chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered, Investigation, Off label use, Pyrexia
Clinical narrative: Chills; Joint pain; Fever actually its getting worse. Last time I checked it was 100.8 and now it's 103; Fever actually its getting worse. Last time I checked it was 100.8 and now it's 103; I am calling to report the side effects. I took the booster shot yesterday. Chills, joint pain and fever and fever actually its getting worse. Last time I checked it was 100.8 and now it's 103."; I am calling to report the side effects. I took the booster shot yesterday. Chills, joint pain and fever and fever actually its getting worse. Last time I checked it was 100.8 and now it's 103."; This is a spontaneous report from a contactable consumer or other non health professional (patient). A 50-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: FD8448, NDC number, UPC number and Expiry Date are unknown), via an unspecified route of administration on 21Aug2021 at the age of 50-years-old as dose 3, single (Booster dose) for covid-19 immunisation. The patient's relevant medical history and concurrent conditions included Immune disease  and fever from an unknown date. Concomitant medications included gabapentin (GABAPENTIN) taken for an unspecified indication, start and stop date were not reported; tizanidine (TIZANIDINE) taken for an unspecified indication, start and stop date were not reported; rituximab (RITUXIMAB) taken for an unspecified indication, start and stop date were not reported. The patient previously took first dose of historical vaccine, bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EP7534) on 19Mar2021 at the age of 50-years-old as single dose and second dose of historical vaccine, bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EW958) on 19Apr2021 at the age of 50-years-old as single dose for covid-19 immunisation. The patient did not receive any other vaccine prior to Covid-19 Vaccine in four weeks of vaccination. There was investigation Assessment. The reporter stated that she was calling to report the side effects. She took the booster shot the previous day. On an unspecified date, the patient experienced Chills, joint pain and fever and fever actually its getting worse. Last time she checked it was 100.8 and then it was 103. It was reported that morning, she had fever. she had chills last night. Treatment for adverse events included Tylenol. The patient underwent lab tests and procedures which included blood test: unknown results on an unspecified date in 2021, body temperature: 100.8 on an unspecified date, body temperature: 103 on an unspecified date, investigation: unknown results on an unspecified date in 2021. She stated, "Yeah, well I had the toxin within past two weeks, its 'fusion of toxin or toxin map' (further not clarified) and in blood work we had within the past 3 weeks." (further not clarified). The outcome of events was unknown.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Arrhythmia, Chest discomfort, Hypoaesthesia, Palpitations
Clinical narrative: Heart palpitations/arrhythmia, chest tightness, numb fingers so severe I went to the ER.; Heart palpitations/arrhythmia, chest tightness, numb fingers so severe I went to the ER.; Heart palpitations/arrhythmia, chest tightness, numb fingers so severe I went to the ER.; Heart palpitations/arrhythmia, chest tightness, numb fingers so severe I went to the ER.; This is a spontaneous report from a contactable consumer (patient). This non-pregnant 30-year-old female patient received bnt162b2 (brand=Pfizer), dose 2 via an unspecified route of administration, administered in arm right on 10May2021 10:00 (Batch/Lot Number: ER8731) as dose 2, single at the age of 29-year-old for covid-19 immunisation. Dose 1 was received with lot number: EW0176, 19Apr2021 09:00, dose number 1, vaccine location: right arm at the age of 29-year-old for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Facility type vaccine: pharmacy or drug store. No other vaccine in four weeks. Adverse event reported as heart palpitations/arrhythmia, chest tightness, numb fingers so severe patient went to the ER on 24Jul2021 21:00. Events resulted in Emergency room/department or urgent care. Patient recovered with lasting effects. No treatment. No COVID prior vaccination. No COVID tested post vaccination. The outcome of event was recovered with sequelae.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Body temperature, Chills, Cough
Clinical narrative: fever in 17Aug2021 at 5:15 AM 99.1°C, 5:30 96.7°C, 5:40 98.4°C, 6:00 97.8 °C, 6:30 99.0°C, 7AM 97.6°C, 10:30 95.1°C, at 2PM 99.4°C.; chills; he was one sick SOB last week; he was one sick SOB last week; mucus out of his lungs; sore shoulder/joint pain in his body, shoulders and my knees; feeling blah/pin needy feeling; coughing; feeling a little weak; This is a spontaneous report from a contactable consumer. A 67-year-old male consumer (patient) reported for himself that he received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number FC3181) via an unspecified route of administration in right arm on 09Aug2021 (at the age of 67-year-old) at single dose for COVID-19 immunisation. Relevant medical history included ongoing chronic obstructive pulmonary disease (COPD) and cancer in the left arm. Concomitant medications were not reported. The patient reported a sore shoulder and "feeling blah" on 09Aug2021, his highest temperature was 99.4 on 17Aug2021. He felt like someone punch him in the shoulder, he didn't feel up to par. He also experienced coughing and mucus out of his lungs on 09Aug2021. Clinical course was provided as follows. He went in and had the shot. He waited for 15 minutes. He didn't feel anything at first. The next day he felt like somebody hold off and punch him real hard in the shoulder. He was feeling a little weak and "pin needy feeling" on 09Aug2021. The patient had joint pain in his body, shoulders and knees. He monitored his fever on 17Aug2021 at 5:15 AM 99.1, 5:30 96.7, 5:40 98.4, 6:00 97.8, 6:30 99.0, 7AM 97.6, 10:30 95.1, at 2PM 99.4. It was fluctuating like that sometimes he got chills temperature vice versa. The patient was one sick SOB (as reported) the week before and had most of the symptoms, felt blah, wasn't that fun (as reported) and didn't feel up to par on 09Aug2021. The patient was being coughing and trying to get the mucous out on 09Aug2021. After his shoulder got sore and he felt blah, the next day he felt worse and the next he felt worse. The patient was treated with arthritis pain relief pills, robitussin and albuterol. Case was reported as non-serious. Feeling a little weak was not resolved, pyrexia resolved in Aug2021, outcome for chills was unknown and other events were resolving.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101097451 same reporter/drug, different patient.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Feeling abnormal, Illness, Increased bronchial secretion, Pyrexia
Clinical narrative: fever in 17Aug2021 at 5:15 AM 99.1°C, 5:30 96.7°C, 5:40 98.4°C, 6:00 97.8 °C, 6:30 99.0°C, 7AM 97.6°C, 10:30 95.1°C, at 2PM 99.4°C.; chills; he was one sick SOB last week; he was one sick SOB last week; mucus out of his lungs; sore shoulder/joint pain in his body, shoulders and my knees; feeling blah/pin needy feeling; coughing; feeling a little weak; This is a spontaneous report from a contactable consumer. A 67-year-old male consumer (patient) reported for himself that he received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number FC3181) via an unspecified route of administration in right arm on 09Aug2021 (at the age of 67-year-old) at single dose for COVID-19 immunisation. Relevant medical history included ongoing chronic obstructive pulmonary disease (COPD) and cancer in the left arm. Concomitant medications were not reported. The patient reported a sore shoulder and "feeling blah" on 09Aug2021, his highest temperature was 99.4 on 17Aug2021. He felt like someone punch him in the shoulder, he didn't feel up to par. He also experienced coughing and mucus out of his lungs on 09Aug2021. Clinical course was provided as follows. He went in and had the shot. He waited for 15 minutes. He didn't feel anything at first. The next day he felt like somebody hold off and punch him real hard in the shoulder. He was feeling a little weak and "pin needy feeling" on 09Aug2021. The patient had joint pain in his body, shoulders and knees. He monitored his fever on 17Aug2021 at 5:15 AM 99.1, 5:30 96.7, 5:40 98.4, 6:00 97.8, 6:30 99.0, 7AM 97.6, 10:30 95.1, at 2PM 99.4. It was fluctuating like that sometimes he got chills temperature vice versa. The patient was one sick SOB (as reported) the week before and had most of the symptoms, felt blah, wasn't that fun (as reported) and didn't feel up to par on 09Aug2021. The patient was being coughing and trying to get the mucous out on 09Aug2021. After his shoulder got sore and he felt blah, the next day he felt worse and the next he felt worse. The patient was treated with arthritis pain relief pills, robitussin and albuterol. Case was reported as non-serious. Feeling a little weak was not resolved, pyrexia resolved in Aug2021, outcome for chills was unknown and other events were resolving.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101097451 same reporter/drug, different patient.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Blood urine present, SARS-CoV-2 test
Clinical narrative: Blood in pee; This is a spontaneous report from a contactable consumer (patient).  A 31-year-old female (not pregnant) patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in the left arm, on 23Aug2021 at 12:45 (Batch/Lot Number: Fc3181), at the age of 31 years old, as 1st single dose, for COVID-19 immunisation. Medical history included fatty liver disease, esophilic esophagitis, atrial fibrillation, all from 2019, and no periods due to birth control. There were no known allergies. Concomitant medications included colecalciferol (VITAMIN D 3), and phentermine (PHENTERMINE). The patient had not received any other vaccines in the 4 weeks prior to BNT162b2 vaccination. The patient never had COVID prior to vaccination. The patient complained about blood in pee on 23Aug2021 at 13:45 and specified that she no longer had periods anymore due to birth control. No treatment was required for the event. The patient had a COVID test (nasal swab) post vaccination on 23Aug2021 that resulted negative. The patient had not recovered from the event.   Follow-up attempts are completed. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Hypoaesthesia, Neuropathy peripheral, Pain in extremity, Paraesthesia
Clinical narrative: Numbness in hands and legs; Joint pain in feet and hands; No sensation in bottom of foot; Pain in leg; Pins and needles; wrinkled fingertips; This is a spontaneous report from a contactable consumer (patient).   A 33-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 31Mar2021 (Batch/Lot number was not reported) as single dose (at the age of 33) for covid-19 immunisation. No other vaccine in four weeks. No Covid prior vaccination. No Covid tested post vaccination. Medical history was none. The patient's concomitant medications were not reported. The patient experienced numbness in hands and legs on 05Apr2021, joint pain in feet and hands on 05Apr2021, no sensation in bottom of foot on 05Apr2021, pain in leg on 05Apr2021, pins and needles on 05Apr2021, wrinkled fingertips on 05Apr2021. No treatment. The events outcome was unknown.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Skin wrinkling
Clinical narrative: Numbness in hands and legs; Joint pain in feet and hands; No sensation in bottom of foot; Pain in leg; Pins and needles; wrinkled fingertips; This is a spontaneous report from a contactable consumer (patient).   A 33-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 31Mar2021 (Batch/Lot number was not reported) as single dose (at the age of 33) for covid-19 immunisation. No other vaccine in four weeks. No Covid prior vaccination. No Covid tested post vaccination. Medical history was none. The patient's concomitant medications were not reported. The patient experienced numbness in hands and legs on 05Apr2021, joint pain in feet and hands on 05Apr2021, no sensation in bottom of foot on 05Apr2021, pain in leg on 05Apr2021, pins and needles on 05Apr2021, wrinkled fingertips on 05Apr2021. No treatment. The events outcome was unknown.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Blepharospasm, Hypoaesthesia, Limb discomfort, Presyncope
Clinical narrative: My arm went numb; my toes went numb; my eye lids fluttering/ my eye lids are twitching; felt like someone hit your arm; was about to black out; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot number was not reported), via an unspecified route of administration on 04Aug2021 (52-year-old at the time of vaccination) as dose 1, single for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. On 04Aug2021, the patient had arm and toes went numb, her eye lids fluttering/ eye lids are twitching, felt like someone hit arm and was about to black out. It was reported that, after the first dose, the patient had some side effects. The patient stated that she had no idea she was supposed to wait after the shot because people were getting up and leaving and the patient was fine until she got 3-4 minutes down the road. The patient's arm went numb, her toes went numb and her eye lids were fluttering. The patient was balling up in a ball. The patient had to kick her shoes off and was about to black out. The patient had to call her mom to sit with her on the side of the road for an hour and a half. It was terrible. The patient really does not care to have any other dose of it put in her body. The patient mentioned that her eye lids were twitching as she spoke. The patient worked for the postal service 5-6 days per week. The patient reported that she still felt that thing in her arm. The patient heard it felt like someone hit her arm. It didn't even feel as bad as a bee sting at first but then both arms went numb, toes went numb and her eyes started fluttering. The patient's eye lids were fluttering constantly. The outcome of the events were unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, SARS-CoV-2 test, Vaccination site pain
Clinical narrative: Headache; Fatigue; Muscle pain at injection site; This is a spontaneous report received from a non-contactable consumer(patient). A 38-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE - solution for injection; lot number- FC3182, expiry date not reported) via an unspecified route of administration, on 22Aug2021 15:30, at the age of 38-year-old, at dose number unknown, single for covid-19 immunisation in a pharmacy or drug store. The patient did not have any medical history. The concomitant medications include aleeve and sumatripta. The patient is not pregnant at the time of vaccination. The patient did not receive other vaccine in four weeks. The patient experienced headache, fatigue, muscle pain at injection site on an unspecified date. The patient did not have prior COVID vaccination and was tested for post vaccination. The patient tested binax rapid test on 23Aug2021 and had negative result. The patient did not receive treatment in response to the events. The outcome of the events was recovering at the time of report.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: Patient also stated feeling flu-like symptoms such as chills and fatigue.; This is a spontaneous report from a contactable Other Health Care Professional. A 55-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number, Expiry date was not reported), via an unspecified route of administration on an unspecified date in 2021 as dose 2, single for COVID-19 immunization. Medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number, Expiry date was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. Patient stopped taking Xeljanz XR approximately 2 weeks ago due to concern of immunosuppressed effect because patient recently completed 2nd dose of COVID-19 vaccine. On an unspecified date in 2021, after vaccination, Patient experienced feeling flu-like symptoms such as chills and fatigue. The outcome of the event 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 available the causal association between the event flu-like symptoms and the usage of the vaccine 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 RAs, Ethics Committees, and Investigators, as appropriate.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Aphthous ulcer, Dehydration, Delirium, Feeding disorder, Mouth ulceration
Clinical narrative: Had canker sores in his mouth, tongue, and gums which got so bad he can't hardly move his mouth,; Strange to eat and drink at the back of his throat; He can eat, but it's painful; High fever for 4 days/severe fever; Dehydration; Deliriousness; Lost 12 pounds in weight; Blisters and ulcers in mouth; Blisters and ulcers in mouth; Could not eat; This is a spontaneous report from a contactable consumer. A 59-year-old male consumer (patient) reported that he received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EW0170) intramuscularly in left arm on 29Apr2021 (at the age of 58-year-old) at single dose for COVID-19 immunisation. The patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number FP6955) on 27Mar2021 (at the age of 58-year-old) at single dose (left arm) for COVID-19 immunisation. Both doses were given in the morning. Other relevant medical history was none. Concomitant medications were not reported. After second vaccination, the patient had high fever for 4 days, dehydration, and deliriousness. He said he was rushed to the emergency room, was given fluid and was stabilized. He also added that he had canker sores in his mouth, tongue, and gums which got so bad he can't hardly move his mouth, and had clusters of them inside his mouth. He said it was strange to eat and drink at the back of his throat. He also said it happened last April (24Apr2021 for fever, 28Apr2021 for dehydration and 24Apr2021 for blisters and ulcers in mouth), but the sores returned at the beginning of August, and was not subsiding. He said he can eat, but it's painful. He also mentioned that he lost 12 pounds in weight. Clinical course was further reported as follows. The first stage for him after the second dose of the Pfizer COVID vaccine was a severe fever, he was in bed for 4 days, he then got dehydrated and had to be treated in the emergency room (was not admitted) and was treated with 1.5 liters of saline to stabilize him because they were worried about his organs. He also started to get blisters and ulcers in his mouth, stated the ulcers were canker sores on tongue and inside of mouth, not in his throat, got so bad he could not eat. The patient spent three weeks trying to eat and drink using a syringe in the back of his throat, states he lost 12 pounds. He saw the doctor about his symptoms, it was recognized he had chicken pox as a kid and wondered if this vaccine triggered that dormant virus, he was concerned because the ulcers were returning to his gums and he was concerned about ongoing ulcers in his mouth. Fever resolved 4 to 5 days after onset (exact date unknown). Outcome for delirium, weight decreased, dehydration and could not eat was unknown, other events were not resolved.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Oral mucosal blistering, Oral pain, Oropharyngeal discomfort, Pyrexia, Weight decreased
Clinical narrative: Had canker sores in his mouth, tongue, and gums which got so bad he can't hardly move his mouth,; Strange to eat and drink at the back of his throat; He can eat, but it's painful; High fever for 4 days/severe fever; Dehydration; Deliriousness; Lost 12 pounds in weight; Blisters and ulcers in mouth; Blisters and ulcers in mouth; Could not eat; This is a spontaneous report from a contactable consumer. A 59-year-old male consumer (patient) reported that he received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EW0170) intramuscularly in left arm on 29Apr2021 (at the age of 58-year-old) at single dose for COVID-19 immunisation. The patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number FP6955) on 27Mar2021 (at the age of 58-year-old) at single dose (left arm) for COVID-19 immunisation. Both doses were given in the morning. Other relevant medical history was none. Concomitant medications were not reported. After second vaccination, the patient had high fever for 4 days, dehydration, and deliriousness. He said he was rushed to the emergency room, was given fluid and was stabilized. He also added that he had canker sores in his mouth, tongue, and gums which got so bad he can't hardly move his mouth, and had clusters of them inside his mouth. He said it was strange to eat and drink at the back of his throat. He also said it happened last April (24Apr2021 for fever, 28Apr2021 for dehydration and 24Apr2021 for blisters and ulcers in mouth), but the sores returned at the beginning of August, and was not subsiding. He said he can eat, but it's painful. He also mentioned that he lost 12 pounds in weight. Clinical course was further reported as follows. The first stage for him after the second dose of the Pfizer COVID vaccine was a severe fever, he was in bed for 4 days, he then got dehydrated and had to be treated in the emergency room (was not admitted) and was treated with 1.5 liters of saline to stabilize him because they were worried about his organs. He also started to get blisters and ulcers in his mouth, stated the ulcers were canker sores on tongue and inside of mouth, not in his throat, got so bad he could not eat. The patient spent three weeks trying to eat and drink using a syringe in the back of his throat, states he lost 12 pounds. He saw the doctor about his symptoms, it was recognized he had chicken pox as a kid and wondered if this vaccine triggered that dormant virus, he was concerned because the ulcers were returning to his gums and he was concerned about ongoing ulcers in his mouth. Fever resolved 4 to 5 days after onset (exact date unknown). Outcome for delirium, weight decreased, dehydration and could not eat was unknown, other events were not resolved.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Pain in extremity
Clinical narrative: chest pain; arm pain; This is a spontaneous report from a contactable other HCP (patient). A 52-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in left arm on 18Aug2021 at 08:00 (at the age of 52-years-old) as dose 2, single for COVID-19 immunisation. The patient previously received the first dose of bnt162b2 (lot number er8731) on an unspecified date in Jul2021 for Covid-19 immunisation. Medical history included schizoaffective disorder and allergies to compazine. Th epatient did not have COVID prior vaccination. Concomitant medications included olanzapine and melatonin, bot taken for an unspecified indication, start and stop date were not reported. On 18Aug2021 at 08:00 the patient experienced chest pain and arm pain. Th patient stated that she had stabbing pain in chest right and left side. The events resulted in Emergency room/department or urgent care and were treated with rest in bed. The patient was not COVID tested post vaccination. The outcome of events was not recovered.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dementia, Gout, Immunodeficiency
Clinical narrative: dementia; immunocompromised; chills; gout; This is a spontaneous report from a Pfizer sponsored program received from a contactable consumer (patient's wife). An elderly male patient of an unspecified age (reported as over 65) received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose at dose 1, single and second dose at dose 2, single for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient received both doses of BNT162b2 and currently they were hearing about a third dose. Reporter stated that a lot of people were being told by their doctor to go and get the third dose of the vaccine because if they were over 65 then they were at increased risk but they were not immunosuppressed. The patient had gout and dementia and the reporter was worried if she were to contract the virus and had to go into the hospital that he would not have anyone to care for him. She stated that with the first two doses the only side effects that her husband had were some chills but her friend who got Moderna said she felt like she got hit by a truck so it was much worse. She stated that someone in their community was around unvaccinated people and got the virus even though she was vaccinated and she ended up on a ventilator. She stated that she had to have had underlying conditions. Reporter would like to know if the 3rd dose of the vaccine was the same as the other two. The patient also had dementia and was considered immunocompromised, she would like to know if husband should also get the 3rd dose. The outcome of the events was unknown.   The lot number for BNT162b2 was not provided and will be requested during follow up
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: tested positive for Covid 19; This is a spontaneous report from a contactable consumer or other non hcp. A 70-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number and expiration date was not reported) via an unspecified route of administration on 02Aug2021 as dose 1, single for COVID-19 immunization. The patient medical history was not reported. There were no concomitant medications. The patient tested positive for COVID-19 on 11Aug2021. She had mild fever, fatigue, nausea and headache. It was reported that, patient had the Covid 19 vaccine and did fine. But about 6 or so days after her Covid 19 vaccine she thought she had the Covid 19 virus and she had a test done and it was positive for the Covid 19 virus. Patient were exposed to people who later tested positive. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 11Aug2021. The outcome of the event was unknown.  Follow up attempts are needed. Information on the lot/batch number has been requested.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cough, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Terrible deep cough; Tested positive for COVID; Tested positive for COVID; This is a spontaneous report from a contactable consumer. This is report 3 of 5. A female patient of unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: unknown) via an unspecified route of administration in arm left on 07Aug2021 as dose number unknown, single for COVID-19 immunization. Medical history and concomitant medications were none. On an unspecified date, patient tested positive for COVID and experienced cough. Reporter also stated she was with person who was coughing their brains out but had a mask on, another person who wasn't wearing a mask, and the third per-son who only had one shot. All three tested positive for COVID and she was the only one who did-n't. She had a terrible deep cough. She was very contagious. Patient's husband had COVID and didn't know it but was cured. His symptoms resolved in 2 days but was shedding the virus appar-ently. She clarifies husband was not wearing a mask and was talking a mile a minute, he had just gotten over COVID that week and was fine. He had gone back to work and everything. Reporter confirms they all three people at the dinner with her tested positive for COVID. The outcome of events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chest pain, Disease recurrence, Dyspnoea, Pericarditis
Clinical narrative: chest pain that radiated to my back (between by shoulder blades); chest pain that radiated to my back (between by shoulder blades); difficulty breathing; Disease recurrence; Pericarditis; This is a spontaneous report from a contactable consumer (patient).  A 49-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in Arm Right as single doses for covid-19 immunisation on 24Mar2021 at 08:00 (first dose at 49 years; Lot Number EP6955) and  on 14Apr2021 at 08:00 (second dose at 49 years; Lot Number ER8731) . Medical history was none. Prior to vaccination, the patient was not diagnosed with COVID-19.Concomitant medications included vitamin b complex (B COMPLEX) and minerals nos, vitamins nos both taken for an unspecified indication, start and stop date were not reported.On 06Apr2021 at 06:00 AM, patient began having chest pain that radiated to her back (between by shoulder blades) and was having difficulty breathing.  After two days, she got better (recovered in Apr2021).  On 28Apr2021, she had another episode similar to the one noted above.  That episode lasted 3 days. On 21May2021, she had a third episode which lasted 3 days (recovered in May2021). She saw a cardiologist on 11Jun2021 who stated that she likely had Pericarditis (onset on an unspecified date in 2021, unknown outcome). She has had a number of episodes since.  On 03Aug2021, the chest pain was so bad, she had to go to the Emergency Room.  The chest pain has gotten progressively worse even with treatment (anti-inflammatory). Nasal Swab on 03Aug2021 was negative. On 23Aug2021 the patient been tested for COVID-19, no result provided. Events required Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care; Sender's Comments: ~~~
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: chest pain that radiated to my back (between by shoulder blades); chest pain that radiated to my back (between by shoulder blades); difficulty breathing; Disease recurrence; Pericarditis; This is a spontaneous report from a contactable consumer (patient).  A 49-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in Arm Right as single doses for covid-19 immunisation on 24Mar2021 at 08:00 (first dose at 49 years; Lot Number EP6955) and  on 14Apr2021 at 08:00 (second dose at 49 years; Lot Number ER8731) . Medical history was none. Prior to vaccination, the patient was not diagnosed with COVID-19.Concomitant medications included vitamin b complex (B COMPLEX) and minerals nos, vitamins nos both taken for an unspecified indication, start and stop date were not reported.On 06Apr2021 at 06:00 AM, patient began having chest pain that radiated to her back (between by shoulder blades) and was having difficulty breathing.  After two days, she got better (recovered in Apr2021).  On 28Apr2021, she had another episode similar to the one noted above.  That episode lasted 3 days. On 21May2021, she had a third episode which lasted 3 days (recovered in May2021). She saw a cardiologist on 11Jun2021 who stated that she likely had Pericarditis (onset on an unspecified date in 2021, unknown outcome). She has had a number of episodes since.  On 03Aug2021, the chest pain was so bad, she had to go to the Emergency Room.  The chest pain has gotten progressively worse even with treatment (anti-inflammatory). Nasal Swab on 03Aug2021 was negative. On 23Aug2021 the patient been tested for COVID-19, no result provided. Events required Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care; Sender's Comments: ~~~
Sex: F
Vaccine: COVID19
Symptoms: Conjunctival haemorrhage
Clinical narrative: Subconjunctival hemorrhage; This is a spontaneous report from a contactable nurse (patient herself).  This 50-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number not provided), via an unknown route, on 19Aug2021 16:00 at single dose for COVID-19 immunisation, administered at pharmacy/drug store.  No other vaccine was received in four weeks. Relevant medical history included colitis ulcerative. No known allergies. The patient was taking concomitant medications (no details provided). On 19Aug2021, the patient developed subconjunctival hemorrhage. No seriousness criterion was provided by the reporter. Pre-vaccination and post-vaccination COVID tests were not performed. The patient was not treated for the event. The patient had not recovered from the event.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on temporal relation, the association between the event of subconjunctival haemorrhage and the suspect product of BNT162B2 cannot be completely ruled out.  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: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Rheumatoid arthritis, Vaccination site pain
Clinical narrative: Shingles; chronic pain at injection site, L deltoid; Increased incidence and severity of acute Rheumatoid Arthritis flares; This is a spontaneous report from a contactable nurse. A 52-year-old female nurse (patient) reported for herself that she received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL1283) intramuscularly in left arm (deltoid) on 01Feb2021 at 12:45PM (at the age of 52-year-old) for COVID-19 immunisation. The patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EH9899) intramuscularly in left arm on 08Jan2021 at 10:30AM (at the age of 52-year-old) at single dose for COVID-19 immunisation. Relevant medical history included depression, rheumatoid arthritis and endometriosis. The patient did not receive other vaccines within 4 weeks prior to the COVID-19 vaccine. Concomitant medications included an unspecified anti-depressive drug. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. The patient had chronic pain at injection site (left deltoid) since second shot and increased incidence and severity of acute rheumatoid arthritis flares on 02Feb2021, along with diagnosis of shingles in Mar2021. The events were serious as medically significant and disabling, and required emergency room and physician office visit. Antiviral for shingles were given. The events were resolving with sequelae at the time of report.; Sender's Comments: Based on the available information and the close drug event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events rheumatoid arthritis flares up, herpes zoster and vaccination site pain cannot be totally 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 RAs, Ethics Committees, and Investigators, as appropriate.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Abortion spontaneous, Headache, Nausea, Pain in extremity
Clinical narrative: Miscarriage; Left Arm pain; Nausea; Headache (HA); This is a spontaneous report from a contactable consumer (patient). A 29-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0185), via an unspecified route of administration, administered in left arm on 20Aug2021 at 12:45 (at the age of 29-years-old) as dose 1, single for COVID-19 immunisation. 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. The patient medical history was not reported. The patient's concomitant medications were not reported. On 21Aug2021 at 08:00 the patient experienced left arm pain, nausea and headache (HA). The vents were resolved with sequelae on an unspecified date in Aug2021. On 22Aug2021 the patient experienced miscarriage. The mother reported she became pregnant while taking bnt162b2. The mother was 5 weeks pregnant at the onset of the event. The mother was due to deliver on 18Apr2022. The outcome of event miscarriage was reported as unknown. The patient did not receive treatment for events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the available information and a possible contributory role of the suspect product BNT162B2 to the development of event abortion spontaneous cannot be totally 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 RAs, Ethics Committees, and Investigators, as appropriate.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for COVID; tested positive for COVID; This is a spontaneous report from contactable consumer.   A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced tested positive for covid on an unspecified date. The events outcome was unknown. The patient was hospitalized for tested positive for covid for 14 days. The patient was hospitalized for tested positive for covid (covid-19) for 14 days. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on an unknown date.   Additional information:  Caller makes the comment she was with three people on 24Jul2021, inside at dinner. She was with person who was coughing their brains out but had a mask on, another person who wasn't wearing a mask, and the third person who only had one shot. All three tested positive for COVID and she was the only one who didn't. She clarifies she still has immunity obviously, and she doesn't want to get another shot. The guy next to the caller had one vaccine but he must have caught COVID from both of the other two guests at dinner. The guy next to the caller was barely masked because he was eating and talking throughout dinner, but he must have been catching COVID during that time. He didn't show any symptoms at all that night, but tested positive later. Apparently the male guest that had COVID that week was still shedding the virus because the other male guest at the dinner got COVID and was in the hospital for 2 weeks.  Caller confirms they all three tested positive for COVID. Caller declines to complete a report on these 3 people at the time of the call, requesting she would rather have her medical questions addressed at this time. No further details were provided or obtained.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: had a reaction and you know it felt, flu like symptoms; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number, expiration date was not reported), via an unspecified route of administration, on an unspecified date, at dose 2, single for covid-19 immunization. The patient had the third shot of vaccination on an unspecified date for covid-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number, expiration date was not reported), via an unspecified route of administration, on an unspecified date, at dose 1, single for covid-19 immunization.  The patient experienced a reaction and it felt like flu like symptoms on an unspecified date. The outcome of the 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: COVID-19, Cardiac disorder, Vaccination failure
Clinical narrative: she catch COVID; she catch COVID; heart issues from COVID; This is a spontaneous report from a contactable consumer. This consumer reported for a female patient (Reporter's sister-in-law). A female patient of an unspecified age received second dose of 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 as single dose for COVID-19 immunization. The patient's medical history and concomitant medications was not reported. The patient previously received first dose of 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 as single dose for COVID-19 immunization. On an unspecified date, it was reported that, the patient got both doses and 2 months after she was fully vaccinated, not only did she catch COVID, the patient now has heart issues from COVID and had spread it to her in-laws as well. The patient was very confused on how this vaccine could protect her community the patient got sick. The patient was also the only one that developed severe issues while all the family did not have much symptoms at all. How was that safe and effective and protecting the community if her sister-in-law received both vaccines and had the worst symptoms of COVID than everyone else who did not receive the vaccine. Caller also asked if the vaccine would protect individuals in transmission of the COVID vaccine. The outcome of the events was unknown.  The lot number for the vaccine BNT162B2, was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dyspnoea, Inflammation, Pericardial effusion
Clinical narrative: inflammation around his heart; pericardial effusion; difficulty breading; severe weakness; This is a spontaneous report received from a contactable consumer (patient's wife).  A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 14Feb2021 (Lot Number: EL9263) as DOSE 2, SINGLE for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. The patient previously took the first dose of BNT162B2 on 24Jan2021 (Lot: EL3247) for covid-19 immunisation. After two dose of vaccination, the patient developed inflammation around his heart. He had difficulty breading and had severe weakness. He was taken to the emergency on 13Apr2021 and given steroid treatment. He was taken again on 10May2021 and admitted with steroid treatment. On 14Jun2021, he was admitted again and they did a pericardial effusion. His symptoms have returned. Need some answers. The outcome of the events was not resolved.  Follow-up attempts are completed. No further information is expected.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: It has been 4 months since the last shot . If I have to describe the pain I would describe it as pain muscle; This is a spontaneous report from a contactable consumer reporting for herself  A 42-year-old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) at the age of 42 years as DOSE 2, SINGLE for covid-19 immunisation. Historical Vaccine dose 1 of bnt162b2 for covid-19 immunisation. The patient medical history and concomitant medications were not reported.  The patient reported that "it has been 4 months since the last shot . if I have to describe the pain I would describe it as pain muscle (medically significant) on 2021 with outcome of unknown.   The lot number for the vaccine, [Pfizer Covid-19 Vaccine], was not provided and will be requested during follow up.