chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram, Hypertension, SARS-CoV-2 test
Clinical narrative: High blood pressure and went the emergency room twice.; This is a spontaneous report from a contactable consumer (patient). A 44-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 11Aug2021 10:30 (at the age of 44 years-old) (Batch/Lot Number: 3181) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included Known allergies: Penicillin, covid-19 from an unknown date and unknown if ongoing. There were no concomitant medications. On 12Aug2021 22:00, the patient experienced high blood pressure and went to the emergency room twice. The patient underwent lab tests and procedures which included electrocardiogram: unknown results on an unspecified date, sars-cov-2 test: negative on 08Sep2021 Covid test type post vaccination=Nasal Swab  result=Negative. Therapeutic measures were taken as a result of high blood pressure and went the emergency room twice. (hypertension): IV fluids, EKG. Told to rest, excused from work. The outcome of the event was not recovered. The patient did not have COVID prior vaccination, and the patient was covid tested post vaccination.
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: he had a family member who had vaccines and had COVID.; he had a family member who had vaccines and had COVID.; This is a spontaneous report from a non-contactable consumer (family member). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date (Lot number was not reported) as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The reporter stated that he had a family member (patient) who had vaccines and had covid. The outcome of the events was unknown.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Condition aggravated, Loss of personal independence in daily activities
Clinical narrative: thought you should know that it got worse after the second dose.; avid runner and now cannot run, got worse after the second dose; terrible knee pain, got worse after the second dose; This is a spontaneous report from a contactable consumer (patient) via Pfizer RXPathways. A patient of unspecified age and gender received BNT162b2 (Pfizer BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number and Expiration date was not reported) via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included patient received BNT162b2 (Pfizer BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number and Expiration date was not reported) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation and experienced terrible knee pain and was avid runner and now cannot run. On an unspecified date, patient thought that Pfizer should know that terrible knee pain and was avid runner and now cannot run, it got worse after the second dose. The outcome of terrible knee pain got worse after the second dose was not recovered and unknown for rest of the events.  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
Age: 73.0
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Blood test, Brain natriuretic peptide, Full blood count, Pulmonary function test
Clinical narrative: Shoulder pain; This is a spontaneous report from a contactable physician (patient). A 73-year-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration, on 01Feb2021 (Batch/Lot Number: EL9265) (at the age of 73 years old) as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient didn't have much of local discomfort with the first vaccine injection and only reported to experience shoulder pain on an unspecified date in Feb2021. The patient underwent lab tests and procedures on an unspecified date, which included multiphasic blood chemistry, brain natriuretic peptide (BNP), full blood count (CBC), and pulmonary function test: All with an unknown results. The outcome of event shoulder pain was unknown.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Genital herpes zoster, Intermenstrual bleeding, Pain, Pain assessment
Clinical narrative: she was in full blown pain on scale 1-10 it was a 10; she thought she was getting her period because she normally gets a little discharge and thought her period was coming.; breaking out with shingles in the vaginal area; This is a spontaneous report from a contactable consumer (patient) via Pfizer sponsored program.  A 34-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: FD8448; expiration date: not reported) via an unspecified route of administration, administered in left arm on 03Sep2021 (at the age of 34-years-old) at 13:30 as dose 1, single for covid-19 immunization. Medical history included diagnosed allergies, compromised immune status, respiratory illness, genetic/chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity: Chicken pox as a child, allergy to penicillin, start and stop date was unknown. Patient previously took Penicillin for cystic acne and experienced neck got red and wheezing, like boils turning up on her face, chest, and back. Had no other shots the same day or 4 weeks prior. The patient's concomitant medications were not reported.On 13Sep2021, patient experienced breaking out with shingles in the vaginal area.On 13Sep, does not know if she prolonged it or not, but she thought she was getting her period because she normally gets a little discharge and thought her period was coming. On Tuesday the 14Sep it got worse, by the 15Sep she was in full blown pain on scale 1-10 it was a 10. On Thursday the 16Sep she went to the emergency room. So everything really started on the 13th and it's completely gone now she believes because of the medication the Ob/Gyn gave her. Again, mentions she took it for 10 days and her last dose was yesterday. Patient took treatment of Valopress, 2 pills for 10 days. On 15Sep2021, patient underwent lab tests and procedures which included pain assessment resulted 10, on and unspecified date underwent lab test of sars-cov-2 test resulted positive and negative, both rechecks were negative. Therapeutic measures were taken as a result of breaking out with shingles in the vaginal area (genital herpes zoster), she was in full blown pain on scale 1-10 it was a 10 (pain). The outcome of event breaking out with shingles in the vaginal area and she thought she was getting her period because she normally gets a little discharge and thought her period was coming was recovered in Sep2021. At the time of reporting, the event she was in full blown pain on scale 1-10 it was a 10 was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure fluctuation
Clinical narrative: Wild fluctuations on blood pressure; This is a spontaneous report from a Contactable Consumer. A female patient of unspecified age received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: Unknown), via an unspecified route on 25Sep2021 as dose number unknown, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On unspecified date, the patient experienced wild fluctuations on blood pressure. The outcome of the event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Immunisation, Malaise, Off label use
Clinical narrative: I got the booster, Pfizer shot; I got the booster, Pfizer shot; I am just not feeling great right now / I feel like I am having an adverse reaction; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received third dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: Unknown, and Expiration date: Unknown), via an unspecified route of administration on an unspecified date as dose 3 (booster), single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received first and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: Unknown, and Expiration date: Unknown), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient reported "I got the booster, Pfizer shot" well, what considered to be booster on Friday and on an unspecified date "I am just not feeling great right now / I feel like I am having an adverse reaction" (further clarifications unknown). The patient stated "That's kind of sink when you get a shot on the weekend and you get a reaction, you got to wait till Monday to find out if that's what causing your problem. Is that so". The patient wanted to know whether this could be from the shot. The patient preferred not to probe further as patient was not feeling great. The patient was unwilling to complete the report. Further probing could not done. Hence, limited information was available over the call. The outcome of the events was unknown.  Follow-up attempts have been completed. Batch/lot number not available for BNT162B2. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Dyspepsia, Feeling hot
Clinical narrative: epigastric burning; warm inside; BP elevated to 224/93; This is a spontaneous report from a non-contactable pharmacist. A 64-years-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in Arm Right on 24Feb2021 (Batch/Lot Number: en6200) as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The adverse events resulted in Emergency room/department or urgent care unit. Patient did not receive other vaccine in four weeks of vaccination. Patient did not receive other medications in two weeks of vaccination. Patient was not diagnosed with COVID, prior vaccination. Patient has not been tested for COVID, post vaccination. On 24Feb2021 the patient experienced epigastric burning, warm inside, bp elevated to 224/93 on 24Feb2021. The patient underwent lab tests and procedures which included blood pressure measurement: elevated to 224/93, elevated to 224/93. Therapeutic measures were taken as a result of events. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Neoplasm malignant, Portal vein thrombosis
Clinical narrative: cancer blown out of nowhere; portal vein thrombosis; strokes.; This is a spontaneous report from non-contactable healthcare professionals (one is a physician assistant).  A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 2021 (Batch/Lot number was not reported) as dose number unknown, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported.  The reporter stated that just Tuesday, they shipped out three cardiomyopathies, and a blood clot. On 27Sep2021, the patient on the floor just died and the reporter just pronounced him a second ago. The patient got his shot and literally two weeks later, the patient ended up with cancer blown out of nowhere, a portal vein thrombosis like and got strokes in 2021. The patient died on 27Sep2021.  It was not reported if an autopsy was performed.  The lot number for bnt162b2, was not provided and will be requested during follow up.; Sender's Comments: Based on the current limited available information, a possible contributory role of the suspect product BNT162B2 to the development of events cancer, portal vein thrombosis and strokes cannot be excluded.  The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: portal vein thrombosis; cancer blown out of nowhere; strokes.
Sex: F
Vaccine: COVID19
Symptoms: Eye disorder, Migraine, Palpitations, Polymerase chain reaction, Rash
Clinical narrative: Rash was blistering; She had a terrible rash; Had open sores on her body; Heart palpitations; On her arms she has scar tissues from the first dose; Her eyes were going to pop out of her head from her migraines; Her eyes were going to pop out of her head from her migraines; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: 041C2A and expiration date was not reported), via an unspecified route of administration on 11Aug2021 at dose 1, single for covid-19 immunization. She never had issues with migraines except when she was pregnant and also has infertility issues. The patient's concomitant medications were not reported. Patient who was surgical technologist, had a terrible rash and having heart palpitations after the first dose, she felt like her eyes were going to pop out of her head from her migraines in Aug2021. Reported that her rash was blistering and she had open sores on her body, not like hives, almost like shingles but she did a shingle test and it was negative. On her arms she has scar tissues from the first dose, skin was still raised and healing in that area. She has been in and out of ERs getting steroid injections in her butt and having to be on high doses of steroid pills because of this. She had to get her second dose on 08Sep2021 to be compliant for school. The patient underwent lab tests and procedures which included Shingles test: negative in Aug2021. Therapeutic measures were taken as a result of events (rash was blistering, had a terrible rash (rash), had open sores on her body, on her arms, has scar tissues). The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101275965 same patient/vaccine, different dose , similar events
Sex: F
Vaccine: COVID19
Symptoms: Rash vesicular, Scar, Skin lesion
Clinical narrative: Rash was blistering; She had a terrible rash; Had open sores on her body; Heart palpitations; On her arms she has scar tissues from the first dose; Her eyes were going to pop out of her head from her migraines; Her eyes were going to pop out of her head from her migraines; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: 041C2A and expiration date was not reported), via an unspecified route of administration on 11Aug2021 at dose 1, single for covid-19 immunization. She never had issues with migraines except when she was pregnant and also has infertility issues. The patient's concomitant medications were not reported. Patient who was surgical technologist, had a terrible rash and having heart palpitations after the first dose, she felt like her eyes were going to pop out of her head from her migraines in Aug2021. Reported that her rash was blistering and she had open sores on her body, not like hives, almost like shingles but she did a shingle test and it was negative. On her arms she has scar tissues from the first dose, skin was still raised and healing in that area. She has been in and out of ERs getting steroid injections in her butt and having to be on high doses of steroid pills because of this. She had to get her second dose on 08Sep2021 to be compliant for school. The patient underwent lab tests and procedures which included Shingles test: negative in Aug2021. Therapeutic measures were taken as a result of events (rash was blistering, had a terrible rash (rash), had open sores on her body, on her arms, has scar tissues). The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101275965 same patient/vaccine, different dose , similar events
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Appendicitis, SARS-CoV-2 test
Clinical narrative: Appendicitis 11 days after vaccination; This is a spontaneous report from a non-contactable consumer (patient). A 39-year-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration on 14Sep2021 (at the age of 39-years-old) (Batch/Lot number was not reported) as single for COVID-19 immunisation. Medical history was not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have concomitant medications or other medications received within 2 weeks of vaccination. Prior to vaccination the patient was not diagnosed with COVID-19. The patient had appendicitis 11 days after vaccination (as reported) (also reported as 24Sep2021). The patient had a negative nasal swab on 24Sep2021. The patient required emergency room/department or urgent care. The patient received surgery as treatment for the event. The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: diagnosed with COVID-19; diagnosed with COVID-19; This is a spontaneous report from a contactable consumer (Pfizer colleague). A non-pregnant adult female patient received the dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number and expiration date not reported), via an unspecified route of administration on an unspecified date (at an unspecified age) at dose number unknown, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, it was unknown if the patient was diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19.  On 21Sep2021, the patient was diagnosed with COVID-19. No treatment was received. The patient underwent COVID-19 test on 21Sep2021 with positive result. Outcome of the events was recovering.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash on his, it was a full body rash and lasted approximately 3 months; This is a spontaneous report from a contactable consumer. A 34-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for COVID-19 immunization. Medical history included heat rashes (further not clarified) sometimes on his waist but that was it. There were no concomitant medications. On an unspecified date, the patient experienced rash on his, it was a full body rash and lasted approximately 3 months. He went to urgent care and got a Cortisone shot after 2 weeks of rash and it didn't really work and then he took during the day cetirizine hydrochloride (ZYRTEC) and he also took diphenhydramine (BENADRYL) at night. He did go to the ER but all the blood work were normal. The outcome of the event was recovered on an unspecified date in 2021.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Neuropathy peripheral, Paraesthesia, SARS-CoV-2 test
Clinical narrative: Neuropathy; Numbness/ pins and needles in both hands and feet and abdomen; Numbness/ pins and needles in both hands and feet and abdomen; This is a spontaneous report from a contactable consumer. A 32-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in the right arm on 05Apr2021 (Batch/Lot Number: EW0170) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient had no medical history. The patient's concomitant medications were not reported. On 26Jul2021, the patient experienced neuropathy and numbness/pins and needles in both hands and feet and abdomen. Conditions has been consistent for more than 2 months. The event neuropathy was assessed as serious (medically significant). It was mentioned that the adverse event resulted in a doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Lab data includes nasal swab (SARS-CoV-2 test): negative on 30Aug2021. The patient did not received treatment for the events. The outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Autoimmune thyroiditis
Clinical narrative: diagnosed with the auto immune Hashimoto's disease; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, lot number and expiry date not reported), via an unspecified route of administration, on an unspecified date in Apr2021, as dose 2, single, for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, lot number and expiry date not reported), via an unspecified route of administration, on an unspecified date, as dose 1, single for covid-19 immunisation. It was reported that, the patient completed the 2 vaccine shots back in April2021. 5 months later, the patient was diagnosed with the auto immune Hashimoto's disease. The outcome for the event was unknown.  The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Ophthalmological examination, Thrombosis, Visual impairment
Clinical narrative: bleed clot in my left eye; now I have just 40% vision in left eye; This is a spontaneous report from a contactable consumer (patient).   A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number was not reported), via an unspecified route of administration on Apr2021 as dose 2, single for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. The patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number was not reported), via an unspecified route of administration on Mar2021 as dose 1, single for covid-19 immunisation. The patient had a bleed clot in my left eye. Patient was healthy before the shot and had 20/20 vision. Patient had just 40% vision in left eye due to which getting shots in the left eye. The outcome of the event was unknown.    The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: Seizure; This is a spontaneous report from a non contactable other HCP.   A 57-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date unknown), via an unspecified route of administration on 02Jun2021 as single dose for COVID-19 immunisation.  Medical history included seizure disorder.  Concomitant medications were not reported.  On 02Jun2021 the patient experienced seizure (assessed as medically significant) with outcome of unknown.  The event resulted in emergency room/department or urgent care visit. Therapeutic measures were taken as a result of seizure, not further specified.   No follow-up attempts possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Eye swelling, Lip swelling, Pruritus, Rash, Rash erythematous
Clinical narrative: red rash all over his face; rash on part of his neck and chest area; face itching all night long; swollen eyes, cheeks, lips; swollen eyes, cheeks, lips; swollen eyes, cheeks, lips; This is a spontaneous report from a contactable other health professional (HCP). A 14-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: 301308A), via an unspecified route of administration, administered in arm right on 23Sep2021 at 19:30 (at the age of 14-years-old) as dose number unknown, single for COVID-19 immunisation. Medical history included mild seasonal allergies. The patient's concomitant medications were not reported. The patient experienced red rash all over his face, rash on part of his neck and chest area, face itching all night long, swollen eyes, cheeks, lips on 25Sep2021 at 09:00. Events took place after use of product. The events resulted in emergency room visit. The clinical course was as follows: Woke up on 25Sep2021 at 9:00am with swollen eyes, cheeks, lips and red rash all over his face. Complained of face itching all night long. Also has rash on part of his neck and chest area. The patient has no underlying conditions. Patient does not take any prescribed medications. Patient took diphenhydramine (BENADRYL) every 4 hours since rash developed. No history of food allergy. Patient does have mild seasonal allergies. Patient has never had a rash like this before. Patient is going to urgent care today to see a physician. Therapeutic measures were taken as a result of all events. The events red rash all over his face and rash on part of his neck and chest area were assessed as serious and medically significant by the regulatory authority. The outcome of the events was not recovered.; Sender's Comments: Based on the information provided in the narrative, a causal association between the suspect drug and the events cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Swelling face
Clinical narrative: red rash all over his face; rash on part of his neck and chest area; face itching all night long; swollen eyes, cheeks, lips; swollen eyes, cheeks, lips; swollen eyes, cheeks, lips; This is a spontaneous report from a contactable other health professional (HCP). A 14-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: 301308A), via an unspecified route of administration, administered in arm right on 23Sep2021 at 19:30 (at the age of 14-years-old) as dose number unknown, single for COVID-19 immunisation. Medical history included mild seasonal allergies. The patient's concomitant medications were not reported. The patient experienced red rash all over his face, rash on part of his neck and chest area, face itching all night long, swollen eyes, cheeks, lips on 25Sep2021 at 09:00. Events took place after use of product. The events resulted in emergency room visit. The clinical course was as follows: Woke up on 25Sep2021 at 9:00am with swollen eyes, cheeks, lips and red rash all over his face. Complained of face itching all night long. Also has rash on part of his neck and chest area. The patient has no underlying conditions. Patient does not take any prescribed medications. Patient took diphenhydramine (BENADRYL) every 4 hours since rash developed. No history of food allergy. Patient does have mild seasonal allergies. Patient has never had a rash like this before. Patient is going to urgent care today to see a physician. Therapeutic measures were taken as a result of all events. The events red rash all over his face and rash on part of his neck and chest area were assessed as serious and medically significant by the regulatory authority. The outcome of the events was not recovered.; Sender's Comments: Based on the information provided in the narrative, a causal association between the suspect drug and the events cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Myalgia, Pyrexia
Clinical narrative: Chills; Fever; Muscles aches; This is a spontaneous report from a contactable physician. An 82-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: 6205), intramuscular, administered in left deltoid on 27Feb2021 (at the age of 82-years-old) as dose 2, single for COVID-19 immunization. Medical history ongoing hypothyroidism, depression and vitamin d deficiency. Concomitant medications included levothyroxine taken for hypothyroidism, paroxetine taken for depression and vitamin d taken for vitamin d deficiency. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN9581), intramuscular, administered in right deltoid on 06Feb2021 (at the age of 82-years-old) as dose 1, single for COVID-19 immunization after which the patient experienced chills, myalgia, pyrexia, pain in extremity, feeling cold, fatigue and arthropathy. The patient experienced chills, fever and muscles aches on 28Feb2021. The patient did not receive any treatment for the events. The outcome of the events was recovered on an unspecified date.  COMMENTS: She had chills, fever, muscle aches with both Covid vaccine. Both times these symptoms started the late evening/ morning after shot and resolved 2 days later. She does not have any tingling symptoms.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Hospitalized From COVID; Hospitalized From COVID; This is a spontaneous report from a contactable consumer. An adult male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE),  via an unspecified route of administration, on an unspecified date as dose 1, single (Lot number: Unknown, Expiration date: Not reported) and dose 2, single (Lot number and expiration date were not reported) for COVID-19 immunization. The most recent COVID-19 vaccine was administered in a facility reported as unknown. Medical history included kidney transplant in 2011 which was reported as 10 years ago and the patient was immunocompromised. It was unknown if the patient had relevant past drug history. It was unknown if the patient received concomitant medications/any other medications the patient received within 2 weeks of vaccination. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, it was unknown if the patient was diagnosed with COVID-19. It was reported that the patient was hospitalized for COVID-19 after receiving both the doses of Pfizer vaccine. He had fever and was hospitalized on an unspecified date. He's being treated with remdesivir and sleeping with an oxygen tube. These events resulted in emergency room/department or urgent care. The patient had no prolonged hospitalization. Since the vaccination, the patient had been tested for COVID-19 with positive result on an unspecified date. The outcome of these events was unknown at the time of report.   The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: painful shingles; This is a spontaneous report based on the information received by Pfizer. A contactable consumer reported for a patient (family member) of unspecified age and gender received bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: Not reported) via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. Product was reported as Shingles vaccine. The patient's medical history and concomitant medications were not reported. It was reported that family member struggling for over two months now with painful shingles. Which occurred a week after Pfizer/BioNTech mRNA vaccine was administered. Doctors then told them, it was a possible side effect and hes looking at least year before it will clear up. Social media team became aware of potential AE was reported as 18Aug2021. Date the Author published the social media post was reported as 18Aug2021 6:35:58 PM. The outcome of the event was not recovered.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Death; This is a spontaneous report from a contactable other healthcare professional (HCP). A 67-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via unspecified route of administration in right arm on 27May2021 at 09:00 as single dose for COVID-19 immunisation. The relevant medical history included atherosclerosis from unspecified date. Concomitant medications included rosuvastatin calcium (CRESTOR). No other vaccine in four weeks. The patient experienced death on 07Jun2021 at 04:45. No treatment received for the events. No covid prior vaccination and no covid tested post vaccination. The patient died on 07Jun2021. It was unknown if an autopsy was performed. The outcome of the event was fatal.  The Lot number for the vaccine [BNT162B2] was not provided and will be requested during Follow-up.; Sender's Comments: The information currently provided is too limited to make a meaningful medical assessment. However, per company causality assessment guidance, the event of death with unknown cause is assessed as related until the cause of death is clarified. 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.; Reported Cause(s) of Death: Death
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: died; This is a spontaneous report from a contactable pharmacist. A 37-year-old female patient received bnt162b2 (COMIRNATY, Lot Number: FK0112; Expiration Date: 30Jan2022), via an unspecified route of administration on an unspecified date (37-year-old at time of vaccination) as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient died on an unspecified date. Verbatim: The reporting pharmacist states that she is located in the (country A) but has patients in (country B) who travel back and forth for business. These patients are stuck in (country B) due to the high rates of the delta variant there the pharmacist explained. She states that Pfizer COVID 19 vaccines as well as Moderna COVID 19 vaccines are being donated by other countries to (country B) to help provide vaccination. She states that one of her patients who is in (country B) received one of these donated vaccine with lot number FK0112 and customer service was again to look up this lot number and provide the expiration date of (30Jan2022) stated the pharmacist. She relays that there have been multiple adverse events that have happened with this lot number and she would like to know if it is possible that there was something wrong with that lot. Her patient who was a 37-year-old healthy female received the vaccine from this lot and died 4 hours later. She would like to know why this could have occurred. What data is available on deaths being reported. It was unknown if an autopsy was performed. The cause of death was unknown.; Sender's Comments: Based on the information available and close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events . The case will be reassessed once new information is available   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: died
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, Erythema, Feeling hot
Clinical narrative: Bell's Palsy; arm became hot; area became red (Approx 6 inch diameter); This is a spontaneous report from a contactable pharmacist via medical information team. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The reporter mentioned within minutes (after vaccination) patients arm became hot, and area became red (Approx 6 inch diameter). Within 24 hours patient had bell's Palsy. Reporter was inquiring if the patient should receive the second dose. What are the current recommendations under this situation?. Therapeutic measures were taken for bell's palsy under MD treatment and care. Outcome of event bell's palsy was recovered on an unspecified date in 2021 and other events it was unknown.  The lot number for BNT162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the available reported information, the causal association between the event bell's palsy and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: M
Vaccine: COVID19
Symptoms: Immunisation, Off label use
Clinical narrative: the third dose 2 weeks ago.; the third dose 2 weeks ago.; This is a spontaneous report from a contactable consumer (patient) reported for himself. A 75-years-old male patient received third dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on an unspecified date in 2021 (age at vaccination was unknown) as dose 3 (booster), single for COVID-19 immunization. The patient's medical history included ongoing rheumatoid arthritis. Concomitant medication included methotrexate taken for rheumatoid arthritis. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on an unspecified date in Feb2021 (age at vaccination was unknown) as dose 1, single and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on an unspecified date in Mar2021 (age at vaccination was unknown) as dose 2, single for COVID-19 immunization. The patient stated that he received the first dose of the Pfizer COVID-19 vaccine in Feb2021, the second dose in early Mar2021 and the third dose 2 weeks ago. He took Methotrexate 2 days later for his Rheumatoid Arthritis. He had received 2 doses of Methotrexate since receiving his shot. The patient referenced an article stating that people who take methotrexate may have less effectiveness of the vaccine and that they don't recommend to take methotrexate when anyone take the shot. He was supposed to take another dose of the methotrexate that day. The patient wanted to know how much less effective it was and what could he expect. The case was assessed as non-serious.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Mass, Pain in extremity, Peripheral swelling
Clinical narrative: Arm was sore; swelling in clavicle area; bump, which feels like a lymph node on top; This is a spontaneous report from a contactable consumer (patient). A 59-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL9261), dose 2 via an unspecified route of administration, administered in Arm Left on 16Feb2021 at 11:30 (at the age of 59-years-old) as dose 2, single for covid-19 immunisation.  Medical history included type 2 diabetes. Concomitant medication included metformin hydrochloride, sitagliptin phosphate (JANUMET LONG) (50-1000mg, take two tablets once a day) taken for type 2 diabetes mellitus, start and stop date were not reported. Historical Vaccine included bnt162b2 (Batch/Lot Number: EL1283) as first dose on 26Jan2021 (at the age of 59-years-old) for COVID-19 immunisation and experienced arm soreness and Headache.  On an unspecified date, the patient experienced arm was sore and swelling in clavicle area on 17Feb2021, bump, which feels like a lymph node on top on 17Feb2021. She wanted to know if the event was commonly reported, how long it would last, and when she should be concerned/seek treatment. Received second dose of vaccine two days ago on Tuesday. Arm was sore. Yesterday noticed a bump, which feels like a lymph node on top. Patient wasn't sure how long she should wait before she goes to get the event checked. She was fairly healthy. She tried and avoid anything with nurses and doctors. Usually she saw a PAs in the office. Thought maybe she needs to go see a full-fledged doctor. Tried to report through Website, but it was crashing. Report wouldn't go through. She read somewhere on the internet that swollen lymph nodes may occur. She wanted to know how long it last, was there any indication of how long it lasts and if it was it normal. She asked if there was any indication of how long it will be there before the swelling goes down or away. Paperwork shows there can be swelling but doesn't say how long. She doesn't have any more information. She knows it is very early. She was a teacher. She was allowed to make the appointment early. History of All Previous Immunizations was not provided. Prior Vaccinations Within 4 Weeks was none. Outcome of the events were unknown.   Follow up (18Feb2021): This is a follow up spontaneous report from a contactable consumer. This 59-year-old female consumer (patient) reported included height and weight and clinical information.  No follow-up attempts are possible. No further information is expected.
Age: 94.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Jaw disorder, Mastication disorder
Clinical narrative: she swallows she feel a lump on the left hand side; issues with chewing; issues with your jaw; This is a spontaneous report from a contactable consumer or other non hcp (Patient).  A 94-years-old female patient received first dose of bnt162b2 (BNT162B2, PFIZER-BIOTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 13Feb2021 15:00 (Age at vaccination: 94-years-old) as SINGLE DOSE for covid-19 immunization. (Vaccination facility: Hospital). Vaccine was not administered at facility. Medical history included Heart attack, Hysterectomy, Gallbladder removal all from an unknown date and unknown if ongoing. The patient concomitant medications were reported as Stated she takes vitamins and a blood pressure pill. Prior vaccines within 4 weeks was reported as none. It was reported hat She got the shot on Saturday and the next morning, Sunday, when she got up her jaw was bothering her. It felt like it had shifted and she was not chewing too well. It progressively has gotten better. She had cereal today and she can still feel her jaw/chewing bothering her. When she swallows she feel a lump on the left hand side. However, it seems like this has subsided. It is on the left side face from jaw up to ear. This is where she is having trouble. She does not know if she has a cold or something else or if this is a possible reaction from the vaccine. Stated she is basically healthy. Stated she was fine up until starting to have to deal with this. She is feeling better now and chewing better day. Additional vaccines on same date was reported as none. Adverse events not resulted in Emergency Room or Physician Office visit. The outcome for the event experienced she swallows she feel a lump on the left-hand side was unknown and for remaining events outcome was reported as resolving.   No follow up attempts are possible; information about lot/batch number cannot be obtained.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Sleep disorder
Clinical narrative: trouble sleeping; body was hurting from head to toe; This is a spontaneous report from a contactable consumer or other non hcp.   A 74-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 07Feb2021 (Batch/Lot Number: EL3302; Expiration Date: Mar2021) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included from an unknown date and unknown if ongoing. There were no concomitant medications. on 17Feb2021 the patient experienced trouble sleeping, body was hurting from head to toe. Caller wants to know if she could be experiencing any side effects from the vaccine, States her second dose is scheduled for the 28Feb2021. Outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.