chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report from a contactable consumer reporting same event under the same suspect product for 28 patients. This is one of 28 reports. A patient of unspecified age and gender received bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN,SINGLE for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced COVID-19 (medically significant) on an unspecified date with outcome of unknown. The patient underwent lab tests and procedures which included COVID-19 virus test: positive on unknown date. The reporter stated that 28 people from a certain location tested positive.  The lot number for bnt162b2 was not provided and will be requested during follow-up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101237061 Same reporter/product/events, different patient;US-PFIZER INC-202101237061 Same reporter/product/events, different patient
Age: 43.0
Sex: F
Vaccine: UNK
Symptoms: Cough
Clinical narrative: Coughing spells; This is a spontaneous report from a contactable consumer. A 43-year-old female patient received BNT162B2 (COMIRNATY, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 07Sep2021 (at the age of 43 year) as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 23Sep2021, consumer stated that she did not have chills but had coughing spells. Consumer would like to know if she can still get COVID even after being vaccinated and if the cough just might be from the vaccine. The outcome of events was not recovered.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Developed shingles 10 days post-vaccination; This is a spontaneous report from contactable consumer reported for herself. A 45-year-old non-pregnant female patient received first dose of bnt162b2 (Pfizer COVID-19 vaccine, Solution for injection, Batch/lot number: FD8448), via an unspecified route in the right arm on 20Aug2021 (age at vaccination: 45-year-old), as a single dose for COVID-19 immunization. The patient medical history was reported as none. Concomitant medications included Vitamin D3 and ascorbic acid (VITAMIN C). No known drug allergies were reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. On 30Aug2021, patient developed shingles 10 days post-vaccination. Adverse event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures taken as a result of the events included unknown medications. The clinical outcome of the event was recovering/ resolving.   Follow-up attempts are needed. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Inappropriate schedule of product administration, SARS-CoV-2 test
Clinical narrative: Covid positive; Covid positive; First and second dose on 05Mar2021; This is a spontaneous report from a contactable consumer (patient). A 27-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in Arm Right on 05Mar2021 (at the age of 27-year-old) as dose 1, single (Lot Number: EN6204) and via an unspecified route of administration, administered in Arm Right on 05Mar2021 (as reported) as dose 2, single (Lot Number: ER8730) for COVID-19 immunization. Medical history included PCOS and Known allergies: Gluten, tree nuts. The patient received medication within 2 weeks of vaccination which included birth control & anxiety meds. The patient experienced COVID positive on 18Sep2021. Case was reported as non-serious. The events resulted to a doctor or other healthcare professional office/clinic visit. No treatment was received. The facility where the vaccine was administered was in a hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient underwent lab tests and procedures which included covid-19 Test: positive (Nasal Swab) on 18Sep2021. Outcome of the event was recovering.
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: I know 3 people died because of the vaccine; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer reported similar events for 3 patients. This report is for 1st of 3 patients.   This consumer reported that a patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date as single dose for covid-19 immunisation. Medical history and concomitant medications were not reported. Reporter was reading a letter, asking for the ingredients of COMIRNATY. The reporter asked when was Comirnaty going to be available and why was it already FDA approved then it was not available right now It's scary because people are dying because of the vaccine. Reporter knew 3 people died because of the vaccine. Reporter also mentioned she was concerned about the liability of Pfizer since the available one was the Pfizer Biontech COVID 19 vaccine. Reporter was unsure if it was Pfizer. It was unknown if Autopsy Done. The outcome of the event was fatal.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow-up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101266047 same drug/AE, different patient;US-PFIZER INC-202101266048 same drug,AE, different patient; Reported Cause(s) of Death: I know 3 people died because of the vaccine
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Apnoea, Diarrhoea, Dyspnoea, Headache, Migraine
Clinical narrative: Dyspnea; Migraine; More headache; Diarrhea; diagnosed with dyspnea, which stops breathing; Left side started hurting really bad/pain; This is a spontaneous report from a contactable consumer (patient).   A 42-year-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration on 09Sep2021, at the age of 42-years-old, (Lot Number: FF2587) as DOSE 1, SINGLE for covid-19 immunisation.  Medical history included anaemia and border line diabetic. Concomitant medication included bupropion hydrochloride (WELLBUTRIN) 450mg. After taking the 1st vaccine, patient stated that the left side started hurting really bad/pain and she had diarrhea from it, but the pain lasted about 7 days. She thought it was gone, the patient asked what does she have to do to getting stop hurting. The patient had been diagnosed with dyspnea, which stops breathing something like asthma and she had more issue in her breath. The patient also had migraine. She stated that she think have more headache now. The outcome of the event left side started hurting really bad/pain was recovered after about 7 days; the outcome of the other events was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain
Clinical narrative: Dyspnea; Migraine; More headache; Diarrhea; diagnosed with dyspnea, which stops breathing; Left side started hurting really bad/pain; This is a spontaneous report from a contactable consumer (patient).   A 42-year-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration on 09Sep2021, at the age of 42-years-old, (Lot Number: FF2587) as DOSE 1, SINGLE for covid-19 immunisation.  Medical history included anaemia and border line diabetic. Concomitant medication included bupropion hydrochloride (WELLBUTRIN) 450mg. After taking the 1st vaccine, patient stated that the left side started hurting really bad/pain and she had diarrhea from it, but the pain lasted about 7 days. She thought it was gone, the patient asked what does she have to do to getting stop hurting. The patient had been diagnosed with dyspnea, which stops breathing something like asthma and she had more issue in her breath. The patient also had migraine. She stated that she think have more headache now. The outcome of the event left side started hurting really bad/pain was recovered after about 7 days; the outcome of the other events was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest X-ray, Condition aggravated, Dyspnoea, Migraine, Ocular discomfort
Clinical narrative: Dyspnea; Migraine; More headache; Diarrhea; diagnosed with dyspnea, which stops breathing; Left side started hurting really bad/pain; This is a spontaneous report from a contactable consumer (patient).   A 42-year-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration on 09Sep2021, at the age of 42-years-old, (Lot Number: FF2587) as DOSE 1, SINGLE for covid-19 immunisation.  Medical history included anaemia and border line diabetic. Concomitant medication included bupropion hydrochloride (WELLBUTRIN) 450mg. After taking the 1st vaccine, patient stated that the left side started hurting really bad/pain and she had diarrhea from it, but the pain lasted about 7 days. She thought it was gone, the patient asked what does she have to do to getting stop hurting. The patient had been diagnosed with dyspnea, which stops breathing something like asthma and she had more issue in her breath. The patient also had migraine. She stated that she think have more headache now. The outcome of the event left side started hurting really bad/pain was recovered after about 7 days; the outcome of the other events was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain, Urine analysis
Clinical narrative: Dyspnea; Migraine; More headache; Diarrhea; diagnosed with dyspnea, which stops breathing; Left side started hurting really bad/pain; This is a spontaneous report from a contactable consumer (patient).   A 42-year-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration on 09Sep2021, at the age of 42-years-old, (Lot Number: FF2587) as DOSE 1, SINGLE for covid-19 immunisation.  Medical history included anaemia and border line diabetic. Concomitant medication included bupropion hydrochloride (WELLBUTRIN) 450mg. After taking the 1st vaccine, patient stated that the left side started hurting really bad/pain and she had diarrhea from it, but the pain lasted about 7 days. She thought it was gone, the patient asked what does she have to do to getting stop hurting. The patient had been diagnosed with dyspnea, which stops breathing something like asthma and she had more issue in her breath. The patient also had migraine. She stated that she think have more headache now. The outcome of the event left side started hurting really bad/pain was recovered after about 7 days; the outcome of the other events was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Apnoea, Diarrhoea, Dyspnoea, Headache, Migraine
Clinical narrative: Pain in lower left side, first week of vaccine, migraines worse, pressure behind eyes, difficulty breathing
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain
Clinical narrative: Pain in lower left side, first week of vaccine, migraines worse, pressure behind eyes, difficulty breathing
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest X-ray, Condition aggravated, Dyspnoea, Migraine, Ocular discomfort
Clinical narrative: Pain in lower left side, first week of vaccine, migraines worse, pressure behind eyes, difficulty breathing
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain, Urine analysis
Clinical narrative: Pain in lower left side, first week of vaccine, migraines worse, pressure behind eyes, difficulty breathing
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: I know 3 people died because of the vaccine; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer reported same event for 3 patients. This report is for 2nd of 3 patients.   This consumer reported that a patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date as single dose for covid-19 immunisation. Medical history and concomitant medications were not reported. Reporter was reading a letter from FDA dated 23Aug2021, asking for the ingredients of COMIRNATY. The reporter asked when was Comirnaty going to be available and why was it already FDA approved then it was not available right now It's scary because people are dying because of the vaccine. Reporter knew 3 people died because of the vaccine. Reporter also mentioned she was concerned about the liability of Pfizer since the available one was the Pfizer Biontech COVID 19 vaccine. Reporter was unsure if it was Pfizer. It was unknown if Autopsy Done. The outcome of the event was fatal.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow-up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101265404 same drug,AE, different patient;US-PFIZER INC-202101266048 same drug,AE, different patient; Reported Cause(s) of Death: I know 3 people died because of the vaccine
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: I know 3 people died because of the vaccine; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer reported same event for 3 patients. This report is for 3rd of 3 patients.   This consumer reported that a patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date as single dose for covid-19 immunisation. Medical history and concomitant medications were not reported. Reporter was reading a letter from FDA dated 23Aug2021, asking for the ingredients of COMIRNATY. The reporter asked when was Comirnaty going to be available and why was it already FDA approved then it was not available right now It's scary because people are dying because of the vaccine. Reporter knew 3 people died because of the vaccine. Reporter also mentioned she was concerned about the liability of Pfizer since the available one was the Pfizer Biontech COVID 19 vaccine. Reporter was unsure if it was Pfizer. It was unknown if Autopsy Done. The outcome of the event was fatal.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow-up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101265404 same drug,AE, different patient;US-PFIZER INC-202101266047 same drug,AE, different patient; Reported Cause(s) of Death: I know 3 people died because of the vaccine
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: Caller stated he has 1st Pfizer Covid 19 vaccine in March and within 8 hours developed Bells Palsy; This is a spontaneous report from a Pfizer-sponsored program Support. A non-contactable male consumer (patient) reported for himself that: A male patient of an unspecified age received bnt162b2 (BNT162B2), via an unspecified route of administration on Mar2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient stated that he had first dose of Pfizer Covid-19 vaccine on Mar2021 and within 8 hours developed Bell's Palsy with outcome of unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood test, COVID-19, Extra dose administered, Malaise, Off label use
Clinical narrative: had the booster shot and the test became positive; her husband tested positive; he doesn't feel good/ felt ill; had the booster shot and the test became positive; had the booster shot and the test became positive; This is a spontaneous report from a contactable consumer or other non-health care professional (patient's wife) and from a Pfizer Sponsored Program. An 83-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number BO130 EA or 8A), via an unspecified route of administration on 20Sep2021 as dose 3 (booster), single for covid-19 immunization. The patient medical history included blood pressure and prostrate. The patient was taking unspecified medications for his blood pressure and for his prostate. Concomitant medications were not reported. The patient had previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: EL3249), via an unspecified route of administration on 09Jan2021 as dose 1, single and received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: EL9252), via an unspecified route of administration on 04Feb2021 as dose 2, single for covid-19 immunization. The reporter stated that she had called for husband and herself. They both had received the Pfizer-BioNTech Covid19 Vaccine booster shot on Monday 20Sep2021 (extra dose administered). The patient had felt ill on Tuesday 21Sep2021 and stated that he had not felt good. The patient had only mild symptoms and still able to work and do house chores. The reporter queried if the vaccine or booster shot that they had got caused them to be positive with Covid19. The patient underwent lab tests and procedures which included blood test with unknown results on 21Sep2021 and on Thursday 23Sep2021, covid-19 virus test and the result was positive. The outcome of the events was unknown.   The lot number for the vaccine [BNT162B2] was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Vaccination failure
Clinical narrative: had the booster shot and the test became positive; her husband tested positive; he doesn't feel good/ felt ill; had the booster shot and the test became positive; had the booster shot and the test became positive; This is a spontaneous report from a contactable consumer or other non-health care professional (patient's wife) and from a Pfizer Sponsored Program. An 83-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number BO130 EA or 8A), via an unspecified route of administration on 20Sep2021 as dose 3 (booster), single for covid-19 immunization. The patient medical history included blood pressure and prostrate. The patient was taking unspecified medications for his blood pressure and for his prostate. Concomitant medications were not reported. The patient had previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: EL3249), via an unspecified route of administration on 09Jan2021 as dose 1, single and received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: EL9252), via an unspecified route of administration on 04Feb2021 as dose 2, single for covid-19 immunization. The reporter stated that she had called for husband and herself. They both had received the Pfizer-BioNTech Covid19 Vaccine booster shot on Monday 20Sep2021 (extra dose administered). The patient had felt ill on Tuesday 21Sep2021 and stated that he had not felt good. The patient had only mild symptoms and still able to work and do house chores. The reporter queried if the vaccine or booster shot that they had got caused them to be positive with Covid19. The patient underwent lab tests and procedures which included blood test with unknown results on 21Sep2021 and on Thursday 23Sep2021, covid-19 virus test and the result was positive. The outcome of the events was unknown.   The lot number for the vaccine [BNT162B2] was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Immunisation, Off label use, Vaccination failure
Clinical narrative: had the booster shot and the test became positive; her husband tested positive; he doesn't feel good/ felt ill; had the booster shot and the test became positive; had the booster shot and the test became positive; This is a spontaneous report from a contactable consumer or other non-health care professional (patient's wife) and from a Pfizer Sponsored Program. An 83-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number BO130 EA or 8A), via an unspecified route of administration on 20Sep2021 as dose 3 (booster), single for covid-19 immunization. The patient medical history included blood pressure and prostrate. The patient was taking unspecified medications for his blood pressure and for his prostate. Concomitant medications were not reported. The patient had previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: EL3249), via an unspecified route of administration on 09Jan2021 as dose 1, single and received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: EL9252), via an unspecified route of administration on 04Feb2021 as dose 2, single for covid-19 immunization. The reporter stated that she had called for husband and herself. They both had received the Pfizer-BioNTech Covid19 Vaccine booster shot on Monday 20Sep2021 (extra dose administered). The patient had felt ill on Tuesday 21Sep2021 and stated that he had not felt good. The patient had only mild symptoms and still able to work and do house chores. The reporter queried if the vaccine or booster shot that they had got caused them to be positive with Covid19. The patient underwent lab tests and procedures which included blood test with unknown results on 21Sep2021 and on Thursday 23Sep2021, covid-19 virus test and the result was positive. The outcome of the events was unknown.   The lot number for the vaccine [BNT162B2] was not provided and will be requested during follow up.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles out break -- appeared 10 days after the vaccine; This is a spontaneous report from a contactable consumer or other non-healthcare professional (patient reported for herself). A 39-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: FC3184), first dose via an unspecified route of administration, administered in left arm on 11Sep2021 at 11:00 (at the age of 39-year-old) as dose 1, single for COVID-19 immunisation at pharmacy or drug store. Medical history included breast cancer female from an unknown date and unknown if ongoing in remission from Breast Cancer 3 years since no evidence of disease. There were no concomitant medications. 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 did not diagnose with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. On 21Sep2021, the patient experienced shingles outbreak appeared 10 days after the vaccine (herpes zoster) (non-serious) with outcome of not recovered. The event had not resulted in for death, life-threatening, prolonged hospitalisation, disabling/incapacitating or Congenital anomaly/birth defect. Adverse event result in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of shingles outbreak appeared 10 days after the vaccine (herpes zoster) with Valtrex. The outcome of the event was reported as not resolved.  Follow-up attempts are completed. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Hypoaesthesia oral, Pruritus, Vaccination site pruritus
Clinical narrative: Itchy nose,head,injection site; Itchy nose,head,injection site; top lip got numb; severe diarrhea; This is a spontaneous report received from a contactable consumer (patient). A 66-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot number: FF2588) via an unspecified route of administration on 24Sep2021 14:00 (at the age of 66-year-old) as dose number unknown, single for COVID-19 immunisation. Medical history included High blood pressure and allergy. Concomitant medication included losartan potassium (LOSARTIN). Patient received other vaccine on the same date i.e 24Sep2021 at right arm. Patient was not diagnosed with COVID-19 prior to vaccination and since the vaccination patient has not been tested for COVID-19. The patient experienced itchy nose, head, injection site, top lip got numb and severe diarrhea on 24Sep2021 14:30. AE resulted in physician office visit, Life threatening illness (immediate risk of death from the event). Patient received treatment with Benadryl for the events. Outcome of all events was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Abnormal behaviour, Aggression, Bradykinesia, Disturbance in attention, Dyskinesia
Clinical narrative: Became very violent, aggressive and he wasn't really himself; Twitching; Slow movement; Jerking; Sometimes he closed his eyes and he couldn''t open; He is been doing more like own instruction the only thing he did differently after the vaccine; allowed to go to the school but not catching anything; allowed to go to the school but not catching anything; This is a spontaneous report from a contactable consumer (parent). A male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number not reported, Expiration date unknown), via an unspecified route of administration on 12Aug2021 as Dose 1, Single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unknown date in Aug2021, patient experienced twitching, slow movement, jerking (Jerkiness), and sometimes he closed his eyes and couldn't open it. On 15Aug2021, 3 days after vaccination, patient became very violent and aggressive. He wasn't really himself and was taken to the Emergency room and discharged the following day. It was reported that, patient was still not really back to baseline and had been out since the beginning of the school year. He was doing more like own instruction, the only thing he did differently after the vaccine. Patient was allowed to go to the school but was not catching anything. The outcome of all the events was unknown.  The lot number for the vaccine [BNT162B2] was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Eye disorder, Muscle twitching
Clinical narrative: Became very violent, aggressive and he wasn't really himself; Twitching; Slow movement; Jerking; Sometimes he closed his eyes and he couldn''t open; He is been doing more like own instruction the only thing he did differently after the vaccine; allowed to go to the school but not catching anything; allowed to go to the school but not catching anything; This is a spontaneous report from a contactable consumer (parent). A male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number not reported, Expiration date unknown), via an unspecified route of administration on 12Aug2021 as Dose 1, Single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unknown date in Aug2021, patient experienced twitching, slow movement, jerking (Jerkiness), and sometimes he closed his eyes and couldn't open it. On 15Aug2021, 3 days after vaccination, patient became very violent and aggressive. He wasn't really himself and was taken to the Emergency room and discharged the following day. It was reported that, patient was still not really back to baseline and had been out since the beginning of the school year. He was doing more like own instruction, the only thing he did differently after the vaccine. Patient was allowed to go to the school but was not catching anything. The outcome of all the events was unknown.  The lot number for the vaccine [BNT162B2] was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: Stroke; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 20Mar2021 (Lot Number: EN6206) as dose 2, single for COVID-19 immunisation. The patient's medical history was reported as none (stated that patient had no previous history). Concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), on 16Feb2021 (LOT#: EL9266) as dose 1, single for COVID-19 immunisation. The patient experienced stroke on 04Apr2021. The patient was hospitalized for the event from 04Apr2021 to an unknown date. The outcome of the event was unknown.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Headache, Illness, Nausea
Clinical narrative: miserable headache; stomach ache; nausea (mentioned that she was so sick); nausea (mentioned that she was so sick); This is a spontaneous report from a contactable consumer (patient, self-reported). A 64-year-old female patient received first dose of bnt162b2 (COMIRNATY, solution for injection, lot number and expiry date was not reported), via an unspecified route of administration on 02Apr2021, as single dose for COVID-19 immunisation (Age at vaccination: 64 years). The patient medical history and concomitant medications were not reported. The patient experienced miserable headache, stomach ache, nausea (mentioned that she was so sick) after the first vaccination on an unspecified date in 2021. She thought she had to restart the series of vaccination since it's been months since she had her first dose. Vaccinator told her (not sure if pharmacist or nurse) that she is already fully vaccinated and no need to repeat the series. She was also advised to come back after 6 months for the booster. She wants to confirm if that is true. Patient got her 2nd dose of bnt162b2 (COMIRNATY) on 24Sep2021 and had headache, sore arm, a little bit of nausea. Outcome of the events were unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Emphysema
Clinical narrative: emphysemic changes to the lungs; This is a spontaneous report from a contactable consumer (patient herself). This female consumer of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot number was not reported, Expiry date: Unknown) via an unspecified route of administration on an unspecified date in Apr2021 as dose 2, single and bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot number was not reported, Expiry date: Unknown) via an unspecified route of administration on an unspecified date in Mar2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced emphysemic changes to the lungs. The patient underwent lab tests and procedures which included computerised tomogram: showed emphysemic changes to the lungs on last two CT scans which have been since she received the vaccination. The outcome of event was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen lymph on his neck; a big one and now it is the small one coming out; This is a spontaneous report from a contactable consumer. This consumer reported for a 13-year-old male patient (Reporter's son). The male patient received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EW0181/Batch number was not reported), dose 2 via an unspecified route of administration on an unspecified date in Aug2021 as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EW0181/Batch number was not reported), dose 1 via an unspecified route of administration on an unspecified date in 2021 as dose 1, single for covid-19 immunisation. On an unspecified date in 2021, the consumer reported that, the patient experienced swollen lymph on his neck; a big one and now it is the small one coming out. The reporter states that it is a lymph node on her son's neck and that it is painless but it sticks and it's not getting better. The outcome of the event was not resolved.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Illness
Clinical narrative: Chills; Sick; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number and expiration date were not reported), via an unspecified route of administration in left arm, on an unspecified date as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EL9265, Expiration date: 31May2021), via an unspecified route of administration in left arm, on 27Jan2021 at 17:00 (at the age of 65-years-old) as dose 1, single for COVID-19 immunization and experienced sickness like a dog, fever, chills, nauseated, body aches and cannot get warm. After the vaccination with second dose, the patient experienced chills and sick on an unspecified date. The outcome of the events was unknown at the time of report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Tested positive for Covid; Tested positive for Covid; This is a spontaneous report from a contactable pharmacist (Patient's mother) via medical information team. A 17-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 27Aug2021 as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On 20Sep2021, the patient had tested positive for covid, the event was medically significant and on an unspecified date in Sep2021 she experienced febrile. Patient has not received second dose. The patient underwent lab tests and procedures which included sars-cov-2 test result was positive on 20Sep2021. Outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up. ; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events  Drug Ineffective and COVID-19 and the suspect drug BNT162B2.
Sex: F
Vaccine: COVID19
Symptoms: Eye infection, Gingival blister, Oral mucosal blistering, Oropharyngeal blistering, Pain
Clinical narrative: getting blisters in her mouth, on her gums, and down her throat; getting blisters in her mouth, on her gums, and down her throat; getting blisters in her mouth, on her gums, and down her throat; got an infection in her eyes where both of her eyes were sealed shut; having sensitivity to light; her hands and wrists look like psoriasis like her whole body gave up; more pain than she imagined she could take; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 55-years-old female patient received first dose of bnt162b2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiry date was not reported) via an unspecified route of administration on 12Sep2021 as dose 1, single for COVID-19 immunization. Medical history included rheumatoid arthritis. Concomitant medications included leflunomide (ARAVA) taken for an unspecified indication, for last 8 years from an unspecified date, upadacitinib (RINVOQ) 50 mg twice a day taken for an unspecified indication from Jul2021 to an unspecified stop date (2.5 months). On unspecified date in Sep2021 the patient experienced getting blisters in her mouth, on her gums, and down her throat, got an infection in her eyes where both of her eyes were sealed shut, having sensitivity to light, her hands and wrists look like psoriasis like her whole body gave up and more pain than she imagined she could take. States she doesn't know if this is related to her biologic. Patient asked if these are symptoms of receiving the vaccine. Patient didn't know if it was a mix of going off of the immunosuppressant drug and is scared of getting the next shot. The outcome of the events was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Photophobia, Psoriasis
Clinical narrative: getting blisters in her mouth, on her gums, and down her throat; getting blisters in her mouth, on her gums, and down her throat; getting blisters in her mouth, on her gums, and down her throat; got an infection in her eyes where both of her eyes were sealed shut; having sensitivity to light; her hands and wrists look like psoriasis like her whole body gave up; more pain than she imagined she could take; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 55-years-old female patient received first dose of bnt162b2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiry date was not reported) via an unspecified route of administration on 12Sep2021 as dose 1, single for COVID-19 immunization. Medical history included rheumatoid arthritis. Concomitant medications included leflunomide (ARAVA) taken for an unspecified indication, for last 8 years from an unspecified date, upadacitinib (RINVOQ) 50 mg twice a day taken for an unspecified indication from Jul2021 to an unspecified stop date (2.5 months). On unspecified date in Sep2021 the patient experienced getting blisters in her mouth, on her gums, and down her throat, got an infection in her eyes where both of her eyes were sealed shut, having sensitivity to light, her hands and wrists look like psoriasis like her whole body gave up and more pain than she imagined she could take. States she doesn't know if this is related to her biologic. Patient asked if these are symptoms of receiving the vaccine. Patient didn't know if it was a mix of going off of the immunosuppressant drug and is scared of getting the next shot. The outcome of the events was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Deafness, Groin pain, Neuropathy peripheral
Clinical narrative: Neuropathy in the legs got worst; Hearing loss; Protein in the urine (undergone test); Pain on the groin each side; So much pain in the back; This is a spontaneous report from a contactable consumer (patient). An 81-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single; and via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunisation. Medical history included transplant patient. The patient's concomitant medications were not reported. Patient reported to be a transplant patient who got both doses of the COMIRNATY vaccine. Post-vaccination, she reported that she had experienced the following adverse events (AEs) on an unspecified date: protein in the urine (undergone test), neuropathy in the legs got worst, pain on the groin each side, so much pain in the back, and hearing loss. The patient has to stay in one place all night long because of the pain (had to undergo laminectomy); the neurosurgeon had to give codeine and acetaminophen and a muscle relaxer for the pain. In line with the side effects she had experienced, the patient would like to know if it's recommended that she get her booster/third dose. She would also like to know if the side effects of the booster dose are the same as that of the first 2 doses. Being that they have found protein in her urine, patient would like to know if the vaccine contains any protein. Patient would like to know if the booster dose/third dose has the same ingredients as the first 2 doses and would like to have lists of risks associated with the COMIRNATY vaccine be sent to her. The patient was referred to the healthcare professional (HCP). The outcome of the events was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Feeling abnormal, Hypoacusis, Tinnitus
Clinical narrative: he could hear himself talk/ he could bearly hear; tightness in chest; ringing in ears; had an echo in his head; This is a spontaneous report from a contactable consumer (patient). A 53-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 24Sep2021 19:00 at 53-years-old (Batch/Lot Number: FF2588) as DOSE 2, SINGLE for COVID-19 immunization. Medical history included ongoing High cholesterol, ongoing high blood pressure. Vaccination Facility Type: Pharmacy/Drug Store. Concomitant medications included pravastatin taken for High cholesterol from an unspecified start date and ongoing; amlodipine besylate taken for high blood pressure from an unspecified start date and ongoing. The patient previously took bnt162b2 on 03Sep2021 in the left arm at 53-years-old (Batch/Lot Number: FC3182) as DOSE 1, SINGLE for COVID-19 immunization. The patient also previously took shingles vaccine for Immunization and never had any reactions; flu vaccine for Immunization and never had any reactions. The patient started having tightness in chest 25Sep2021 along with ringing in ears, etc.. He have never experienced this before. He might go to his doctor or ER if it does not let up by this Monday. He's calling about the Covid 19 vaccine. He had his second Covid 19 vaccine on Friday, 24Sep2021. He went to work Saturday, 25Sep2021 and it was the weirdest thing, on Saturday night, 25Sep2021, he started having ringing in his left ear, he could hear himself talk, he had an echo in his head, and he could barely hear. He bought some over the counter medicine to help with the ringing in his ear called Lipoflavonoid daytime and night time pills. He states he gets all his regular medication too and he received his Covid 19 vaccines. He is asking if this is normal. He reports it's a little bit better today, 27Sep2021. He states he had to miss work because of this. He tried to get an appointment with a specialist, an Ear, Nose, Throat doctor but the earliest date he could be seen was 04Oct2021. He decided to wait it out. He wasn't seen by any other doctor and it's better now compared to Saturday night, 25Sep2021. He is seen at the Healthcare Center but his regular doctor is no longer at the practice. He sees any doctor that is available if he needs to be seen. No further contact details provided by the caller. The patient experienced he could hear himself talk/ he could bearly hear on 25Sep2021 with outcome of not recovered, tightness in chest on 25Sep2021 with outcome of unknown, ringing in ears on 25Sep2021 with outcome of recovering, had an echo in his head on 25Sep2021 with outcome of recovering.    No follow-up attempts are possible. No further information expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Cataract, Cystitis, Myopia, Urinary tract infection, Visual impairment
Clinical narrative: increased myopia and cataract growth; increased myopia and cataract growth; vision exam in Jun2021 detected significant change; bladder/urinary tract infection resistant to antibiotics; bladder/urinary tract infection resistant to antibiotics; This is a spontaneous report from a contactable consumer (patient herself). A 60-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EK5730), via intramuscular route of administration, administered in Arm Left on an unspecified date as dose 2, single for COVID-19 immunization (Age at Vaccination was 60 years). The patient medical history included Occasional high blood pressure and borderline cholesterol. Concomitant medications included multivitamin (MULTIVITAMIN (VITAMINS NOS). She was not diagnosed with COVID-19 prior to vaccination, and not been tested for COVID-19 since the vaccination. She had no known allergies. She was not a pregnant at the time of vaccination. She did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EJ1685), via intramuscular route of administration, administered in Arm Left on 02Mar2021 16:45 as dose 1, single for COVID-19 immunization (Age at Vaccination was 60 years). On an unspecified date in Jun2021, the patient experienced increased myopia and cataract growth, vision exam detected significant change, bladder/urinary tract infection resistant to antibiotics. Therapeutic measures were taken as a result of events includes surgical removal of cataracts and antibiotics. Patient visited emergency room and physician office as a result of events. The seriousness of the events was serious and disability. The outcome of the events was not recovered.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Tested positive for Covid; Tested positive for Covid; This is a spontaneous report from a contactable pharmacist (Patient's mother). A 16-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 27Aug2021 as DOSE 1, SINGLE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient on an unspecified date in 2021, tested positive for COVID. The patient underwent lab tests and procedures which included COVID test: positive on an unspecified date in 2021 tested positive for COVID. The clinical outcome for the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Based on available information a contributory role of BNT162B2 to the reported Covid-19 and Drug ineffective cannot be totally excluded as efficacy of a drug varies from individual to individual depending upon the immune status and various other contributory factors. As with any vaccine, vaccination with BNT162B2 may not protect all vaccine recipients, so the expectedness of covid-19 and drug ineffective is : expected. The case will be reassessed further 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.