chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Pulmonary embolism
Clinical narrative: Experienced bilateral pulmonary embolism two days after receiving the BNT 162 Covid vaccine.; This is a spontaneous report from a contactable physician. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, lot number and expiry date were not reported) via an unspecified route of administration on an unspecified date as unknown, single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced bilateral pulmonary embolism (PE) two days after receiving the BNT 162 Covid vaccine. Patient was hospitalized (dates unknown) and treated for his bilateral PEs and was currently home recovering.  Information on the lot/batch number has been requested.; Sender's Comments: Current information is limited and does not allow full medical assessment.  The patient's relevant medical history and concomitant medications are not reported.  Case will be reassessed once receiving additional 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 to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Intermenstrual bleeding, Product administered to patient of inappropriate age
Clinical narrative: Bleeding intermenstrual; Inappropriate age at vaccine administration; This is a spontaneous report from a contactable pharmacist. A 13-year-old female patient received bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration, on 23May2021, as single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced bleeding intermenstrual on 24May2021 with outcome of unknown. It was reported that the patient had her monthly period earlier in month so this was very early, after about 18 days since last period.  The information on the lot/batch number has been requested.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Myocardial infarction
Clinical narrative: thought it might be a heart attack; Sharp pain in center of chest. Noticed mild pain first; This is a spontaneous report from a contactable consumer (patient). A 51-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in left arm on 26Apr2021 09:30 (Batch/Lot Number: ew0167) (at the age of 51 years old) as 2nd dose, single dose for COVID-19 immunization. Medical history included T1 diabetic. Concomitant medications included insulin lispro (HUMALOG) and colecalciferol (VITAMIN D [COLECALCIFEROL]). The patient received the first dose of BNT162B2 in left arm on 02Apr2021 09:30 (lot: er8734) for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered was in Pharmacy or Drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 27Apr2021 22:30, the patient experienced sharp pain in center of chest. Patient noticed mild pain first, he considered going to hospital at peak, thought it might be a heart attack. Patient didn't have any other symptoms and it subsided so he didn't think to do anything. There was no treatment for the events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was recovered on unspecified date in Apr2021.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Crying, Depression, Dizziness, Nausea
Clinical narrative: crying; feeling nausea; depression; feeling dizziness; This is a spontaneous report from a contactable consumer (patient's wife). An 80-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 17May2021 09:00 (Batch/Lot Number: ER8729) as 1st dose, single for covid-19 immunization. Medical history included heart valve replacement from 12Mar2021, kidney infection, had a heart bypass and is diabetic. The patient has no concomitant medications. The patient got the Pfizer Covid Vaccine on 17May2021, and the next day (18May2021) he woke up with dizziness. The reporter asked how long the symptoms last after the Covid vaccine. He is sort of getting nausea when he tries to get up. He was also real depressed. It kind of started the next day after the vaccine (18May2021), but Wednesday she was concerned because the patient was crying a lot which is unusual for him. The nausea started today (25May2021). He hasn't been up and about. The dizziness is about the same. They called his primary caregiver who started him on some antidepressants. She picked up the information sheet that was given to them with the Covid vaccine and read there that dizziness was a side effect and a feeling of impending doom which is sort of how he was feeling. Now that's why she was wondering when the symptoms would be over. She doesn't really think he needs anything. He has never been depressed. She thinks now it is a side effect from the vaccine. She thinks the depression has improved. He is not crying anymore, but somebody is with him all the time. This was his first dose of the vaccine. He is supposed to go back on 07Jun2021 for his second. The outcome the event depression was recovering, event crying was recovered on an unspecified date and the other events was not recovered.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Heart rate increased, Heart rate irregular
Clinical narrative: heart rate slows it is irregular/heart rate increased to over 100-110; This is a spontaneous report from a contactable consumer (patient). A 63-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration, administered in arm left on 06Apr2021 at 11:00 (at the age of 63-years-old) as 1st dose, single dose for COVID-19 immunisation. Medical history included replaced mitral valve from an unknown date and unknown if ongoing. Concomitant medications included acetylsalicylic acid (BABY ASPIRIN), levothyroxine and folic acid, all taken for an unspecified indication, start and stop date were not reported. Two weeks after the patient's first shot, on 20Apr2021 at 07:00, her heart rate increased to over 100-110. She has an artificial mitral valve - Bio bovine. Her heart rate slows - it is irregular. They are testing now. Event resulted in doctor or other healthcare professional office/clinic visit. It was unknown whether treatment was received for the event. The outcome of the event was not recovered.   Information on the lot/batch number has been requested.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Cardiac monitoring, Cardioversion, Heart rate increased
Clinical narrative: heart rate slows it is irregular/heart rate increased to over 100-110; This is a spontaneous report from a contactable consumer (patient). A 63-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration, administered in arm left on 06Apr2021 at 11:00 (at the age of 63-years-old) as 1st dose, single dose for COVID-19 immunisation. Medical history included replaced mitral valve from an unknown date and unknown if ongoing. Concomitant medications included acetylsalicylic acid (BABY ASPIRIN), levothyroxine and folic acid, all taken for an unspecified indication, start and stop date were not reported. Two weeks after the patient's first shot, on 20Apr2021 at 07:00, her heart rate increased to over 100-110. She has an artificial mitral valve - Bio bovine. Her heart rate slows - it is irregular. They are testing now. Event resulted in doctor or other healthcare professional office/clinic visit. It was unknown whether treatment was received for the event. The outcome of the event was not recovered.   Information on the lot/batch number has been requested.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dyspnoea, Fatigue
Clinical narrative: tired; coughing; Breathing reaction; This is a spontaneous report from a contactable consumer. A 15-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 23May2021 (at the age of 15-year-old) (Batch/Lot number was not reported) as 1ST DOSE, SINGLE DOSE for covid-19 immunisation. Medical history included allergic to amoxicillin where it was a couple of times when she was little and she would get blotches and red; and has been vaping without her parents knowing. Concomitant medication included etonogestrel (NEXPLANON). On 23May2021, the patient experienced breathing reaction. The mother stated that her daughter took the vaccine, she was 15, she was aware of the normal side effect problems and heart problems as she has been hearing in the news, she was concerned because she just figured out her daughter has been vaping without her parents knowing. The mother stated that she was a family therapist, and many teens vape age 12-15, parents don't have a clue about vaping and the chemicals in the vape that can cause heart and lung problems. She was contacting Pfizer because she wants to make sure this was in the radar, because of side effects. They should consider asking these types of things prior to administering the product. The mother was concerned watching her daughters breathing reaction. Her daughter was better today. The mother was reading side effects on vaping and there was some link to heart and lung issues, some even have lead in the chemicals or nicotine. The mother stated that she has also realized, in general when people ask if they are taking medications, especially for women they don't say anything about taking pills, or combination of pills. Her daughter experienced a Breathing reaction after the first dose. She was better today, she took the shot on Sunday, she was tired and coughing on an unspecified date but was better now. Her main concern was the age group and the Heart problems for this group. Her First Dose was on 23May2021, she was worse yesterday but today she was better. The breathing reaction started on the 23rd. Yesterday her daughter was in bed all day. Her daughter has made no physician office visit or went to the emergency room because of this. Treatment: Not to her knowledge, Unknown for breathing reaction. The mother again stated that she just wanted to express he concerns with this age group. The patient was recovering from all events.  Information on the Lot/Batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Pemphigus
Clinical narrative: Pemphigus; This is a spontaneous report from a contactable pharmacist. A 94-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Lot number was not reported) as UNKNOWN, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced pemphigus on an unspecified date with outcome of unknown.    No follow-up attempts are possible. Information about lot/batch number cannot be obtained.; Sender's Comments: The information currently provided is too limited to make a meaningful medical assessment hence, the events are conservatively assessed as related to the suspect drug BNT162B2 until further information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Sex: U
Vaccine: COVID19
Symptoms: Migraine
Clinical narrative: migrane headaces to the forehead; 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), dose 1 via an unspecified route of administration, administered in arm left on an unspecified date (Batch/Lot number was not reported) as 1ST DOSE, SINGLE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient wrote her concern of the first dose of the Pfizer covid vaccination. She asked for an explanation in full detail why, after 29 days of taking the Pfizer shot to the left arm, she was having migraine headaches to the forehead (side effects). She tried aspirins and over the counter medications, with having no affect. She added that this was one of the reason why she and others were debating on taking covid vaccinations, now she was deciding if she still wanted to take the second Dose. Therapeutic measures were taken as a result of the event. The outcome of the event was unknown.    Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Arthritis, Blister, Feeling abnormal, Rheumatoid arthritis, Skin atrophy
Clinical narrative: Rheumatoid arthritis flare up/AFFECTING SHOULDER JOINTS; ARTHRITIS IN HAND; Feels bad; Skin thinning of; Blister; get rips really easily; This is a solicited report based on information received by Pfizer. A contactable consumer (patient) reported that a 50-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 1 intramuscular on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunisation; adalimumab (HUMIRA) subcutaneous from an unspecified date (Batch/Lot number was not reported) at unspecified dose for rheumatoid arthritis. The patient had immune compromised since childhood, prior to taking adalimumab. She had hand surgery due to arthritis. The outcome for surgery was reported as recovered and causality was reported as no reasonable possibility. BNT162B2 vaccine caused her a slight flare up of rheumatoid arthritis which affected the shoulder joint and she felt bad for couple of days. Her skin was getting thin and not regenerating like it should. It get rips really easily and gets blisters. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The outcome of events was unknown.   The reporter's assessment of the causal relationship of the events with the suspect product BNT162B2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  The reporter's causality for the event(s) of arthritis in hand, felt bad, blister and rheumatoid arthritis flare up affecting shoulder joints was not provided. the reporter's causality for the event(s) of skin was thinning not regenerating/skin rips really easily with HUMIRA (adalimumab) was a reasonable possibility. (privacy) opinion is that there is no reasonable possibility that the events of arthritis in hand, felt bad, skin was thinning not regenerating/skin rips really easily, blister and rheumatoid arthritis flare up affecting shoulder joints are related to HUMIRA (adalimumab).; Sender's Comments: Based on the current available information, the events are most likely related to an intercurrent or underlying condition which is not related to the suspected drug BNT162B2. Concomitant using HUMIRA (adalimumab) may provide a plausible alternative explanation for the events.  The case will be reassessed if additional information becomes available.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Skin laceration
Clinical narrative: Rheumatoid arthritis flare up/AFFECTING SHOULDER JOINTS; ARTHRITIS IN HAND; Feels bad; Skin thinning of; Blister; get rips really easily; This is a solicited report based on information received by Pfizer. A contactable consumer (patient) reported that a 50-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 1 intramuscular on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunisation; adalimumab (HUMIRA) subcutaneous from an unspecified date (Batch/Lot number was not reported) at unspecified dose for rheumatoid arthritis. The patient had immune compromised since childhood, prior to taking adalimumab. She had hand surgery due to arthritis. The outcome for surgery was reported as recovered and causality was reported as no reasonable possibility. BNT162B2 vaccine caused her a slight flare up of rheumatoid arthritis which affected the shoulder joint and she felt bad for couple of days. Her skin was getting thin and not regenerating like it should. It get rips really easily and gets blisters. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The outcome of events was unknown.   The reporter's assessment of the causal relationship of the events with the suspect product BNT162B2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  The reporter's causality for the event(s) of arthritis in hand, felt bad, blister and rheumatoid arthritis flare up affecting shoulder joints was not provided. the reporter's causality for the event(s) of skin was thinning not regenerating/skin rips really easily with HUMIRA (adalimumab) was a reasonable possibility. (privacy) opinion is that there is no reasonable possibility that the events of arthritis in hand, felt bad, skin was thinning not regenerating/skin rips really easily, blister and rheumatoid arthritis flare up affecting shoulder joints are related to HUMIRA (adalimumab).; Sender's Comments: Based on the current available information, the events are most likely related to an intercurrent or underlying condition which is not related to the suspected drug BNT162B2. Concomitant using HUMIRA (adalimumab) may provide a plausible alternative explanation for the events.  The case will be reassessed if additional information becomes available.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Psoriatic arthropathy, Rheumatoid arthritis
Clinical narrative: Psoriatic arthritis aggravated; Rheumatoid arthritis flare up; This is a solicited report based on the information received by Pfizer, (Mfr. Control No.: 21K-163-3918137-00). A non-contactable consumer (patient) reported that solicited report from the (country) by a consumer of a 63 year old female with events of Flare up of psoriatic and rheumatoid arthritis with humira (Adalimumab). PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. In 2021, patient received 1st dose COVID-19 Vaccine manufactured by Pfizer. On 13Apr2021, patient received 2nd dose COVID-19 Vaccine manufactured by Pfizer. A 63-years-old female patient received bnt162b2, dose 2 via intramuscular on 13Apr2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation; adalimumab (HUMIRA), via subcutaneous from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at unspecified dose for psoriatic arthritis and moderate to severe rheumatoid arthritis. There was no reported medical history. The patient's concomitant medications were not reported. Historical vaccine included 1st dose of BNT162B2 in 2021 for COVID-19 immunization. In 2021, the patient experienced flare up of psoriatic and rheumatoid arthritis. In 2021, the flare up of psoriatic and rheumatoid arthritis resolved. The patient was treated with Prednisone.  Causality for adalimumab: The reporter's causality for the events of flare up of psoriatic and rheumatoid arthritis onset in 2021 and flare up of psoriatic and rheumatoid arthritis onset in 2021 with humira (adalimumab) was no reasonable possibility.  The reporter's assessment of the causal relationship of the events with the suspect product bnt162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are possible. No further information is expected. Information about batch number cannot be obtained.; Sender's Comments: Based on the narrative information provided, there is no reasonable possibility that the reported event Rheumatoid arthritis and Psoriatic arthropathy is related to BNT162B2 (COVID-19 mRNA VACCINE).
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Confusional state, Fall, Malaise
Clinical narrative: fell out of his chair; confused; did not feel well; This is a spontaneous report from a contactable other health professional (patient). A 23-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EW00185) intramuscularly administered into right arm on 20May2021 (at the age of 23-year-old) as 1st dose, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On 20May2021, patient was in observation for 20 minutes then he fell out of his chair, he was confused and did not feel well. The events resulted in emergency room visit. Outcome of events was unknown.  Information on Lot/Batch number was available. Additional information has been requested.; Sender's Comments: The contributory role of the suspect product to reported fall cannot be excluded.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging, Myelitis transverse, Spinal cord injury
Clinical narrative: Cervical transverse myelitis, asymptomatic thoracic cord lesion as well; both enhancing on post-gado MRI; Cervical transverse myelitis, asymptomatic thoracic cord lesion as well; both enhancing on post-gado MRI; This is a spontaneous report received from a contactable physician (HCP). A 36 year old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: unknown), via an unspecified route of administration (age at vaccination 33 year) on 30Apr2021 as unknown single dose for Covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date of May2021, patient experienced Cervical transverse myelitis, asymptomatic thoracic cord lesion as well; both enhancing on post-gado magnetic resonance imaging (MRI). Patient visited to physician office for the event. The outcome of the event was reported as not recovered.  information on the lot/batch number has been requested.; Sender's Comments: Based on temporal association of the product bnt162b2, the causal association between the event Cervical transverse myelitis and Thoracic cord lesion the suspect drug cannot be excluded. As there is limited information provided about the  patient medical history and concomitant drugs  ,the case will be reevaluated should additional information become available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Blood creatinine, Blood urea, Carbon dioxide, Glomerular filtration rate, Renal injury
Clinical narrative: kidney damage; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose at the age of 74-years-old via an unspecified route of administration on 10Mar2021 10:00 (Batch/Lot Number: EN6208) as 2nd dose, single dose for covid-19 immunisation. Medical history included severe acid reflux from an unknown date and unknown if ongoing (treated with omeprazole for 8 days). The patient's concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 01Feb2021 (lot number: EL9265) and experienced kidney damage, fever/temperature started out at 99.9 and went up to 101, had joint pain and a headache, chills, light ache, weird feeling, getting sick and little bit of jaw chopping due to chills.The patient previously took omeprazole for severe acid reflux. The patient experienced kidney damage on an unspecified date. She says the kidney damage is ongoing because her GFRs were down and she doesn't know why they dropped all of the sudden. She says they dropped all the way to 21 and 24, her creatinine was up 2 and a quarter, she never had a problem, and currently as of today the kidney doctor can finally say it was the vaccine. She says her creatinine was up, in her past numbers stuff is dropping off but creatinine was up at 2.25. She says her BUN was 23, 24. She says those GFRs the higher GFR, the 29 one, was at 24 on 16Feb2021. When asked if she means GFR EST she says whatever one was 29. She says one of her GFRs was 24, and the GFR EST was 12. She says 15 is kidney failure so she was just above kidney failure. She says it is slowly coming back. She says the GFR one increased 2 points, the other 1 points. She says the other thing that is going on could be related to the kidney is that her CO2 numbers went from normal to increasing. She says today it is 34, a little above. She says she had 3 metabolic panels after that. She says she hasn't had a test; then last metabolic panel was 24Apr2021 and the numbers for her CO2 all along has been 31 or 32, now all of the sudden for 2 months in a row is is 33, now 34. She says something is going on. She says she had a urine test today but has trouble locating it on her report.  The patient underwent lab tests and procedures which included blood creatinine: 1.93 on 26Feb2021; 1.34 on 24May2021, carbon dioxide: 34 on 24May2021; 31 or 32 on 24Apr2021, GFR EST: 29 on 26Feb2021; 45 on 24May2021, GFR EST-other: 25 on 26Feb2021; 39 on 24May2021, GFR: 12 on 16Feb2021, BUN: 23, 24 on an unspecified date. The patient was recovering from the event.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021147970 same patient, vaccine, similar event, first dose
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: challenging case of  Covid-19 several months after completing the two doses of Pfizer COVID vaccine; challenging case of  Covid-19 several months after completing the two doses of Pfizer COVID vaccine; This is a spontaneous report from a contactable other health professional via a company representative. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on an unspecified date (batch/lot number was not reported), as 2nd dose, single dose; and via an unspecified route of administration, on an unspecified date (batch/lot number was not reported) as 1st dose, single dose, for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced a challenging case of COVID-19 several months after completing the two doses of Pfizer COVID vaccine on an unspecified date. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. However, full immunity is only expected 7 days after the second dose.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Rash, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report from a contactable consumer (patient) via the Pfizer sponsored program. A patient of unspecified age and gender received bnt162b2, via an unspecified route of administration on 07May2021 (Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and medications were not reported. Had the Pfizer vaccine on May 7, by next morning patient had a horrible headache, fever. Assumed it would fade, but continued, developed chills, body aches, shortness of breath, severe fatigue, rash. Went to urgent care, tested positive, ended up having the monoclonal immunotherapy on Friday, 21May2021. The outcome of the events was unknown.  Information on lot/Batch number has been requested.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Urticaria
Clinical narrative: Breakthrough hives; condition deterioration; This is a spontaneous report from a non-contactable other Healthcare Professional reported for patient. A 35-years-old female patient received an unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: unknown, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on an unknown date (age at vaccination was 35 years) as UNKNOWN, SINGLE DOSE for COVID-19 immunization. The patient's medical history included urticaria from an unknown date. The patient's concurrent condition included ongoing chronic idiopathic urticaria. The patient's concomitant medications were not reported. On unknown date, it was reported that patient experienced breakthrough hives. The outcome of the reported event was condition deteriorated (not resolved).  No further information was added.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood test, Headache, Pain, Pyrexia
Clinical narrative: body ache; headache; non-stop vomiting; Fever; weak; This is a spontaneous report from a contactable consumer (patient) via Medical information team and Pfizer sponsored program. A 46-year-old female received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: ER8729, NDC number/Expiry date: Unknown) via an unspecified route of administration in the left arm on 21Apr2021 03:40 PM, as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included first dose BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: ER8737) via an unspecified route of administration in the left arm on 31Mar2021 as single dose for COVID-19 immunisation. It was reported that after 12 hours of vaccination (conservatively took 22Apr2021), the patient had a body ache. Twelve hours after the second dose symptoms showed up. She developed body aches, headaches, fever, and non-stop vomiting. On 22Apr2021 at 04:00 AM in the morning, the patient experienced headache and fever and in the afternoon non-stop vomiting. The patient stated that due to her side effects she had to go to the emergency room and they gave her a lot of things, but she did not know what they were. The patient was there in the emergency room for 5-6 hours and underwent lab tests which included blood test and X-Ray and the results were obtained as normal. She was verbally told that everything was fine. There were no concerns about the tests. The patient also stated that because of emergency room visit she had a 2400 dollar bill. She would like to know if there was any program for assistance in paying for her medical bills. Response received as a federal program that had been created to help pay for related costs of medical care and other specific expenses to compensate people injured after use of certain medical countermeasures. Medical countermeasures are specific vaccines, medications, devices, or other items used to prevent, diagnose, or treat the public during a public health emergency or a security threat. It was reported that by the time she left the emergency room she left on two feet, but was weak but okay, she had no pain or fever, had a little temperature not a fever. On Apr2021, the outcome of the events (reported as around 36 hour, early in the morning the patient felt fine and well) body ache, fever, non-stop vomiting and headache were recovered on an unspecified date. The outcome of the weak was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting, X-ray
Clinical narrative: body ache; headache; non-stop vomiting; Fever; weak; This is a spontaneous report from a contactable consumer (patient) via Medical information team and Pfizer sponsored program. A 46-year-old female received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: ER8729, NDC number/Expiry date: Unknown) via an unspecified route of administration in the left arm on 21Apr2021 03:40 PM, as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included first dose BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: ER8737) via an unspecified route of administration in the left arm on 31Mar2021 as single dose for COVID-19 immunisation. It was reported that after 12 hours of vaccination (conservatively took 22Apr2021), the patient had a body ache. Twelve hours after the second dose symptoms showed up. She developed body aches, headaches, fever, and non-stop vomiting. On 22Apr2021 at 04:00 AM in the morning, the patient experienced headache and fever and in the afternoon non-stop vomiting. The patient stated that due to her side effects she had to go to the emergency room and they gave her a lot of things, but she did not know what they were. The patient was there in the emergency room for 5-6 hours and underwent lab tests which included blood test and X-Ray and the results were obtained as normal. She was verbally told that everything was fine. There were no concerns about the tests. The patient also stated that because of emergency room visit she had a 2400 dollar bill. She would like to know if there was any program for assistance in paying for her medical bills. Response received as a federal program that had been created to help pay for related costs of medical care and other specific expenses to compensate people injured after use of certain medical countermeasures. Medical countermeasures are specific vaccines, medications, devices, or other items used to prevent, diagnose, or treat the public during a public health emergency or a security threat. It was reported that by the time she left the emergency room she left on two feet, but was weak but okay, she had no pain or fever, had a little temperature not a fever. On Apr2021, the outcome of the events (reported as around 36 hour, early in the morning the patient felt fine and well) body ache, fever, non-stop vomiting and headache were recovered on an unspecified date. The outcome of the weak was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: received the Pfizer Covid vaccine in April and the next day tested positive for Covid-19; It has been over 42 days since the first dose of the Pfizer Covid Vaccine; This is a spontaneous report received from a contactable pharmacist reported for male consumer (patient). A male patient of unspecified age received first dose of BNT162B2 (Pfizer-BioNTech COVID-19 Vaccine, Solution for injection, Batch/Lot Number was not reported) via unspecified route of administration at an unspecified location on an unknown date in Apr2021 as 1ST DOSE, SINGLE for covid-19 immunisation. Medical history and concomitant medications were not reported. Pharmacist on behalf of a patient who received the Pfizer Covid vaccine in April and the next day tested positive for Covid-19. It has been over 42 days since the first dose of the Pfizer Covid Vaccine, does he have to start the series over? When can she get the second dose of the vaccine after testing positive for Covid-19? Outcome of events was unknown.   Information about lot/batch number has been requested.; Sender's Comments: As per the information in the case provided, the causal association between the event of COVID-19, Vaccination failure and the suspect vaccine BNT162B2 cannot be excluded. The case will be reassessed once new information is available.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: He was fully vaccinated a couple of months ago, and he just tested positive for covid; He was fully vaccinated a couple of months ago, and he just tested positive for covid; This is a spontaneous report from a contactable consumer (patient). A 45-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EM9809 and Expiration Date not reported) via intramuscular route of administration in Arm Left on 27Feb2021 in between 21:00 and 22:00, as 1st dose, single dose and  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ER8730 and Expiration Date not reported) via intramuscular route of administration in Arm Left on 25Mar2021 in between 10:30 and 11:00, as 2nd dose, single dose (at the age of 45 year) for COVID-19 immunization. The patient medical and family history reported as none. Patient was not administered any additional vaccines on same date. Patient was not received any other vaccine prior four weeks of vaccination. Concomitant medication(s) included vitamins nos (VITAMINS NOS) taken for an unspecified indication, start and stop date were not reported. He was calling to report something, just to let Pfizer know. He was fully vaccinated a couple of months ago, and he just tested positive for covid. He first tested positive for covid on Monday morning, 24May2021. At first, he took an over the counter rapid covid test, and it came positive. He did not trust it. He did not feel that sick. His kids are not vaccinated. He went and got a PCR covid test yesterday, and it came back positive. He tried another over the counter rapid covid test, and it was positive. He was asking does the CDC recommend for people to get tested for covid if they have symptoms. He thinks that currently, the CDC does not recommend for people to get tested. The policy at his company was designed around the CDC recommendation. His company policy was that if people are fully vaccinated then they do not have to get covid tested, they just come back whenever they feel better. He thinks that fully vaccinated people are not getting tested because they think they are immune to covid. Another employee that he works with got fully vaccinated in January, and then got covid a few months later. He does not know any information, as that was private information. The outcome of the events was unknown.  Information on Lot/Batch number was available. Additional information has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021615569 same drug, different patient/event
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 antibody test, Vaccination failure
Clinical narrative: Tested positive for Covid virus/cough/Low grade fever; Tested positive for Covid virus/cough/Low grade fever; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient) reported that a 73-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL9266), via an unspecified route of administration on 16Feb2021 (at the age of 72-year-old) as single dose and second dose via an unspecified route of administration on 09Mar2021 (at the age of 72-year-old) (Lot Number: EN6208) as single dose both for covid-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient tested positive for covid virus on 11May2021. Patient reported that she and her husband were fully vaccinated with the Covid vaccine and then recently they both tested positive for Covid virus. Mentions there were also 2 children and 2 adults who were positive. She received her first Covid vaccine on 16Feb2021 and the second dose on 09Mar2021 and then tested positive for Covid virus on 11May2021. She thinks she had a rapid test and another testing that was sent to Lab. Stated she had one shot in the right and one in the left, but unsure which dose was in which arm. No other vaccines given the same day and no problems with vaccines in past. she would like to know which variant they had. She stated after she tested positive for Covid she experienced cough and low grade fever. Stated she and her husband were given monoclonal antibodies at Hospital on Wednesday, 12May2021 she believes. At end of call, patient clarifies that they were all at a dinner party together with 4 adults vaccinated and 2 unvaccinated children, one being her daughter and niece they both also tested positive for Covid virus, which she finds profound. Mentions she just read that the CDC is only interested in post vaccination serious cases. She declines to complete reports for her daughter and niece stating she will have her call herself. No history of all previous immunization with the Pfizer vaccine considered as suspect. No Additional Vaccines administered on same date of the Pfizer Suspect. The events required a visit to Physician Office. Adverse events following prior vaccinations was none. The patient underwent lab tests and procedures which included Covid virus testing: positive on 11May2021, had both rapid and other testing that was sent to Lab. The outcome of the events was unknown.  Information on Lot/Batch number was available. Additional information has been requested
Sex: F
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: she had a seizure; This is a spontaneous report from a contactable consumer (patient's mother). A 16-years-old age female patient (reporter's daughter) received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, 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 immunisation. The patient's medical history and concomitant medications were not reported. The reporter stated her daughter today had the first Pfizer shot, she will be 17 in July and she had a seizure. She had a seizure when she had the first shot (Unspecified Vaccine), she's only 16 she will be 17 years old. She wanted to know if there is any precautions she have to look for, should she have her sleep with her so she could watch her. The clinical outcome of the events was unknown.   Information on the lot/batch number has been requested.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested "positive" for covid 19 (unknown covid 19 symptoms); tested "positive" for covid 19 (unknown covid 19 symptoms); This is a spontaneous report received from a contactable physician. A 57-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date not reported), via an unspecified route of administration on an unspecified date as single for covid-19 immunization. The patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date not reported), via an unspecified route of administration on an unspecified date as single for covid-19 immunizations. The patient's medical history included rheumatoid arthritis. Concomitant medications included Xeljanz XR (tofacitinib citrate) for rheumatoid arthritis from NOV2020 to ongoing. On an unspecified date, patient tested "positive" for covid 19 with unknown covid 19 symptoms. The event did not result in hospitalization; however, she quarantined herself for two weeks. The patient completed the covid 19 vaccine shots, with no missed doses of (Xeljanz XR) reported while receiving the vaccine. MD was aware. The outcome of events was unknown.    Information about lot/batch number has been requested.; Sender's Comments: Based on the known safety profile and a positive temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported Covid-19.
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose increased, Dyspnoea, Heart rate increased
Clinical narrative: shortness of breath/He reports feeling winded walkaing the 10 feet to the washer/dryer; blood sugar over 200; fast heart rate; This is a spontaneous report from a contactable consumer (Patient). A 67-year-old male patient received second dose of bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 21May2021 as 2nd dose, single dose for covid-19 immunisation. Medical history included chronic obstructive pulmonary disease, emphysema, diabetes mellitus, "drinking and smoking for 40 years", covid-19 from Jan2021 to an unknown date. The patient's concomitant medications were not reported. On an unspecified date, patient experienced blood sugar over 200, fast heart rate and shortness of breath/He reports feeling winded walking the 10 feet to the washer/dryer. Patient also reports having had Covid illness in Jan2021, and waiting 3 months before being vaccinated. Patient thought that his increased heart rate could have been a symptom of his inhaler use but read "shortness of breath" in our fact sheet for the vaccine. He reports feeling winded walking the 10 feet to the washer/dryer "and thats without even bending over". Caller does report he's "going to my lung doctor again today". Patients wants to know when normal function will return or if the symptoms will resolve now and return in 6 months. Response Reviewed fact sheet for "tachycardia", "increased heart rate", "blood sugar", "hyperglycemia", and "shortness of breath" with no results in the AEs reported from clinical trials. The only mention of "shortness of breath" was in the description of Covid illness/symptoms. The patient underwent lab test and procedures which included blood sugar which resulted 200. The outcome of the events was unknown.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Asthma, COVID-19, Diarrhoea, Polymerase chain reaction, Vaccination failure
Clinical narrative: On 25May2021, patient undergone pcr nasal swab test and tested positive for covid with symptoms (loss of smell and taste, malaise, runny nose); On 25May2021, patient undergone pcr nasal swab test and tested positive for covid with symptoms (loss of smell and taste, malaise, runny nose); And I have the COVID I feel really bad asthma is cronic now; diarrhea; This is a spontaneous report from a contactable consumer (patient) from a Pfizer sponsored program. A 34-years-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 intramuscular, administered in Arm Left on 23Apr2021 (Batch/Lot Number: ER 8735) as single dose, dose 1 intramuscular, administered in Arm Left on 02Apr2021 (Batch/Lot Number: ER 8730) as single dose, both at the age of 34-years-old, for COVID-19 immunisation. The patient medical history was not reported. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. It was reported that the patient had the vaccine double shot. And she had the COVID, she felt really bad asthma was cronic now. Since 22May2021 9.00, the patient had all COVID symptoms. Loss of smell and taste, diarrhea, malaise, runny nose and asthma. Since the vaccination, the patient had been tested for COVID-19. The patient underwent lab tests and procedures post vaccination which included PCR test (Nasal Swab): positive on 25May2021. The patient took treatment with Seretide inhalation, Tylenol nose drops. Outcome of the events was not recovered.  Information on batch/lot number was obtained. Further information has been requested.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product BNT162B2 or comirnaty to the reported event vaccination failure and covid-19 cannot be ruled out.