chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 47.0
Sex: U
Vaccine: COVID19
Symptoms: Hypersensitivity, Pruritus, Sneezing, Urticaria
Clinical narrative: hives; itchy; Sneezing; severe allergies; This is a spontaneous report from a contactable consumer, the patient. This 47-year-old patient of unspecified gender received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot: EW0179) via unspecified route in the left arm on 19May2021 at 14:00 (at the age of 47-years-old) and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot: EW0778) via unspecified route in the left arm on 09Jun2021 at 14:00 (at the age of 47-years-old), both doses as single doses for COVID-19 immunization. Medical history included high blood pressure. The patient did not receive any vaccinations prior to the COVID vaccine. Concomitant medication included azilsartan medoxomil, chlortalidone (EDARBYCLOR) for high blood pressure. On an unspecified date in 2021, after the first vaccine, the patient broke out in hives they are mainly really itchy. Patient had to take diphenhydramine hcl (BENADRYL) and his/her doctor gave prednisone. Then a month later (2021) the same thing happened, patient got the hives again and got itchy all over again. It only happens on the same side and the same arm, that patient got the vaccine in. Patient reported he/she received it from the both doses of the vaccine, but the second one was worse than the first one. Patient stated got the regular Benadryl over the counter but the doctor has been prescribing prednisone (patient thinks it was 10 mg) for severe allergies to help with the itching and the sneezing. Patient only take its during that time when he/she had the hives and itching. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Gait disturbance, Hemiplegia, Muscle spasms, Near death experience
Clinical narrative: Had a stroke a week after the first vaccine; His left side is nonfunctional/ his left side never came back; He almost died; Muscle spasm; He is not able to walk; This is a spontaneous report from a contactable consumer (patient's wife). A 67-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: EN5813) via an unspecified route of administration on 30Jan2021 (at the age of 67-years-old) as dose 1, single for COVID-19 immunization. The patient's medical history included rheumatoid arthritis, diabetes both from an unknown date and unknown if ongoing, he was diabetic, he was borderline diabetic so he was controlling it from diet. Concomitant medications included methotrexate taken for rheumatoid arthritis, start and stop date were not reported. On 10Feb2021, the patient experienced had a stroke a week after the first vaccine, in 2021 patient experienced he almost died, muscle spasm, he was not able to walk, his left side was non-functional/his left side never came back. Reporter was taking care of her husband 24/7 at home, his left side was non-functional. Reporter stated, his blood pressure pretty normal, of course after he got the, after he had the stroke a lot of stuff went. He was in the hospital for 30 days, he almost died. It had not did any improvement on the left side. Seriousness criteria reported as caused/prolonged hospitalization. The patient was hospitalized for had a stroke a week after the first vaccine (cerebrovascular accident) from 10Feb2021 to Mar2021. Reporter stated, 10Feb2021 was when it happened, he went right in and he stayed there 30 days and then he went to rehab for another 30 days so, 10Feb2021 she would say, Mar2021 he came out of the hospital around in middle of the Mar2021. He was not able to walk, his left side never came back. Reporter seriousness for other events was unspecified. Reporter stated, He was on a blood thinner Eliquis, which was very expensive but other one for that so we have to keep him on that, he was on, they put him on the cholesterol medication to keep his arteries clear and they did a procedure with an open duct the blockage and they took care of that, but by the time they did that the damage had been done so and he was also on Baclofen for his muscle spasm (further clarification unknown). Outcome of the events he was not able to walk, his left side is non-functional/ his left side never came back was not recovered and for all other events was unknown.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Appendicitis, Appendicitis perforated
Clinical narrative: Appendix ruptured; Possible appendicitis; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient of an unspecified age received bnt162b2  (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) Dose 2 via an unspecified route of administration, administered in the left arm on 31Mar2021 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. Medical history included blood cholesterol from an unknown date and unknown if ongoing (Verbatim: Cholesterol), thyroid disorder from an unknown date and unknown if ongoing (Verbatim: Thyroid). Concomitant medications included levothyroxine for thyroid disorder, start and stop date were not reported; simvastatin for an unspecified indication, start and stop date were not reported. The patient previously received the first dose of BNT162b2 on 10Mar2021 (Lot Number: EN6208) via an unspecified route of administration in the left arm for COVID-19 immunisation. Consumer stated, "I didn't know if you are collecting data on possible appendicitis side effects from the Pfizer vaccines. I started getting sick on 21May2021 and then, went to the doctor on 25May2021, who just told me I had a gastric virus and to take probiotic. I continued to feel bad and the pain got severe with fever on the 29May2021 and I went to the walk-in clinic on 31May2021, and they sent me to the ER and I was admitted to the hospital on 31May2021. Consumer stated reason of hospitalization was "my appendix ruptured." I was released on 03Jun2021." Outcome of the events was unknown.   Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: positive COVID-19 test; positive COVID-19 test; loss of taste; loss of taste and smell; This is a spontaneous report from a non-contactable consumer, the patient. This report was received via a sales representative. A 30-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported) via an unspecified route of administration on an unspecified date as dose 1, single and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported) via an unspecified route of administration on 12Apr2021 as dose 2, single and for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient stated that, recently on an unspecified date in 2021, she had received a positive COVID-19 test and loss of taste and smell. These loss of taste and smell have begun to return to normal after three days. She also reported that the event took place after use of product and she did not wish to be contacted for follow-up. The patient underwent lab test which included COVID-19 test: received a positive COVID-19 test on an unspecified date in 2021. The outcome for the event positive COVID-19 test was unknown and loss of taste and smell was recovered on an unspecified date in 2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebral haemorrhage, Computerised tomogram, Dizziness, Electrocardiogram, Eye swelling
Clinical narrative: Dizzy; Fall; left eye is swollen shut and the right is swollen half shut; she might have a little flu-like symptoms; brain bleed; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 66-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EW0191) via an unspecified route of administration, administered in Arm Left on 11Aug2021 (at the age of 66-years-old) at about 11:30-12 noon as a dose 1, single for covid-19 immunisation. Medical history included ongoing bad heart she had this since she was 44 years old, it was check in the emergency room. There were no concomitant medications. The patient did not take any other vaccines within four weeks prior to vaccination. It was reported that the patient got her first dose. she might have a little flu like symptoms on an unspecified date in 2021 and so she thought she could handle that. Yesterday (12Aug2021) she felt like a tornado hit her, was dizzy. When she got up, she hit the wall twice, hit her head, bounce off the wall 2 more time, then hit her head again and ended up on the floor, had fall on 12Aug2021. She ended up going to the emergency room but to be honest, she cannot remember much of yesterday (12Aug2021). she did not pass out but felt like she was flying through the kitchen. When at the emergency room, she was treated and released. They did a CT scan and EKG. The test showed no brain bleed. She reports she was on a blood thinner which caused them to be worried. If this had happened 4 weeks when her blood was 3.9 it might had been a brain bleed on an unspecified date in 2021. Everything hurts her left eye was swollen shut and the right was swollen half shut on 12Aug2021, this was from the fall and bouncing off the walls when trying to walk. She explains this was not like getting dizzy where she can grab a wall or something to hold on to, it was different. She was still a little funny on her feet and was given something for dizziness but was told this could happen again, so she was being careful. She was told there this was because of the COVID vaccine she got. In the emergency room the doctor told her there were a lot of people with a lot different reaction to the COVID vaccine. The patient underwent lab tests and procedures which included CT (Computerised tomogram) scan the test results showed no brain bleed, and underwent EKG the test resulted showed no brain bleed both on an unspecified date. The patient received treatment for the event brain bleed. The patient was not recovered from the event dizzy. The outcome of the events brain bleed, fall, left eye is swollen shut and the right is swollen half shut, she might have a little flu like symptoms was unknown at the time of report.   No follow-up attempts are possible. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Fall, Influenza like illness
Clinical narrative: Dizzy; Fall; left eye is swollen shut and the right is swollen half shut; she might have a little flu-like symptoms; brain bleed; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 66-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EW0191) via an unspecified route of administration, administered in Arm Left on 11Aug2021 (at the age of 66-years-old) at about 11:30-12 noon as a dose 1, single for covid-19 immunisation. Medical history included ongoing bad heart she had this since she was 44 years old, it was check in the emergency room. There were no concomitant medications. The patient did not take any other vaccines within four weeks prior to vaccination. It was reported that the patient got her first dose. she might have a little flu like symptoms on an unspecified date in 2021 and so she thought she could handle that. Yesterday (12Aug2021) she felt like a tornado hit her, was dizzy. When she got up, she hit the wall twice, hit her head, bounce off the wall 2 more time, then hit her head again and ended up on the floor, had fall on 12Aug2021. She ended up going to the emergency room but to be honest, she cannot remember much of yesterday (12Aug2021). she did not pass out but felt like she was flying through the kitchen. When at the emergency room, she was treated and released. They did a CT scan and EKG. The test showed no brain bleed. She reports she was on a blood thinner which caused them to be worried. If this had happened 4 weeks when her blood was 3.9 it might had been a brain bleed on an unspecified date in 2021. Everything hurts her left eye was swollen shut and the right was swollen half shut on 12Aug2021, this was from the fall and bouncing off the walls when trying to walk. She explains this was not like getting dizzy where she can grab a wall or something to hold on to, it was different. She was still a little funny on her feet and was given something for dizziness but was told this could happen again, so she was being careful. She was told there this was because of the COVID vaccine she got. In the emergency room the doctor told her there were a lot of people with a lot different reaction to the COVID vaccine. The patient underwent lab tests and procedures which included CT (Computerised tomogram) scan the test results showed no brain bleed, and underwent EKG the test resulted showed no brain bleed both on an unspecified date. The patient received treatment for the event brain bleed. The patient was not recovered from the event dizzy. The outcome of the events brain bleed, fall, left eye is swollen shut and the right is swollen half shut, she might have a little flu like symptoms was unknown at the time of report.   No follow-up attempts are possible. No further information is expected.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Cough, Drug ineffective, Infection, SARS-CoV-2 test
Clinical narrative: breakthrough infection diagnosed via PCR (mild head congestion and cough); breakthrough infection diagnosed via PCR (mild head congestion and cough); breakthrough infection diagnosed via PCR (mild head congestion and cough); breakthrough infection diagnosed via PCR (mild head congestion and cough); breakthrough infection diagnosed via PCR (mild head congestion and cough); This is a spontaneous report from a contactable consumer. A 50-years-old male patient received BNT162B2 (Pfizer-Biontech COVID-19 Vaccine, Solution for injection, Batch/lot number: unknown), via an unknown route of administration in Apr2021 (at the age of 50-years-old) as dose number unknown, single for COVID-19 immunisation. The patient's medical history included asthma. Concomitant medications were not reported. No other vaccine in four weeks. On 11Aug2021, the patient had breakthrough infection diagnosed via PCR (mild head congestion and cough). Patient had not been diagnosed with COVID-19 prior to vaccination. He had tested post the vaccination. On 13Aug2021, the patient had Covid test PCR by nasal swab which resulted positive post vaccination. No treatment received. The outcome of the event was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Upper respiratory tract congestion
Clinical narrative: breakthrough infection diagnosed via PCR (mild head congestion and cough); breakthrough infection diagnosed via PCR (mild head congestion and cough); breakthrough infection diagnosed via PCR (mild head congestion and cough); breakthrough infection diagnosed via PCR (mild head congestion and cough); breakthrough infection diagnosed via PCR (mild head congestion and cough); This is a spontaneous report from a contactable consumer. A 50-years-old male patient received BNT162B2 (Pfizer-Biontech COVID-19 Vaccine, Solution for injection, Batch/lot number: unknown), via an unknown route of administration in Apr2021 (at the age of 50-years-old) as dose number unknown, single for COVID-19 immunisation. The patient's medical history included asthma. Concomitant medications were not reported. No other vaccine in four weeks. On 11Aug2021, the patient had breakthrough infection diagnosed via PCR (mild head congestion and cough). Patient had not been diagnosed with COVID-19 prior to vaccination. He had tested post the vaccination. On 13Aug2021, the patient had Covid test PCR by nasal swab which resulted positive post vaccination. No treatment received. The outcome of the event was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 20.0
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: I got corona virus 19, I tested positive; I got corona virus 19, I tested positive; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 20-years-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 08Aug2021 (age at vaccination: 20 years) as dose number unknown, single for covid-19 immunisation at Pharmacy. Medical history included herpes (was sexually transmitted disease; Treatment: "Valacyclovir 1000mg tablets morning and night") from an unknown date and unknown if ongoing. Concomitant medication included valacyclovir [VALACICLOVIR] at the dose of 1000 mg, two times a day, taken for herpes virus infection, start and stop date were not reported. The patient got the vaccine 6 days ago and on 13Aug2021 (yesterday), tested positive on 13Aug2021, was feeling a little sick on an unspecified date in Aug2021 and went to the doctor and they tested the patient, and had corona virus. So, the patient was just wondering what the vaccine does if it does not stop the patient from getting corona virus. The patient underwent lab tests and procedures which included Corona virus 19, tested positive on 13Aug2021. The outcome of the event Covid-19 was unknown at the time of this report.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue
Clinical narrative: Fatigue; My energy level has not fully retuned.; This is a spontaneous report from a contactable consumer (patient). A 30-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection; Batch/Lot number was not reported), via an unspecified route of administration, administered in the right arm on 19Apr2021 at 07:00 (at the age of 30-years-old) as dose 2, single for COVID-19 immunization in hospital. Medical history included influenza from 2003 to an unknown date; Asthma (triggered by smoke) and congenital hearing loss; both from an unknown date and unknown if ongoing. Patient had past drug history or known allergies to Tree nuts, coconuts, palm oil. The patient previously took first dose of BNT162B2 (Batch/Lot Number: not reported) via an unspecified route of administration, administered in the right arm on 20Mar2021 at 07:00 (at the age of 30-years-old) as dose 1, single for COVID-19 immunization and experienced no reaction on previous exposure to vaccine. Concomitant medications within 2 weeks of vaccination included cetirizine hydrochloride (ZYRTEC); paracetamol (TYLENOL) (reported as 9 days before); benzocaine (ANBESOL); all taken for unspecified indication, start date and stop date were not provided. Prior to vaccination, patient was not diagnosed with COVID-19 and not received any other vaccines within 4 weeks. Since the vaccination, the patient has not been tested for COVID-19. On 21Apr2021 at 08:00, after second vaccination, patient experienced fatigue for about 3 months and patient's energy level has not fully retuned. Further clarified that patient was normally active, and reports walks 3 miles/day, go to a dog park almost daily and walk an additional 3 miles, and pedal on an exercise bike with moderate resistance for 60 minutes. But after the 2nd dose, walking 1 mile exhausted her and she could only bike for 5 minutes. Patient was easily exhausted until 16Jul2021 and my energy became to come back. Her energy level still has not fully returned. Patient used to work 12 hour days and still felt energized at the end of the day. Now, after working 8 hours, She feel fatigued and unable to exercise. There is no hospitalization prolonged due to events. Patient did not receive any treatment for adverse events. The outcome of events was recovering at the time of report.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: has gotten Covid; has gotten Covid; This is a spontaneous report from a Pfizer sponsored program. A contactable nurse (patient's wife) reported for a male patient (reporters husband) that male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EL9263; Expiration Date: 31May2021), via an unspecified route of administration on 16Feb2021 as dose 1, single, via an unspecified route of administration on 16Mar2021 (Batch/Lot Number: EL9266; Expiration Date: 30Mar2021) as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 09Aug2021, the patient experienced has gotten covid. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 09Aug2021. Reporter stated her husband had the Covid vaccines. Patient had the Pfizer Covid vaccines and was diagnosed with Covid on this past Monday. Patient got both doses of the Pfizer Covid vaccine and since then has gotten Covid. Diagnosed with Covid on 09Aug2021. got the first Covid dose 16Feb2021 with Lot number of EL9263. Received the second dose on 16Mar2021 with Lot number of EL9266 and what she believes is an expiry of 30Mar2021. Investigation Assessment: Yes. The clinical outcome of event was unknown. There was product complaint. Description of Product Quality Complaint: Conclusion of Previously Completed Investigation: The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE lot EL9266 and lot EL9263 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope included the reported finished goods lot EL9266, fill lot EL9257, and the formulated drug product lot EL9248. A complaint sample was not returned, and photographs were not received. No related quality issues were not identified during the investigation. There was no impact to product quality. No root cause or corrective/preventative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on the known drug safety profile, a causal association between the reported events of vaccination failure and covid-19 cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Maternal exposure during pregnancy, Vomiting
Clinical narrative: my wife puts the vaccine two days ago and she is also pregnant and she feels bad; Vomiting; she feel bad with vaccine; This is a spontaneous report from a contactable consumer (husband) reported for a patient (wife). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date on Aug2021 as dose number unknown, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced as, my wife puts the vaccine two days ago and she is also pregnant and she feels bad, vomiting, she feel bad with vaccine on an unspecified date on Aug2021. Reported as, "Well, my wife she was pregnant and she takes the vaccine two days ago and she feel bad with vaccine, she started vomited, she vomit, she started getting vomiting and I take yesterday to the hospital (Further clarification unknown) and they say that it seems look I mean the laboratory is looking good but she still feel the same thing she started vomiting and then she takes that kind of shower in the head". The mother reported she became pregnant while taking bnt162b2. Outcome of all the events were unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Chills, Ear pain, Fatigue, Hallucination
Clinical narrative: when I lay down to close my eyes, I've had hallucinations; Chest pain; headache; ear ache; nausea; tiredness/ extremely tired; sweating; chills; major night sweats; terrible nightmares; body feels like someone has beat me with a bat; This is a spontaneous report from a contactable (patient) via Regulatory Authority.   A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in Arm Left on 11Aug2021 17:00 (lot number: 59267-1000-01; expiry date: unknown) as dose 1, single, for COVID-19 immunization. The patient had no relevant medical history. The patient had no known allergies. Concomitant medications included fluoxetine hydrochloride (PROZAC) taken for an unspecified indication, start and stop date were not reported. The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in a pharmacy/drug store. On 12Aug2021, at 3:00 AM, the patient experienced chest pain, headache, ear ache, nausea, tiredness, sweating, chills, major night sweats, terrible nightmares, body feels like someone has beat her with a bat, extremely tired and when she lays down to close her eyes, she had hallucinations. The patient did not receive treatment for the events. The patient has not been tested for COVID-19 since vaccination. Outcome of the events was not recovered.  .; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events hallucination and suspect drug BNT162B2 cannot be excluded The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hyperhidrosis, Nausea, Night sweats, Nightmare
Clinical narrative: when I lay down to close my eyes, I've had hallucinations; Chest pain; headache; ear ache; nausea; tiredness/ extremely tired; sweating; chills; major night sweats; terrible nightmares; body feels like someone has beat me with a bat; This is a spontaneous report from a contactable (patient) via Regulatory Authority.   A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in Arm Left on 11Aug2021 17:00 (lot number: 59267-1000-01; expiry date: unknown) as dose 1, single, for COVID-19 immunization. The patient had no relevant medical history. The patient had no known allergies. Concomitant medications included fluoxetine hydrochloride (PROZAC) taken for an unspecified indication, start and stop date were not reported. The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in a pharmacy/drug store. On 12Aug2021, at 3:00 AM, the patient experienced chest pain, headache, ear ache, nausea, tiredness, sweating, chills, major night sweats, terrible nightmares, body feels like someone has beat her with a bat, extremely tired and when she lays down to close her eyes, she had hallucinations. The patient did not receive treatment for the events. The patient has not been tested for COVID-19 since vaccination. Outcome of the events was not recovered.  .; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events hallucination and suspect drug BNT162B2 cannot be excluded The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: when I lay down to close my eyes, I've had hallucinations; Chest pain; headache; ear ache; nausea; tiredness/ extremely tired; sweating; chills; major night sweats; terrible nightmares; body feels like someone has beat me with a bat; This is a spontaneous report from a contactable (patient) via Regulatory Authority.   A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in Arm Left on 11Aug2021 17:00 (lot number: 59267-1000-01; expiry date: unknown) as dose 1, single, for COVID-19 immunization. The patient had no relevant medical history. The patient had no known allergies. Concomitant medications included fluoxetine hydrochloride (PROZAC) taken for an unspecified indication, start and stop date were not reported. The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in a pharmacy/drug store. On 12Aug2021, at 3:00 AM, the patient experienced chest pain, headache, ear ache, nausea, tiredness, sweating, chills, major night sweats, terrible nightmares, body feels like someone has beat her with a bat, extremely tired and when she lays down to close her eyes, she had hallucinations. The patient did not receive treatment for the events. The patient has not been tested for COVID-19 since vaccination. Outcome of the events was not recovered.  .; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events hallucination and suspect drug BNT162B2 cannot be excluded The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Haematemesis
Clinical narrative: Throwing up blood; This is a spontaneous report from a contactable consumer. A 40-year-old male patient received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Right on 12Aug2021 (Lot Number: FD8448) as single dose (at age of 40-year-old) for covid-19 immunisation. Medical history and concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 12Aug2021 patient experienced throwing up blood. Reporter stated that patient got first dose of Pfizer Vaccine on 12Aug2021 after 12:10 at (Withheld) and he was throwing up blood at the time of the report. Reporter stated that patient was not treated for the event. Second dose vaccination date was reported as 02Sep2021. Outcome of the event was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ear discomfort, Nausea, Tinnitus
Clinical narrative: tinnitus; ear fullness; nausea; This is a spontaneous report from a contactable consumer (patient). A 54-year-old non-pregnant female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/lot number: FA6780), via unspecified route of administration, administered in left arm, on 29Jul2021 17:00 (age at the time of vaccination 54-year-old) as single dose for COVID-19 immunization. The patient was not a pregnant at the time of vaccination. Medical history and concomitant medications were not reported. The patient was allergic to penicillin. On 29Jul2021 at 19:00, the patient experienced horrible non-stop tinnitus, ear fullness and nausea. The patient visited emergency room and physician office. The patient had not received any treatment for the events. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The seriousness was reported as disability. Device Date was reported as 15Aug2021. The outcome of the events was not resolved.  Follow-up attempts are completed. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Acoustic stimulation tests, Blood test, Dizziness, Ear discomfort, Ear pain
Clinical narrative: tinnitus; ear fullness; nausea; This is a spontaneous report from a contactable consumer (patient). A 54-year-old non-pregnant female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/lot number: FA6780), via unspecified route of administration, administered in left arm, on 29Jul2021 17:00 (age at the time of vaccination 54-year-old) as single dose for COVID-19 immunization. The patient was not a pregnant at the time of vaccination. Medical history and concomitant medications were not reported. The patient was allergic to penicillin. On 29Jul2021 at 19:00, the patient experienced horrible non-stop tinnitus, ear fullness and nausea. The patient visited emergency room and physician office. The patient had not received any treatment for the events. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The seriousness was reported as disability. Device Date was reported as 15Aug2021. The outcome of the events was not resolved.  Follow-up attempts are completed. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tinnitus
Clinical narrative: tinnitus; ear fullness; nausea; This is a spontaneous report from a contactable consumer (patient). A 54-year-old non-pregnant female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/lot number: FA6780), via unspecified route of administration, administered in left arm, on 29Jul2021 17:00 (age at the time of vaccination 54-year-old) as single dose for COVID-19 immunization. The patient was not a pregnant at the time of vaccination. Medical history and concomitant medications were not reported. The patient was allergic to penicillin. On 29Jul2021 at 19:00, the patient experienced horrible non-stop tinnitus, ear fullness and nausea. The patient visited emergency room and physician office. The patient had not received any treatment for the events. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The seriousness was reported as disability. Device Date was reported as 15Aug2021. The outcome of the events was not resolved.  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chills, Cold sweat, Diarrhoea, Guillain-Barre syndrome
Clinical narrative: this effect is similar to Guillain-Barre syndrome; Pain at the site for 2 to 3 days off and on; Loose bowels; minor stomach cramps; Cold sweat; Chills; Tingling all over my hands, my body but mostly my hands 1000's of needle pricks, that is the effect; Shaking; Could not move; Cramps in legs; This is a spontaneous report from a contactable consumer, the patient. An unspecified patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: FC3180, expiration date: 01Oct2021), 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. Patient stated that, patient wanted to report a side effect. There was pain at the site for 2 to 3 days off and on, loose bowels, minor stomach cramps. About on the 4th day patient was woken up, about 4 in the morning, cold sweat, chills, tingling all over hands, patient's body but mostly patient's hands 1000's of needle pricks, that was the effect. Patient was shaking. Patient could not move, Patient had cramps in legs and this lasted 3 hours. If Patient had been driving a car when this happened, patient did not know if patient could operate the car. Patient further stated, from what I understood, it was not a good idea for me to have a second shot, this effect was similar to Guillain-Barre syndrome. Outcome of the event cramps in legs was recovered on an unknown date and outcome of the rest events was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Movement disorder, Muscle spasms, Paraesthesia, Tremor, Vaccination site pain
Clinical narrative: this effect is similar to Guillain-Barre syndrome; Pain at the site for 2 to 3 days off and on; Loose bowels; minor stomach cramps; Cold sweat; Chills; Tingling all over my hands, my body but mostly my hands 1000's of needle pricks, that is the effect; Shaking; Could not move; Cramps in legs; This is a spontaneous report from a contactable consumer, the patient. An unspecified patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: FC3180, expiration date: 01Oct2021), 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. Patient stated that, patient wanted to report a side effect. There was pain at the site for 2 to 3 days off and on, loose bowels, minor stomach cramps. About on the 4th day patient was woken up, about 4 in the morning, cold sweat, chills, tingling all over hands, patient's body but mostly patient's hands 1000's of needle pricks, that was the effect. Patient was shaking. Patient could not move, Patient had cramps in legs and this lasted 3 hours. If Patient had been driving a car when this happened, patient did not know if patient could operate the car. Patient further stated, from what I understood, it was not a good idea for me to have a second shot, this effect was similar to Guillain-Barre syndrome. Outcome of the event cramps in legs was recovered on an unknown date and outcome of the rest events was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Neoplasm malignant, Vaccination site discomfort
Clinical narrative: having slight discomfort at the site of injection; cancer; This is a spontaneous report from a contactable physician (patient) from a Pfizer-sponsored program. This male patient of unspecified age reported that he received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: Unknown) via an unspecified route in Mar2021 as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: Unknown) via unspecified route in Mar2021 as a single dose for COVID-19 immunization and experienced slight discomfort at the site of injection. The patient was diagnosed with cancer in May2021. He was treated with chemo and radiation. Today (13Aug2021) was the last dose of both chemo and radiation. He stated he will go to his oncologist Monday. Patient reported that he received both doses of the Pfizer Covid-19 vaccine in Mar2021, reports having no side effects other than having slight discomfort at the site of injection. The patient reported that his cancer was not related to the vaccine itself. It was HPV related. The patient inquired about the timing of the booster after chemo being given. He just finished treatment (chemotherapy and radiation) today (13Aug2021) and his oncologist suggested he wait a couple weeks to "perk up". He saw his oncologist for a consult in terms of the vaccine. His doctor said they could wait two weeks and reassess and see if he has any antibodies. He did get the vaccine in Mar2021. He just doesn't know if he has antibodies from Mar2021. So his doctor said to wait a couple of weeks before getting any vaccine. The outcome of the events was unknown.  The lot/batch number for the vaccine, BNT162b2, was not provided and will be requested during follow-up.; Sender's Comments: There is no reasonable possibility of causal association between the event of Neoplasm malignant and BNT162b2. The case will be reassessed if additional information becomes available.,Linked Report(s) : US-PFIZER INC-202101048314 same patient, same drug, different AE, different dose of vaccine
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Vaccination site discomfort
Clinical narrative: having slight discomfort at the site of injection; cancer; This is a spontaneous report from a contactable physician (patient) from a Pfizer-sponsored program. This male patient of unspecified age reported that he received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: Unknown) via an unspecified route in Mar2021 as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: Unknown) via unspecified route in Mar2021 as a single dose for COVID-19 immunization and experienced slight discomfort at the site of injection. The patient was diagnosed with cancer in May2021. He was treated with chemo and radiation. Today (13Aug2021) was the last dose of both chemo and radiation. He stated he will go to his oncologist Monday. Patient reported that he received both doses of the Pfizer Covid-19 vaccine in Mar2021, reports having no side effects other than having slight discomfort at the site of injection. The patient reported that his cancer was not related to the vaccine itself. It was HPV related. The patient inquired about the timing of the booster after chemo being given. He just finished treatment (chemotherapy and radiation) today (13Aug2021) and his oncologist suggested he wait a couple weeks to "perk up". He saw his oncologist for a consult in terms of the vaccine. His doctor said they could wait two weeks and reassess and see if he has any antibodies. He did get the vaccine in Mar2021. He just doesn't know if he has antibodies from Mar2021. So his doctor said to wait a couple of weeks before getting any vaccine. The outcome of the events was unknown.  The lot/batch number for the vaccine, BNT162b2, was not provided and will be requested during follow-up.; Sender's Comments: There is no reasonable possibility of causal association between the event of Neoplasm malignant and BNT162b2. The case will be reassessed if additional information becomes available.,Linked Report(s) : US-PFIZER INC-202101048314 same patient, same drug, different AE, different dose of vaccine
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Neoplasm malignant
Clinical narrative: having slight discomfort at the site of injection; cancer; This is a spontaneous report from a contactable physician (patient) from a Pfizer-sponsored program. This male patient of unspecified age reported that he received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: Unknown) via an unspecified route in Mar2021 as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: Unknown) via unspecified route in Mar2021 as a single dose for COVID-19 immunization and experienced slight discomfort at the site of injection. The patient was diagnosed with cancer in May2021. He was treated with chemo and radiation. Today (13Aug2021) was the last dose of both chemo and radiation. He stated he will go to his oncologist Monday. Patient reported that he received both doses of the Pfizer Covid-19 vaccine in Mar2021, reports having no side effects other than having slight discomfort at the site of injection. The patient reported that his cancer was not related to the vaccine itself. It was HPV related. The patient inquired about the timing of the booster after chemo being given. He just finished treatment (chemotherapy and radiation) today (13Aug2021) and his oncologist suggested he wait a couple weeks to "perk up". He saw his oncologist for a consult in terms of the vaccine. His doctor said they could wait two weeks and reassess and see if he has any antibodies. He did get the vaccine in Mar2021. He just doesn't know if he has antibodies from Mar2021. So his doctor said to wait a couple of weeks before getting any vaccine. The outcome of the events was unknown.  The lot/batch number for the vaccine, BNT162b2, was not provided and will be requested during follow-up.; Sender's Comments: There is no reasonable possibility of causal association between the event of Neoplasm malignant and BNT162b2. The case will be reassessed if additional information becomes available.,Linked Report(s) : US-PFIZER INC-202101048314 same patient, same drug, different AE, different dose of vaccine