chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Optic nerve injury
Clinical narrative: 3 patients experiencing optic nerve damage approximately 3 months after second dose of vaccine. 2 patients were Moderna and 1 was Pfizer.; This is a spontaneous report from a non-contactable other hcp. A 7-decade-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, (Batch/Lot number was not reported)), dose 2 via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Historical vaccine information included bnt162b2 (COMIRNATY) 1st dose on an unknown date for Covid-19 Immunization and experienced no events reported. On an unspecified date, 3 patients experiencing optic nerve damage approximately 3 months after second dose of vaccine. 2 patients were moderna and 1 was Pfizer on an unspecified date. The outcome for event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on the information available  a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of  optic nerve damage. 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
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Neuralgic amyotrophy
Clinical narrative: diagnosed with Parsonage-Turner Syndrome; This is a spontaneous report from a contactable physician (patient). A 64-year old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in right arm on 07Jan2021 10:00 (Batch/Lot Number: FL3246) (at the age of 63 years old) as dose 2, single for COVID-19 immunisation. Facility where the most recent COVID-19 vaccine was administered was in the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient medical history was not reported. Patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  Concomitant medication included atorvastatin calcium taken for an unspecified indication, start and stop date were not reported. The patient took the first dose of BNT162B2 via unspecified route in right arm on 17Dec2020 10:00 (lot number: EK5730) for COVID-19 immunisation. On 11May2021 15:00, the patient had been diagnosed with parsonage-turner syndrome. The treatment received for the adverse event included occupational therapy. The adverse event resulted in Doctor or other healthcare professional office/clinic visit, disability or permanent damage. The outcome of the event was not recovered.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event Neuralgic amyotrophy and the suspect drug.  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: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: Swollen feet 3 weeks after 1st dose and 1 week after second dose.  Lasted for three days.; This is a spontaneous report from a contactable consumer. A 58-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 27May2021 11:30 (Batch/Lot Number: EW0191) as DOSE 1, SINGLE, dose 2 via an unspecified route of administration, administered in Arm Left on 24Jun2021 11:15 (Batch/Lot Number: EW0181) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included asthma, Sulfa antibiotics, DCIS. The patient is not pregnant. Facility where the most recent COVID-19 vaccine was administered: Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior the vaccination the patient was not diagnosed with COVID-19. The patient has not been tested for COVID-19. The patient's concomitant medications were not reported. ON 17Jun2021, the patient experienced Swollen feet 3 weeks after 1st dose and 1 week after second dose.  Lasted for three days. The patient did not receive treatment for the event. The outcome of the event was recovered on an unspecified date in Jun2021.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pyrexia
Clinical narrative: tired; little fever; chills; This is a spontaneous report from Pfizer-sponsored program via a contactable consumer. A 40-years-old female patient received BNT162B2 (PFIZER COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The reporter stated that the patient was tired for the first Pfizer vaccine for a day or day and a half and got up and was fine and felt a little fever and chills. The outcome of the event tired was resolved, while the outcome of other events was unknown.  The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Illness, Vomiting
Clinical narrative: throwing up; chills; sick; This is a spontaneous report from a contactable consumer.. A 40-year-old female patient received BNT162B2 (Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunisation. Medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2, lot number unknown, via an unspecified route of administration on an unspecified date, as single dose for COVID-19 immunization and the patient experienced tired for like a day or day and a half and got up and was fine and felt a little fever and chills.  It was reported that with 2nd dose patient was sick for 3 days, throwing up and chills and it was bad. The outcome of the event sick  was recovered; while the other events was unknown.  Information on Lot/Batch information has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Chronic obstructive pulmonary disease, Pain in extremity
Clinical narrative: He was down the first day and had sore arm; He also has COPD and wears Oxygen 24/7; This is a spontaneous report from a contactable consumer (patient's wife). A 73-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, lot number and expiry date were not reported) via an unspecified route of administration on an unspecified date as dose 1 single and second dose (lot number and expiry date were not reported) via an unspecified route of administration on an unspecified date as dose 2 single, both doses for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Reporter stated that her husband had both doses of the Pfizer covid vaccine, he was down the first day and had sore arm. He also had COPD and wears Oxygen 24/7. Reporter wanted to know about the 3rd dose for her husband and herself. She also stated that she saw in the news that Pfizer covid vaccine is only 39 percent effective against the delta variant and that really concerns her. The outcome of the events was unknown.  Information about Lot/batch number has been requested.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Breakthrough COVID positive on 22Jul2021; Breakthrough COVID positive on 22Jul2021; This is a spontaneous report from a contactable Nurse(patient).   A 49-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Batch/Lot number was not reported), via intramuscular, administered in Arm Left on Jan2021(age at time of vaccination 49-year-old) as dose 2, single for covid-19 immunisation and received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Batch/Lot number was not reported) via intramuscular, administered in Arm Left on 24Dec2020 (age at time of vaccination 49-year-old) as dose 1, single for covid-19 immunisation. The patient previously took Levaquin and experienced drug hypersensitivity and concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient did not receive other medications in two weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient was tested COVID-19 post vaccination. On 19Jul2021 the patient experienced breakthrough covid positive on 22Jul2021. The adverse event was not resulted in a visit to Doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the events. The patient underwent lab tests and procedures which included sars-cov-2 test (Nasal Swab) was positive on 22Jul2021. The outcome of the events was recovering.  Information on lot/ batch number has been requested.; Sender's Comments: Based on the current limited available information a possible contributory role of the suspect product BNT162B2 to the development of events of Vaccination failure and COVID-19 cannot be excluded.  The case will be reassessed if additional information becomes available.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Decreased appetite, Diarrhoea, Insomnia, Palpitations
Clinical narrative: Extreme anxiety; Diarrhea; Insomnia; Lack of Appetite; Sinus arrhythmia; Heart Palpitations; This is a spontaneous report from a contactable consumer (patient). A 34-years-old male patient received BNT162B2,  (Lot number was not reported), via an unspecified route of administration, administered in left arm, on 12Jul2021 17:00 (at the age of 34 years old), as dose 1, single for COVID-19 immunisation.  Medical history included bradycardia from an unknown date. Patient had COVID-19 prior to vaccination. There were no concomitant medications received within 2 weeks of vaccination.  The patient had known allergies of Wellbutrin and Prozac.  The patient experienced extreme anxiety, diarrhea, insomnia , lack of appetite, sinus arrhythmia and heart palpitations on 15Jul2021 07:00. The events resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. It was reported that COVID was not tested post vaccination. No treatment was given for the events. The outcome of the events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Sinus arrhythmia
Clinical narrative: Extreme anxiety; Diarrhea; Insomnia; Lack of Appetite; Sinus arrhythmia; Heart Palpitations; This is a spontaneous report from a contactable consumer (patient). A 34-years-old male patient received BNT162B2,  (Lot number was not reported), via an unspecified route of administration, administered in left arm, on 12Jul2021 17:00 (at the age of 34 years old), as dose 1, single for COVID-19 immunisation.  Medical history included bradycardia from an unknown date. Patient had COVID-19 prior to vaccination. There were no concomitant medications received within 2 weeks of vaccination.  The patient had known allergies of Wellbutrin and Prozac.  The patient experienced extreme anxiety, diarrhea, insomnia , lack of appetite, sinus arrhythmia and heart palpitations on 15Jul2021 07:00. The events resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. It was reported that COVID was not tested post vaccination. No treatment was given for the events. The outcome of the events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Fatigue, Gastrooesophageal reflux disease, Headache, Myalgia
Clinical narrative: Headaches are from mild to severe; acid reflux; nausea; tiredness; body muscle and skeletal pain; body muscle and skeletal pain; This is a spontaneous report from a contactable other hcp (patient). A 44-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in right arm on 18Jun2021 12:30 (Lot Number: EW0191) as dose 1, single for covid-19 immunisation. Medical history included some fish allergy. The patient previously took BENADRYL and experienced hypersensitivity (allergies). The patient did not receive any concomitant medication within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced headaches are from mild to severe, acid reflux, nausea, tiredness, body muscle and skeletal pain on 11Jul2021. The patient did not receive treatment for adverse event. The patient did not have Covid prior vaccination and she tested for Covid post vaccination as polymerase chain reaction (PCR) nasal swab on 16Jul2021 which resulted negative. The outcome of the events was not recovered.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, SARS-CoV-2 test
Clinical narrative: Headaches are from mild to severe; acid reflux; nausea; tiredness; body muscle and skeletal pain; body muscle and skeletal pain; This is a spontaneous report from a contactable other hcp (patient). A 44-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in right arm on 18Jun2021 12:30 (Lot Number: EW0191) as dose 1, single for covid-19 immunisation. Medical history included some fish allergy. The patient previously took BENADRYL and experienced hypersensitivity (allergies). The patient did not receive any concomitant medication within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced headaches are from mild to severe, acid reflux, nausea, tiredness, body muscle and skeletal pain on 11Jul2021. The patient did not receive treatment for adverse event. The patient did not have Covid prior vaccination and she tested for Covid post vaccination as polymerase chain reaction (PCR) nasal swab on 16Jul2021 which resulted negative. The outcome of the events was not recovered.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Mild rach all over the body; This is a spontaneous report from a contactable consumer (patient). A 12-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in left arm on 23Jul2021 10:00 (Lot Number: FA7484) (at age of 12-years-old) as dose 1, single for covid-19 immunisation. The patient had no medical history or known allergies. The patient did not receive any concomitant medication within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have Covid prior vaccination and was not tested for Covid tested post vaccination. The patient experienced mild rash all over the body on 23Jul2021 17:00. The patient did not receive the treatment for the adverse events. The outcome of the event was not recovered.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Nasopharyngitis, SARS-CoV-2 test
Clinical narrative: her friend was tested positive for COVID-19 about 2 months after received the full 2 doses of the Pfizer COVID-19 vaccine; her friend was tested positive for COVID-19 about 2 months after received the full 2 doses of the Pfizer COVID-19 vaccine; Her friend thought she had a cold but turns out she had COVID-19.; This is a spontaneous report from a contactable consumer via Pfizer. This consumer reported for a female patient that A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number, Expiry Date: Unknown), via an unspecified route of administration on an unspecified date as dose 2, single, and first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number, Expiry Date: Unknown), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunization. It was unknown if the patient was pregnant. The patient medical history and concomitant medications were not reported. It is unknown if patient had COVID prior vaccination. It was unknown whether the patient received other vaccine in four weeks or not. Reporter's friend informed her that her friend was tested positive for COVID-19. About 2 months after she received the full 2 doses of the Pfizer COVID-19 vaccine. Her friend thought that she had a cold but turns out she had COVID-19. It was unknown if the AE required treatment. The patient was tested COVID post vaccination. The patient underwent lab test SARS-CoV-2 test which showed positive result. The outcome was all events were unknown.  Follow-up attempts are needed; Information about lot/batch number has been requested. .
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, COVID-19, Drug ineffective, SARS-CoV-2 antibody test
Clinical narrative: had diagnosed COVID; had diagnosed COVID; Hair loss; This is a spontaneous report from contactable consumer received via Pfizer sales representative.   An elderly female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 2, single and via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Prior to the vaccination, the patient was diagnosed with COVID-19. It was reported that, the patient experienced hair loss after having had diagnosed COVID and two doses of vaccine. The patient underwent lab tests and procedures which included COVID-19 test: unknown, COVID-19 test: positive on an unknown date. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Covid 19; Covid 19; This is a spontaneous report from a contactable consumer (patient's brother). A 71-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date were unknown), via an unspecified route of administration, administered in left arm on 21Jan2021 (at the age of 71-year-old) as dose number unknown, single for COVID-19 immunization. Medical history included arthritis and high BP (blood pressure). The patient was not pregnant at the time of vaccination. Patient had no COVID-19 prior vaccination. Known allergies reported as unknown. Concomitant medication was not reported. The patient experienced no adverse reaction to the injection, however patient was presently in ICU (intensive care unit) on a ventilator with COVID-19. This was simply an information for knowledge. Adverse event started on 20Jul2021, adverse event resulted in, doctor or other health care professional office/clinic visit, emergency room/department or urgent care, hospitalization, life threatening illness (immediate risk of death from the event). Patient received treatment for adverse event. The patient underwent lab tests and procedures which included SARS-CoV-2 test positive on an unspecified date. The outcome of the events was not recovered.    Information about lot/batch number has been requested.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Costochondritis, Dehydration, Dyspnoea, Illness
Clinical narrative: dehydration; Sick for 5 days after - including chest pain; Sick for 5 days after - including chest pain; shortness if breath; nausea; vomiting; injection sight swelling; body aches; costochondritis after 2 weeks; This is a spontaneous report from a non-contactable consumer (patient). A 22-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EW0168) via an unspecified route of administration, administered in right arm on 18Jun2021 09:15 (at the age of 22-years-old) at dose 2, single for COVID-19 immunization. Medical history included polycystic ovarian syndrome, known allergies reported as intolerance to gluten, dairy and eggs, all from an unknown date and unknown if ongoing. Concomitant medication was not reported. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EW0182) via an unspecified route of administration in right arm on 28May2021 10:30 at single dose for COVID-19 immunization. Prior to vaccination, the patient did not have COVID and had no other vaccines within four weeks. The patient has not been tested for COVID post-vaccination. The patient was sick for 5 days after vaccination on 18Jun2021 18:00 including chest pain, shortness of breath, nausea, vomiting, injection sight swelling, and body aches. The patient also experienced continued dehydration for two weeks. Costochondritis developed after two weeks and stated that continued shortness of breath presented similarly to asthma but she had no previous history of asthma or costochondritis. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The patient received treatment with NSAIDs and Zofran for the adverse events. The outcome of the events sick, chest pain, nausea, vomiting, injection site swelling, and body aches was recovered on 24Jun2021; shortness of breath was not recovered; dehydration was recovered on an unspecified date in 2021, and costochondritis as recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Vaccination site swelling, Vomiting
Clinical narrative: dehydration; Sick for 5 days after - including chest pain; Sick for 5 days after - including chest pain; shortness if breath; nausea; vomiting; injection sight swelling; body aches; costochondritis after 2 weeks; This is a spontaneous report from a non-contactable consumer (patient). A 22-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EW0168) via an unspecified route of administration, administered in right arm on 18Jun2021 09:15 (at the age of 22-years-old) at dose 2, single for COVID-19 immunization. Medical history included polycystic ovarian syndrome, known allergies reported as intolerance to gluten, dairy and eggs, all from an unknown date and unknown if ongoing. Concomitant medication was not reported. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EW0182) via an unspecified route of administration in right arm on 28May2021 10:30 at single dose for COVID-19 immunization. Prior to vaccination, the patient did not have COVID and had no other vaccines within four weeks. The patient has not been tested for COVID post-vaccination. The patient was sick for 5 days after vaccination on 18Jun2021 18:00 including chest pain, shortness of breath, nausea, vomiting, injection sight swelling, and body aches. The patient also experienced continued dehydration for two weeks. Costochondritis developed after two weeks and stated that continued shortness of breath presented similarly to asthma but she had no previous history of asthma or costochondritis. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The patient received treatment with NSAIDs and Zofran for the adverse events. The outcome of the events sick, chest pain, nausea, vomiting, injection site swelling, and body aches was recovered on 24Jun2021; shortness of breath was not recovered; dehydration was recovered on an unspecified date in 2021, and costochondritis as 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: Monoplegia
Clinical narrative: his left arm feels dead; This is a spontaneous report based on information received by Pfizer. A 63-year-old male patient received bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date (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. On an unspecified date, Patient reported he had the Covid-19 vaccine few weeks after he noticed that his left arm feels dead. The outcome of the event was unknown.   No follow-up attempts are possible. Information about Lot/Batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Appendicitis perforated
Clinical narrative: Appendix ruptured, after the vaccine.; This is a spontaneous report from a contactable consumer other non health professional. This consumer reported for other people. A patient of unspecified age and gender received the unknown dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number and expiration date: unknown), via an unspecified route of administration on an unspecified anatomical location on unspecified date as a single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. Caller stated that she had heard that other people have had ruptured appendix, after the vaccine on an unspecified date. The outcome of the event was unknown.  Lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Illness, SARS-CoV-2 test
Clinical narrative: my brother-in-law had Pfizer vaccine also and is sick with Covid; my brother-in-law had Pfizer vaccine also and is sick with Covid; sick with Covid; This is a spontaneous report from a contactable consumer. A male patient (reporter's brother-in-law) of unspecified age received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: Unknown), via an unspecified route in the left arm on unspecified date as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. On unspecified date, the patient experienced sick with Covid and has required ER visits at the same hospital. Reporter presented in ICU on a ventilator with Covid 19. reporter stated her patient had Pfizer vaccine also and is sick with Covid. The patient underwent lab tests and procedures which included Covid-19 test was positive on unspecified date. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Herpes simplex, Oral pain, Oropharyngeal pain, Vaccination site mass
Clinical narrative: herpes/herpes flare-ups; woke up with a sore in her mouth; knot on her left arm; little run down; sore throat; This is a spontaneous report from a contactable consumer (patient). A 53-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: FA6780), dose 1 via an unspecified route of administration, administered in arm left on 21Jul2021 (at the age of 53-years-old) as dose 1, single for COVID-19 immunisation. The patient medical history included herpes and COVID-19. The patient's family history included COVID-19 from 09Mar2021 to 09Mar2021 (Mother passed away on 09Mar2021 of COVID and her step dad tested positive for COVID too), cough (Mother was coughing) and cardiac arrest (the nursing home kept her mother and worked on her for 2 hours during the cardiac arrest before taking her mother to the ER, where she was placed on a ventilator just until the caller could get there and then she passed away, patient cried for two months straight). Concomitant medication(s) included ACYCLOVIR taken for herpes simplex (as needed for Herpes but has not need to take it in a long time). In Jul2021, the patient experienced little run down, sore throat and knot on her left arm. On 26Jul2021, the patient experienced herpes/herpes flare-ups and woke up with a sore in her mouth. The patient reported that after receiving her first dose of the Pfizer-Biontech Covid19 vaccine on 21Jul2021, it "woke up her herpes". This outbreak was the first in over a year, and confirmed with the pharmacist that treatment dose of Valacyclovir was twice daily for 7 days. She also reported that she had a "knot in her arm" that her vaccination site advised her was normal and to treat with a warm compress and can be there for 7 days. She has been using a warm compress on it and it was going down a little. She noted feeling "a little run-down" and "a sore throat" after her first dose, which she told might have contributed to the development of the herpes outbreak. She indicated she would take lots of vitamins, vitamin C and zinc. The patient further reported that on 26Jul2021 morning, she woke up with a sore in her mouth, and she thought the vaccine might have woken her herpes. She was wondering if anyone at Pfizer was familiar with something like that. She wanted to know if herpes flare-ups have been reported before and should she take the valacyclovir prophylactic dose (once daily) until she gets her second dose on 11Aug2021. Therapeutic measures were taken as a result of herpes and knot on her left arm. The outcome of all the events was unknown.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Last week I apparently contracted the sar-cov-2 virus/tested positive; Last week I apparently contracted the sar-cov-2 virus/tested positive; 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, Solution for injection, Batch/Lot number was not reported, Expiry date: unknown), dose 1 via an unspecified route of administration on an unspecified date in Jan2021 as dose 1, single, and then dose 2 via an unspecified route of administration on an unspecified date Jan2021 (Batch/Lot number was not reported, Expiry date: unknown) as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that last week the patient apparently contracted the SAR-COV-2 virus and had been quite sick since then. The patient had tested positive and had GI issues, fever, congestion, lethargy, chest pains, and shallow breathing. The patient was confounded and frustrated. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on an unspecified date in Jul2021. Outcome of the events was unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Cough, Gastrointestinal disorder, Lethargy, Nasal congestion, Pyrexia
Clinical narrative: Last week I apparently contracted the sar-cov-2 virus/tested positive; Last week I apparently contracted the sar-cov-2 virus/tested positive; 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, Solution for injection, Batch/Lot number was not reported, Expiry date: unknown), dose 1 via an unspecified route of administration on an unspecified date in Jan2021 as dose 1, single, and then dose 2 via an unspecified route of administration on an unspecified date Jan2021 (Batch/Lot number was not reported, Expiry date: unknown) as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that last week the patient apparently contracted the SAR-COV-2 virus and had been quite sick since then. The patient had tested positive and had GI issues, fever, congestion, lethargy, chest pains, and shallow breathing. The patient was confounded and frustrated. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on an unspecified date in Jul2021. Outcome of the events was unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: second vaccine administered in Feb2021. 17Jul2021 began covid symptoms; COVID-19; This is a spontaneous report from a contactable consumer (patient). A 58-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration on an unknown date in Feb2021 (at the age of 58-year-old) (Batch/Lot number was not reported) as dose 2, single at workplace clinic, via an unspecified route of administration in right arm on an unknown date in Jan2021 at 15:00 (at the age of 58-year-old) (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. It was reported that second vaccine administered in Feb2021 and on 17Jul2021 began COVID symptoms. The adverse event was resulted in visit of doctor or other health care professional office/clinic visit. The patient underwent lab tests and procedures which included COVID test (nasal swab test): positive on 20Jul2021. Therapeutic measures were taken as a result of COVID-19. The outcome of the COVID-19 was reported as resolved on an unknown date in 2021.  The lot number for the vaccine, (PFIZER-BIONTECH COVID-19 vaccine), was not provided and will be requested during follow up.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Dyspnoea, Fatigue, Inappropriate schedule of product administration, Malaise
Clinical narrative: blood clots in his lungs; Shortness of breath; feeling kind of bad; when he started feeling tired; off label use; The caller thinks he received it 14 days before the second shot; This is a spontaneous report from a contactable consumer (reported himself). A 57-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported) via an unspecified route of administration, administered in arm left on 30Mar2021 (age at vaccination was 57-year-old) as dose 2, single for COVID-19 immunization. Medical history included hypertension (diagnosed a while ago). The patient concomitant medications were not reported. The patient previously received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VAC-CINE, Solution for injection, Lot number was not reported) via an unspecified route of administration, administered on 16Mar2021 (age at vaccination was 57-year-old) as dose 1, single for COVID-19 immunization. The patient thinks he received it 14 days before the second shot. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 30Mar2021 the patient received his second shot and that's when he started feeling tired and couldn't get himself together. On 14Apr2021, the patient came into work and got out of the vehicle and was feeling kind of bad. The patient stated that he got shortness of breath and couldn't make it to the office. The patient had to call security who called the ambulance and then he was rushed to the hospital. The patient was in hospital and the doctor said he had developed blood clots in his lungs and the patient has never had them in his life. The patient stayed in the hospital from 14Apr2021 to 16Apr2021 for blood clots in his lungs. The event blood clots in his lungs resulted in emergency room visit and physician office visit. On an unknown date 2021, the patient lab data included all sorts of blood work (some with a hematologist about 3 weeks ago and followed up with that). The hematologist determined that the vaccine gave him the blood clots. The patient had sonograms all over his body when he was in the hospital and all sorts of things. The patient stated that he was taking blood thinner to treat the clots and he has constipation and all of that stuff from the medications. The patient may be on the blood thinners for the rest of his life because of this and that worries him. The patient can't seem to get himself back to 100 percent because before this he was working out but now it was a struggle. The outcome of the event blood clots in his lungs, feeling kind of bad was not resolved. The outcome of the event shortness of breath was resolving. The outcome of the event when he started feeling tired was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Off label use, Pulmonary thrombosis, Ultrasound scan
Clinical narrative: blood clots in his lungs; Shortness of breath; feeling kind of bad; when he started feeling tired; off label use; The caller thinks he received it 14 days before the second shot; This is a spontaneous report from a contactable consumer (reported himself). A 57-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported) via an unspecified route of administration, administered in arm left on 30Mar2021 (age at vaccination was 57-year-old) as dose 2, single for COVID-19 immunization. Medical history included hypertension (diagnosed a while ago). The patient concomitant medications were not reported. The patient previously received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VAC-CINE, Solution for injection, Lot number was not reported) via an unspecified route of administration, administered on 16Mar2021 (age at vaccination was 57-year-old) as dose 1, single for COVID-19 immunization. The patient thinks he received it 14 days before the second shot. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 30Mar2021 the patient received his second shot and that's when he started feeling tired and couldn't get himself together. On 14Apr2021, the patient came into work and got out of the vehicle and was feeling kind of bad. The patient stated that he got shortness of breath and couldn't make it to the office. The patient had to call security who called the ambulance and then he was rushed to the hospital. The patient was in hospital and the doctor said he had developed blood clots in his lungs and the patient has never had them in his life. The patient stayed in the hospital from 14Apr2021 to 16Apr2021 for blood clots in his lungs. The event blood clots in his lungs resulted in emergency room visit and physician office visit. On an unknown date 2021, the patient lab data included all sorts of blood work (some with a hematologist about 3 weeks ago and followed up with that). The hematologist determined that the vaccine gave him the blood clots. The patient had sonograms all over his body when he was in the hospital and all sorts of things. The patient stated that he was taking blood thinner to treat the clots and he has constipation and all of that stuff from the medications. The patient may be on the blood thinners for the rest of his life because of this and that worries him. The patient can't seem to get himself back to 100 percent because before this he was working out but now it was a struggle. The outcome of the event blood clots in his lungs, feeling kind of bad was not resolved. The outcome of the event shortness of breath was resolving. The outcome of the event when he started feeling tired was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Loss of consciousness, Vomiting
Clinical narrative: neighbors son passed out; has dizzy spells; vomiting; This is a spontaneous report from a non-contactable consumer. A potential AE has been reported. A male patient (neighbor's son) of unknown age received dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), unknown dose via an unspecified route of administration on unknown date at dose number unknown, single for COVID-19 immunization. No medical history and concomitant medications were reported. The Caller and her husband got Pfizer Covid vaccines in Jan2021. They haven't had any problems, until about 2 months ago. Her husband started having headaches and he was dizzy. He has had an MRI, EEG, wore a heart monitor, and a carotid artery check and they can't find anything wrong. It was reported that, reporter neighbors had similar side effects, neighbor's son passed out and has dizzy spells, and neighbors boyfriend has passed out several times and vomits. The outcome of events was unknown.  Information about lot/batch has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202100956276 Same reporter and drug,  different patients
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Diabetes mellitus, Drug ineffective, Glycosylated haemoglobin
Clinical narrative: patient was admitted with COVID after having the Pfizer COVID-19 vaccine; patient was admitted with COVID after having the Pfizer COVID-19 vaccine; undiagnosed diabetic; This is a spontaneous report from a Pfizer-sponsored program via a contactable nurse. This nurse reported similar events for three patients. This is one of three reports. A 49-years-old patient of an unspecified gender received BNT162B2 (PFIZER COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single dose for covid-19 immunisation. Medical history included body mass index (BMI) increased, BMI of 45. The patient's concomitant medications were not reported. The reporter stated that the patient was admitted with COVID after having the PFIZER COVID-19 vaccine and that they had not tested patient's antibodies. The reporter thought that it was medically significant that the patient was in the hospital with COVID after getting dose of the PFIZER COVID-19 vaccine. The patient was an undiagnosed diabetic when they came into the hospital, with an A1C (Glycosylated haemoglobin) 6.5 which was right there on the threshold. The outcomes of the events was unknown.  The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect vaccine BNT162B2 or comirnarty in triggering the onset of drug ineffective,covid-19 and diabetes mellitus 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,Linked Report(s) : US-PFIZER INC-202100956381 same reporter, different patient, same drug, similar events;US-PFIZER INC-202100957303 same reporter, different patient, same drug, similar events
Sex: M
Vaccine: COVID19
Symptoms: Pain, Rash, Urticaria
Clinical narrative: Father of his friend got the vaccine (not sure if it is Moderna or Pfizer) got rash and hives; Father of his friend got the vaccine (not sure if it is Moderna or Pfizer) got rash and hives; so much pain; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received bnt162b2 (COVID-19 VACCINE MANUFACTURER UNKNOWN, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date, as a dose number unknown, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced father of his friend got the vaccine (not sure if it is moderna or pfizer) got rash and hives. Caller was planning to get the Pfizer COVID 19 vaccine. He wants to know if there will be any issues or interaction if he was taking any nutritional products and supplements. He saw in the news that some people who have received the vaccine had violent reactions and not sure if it was due to taking lots of nutritional products. Caller wants to know if there was any information about nutritional products that could affect the vaccine. Father of his friend got the vaccine (not sure if it is Moderna or Pfizer) got rash and hives, so much pain, need to inject morphine for 3 weeks. Caller heard on the news about people who had violent reactions from the vaccine, father of his friend had rash and hives. He mentioned that he will ask his friend if it was Moderna or Pfizer that his father got. Caller refused to provide other contact information and personal details. Father of his friend got the vaccine (not sure if it is Moderna or Pfizer) got rash and hives, so much pain, need to inject morphine for 3 weeks. Caller mentioned that the fact sheet for recipients and caregivers for Pfizer COVID-19 vaccine does not contain any information about interaction between nutritional products/herbs and vaccine. He also mentioned that it should be somehow discussed in the fact sheet about what nutritional products could or could not be appropriate before taking the vaccine. It was reported that product quality compliant was reported. The outcome of the events was reported as unknown.  Information about lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Malaise, SARS-CoV-2 test, Sluggishness
Clinical narrative: but then contracted Covid; but then contracted Covid; feels sluggish; ill; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: not reported), via an unspecified route of administration on an unspecified date as single dose and first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: not reported), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unknown date, patient received both shots of the Pfizer COVID vaccine, but then contracted COVID, felt sluggish and ill. The patient underwent lab tests and procedures which included COVID test: contracted COVID. The clinical outcome of the events was unknown.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.