chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Biopsy skin, Pemphigus, Urticaria
Clinical narrative: Pemphigus; Hives in the back; This is a spontaneous report from a contactable physician (patient). An 82-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EL 1284), via an unspecified route of administration, on the left arm, on 30Dec2020 at a single dose for Covid-19 immunisation. Medical history included glaucoma, age-related macular degeneration (AMD), arrhythmia. The patient has no known allergies. The patient did not receive other vaccine in four weeks. The patient has no Covid prior vaccination and not Covid tested Concomitant medications included nebivolol hydrochloride (BYSTOLIC), rosuvastatin calcium (CRESTOR), and timolol.  On an unspecified date, the patient developed hives in the back within a week after 1st shot and broke out in blisters over upper body 3 wks after 2nd shot of vaccine. Skin biopsy (Bx) done to confirm Pemphigus. Treatment for the events was Kenalog 60 mg IM/ also 3 wks later prednisone po. The outcome of the events was not recovered.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect drug in the reported event Pemphigus cannot be completely excluded given the known suspect drug profile and/or implied temporal association. 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 Regul atory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Pain in extremity, Thrombosis
Clinical narrative: developed two blood clots in his right calf; pain in his leg; This is a spontaneous report from a contactable consumer reporting for himself. A 70-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EN9581/expiration date: not provided), via an unspecified route of administration, on 04Feb2021 (at the age of 70 years old) as a single dose for COVID-19 IMMUNIZATION. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EL3249/expiration date: not provided), via an unspecified route of administration, on 15Jan2021 (at the age of 70 years old) as a single dose for COVID-19 IMMUNIZATION. Relevant medical history included was not provided. Concomitant medication included acetylsalicylic acid (BABY ASPIRIN), meloxicam, an allergy medication and anti-depressants. On 19Feb2021, the patient reported that he developed two blood clots in his right calf, one towards his ankle and one towards his knee and pain in his leg which required hospitalization on 22Feb2021. The patient was discharged on the same day, 22Feb2021. Relevant lab data included: blood test on 22Feb2021 were done to determine what medication to put him on. The results of the blood test was unknown. Treatment received for the event thrombosis included abixaban (ELIQUIS) tablets as a blood thinner. The patient reported he never had blood clots in his life. The outcome of the events thrombosis and pain in leg was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Pneumonia
Clinical narrative: pneumonia; This is a spontaneous report from a Pfizer-sponsored program, A contactable consumer (patient) 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 31Jan2021 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced pneumonia on an unspecified date. The patient was currently taking antibiotics for pneumonia, almost done with the treatment. The patient was scheduled to get her second COVID-19 vaccination tomorrow (at the time of report) and asked if it was safe for her to do so. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Extrasystoles, Fatigue, Malaise, Nausea
Clinical narrative: few heart quivers/heart is trembling/occasionally feeling her heart jumping around a bit/occasionally her heart is still quivering for no rhyme or reason; Vomiting; exhausted all day from being sick; exhausted all day from being sick; feeling slightly queasy/queasiness; diarrhea actually started before 1 AM/but was mild and escalated and by 1 AM it was extremely bad; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot Number: EL9264; Expiration Date: May2021), intramuscular, administered in Arm Left (left upper arm) on 25Feb2021 11:00 (at 70-year-old) at 0.3 mL, single for COVID-19 immunization. The patient medical history was not reported. There were no concomitant medications.  Vaccination Facility Type was clinic. The patient previously took flu shot (she took the flu shot every fall and she has never had a reaction like this). It was reported that the patient started feeling queasy within 1 hour of the dose the same day. She confirmed by 1 AM 26Feb2021 she had diarrhea and vomiting which was about 14 hours after shot. She says the diarrhea actually started before 1 AM, so could have been 25Feb2021, but was mild and escalated and by 1 AM it was extremely bad. She confirmed the diarrhea was mild the same day as the vaccine and then got worse. She has also had a few heart quivers since this happened nothing constant but occasionally she feels like her heart is trembling. She thinks it was Saturday which would have 27Feb2021 because Friday, the day after the vaccine she was exhausted all day from being sick and maybe from the vaccine also but she thinks it was the next day, Saturday when she started occasionally feeling her heart  jumping around a bit. She says occasionally her heart is still quivering for no rhyme or reason, just every once in a while she notices it. She says hopefully if she does take the second shot she will do better. The outcome of the event " few heart quivers/heart is trembling/occasionally feeling her heart jumping around a bit/occasionally her heart is still quivering for no rhyme or reason" was not recovered, "exhausted all day from being sick" was unknown, while for other events was recovered.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: few heart quivers/heart is trembling/occasionally feeling her heart jumping around a bit/occasionally her heart is still quivering for no rhyme or reason; Vomiting; exhausted all day from being sick; exhausted all day from being sick; feeling slightly queasy/queasiness; diarrhea actually started before 1 AM/but was mild and escalated and by 1 AM it was extremely bad; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot Number: EL9264; Expiration Date: May2021), intramuscular, administered in Arm Left (left upper arm) on 25Feb2021 11:00 (at 70-year-old) at 0.3 mL, single for COVID-19 immunization. The patient medical history was not reported. There were no concomitant medications.  Vaccination Facility Type was clinic. The patient previously took flu shot (she took the flu shot every fall and she has never had a reaction like this). It was reported that the patient started feeling queasy within 1 hour of the dose the same day. She confirmed by 1 AM 26Feb2021 she had diarrhea and vomiting which was about 14 hours after shot. She says the diarrhea actually started before 1 AM, so could have been 25Feb2021, but was mild and escalated and by 1 AM it was extremely bad. She confirmed the diarrhea was mild the same day as the vaccine and then got worse. She has also had a few heart quivers since this happened nothing constant but occasionally she feels like her heart is trembling. She thinks it was Saturday which would have 27Feb2021 because Friday, the day after the vaccine she was exhausted all day from being sick and maybe from the vaccine also but she thinks it was the next day, Saturday when she started occasionally feeling her heart  jumping around a bit. She says occasionally her heart is still quivering for no rhyme or reason, just every once in a while she notices it. She says hopefully if she does take the second shot she will do better. The outcome of the event " few heart quivers/heart is trembling/occasionally feeling her heart jumping around a bit/occasionally her heart is still quivering for no rhyme or reason" was not recovered, "exhausted all day from being sick" was unknown, while for other events was recovered.
Sex: F
Vaccine: PNC13
Symptoms: Anaphylactic reaction, Dizziness, Dyspnoea, Pharyngeal swelling, Swollen tongue
Clinical narrative: anaphylaxis reaction to Prevnar 13; Prevnar 13: back of her throat was swelling; Prevnar 13: tongue was swelling; problem breathing; dizziness; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13; lot number and expiry date not reported), via an unspecified route of administration on an unspecified date at single dose for immunization. The patient's medical history and concomitant medications were not reported.  The patient wanted to know the ingredients in Covid vaccine and Prevnar 13 (pneumonia 13 vaccine). Wanted to know if any ingredients in pneumonia vaccine are in Covid vaccine. She had an anaphylaxis reaction to Prevnar 13. Stated that she does not think that her doctor's office reported the problem breathing and dizziness. She further stated that the back of her throat and tongue were swelling to Prevnar 13. Stated that she ended up going to the ER. She also stated that it resolved in an hour. Is checking to see if she can get the Covid vaccine. Clarified that she has not had the Covid vaccine yet. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Prostate cancer
Clinical narrative: prostate cancer; This is a spontaneous report from a contactable consumer reporting for himself. A 65-year-old male patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration in arm left, on an unspecified date, at single dose, for COVID-19 immunisation. Medical history and concomitant medications were none.  The patient experienced prostate cancer (medically significant) on an unspecified date with outcome of unknown. Therapeutic measures were taken as a result of the event and included treatment with Lasix (not clarified over the call, reported as for his urine). Patient reported he had to underwent a surgery.  The information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: positive COVID-19 test with symptoms; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 05Feb2021 (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 1st shot of vaccine on 05Feb2021. On 14Feb2021, the patient was not feeling well. On 16Feb2021, the patient tested positive for COVID-19. The patient wanted to know if she needs to be tested before the 2nd dose. She has been quarantined for 3 weeks in her home; even though the health department had said "quarantine for 14 days", but she did not go out because the weather was too cold. She had a problem of getting her second shot of the Pfizer COVID-19 Vaccine. She was supposed to get the second dose of the Pfizer COVID-19 vaccine on 26Feb2021 but could not due to being quarantined. She asked what is the timeframe that she should get the second dose is relative to having COVID. Outcome of the event was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: positive COVID-19 test with symptoms; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 05Feb2021 (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 1st shot of vaccine on 05Feb2021. On 14Feb2021, the patient was not feeling well. On 16Feb2021, the patient tested positive for COVID-19. The patient wanted to know if she needs to be tested before the 2nd dose. She has been quarantined for 3 weeks in her home; even though the health department had said "quarantine for 14 days", but she did not go out because the weather was too cold. She had a problem of getting her second shot of the Pfizer COVID-19 Vaccine. She was supposed to get the second dose of the Pfizer COVID-19 vaccine on 26Feb2021 but could not due to being quarantined. She asked what is the timeframe that she should get the second dose is relative to having COVID. Outcome of the event was unknown.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Cardiac flutter
Clinical narrative: heart flutters; This is a spontaneous report from a Pfizer Sponsored, a contactable Nurse. A male patient of an unspecified age receive the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 24Feb2021 at SINGLE DOSE for covid-19 immunisation.  The patient's medical history and concomitant medications were not reported.  Historical vaccine information included BNT162B2 on 03Feb2021 was the first dose. The patient experienced heart flutters, several times a day from an unspecified date. She is wondering if this is a normal reaction and what she should do about it. Outcome of the event was unknown.  Information on Lot/Batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Kidney infection
Clinical narrative: Kidney infections; This is a spontaneous report from a contactable consumer from a Pfizer-sponsored program. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date not reported), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that the patient was scheduled to get her second dose of vaccine this Friday, but she said that after getting the first dose she had kidney infections on an unspecified date that's why she is taking antibiotics now and she wanted to know if she can still take second dose. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: Bacterial infection, Investigation, Rash, Urinary tract infection bacterial
Clinical narrative: Very serious bacterial urinary tract infection; Rash; on face, underneath nose and underneath chin, aggravating rash; Bacterial infection; This is a spontaneous report from a contactable consumer (the patient). A 91-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6198), via an unspecified route of administration on 26Feb2021 (at the age of 91-years) as a single dose for COVID-19 immunization.  Medical history was none. There were no concomitant medications. The patient received the first dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNONW), via an unspecified route of administration on unknown date as a single dose for COVID-19 immunization.  The patient reported that she got her second COVID-19 vaccine Friday, and she has gotten a rash. It is just on her face, underneath her nose and underneath her chin. It is aggravating rash. She does not know what it is. She does not know what it could be or something else. The patient also reported "I had a very serious bacterial urinary tract infection, bacterial infection". The patient did not have any treatment for the rash. The clinical outcome of the events very serious bacterial urinary tract infection, Rash; on face, underneath nose and underneath chin, aggravating rash, and Bacterial infection was unknown.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Gingival pain, Hypoaesthesia, Muscle discomfort, Nasal congestion
Clinical narrative: muscle and nerve on both side of her face and the area along the back of both ears on the back head are very uncomfortable; muscle and nerve on both side of her face and the area along the back of both ears on the back head are very uncomfortable; From thumb finger till middle figure of both hands are numb especially after getting up daily.; The nerve of both front elbows is uncomfortable a lot stronger (e.g. sensation of soreness and distention); Both gums are very soreness and distention; Both gums are very soreness and distention; Stuffy nose; night sweats; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiry date not reported) via an unspecified route of administration, at the age of 66-year-old, on 20Feb2021, single dose for COVID-19 immunization. Relevant medical history included diabetes. The patient had no known allergies. Patient is not pregnant. Concomitant medications included metformin, thiamine hydrochloride (VITAMIN B1 [THIAMINE HYDROCHLORIDE]) taken for covid-19 immunisation; and cyanocobalamin (VITAMIN B12 [CYANOCOBALAMIN]). The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration (left arm), at the age of 66-year-old, on 23Jan2021, single dose for COVID-19 immunization and experienced muscle and nerve on both side of face (especial jawline area) are uncomfortable. On 21Feb2021 at 07:00 am, her muscle and nerve on both side of her face (especial jawline area, marionette line area, nasolabial folds, both temples and lower eyelid region) and the area along the back of both ears on the back head are very uncomfortable. From thumb finger till middle figure of both hands are numb especially after getting up daily. The nerve of both front elbows is uncomfortable a lot stronger (e.g. sensation of soreness and distention). Both gums are very soreness and distention. Stuffy nose and night sweats in the whole body happen a few times daily after the 2nd dose as well. The patient did not have covid prior vaccination and was not tested for covid post vaccination. The patient did not receive any treatment in response to the events. Outcome of the events was not recovered.  Information on the lot/batch number has been requested.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Nervous system disorder, Neuralgia, Night sweats
Clinical narrative: muscle and nerve on both side of her face and the area along the back of both ears on the back head are very uncomfortable; muscle and nerve on both side of her face and the area along the back of both ears on the back head are very uncomfortable; From thumb finger till middle figure of both hands are numb especially after getting up daily.; The nerve of both front elbows is uncomfortable a lot stronger (e.g. sensation of soreness and distention); Both gums are very soreness and distention; Both gums are very soreness and distention; Stuffy nose; night sweats; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiry date not reported) via an unspecified route of administration, at the age of 66-year-old, on 20Feb2021, single dose for COVID-19 immunization. Relevant medical history included diabetes. The patient had no known allergies. Patient is not pregnant. Concomitant medications included metformin, thiamine hydrochloride (VITAMIN B1 [THIAMINE HYDROCHLORIDE]) taken for covid-19 immunisation; and cyanocobalamin (VITAMIN B12 [CYANOCOBALAMIN]). The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration (left arm), at the age of 66-year-old, on 23Jan2021, single dose for COVID-19 immunization and experienced muscle and nerve on both side of face (especial jawline area) are uncomfortable. On 21Feb2021 at 07:00 am, her muscle and nerve on both side of her face (especial jawline area, marionette line area, nasolabial folds, both temples and lower eyelid region) and the area along the back of both ears on the back head are very uncomfortable. From thumb finger till middle figure of both hands are numb especially after getting up daily. The nerve of both front elbows is uncomfortable a lot stronger (e.g. sensation of soreness and distention). Both gums are very soreness and distention. Stuffy nose and night sweats in the whole body happen a few times daily after the 2nd dose as well. The patient did not have covid prior vaccination and was not tested for covid post vaccination. The patient did not receive any treatment in response to the events. Outcome of the events was not recovered.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: PNC13
Symptoms: Pneumonia viral
Clinical narrative: Viral pneumonia; This is a spontaneous report from two contactable consumers received by Pfizer from Merck & Co., Inc. manufacturer control number: 01872889. A male patient of an unspecified age received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13, Solution for injection in pre-filled syringe, lot number: not reported), via an unspecified route of administration on an unspecified date as single dose for immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, it was reported that the patient experienced viral pneumonia after vaccination. No further details were provided. The outcome of the event was unknown.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation
Clinical narrative: AFIB; This is a spontaneous report from a Pfizer-sponsored program from a non-contactable consumer (patient's wife). A male patient of an unspecified age received bnt162b2, dose 1 via an unspecified route of administration on 01Feb2021 (Batch/Lot number was not reported) at a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced AFIB in Feb2021 with outcome of unknown. The patient was hospitalized for event in Feb2021 to an unknown date.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Aphasia
Clinical narrative: Patient was hospitalized for dysphasia after receiving 2nd dose of Pfizer COVID-19 vaccine.; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date: unknown), second dose 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 hospitalized for dysphasia after receiving 2nd dose of Pfizer covid-19 vaccine. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: PNC13
Symptoms: Fatigue, Illness, Malaise, Pneumonia
Clinical narrative: Pneumonia; Pneumonia; I was tired; This is a spontaneous report from a contactable consumer (patient) from a Pfizer-sponsored program, PCV20 Adult Consumer Quant DTC Testing.   A female patient of an unspecified age (reported as 70 unit of measure not provided) received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13; lot number and expiry date not reported), via an unspecified route of administration, on an unspecified date, single dose for immunization.  The patient medical history was not reported. The patient's concomitant medications were not reported. The patient had pneumonia once and was sick for months and was tired for a long time afterwards. Fortunately, the patient didn't have to go to the hospital, but felt badly enough to go. When her primary physician thought things were headed in that direction, the patient was treated with the strongest medications possible, and checked with her at home, with regularity. The patient had taken the (Prevnar) vaccine prior to this event. Outcome of the events was unknown.  Information on Lot/Batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Asymptomatic COVID-19, COVID-19, Drug ineffective, Investigation
Clinical narrative: positive COVID-19 test with no symptoms; positive COVID-19 test with no symptoms; This is a spontaneous report from a contactable Other Health Professional and a contactable consumer (patient). A 58-year-old female patient received both doses of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot/batch number and Expiration date were not provided), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient had no event from vaccine. She tested positive for Covid after receiving vaccine and had another test performed that came back negative.  The outcome of events was unknown.   Information on the lot/batch number has been requested.; Sender's Comments: A contributory role of BNT162B2 to event tested positive for Covid after receiving cannot be excluded based on temporal association and limited information.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Pancytopenia
Clinical narrative: Pancytopenia; This is a spontaneous report from a contactable Physician.   A 78-year-old female patient received her second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), intramuscularly at Left arm on 24Feb2021 (at the age of 78-year-old) for COVID-19 immunization at the Hospital. The patient medical history included Non-Hodgkin's lymphoma. Concomitant medications were none. The patient had received the first dose of vaccine on unknown date. The patient had not known allergies. The patient was not pregnant. Patient has not tested positive for COVID-19 since having the vaccine. Patient had not a COVID-19 prior vaccination. On 01Mar2021 the patient experienced pancytopenia. The outcome was reported as not recovered.  No treatment received. The event was assessed as serious Life threatening  Information on Lot/Batch has been requested.; Sender's Comments: Reported life threatening pancytopenia is considered unrelated to BNT162b2 but more likely associated with patient's medical history of Non-Hodgkin's lymphoma.  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.
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Resulted in the death; This is a spontaneous report from a Pfizer sponsored program: A contactable consumer reporting on behalf of the sister reported that a female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unknown date, at single dose, for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient experienced an adverse effect that resulted in death on an unspecified date. Cause of death was unknown. It was unknown if an autopsy was done. Information on the lot/batch number has been requested.; Reported Cause(s) of Death: Resulted in the death
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nausea, Pruritus, SARS-CoV-2 test, Swollen tongue
Clinical narrative: First dizziness and nausea; First dizziness and nausea; Then itching; Then tongue swelling/throat closing; throat closing; This is a spontaneous report from a contactable consumer (Patient herself). A 46-Year-Old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL9266), via an unspecified route of administration at Left arm on 16Feb2021 17:45 (at age of 46 years old) at single dose for COVID-19 immunisation. Relevant medical history included: Athsma-lasting trouble breathing after allergic reaction, Ehlers-Danlos Syndrome, PCOS (Polycystic ovarian syndrome), Hypothyroid. Known allergies was Cashews, pistachios, cat dander. The patient's concomitant medications were not reported. No other vaccine in four weeks. No COVID prior vaccination. COVID tested post vaccination. The patient experienced first dizziness and nausea Then itching Then tongue swelling/throat closing, all Adverse events started on 16Feb2021 17:45. AE resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Life threatening illness (immediate risk of death from the event). The patient underwent lab tests and procedures which included COVID test type post vaccination was Nasal Swab, COVID test name post vaccination=PCR on 21Feb2021 with result Negative. Treatment (Epipen, IV Benadryl, Pepcid, Prednisone) received for all AE. The outcome of the events was recovered in 2021.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Throat tightness
Clinical narrative: First dizziness and nausea; First dizziness and nausea; Then itching; Then tongue swelling/throat closing; throat closing; This is a spontaneous report from a contactable consumer (Patient herself). A 46-Year-Old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL9266), via an unspecified route of administration at Left arm on 16Feb2021 17:45 (at age of 46 years old) at single dose for COVID-19 immunisation. Relevant medical history included: Athsma-lasting trouble breathing after allergic reaction, Ehlers-Danlos Syndrome, PCOS (Polycystic ovarian syndrome), Hypothyroid. Known allergies was Cashews, pistachios, cat dander. The patient's concomitant medications were not reported. No other vaccine in four weeks. No COVID prior vaccination. COVID tested post vaccination. The patient experienced first dizziness and nausea Then itching Then tongue swelling/throat closing, all Adverse events started on 16Feb2021 17:45. AE resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Life threatening illness (immediate risk of death from the event). The patient underwent lab tests and procedures which included COVID test type post vaccination was Nasal Swab, COVID test name post vaccination=PCR on 21Feb2021 with result Negative. Treatment (Epipen, IV Benadryl, Pepcid, Prednisone) received for all AE. The outcome of the events was recovered in 2021.
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia oral, Pain in extremity, Paraesthesia oral
Clinical narrative: Soreness in arm; tingling/numbness in lips; Soreness in arm; tingling/numbness in lips; Soreness in arm; tingling/numbness in lips; This is a spontaneous report from a contactable pharmacist. A 7-decade-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number and expiration date unknown) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient had allergy to bees. The patient's concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number and expiration date unknown) via an unspecified route of administration at single dose for COVID-19 immunization. The patient experienced soreness in arm; tingling/numbness in lips that started within 30 min of shot (2nd dose) and resolved on own about 15-20 min after tingling started. The outcome of the events tingling/numbness in lips was resolved on an unspecified date, while for event soreness in arm 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: Received first dose and got covid and wants to cancel her second dose; Received first dose and got covid and wants to cancel her second dose; This is a spontaneous report received from a 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) via an unspecified route of administration, on an unspecified date (unknown age at time of vaccination), at single dose, for COVID-19 immunization. The patient's medical history included ongoing cancer. Concomitant medications were not reported. The patient received first dose and got COVID and wants to cancel her second dose. The patient also had an infusion the day before reporting and is a cancer patient. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: U
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: very sick for many days; Initial information was received on 08-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer or other non professional via social media.  This case involves an adult patient (age and gender unspecified) who become very sick for many days (illness), after receiving INFLUENZA VACCINE.  The patient had no medical history, concomitant disease or risk factor. Past medical treatment, vaccination, concomitant medication and family history were not provided.  On an unknown date, in 1976, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [lot number, expiry date and other dosing details were not reported] for prophylactic vaccination.  On an unknown date, the patient developed a non-serious very sick for many days (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  It was also reported that, in the same year of vaccination, some ended up with paralysis but reporter was fortunate.  It was unknown if the patient experienced any additional symptoms/events.  There were no laboratory data/results available.  It was not reported if the patient received any corrective treatment.  At the time of reporting, event outcome for reported event was unknown.  There will be no information available on the batch number for this case.
Sex: F
Vaccine: DTAPIPV, TDAP
Symptoms: Exposure during pregnancy, Wrong product administered
Clinical narrative: pregnant was given Quadracel by mistake instead of Adacel -with no adverse event; pregnant was given Quadracel by mistake instead of Adacel -with no adverse event; Initial information received on 01-Mar-2021 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 23-years old female patient who was exposed to vaccines DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] and DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] in context of pregnant (exposure during pregnancy and wrong product administered).  The date of last menstrual period was not reported.  The estimated due date was not reported (she was 31 weeks pregnant).  Medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications were not reported.  On an unknown date, the patient received DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [lot number: unknown and expiration date: unknown] at an unknown dose via unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, the patient received DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [lot number: C5656AA and expiration date: unknown] at an unknown dose via intramuscular route in an unknown administration site for prophylactic vaccination.  On an unknown date, the patient who pregnant was given quadracel by mistake instead of adacel  (exposure during pregnancy and wrong product administered), (latency: unknown) following the administration of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE and following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  No laboratory data was reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, outcome of the event was not applicable.  Disclaimer: This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 56.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Erythema, Skin test positive, Swelling
Clinical narrative: patient had anaphylactic reaction; labored breathing; Initial information received on 02-Mar-2021 regarding an unsolicited valid serious case from physician and consumer.  This case involves a 56 years old female patient who had anaphylactic reaction with labored breathing (dyspnoea), after receiving INFLUENZA VACCINE.  The patient's past medical history included other anaphylactic reactions but didn't clarify to what products.  The patient's past medical treatment(s), vaccination(s) and family history were not provided and no Concomitant Medication(s).   On an unknown date in 2014 at 3 in the evening, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer [lot number and expiry date not reported] via unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date in 2014, the patient developed a serious anaphylactic reaction, while patient went to dinner at 5 in the evening with friends started having labored breathing (dyspnoea), (exact latency unknown) following INFLUENZA VACCINE. These events were assessed as medically significant.  Patient states that the influenza vaccine that she had by Sanofi back in 2014 caused her to have an anaphylactic reaction and allergist was trying to find out what was in the flu shot to narrow down the reaction to what she was allergic to.   Doctor office states that the patient received the Fluzone for under 65 years of age back in 2014 but that office did not have records of exactly what vaccine she used.   Patient did not seek any medical care until the next day when she went to the office and physician subsequently sent her for test and to an allergist.  Patient was not sure of any other details of the injection from 2014.   In Dec 2020 her allergist gave her a skin test from Afluria and she had a "bad skin reaction" so then he gave her a "watered down" version of Afluria and she had redness with raised areas so he told her that she could not have further flu shots.  No laboratory data reported.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome is unknown for the reported events.  Information regarding the batch number should be requested.; Sender's Comments: This case concerns a 56 years old female patient who presented with anaphylactic reaction and dyspnoea, after vaccination with INFLUENZA VACCINE .The time to onset is compatible. Past medical history included anaphylactic reactions. There is, however, no information regarding patient's condition at time of vaccination, past medical treatment, family history and  other relevant laboratory tests ruling out alternate etiologies. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Diarrhoea, Fatigue, Feeling cold
Clinical narrative: 72 hours...exhaustion, super hot/icy cold within minutes, continued headache, diarrhea, nausea, could not eat for 2 days, 3rd day lost sense of taste and smell, 3rd day rash on arms and chest (4 hours), difficult to sleep soundly but needed to stay in bed or rest for the most part.  3/16 woke up feeling much better and able to eat, smell and taste about 75%.  Spoke via text with  doctors office personnel for advice 3/14 and 3/15...very supportive!
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Headache, Nausea, Rash, Sleep disorder
Clinical narrative: 72 hours...exhaustion, super hot/icy cold within minutes, continued headache, diarrhea, nausea, could not eat for 2 days, 3rd day lost sense of taste and smell, 3rd day rash on arms and chest (4 hours), difficult to sleep soundly but needed to stay in bed or rest for the most part.  3/16 woke up feeling much better and able to eat, smell and taste about 75%.  Spoke via text with  doctors office personnel for advice 3/14 and 3/15...very supportive!
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Mobility decreased, Pyrexia
Clinical narrative: Severe joint pain limiting mobility Minor fever Extreme chills/shaking lasting over 2 hours Extreme fatigue next day
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: Severe joint pain limiting mobility Minor fever Extreme chills/shaking lasting over 2 hours Extreme fatigue next day
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills
Clinical narrative: Chills Joint ache
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, SARS-CoV-2 test negative, Wheezing
Clinical narrative: Cough and wheezing starting about 48 hours after 2nd COVID vaccine (Moderna). Symptoms lasted approximately 1 week. Resolved after using Albuterol and Alvesco inhalers.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Decreased appetite, Dizziness, Hyperhidrosis
Clinical narrative: Fever, Chills, Body pain/ache, Muscle weakness/pain, Nausea, Loss of appetite, Dizziness, Sweating, Joint weakness/pain, High blood pressure
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Hypertension, Muscular weakness, Myalgia, Nausea, Pain
Clinical narrative: Fever, Chills, Body pain/ache, Muscle weakness/pain, Nausea, Loss of appetite, Dizziness, Sweating, Joint weakness/pain, High blood pressure
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever, Chills, Body pain/ache, Muscle weakness/pain, Nausea, Loss of appetite, Dizziness, Sweating, Joint weakness/pain, High blood pressure
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Electric shock sensation
Clinical narrative: About 1/12-2 weeks s/p injection, my nervous system became extremely hyper. I was getting electric shocks down to my right three middle toes. I got the vaccine on my left side. I thought it was my back (sacro-iliac dysfunction), but it doesn't follow a dermatone. Then my R thumb started getting the shocks, with pain on one side, numbness on the other.  This went on for a couple of weeks then calmed down. I got my second shot on 2/15/21 and a week or so after that the electric shocks came back even stronger and they are still  doing it, only it appears to be slowing down now. I went to my pulmonary doc for an asthma check  and asked her if I should report this, and she said yes.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Ear swelling, Erythema, Peripheral swelling, Pharyngeal swelling, Pruritus
Clinical narrative: Swelling, intense itching and redness on face particularly around eyes and eyelids, cheeks, neck and back of ears. Also present in and around the bellybutton and on both arms (strong on right arm). Started day after injection and continued to intensify despite doses of benedryl and loratadine, and topical cortisone. Morning of 3/16 woke up to slight swelling in throat and overall intensified swelling in face and neck.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Swelling, Swelling face, Swelling of eyelid, Umbilical erythema
Clinical narrative: Swelling, intense itching and redness on face particularly around eyes and eyelids, cheeks, neck and back of ears. Also present in and around the bellybutton and on both arms (strong on right arm). Started day after injection and continued to intensify despite doses of benedryl and loratadine, and topical cortisone. Morning of 3/16 woke up to slight swelling in throat and overall intensified swelling in face and neck.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion
Clinical narrative: Developed Large Bruise on inside calf left leg after 1.5 day.s. Large bruise above inside left ankle on day 16 after 1st shot.
Age: 22.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: ADAMTS13 activity assay, Alanine aminotransferase increased, Aspartate aminotransferase increased, Bacterial test positive, Bilirubin conjugated decreased
Clinical narrative: Within minutes of 2nd dose of vaccine, pt started urinating dark brown urine.  This turned bloody / dark red in color.  Over the next several days she had migraines, fever, nausea, diarrhea.  She had a very heavy period that was not normal for her.  She was treated twice for presumed UTI (once with macrobid and then with cefuroxime) in the days after the vaccine though cultures ended up negative.  She was referred to me, a hematologist, when she was noted to have a dropping hemoglobin and platelet count.  She appears to have a Coombs-negative hemolytic anemia and possibly ITP.  She is feeling a little better but her labs remain abnormal.  Please note this was reported on Pfizer website as well but I have not been contacted.  Guidance would be sincerely appreciated.  My cell phone was provided.
Age: 22.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood alkaline phosphatase normal, Blood bilirubin increased, Blood creatine phosphokinase normal, Blood culture negative, Blood fibrinogen increased
Clinical narrative: Within minutes of 2nd dose of vaccine, pt started urinating dark brown urine.  This turned bloody / dark red in color.  Over the next several days she had migraines, fever, nausea, diarrhea.  She had a very heavy period that was not normal for her.  She was treated twice for presumed UTI (once with macrobid and then with cefuroxime) in the days after the vaccine though cultures ended up negative.  She was referred to me, a hematologist, when she was noted to have a dropping hemoglobin and platelet count.  She appears to have a Coombs-negative hemolytic anemia and possibly ITP.  She is feeling a little better but her labs remain abnormal.  Please note this was reported on Pfizer website as well but I have not been contacted.  Guidance would be sincerely appreciated.  My cell phone was provided.