chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Dyspnoea, Nausea, Pain, Pyrexia
Clinical narrative: Fainting; Fever of 103; Vomiting Green Fluid; Nausea; Body Aches; Shortness of breath; This is a spontaneous report from a contactable consumer (patient). A 26-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date unspecified), via an unspecified route of administration, administered in left arm on 03Apr2021 15:00 as single dose for COVID-19 immunisation. Medical history included psoriasis. The patient was not pregnant and had no known allergies. There were no concomitant medications. The patient received first dose of bnt162b2 on 13Mar2021, 14:30 for COVID-19 immunisation. On 04Apr2021 03:45, the patient experienced fainting, fever of 103, vomiting green fluid, nausea, body aches and shortness of breath that lasted 7 days after the second dose. There was no therapy for the events. There was no other vaccine in four weeks and no other medications in two weeks. The patient did not have Covid prior vaccination and was not covid tested post vaccination. Outcome of the events was recovered on an unspecified date.  Information on the lot/batch number has been requested.; Sender's Comments: Based on temporal association, the causal relationship between bnt162b2 and the event syncope cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional 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 Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope, Vomiting
Clinical narrative: Fainting; Fever of 103; Vomiting Green Fluid; Nausea; Body Aches; Shortness of breath; This is a spontaneous report from a contactable consumer (patient). A 26-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date unspecified), via an unspecified route of administration, administered in left arm on 03Apr2021 15:00 as single dose for COVID-19 immunisation. Medical history included psoriasis. The patient was not pregnant and had no known allergies. There were no concomitant medications. The patient received first dose of bnt162b2 on 13Mar2021, 14:30 for COVID-19 immunisation. On 04Apr2021 03:45, the patient experienced fainting, fever of 103, vomiting green fluid, nausea, body aches and shortness of breath that lasted 7 days after the second dose. There was no therapy for the events. There was no other vaccine in four weeks and no other medications in two weeks. The patient did not have Covid prior vaccination and was not covid tested post vaccination. Outcome of the events was recovered on an unspecified date.  Information on the lot/batch number has been requested.; Sender's Comments: Based on temporal association, the causal relationship between bnt162b2 and the event syncope cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional 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 Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Haematochezia, Thrombocytopenia
Clinical narrative: thrombocytopenia; Heavy blood in the stool; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received second dose of BNT162B2 (Lot Number: EN6148), via an unspecified route of administration in arm left on 21Mar2021 as single dose for COVID-19 immunisation. Medical history was none. No known allergies. The pateint was not pregnant. The patient's concomitant medications were not reported. The patient previously received first dose of BNT162B2 on 28Feb2021 for COVID-19 immunisation. No other vaccine in four weeks. No ther medications in two weeks. The patient experienced Heavy blood in the stool, thrombocytopenia on 07Apr2021. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, disability or permanent damage. No treatment received. No covid prior vaccination. No covid tested post vaccination. No covid tested post vaccination. The outcome of events was not recovered.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Dyspnoea, Fatigue, Headache, Pulmonary thrombosis
Clinical narrative: Blood clot in lung; Shortness of breath; Felt tired; Slight headache; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EN6201), dose 2 intramuscular, administered in Arm Right (also reported as "injected intramuscularly in right arm") on 23Feb2021 13:00 (at the age of 79years) as single dose for Covid-19 immunization. The patient received the first dose of BNT162B2 (lot number: EL8982) on 02Feb2021 (at the age of 79years) for Covid-19 immunization. Medical history included high blood pressure (diagnosed prior to 10 years ago), respiratory illness, genetic/chromosomal abnormalities, endocrine abnormalities including diabetes, diagnosed allergies, compromised immune status, and obesity (Little on the heavy side but she does not think she is obese); all from an unknown date and unknown if ongoing. Concomitant medication included lisinopril taken for high blood pressure at 20 mg once daily, started at least 10 years ago. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that the patient had received the two doses, she had shortness of breath in the morning around 08:30 on 08Mar2021 and went to her doctor. They did blood work and she was put in the hospital because the doctor found out she had blood clots in her lungs (11Mar2021, 13:00). The patient was hospitalized for blood clot in lung from 11Mar2021 to 13Mar2021. She doesn't know if it came from the vaccine or not. She was sent home on Eliquis for 6 months to get blood clots from her lungs. She also has oxygen for when she needs it and mostly for when she is ambulatory. It was further clarified that when she went to her doctor's office, they did blood work. When they got results, they called her at home and told her that she had to call the ambulance and go the hospital in the ambulance, so she did; Ambulance to ER (hospital) on 11Mar2021. There was also a problem with the left ventricle of her heart (12 Mar2021 12:30). She stated whichever part pumps blood into the pulmonary vein, something is wrong there. She was going to have an echocardiogram to check that out again on 29Apr2021. She does not know the outcome of that yet until she gets that done. They gave her Eliquis as a blood thinner and oxygen.  She has not really needed the oxygen around the house.  But if she goes outside, she may. She took it to the grocery store with her and if she needed it, she used it.  She also had a headache after second dose on 24Feb2021 09:00. She felt tired on 24Feb2021 21:00 and stuff (as reported). The outcome of event blood clot in lung was unknown; the outcome of other events was recovering.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: This is a spontaneous report from a contactable consumer (the patient). A 42-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number not provided), via an unspecified route of administration in the left arm on 13Apr2021 10:45 (at the age of 42-years-old) as a single dose for COVID-19 immunization. The patient's medical history included: tonsils removed at age 6 and heart rate at rest low. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had no allergies to medications, food, or other products. Concomitant medications included: acetylsalicylic acid/ caffeine, paracetamol (EXCEDRIN EXTRA STRENGTH) and cetirizine hydrochloride (ZYRTEC), both taken for an unspecified indication, start and stop date were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number not provided), via an unspecified route of administration in the left arm on 23Mar2021 11:15 (at the age of 42-years-old) as a single dose for COVID-19 immunization. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient stated he fainted the morning after receiving the shot on 14Apr2021 06:00. No treatment was received for the event. The outcome of fainted was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19. Information about lot/batch number has been requested.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac stress test, Chronic obstructive pulmonary disease, Dyspnoea, Headache, SARS-CoV-2 test
Clinical narrative: 6 days later I had breathing problems , I have copd. But I had severe headaches n breathing problems increased.; 6 days later I had breathing problems , I have copd. But I had severe headaches n breathing problems increased.; 6 days later I had breathing problems , I have copd. But I had severe headaches n breathing problems increased.; This is a spontaneous report from a contactable consumer (patient).  A 55 years old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration, administered in Arm Left on 05Apr2021 at 16:00 (Batch/Lot number was not reported) as SINGLE DOSE for Covid19 immunization.  Medical history included diabetes mellitus,  chronic obstructive pulmonary disease,  hypertension. Concomitant medications included high blood pressure medication (details not provided); ascorbic acid, ergocalciferol, nicotinamide, retinol, riboflavin, thiamine hydrochloride (VITAMINS [ASCORBIC ACID;ERGOCALCIFEROL;NICOTINAMIDE;RETINOL;RIBOFLAVIN;THIAMINE HYDROCHLORIDE]); elderberry [Sambucus nigra] (ELDERBERRY [SAMBUCUS NIGRA]). The patient previously took hydrocodone and experienced drug hypersensitivity. Historical Vaccine includes Flu Shot on 11Feb2021 at the age of 55 years old (Flu vaccine given within 4weeks, other vaccine 4weeks vaccine location Left arm).  On 11Apr2021 at 12:00,  the patient experience '6 days later I had breathing problems, I have COPD. But I had severe headaches and  breathing problems increased'. The patient was hospitalized for 3 days. Treatment was given included 'High blood pressure meds, rest, stress tests'.   The patient underwent lab tests and procedures which included Sars-cov-2 test Nasal Swab: results negative  on 08Apr2021, stress test results not provided on an unspecified date. The clinical outcome of the events were recovering.     Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Seizure, Urinary incontinence
Clinical narrative: Seizure; lost control of her blaster as soon as she stood; dull headache; This is a spontaneous report from a contactable consumer (patient) reported that a 75-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: er2613), via an unspecified route of administration, administered in arm left on 17Mar2021 12:00 as a single dose for covid-19 immunisation. The patient had no other medical history. The patient had no known allergies. The patient had no covid-19 prior vaccination. The patient was not pregnant at the time of vaccination. The patient did not have any other vaccine in four weeks. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: En6202), administered in left arm on 24Feb2021 12:00 PM (at the age of 75-years-old) for covid-19 immunization. The patient did received other medications in two weeks. On 18Mar2021 02:00 AM, the patient experienced seizure, recovered from the desire about 30 minutes after stood up, lost control of her blaster as soon as she stood, and dull headache daily. The patient did not received any treatment for the events. The outcome of the events was unknown.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Colitis, Computerised tomogram, Haematochezia, Investigation
Clinical narrative: Colitis; Blood in stool; Stomach pains; This is a spontaneous report from a contactable consumer (patient). A 25-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration, administered in Arm Right on 22Mar2021 16:30 (25-years-old) as single dose for COVID-19 immunization (to go on vacation). The patient medical history and concomitant medications were not reported. Vaccination facility type was Convention Center. Caller reported that he thinks that he got the first dose on 22Mar2021 and is scheduled to get the second dose on Friday, 16Apr2021. Caller reported that on Monday, 22Mar2021 he got the first dose of the Pfizer Covid-19 vaccine.  Caller reported that he went to sleep on 22Mar2021 and woke up starting to feel stomach pains on 23Mar2021.  Caller reported that he felt the stomach pains throughout the day on 23Mar2021. Caller reported that he ended up going to the emergency room due to the stomach pains.  Caller also reported that while using the bathroom, there was blood in his stool. Caller reported that when he went to the emergency room, he was diagnosed with colitis on 24Mar2021.  Caller reported that his discharge paperwork from the emergency room states that colitis can happen from vaccines.  Caller reported that the emergency room staff could not rule out the Covid-19 vaccine as the cause of the caller's colitis because the vaccine is so new. Caller reported that he was prescribed antibiotics for the colitis, which helped. Caller reported that the stomach pains stopped in Mar2021 (also reported as about 5 days afterward he got the antibiotics on Wednesday, 24Mar2021). Caller reported that he is no longer experiencing blood in his stool at all.  Caller reported that he had blood in his stool on the night of Tuesday, 23Mar2021 and the morning of Wednesday, 24Mar2021.  Caller reported that the blood in his stool resolved around 4-5 days after beginning the antibiotics prescribed for his colitis. Caller reported that his colitis resolved completely about 4-5 days after beginning the antibiotics, around Friday 26Mar2021 or Saturday 27Mar2021. Caller reported that he had not been able to find his vaccine card and he did not have anything with the product NDC number, lot number, or expiry date. Caller reported that when he went to the emergency room, the emergency room staff took blood and did a CAT scan on 24Mar2021.  Caller reported that he did not know the results of these investigations, but that the emergency room staff said everything looked normal. The patient underwent lab tests and procedures which included CAT scan: unknown results (everything looked normal) and Unspecified lab work: unknown results on 24Mar2021. The outcome of the events was recovered in Mar2021.   Information on the lot/batch number has been requested.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Pulmonary thrombosis, SARS-CoV-2 test
Clinical narrative: Blood clot in right lung; This is a spontaneous report from a contactable consumer (patient). A 33-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN6204; Expiration date was not reported) on the right arm on 26Mar2021 (18:45) as a single dose, with route of administration unspecified, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) on an unspecified date for COVID-19 immunization. On 31Mar2021, the patient had blood clot in the right lung. The event resulted into doctor or other healthcare professional office/clinical visit and emergency room/department or urgent care, and the patient was hospitalized on an unspecified date in 2021 for two days due to the event. The patient did not receive any treatment for the event. The outcome of the event, 'blood clot in the right lung', was recovered on an unspecified date in 2021 with lasting effects. The patient was not diagnosed with COVID-19 prior to vaccination, and had tested negative for COVID-19 nasal swab test on 01Apr2021.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Deep vein thrombosis
Clinical narrative: DVT Right Leg; This is a spontaneous report from a contactable other healthcare professional (patient).   A 60-year-old female patient received second dose bnt162b2 (BNT162B2), via an unspecified route of administration, administered in right arm on 04Feb2021 08:30 (Lot Number: EL1283), at the age of 60-years at vaccination, as SINGLE DOSE for covid-19 immunisation.  Medical history included osteoarthritis, asthma, fibromyalgia. Historical vaccine includes first dose of BNT162B2, Lot number: EL1283, on 14Jan2021 08:45 AM in left arm at the age of 60-years.  The patient is not pregnant at the time of vaccination. The patient did not have COVID-19 prior vaccination. Concomitant medications included etodolac (LODINE); montelukast; amitriptyline; acetylsalicylic acid (BREOPRIN), all were taken for unspecified indication, start and stop date were not reported.  The patient previously took Vioxx and experienced allergies.  The patient experienced DVT on right leg on 21Feb2021 with outcome of recovered.  The event required physician office visit. The patient has not been tested for COVID-19 post vaccination. Therapeutic measures were taken as a result of DVT in right leg which includes Eliquis.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Dystonia, Pain, Pain in extremity
Clinical narrative: Dystonic storm that lasted 45 minutes; Pain radiating from feet up; Pain radiating from feet up; This is a spontaneous report received a contactable consumer, the patient. A 24-year-old adult female received the second dose of BNT162b2 (solution for injection; Lot ER8733 expiry information not provided) via unspecified route in the right arm on 05Apr2021 at 10:45 (at 24-years-old) for COVID-19 immunisation. Relevant medical history included CTNNB1, Klippel Feil syndrome, dystonia, spastic tetraplegia, and pulmonary stenosis. The patient denied any known allergies. Concomitant medications included baclofen, carbidopa/ levodopa (SINEMET), omeprazole, diazepam (VALIUM), and nortriptyline. The patient previously received COVID-19 immunisation with the first dose of BNT162b2 (Lot EN6203) in the right arm on 13Mar2021 at 10:45 (at 24-years-old). It was reported unknown if the patient was diagnosed with COVID-19 prior to the vaccine. The patient denied receiving any other vaccine within four weeks of this vaccine. The patient reported that on 06Apr2021 at 17:30 he experienced a dystonic storm lasting forty-five minutes and pain radiating from his feet. It was unknown if treatment was received for the events. The patient has not been tested for COVID-19 since the vaccine. The outcome of the events dystonic storm lasting forty-five minutes and pain radiating from his feet was recovered with sequelae (described as lasting effects) on an unspecified date in Apr2021.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: presenting symptoms of Covid/she received the vaccine a couple of days ago; This is a spontaneous report from a contactable pharmacist reported that a 57-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number was not reported), via an unspecified route of administration on Apr2021 as a single dose for covid-19 immunisation. The patient medical history included chronic obstructive pulmonary disease (COPD) from an unknown date and was a frequent flyer with her exacerbations. The patient's concomitant medications were not reported. The reporter stated that the patient was now presenting symptoms of Covid and the physician wanted to give monoclonal antibodies. The reporter asked if that was okay or if there was a time limit that she needed to wait to receive them since she received the vaccine a couple of days ago. The outcome of presenting symptoms of Covid was unknown. The pharmacist does not believed that the patient received it from the vaccine.   Information on the lot/batch number has been requested.; Sender's Comments: Considering the mode of transmission (respiratory droplet transmission) and current pandemic situation, the reported event COVID 19 is considered as not related to  BNT162B2 vaccine.  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: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Immune thrombocytopenia, Oral blood blister, Petechiae, Platelet count, Platelet count decreased
Clinical narrative: Immune Thrombocytopenia Purpura; blood blisters in mouth; petechia; platelets were zero; This is a spontaneous report from a contactable consumer. A 60-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) dose 2 via an unspecified route of administration on 19Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE (at the age of 60 years old) for covid-19 immunisation.  Medical history included Multiple myeloma status post (s/p) CAR T therapy (Apr2020), on Pomalyst starting from Apr2020 to an unknown date.  Concomitant medications included pomalidomide (POMALYST) taken for an unspecified indication from Jan2021 to an unspecified stop date; acyclovir [aciclovir] (ACYCLOVIR [ACICLOVIR]) taken for an unspecified indication, start and stop date were not reported.   On 20Mar2021, the patient experienced immune thrombocytopenia purpura, blood blisters in mouth, petechia. In Mar2021, the patient experienced platelets were zero. Clinical course was as follows Immune Thrombocytopenia Purpura- About 24 hours after receiving the 2nd dose of the vaccine, started noticing blood blisters in mouth and petechia in 20Mar2021. Patient went to doctor on 22Mar2021 after 19Mar2021 vaccine and platelets were zero in Mar2021 and prednisone was started. Platelets were still 0 on 24Mar2021, and then was admitted to the hospital and was given steroids, IVIG, and Nplate. Now improvement. Of note, platelets were checked on 18Mar2021 and were 26, and then received 1 bag of platelets and they were not rechecked after. The patient underwent lab tests and procedures which included platelet: zero in Mar2021, platelet: 26 on 18Mar2021, platelet: were still 0 on 24Mar2021, Covid test: negative on unknown.  Therapeutic measures were taken as a result of immune thrombocytopenia purpura, blood blisters in mouth, petechia, platelets were zero. Outcome of the events was recovered.  Information about Batch/Lot number has been requested.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Immune Thrombocytopenia Purpura; blood blisters in mouth; petechia; platelets were zero; This is a spontaneous report from a contactable consumer. A 60-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) dose 2 via an unspecified route of administration on 19Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE (at the age of 60 years old) for covid-19 immunisation.  Medical history included Multiple myeloma status post (s/p) CAR T therapy (Apr2020), on Pomalyst starting from Apr2020 to an unknown date.  Concomitant medications included pomalidomide (POMALYST) taken for an unspecified indication from Jan2021 to an unspecified stop date; acyclovir [aciclovir] (ACYCLOVIR [ACICLOVIR]) taken for an unspecified indication, start and stop date were not reported.   On 20Mar2021, the patient experienced immune thrombocytopenia purpura, blood blisters in mouth, petechia. In Mar2021, the patient experienced platelets were zero. Clinical course was as follows Immune Thrombocytopenia Purpura- About 24 hours after receiving the 2nd dose of the vaccine, started noticing blood blisters in mouth and petechia in 20Mar2021. Patient went to doctor on 22Mar2021 after 19Mar2021 vaccine and platelets were zero in Mar2021 and prednisone was started. Platelets were still 0 on 24Mar2021, and then was admitted to the hospital and was given steroids, IVIG, and Nplate. Now improvement. Of note, platelets were checked on 18Mar2021 and were 26, and then received 1 bag of platelets and they were not rechecked after. The patient underwent lab tests and procedures which included platelet: zero in Mar2021, platelet: 26 on 18Mar2021, platelet: were still 0 on 24Mar2021, Covid test: negative on unknown.  Therapeutic measures were taken as a result of immune thrombocytopenia purpura, blood blisters in mouth, petechia, platelets were zero. Outcome of the events was recovered.  Information about Batch/Lot number has been requested.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Ischaemic stroke, SARS-CoV-2 test
Clinical narrative: had 3 ischemic strokes; This is a spontaneous report from a contactable consumer (patient). A 68-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 27Feb2021 (at the age of 68-years-old) as a single dose for COVID-19 immunisation. Medical history included antiphospholipid syndrome from an unknown date and unknown if ongoing. Concomitant medication included rivaroxaban (XARELTO) taken for an unspecified indication, start and stop date were not reported. On 19Mar2021, the patient was admitted to the hospital with stroke symptoms, it was determined that she had 3 ischemic strokes on 18Mar2021. The patient was hospitalized for the event from 19Mar2021 to an unknown date for 2 days. The patient underwent lab tests and procedures which included SARS-COV-2 test: negative on 20Mar2021. Therapeutic measures were taken as a result of the event. The outcome of the event was recovered on an unspecified date.    Information on the lot/batch number has been requested.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Body temperature, Chills, Dizziness
Clinical narrative: fainted; weak; tired; dizziness, light headed; nausea; soreness and aches in upper legs; ear pain; swollen throat; joint pain; fever 101; chills; shortness of breath; elevated heart rate; sinus drainage; entire body pain; This is a spontaneous report from a contactable consumer (patient). A 35-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration, administered in the right arm on 05Apr2021 at 09:00 (Batch/Lot Number: ER8734) at 35-years-old as a single dose for COVID-19 immunisation. The patient did not receive any other vaccine within four weeks of the suspect vaccine.  The patient medical history was not reported. It was unknown if the patient had COVID prior to the vaccination.  There were no concomitant medications. On 09Apr2021 (as reported), the patient experienced: fainted (medically significant; also reported as 4 days after vaccine), weak (non-serious; also reported as 1-2 days after vaccine), tired (non-serious; also reported as 1-2 days after vaccine), dizziness, light headed (non-serious; also reported as 4 days after vaccine/ 7 days after vaccine), nausea (non-serious; also reported as 4 days after vaccine), soreness and aches in upper legs (non-serious; also reported as 4-7 days after vaccine), sinus drainage (non-serious; also reported as 4-7 days after vaccine), ear pain (non-serious; also reported as 4-7 days after vaccine), swollen throat (non-serious; also reported as 4-7 days after vaccine), joint pain (non-serious; also reported as 4-7 days after vaccine), fever 101 (non-serious; also reported as 7 days after vaccine), chills (non-serious; also reported as 7 days after vaccine), entire body pain (non-serious; also reported as 7 days after vaccine) shortness of breath (non-serious; also reported as 7 days after vaccine), and elevated heart rate (non-serious; also reported as 7 days after vaccine).  The patient underwent lab tests and procedures which included body temperature: 101 on 09Apr2021, heart rate: 118-125 beats per minute (bpm) on 09Apr2021. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events was not recovered. The patient was not tested for COVID post vaccination.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Ear pain, Fatigue, Heart rate, Heart rate increased
Clinical narrative: fainted; weak; tired; dizziness, light headed; nausea; soreness and aches in upper legs; ear pain; swollen throat; joint pain; fever 101; chills; shortness of breath; elevated heart rate; sinus drainage; entire body pain; This is a spontaneous report from a contactable consumer (patient). A 35-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration, administered in the right arm on 05Apr2021 at 09:00 (Batch/Lot Number: ER8734) at 35-years-old as a single dose for COVID-19 immunisation. The patient did not receive any other vaccine within four weeks of the suspect vaccine.  The patient medical history was not reported. It was unknown if the patient had COVID prior to the vaccination.  There were no concomitant medications. On 09Apr2021 (as reported), the patient experienced: fainted (medically significant; also reported as 4 days after vaccine), weak (non-serious; also reported as 1-2 days after vaccine), tired (non-serious; also reported as 1-2 days after vaccine), dizziness, light headed (non-serious; also reported as 4 days after vaccine/ 7 days after vaccine), nausea (non-serious; also reported as 4 days after vaccine), soreness and aches in upper legs (non-serious; also reported as 4-7 days after vaccine), sinus drainage (non-serious; also reported as 4-7 days after vaccine), ear pain (non-serious; also reported as 4-7 days after vaccine), swollen throat (non-serious; also reported as 4-7 days after vaccine), joint pain (non-serious; also reported as 4-7 days after vaccine), fever 101 (non-serious; also reported as 7 days after vaccine), chills (non-serious; also reported as 7 days after vaccine), entire body pain (non-serious; also reported as 7 days after vaccine) shortness of breath (non-serious; also reported as 7 days after vaccine), and elevated heart rate (non-serious; also reported as 7 days after vaccine).  The patient underwent lab tests and procedures which included body temperature: 101 on 09Apr2021, heart rate: 118-125 beats per minute (bpm) on 09Apr2021. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events was not recovered. The patient was not tested for COVID post vaccination.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pain, Pain in extremity, Pharyngeal oedema, Pyrexia
Clinical narrative: fainted; weak; tired; dizziness, light headed; nausea; soreness and aches in upper legs; ear pain; swollen throat; joint pain; fever 101; chills; shortness of breath; elevated heart rate; sinus drainage; entire body pain; This is a spontaneous report from a contactable consumer (patient). A 35-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration, administered in the right arm on 05Apr2021 at 09:00 (Batch/Lot Number: ER8734) at 35-years-old as a single dose for COVID-19 immunisation. The patient did not receive any other vaccine within four weeks of the suspect vaccine.  The patient medical history was not reported. It was unknown if the patient had COVID prior to the vaccination.  There were no concomitant medications. On 09Apr2021 (as reported), the patient experienced: fainted (medically significant; also reported as 4 days after vaccine), weak (non-serious; also reported as 1-2 days after vaccine), tired (non-serious; also reported as 1-2 days after vaccine), dizziness, light headed (non-serious; also reported as 4 days after vaccine/ 7 days after vaccine), nausea (non-serious; also reported as 4 days after vaccine), soreness and aches in upper legs (non-serious; also reported as 4-7 days after vaccine), sinus drainage (non-serious; also reported as 4-7 days after vaccine), ear pain (non-serious; also reported as 4-7 days after vaccine), swollen throat (non-serious; also reported as 4-7 days after vaccine), joint pain (non-serious; also reported as 4-7 days after vaccine), fever 101 (non-serious; also reported as 7 days after vaccine), chills (non-serious; also reported as 7 days after vaccine), entire body pain (non-serious; also reported as 7 days after vaccine) shortness of breath (non-serious; also reported as 7 days after vaccine), and elevated heart rate (non-serious; also reported as 7 days after vaccine).  The patient underwent lab tests and procedures which included body temperature: 101 on 09Apr2021, heart rate: 118-125 beats per minute (bpm) on 09Apr2021. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events was not recovered. The patient was not tested for COVID post vaccination.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Syncope, Upper-airway cough syndrome
Clinical narrative: fainted; weak; tired; dizziness, light headed; nausea; soreness and aches in upper legs; ear pain; swollen throat; joint pain; fever 101; chills; shortness of breath; elevated heart rate; sinus drainage; entire body pain; This is a spontaneous report from a contactable consumer (patient). A 35-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration, administered in the right arm on 05Apr2021 at 09:00 (Batch/Lot Number: ER8734) at 35-years-old as a single dose for COVID-19 immunisation. The patient did not receive any other vaccine within four weeks of the suspect vaccine.  The patient medical history was not reported. It was unknown if the patient had COVID prior to the vaccination.  There were no concomitant medications. On 09Apr2021 (as reported), the patient experienced: fainted (medically significant; also reported as 4 days after vaccine), weak (non-serious; also reported as 1-2 days after vaccine), tired (non-serious; also reported as 1-2 days after vaccine), dizziness, light headed (non-serious; also reported as 4 days after vaccine/ 7 days after vaccine), nausea (non-serious; also reported as 4 days after vaccine), soreness and aches in upper legs (non-serious; also reported as 4-7 days after vaccine), sinus drainage (non-serious; also reported as 4-7 days after vaccine), ear pain (non-serious; also reported as 4-7 days after vaccine), swollen throat (non-serious; also reported as 4-7 days after vaccine), joint pain (non-serious; also reported as 4-7 days after vaccine), fever 101 (non-serious; also reported as 7 days after vaccine), chills (non-serious; also reported as 7 days after vaccine), entire body pain (non-serious; also reported as 7 days after vaccine) shortness of breath (non-serious; also reported as 7 days after vaccine), and elevated heart rate (non-serious; also reported as 7 days after vaccine).  The patient underwent lab tests and procedures which included body temperature: 101 on 09Apr2021, heart rate: 118-125 beats per minute (bpm) on 09Apr2021. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events was not recovered. The patient was not tested for COVID post vaccination.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Cerebrovascular accident, Hypersensitivity
Clinical narrative: Stroke; severe allergic reaction; This is a spontaneous report from a contactable consumer (the patient's father) from the Pfizer-sponsored program. A 16-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration, administered in the Right Arm (also reported as: right shoulder) on 23Mar2021 (Batch/Lot Number: ER8732; Expiration Date: 31Jul2021) at 16-years-old as a single dose for COVID-19 immunisation.  Medical history included heart valve operation from an unknown date and unknown if ongoing (Mechanical heart valves).  Concomitant medications included an unspecified medication, taken for an unspecified indication from an unspecified date to an unspecified date, which was reported as: "Yes she is taking other medication." On 29Mar2021, the patient experienced stroke and severe allergic reaction (medically significant). The clinical course was reported as follows: On behalf of his 16-year-old daughter, the patient's father reported that she had the first dose administer in the right shoulder on 23Mar2021. On 29Mar2021, the patient had a stroke.  The patient's father stated, "our lives have changed, completely." The patient's father reported that his daughter was receiving medical care ever since then; and was also being treated by a physician.  The patient's father was asking about compensation from Pfizer regarding his daughter's severe adverse event (AE) that occurred after the first dose of vaccine. The patient's father reported that the case had been submitted by the (Name) healthcare team "to the FDA and to Pfizer, and I haven't heard back from either." The patient's father mentioned in passing, that he "could call (Name) and have this all over the news" but that he "wants to be responsible" and doesn't want to do that.  The patient's father stated the concern, "Well my concern I am not sure that medical profession is what I really need to do, my concern is that my daughter took the Pfizer COVID vaccine on 23Mar2021 in (Name) in vaccination location. On 29Mar2021, 6 days later, she had a stroke, and that she is receiving a medical care ever since then , now  my question is like I said probably for  maybe for correlated relation type of person define as well as  for it  there is a compensation for adverse reaction to COVID vaccination being that this was only thing that was introduce in her system as far as doing that time the vaccination shot." The patient underwent lab tests and procedures which included blood test: "that's for 4/2 out of normal" on an unknown date; also reported: "Yes that's been ongoing as far as giving blood. That's for 4/2 out of normal". Therapeutic measures were not taken and was reported as "no she isn't taking anything for it." The clinical outcome of the events, stroke and severe allergic reaction, was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021411875 Pfizer
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Loss of consciousness, Vomiting
Clinical narrative: passing out; Vomiting; diarrhea; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 17-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration, administered in the left arm on 13Apr2021 at 13:45 (Batch/Lot Number: Ew0161) at 17-years-old as a single dose for COVID-19 immunization. The patient did not receive any other vaccine within four weeks of the suspect vaccine. The patient's medical history was reported as none (no known allergies). The patient did not have COVID prior to the vaccination. Concomitant medications included ethinylestradiol, ferrous fumarate, norethisterone acetate (LO LOESTRIN FE) taken for an unspecified indication, start and stop date were not reported. On 14Apr2021 at 13:15, the patient experienced passing out (medically significant), vomiting (non-serious), and diarrhea (non-serious). The clinical outcome of the events was recovering. The patient was not tested for COVID post vaccination.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: Fainted in the shower while shaving; This is a spontaneous report from a contactable consumer (patient). A 22-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration, administered in arm left on 13Apr2021 at 11:00 (at the age of 22-years-old) as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient fainted in the shower while shaving on 14Apr2021 at 15:30. There was no treatment received for the event. The outcome of the event was recovering.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Fall, Head injury, Joint injury, Loss of consciousness
Clinical narrative: After going to the bathroom, I blacked out and fell backwards; After going to the bathroom, I blacked out and fell backwards; hurt my elbow; hurt the back of my head; This is a spontaneous report from a contactable consumer (patient).  A female patient of an unspecified age (reported as Age: 74; Unit: Unknown) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 02Apr2021 (Lot number was not reported) as single dose for covid-19 immunisation. Medical history included covid-19 from 05Jan2021 to an unknown date. Concomitant medications were not reported. Patient stated that on 02Apr2021 she had her first Pfizer vaccine. In the middle of the night she had a bad reaction. After going to the bathroom, she blacked out and fell backwards and hurt her elbow and hurt the back of her head. Patient wanted to know if she should get the second (2 nd) vaccine and If so, she wanted to know if she should get it on the three weeks interval or wait longer. Outcome of the events was unknown. Information on about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Dyspnoea, Hypersensitivity
Clinical narrative: anaphylactic reaction/rash /itching; difficulty breathing; allergic reaction; This is a spontaneous report from a contactable consumer or other non-health care professional via Medical Information Team. A female patient of an unspecified age received first does of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number: Not reported) via an unspecified route of administration on 25Mar2021 as single dose for COVID-19 immunization. The patient's medical and concomitant medications were not reported. On an unspecified date, the patient experienced anaphylactic reaction/rash /itching, difficulty breathing and allergic reaction. The events resulted in emergency room visit. The patient was told that she was not a candidate for the second dose. The patient wanted to know that for how long it was supposed to last. The outcome of the events was unknown.  Information about batch/lot number has been requested.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of consciousness, Pain, Pain in extremity
Clinical narrative: I have passed out three times.; arm pain; body aches; This is a spontaneous report from a non-contactable consumer (patient). A 21-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 on an unspecified date at a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The facility type vaccine was school or student health clinic. There were no other vaccine in four weeks. On 09Apr2021 at 14:45, the patient have passed out three times. The patient also had arm pain and body aches on 09Apr2021 14:45. She had no fever, and she was well hydrated. She have not taken any medication at all since then. There was no treatment for the events. The patient had no COVID prior vaccination and has not been tested for COVID post vaccination. The outcome of the events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased
Clinical narrative: his heart rate was 131. States he took some additional medication and it went back down to 82, then up to 128, down to 48, up to 115; This is a spontaneous report from a contactable consumer. A 78-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in the left arm on 10Apr2021 15:30 (Batch/Lot Number: ER2613) as a single dose for COVID-19 immunisation. Medical history included atrial fibrillation (AFib) on 10Mar2021 (had A-Fib while hospitalized from 10Mar2021 to 22Mar2021. Did a cardioversion) and Guillain Barre syndrome on an unspecified date. Concomitant medication included metoprolol taken for heart (disorder). It was reported that on 10Apr2021 15:30, the patient got his first vaccine. The next morning (11Apr2021 08:30) when he did his vital check, that he does every morning, his heart rate was 131. Stated that he took some additional medication and it went back down to 82, then up to 128, down to 48, up to 115. Stated he was reading where fast heart rate can be one of the side effects. Stated today (12Apr2021) the highest his heart rate has been is 109 and lowest at 42. The patient stated that his heart rate goes from high to low. The patient stated that he normally takes Metoprolol 25 mg a day but he upped it to 100 mg on 11Apr2021 because that's what they did when he had AFib. The outcome of the event was recovering.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Anal incontinence, Asthenia, Impaired self-care, Malaise, Rhinorrhoea
Clinical narrative: Reports his dad is barely able to even feed himself.; Absolutely no strength; Lost control of bowels; Runny Nose; Dad is not doing well; This is a spontaneous report from a contactable consumer (patient's son). A 69-year-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 08Apr2021 (at the age of 69-year-old) as SINGLE DOSE for COVID-19 immunisation. Medical history included diabetes. The patient was on several different medications. The son reported that his Dad had absolutely no strength, lost control of bowels, and a runny nose on an unspecified date. The son also reported that his dad was barely able to even feed himself on an unspecified date. Two weeks ago, the son's Dad was walking around fine, now it seems like he was headed to death's door. Reported that when his Dad looks at you, its like a distant stare. The consumer also mentioned that his Dad was not doing well on an unspecified date. The consumer reported he has no idea what the date was his Dad received second dose Covid Vaccine, just knows it was about the same time the caller received his first dose. The consumer also mentioned that he does not know when any of his Dad's symptoms began. The outcome of the events was unknown.  Information on the lot/batch number has been requested.