chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Loss of consciousness, Seizure, Unresponsive to stimuli
Clinical narrative: SEIZURE; ALLERGIC REACTION; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) 1 total, dose and start therapy date were not reported for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, within five minutes of getting the vaccine patient had an allergic reaction and went into a seizure. An unspecified allergic pen was administered and then patient was sent to the hospital. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the allergic reaction and seizure was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0:20210642922-covid-19 vaccine ad26.cov2.s -Seizure. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). 20210642922-covid-19 vaccine ad26.cov2.s -allergic reaction. This event(s) is labeled per RSI and is therefore considered potentially related.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Hypersensitivity, Seizure
Clinical narrative: SEIZURE; ALLERGIC REACTION; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) 1 total, dose and start therapy date were not reported for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, within five minutes of getting the vaccine patient had an allergic reaction and went into a seizure. An unspecified allergic pen was administered and then patient was sent to the hospital. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the allergic reaction and seizure was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0:20210642922-covid-19 vaccine ad26.cov2.s -Seizure. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). 20210642922-covid-19 vaccine ad26.cov2.s -allergic reaction. This event(s) is labeled per RSI and is therefore considered potentially related.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dizziness, Physical examination, Vestibular neuronitis
Clinical narrative: mild dizziness; This is a spontaneous report from a contactable other healthcare professional, the patient. A 52-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number and Expiration date unknown), via an unspecified route of administration, administered in right arm on 03Apr2021 at 14:30 hours as 1ST DOSE, SINGLE (at the age of 52-years-old) for COVID-19 immunization. Medical history included Gastrooesophageal Reflux Disease (GERD), food sensitives and known allergies of eggs, gluten, dairy and sulfa meds (from an unknown date and unknown if ongoing). Prior to vaccination, patient was not diagnosed with COVID-19. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient received vitamins and digestive enzymes within 2 weeks of vaccination. Since the vaccination, patient had not been tested for COVID-19. On 05Apr2021, at 18:00 hours, patient experienced mild dizziness two days following first COVID-19 vaccine which continued for the next 3 weeks. Patient had a physician office/clinic visit for dizziness. Patient was not dizzy prior to this vaccine. Reporter assessed the event as non-serious. Event recovered in Apr2021. Patient considered that Pfizer product had a casual effect to the adverse event.  Information on the lot/batch number has been requested.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dizziness
Clinical narrative: mild dizziness; This is a spontaneous report from a contactable other healthcare professional, the patient. A 52-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number and Expiration date unknown), via an unspecified route of administration, administered in right arm on 03Apr2021 at 14:30 hours as 1ST DOSE, SINGLE (at the age of 52-years-old) for COVID-19 immunization. Medical history included Gastrooesophageal Reflux Disease (GERD), food sensitives and known allergies of eggs, gluten, dairy and sulfa meds (from an unknown date and unknown if ongoing). Prior to vaccination, patient was not diagnosed with COVID-19. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient received vitamins and digestive enzymes within 2 weeks of vaccination. Since the vaccination, patient had not been tested for COVID-19. On 05Apr2021, at 18:00 hours, patient experienced mild dizziness two days following first COVID-19 vaccine which continued for the next 3 weeks. Patient had a physician office/clinic visit for dizziness. Patient was not dizzy prior to this vaccine. Reporter assessed the event as non-serious. Event recovered in Apr2021. Patient considered that Pfizer product had a casual effect to the adverse event.  Information on the lot/batch number has been requested.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dizziness, Inflammation
Clinical narrative: mild dizziness; This is a spontaneous report from a contactable other healthcare professional, the patient. A 52-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number and Expiration date unknown), via an unspecified route of administration, administered in right arm on 03Apr2021 at 14:30 hours as 1ST DOSE, SINGLE (at the age of 52-years-old) for COVID-19 immunization. Medical history included Gastrooesophageal Reflux Disease (GERD), food sensitives and known allergies of eggs, gluten, dairy and sulfa meds (from an unknown date and unknown if ongoing). Prior to vaccination, patient was not diagnosed with COVID-19. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient received vitamins and digestive enzymes within 2 weeks of vaccination. Since the vaccination, patient had not been tested for COVID-19. On 05Apr2021, at 18:00 hours, patient experienced mild dizziness two days following first COVID-19 vaccine which continued for the next 3 weeks. Patient had a physician office/clinic visit for dizziness. Patient was not dizzy prior to this vaccine. Reporter assessed the event as non-serious. Event recovered in Apr2021. Patient considered that Pfizer product had a casual effect to the adverse event.  Information on the lot/batch number has been requested.
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Death, SARS-CoV-2 test positive
Clinical narrative: DEATH; COVID-19 INFECTION; This spontaneous report received from a health care professional concerned a 61 year old White and Not Hispanic or Latino male. The patient's height, and weight were not reported. The patient's past medical history included health issues The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and expiry: unknown) dose was not reported, one total administered on right arm on 31-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 19-APR-2021, the patient experienced covid-19 infection, he was tested positive for Covid-19 using PCR. On 08-MAY-2021, the patient died from unknown cause of death, it was unknown whether autopsy was performed or not. He was not a home bound patient. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of death on 08-MAY-2021, and the outcome of covid-19 infection was not reported. This case was associated with product quality complaint number : 90000183355. The suspected product quality complaint has been confirmed to be confirmed no PQC was identified within the reported complaint reported. complaint is approved for void. Void:y. based on the PQC evaluation/investigation performed. This report was serious (Death).  Additional information was received from Central Complaint Vigilance on 21-JUN-2021. The following information was updated and incorporated into the case narrative: Product complaint investigation result updated.; Sender's Comments: V0: 20210642793-covid-19 vaccine ad26.cov2.s -Death. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Death, SARS-CoV-2 test
Clinical narrative: DEATH; COVID-19 INFECTION; This spontaneous report received from a health care professional concerned a 61 year old White and Not Hispanic or Latino male. The patient's height, and weight were not reported. The patient's past medical history included health issues The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and expiry: unknown) dose was not reported, one total administered on right arm on 31-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 19-APR-2021, the patient experienced covid-19 infection, he was tested positive for Covid-19 using PCR. On 08-MAY-2021, the patient died from unknown cause of death, it was unknown whether autopsy was performed or not. He was not a home bound patient. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of death on 08-MAY-2021, and the outcome of covid-19 infection was not reported. This case was associated with product quality complaint number : 90000183355. The suspected product quality complaint has been confirmed to be confirmed no PQC was identified within the reported complaint reported. complaint is approved for void. Void:y. based on the PQC evaluation/investigation performed. This report was serious (Death).  Additional information was received from Central Complaint Vigilance on 21-JUN-2021. The following information was updated and incorporated into the case narrative: Product complaint investigation result updated.; Sender's Comments: V0: 20210642793-covid-19 vaccine ad26.cov2.s -Death. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Age: 75.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram abnormal, Mass, Pericardial effusion, Pleural effusion, Positron emission tomogram normal
Clinical narrative: diagnosed with pericardial effusion on his heart and lung/had a slight subtle tightness in his left chest and he thought it was heart trouble and it started after the 2nd dose of the Covid 19 vaccine; This is a spontaneous report from a contactable consumer (patient). A 75-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in left arm on 26Mar2021 15:39 (Batch/Lot Number: EP9655) (at the age of 75-years-old) as second dose, single for COVID-19 immunisation. Medical history included routine cancer screening, artery disease, swollen prostate and he takes 8 different kinds of pills, Guillain-Barre syndrome from 1998, Fuchs' Marginal Keratitis (at the edge of the cornea) from 1996, had pneumonia 3 times in his life in 1947, 1952 and 1983, ongoing blood pressure high, ongoing blood clot in lung. Concomitant medications included apixaban (ELIQUIS) for blood clot in lung from 2018 and ongoing; lisinopril dihydrate (LISINOPRIL) for high blood pressure from 2013 and ongoing; carvedilol taken for an unspecified indication from 2013 and ongoing; isosorbide mononitrate taken for an unspecified indication from 2018 and ongoing; clopidogrel besilate to keep stents from closing off in his artery from 2013 and ongoing; atorvastatin sodium taken for an unspecified indication from 2013 and ongoing and tamsulosin started 6-7 years ago for prostate. The patient was previously administered with first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EN6202) in the left arm on 06Mar2021 at 13:43 (at the age of 75-years-old) for COVID-19 immunisation. Patient reported that after a routine cancer screening on 19May2021 he was diagnosed with pericardial effusion on his heart and lung. Patient stated there were 2 of them, one is the pericardial sac and one in his lung. Patient said he had a routine CT scan on an unspecified date. Patient stated he had a slight subtle tightness in his left chest, and he thought it was heart trouble and it started after the 2nd dose of the Covid 19 vaccine. Patient stated it was 15May2021 around the morning when he ran around 9am. Patient stated that it is about the same and sometimes he doesn't feel it at all and at other times he can, if he coughs he knows it is there; otherwise it is not a problem. Outcome of event was unknown.
Age: 75.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram, Investigation, Pericardial effusion
Clinical narrative: diagnosed with pericardial effusion on his heart and lung/had a slight subtle tightness in his left chest and he thought it was heart trouble and it started after the 2nd dose of the Covid 19 vaccine; This is a spontaneous report from a contactable consumer (patient). A 75-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in left arm on 26Mar2021 15:39 (Batch/Lot Number: EP9655) (at the age of 75-years-old) as second dose, single for COVID-19 immunisation. Medical history included routine cancer screening, artery disease, swollen prostate and he takes 8 different kinds of pills, Guillain-Barre syndrome from 1998, Fuchs' Marginal Keratitis (at the edge of the cornea) from 1996, had pneumonia 3 times in his life in 1947, 1952 and 1983, ongoing blood pressure high, ongoing blood clot in lung. Concomitant medications included apixaban (ELIQUIS) for blood clot in lung from 2018 and ongoing; lisinopril dihydrate (LISINOPRIL) for high blood pressure from 2013 and ongoing; carvedilol taken for an unspecified indication from 2013 and ongoing; isosorbide mononitrate taken for an unspecified indication from 2018 and ongoing; clopidogrel besilate to keep stents from closing off in his artery from 2013 and ongoing; atorvastatin sodium taken for an unspecified indication from 2013 and ongoing and tamsulosin started 6-7 years ago for prostate. The patient was previously administered with first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EN6202) in the left arm on 06Mar2021 at 13:43 (at the age of 75-years-old) for COVID-19 immunisation. Patient reported that after a routine cancer screening on 19May2021 he was diagnosed with pericardial effusion on his heart and lung. Patient stated there were 2 of them, one is the pericardial sac and one in his lung. Patient said he had a routine CT scan on an unspecified date. Patient stated he had a slight subtle tightness in his left chest, and he thought it was heart trouble and it started after the 2nd dose of the Covid 19 vaccine. Patient stated it was 15May2021 around the morning when he ran around 9am. Patient stated that it is about the same and sometimes he doesn't feel it at all and at other times he can, if he coughs he knows it is there; otherwise it is not a problem. Outcome of event was unknown.
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Body temperature increased, Brain injury, Death, Intensive care, Pain in extremity
Clinical narrative: he was found unresponsive in his home; temperature of 115 degrees; his arm was hurting; This is a spontaneous report from a contactable consumer.  A 70-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, administered in Arm Right on 06Mar2021 12:30 (Batch/Lot Number: EN6206) at the age of 70-year-old, as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had known allergies Lisinopril. Prior to vaccination, the patient was not diagnosed with COVID-19. It was reported the vaccine was administered at 12:30 on Saturday, 06Mar2021. That night around 19:00 he called to tell that his arm was hurting. That was the last time anyone heard from him. Two days later on the evening of Monday, 08Mar2021, he was found unresponsive in his home. When the ambulance arrived they found he had a temperature of 115 degrees. He was taken to the emergency room at (Withheld) and placed in the critical care unit. It was determined that he suffered irreversible damage and would never recover. He passed away on 21Mar2021. The adverse event result in Emergency room/department or urgent care. The patient was hospitalized for he was found unresponsive in his home and temperature of 115 degrees for 8 days. Since the vaccination, the patient has been tested for COVID-19. The Covid-19: negative on 08Mar2021. The outcome of unresponsive in his home and temperature of 115 degrees was fatal. The outcome of his arm was hurting was unknown. The patient died on 21Mar2021. Autopsy-determined causes of death reported as: Final result to be determined (TBD).  Follow up attempts are needed. Further information has been requested.; Reported Cause(s) of Death: he was found unresponsive in his home; temperature of 115 degrees
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Unresponsive to stimuli
Clinical narrative: he was found unresponsive in his home; temperature of 115 degrees; his arm was hurting; This is a spontaneous report from a contactable consumer.  A 70-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, administered in Arm Right on 06Mar2021 12:30 (Batch/Lot Number: EN6206) at the age of 70-year-old, as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had known allergies Lisinopril. Prior to vaccination, the patient was not diagnosed with COVID-19. It was reported the vaccine was administered at 12:30 on Saturday, 06Mar2021. That night around 19:00 he called to tell that his arm was hurting. That was the last time anyone heard from him. Two days later on the evening of Monday, 08Mar2021, he was found unresponsive in his home. When the ambulance arrived they found he had a temperature of 115 degrees. He was taken to the emergency room at (Withheld) and placed in the critical care unit. It was determined that he suffered irreversible damage and would never recover. He passed away on 21Mar2021. The adverse event result in Emergency room/department or urgent care. The patient was hospitalized for he was found unresponsive in his home and temperature of 115 degrees for 8 days. Since the vaccination, the patient has been tested for COVID-19. The Covid-19: negative on 08Mar2021. The outcome of unresponsive in his home and temperature of 115 degrees was fatal. The outcome of his arm was hurting was unknown. The patient died on 21Mar2021. Autopsy-determined causes of death reported as: Final result to be determined (TBD).  Follow up attempts are needed. Further information has been requested.; Reported Cause(s) of Death: he was found unresponsive in his home; temperature of 115 degrees
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Hyperpyrexia, Pain in extremity, SARS-CoV-2 test, Unresponsive to stimuli
Clinical narrative: he was found unresponsive in his home; temperature of 115 degrees; his arm was hurting; This is a spontaneous report from a contactable consumer.  A 70-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, administered in Arm Right on 06Mar2021 12:30 (Batch/Lot Number: EN6206) at the age of 70-year-old, as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had known allergies Lisinopril. Prior to vaccination, the patient was not diagnosed with COVID-19. It was reported the vaccine was administered at 12:30 on Saturday, 06Mar2021. That night around 19:00 he called to tell that his arm was hurting. That was the last time anyone heard from him. Two days later on the evening of Monday, 08Mar2021, he was found unresponsive in his home. When the ambulance arrived they found he had a temperature of 115 degrees. He was taken to the emergency room at (Withheld) and placed in the critical care unit. It was determined that he suffered irreversible damage and would never recover. He passed away on 21Mar2021. The adverse event result in Emergency room/department or urgent care. The patient was hospitalized for he was found unresponsive in his home and temperature of 115 degrees for 8 days. Since the vaccination, the patient has been tested for COVID-19. The Covid-19: negative on 08Mar2021. The outcome of unresponsive in his home and temperature of 115 degrees was fatal. The outcome of his arm was hurting was unknown. The patient died on 21Mar2021. Autopsy-determined causes of death reported as: Final result to be determined (TBD).  Follow up attempts are needed. Further information has been requested.; Reported Cause(s) of Death: he was found unresponsive in his home; temperature of 115 degrees
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Dyskinesia, Fatigue, Headache, Laboratory test
Clinical narrative: 16 hours after the shot I started having convulsions/spasms around 1 am on 6/8/21. I am still having convulsions/spasms symptoms on 6/12/21; spasms; This is a spontaneous report from a contactable consumer (patient herself). A 32-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: ew0182, Expiry date: Unknown) via an unspecified route of administration in Left arm on 07Jun2021 09:00 at the age of 32-years-old as 2nd dose, single for COVID-19 immunisation. Medical history included ADHD (attention deficit hyperactivity disorder), depression and tinnitus from an unknown date and unknown if ongoing. Concomitant medications included sertraline (SERTRALINE) taken for an unspecified indication, lisdexamfetamine mesilate (VYVANSE) taken for an unspecified indication, on unspecified date received within 2 weeks of vaccination. The patient previously took penicillin and experienced drug allergy and first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: ew0191, Expiry date: Unknown) via an unspecified route of administration in Left arm on 17May2021 at 09:00 as single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. It was unknown if the patient had been tested for COVID-19 since the vaccination. on 08Jun2021, 01:00AM, 16 hours after the shot, the patient started having convulsions/spasms. She was still having convulsions/spasms symptoms on 12Jun2021. The adverse events resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. The patient received treatment with Benadryl. The patient underwent lab tests and procedures on an unspecified date in Jun2021 which included blood test: unknown results, EKG (electrocardiogram): unknown results and labs (laboratory test): unknown. The outcome of events was not recovered.  Follow-up attempts are needed. Further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Loss of personal independence in daily activities, Muscle spasms, Pain, Pyrexia, Tremor
Clinical narrative: 16 hours after the shot I started having convulsions/spasms around 1 am on 6/8/21. I am still having convulsions/spasms symptoms on 6/12/21; spasms; This is a spontaneous report from a contactable consumer (patient herself). A 32-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: ew0182, Expiry date: Unknown) via an unspecified route of administration in Left arm on 07Jun2021 09:00 at the age of 32-years-old as 2nd dose, single for COVID-19 immunisation. Medical history included ADHD (attention deficit hyperactivity disorder), depression and tinnitus from an unknown date and unknown if ongoing. Concomitant medications included sertraline (SERTRALINE) taken for an unspecified indication, lisdexamfetamine mesilate (VYVANSE) taken for an unspecified indication, on unspecified date received within 2 weeks of vaccination. The patient previously took penicillin and experienced drug allergy and first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: ew0191, Expiry date: Unknown) via an unspecified route of administration in Left arm on 17May2021 at 09:00 as single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. It was unknown if the patient had been tested for COVID-19 since the vaccination. on 08Jun2021, 01:00AM, 16 hours after the shot, the patient started having convulsions/spasms. She was still having convulsions/spasms symptoms on 12Jun2021. The adverse events resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. The patient received treatment with Benadryl. The patient underwent lab tests and procedures on an unspecified date in Jun2021 which included blood test: unknown results, EKG (electrocardiogram): unknown results and labs (laboratory test): unknown. The outcome of events was not recovered.  Follow-up attempts are needed. Further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Electrocardiogram, Laboratory test, Muscle spasms, Seizure
Clinical narrative: 16 hours after the shot I started having convulsions/spasms around 1 am on 6/8/21. I am still having convulsions/spasms symptoms on 6/12/21; spasms; This is a spontaneous report from a contactable consumer (patient herself). A 32-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: ew0182, Expiry date: Unknown) via an unspecified route of administration in Left arm on 07Jun2021 09:00 at the age of 32-years-old as 2nd dose, single for COVID-19 immunisation. Medical history included ADHD (attention deficit hyperactivity disorder), depression and tinnitus from an unknown date and unknown if ongoing. Concomitant medications included sertraline (SERTRALINE) taken for an unspecified indication, lisdexamfetamine mesilate (VYVANSE) taken for an unspecified indication, on unspecified date received within 2 weeks of vaccination. The patient previously took penicillin and experienced drug allergy and first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: ew0191, Expiry date: Unknown) via an unspecified route of administration in Left arm on 17May2021 at 09:00 as single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. It was unknown if the patient had been tested for COVID-19 since the vaccination. on 08Jun2021, 01:00AM, 16 hours after the shot, the patient started having convulsions/spasms. She was still having convulsions/spasms symptoms on 12Jun2021. The adverse events resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. The patient received treatment with Benadryl. The patient underwent lab tests and procedures on an unspecified date in Jun2021 which included blood test: unknown results, EKG (electrocardiogram): unknown results and labs (laboratory test): unknown. The outcome of events was not recovered.  Follow-up attempts are needed. Further information is expected.
Age: 12.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Immunisation, Needle issue, Underdose
Clinical narrative: barrel of the syringe became detached and some of the vaccine leaked out of the arm and sprayed on the face shield of the patient; They were not exactly sure how much but it was less than 0.2mL for sure/the needle of the syringe came apart from the barrel and not all of the vaccine was administered; This is a spontaneous report from a contactable pharmacist.A 12-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm on 10Jun2021 (Batch/Lot Number: EW0196; Expiration Date: Aug2021) as DOSE 2, SINGLE for covid-19 immunisation, prophylaxis.  The patient medical history and concomitant medications were not reported.  She previously received the first dose of BNT162B2 (lot number EW0170, expiration Aug 2021) on 20May2021 for covid-19 immunization. Upon administration, the barrel of the syringe became detached and some of the vaccine leaked out of the arm and sprayed on the face shield of the patient. They noticed that 0.1mL remained in the syringe and about 0.2mL was potentially administered. They were not exactly sure how much but it was less than 0.2mL for sure. She would like to know if they should revaccinate the patient. Reporter seriousness for the needle of the syringe came apart from the barrel and not all of the vaccine was administered was Medically significant.; Sender's Comments: Based on the temporal association there is reasonable possibility of causal association between the event underdose and the suspect drug BNT162B2 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: 12.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product leakage, Underdose
Clinical narrative: barrel of the syringe became detached and some of the vaccine leaked out of the arm and sprayed on the face shield of the patient; They were not exactly sure how much but it was less than 0.2mL for sure/the needle of the syringe came apart from the barrel and not all of the vaccine was administered; This is a spontaneous report from a contactable pharmacist.A 12-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm on 10Jun2021 (Batch/Lot Number: EW0196; Expiration Date: Aug2021) as DOSE 2, SINGLE for covid-19 immunisation, prophylaxis.  The patient medical history and concomitant medications were not reported.  She previously received the first dose of BNT162B2 (lot number EW0170, expiration Aug 2021) on 20May2021 for covid-19 immunization. Upon administration, the barrel of the syringe became detached and some of the vaccine leaked out of the arm and sprayed on the face shield of the patient. They noticed that 0.1mL remained in the syringe and about 0.2mL was potentially administered. They were not exactly sure how much but it was less than 0.2mL for sure. She would like to know if they should revaccinate the patient. Reporter seriousness for the needle of the syringe came apart from the barrel and not all of the vaccine was administered was Medically significant.; Sender's Comments: Based on the temporal association there is reasonable possibility of causal association between the event underdose and the suspect drug BNT162B2 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, COVID19
Symptoms: Blood immunoglobulin M decreased, Blood test, Neuropathy peripheral, Paraesthesia
Clinical narrative: Neuropathy all over body; adversely low immunoglobulin M; This is a spontaneous report from a contactable consumer (patient). A 61-year-old non-pregnant female patient received bnt162b2 (Pfizer COVID 19 brand), dose 1 via an unspecified route of administration, administered in left arm on 26Apr2021 16:00 (Lot Number: EWO165) as single for COVID-19 immunization. The patient's medical history was not reported. The patient was on unspecified vitamins. The patient previously took sulfadiazine (SULFA) and ciprofloxacin (CIPRO) and experienced allergies. The patient experienced pins and needles - neuropathy all over body daily, worse in afternoon, transient and so far lasting 6 and half weeks. Also, had blood test and adversely low immunoglobulin M not explained by doctors. Onset of events reported as on 26Apr2021 16:15 with outcome of not recovered. Events resulted in doctor or other healthcare professional office/clinic visit. No treatment was given for events. The patient has not received other vaccine in four weeks. The patient was not diagnosed of covid prior vaccination and has not tested for covid post vaccination.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood immunoglobulin M, Blood immunoglobulin M decreased, Neuropathy peripheral
Clinical narrative: Neuropathy all over body; adversely low immunoglobulin M; This is a spontaneous report from a contactable consumer (patient). A 61-year-old non-pregnant female patient received bnt162b2 (Pfizer COVID 19 brand), dose 1 via an unspecified route of administration, administered in left arm on 26Apr2021 16:00 (Lot Number: EWO165) as single for COVID-19 immunization. The patient's medical history was not reported. The patient was on unspecified vitamins. The patient previously took sulfadiazine (SULFA) and ciprofloxacin (CIPRO) and experienced allergies. The patient experienced pins and needles - neuropathy all over body daily, worse in afternoon, transient and so far lasting 6 and half weeks. Also, had blood test and adversely low immunoglobulin M not explained by doctors. Onset of events reported as on 26Apr2021 16:15 with outcome of not recovered. Events resulted in doctor or other healthcare professional office/clinic visit. No treatment was given for events. The patient has not received other vaccine in four weeks. The patient was not diagnosed of covid prior vaccination and has not tested for covid post vaccination.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Tinnitus
Clinical narrative: Maddening constant tinnitus and hearing loss per hearing test; Maddening constant tinnitus and hearing loss per hearing test; This is a spontaneous report received from a contactable consumer (patient reported for herself). A 49-year-old female patient (Non-pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: ER8737), dose 1 via an unspecified route of administration, administered in Arm Right on 31Mar2021 (at the age of 49-year-old) as single, dose 2 via an unspecified route of administration, administered in Arm Left on unspecified date in 2021 (Batch/Lot Number: EW0170) (at the age of 49-year-old) as single for covid-19 immunisation. Medical history included none. The patient had non known allergies. The patient concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 Prior to vaccination. On 26Apr2021, the patient experienced maddening constant tinnitus and hearing loss per hearing test. On unspecified date, the patient had a visit to physician office for the events. The patient was not tested for COVID-19 since the vaccination. The patient received treatment with Claritin to treat the events. The outcome the events was reported as not resolved at the time of this report.  Follow-up attempts are needed. Further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Acoustic stimulation tests, Deafness, Tinnitus
Clinical narrative: Maddening constant tinnitus and hearing loss per hearing test; Maddening constant tinnitus and hearing loss per hearing test; This is a spontaneous report received from a contactable consumer (patient reported for herself). A 49-year-old female patient (Non-pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: ER8737), dose 1 via an unspecified route of administration, administered in Arm Right on 31Mar2021 (at the age of 49-year-old) as single, dose 2 via an unspecified route of administration, administered in Arm Left on unspecified date in 2021 (Batch/Lot Number: EW0170) (at the age of 49-year-old) as single for covid-19 immunisation. Medical history included none. The patient had non known allergies. The patient concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 Prior to vaccination. On 26Apr2021, the patient experienced maddening constant tinnitus and hearing loss per hearing test. On unspecified date, the patient had a visit to physician office for the events. The patient was not tested for COVID-19 since the vaccination. The patient received treatment with Claritin to treat the events. The outcome the events was reported as not resolved at the time of this report.  Follow-up attempts are needed. Further information is expected.
Age: 15.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Dyspnoea, Fatigue, Headache, Influenza like illness
Clinical narrative: Heart really hurts; Difficulty breathing; Pain in her chest; Sore arm; Body aches; Fever; Fatigue; Headache; This is a spontaneous report from a contactable consumer or other non-health care professional (parent). A 15-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EW0127 and expiration date was not reported), second dose via an unspecified route of administration, administered in arm left on 08Jun2021 17:45 (at the age of 15 years) as single for covid-19 immunisation. Medical history included vocal cord dysfunction, allergy to animal (cat), Low blood pressure issue, (Patient had to stay hydrated, or she can become faint when she stands up (it is a low blood pressure issue) (she has to stay hydrated or can become faint when she stands up) from an unknown date and unknown if ongoing. Concomitant medication included ibuprofen (ADVIL) taken for an unspecified indication, start and stop date were not reported and patient received within 2 weeks of vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19, prior vaccination and since the vaccination. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EW0173 02:30 PM and expiration date was not reported), first dose on 15May2021 as single for covid-19 immunisation. The patient experienced heart really hurts, difficulty breathing and Pain in her chest on 10Jun2021 03:00, sore arm, body aches, fever, fatigue and headache on 09Jun2021. Reported as Patient experienced many of the typical side effects like a sore arm, body aches, a fever, fatigue and a headache. Overnight from Wed to Thurs, patient woke up at about 3 AM with bad pain in her chest and difficulty breathing. In her words "my heart really hurts and it is hurts to breath." She was received one 500 mg Tylenol capsule (she had not had anything up to that point) along with Frankincense oil topically. patient was in too much pain to go back to sleep so she was up for about 2 hours but then she did finally fall back asleep. Her heart pain decreased during the day on Thursday and today she says it is not hurting. When father of patient heard about children (withheld) age experiencing myocarditis after the vaccine, he thought it sounded like what she experienced. Father of patient am concerned that there might be some kind of long-term damage to her heart. Therapeutic measures were taken as a result of heart really hurts, sore arm, body aches, fever, headache, pain in her chest, difficulty breathing and therapeutic measures not taken for Fatigue. The outcome for the event Heart really hurts was resolved on 11Jan2021 and other events was unknown.   Information on lot/batch number was available. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain, Pain in extremity, Painful respiration
Clinical narrative: Heart really hurts; Difficulty breathing; Pain in her chest; Sore arm; Body aches; Fever; Fatigue; Headache; This is a spontaneous report from a contactable consumer or other non-health care professional (parent). A 15-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EW0127 and expiration date was not reported), second dose via an unspecified route of administration, administered in arm left on 08Jun2021 17:45 (at the age of 15 years) as single for covid-19 immunisation. Medical history included vocal cord dysfunction, allergy to animal (cat), Low blood pressure issue, (Patient had to stay hydrated, or she can become faint when she stands up (it is a low blood pressure issue) (she has to stay hydrated or can become faint when she stands up) from an unknown date and unknown if ongoing. Concomitant medication included ibuprofen (ADVIL) taken for an unspecified indication, start and stop date were not reported and patient received within 2 weeks of vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19, prior vaccination and since the vaccination. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EW0173 02:30 PM and expiration date was not reported), first dose on 15May2021 as single for covid-19 immunisation. The patient experienced heart really hurts, difficulty breathing and Pain in her chest on 10Jun2021 03:00, sore arm, body aches, fever, fatigue and headache on 09Jun2021. Reported as Patient experienced many of the typical side effects like a sore arm, body aches, a fever, fatigue and a headache. Overnight from Wed to Thurs, patient woke up at about 3 AM with bad pain in her chest and difficulty breathing. In her words "my heart really hurts and it is hurts to breath." She was received one 500 mg Tylenol capsule (she had not had anything up to that point) along with Frankincense oil topically. patient was in too much pain to go back to sleep so she was up for about 2 hours but then she did finally fall back asleep. Her heart pain decreased during the day on Thursday and today she says it is not hurting. When father of patient heard about children (withheld) age experiencing myocarditis after the vaccine, he thought it sounded like what she experienced. Father of patient am concerned that there might be some kind of long-term damage to her heart. Therapeutic measures were taken as a result of heart really hurts, sore arm, body aches, fever, headache, pain in her chest, difficulty breathing and therapeutic measures not taken for Fatigue. The outcome for the event Heart really hurts was resolved on 11Jan2021 and other events was unknown.   Information on lot/batch number was available. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Angina pectoris, Chest pain, Dyspnoea, Fatigue, Headache
Clinical narrative: Heart really hurts; Difficulty breathing; Pain in her chest; Sore arm; Body aches; Fever; Fatigue; Headache; This is a spontaneous report from a contactable consumer or other non-health care professional (parent). A 15-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EW0127 and expiration date was not reported), second dose via an unspecified route of administration, administered in arm left on 08Jun2021 17:45 (at the age of 15 years) as single for covid-19 immunisation. Medical history included vocal cord dysfunction, allergy to animal (cat), Low blood pressure issue, (Patient had to stay hydrated, or she can become faint when she stands up (it is a low blood pressure issue) (she has to stay hydrated or can become faint when she stands up) from an unknown date and unknown if ongoing. Concomitant medication included ibuprofen (ADVIL) taken for an unspecified indication, start and stop date were not reported and patient received within 2 weeks of vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19, prior vaccination and since the vaccination. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EW0173 02:30 PM and expiration date was not reported), first dose on 15May2021 as single for covid-19 immunisation. The patient experienced heart really hurts, difficulty breathing and Pain in her chest on 10Jun2021 03:00, sore arm, body aches, fever, fatigue and headache on 09Jun2021. Reported as Patient experienced many of the typical side effects like a sore arm, body aches, a fever, fatigue and a headache. Overnight from Wed to Thurs, patient woke up at about 3 AM with bad pain in her chest and difficulty breathing. In her words "my heart really hurts and it is hurts to breath." She was received one 500 mg Tylenol capsule (she had not had anything up to that point) along with Frankincense oil topically. patient was in too much pain to go back to sleep so she was up for about 2 hours but then she did finally fall back asleep. Her heart pain decreased during the day on Thursday and today she says it is not hurting. When father of patient heard about children (withheld) age experiencing myocarditis after the vaccine, he thought it sounded like what she experienced. Father of patient am concerned that there might be some kind of long-term damage to her heart. Therapeutic measures were taken as a result of heart really hurts, sore arm, body aches, fever, headache, pain in her chest, difficulty breathing and therapeutic measures not taken for Fatigue. The outcome for the event Heart really hurts was resolved on 11Jan2021 and other events was unknown.   Information on lot/batch number was available. Additional information has been requested.