chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Computerised tomogram, Cough, Dyspnoea, Echocardiogram
Clinical narrative: pericarditis; recurrent nonexertional, positional chest pain; SOB; dry cough with evidence of pericardial effusion and bilateral pleural effusions; dry cough with evidence of pericardial effusion and bilateral pleural effusions; dry cough with evidence of pericardial effusion and bilateral pleural effusions; This is a spontaneous report from a contactable Physician. A 56-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot/batch number not provided), via an unspecified route of administration on 01Mar2021 (at age of 56 years old) at single dose for COVID-19 immunisation. Medical history included Asthma. There were no concomitant medications. No COVID prior vaccination. No COVID tested post vaccination. No other vaccine in four weeks. The patient previously took first dose of BNT162B2 (lot/batch number not provided) for COVID-19 immunisation, tioconazole and had Known allergies to Tioconazole. On 02Mar2021, the patient presented with recurrent nonexertional, positional chest pain, SOB (Shortness of breath) and dry cough with evidence of pericardial effusion and bilateral pleural effusions on CTA (Computerised tomogram). ECHO (Echocardiogram) confirming pericarditis. Labs and additional workup negative for AI or malignancy, all lab test in 2021. No. of days hospitalization was 2. AE resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization. Treatment received (Colchicine, Ibuprofen) for all events. The outcome of the events was Recovering.  information on the lot/batch number has been requested.; Sender's Comments: Based on data provided, the reported events are assessed as possibly related to BNT162B2. This case will be reassessed upon receipt of further information. 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.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Laboratory test, Pericardial effusion, Pericarditis, Pleural effusion
Clinical narrative: pericarditis; recurrent nonexertional, positional chest pain; SOB; dry cough with evidence of pericardial effusion and bilateral pleural effusions; dry cough with evidence of pericardial effusion and bilateral pleural effusions; dry cough with evidence of pericardial effusion and bilateral pleural effusions; This is a spontaneous report from a contactable Physician. A 56-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot/batch number not provided), via an unspecified route of administration on 01Mar2021 (at age of 56 years old) at single dose for COVID-19 immunisation. Medical history included Asthma. There were no concomitant medications. No COVID prior vaccination. No COVID tested post vaccination. No other vaccine in four weeks. The patient previously took first dose of BNT162B2 (lot/batch number not provided) for COVID-19 immunisation, tioconazole and had Known allergies to Tioconazole. On 02Mar2021, the patient presented with recurrent nonexertional, positional chest pain, SOB (Shortness of breath) and dry cough with evidence of pericardial effusion and bilateral pleural effusions on CTA (Computerised tomogram). ECHO (Echocardiogram) confirming pericarditis. Labs and additional workup negative for AI or malignancy, all lab test in 2021. No. of days hospitalization was 2. AE resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization. Treatment received (Colchicine, Ibuprofen) for all events. The outcome of the events was Recovering.  information on the lot/batch number has been requested.; Sender's Comments: Based on data provided, the reported events are assessed as possibly related to BNT162B2. This case will be reassessed upon receipt of further information. 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.
Age: 57.0
Sex: F
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 a contactable consumer (Patient) via a Pfizer-sponsored program.  A 58 years old female patient received first dose BNT162B2 (Pfizer BioNTech Covid 19 vaccine, lot number ER8733), via an unspecified route of administration on 24-MAR-2021 at the 57 years old at single dose for COVID-19 immunization.  The medical history and concomitant medications were not reported. The patient received the first dose of Pfizer's COVID vaccine on 24Mar2021 and tested positive for COVID on 12Apr2021. She missed her second dose on 14Apr2021 due to her isolation period which was up at 22Apr2021. The patient was wondering when can she take her second dose. The outcome of the events was unknown.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Reports having symptoms of COVID after exposure with a positive case. Tested positive for COVID; Reports having symptoms of COVID after exposure with a positive case. Tested positive for COVID; This is a spontaneous report from a contactable nurse.    A 45-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 29Jan2021 intramuscular at single dose (first dose at 44 years; Lot Number: EN5318) and on 19Feb2021 intramuscular at single dose (second dose at 44 years ; Lot Number: EN5318) for covid-19 immunisation. Medical history included exposure with a positive case on an unknown date in 2021. The patient's concomitant medications were not reported.  The patient reported having symptoms of covid on 11Apr2021 after exposure with a positive case. He was tested positive for COVID on 12Apr2021 via Nasal Swab. The outcome of the event was recovering.; Sender's Comments: Based on the information provided, the contributory role of the suspect product BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN5318), to reported events and tested positive for COVID via Nasal Swab is probable.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Deafness, Dizziness, Musculoskeletal chest pain, SARS-CoV-2 test
Clinical narrative: Loss of hearing in left ear; Dizziness more than 24 hours after; loud tinnitus; Deep pain in left side upper abdomen/ lower ribcage.; Deep pain in left side upper abdomen/ lower ribcage.; This is a spontaneous report from a contactable consumer (patient). A 29-year-old male consumer received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 16Apr2021 at 14:15 at single dose in left arm for COVID-19 immunisation at the age of 29-year-old. Medical history and concomitant medications were unknown. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 24Mar2021 at 13:00 in left arm for COVID-19 immunisation at the age of 29-year-old. On 17Apr2021 at 16:00, the patient experienced loss of hearing in left ear, loud tinnitus, deep pain in left side upper abdomen/ lower ribcage, dizziness (also reported as more than 24 hours after). The patient was no treated due to the events. On 19Apr2021, nasal swab resulted negative. The patient did not recover from the events. Prior to vaccination, the patient was not diagnosed with COVID-19; since the vaccination, the patient has not been tested for COVID-19. Information on the lot/batch number has been requested.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Loss of hearing in left ear; Dizziness more than 24 hours after; loud tinnitus; Deep pain in left side upper abdomen/ lower ribcage.; Deep pain in left side upper abdomen/ lower ribcage.; This is a spontaneous report from a contactable consumer (patient). A 29-year-old male consumer received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 16Apr2021 at 14:15 at single dose in left arm for COVID-19 immunisation at the age of 29-year-old. Medical history and concomitant medications were unknown. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 24Mar2021 at 13:00 in left arm for COVID-19 immunisation at the age of 29-year-old. On 17Apr2021 at 16:00, the patient experienced loss of hearing in left ear, loud tinnitus, deep pain in left side upper abdomen/ lower ribcage, dizziness (also reported as more than 24 hours after). The patient was no treated due to the events. On 19Apr2021, nasal swab resulted negative. The patient did not recover from the events. Prior to vaccination, the patient was not diagnosed with COVID-19; since the vaccination, the patient has not been tested for COVID-19. Information on the lot/batch number has been requested.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure decreased, Blood pressure measurement, Loss of consciousness
Clinical narrative: Passed out; blood pressure dropped to 70/50/ big blood pressure drop from 110/90 to 70/50; The initial safety information received was reporting only non-serious adverse drug reaction. Upon receipt of follow-up information on 19Apr2021, this case now contains serious adverse reaction. Information processed together.  This is a spontaneous report from a contactable consumer (patient's father) via Medical Information team. A 31-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 01Apr2021 (Batch/Lot number and Expiration date were not reported) at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was in excellent health and had no known allergies. The patient had took the Pfizer COVID-19 vaccine 18 days prior reporting (on 01Apr2021) and had blood pressure dropped to 70/50 and emergency medical services (EMS) was called an hour with him. The reporter was asking if the patient should take the second dose being that he had this reaction. The reporter further asked for the efficacy of one dose of the Pfizer COVID-19 vaccine and how long was the coverage of the vaccine as far as needing a booster shot. The reporter also asked about the 6 months topline analysis results of the Pfizer-BioNTech COVID-19 vaccine. It was further reported that fifteen minutes after the COVID-19 shot on 01Apr2021, the patient passed out; the patient had a big blood pressure drop from 110/90 to 70/50. The EMS was called in and attended to the patient. The patient was there for about an hour. The reporter was just calling to find out if the patient could get the second shot. The outcome of the events was unknown.  Information on the batch/lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Diplegia, Muscular weakness, Myopathy
Clinical narrative: she developed " a myopathy,  weakness, (almost like a paralysis), mostly in both lower extremities."; she developed " a myopathy,  weakness, (almost like a paralysis), mostly in both lower extremities."; she developed " a myopathy,  weakness, (almost like a paralysis), mostly in both lower extremities."; This is a spontaneous report from a contactable pharmacist. A 30-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 15Apr2021 (Lot number and expiration date was not reported) as single dose for COVID-19 immunisation. Medical history included history of a bone marrow transplant from 2018 (reported as 3 years ago) to an unknown date. The patient's concomitant medications were not reported. She was currently not taking any immunosuppressant medications at this time. On 19Apr2021, 4 days after receiving the 1st dose, she developed a myopathy, weakness, (almost like a paralysis), mostly in both lower extremities. The Medical Director and the Neurologist are looking for any data Pfizer has on this type of adverse event, any treatment recommendations based from the post EUA AE reports received by Pfizer DSU. The outcome of the events was unknown.  Information about the Lot/batch number has been requested.; Sender's Comments: Based on temporal association a contributory role of BNT162B2  cannot be totally excluded.  Case will be reassessed if additional information is received.   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 Ethics Committees and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Chest discomfort, Chest pain, Condition aggravated, Electrocardiogram
Clinical narrative: heaviness and pressure on her chest which got worse and worse. She went to the ER; heaviness and pressure on her chest which got worse and worse. She went to the ER; chest pain; sick; acid reflux; This is a spontaneous report from a contactable consumer. This consumer reported for a 58-Year-old female patient (Mother) received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 05Apr2021 at single dose for covid-19 immunization. Medical history was chronic bronchitis and allergies. Concomitant drug was not reported. Caller is calling for her 58 year old mother who received the 1st dose of the Pfizer COVD Vaccine on 05Apr2021. She mentioned that she was totally fine on the 1st day, but after 20 hours, she felt a heaviness and pressure on her chest which got worse and worse. She went to the ER and stayed there for 8 hours. Her mother had chronic bronchitis and allergies, so they did bloodwork on her, had an EKG, and other test but everything was normal. She was given a ventolin inhaler and was sick the whole week with chest pan and acid reflux. She is scheduled to receive her 2nd dose on 26Apr2021 and the ER told her to call Pfizer and ask if it was okay for her to take the 2nd shot. She mentioned that her mother was fine now. Outcome of the event heaviness and pressure on her chest was not recovered, for other events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Gastrooesophageal reflux disease, Illness
Clinical narrative: heaviness and pressure on her chest which got worse and worse. She went to the ER; heaviness and pressure on her chest which got worse and worse. She went to the ER; chest pain; sick; acid reflux; This is a spontaneous report from a contactable consumer. This consumer reported for a 58-Year-old female patient (Mother) received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 05Apr2021 at single dose for covid-19 immunization. Medical history was chronic bronchitis and allergies. Concomitant drug was not reported. Caller is calling for her 58 year old mother who received the 1st dose of the Pfizer COVD Vaccine on 05Apr2021. She mentioned that she was totally fine on the 1st day, but after 20 hours, she felt a heaviness and pressure on her chest which got worse and worse. She went to the ER and stayed there for 8 hours. Her mother had chronic bronchitis and allergies, so they did bloodwork on her, had an EKG, and other test but everything was normal. She was given a ventolin inhaler and was sick the whole week with chest pan and acid reflux. She is scheduled to receive her 2nd dose on 26Apr2021 and the ER told her to call Pfizer and ask if it was okay for her to take the 2nd shot. She mentioned that her mother was fine now. Outcome of the event heaviness and pressure on her chest was not recovered, for other events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Galactostasis, Mastitis, Off label use, Product use issue
Clinical narrative: mastitis; she is a breastfeeding mom; she is a breastfeeding mom; clogged ducts (she is breastfeeding); This is a spontaneous report from a contactable consumer (patient) via the Pfizer sponsored program. A 28-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration on 16Apr2021 (Batch/Lot number was not reported) as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient got her first dose on Friday and mentioned that she is a breastfeeding mom. She ended up with mastitis and her doctor wanted her to start on an antibiotic. She asked if the antibiotic will interfere with her getting the second dose of the vaccine. She added that she got her first dose of the vaccine last Friday, 16Apr2021. Today (Apr2021), she woke up with clogged ducts (she is breastfeeding). Her (initial provided) started her with an antibiotic for 11 days starting today. She asked if she can still take the second dose, after the antibiotic. The outcome of the events was unknown. Therapeutic measures were taken as a result of mastitis and clogged ducts.  Information on the lot/batch number has been requested.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Loss of consciousness, Vision blurred
Clinical narrative: going to pass out on; blurred vision; little lightheaded; This is a spontaneous report from a contactable consumer reported for self. This 71-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose on 07Apr2021 for COVID-19 immunisation. Medical history and concomitant medication were not reported. Patient was a "little lightheaded" the first day (on 07Apr2021) but "it wasn't bad". He then explained since Saturday, 10Apr2021, he was experiencing "dizziness, a blurred vision, and was lightheaded". He specified he thought he was "going to pass out on" that Saturday 10Apr2021. He explained that his symptoms "won't go away" and he was concern about their persistence. He asked if similar symptoms were reported as side effects from the vaccine. Patient was concerned on getting the second dose due this coming Monday. He then said he would need medical advice. The outcome of events was not recovered.  Information about Batch/Lot number has been requested.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Hypoaesthesia, Musculoskeletal chest pain, Pain in extremity
Clinical narrative: Left arm is in a lot of pain.; It falls asleep and I feel my circulation stopping. I feel numb and it causes my arm to fall asleep.; The pain runs to my chest and behind to the back of my ribs.; The pain runs to my chest and behind to the back of my ribs.; This is a spontaneous report from a contactable consumer (patient). This 62-year-old male patient received 2nd dose of BNT162B2 (lot_number EP6955) on 25Mar2021 at single dose on Left Arm for COVID-19 immunisation. Medical history was heart attack and was hospitalized to rule anything out, Hugh blood pressure, Cholesterol. Historical Vaccine was 1st dose of BNT162B2 (Lot number=EN6199) on 04Mar2021 on Left arm for COVID-19 immunisation. No other vaccine in four weeks. Left arm is in a lot of pain. It falls asleep and I feel my circulation stopping. I feel numb and it causes my arm to fall asleep. The pain runs to my chest and behind to the back of my ribs. I have a history of heart attack and was hospitalized to rule anything out. Events started from 08Apr2021. Events results in healthcare professional office/clinic visit, Emergency room/department or urgent care, hospitalization (3 days), disability or permanent damage. Treatment was Pain meds. Outcome of the event was Not Recovered. No covid prior vaccination. No covid tested post vaccination. No Known allergies.   No follow-up attempts needed. No further information expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Computerised tomogram, Fall, Magnetic resonance imaging, Monoplegia
Clinical narrative: left leg was paralyzed; muscle aches; vertigo; fell; This is a spontaneous report from a contactable other health care professional(patient). This 51-year-old female patient (not pregnant) received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose on 19Jan2021 11:30 via an unknown route in left arm for Covid-19 immunization. Medical history included diabetic (diagnosed during hospitalization) and chronic pain. Concomitant drug was not provided. Historical vaccine included 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at 29Dec2020 11:30 AM in left arm for Covid-19 immunization. Patient had no other vaccine in four weeks, no other medications in two weeks. Patient had no covid prior vaccination. Patient had no known allergies. Patient started to have muscle aches on Wednesday morning (20Jan2020 08:00) the day after second COVID shot. Patient felt worse on Thursday. Patient went about daily activities to prepare for 24 hr shift on Friday. went to bed at 8:00pm because she had to get up at 04:00am for her shift. She tried to get out of bed and when she stood up and tried to take a step, left leg didn't move and patient fell forward on face. Patient thought she might of had vertigo. Patient struggled to get to the kitchen where she called of if work to her boss. Her left leg was weak. On Saturday the same thing happened. On Sunday she did the same thing. This time when she fell, left leg was paralyzed. She tried for 6 hours to get it to move. She called the ambulance and was taken to Hospital. She was admitted for 3 days. She had multiple tests and had been off work since then.  Lab data included CT, MRI, and bloodwork. Treatment included IV fluids. Outcome of the events was resolving. Covid tested (Nasal Swab) post vaccination on 24Jan2021 was negative.  Information about lot/batch number has been requested.; Sender's Comments: Based on the information currently available and due to a plausible temporal relationship, a possible contribution of the suspect drug administration to the reported events 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  Ethics Committees and Investigators, as appropriate.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, SARS-CoV-2 test, Vertigo
Clinical narrative: left leg was paralyzed; muscle aches; vertigo; fell; This is a spontaneous report from a contactable other health care professional(patient). This 51-year-old female patient (not pregnant) received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose on 19Jan2021 11:30 via an unknown route in left arm for Covid-19 immunization. Medical history included diabetic (diagnosed during hospitalization) and chronic pain. Concomitant drug was not provided. Historical vaccine included 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at 29Dec2020 11:30 AM in left arm for Covid-19 immunization. Patient had no other vaccine in four weeks, no other medications in two weeks. Patient had no covid prior vaccination. Patient had no known allergies. Patient started to have muscle aches on Wednesday morning (20Jan2020 08:00) the day after second COVID shot. Patient felt worse on Thursday. Patient went about daily activities to prepare for 24 hr shift on Friday. went to bed at 8:00pm because she had to get up at 04:00am for her shift. She tried to get out of bed and when she stood up and tried to take a step, left leg didn't move and patient fell forward on face. Patient thought she might of had vertigo. Patient struggled to get to the kitchen where she called of if work to her boss. Her left leg was weak. On Saturday the same thing happened. On Sunday she did the same thing. This time when she fell, left leg was paralyzed. She tried for 6 hours to get it to move. She called the ambulance and was taken to Hospital. She was admitted for 3 days. She had multiple tests and had been off work since then.  Lab data included CT, MRI, and bloodwork. Treatment included IV fluids. Outcome of the events was resolving. Covid tested (Nasal Swab) post vaccination on 24Jan2021 was negative.  Information about lot/batch number has been requested.; Sender's Comments: Based on the information currently available and due to a plausible temporal relationship, a possible contribution of the suspect drug administration to the reported events 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  Ethics Committees and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Nervousness, Vaccination site haemorrhage
Clinical narrative: she is nervous and fretting; inserted the needle in her arm, she started to bleed and bleed and bleed; This is a spontaneous report from a non-contactable consumer (reporting for herself) via the medical information team. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 18Apr2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 18Apr2021, as soon as the pharmacist inserted the needle in her arm, the patient started to bleed and bleed and bleed. The patient stated the RPh wiped off the blood and she started to bleed again. The patient questioned if the vaccine actually went into her arm and asked if did the vaccine get a chance to penetrate into her muscle or not. The patient stated her first vaccine went OK but her second one had a bad outcome. The patient asked if there was nothing that says when a person bleeds while the vaccine was being administered means that the vaccine did not go in. The patient asked if there was information about anyone bleeding instantly once the needle goes in. On an unspecified date, The patient was nervous and fretting. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: My ears are ringing so loudly that I can barely hear the TV; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: ER8733), second dose via an unspecified route of administration, administered in Arm Left on 07Apr2021 10:45 (at 66 years old, not pregnant) single dose for covid-19 immunisation. Medical history included diabetes from an unknown date. Concomitant medications included metformin; insulin glargine (TOUJEO). The patient previously took codeine experienced Known allergies: Codeine. Patient had her first dose of BNT162B2 vaccine on 17Mar2021 11:15 at 66 years old for COVID-19 immunisation Lot number=ER2613 on left arm. Patient experienced ears are ringing so loudly that she can barely hear the TV on 08Apr2021 08:00. No Covid prior vaccination. Not Covid tested post vaccination. No other vaccine in four weeks. Treatment was received for the adverse event. The outcome of the event was not recovered. The event was reported as serious with disability criteria.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Laboratory test, SARS-CoV-2 test, Transient ischaemic attack
Clinical narrative: transient ischemic attack; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9265), via an unspecified route of administration, administered in the left arm, on 30Jan2021 17:30, as single dose, for COVID-19 immunisation, at a hospital. Medical history included migraine and back pain. The patient did not have COVID-19 prior to vaccination. The patient was not pregnant at the time of vaccination. Concomitant medications included ketoconazole and hydrocortisone (HYDROCORTISONE), all taken for unspecified indications, start and stop dates were not reported. The patient previously took codeine and sulfur dioxide and experienced allergies to both. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number not reported), on an unspecified date, for COVID-19 immunisation. The patient did not receive any other vaccine in four weeks. On 19Feb2021 at 11:00, the patient experienced transient ischemic attack. This resulted to emergency room visit and hospitalization on an unspecified date. The patient was hospitalized for 1 day. Treatment for the event included unspecified blood thinners. The patient underwent COVID nasal swab on 19Feb2021 which resulted to negative, and an unspecified test on an unknown date with unknown result. The outcome of the event was recovered with sequel (reported as recovered with lasting effects).  No follow-up attempts are possible. No further information expected.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Balance disorder, Blood test, Cerebrovascular accident, Computerised tomogram
Clinical narrative: trouble walking; it was concluded that I had a stroke and the vaccine was likely the main contributor.; the right side of my body was very weak and my balance was off.; the right side of my body was very weak and my balance was off.; This is a spontaneous report from a contactable consumer. A 37-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number was not reported), via an unspecified route of administration, administered on the left arm, at the age of 37 years, on Apr2021 at a SINGLE DOSE for covid-19 immunisation. Medical history included brain tumor from an unknown date and unknown if ongoing. On 09Apr2021, the patient stated, "I am undergoing immunotherapy treatment for a brain tumor. My doctors recommended I take the vaccine 2 weeks following my most recent treatment (administered every 4 weeks). Several hours after receiving the vaccine, the right side of my body was very weak and my balance was off. These symptoms went away by the next morning. 5 days later they came back and progressed. Ultimately, I went to the emergency room having trouble walking, using my right arm and staying balanced. All tests (MRIs, ultrasound, CT scan, extensive bloodwork, and more) proved that there were no apparent causes. Ultimately, it was concluded that I had a stroke and the vaccine was likely the main contributor. I am 37, in shape, and eat extremely well."  The patient was hospitalized for the events. The patient underwent lab tests and procedures which included blood test: there were no apparent causes, computerised tomogram: there were no apparent causes, magnetic resonance imaging: there were no apparent causes, sars-cov-2 test: negative on 15Apr2021 and ultrasound scan: there were no apparent causes on an unspecified date. Therapeutic measures (Aspirin prescription, Castor, physical therapy) were taken as a result of the events. The outcome of the events was recovering.  Information about Batch/Lot number has been requested.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Gait disturbance, Magnetic resonance imaging, SARS-CoV-2 test, Ultrasound scan
Clinical narrative: trouble walking; it was concluded that I had a stroke and the vaccine was likely the main contributor.; the right side of my body was very weak and my balance was off.; the right side of my body was very weak and my balance was off.; This is a spontaneous report from a contactable consumer. A 37-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number was not reported), via an unspecified route of administration, administered on the left arm, at the age of 37 years, on Apr2021 at a SINGLE DOSE for covid-19 immunisation. Medical history included brain tumor from an unknown date and unknown if ongoing. On 09Apr2021, the patient stated, "I am undergoing immunotherapy treatment for a brain tumor. My doctors recommended I take the vaccine 2 weeks following my most recent treatment (administered every 4 weeks). Several hours after receiving the vaccine, the right side of my body was very weak and my balance was off. These symptoms went away by the next morning. 5 days later they came back and progressed. Ultimately, I went to the emergency room having trouble walking, using my right arm and staying balanced. All tests (MRIs, ultrasound, CT scan, extensive bloodwork, and more) proved that there were no apparent causes. Ultimately, it was concluded that I had a stroke and the vaccine was likely the main contributor. I am 37, in shape, and eat extremely well."  The patient was hospitalized for the events. The patient underwent lab tests and procedures which included blood test: there were no apparent causes, computerised tomogram: there were no apparent causes, magnetic resonance imaging: there were no apparent causes, sars-cov-2 test: negative on 15Apr2021 and ultrasound scan: there were no apparent causes on an unspecified date. Therapeutic measures (Aspirin prescription, Castor, physical therapy) were taken as a result of the events. The outcome of the events was recovering.  Information about Batch/Lot number has been requested.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Headache
Clinical narrative: Abdominal pain; Headaches; This is a spontaneous report from a contactable consumer (patient). A 28-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in left arm on 08Apr2021 08:15 (Batch/Lot number was not reported) at the age of 28 years old, as single dose for COVID-19 immunisation. Medical history included acid reflux, asthma, allergy to peanut butter, allergy to dogs, and COVID-19 (COVID-19 prior to vaccination: Yes). The patient was not pregnant at the time of vaccination. The patient took unspecified other medications in two weeks. No other vaccines received in four weeks. On unspecified date the patient experienced abdominal pain (hospitalization) and headaches (hospitalization). No treatment was given for the events. The events resulted in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care visit. The patient has not recovered from the events. The patient has not been tested for COVID-19 post vaccination.   Information on about lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Cough, Drug ineffective
Clinical narrative: incident where someone contracted COVID-19 after receiving the Pfizer vaccine; incident where someone contracted COVID-19 after receiving the Pfizer vaccine; His COVID-19 symptom was mild with a cough; This is a spontaneous report from a contactable consumer reporting on behalf of the patient. A male patient of 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 a single dose for COVID-19 immunisation.  The patient's medical history and concomitant medications were not reported. The reporter reported an incident where someone contracted COVID-19 after receiving the Pfizer vaccine. His COVID-19 symptom was mild with a cough. The reporter did not know if the patient had COVID-19 after the 1st or 2nd dose. Outcome of the events was unknown.   Information on the lot/batch number has been requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Drug ineffective and COVID-19 cannot be totally excluded.  The case will be reassessed if additional information becomes available.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Hypersensitivity, Hypoaesthesia, Influenza like illness
Clinical narrative: I was admitted to the ER with a complex migraine and parathesia in my right arm; I was admitted to the ER with a complex migraine and parathesia in my right arm; after about three days of flu-like symptoms; after about three days of flu-like symptoms (nauseau, tiredness, body aches); after about three days of flu-like symptoms (nauseau, tiredness, body aches); after about three days of flu-like symptoms (nauseau, tiredness, body aches); My throat felt restricted; I had hives and raised bumps and bruising on my left arm where the shot went in; I had hives and raised bumps and bruising on my left arm where the shot went in; I was having difficulty breathing; my body felt like it was swelling up everywhere; allergy symptoms manifest/allergic reaction; I had the normal side effects of numbness and soreness in my left arm; I had the normal side effects of numbness and soreness in my left arm; This is a spontaneous report from a contactable consumer (patient). This 32-year-old female patient (No pregnant) received 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 Vaccine, Lot number: ER8737) on 05Apr2021 06:15 PM at single dose on Left arm for covid-19 immunization. Medical history was Immunocompromised, chronic migraines. Known allergies: Just seasonal allergies. Wheat and soy allergy, restricted diet. Concomitant medications (in two weeks) included fluticasone propionate (FLONASE) for allergies (nasal spray), mirtazapine (REMERON). No other vaccine in four weeks. Patient stated that I had the normal side effects of numbness and soreness in my left arm from 05Apr2021. Three days later I had allergy symptoms manifest, Thursday (the shot was on a Monday), and had to go get allergy medication. My throat felt restricted, I was having difficulty breathing, and my body felt like it was swelling up everywhere. I had hives and raised bumps and bruising on my left arm where the shot went in from 09Apr2021 ( reported as 08Apr2021 12:00 PM). Swelling noticeably went down after the allergy medication and breathing returned to normal. On Tuesday, 13Apr2021, after about three days of flu-like symptoms (nauseau, tiredness, body aches), I was admitted to the ER with a complex migraine and parathesia in my right arm, though the shot was in my left arm, and the migraine was in my left side of my head. I feel that this was an allergic reaction that happened belatedly and is a much stronger reaction than anyone else I have seen take the same dose and the same vaccine. AE resulted in Emergency room/department or urgent care. Treatment was Allergy medication from 08Apr2021 to 13Apr2021 two IV's + Benadryl. Outcome of the event was Recovering. No Covid prior vaccination. No Covid tested post vaccination.  No follow-up attempts needed. No further information expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Nausea, Pain, Pain in extremity, Paraesthesia
Clinical narrative: I was admitted to the ER with a complex migraine and parathesia in my right arm; I was admitted to the ER with a complex migraine and parathesia in my right arm; after about three days of flu-like symptoms; after about three days of flu-like symptoms (nauseau, tiredness, body aches); after about three days of flu-like symptoms (nauseau, tiredness, body aches); after about three days of flu-like symptoms (nauseau, tiredness, body aches); My throat felt restricted; I had hives and raised bumps and bruising on my left arm where the shot went in; I had hives and raised bumps and bruising on my left arm where the shot went in; I was having difficulty breathing; my body felt like it was swelling up everywhere; allergy symptoms manifest/allergic reaction; I had the normal side effects of numbness and soreness in my left arm; I had the normal side effects of numbness and soreness in my left arm; This is a spontaneous report from a contactable consumer (patient). This 32-year-old female patient (No pregnant) received 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 Vaccine, Lot number: ER8737) on 05Apr2021 06:15 PM at single dose on Left arm for covid-19 immunization. Medical history was Immunocompromised, chronic migraines. Known allergies: Just seasonal allergies. Wheat and soy allergy, restricted diet. Concomitant medications (in two weeks) included fluticasone propionate (FLONASE) for allergies (nasal spray), mirtazapine (REMERON). No other vaccine in four weeks. Patient stated that I had the normal side effects of numbness and soreness in my left arm from 05Apr2021. Three days later I had allergy symptoms manifest, Thursday (the shot was on a Monday), and had to go get allergy medication. My throat felt restricted, I was having difficulty breathing, and my body felt like it was swelling up everywhere. I had hives and raised bumps and bruising on my left arm where the shot went in from 09Apr2021 ( reported as 08Apr2021 12:00 PM). Swelling noticeably went down after the allergy medication and breathing returned to normal. On Tuesday, 13Apr2021, after about three days of flu-like symptoms (nauseau, tiredness, body aches), I was admitted to the ER with a complex migraine and parathesia in my right arm, though the shot was in my left arm, and the migraine was in my left side of my head. I feel that this was an allergic reaction that happened belatedly and is a much stronger reaction than anyone else I have seen take the same dose and the same vaccine. AE resulted in Emergency room/department or urgent care. Treatment was Allergy medication from 08Apr2021 to 13Apr2021 two IV's + Benadryl. Outcome of the event was Recovering. No Covid prior vaccination. No Covid tested post vaccination.  No follow-up attempts needed. No further information expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling, Throat tightness, Urticaria, Vaccination site bruising
Clinical narrative: I was admitted to the ER with a complex migraine and parathesia in my right arm; I was admitted to the ER with a complex migraine and parathesia in my right arm; after about three days of flu-like symptoms; after about three days of flu-like symptoms (nauseau, tiredness, body aches); after about three days of flu-like symptoms (nauseau, tiredness, body aches); after about three days of flu-like symptoms (nauseau, tiredness, body aches); My throat felt restricted; I had hives and raised bumps and bruising on my left arm where the shot went in; I had hives and raised bumps and bruising on my left arm where the shot went in; I was having difficulty breathing; my body felt like it was swelling up everywhere; allergy symptoms manifest/allergic reaction; I had the normal side effects of numbness and soreness in my left arm; I had the normal side effects of numbness and soreness in my left arm; This is a spontaneous report from a contactable consumer (patient). This 32-year-old female patient (No pregnant) received 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 Vaccine, Lot number: ER8737) on 05Apr2021 06:15 PM at single dose on Left arm for covid-19 immunization. Medical history was Immunocompromised, chronic migraines. Known allergies: Just seasonal allergies. Wheat and soy allergy, restricted diet. Concomitant medications (in two weeks) included fluticasone propionate (FLONASE) for allergies (nasal spray), mirtazapine (REMERON). No other vaccine in four weeks. Patient stated that I had the normal side effects of numbness and soreness in my left arm from 05Apr2021. Three days later I had allergy symptoms manifest, Thursday (the shot was on a Monday), and had to go get allergy medication. My throat felt restricted, I was having difficulty breathing, and my body felt like it was swelling up everywhere. I had hives and raised bumps and bruising on my left arm where the shot went in from 09Apr2021 ( reported as 08Apr2021 12:00 PM). Swelling noticeably went down after the allergy medication and breathing returned to normal. On Tuesday, 13Apr2021, after about three days of flu-like symptoms (nauseau, tiredness, body aches), I was admitted to the ER with a complex migraine and parathesia in my right arm, though the shot was in my left arm, and the migraine was in my left side of my head. I feel that this was an allergic reaction that happened belatedly and is a much stronger reaction than anyone else I have seen take the same dose and the same vaccine. AE resulted in Emergency room/department or urgent care. Treatment was Allergy medication from 08Apr2021 to 13Apr2021 two IV's + Benadryl. Outcome of the event was Recovering. No Covid prior vaccination. No Covid tested post vaccination.  No follow-up attempts needed. No further information expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Appendicitis
Clinical narrative: appendicitis; This is a Spontaneous report from a non-contactable consumer (patient). A 43-year-old female patient (pregnant: no) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 14Apr2021 (lot number: ewd153) at 14:25 at single dose for COVID-19 immunisation. The relevant medical history was reported as none. Concomitant medications included ascorbic acid (VIT C), zinc, ergocalciferol (VIT D), triamcinolone acetonide (NASACORT AQ) and montelukast sodium (SINGULAIR). The patient previously received the first dose of BNT162B2 (lot number: ep6955, administration time: 02:45 PM, vaccine location: Left arm) on Mar2021 at the age of 43 years old for Covid-19 immunisation. Symptoms of appendicitis started around 1pm the day after 2nd vaccine shot on 15Apr2021. The patient didn't know that they're related, but the timing was suspect. Admitted to the hospital on Friday on 16Apr2021, appendectomy performed that evening. The event resulted in emergency room/department or urgent care. The patient had been hospitalization for 1 day. The outcome of the event was recovering.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: started to exhibit symptoms of Bells Palsy; This is a spontaneous report received from a contactable consumer reported for himself. A patient of unspecified age and gender received bnt162b2 (Pfizer-Biontech Covid-19 Vaccine), dose 1 via an unspecified route of administration in Dec2020 (Batch/Lot number was not reported) at single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient received Pfizer vaccine dose 1 in Dec and dose 2 in Jan. Before dose 2 patient started to exhibit symptoms of Bells Palsy. Pictures were sent to provider and a family member who was also a provider verified it was Bells. Symptoms lasted close to 2 months before any visible change noticeable. Patient attempted to also report to DOH without much luck and the VAERS seemed not to work right. Patient just would like to get it reported with Pfizer to assist patients in making vaccine decisions. The outcome of the event was unknown.  Information about Batch/Lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Loss of consciousness
Clinical narrative: Passed Out; Felt Faint; This is a spontaneous report from a contactable consumer. A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The relevant medical history and concomitant medications were not reported. The consumer's husband's adopted daughter, that passed out after receiving a Covid Vaccine. Stated she felt faint and because of her, she knew to get down on the floor and she passed out and woke up to her dogs licking her face but she didn't do any damage because she got down on the floor. The outcome of the events was unknown.  Information about Lot/Batch number has been requested.