunisation at the age of 62 years old. Since 12Feb2021, patient was very sick, very painful muscles, joints, extreme weakness, very weak hand grip strength. Anorexia, unable to walk, stand up or sit down without max assist. Headache. Horrible. The pain in all of her joints and muscles was a total nightmare. Here it was nearly a month after, she was still quite painful and suffering with joint and muscle pain and weakness. These events resulted in physician office visit and emergency room visit and received treatment for the events, which included pain medication. Patient had COVID tested which included nasal swab (undated) and PCR on 16Feb2021 post vaccination, both results were unknown. Outcome of the events was not recovered.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Grip strength decreased, Headache, Malaise, Myalgia, SARS-CoV-2 test
Clinical narrative: very sick/Horrible; very painful muscles; very painful joints/The pain in all of her joints and muscles was a total nightmare; extreme weakness; very weak hand grip strength; Anorexia; unable to walk, stand up or sit down without max assist; unable to walk, stand up or sit down without max assist; Headache; This is a spontaneous report from a contactable nurse (patient). A 62-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: BL9264) via an unspecified route of administration, administered in arm right on 10Feb2021 12:30 as single dose for covid-19 immunisation. The patient medical history was not reported. Patient has no COVID prior to vaccination. Patient is not pregnant. No Known allergies. There were no concomitant medications.  Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EL9261) via an unspecified route of administration, administered in arm left on 21Jan2021 11:00 AM for covid-19 immunisation at the age of 62 years old. Since 12Feb2021, patient was very sick, very painful muscles, joints, extreme weakness, very weak hand grip strength. Anorexia, unable to walk, stand up or sit down without max assist. Headache. Horrible. The pain in all of her joints and muscles was a total nightmare. Here it was nearly a month after, she was still quite painful and suffering with joint and muscle pain and weakness. These events resulted in physician office visit and emergency room visit and received treatment for the events, which included pain medication. Patient had COVID tested which included nasal swab (undated) and PCR on 16Feb2021 post vaccination, both results were unknown. Outcome of the events was not recovered.
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain
Clinical narrative: sore throat; This is a spontaneous report via a Pfizer-sponsored program. A contactable consumer (patient) reported that a female patient of unspecified age received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date not reported), via an unspecified route of administration on an unspecified date (at an unspecified age) at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. During the call, the patient reported that she wanted to reschedule her 2nd dose due to sore throat. The patient's 2nd dose was due today, 01Mar2020. Outcome of the event was unknown.           Information on the lot/batch number has been requested.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Costochondritis, Dehydration, Pain in extremity, Renal pain
Clinical narrative: Dehydration; Pain in kidney area; Soreness in left arm; Costochondritis flare up; This is a spontaneous report from a contactable consumer (patient). A 51-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EN6206), via an unspecified route of administration administered in left arm on 06Mar2021 at 10:30 AM as SINGLE DOSE for COVID-19 immunisation. The patient had no other vaccine in four weeks. The patient had no COVID prior vaccination and was not COVID tested post vaccination. Medical history included heart attack 3 years prior and a prior kidney stone event. The patient had no known allergies. Concomitant medication included atorvastatin. On 06Mar2021 at 12:30 PM, the patient experienced soreness in left arm starting about 2 hours after administration of the vaccine. On 06Mar2021 at 18:30, the patient experienced dehydration and pain in kidney area on left side starting about 8 hours after vaccination, lasting through the next day. Felt similar (though not as intense) to a prior kidney stone event, but slightly higher and in front left side. Costochondritis flare up overnight after the vaccine on 06Mar2021. There was no treatment given for the events. The patient was recovering from all events.
Sex: U
Vaccine: COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: received the first covid vaccine prior to testing positive for covid; received the first covid vaccine prior to testing positive for covid; This is a spontaneous report from a non-contactable consumer (patient) 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 patient received the first COVID vaccine prior to testing positive for COVID on an unknown date. The outcome of the events was unknown. No follow-up attempts are possible; information about batch/lot number cannot be obtained.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: I just tested positive for Covid; I just tested positive for Covid; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a 27-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 17Dec2020 (first dose) as a single dose then via an unspecified route of administration on 07Jan2021 (second dose) as a single dose for COVID-19 immunization (lot number: EH9899 and expiration date: Apr2021 - for unspecified dose number). There were no medical history included and  concomitant medications. The patient had her second Pfizer Vaccine (Pfizer Covid-19 Vaccine) on 07Jan2021 and reported that she just tested positive for Covid yesterday (on 04Mar2021). The patient underwent lab tests and procedures which included COVID test: positive on 04Mar2021. The outcome of the events was unknown.  Information on lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Malaise
Clinical narrative: Became ill; had to go to the hospital; dizziness/lightheadedness; This is a spontaneous report from a contactable consumer. 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 on 10Feb2021 (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 had his first COVID vaccine (later confirmed) on Wednesday and he was supposed to have his second shot. It was reported that "my first shot was if you got it in the book, my first shot was 10Feb2021 and my second shot was due for 02Mar2021." The patient became ill and had to go to the hospital. It was reported that the patient missed his second dose schedule on 02Mar2021, because he had dizziness and lightheadedness, and would like to make an appointment again. The outcome of the events was unknown   Information about the Lot/batch number has been requested.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Angioedema, Malaise, Peripheral swelling, Pruritus, Swelling face
Clinical narrative: angioedema; Face itching; feel unwell; my face was swelling, dark red; my face was swelling, dark red/Palms of both hands were swelling and dark red/feet turning red; Palms of both hands were swelling and dark red.; Wheezing; This is a spontaneous report from a contactable nurse (patient). A 72-year-old female patient (Not pregnant at the time of vaccination) received first dose of bnt162b2 (Batch/Lot Number: EN6198), via an unspecified route of administration in left arm on 03Mar2021 10:45 as single dose for covid-19 immunization. Relevant medical history included: Heart disease, HTN (hypertension), asthma, hereditary factor X deficiency, breast cancer 5 years ago all from an unknown date and unknown if ongoing. The patient was allergies to Lisinopril and povidone-iodine (BETADINE). The patient's concomitant medications were not reported. The patient experienced angioedema, face itching, feel unwell, face was swelling, dark red, dark red/palms of both hands were swelling and dark red/feet turning red, palms of both hands were swelling and dark red, wheezing on 05Mar2021 17:00. The patient felt fine on the 1st and 2nd day post vaccination. Thrilled to finally get 1st dose Pfizer. On 05Mar2021, she began to feel unwell. She looked in mirror, her face was swelling, dark red. Palms of both hands were swelling and dark red. Also feet turning red. Wheezing. Face itching. She was a retired nurse and she knew this was angioedema. Her husband drove her to ED (emergency department). She was given methylprednisolone sodium succinate (SOLUMEDROL) IM and prescription for prednisone. The outcome of events was not resolved. The events resulted in emergency room/department or urgent care. Treatment included: IM methylprednisolone sodium succinate (SOLUMEDROL) in ED and oral prednisone for 3 days. Facility where the most recent COVID-19 vaccine was administered: Public Health Clinic The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, has the patient hasn't been tested for COVID-19.; Sender's Comments: Based on temporal association and known drug profile, a contributory role of the suspect drug cannot be excluded in the development of the reported events. Relevant medical history includes allergies to lisinopril and betadine, which suggests potential for drug allergies. This case will be reassessed upon receipt of additional information. 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: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Wheezing
Clinical narrative: angioedema; Face itching; feel unwell; my face was swelling, dark red; my face was swelling, dark red/Palms of both hands were swelling and dark red/feet turning red; Palms of both hands were swelling and dark red.; Wheezing; This is a spontaneous report from a contactable nurse (patient). A 72-year-old female patient (Not pregnant at the time of vaccination) received first dose of bnt162b2 (Batch/Lot Number: EN6198), via an unspecified route of administration in left arm on 03Mar2021 10:45 as single dose for covid-19 immunization. Relevant medical history included: Heart disease, HTN (hypertension), asthma, hereditary factor X deficiency, breast cancer 5 years ago all from an unknown date and unknown if ongoing. The patient was allergies to Lisinopril and povidone-iodine (BETADINE). The patient's concomitant medications were not reported. The patient experienced angioedema, face itching, feel unwell, face was swelling, dark red, dark red/palms of both hands were swelling and dark red/feet turning red, palms of both hands were swelling and dark red, wheezing on 05Mar2021 17:00. The patient felt fine on the 1st and 2nd day post vaccination. Thrilled to finally get 1st dose Pfizer. On 05Mar2021, she began to feel unwell. She looked in mirror, her face was swelling, dark red. Palms of both hands were swelling and dark red. Also feet turning red. Wheezing. Face itching. She was a retired nurse and she knew this was angioedema. Her husband drove her to ED (emergency department). She was given methylprednisolone sodium succinate (SOLUMEDROL) IM and prescription for prednisone. The outcome of events was not resolved. The events resulted in emergency room/department or urgent care. Treatment included: IM methylprednisolone sodium succinate (SOLUMEDROL) in ED and oral prednisone for 3 days. Facility where the most recent COVID-19 vaccine was administered: Public Health Clinic The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, has the patient hasn't been tested for COVID-19.; Sender's Comments: Based on temporal association and known drug profile, a contributory role of the suspect drug cannot be excluded in the development of the reported events. Relevant medical history includes allergies to lisinopril and betadine, which suggests potential for drug allergies. This case will be reassessed upon receipt of additional information. 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: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report received from a contactable physician, the patient, reporting on himself. A 47-years-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Batch/Lot Number: EJ1685), via an intramuscular route of administration in the left arm on 17Dec2020 11:00 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced clinically significant adverse events and sore arm on an unspecified date. The outcome of event, clinically significant adverse events and sore arm, was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021021539 second dose
Sex: U
Vaccine: COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: anaphylactic reaction; This is a spontaneous report received from a contactable consumer. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 Vaccine), dose 1 via an unspecified route of administration on 05Mar2021 (Batch/Lot Number: Unknown) as a single dose for covid-19 immunisation. Medical history included allergic to bees and carry an EPI pen (Only allergy is bees which is known potentially to react). The patient's concomitant medications were not reported. Within 15 min on 05Mar2021, the patient had an anaphylactic reaction and was transferred to local Emergency Room. Adverse event result in Emergency room/department or urgent care. The seriousness is reported as medical significant. This is a  comment. It was unknown if treatment was received. The outcome of event was unknown.     Information on the lot/batch number has been requested.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Diagnosed with COVID / The first vaccine was 17Dec and then she tested positive 31Dec; Diagnosed with COVID / The first vaccine was 17Dec and then she tested positive 31Dec; This is a spontaneous report from a contactable Pharmacist. A 64-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot#: UNKNOWN), via an unspecified route of administration on 17Dec2020  (at the age of 64 years) as a single dose for COVID-19 immunization. The patient medical history was not reported. There were no concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 31Dec2020,  the patient was diagnosed with COVID-19. The first vaccine was 17Dec2020 and then she tested positive 31Dec2020. The event was reported medically significant. The patient had lab tests which included sars-cov-2 test: positive on 31Dec2020. The patient went to the emergency room (ER) at the time she was diagnosed with COVID. She was there in the ER overnight. After being diagnosed with COVID she was prescribed Flovent, Flonase, Pro-Air. The clinical course was as follows: Pharmacist had a patient who received the first dose of COVID Vaccine on 17Dec2020 and after receiving the first dose patient was diagnosed with COVID two weeks later on 31Dec2020. The patient received infusion therapy of antibodies clarified as, as spelled out,  Bamlanivimab on 01Jan2021. They are debating since it is coming up on 90 days after the first one and receiving the infusion therapy how to proceed. They are wondering if patient needs to restart the series or can she just pick up where she finished and get the second shot. The pharmacist stated she is thinking the patient would only need to get the one remaining, finish up by getting the second shot,  but she was calling to double check. Others are debating saying the patient needs to get the whole series over again. The clinical outcome of the event diagnosed with COVID-19 was unknown.  The pharmacist reported Diagnosed with COVID - Unrelated to COVID vaccine; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. However, full immunity is only expected 7 days after the second dose. 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: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: Pain at injection site lasting more than 24 hours; fatigue; This is a spontaneous report from a contactable consumer (patient).   This  73-years-old not pregnant female patient received,at hosptial,  bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) administered in Arm Left on 08Mar2021 as SINGLE DOSE  at age of 73 years for covid-19 immunisation  .  Medical history included pneumonia from an unknown date and unknown if ongoing (but have since been vaccinated for it 2x in last 4 yrs ), iodine allergy from an unknown date and unknown if ongoing.  No other vaccine received in the last four weeks .Concomitant medicatoins includes: OTC vitamins & health aids.The patient experienced pain at injection site lasting more than 24 hours on 08Mar2021 21:00 with outcome of unknown  and fatigue on 08Mar2021 21:00 with outcome of unknown.  No treatment recevied for the events.No covid prior vaccination: No covid tested post vaccination.  Information about lot/batch number has been requested.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Eye swelling, Mouth swelling, Swelling face, Swollen tongue
Clinical narrative: Anaphylaxis; swelling of face, eyes, mouth, tongue.; swelling of face, eyes, mouth, tongue.; swelling of face, eyes, mouth, tongue.; swelling of face, eyes, mouth, tongue.; This is a spontaneous report from a contactable consumer (patient). A 39-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot: EN6205), via an unspecified route of administration on 05Mar2021 08:45 (at the age of 39-years-old) as single dose for covid-19 immunisation. The patient was not pregnant at the time of vaccination. Medical history included possible Covid one year ago (in 2020) and known allergies: mild shellfish allergy. Concomitant medication included ibuprofen in two weeks. On 05Mar2021 at 16:00, the patient experienced anaphylaxis, swelling of face, eyes, mouth, tongue that resulted in emergency room/department or urgent care. Treatment included epinephrine, steroids and diphenhydramine hydrochloride (BENADRYL). It was unknown if with covid prior vaccination. Not covid tested post vaccination. The patient had no other vaccine in four weeks. The outcome of the events was recovered in Mar2021.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Flushing, Paraesthesia
Clinical narrative: My face became warmth /her arms felt slightly warm; My face became warm, red/flushed; My face became tight and tingling/her arms felt slightly tingling; This is a spontaneous report from a contactable consumer(patient) reported for herself.  A 61-year-old female patient (not pregnant) received first dose of bnt162b2 BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN6206), in arm right on 08Mar2021 at 18:45 (at 61 years) at single dose for covid-19 immunisation. Medical history included high blood pressure and high cholesterol.Concomitant medications included atorvastatin, lisinopril, "Multi vit", calcium, ascorbic acid (VIT C) and ergocalciferol (VIT D), all taken for an unspecified indication, start and stop date were not reported.  The patient previously took diphenhydramine hydrochloride (BENADRYL) and experienced allergy. On 08Mar2021 at 19:15 the patient's face became warm, red/flushed, tight and tingling and her arms felt slightly warm/tingling. All symptoms were gone within 2 hours of vaccine. No treatment given and patient recovered from all the events on 08Mar2021. No follow-up attempts are needed. No further information is expected
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia oral, Jaw disorder
Clinical narrative: 10 hours later jaw and chin also feeling funny; Numbing of tongue and lips right away; Numbing of tongue and lips right away; This is a spontaneous report received from a contactable consumer. This consumer (patient) reported for herself that a 61-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 61-years, via an unspecified route of administration in left arm at 11:00 on 09Mar2021 at single dose for COVID-19 immunization. Medical history included asthma. Known allergies included nickel, gold, manganese, vanadium. Patient was not pregnant at the time of vaccination. No COVID-19 prior vaccination, no COVID-19 tested post vaccination. Concomitant medications included bupropion hydrochloride (WELLBUTRIN); atomoxetine hydrochloride (STRATTERA); montelukast sodium (SINGULAIR); salbutamol (VENTOLIN). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 09Mar2021 11:00, the patient experienced numbing of tongue and lips right away, 10 hours later jaw and chin also feeling funny. No treatment was received for the adverse events. Outcome of the events was not recovered. Since the vaccination, the patient has not been tested for COVID-19.  Information on the lot/batch number is requested.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: 10 hours later jaw and chin also feeling funny; Numbing of tongue and lips right away; Numbing of tongue and lips right away; This is a spontaneous report received from a contactable consumer. This consumer (patient) reported for herself that a 61-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 61-years, via an unspecified route of administration in left arm at 11:00 on 09Mar2021 at single dose for COVID-19 immunization. Medical history included asthma. Known allergies included nickel, gold, manganese, vanadium. Patient was not pregnant at the time of vaccination. No COVID-19 prior vaccination, no COVID-19 tested post vaccination. Concomitant medications included bupropion hydrochloride (WELLBUTRIN); atomoxetine hydrochloride (STRATTERA); montelukast sodium (SINGULAIR); salbutamol (VENTOLIN). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 09Mar2021 11:00, the patient experienced numbing of tongue and lips right away, 10 hours later jaw and chin also feeling funny. No treatment was received for the adverse events. Outcome of the events was not recovered. Since the vaccination, the patient has not been tested for COVID-19.  Information on the lot/batch number is requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Tested positive for Covid-19; Tested positive for Covid-19; This is a spontaneous report from a contactable other hcp. An adult female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in left arm on 11Jan2021 (Batch/Lot Number: EJ1686), and dose 1 via intramuscular, administered in left arm on 19Dec2020 13:30 (Batch/lot number: EK5730); both as SINGLE DOSE for covid-19 immunisation. Medical history included migraines. The patient was not pregnant at the time of vaccination. Concomitant medication(s) included aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]); topiramate (TOPIRAMATE); fluoxetine (FLUOXETINE); ascorbic acid (VIT C); ibuprofen, paracetamol; taken for unspecified indications, start and stop dates were not reported.  The patient tested positive on 06Mar2021.The patient did not receive treatment for the event. The patient underwent lab tests and procedures which included sars-cov-2 test: positive  on 06Mar2021 Positive.  The outcome of the event was not recovered.   Information on vaccine expiration date has been requested.; Sender's Comments: Based on the information available, the reported event is possibly related to the suspect drug in terms of drug ineffective.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID-19 confirmed by positive COVID-19 test; COVID-19 confirmed by positive COVID-19 test; This is a spontaneous report from a contactable nurse (patient) via the Pfizer-sponsored program. A 58-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular (administered in Arm Left) at the age of 57years at single dose for Covid-19 immunization: 1st dose on 10Jan2021 (13:00) (lot number: EK4245) and 2nd dose on 07Feb2021 (16:45) (lot number: EL9269). Medical history included allergies to medications (Allopurinol), allergy to food, allergy to Sulfa, allergy to Iodine, allergy to Latex, and allergy to Tramadol, NSAIDS. Concomitant medications included atorvastatin, emtricitabine, tenofovir alafenamide fumarate (DESCOVY), febuxostat (ULORIC), pantoprazole, and budesonide (also reported as budesonite-pending clarification); all taken for an unspecified indication, start and stop date were not reported. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient wanted to know if there is any study on people who got the 2 doses of the vaccines and tested positive. The patient clarified that he got both doses of the COVID vaccines and tested positive for COVID a while after. On 05Mar2021, the patient tested positive for Covid-19 via PCR test. The adverse event resulted in Doctor or other healthcare professional office/clinic visit. There was no treatment received for the adverse event. The outcome of events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19 confirmed by positive COVID-19 test; COVID-19 confirmed by positive COVID-19 test; This is a spontaneous report from a contactable other health professional (patient). A 38-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899) via an unspecified route of administration at left arm on 04Jan2021 at 12:00 (38-year-old at time of vaccination) at single dose; then received the second dose of BNT162B2 (lot number: EK4177) via an unspecified route of administration on 25Jan2021 (38-year-old at time of vaccination) at single dose, both for COVID-19 immunization. The patient's medical history was not reported. The patient had no COVID prior to vaccination. Concomitant medications were not reported. There was no other vaccine in four weeks. On 07Mar2021, the patient tested positive for COVID-19 via the Sofia rapid SARS CoV- 2 Antigen FIA COVID-19 test (via nasal swab). The event resulted in doctor or other healthcare professional office/clinic visit. Facility type of vaccine was hospital. No therapeutic measures were taken as a result of the event. The outcome of the event was recovering.; Sender's Comments: Based on data provided and temporal association, the causal association between the reported events and BNT162B2 cannot be excluded. This case will be reevaluated upon receipt of more information.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for Covid and received positive test result 2/9/21; tested positive for Covid and received positive test result 2/9/21; This is a spontaneous report received from a Pfizer sponsored program from a contactable consumer (patient). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 19Jan2021 (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 patient was tested for Covid and received positive test result on 09Feb2021 when she was supposed to receive 2nd vaccine so did not go. First location no longer had any doses left. Trying to find out what she should do next. Event reported as serious. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 09Feb2021. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Eye disorder, Ocular hyperaemia
Clinical narrative: Left eye became blood shot and smaller and shrunk; Left eye became blood shot and smaller and shrunk; This is a spontaneous report from contactable consumer(patient) reported for herself. An unknown age female patient received 1st dose of BNT162B2 (Pfizer COVID-19 Vaccine) on 22Feb2021 at single dose for COVID-19 immunization. Medical history and concomitant drug were not reported. She got the first vaccine on 22Feb2021 and shortly after that her left eye became blood shot and smaller and shrunk and it has not changed since then. And she was due for the second dose on 15Mar2021 and she was wondering if she should take it. Outcome was the event was not recovered.  Information on lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: first dose of the vaccine on 23Feb2021/ tested positive on 08Mar2021; tested positive; This is a spontaneous report received from a non-contactable consumer (patient's housewife). This consumer reported similar events for two patients. This is the second of two reports. A male patient (reporter's husband) of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number not provided), on 23Feb2021 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The caller stated that they received the first dose of the vaccine on 23Feb2021 and her husband was tested positive on 08Mar2021 and their second dose is scheduled on 16Mar2021. She stated she understood they need to be isolating and she assumed they shouldn't go back for the second dose if it was within the 10-day quarantine period they need to reschedule the appointment. The case was reported as non-serious. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot not be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021257947 same reporter/product/events, different patient.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: also tested positive for COVID; also tested positive for COVID; This is a spontaneous report from a Pfizer-sponsored programt. A contactable consumer (patient) reported that 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 in Feb2021 (reported as either last 05Feb2021 or 06Feb2021) as SINGLE DOSE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient mentioned that her next dose will be on 12Mar2021. That was more than 21 days already. Consequently, she also tested positive for COVID yesterday, on 07Mar2021. The outcome of the event was unknown.   Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Lethargy, Myalgia, Pyrexia, Somnolence
Clinical narrative: Drowsy; feverish; muscle pain; inactive; This is a spontaneous report received from a Pfizer sponsored program  from a contactable consumer. A  male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), the second dose, via an unspecified route of administration on 05Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient previously received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for COVID-19 immunization. He got some side effects that are written on the fact sheet. (Drowsy, feverish, muscle pain, inactive.). Outcome of events was unknown.  Information on lot number/batch number was requested.
Sex: M
Vaccine: COVID19
Symptoms: Tachycardia
Clinical narrative: Rapid beating of the heart; This is a spontaneous report from a contactable consumer (patient) from a Pfizer Sponsored Program COVAX Support.  This male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date at SINGLE DOSE for covid-19 immunisation.  The patient medical history and the concomitant medications were not reported.  The patient asked if he can take the 2nd dose of the covid-19 vaccine since he experienced rapid beating of the heart after the 1st dose. The outcome was unknown.    Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Covid 19; Covid 19; This is a spontaneous report from a contactable healthcare professional (patient, self-reported). A 44-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry dates were not provided), via an intramuscular route of administration, in Right arm, on an unspecified date, as single dose for COVID-19 immunization, at Nursing Home/Senior Living Facility. Medical history included Mild congestion. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient has been tested for COVID-19 on 15Jan2021 and the result was positive. The outcome of the event was resolved on 23Jan2021.  Information on the lot/batch number has been requested.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event Covid-19 and the suspect drug BNT162B2.
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, SARS-CoV-2 antibody test negative
Clinical narrative: patient had the second dose a month ago and showed negative antibody tests; This is a spontaneous report from a contactable consumer via the Pfizer-sponsored program. This consumer reported similar events for 2 patients. This is 1st of 2 reports.   A patient of unspecified age and gender received the 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown), 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. It was reported that the patient had the second dose a month ago and showed negative antibody tests on an unspecified date (also reported as "now"). The reporter wanted to know if it was normal. The outcome of event was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021273877 same reporter, product, and event; different patient
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, SARS-CoV-2 antibody test negative
Clinical narrative: two physicians who both had second doses a month ago and both are now showing negative antibody tests; This is a spontaneous report from a contactable consumer from a Pfizer-sponsored program. This consumer reported same event for two patients. This is the second of two reports.  A patient of unspecified age and gender received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; batch/lot number and expiration date unknown), via an unspecified route of administration on 2021 as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient had the second dose a month ago and showed negative antibody tests on an unspecified date (reported as "now"). The reporter wanted to know if it was normal. The outcome of the event was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021273876 Same reporter, product and event/Different patient
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Was diagnosed with covid virus; Was diagnosed with covid virus; This is a spontaneous report from a Pfizer-sponsored program. A contactable pharmacist reported that a patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Just before the second dose, the patient was diagnosed with COVID virus. It had been about 90 days and the pharmacist wanted to know if they can give the second dose or does patient have to start over with the first dose. The outcome of the event was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Drug ineffective and COVID-19 cannot be totally excluded.  The case will be reassessed if additional information becomes available.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Pyrexia
Clinical narrative: Chills fever and fatigue one day after receiving second covid vaccine shot; Chills fever and fatigue one day after receiving second covid vaccine shot; Chills fever and fatigue one day after receiving second covid vaccine shot; This is a spontaneous report received from a contactable consumer (patient). A patient of unspecified age and gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot/batch number not provided), via an unspecified route of administration on an unspecified date (at unknown age) at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced Chills, fever and fatigue one day after receiving second COVID vaccine shot. Event took place after use of product. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19 confirmed by positive COVID-19 test; COVID-19 confirmed by positive COVID-19 test; This is a spontaneous report from Pfizer-sponsored program . A contactable consumer (patient) reported that a female patient of unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number and expiration date unknown) on an unspecified date (unknown age at time of vaccination), at single dose, for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient reported that she was diagnosed COVID positive after first COVID vaccine dose. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: He has muscle pain; Has fever; This is a spontaneous report from a Sponsored Program. A non-contactable consumer (patient) reported that a male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), 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 medical history was not reported. The patient's concomitant medications were not reported.  The patient has muscle pain and fever on an unspecified date. The outcome of events was unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: She had her 1st shot then got COVID; She had her 1st shot then got COVID; This is a spontaneous report from a Pfizer sponsored support from a contactable consumer. A patient of an unspecified age received bnt162b2, dose 1 via an unspecified route of administration on 04Feb2021 (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 patient had her 1st shot then got COVID in 2021. The patient was in hospital and had since recovered but now in physical rehab. Wanted to know when she should get a second shot. Outcome of events was recovered on unspecified date in 2021.  Information on lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nausea, Vomiting
Clinical narrative: Nausea; Vomiting; Dizziness; This is a spontaneous report from contactable consumer (on behalf of his wife) via Medical Information Team. A 65-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: unknown), via an unspecified route of administration on 09Mar2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications was not reported. Historical vaccine of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) administered on an unspecified date for COVID-19 immunization. Second dose was administered on Tuesday (09Mar2021), on Thursday (11Mar2021) experienced nausea/vomiting, was prescribed Zofran/Antivert. Saturday night hospital given IV Ativan/Antivert/Zofran. She still maintains dizziness. She took a lot of medications. The outcome of dizziness was not recovered and for other events was unknown.    Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Angina pectoris, Anxiety, Chest pain, Electrocardiogram, Malaise
Clinical narrative: Felt a very strong pain in the heart; felt a very strong pain in the heartand then pain in the middle of my chest as is I had something in my heart.; I'm still not feeling well; My body hurts; I'm very worried.; This is a spontaneous report from a contactable consumer (patient). A 94-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose, via an unspecified route of administration on 21Feb2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation, age at vaccination. Medical history included Penicillin allergy, iodine, several antibiotics from an unspecified date. Patient received first dose of BNT162B2 on 15Jan2021 for covid-19 immunisation. The patient's concomitant medications were not reported. Patient got the Pfizer Covid-19 vaccine, the first dose on January 15th and the second dose on February 21st. She was having some really bad symptoms and she was really worried because it has been a while and she was still not feeling well. On 23Feb2021, reported as two days after the vaccine she felt a very strong pain in the heart, and then pain in the middle of her chest (unspecified date in 2021) as if she had something in her heart. She went to the doctor, he did an ECG and told me she didn't had a heart attack; then she went to a cardiologist and he cannot find anything that could cause her symptoms. On an unspecified date in 2021, her body hurts, she was still not feeling well and she was very worried. She would like to know if Pfizer has something to make the symptoms go away, she feels very bad and it's been awhile since she got vaccinated. She was really scared and wanted to report this. Events required physician office visit. Outcome of the events was unknown.  Information on lot/batch number has been requested.