chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular
Clinical narrative: Menstrual bleeding (clot) before my period is due.; This is a spontaneous report from a contactable other hcp (patient). A 34-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot Number: EW0167), via an unspecified route of administration, administered in Arm Left on 28Apr2021 11:45 (34-years-old) as 1st dose, single for COVID-19 immunization. The patient medical history was not reported. Patient was not pregnant. Facility where the most recent COVID-19 vaccine was administered was Military Base. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medications included atorvastatin (LIPITOR); drospirenone, ethinylestradiol betadex clathrate (YAZ).  The patient experienced menstrual bleeding (clot) before her period is due on 29Apr2021 13:00 with outcome of not recovered. No treatment was given.; Sender's Comments: Considering the plausible drug-event temporal association, a contributory role of the suspect product bnt162b2 to the reported event cannot be excluded. Case will be reassessed upon receipt of 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.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Circulatory collapse, Haemorrhage, Injury, Memory impairment, Road traffic accident
Clinical narrative: I got out of my truck and collapsed; I had a grand mal seizure, seizing for 5 plus minutes; Slammed my head repeatedly on the concrete during the seizure leaving my head bleeding and cuts all over me.; Slammed my head repeatedly on the concrete during the seizure leaving my head bleeding and cuts all over me.; I leaned forward slamming on the gas colliding with another vehicle.; I don't remember starting my vehicle; This is a spontaneous report from a contactable consumer (patient). A 20-year-old male patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EP7533), via an unspecified route of administration at the age of 20-year-old at arm left on 21Apr2021 22:30 at single dose for COVID-19 immunization. Medical history included epilepsy, haven't had a seizure until now for 2 years. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Concomitant medications included Men's Multivitamin GNC and fish oil received within 2 weeks of vaccination. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The was leaving he apartment complex to go to school after work around 7am 23Apr2021, the patient didn't remember starting he vehicle, but he leaned forward slamming on the gas colliding with another vehicle. he got out of his truck and collapsed, he had a grand mal seizure, seizing for 5 plus minutes, having to go to the emergency room, he slammed his head repeatedly on the concrete during the seizure leaving his head bleeding and cuts all over he. He was now unable to drive for 6 months and need to get an MRI an EEG and be put on medication. Adverse events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization. The patient was hospitalized for one day for events. Facility where the most recent COVID-19 vaccine was administered in workplace clinic. Since the vaccination, the patient hasn't been tested for COVID-19. The patient was received treatment for all events. The outcome of events was unknown. Follow-up attempts are needed. Further information is expected.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: I got out of my truck and collapsed; I had a grand mal seizure, seizing for 5 plus minutes; Slammed my head repeatedly on the concrete during the seizure leaving my head bleeding and cuts all over me.; Slammed my head repeatedly on the concrete during the seizure leaving my head bleeding and cuts all over me.; I leaned forward slamming on the gas colliding with another vehicle.; I don't remember starting my vehicle; This is a spontaneous report from a contactable consumer (patient). A 20-year-old male patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EP7533), via an unspecified route of administration at the age of 20-year-old at arm left on 21Apr2021 22:30 at single dose for COVID-19 immunization. Medical history included epilepsy, haven't had a seizure until now for 2 years. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Concomitant medications included Men's Multivitamin GNC and fish oil received within 2 weeks of vaccination. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The was leaving he apartment complex to go to school after work around 7am 23Apr2021, the patient didn't remember starting he vehicle, but he leaned forward slamming on the gas colliding with another vehicle. he got out of his truck and collapsed, he had a grand mal seizure, seizing for 5 plus minutes, having to go to the emergency room, he slammed his head repeatedly on the concrete during the seizure leaving his head bleeding and cuts all over he. He was now unable to drive for 6 months and need to get an MRI an EEG and be put on medication. Adverse events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization. The patient was hospitalized for one day for events. Facility where the most recent COVID-19 vaccine was administered in workplace clinic. Since the vaccination, the patient hasn't been tested for COVID-19. The patient was received treatment for all events. The outcome of events was unknown. Follow-up attempts are needed. Further information is expected.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Dizziness, Syncope
Clinical narrative: fainted; very light-headed; This is a spontaneous report from a contactable consumer (patient). A 20-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EW0153) via an unspecified route of administration at left arm on 29Apr2021 10:45 (20-year-old at time of vaccination), at single dose, for COVID-19 immunization. The patient's medical history included anxiety, ADHD, and allergies to amoxicillin. Concomitant medications in two weeks included amfetamine aspartate/ amfetamine sulfate/ dexamfetamine saccharate/ dexamfetamine sulfate (ADDERALL) and Vitamin D3. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EW0153) via an unspecified route of administration at left arm on 07Apr2021 10:30 (20-year-old at time of vaccination), at single dose, for COVID-19 immunization. There was no other vaccine in four weeks. The patient was very light-headed and fainted on 29Apr2021 15:45. Adverse events resulted in Emergency room/department or urgent care. Prior to vaccination, the was not patient diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Therapeutic measures were taken as a result of the events and included "Ruled out heart issue, checked blood sugar level". The outcome of the events was unknown.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Axillary pain, Circumstance or information capable of leading to medication error, Fatigue, Headache, Neck pain
Clinical narrative: This is a spontaneous report from a contactable reporter reporting for her son, via Pfizer sponsored program.  A 16-year-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 24Apr2021 (Batch/Lot number was not reported) as single dose at the age of 16-year-old for COVID-19 immunisation.   The patient medical history and concomitant medications were not reported.  After 24 hours from vaccination, on 25Apr2021, he felt pain on the injection site. For that, the mother gave her son Tylenol to treat the symptoms. Then after 24 hours, on 26Apr2021 he felt fine. However, 2 days after, on 28Apr2021, he felt pain underneath the left side of his armpit, had a fever with a temperature of 102.8 F, and the right side of his neck was swollen. In addition to this, he was experiencing a lot of body aches, headache, and pain on his neck. They already contacted their HCP and prescribed him with antibiotics in Apr2021. He was tired and almost lethargic in Apr2021. Reporter wanted to know if her son should still receive the 2nd dose. The reporter was invited to consult her HCP. The outcome of pain on the injection site was recovering, of all other events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of serious events Neck swelling, Armpit pain, and Fever cannot be excluded.  The case will be reassessed if 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: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Swelling, Vaccination site pain
Clinical narrative: This is a spontaneous report from a contactable reporter reporting for her son, via Pfizer sponsored program.  A 16-year-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 24Apr2021 (Batch/Lot number was not reported) as single dose at the age of 16-year-old for COVID-19 immunisation.   The patient medical history and concomitant medications were not reported.  After 24 hours from vaccination, on 25Apr2021, he felt pain on the injection site. For that, the mother gave her son Tylenol to treat the symptoms. Then after 24 hours, on 26Apr2021 he felt fine. However, 2 days after, on 28Apr2021, he felt pain underneath the left side of his armpit, had a fever with a temperature of 102.8 F, and the right side of his neck was swollen. In addition to this, he was experiencing a lot of body aches, headache, and pain on his neck. They already contacted their HCP and prescribed him with antibiotics in Apr2021. He was tired and almost lethargic in Apr2021. Reporter wanted to know if her son should still receive the 2nd dose. The reporter was invited to consult her HCP. The outcome of pain on the injection site was recovering, of all other events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of serious events Neck swelling, Armpit pain, and Fever cannot be excluded.  The case will be reassessed if 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.
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation, Cardiac disorder, Cardiac failure congestive, Inappropriate schedule of product administration, Off label use
Clinical narrative: heart problems; Congestive heart failure; afib was out of whack; Her new 2nd dose schedule is due tomorrow 30Apr2021 and the interval is so long; Her new 2nd dose schedule is due tomorrow 30Apr2021 and the interval is so long; This is a follow-up spontaneous report from a contactable consumer via the Pfizer-sponsored program. A 77-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 04Mar2021 (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 stated that she missed her 2nd dose schedule which is on 25MAR2021 because the day before her 2nd dose appointment she was hospitalized due to heart problems (Congestive heart failure and afib was out of whack, they wanted to change my meds and monitor me; unrelated to the vaccine) and she needs rehab. Her new 2nd dose schedule is due tomorrow 30Apr2021 and the interval is so long, She wanted to know if it's safe to receive her 2nd dose of the vaccine. Events occurred on an unspecified date. The patient was hospitalized for heart problems from 24Mar2021 to an unknown date. Therapeutic measures were taken as a result of heart problems. Outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the information available the reported events are considered not related to suspect drug.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Abdominal pain, Anxiety, Chest discomfort, Chills
Clinical narrative: increase in anxiety to the point of panic attack occurring; Anxiety; Intense abdominal cramping/Abdominal burning/cramps were at an 8 on the pain scale during the worst periods; Abdominal burning/Abdominal burning/cramps were at an 8 on the pain scale during the worst periods; vomiting since the day after the vaccine; Chills; body shakes; periods of chest tightness; shortness of breath; unable to keep food or fluid down; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 23-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at Left arm on 25Apr2021 15:15 at first dose, single for COVID-19 immunization in Pharmacy or Drug Store. Medical history included Major depressive disorder, General anxiety disorder and Known allergies to Z-Pak. concomitant medication was none (the patient was not received any medication within 2 weeks of vaccination). Patient was not Pregnant at Time of Vaccination. the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported on 26Apr2021 16:45, patient experienced intense abdominal cramping and vomiting since the day after the vaccine. Chills, body shakes, and periods of chest tightness and shortness of breath. patient was unable to keep food or fluid down until she received a prescription for Ondansetron from her doctor. Abdominal burning/cramps were at an 8 on the pain scale during the worst periods. Also an increase in anxiety to the point of panic attack occurring on 28Apr2021. the adverse event result in Doctor or other healthcare professional office/clinic visit. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. treatment received for the adverse event included Ondansetron and Proair inhaler. Outcome of the events was recovering.   Information on Lot/Batch number was available. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspepsia, Dyspnoea, Panic attack, Tremor, Vomiting
Clinical narrative: increase in anxiety to the point of panic attack occurring; Anxiety; Intense abdominal cramping/Abdominal burning/cramps were at an 8 on the pain scale during the worst periods; Abdominal burning/Abdominal burning/cramps were at an 8 on the pain scale during the worst periods; vomiting since the day after the vaccine; Chills; body shakes; periods of chest tightness; shortness of breath; unable to keep food or fluid down; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 23-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at Left arm on 25Apr2021 15:15 at first dose, single for COVID-19 immunization in Pharmacy or Drug Store. Medical history included Major depressive disorder, General anxiety disorder and Known allergies to Z-Pak. concomitant medication was none (the patient was not received any medication within 2 weeks of vaccination). Patient was not Pregnant at Time of Vaccination. the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported on 26Apr2021 16:45, patient experienced intense abdominal cramping and vomiting since the day after the vaccine. Chills, body shakes, and periods of chest tightness and shortness of breath. patient was unable to keep food or fluid down until she received a prescription for Ondansetron from her doctor. Abdominal burning/cramps were at an 8 on the pain scale during the worst periods. Also an increase in anxiety to the point of panic attack occurring on 28Apr2021. the adverse event result in Doctor or other healthcare professional office/clinic visit. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. treatment received for the adverse event included Ondansetron and Proair inhaler. Outcome of the events was recovering.   Information on Lot/Batch number was available. Additional information has been requested.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Generalised tonic-clonic seizure, Palpitations
Clinical narrative: Grand Mal seizure; Heart palpitations; This is a spontaneous report from a contactable consumer (patient). A 35-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via unspecified route of administration in left arm on 28Apr2021 at 14:00 (lot number: EW0158) at single dose for COVID-19 immunization. The relevant medical history included epilepsy, childhood leukemia and COVID-19 (Prior to vaccination, the patient was diagnosed with COVID-19), all from unspecified date. Concomitant medications included lamotrigine (LAMICTAL ODT). The patient experienced Grand Mal seizure and heart palpitations on 29Apr2021 at 18:00. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was recovering.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Loss of personal independence in daily activities, Pruritus, Rash erythematous, Swelling face
Clinical narrative: massive itching; There is resolutions till date its painfull itching sleep interupted.; red rashes all over body and face swollen/red rashes erruptions.; face swollen/worsen with swelling; This is a spontaneous report from a contactable consumer (patient). A 65-year-old male patient received he second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot Number: ER8731), via an unspecified route of administration at the age of 65-year-old at arm Left on 14Apr2021 14:30 at single dose for COVID-19 immunization. Medical history was reported as no illness ever before, Prior to vaccination, the patient wasn't diagnosed with COVID-19. Concomitant medications were not reported. There were no other medications the patient received within 2 weeks of vaccination. The patient previously received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number: EP7534) at the age of 65-year-old at left arm on 26Mar2021 01:15 PM for COVID-19 immunisation. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Facility where the most recent COVID-19 vaccine was administered in pharmacy or drug store. Since the vaccination, the patient hasn't been tested for COVID-19. In 8 hours of receiving vaccin second shot on Friday (as reported) red rashes all over body and face swollen on 14Apr2021. Went to Urgent care on Saturday (as reported) the hospital on Sunday (as reported) as situation worsen with swelling and massive itching and red rashes erruptions on 17Apr2021 12:00. There was resolutions till date its painfull itching sleep interrupted on 17Apr2021 12:00, over two weeks now. The patient was hospitalized for one day for events. The adverse event result in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. The patient received treatment (steroid intravenous then oral till date) for the adverse event. The outcome of events was not recovered.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Deafness
Clinical narrative: Lost of hearing; This is a spontaneous report received from a contactable consumer (patient). A 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at left arm on 09Apr2021 04:00 PM at single dose for COVID-19 immunization. Medical history and concomitant medication were not reported. Patient was not pregnant. the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient experienced Lost of hearing (reported on 08Apr2021, pending clarification).  Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Outcome of the event was not recovered.   Information about Batch/Lot number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Deafness, Disease recurrence, Tinnitus
Clinical narrative: his low-level chronic tinnitus and hearing loss became extreme and had stayed that way ever since, 30 days ago, with no relief; his low-level chronic tinnitus and hearing loss became extreme and had stayed that way ever since, 30 days ago, with no relief; his low-level chronic tinnitus and hearing loss became extreme and had stayed that way ever since, 30 days ago, with no relief; This is a spontaneous report from a contactable consumer (patient). A male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via unspecified route of administration in left arm on 30Mar2021 at 11:45 at single dose for COVID-19 immunization. The relevant medical history included low-level chronic tinnitus and idiopathic hearing loss from unspecified date. Concomitant medications were reported as none. On 01Apr2021 at 03:00 AM, one day after the first (AND ONLY) Pfizer injection, his low-level chronic tinnitus and hearing loss became extreme and had stayed that way ever since, 30 days ago, with no relief. Out of fear of making the tinnitus even worse, he had decided not to get the second Pfizer shot. 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 not recovered.  Information about Batch/lot number has been requested.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebral haemorrhage
Clinical narrative: Brain hemorrhage; This is a spontaneous report from a contactable consumer (patient). This 56-year-old male patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number En6200) at single dose on 06Apr2021 13:00 via an unknown route in left arm for Covid-19 immunization. Medical history included hospitalization and vaccine received during existing hospitalization. Prior to vaccination, the patient was not diagnosed with COVID-19. Patient had no known allergies. Concomitant drug was not provided.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced brain hemorrhage on an unknown date in Apr2021. The event resulted in emergency room/department or urgent care, prolongation of existing hospitalization, disability or permanent damage. The report was reported as serious with seriousness criteria of prolonged hospitalization (hospitalization days were 37 days) and disabling. Outcome of the event was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Deafness neurosensory
Clinical narrative: Sudden sensorineural hearing loss; This is a spontaneous report from a contactable physician. An 84-year-old male patient received bnt162b2 (Pfizer COVID 19 vaccine) at the age of 84 years old, via an unspecified route of administration on an unspecified date (Lot Number: Unknown) at single dose for COVID-19 immunization. The patient's medical history was not reported. The patient was not diagnosed with COVID-19 prior to vaccination. The patient's concomitant medications were not reported. The patient experienced sudden sensorineural hearing loss on 13Apr2021. Seriousness criterion was reported as disability. The event resulted in doctor or other healthcare professional office/clinic visit. The patient received high dose prednisone as treatment. The patient has not been tested for COVID-19 since the vaccination. The outcome of event was not resolved.   Information about lot/batch number has been requested.; Sender's Comments: As there is limited information in the case provided, the causal association between the event sudden sensorineural hearing loss and the suspect vaccine BNT162B2 cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Chills, Cold sweat, Colitis ischaemic, Colonoscopy
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). This 60-year-old female (no pregnant) patient received 2nd dose of BNT162B2 on 14Apr2021 03:45 PM on Left arm at single dose for covid-19 immunization. Medical history was Myasthenia Gravis. Past drug was allergies to Z pack. Historical Vaccine was 1st dose of BNT162B2 on 24Mar2021 03:45 PM on Left arm for covid-19 immunization. No other vaccine in four weeks. Other Medications in Two week included Olmesartan, Calcium. On the second day of the second dose of Pfizer (15Apr2021), she had the expected side effects, such as chills, muscle pain during the day. But, around 11 p.m. she suddenly started having abdominal pain, then throwing up, cold sweats, shivering, dizziness. She was taken to ER that night. The ER doctor did a CT, lab work but didn't find anything remarkable, so she was sent home. The next day (16Apr2021) she found blood in the toilet when she had bowel movement, so she went to see family doctor. He confirmed it's blood. He then set up an appointment for her to see a specialist the next Monday, since it's Friday afternoon. The bleeding got worse at night (16Apr2021), so she went to that ER again. She was then admitted to the hospital due to the big drop of red blood cell count. Later, the specialist did a colonoscopy on her and the result showed ischemic colitis. She was released from the hospital on 18Apr2021. This is very surprising to her as she had never had GI problems before. Events results in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization (2 days). Outcome of the event was Recovering. No covid prior vaccination. No covid tested post vaccination.   Information on the lot/batch number has been requested.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Dizziness, Haematochezia, Myalgia, Red blood cell count
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). This 60-year-old female (no pregnant) patient received 2nd dose of BNT162B2 on 14Apr2021 03:45 PM on Left arm at single dose for covid-19 immunization. Medical history was Myasthenia Gravis. Past drug was allergies to Z pack. Historical Vaccine was 1st dose of BNT162B2 on 24Mar2021 03:45 PM on Left arm for covid-19 immunization. No other vaccine in four weeks. Other Medications in Two week included Olmesartan, Calcium. On the second day of the second dose of Pfizer (15Apr2021), she had the expected side effects, such as chills, muscle pain during the day. But, around 11 p.m. she suddenly started having abdominal pain, then throwing up, cold sweats, shivering, dizziness. She was taken to ER that night. The ER doctor did a CT, lab work but didn't find anything remarkable, so she was sent home. The next day (16Apr2021) she found blood in the toilet when she had bowel movement, so she went to see family doctor. He confirmed it's blood. He then set up an appointment for her to see a specialist the next Monday, since it's Friday afternoon. The bleeding got worse at night (16Apr2021), so she went to that ER again. She was then admitted to the hospital due to the big drop of red blood cell count. Later, the specialist did a colonoscopy on her and the result showed ischemic colitis. She was released from the hospital on 18Apr2021. This is very surprising to her as she had never had GI problems before. Events results in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization (2 days). Outcome of the event was Recovering. No covid prior vaccination. No covid tested post vaccination.   Information on the lot/batch number has been requested.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Red blood cell count decreased, Vomiting
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). This 60-year-old female (no pregnant) patient received 2nd dose of BNT162B2 on 14Apr2021 03:45 PM on Left arm at single dose for covid-19 immunization. Medical history was Myasthenia Gravis. Past drug was allergies to Z pack. Historical Vaccine was 1st dose of BNT162B2 on 24Mar2021 03:45 PM on Left arm for covid-19 immunization. No other vaccine in four weeks. Other Medications in Two week included Olmesartan, Calcium. On the second day of the second dose of Pfizer (15Apr2021), she had the expected side effects, such as chills, muscle pain during the day. But, around 11 p.m. she suddenly started having abdominal pain, then throwing up, cold sweats, shivering, dizziness. She was taken to ER that night. The ER doctor did a CT, lab work but didn't find anything remarkable, so she was sent home. The next day (16Apr2021) she found blood in the toilet when she had bowel movement, so she went to see family doctor. He confirmed it's blood. He then set up an appointment for her to see a specialist the next Monday, since it's Friday afternoon. The bleeding got worse at night (16Apr2021), so she went to that ER again. She was then admitted to the hospital due to the big drop of red blood cell count. Later, the specialist did a colonoscopy on her and the result showed ischemic colitis. She was released from the hospital on 18Apr2021. This is very surprising to her as she had never had GI problems before. Events results in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization (2 days). Outcome of the event was Recovering. No covid prior vaccination. No covid tested post vaccination.   Information on the lot/batch number has been requested.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: positive for COVID; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in left arm on 10Apr2021 (Batch/Lot Number: EW0158) (at the age of 46 years old) as 1st dose, single for COVID-19 immunisation  Medical history included ongoing type 2 diabetes (had this for about a year and a half, from unspecified date). There were no concomitant medications. The patient stated that she got COVID, she was thinking on 18Apr2021 and on 20Apr2021 she was tested and she was positive for COVID. She had the "15 rapid COVID test" and the "nasal swab COVID test" and both were positive. She is due for her second COVID vaccine on Saturday. The outcome of the event was unknown.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for Covid-19; tested positive for Covid-19; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0153), via an unspecified route of administration on 09Apr2021 (at an unspecified age) at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced tested positive for covid-19 on 23Apr2021. The outcome of the events was unknown.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: got his 1st dose on 27Mar2021 and then got Covid; got his 1st dose on 27Mar2021 and then got Covid; This is a spontaneous report from a contactable consumer (patient) from a Pfizer-sponsored program. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 27Mar2021 (Batch/Lot number was not reported) as 1st dose, single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient got his 1st dose on 27Mar2021 and then got Covid on an unspecified date. His 2nd dose was supposed to be on 07Apr2021 and when he got Covid he ended up in the hospital and is now out and wanted to know when he can get the 2nd dose. The outcome of the events was unknown.  Information on the batch/lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Mammogram, Tumour pain
Clinical narrative: tumor in breast started hurting after shot; This is a spontaneous report from a contactable consumer (patient's neighbor). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number and expiration date not reported) via an unspecified route of administration on an unspecified date as 1st dose, single for COVID-19 immunization. Medical history included tumor in breast. The patient's concomitant medications were not reported. The patient had a tumor in her breast that started hurting after her shot on an unspecified date. She had a mammogram to find out if it was cancer, and it was not cancer. It just affected the tumor in her breast. How long will it take for it to go away. She talked to her doctor, and he said her would go away. Outcome of the event was unknown.
Age: 65.0
Sex: U
Vaccine: COVID19
Symptoms: Biopsy bone marrow, Bone marrow disorder, Neutropenia, Neutrophil count, SARS-CoV-2 test
Clinical narrative: neutropenic/low neutrophil count; bone marrow problem; UTI; This is a spontaneous report from a contactable consumer (patient). A 65-year-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 13Mar2021 (Lot number was not reported) as 1st dose, single and on 16Apr2021 (Lot number was not reported) as 2nd dose, single for COVID-19 immunization in a pharmacy/drugstore. Medical history included myasthenia gravis from 2015 and lupus from 1995. Concomitant medications included pyridostigmine bromide (MESTINON) taken for myasthenia gravis and calcium (CALCIUM ACTIVATED) taken for an unspecified indication, with start and stop date for both medications were not reported. On 25Mar2021, 12 days after the first dose, the patient was hospitalized for neutropenic/low neutrophil count. The patient was admitted and was determined to also have UTI. Then on Apr2021, after the second shot, the patient was again hospitalized due to low neutrophil count and got UTI. The patient was given IV antibiotics for the UTI. The patient had a bone marrow exam on 07Apr2021 and showed bone marrow problem which started on an unspecified date. Other lab tests were neutrophil count: low on 25Mar2021 and neutrophil count: low  on Apr2021, SARS-CoV-2 test (COVID-19 antigen test): unknown result on 07Apr2021, thyroid function test (T3 and T4): unknown result on 07Apr2021. The outcome of the events neutropenic/low neutrophil count and UTI was not recovered while for the event bone marrow problem was unknown.  Information on the lot/batch number has been requested.
Age: 65.0
Sex: U
Vaccine: COVID19
Symptoms: Thyroid function test, Urinary tract infection
Clinical narrative: neutropenic/low neutrophil count; bone marrow problem; UTI; This is a spontaneous report from a contactable consumer (patient). A 65-year-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 13Mar2021 (Lot number was not reported) as 1st dose, single and on 16Apr2021 (Lot number was not reported) as 2nd dose, single for COVID-19 immunization in a pharmacy/drugstore. Medical history included myasthenia gravis from 2015 and lupus from 1995. Concomitant medications included pyridostigmine bromide (MESTINON) taken for myasthenia gravis and calcium (CALCIUM ACTIVATED) taken for an unspecified indication, with start and stop date for both medications were not reported. On 25Mar2021, 12 days after the first dose, the patient was hospitalized for neutropenic/low neutrophil count. The patient was admitted and was determined to also have UTI. Then on Apr2021, after the second shot, the patient was again hospitalized due to low neutrophil count and got UTI. The patient was given IV antibiotics for the UTI. The patient had a bone marrow exam on 07Apr2021 and showed bone marrow problem which started on an unspecified date. Other lab tests were neutrophil count: low on 25Mar2021 and neutrophil count: low  on Apr2021, SARS-CoV-2 test (COVID-19 antigen test): unknown result on 07Apr2021, thyroid function test (T3 and T4): unknown result on 07Apr2021. The outcome of the events neutropenic/low neutrophil count and UTI was not recovered while for the event bone marrow problem was unknown.  Information on the lot/batch number has been requested.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Tested Positive for Covid19 on 19APR2021, after receiving his second dose of the Covid Vaccine on 8MAR2021.; Tested Positive for Covid19 on 19APR2021, after receiving his second dose of the Covid Vaccine on 8MAR2021.; This is a spontaneous report from a contactable consumer (patient). A 65-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Deltoid Left on 08Mar2021 (Lot Number: EL9269, at age of 65 years old) and first dose on 15Feb2021 (Lot: EN6200), both as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received first vaccine dose of BNT162B2 on 15Feb2021 for COVID-19 immunisation, LOT: EN6200. The patient Tested Positive for Covid-19 on 19Apr2021, was diagnosed with Covid19. The patient stated that was going to require glasses he thought when asked to read the numbers off of the vaccine card. Treatment: None. The outcome of events was recovered on 27Apr2021.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021484060 same drug/reporter/event, different patient
Sex: U
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: more numbness in their body after the second COVID-19 vaccine; This is a spontaneous report received from a contactable other non-HCP (healthcare professional). A patient of unspecified age and gender received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation and experienced numbness in their limbs. On an unspecified date the patient experienced more numbness in their body after the second COVID-19 vaccine, which was serious for hospitalization. One of the reporter's friends was a primary care doctor, and the doctor saw the same type of reaction that the reporter had, in another patient. The caller's friend, who was a doctor, mentioned someone that had numbness in their limbs after receiving the first COVID-19 vaccine. When this person had the second COVID-19 vaccine they had more numbness in their body and now they were hospitalized. That person was having a bad reaction. The reporter did not know anything else about this patient. The clinical outcome of the event more numbness in their body after the second COVID-19 vaccine was unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: developed Covid after receiving the first dose; developed Covid after receiving the first dose; This is a spontaneous report from a contactable 71 year old male consumer (patient) who reported that:  Dates for developed Covid after receiving the first dose: (From: Unspecified To: Unspecified) Reporter seriousness for developed Covid after receiving the first dose: Hospitalization Dates when patient was in hospital for developed Covid after receiving the first dose: Unspecified to Unspecified  Additional Context: Caller received the first dose of the Covid-19 vaccine on 17Mar2021. He was supposed to have received the second dose on 02Apr2021. After receiving the first dose he developed Covid and was in the hospital. He is now negative. He is asking when can he get the second dose?  Declines to provide email address. Declines to provide further details. initially provided date of birth but then requested that his birthdate be eliminated.   Communication: PC filed.   Is there a Product Complaint: Yes Description of Product Complaint: Description of complaint: developed Covid after receiving the first dose Product strength and count size dispensed: Covid 19 vaccine
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Asymptomatic COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: tested positive for COVID-19 but she was asymptomatic; tested positive for COVID-19 but she was asymptomatic; This is a spontaneous report from a contactable consumer (patient's husband). A 65 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 15Jan2021 at 20:30 (at the age of 64 years old) (Batch/Lot Number: EL3249) as a single dose, and dose 2 via an unspecified route of administration on 05Feb2021 at 13:00 (at the age of 64 years old) (Batch/Lot Number: EL9269) as a single dose, dose 2 for COVID-19 immunisation. Relevant medical history and concomitant medication were not provided. On 23Apr2021, the patient tested positive for COVID-19 but she was asymptomatic.  The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 23Apr2021. The patient did not receive treatment for the event. The outcome of the event tested positive for COVID-19 but she was asymptomatic was unknown.    ; Sender's Comments: Linked Report(s) : PFIZER INC-2021483900 same drug/reporter/event, different patient
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Deep vein thrombosis, Pain in extremity, Peripheral swelling, Ultrasound scan
Clinical narrative: Left calf pain started around 4/12; went to Total Access Urgent Care on 4/28 as pain had increased with minor swelling and Ultrasound showed DVT.; swelling; Ultrasound showed DVT; This is a spontaneous report from a contactable other healthcare professional (patient). A 41-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Right on 01Apr2021 (Lot Number: er8733, at age of 41 years old) as single dose for COVID-19 immunisation. The patient was diagnosed with COVID-19 prior to vaccination. Concomitant medications included: Levonorgestrel; Pravastatin. The patient previously received Penicillin, dairy products. Left calf pain started around 12Apr2021; went to Total Access Urgent Care on 28Apr2021 as pain had increased with minor swelling and Ultrasound showed DVT (Deep vein thrombosis) in Apr2021. The adverse event result in Emergency room/department or urgent care. The patient received treatment for the adverse event: On Eliquis blood thinner for 3 months. The outcome of events was unknown.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on the information currently available, a possible contribution of the suspect drug administration to the event deep vein thrombosis cannot be excluded, due to a plausible temporal relationship. 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: Haemorrhage, Intermenstrual bleeding
Clinical narrative: Spotting/bleeding 2 days after 2nd dose.; Spotting/bleeding 2 days after 2nd dose.; This is a spontaneous report from a non-contactable consumer (patient). A 54-year-old female patient received the second dose of BNT162B2, via an unspecified route of administration in left arm on 26Apr2021 at single dose for COVID-19 immunisation. Medical history included COVID-19 diagnosed prior to vaccination and menopause for 2 years. Concomitant medications received within 2 weeks of vaccination included vitamins. Patient previously received the first dose of BNT162B2 for COVID-19 immunisation. Patient experienced spotting/bleeding 2 days after the second dose on 28Apr2021. Since the vaccination, the patient had not been tested for COVID-19. No treatment was received. Outcome of the events was not resolved.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19, UNK, UNK
Symptoms: Asthenia, Epistaxis, Thrombosis
Clinical narrative: blood clots, Clots were going down the back of her throat; currently feels very weak; nose bleed; This is a spontaneous report from a non-contactable consumer. This report was received via a sales representative. A 70-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: unknown), single dose via an unspecified route of administration in Apr2021 for covid-19 immunization. The patient's medical history was not reported. The patient has been on icosapent ethyl (VESCEPA) and ibuprofen for years and currently feels very weak on 25Apr2021. Concomitant medications were unknown. The patient experienced nose bleed blood clots throughout the week on 25Apr2021. Clots were going down the back of her throat. The patient had to seek medical attention. and currently feels very weak on 25Apr2021, two weeks after vaccination. The outcome of nose bleed blood clots and weak was unknown.   No follow-up attempts are possible. No further information expected.