chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dysphagia, Hypoaesthesia oral, Urticaria
Clinical narrative: Tongue became numb; Difficulty swallowing; Chest pain; Hives; This is a spontaneous report from a contactable health care professional (patient). A 26-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), via an unspecified route of administration, administered in the left arm on 17Sep2021 at 11:30 (lot number was not reported) as dose 1, single for COVID-19 immunization.  Medical history included multiple sclerosis and allergies to almonds and apples all from unknown dates. The patient did not have COVID prior to vaccination. The patient was not tested for COVID post vaccination. Concomitant medications included dimethyl fumarate (TECFIDERA) and bupropion hydrochloride (WELLBUTRIN) both taken for an unspecified indication, start and stop date were not reported. The patient did not receive other vaccines in four weeks. The patient previously took iodine and experienced allergies. On 17Sep2021 at 11:45 (also reported as within 30 seconds of receiving the shot), the patient's tongue became numb, had difficulty swallowing, chest pain and hives. The events resulted in a visit to the emergency room/department. The patient received steroids as treatment for the events. The outcome of the events was recovering.   The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.; Sender's Comments: Based on the information provided, known drug safety profile and plausible temporal association, the causality between BNT162B2 and the events Hypoaesthesia oral, Dysphagia , Chest pain, Urticaria cannot be completely excluded. The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study 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: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Nerve compression, Neuralgia
Clinical narrative: Pinched nerve in neck leading to severe nerve pain in left arm (felt like a spoon digging out the bond in forearm); Pinched nerve in neck leading to severe nerve pain in left arm (felt like a spoon digging out the bond in forearm); This is a spontaneous report from a contactable consumer (patient herself).  This 56-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number EL9261), via an unknown route, on 05Feb2021 14:15 (at the age of 56-year-old) at single dose for COVID-19 immunisation, administered at hospital.  Historical vaccine includes the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number EL1283), via an unknown route, on 15Jan2021 (at the age of 56-year-old) at single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Relevant medical history included high blood pressure. Past drug history included allergies to benzylpenicillin (PENICILLIN) and codeine. Relevant concomitant medications included antibiotic therapy for face, sultopride hydrochloride (TOPRAL), irbesartan (AVAPRO), rosuvastatin calcium (CRESTOLIP), and cetirizine hydrochloride (ZYRTEC). On 12Feb2021, the patient had pinched nerve in neck leading to severe nerve pain in left arm (felt like a spoon digging out the bond in forearm). The event was reported serious as medically significant. The patient performed a physician office visit due to the event.Therapeutic measures taken as result of the event included steroids (X 3), muscle relaxers, physical therapy. Pre and Post vaccination COVID-19 tests were not done. The patient had recovered with sequelae from the event on unknown date.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: received the first dose of the Pfizer BioNTech Covid 19 vaccine on 05Sep2021/A week later they both tested positive for Covid; This is a spontaneous report from a contactable consumer or other non hcp (husband) reported for patient (wife). A female patient of an unspecified age received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: UNKNOWN), via an unspecified route of administration on 05Sep2021 as dose 1, single for COVID-19 immunisation. The medical history and concomitant medications of the patient were not reported. The patient received the first dose of the pfizer biontech covid 19 vaccine on 05sep2021/a week later they both tested positive for covid on 12Sep2021. The event resulted in the emergency room visit. The caller stated the patient was scheduled for second dose on 26Sep2021, could she push back the appointment? Not let them schedule it past 42 days. The Regeneron pharmacist said they had to restart the series. Caller asked was there any information on how the second dose may feel after having Covid?  Will there be an interaction with the antibodies? The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 12Sep2021. Therapeutic measures were taken as a result of event that included patient was given Regeneron antibody infusion, to help fight off the virus in the emergency room on 12Sep2021 and was released from the emergency room after the infusion. Caller stated he had read conflicting information if she should get the vaccine on that date, after having Covid and the Regeneron infusion. The outcome of the event was reported as unknown.  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-202101225810 same reporter/product/event, different patient
Sex: F
Vaccine: COVID19
Symptoms: Bacterial test, Rash, Thrombosis
Clinical narrative: one of the side effect of this COVID Vaccine is blood clot all over your body and a rash; one of the side effect of this COVID Vaccine is blood clot all over your body and a rash; This is a spontaneous report received from a contactable consumer. This consumer reported for a female patient (best friend) that. A female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 15Sep2021 as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. It was reported that She was calling because her best friend, who was like her sister, she was in hospital right now, she got the 1st dose of Pfizer COVID-19 Vaccine and then now she got the 2nd one on Wednesday, this Wednesday i.e 15Sep2021 that passed we are concerned because she was actually hospitalized and we want to know if one of the side effect of this COVID Vaccine was blood clot all over your body and a rash." She further stated it's an emergency right like she was in hospital, we don't have answer from anyone, she can't wait till Monday, it's Saturday. Not even the doctor in the ER knows what's going on with her. They have done bacterial test and everything with her. Reporter was requested to contact Physician. Events requires emergency room visit. The patient underwent lab tests and procedures which included bacterial test: unknown results on Sep2021. Outcome of event was unknown.   This lot number for the vaccine, [BNT162B2] was not provided and will be requested during follow-up.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Antinuclear antibody, Injection site pruritus, Injection site urticaria
Clinical narrative: Serious itching and huge hive at injection site; Serious itching and huge hive at injection site; This is a spontaneous report received from contactable consumer (patient). This consumer reported events for the first and second dose. This is the second of two reports (dose 2). Only this case is serious. A 46-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number FC3184 and expiration date Oct2021) administered in right arm on 15Sep2021 16:15 (at the age of 46-year-old) as dose 2, single for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Facility where the most recent COVID-19 vaccine was administered was reported as pharmacy or drug store. The patient's medical history included hypertension, stomach nausea and know allergies to mold, mildew, cats, dogs, and pollen, all from unspecified date. Prior to vaccination the patient was not diagnosed with COVID-19. The patient's concomitant medications taken within two weeks of vaccination included amlodipine from unspecified date at 10 mg, once a day for hypertension, amlodipine/benazepril 10 mg/40 mg from unspecified date and famotidine from unspecified date at 40 mg, once a day for stomach nausea. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number Fa7485), administered in right arm on 20Aug2021 04:15 PM (at the age of 46-year-old) as dose 1, single for COVID-19 immunisation and she experienced soreness in her right arm the day of the vaccination which went away, she had pain in the arm near the site and the neck and the shoulder. On 16Sep2021 the patient experienced serious itching and huge hive at injection site. Patient stated that she was calling to find out if it was normal that after the second vaccine, she had lot of itching and hives at the injection site. Treatment received due to the events was reported as cortisone cream and diphenhydramine (BENADRYL). The events were also reported as non-serious (as reported). The patient underwent to lab test and procedure which included anti-nuclear antibodies test (negative) on 30Aug2021. The outcome of the events was not resolved.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101127602 Same patient/drug, different AE, different dose of vaccine
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Off label use, Pain in extremity
Clinical narrative: sore arm with all 3 doses; sore arm with all 3 doses; sore arm with all 3 doses; This is a spontaneous report from contactable consumer (female patient) via Pfizer sponsored program.  A female patient of an unspecified age received third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: Unknown), via unknown route on unknown date, dose 3, booster single for COVID-19 immunization. The patient's medical history included autoimmune disease, cancer from an unknown date and unknown if ongoing. The concomitant medications were reported as none. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: Unknown), via unknown route on unknown date as dose 1, single for COVID-19 immunization. The patient previously received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: Unknown), via unknown route on unknown date as dose 2, single for COVID-19 immunization. The patient developed sore arms for all 3 doses on an unknown date. The outcome of events was unknown.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Confusional state, Disorientation, Dissociative amnesia, Extra dose administered, Immunisation
Clinical narrative: booster; experienced confusion; disorientation while driving.; Fugue state; slept for 4 hours; Extra dose administered; Off-label; This is a spontaneous report from a non-contactable consumer (Patient). A 61-years-old male patient received third dose of bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Solution for injection; lot number: FC3182), via an unspecified route of administration on 17Aug2021 at 12:00(at the age of 61-years-old) as a single dose for COVID-19 immunisation. The patient had previously received first and second dose of bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Solution for injection; batch/lot number: not provided), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. The patient Medical history was reported as none. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient did not Known about allergies. On 18Aug2021, 12 hours post booster shot (third shot) experienced confusion and disorientation while driving. Fugue state.  Did not know my location, could not read the time of day correctly.  Pulled vehicle over and slept for 4 hours. Awakened oriented. I have no significant medical condition, do not drink or use drugs, had adequate sleep the night before, muscular build. Therapeutic measures were taken as a result of events. The outcome of the events was recovered confusion, disorientation, Fugue state, slept for 4 hours on an unknown date 2021 and unknown for other events.   No follow-up attempts are possible; No further information is expected.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Off label use, Somnolence
Clinical narrative: booster; experienced confusion; disorientation while driving.; Fugue state; slept for 4 hours; Extra dose administered; Off-label; This is a spontaneous report from a non-contactable consumer (Patient). A 61-years-old male patient received third dose of bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Solution for injection; lot number: FC3182), via an unspecified route of administration on 17Aug2021 at 12:00(at the age of 61-years-old) as a single dose for COVID-19 immunisation. The patient had previously received first and second dose of bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Solution for injection; batch/lot number: not provided), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. The patient Medical history was reported as none. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient did not Known about allergies. On 18Aug2021, 12 hours post booster shot (third shot) experienced confusion and disorientation while driving. Fugue state.  Did not know my location, could not read the time of day correctly.  Pulled vehicle over and slept for 4 hours. Awakened oriented. I have no significant medical condition, do not drink or use drugs, had adequate sleep the night before, muscular build. Therapeutic measures were taken as a result of events. The outcome of the events was recovered confusion, disorientation, Fugue state, slept for 4 hours on an unknown date 2021 and unknown for other events.   No follow-up attempts are possible; No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Blood iron, Haematocrit, Haematocrit abnormal, Haemoglobin, Haemoglobin decreased
Clinical narrative: 08Sep2021: Iron 20; Iron Sat 8; 30Jul2021: HGB 14; 26Aug21: HGB: 12.1; 08Sep2021: HGB: 10.8; 30Jul2021: HCT 40; 26Aug2021: HCT: 35.8; 08Sep2021: HCT: 31.9; This is a spontaneous report from a contactable consumer(patient).   A 61-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: ZW0153) on 30Jul2021 at single dose via an unspecified route of administration for COVID-19 immunization. Relevant medical history included multiple myeloma: in remissions since 2017 and allergy to Sulfa and Omnicell. Concomitant medications included thyroid (ARMOUR THYROID) 60 mg, 1x/day since an unspecified date and metoprolol at 25 mg, 1x/day from an unspecified date. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: ECUO153) on 07Jul2021 at 08:00 at single dose on right arm. The patient was found to have decreased hemoglobin, decreased hematocrit and Iron saturation decreased. Treatment received included started on FE supplement.The patient underwent lab test which included 30Jul2021: HGB 14; 26Aug21: HGB: 12.1; 08Sep2021: HGB: 10.8; 30Jul2021: HCT 40; 26Aug2021: HCT: 35.8; 08Sep2021: HCT: 31.9; 08Sep2021: Iron 20; Iron Sat 8. At the time of the reporting events outcome was unknown.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Transferrin saturation, Transferrin saturation decreased
Clinical narrative: 08Sep2021: Iron 20; Iron Sat 8; 30Jul2021: HGB 14; 26Aug21: HGB: 12.1; 08Sep2021: HGB: 10.8; 30Jul2021: HCT 40; 26Aug2021: HCT: 35.8; 08Sep2021: HCT: 31.9; This is a spontaneous report from a contactable consumer(patient).   A 61-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: ZW0153) on 30Jul2021 at single dose via an unspecified route of administration for COVID-19 immunization. Relevant medical history included multiple myeloma: in remissions since 2017 and allergy to Sulfa and Omnicell. Concomitant medications included thyroid (ARMOUR THYROID) 60 mg, 1x/day since an unspecified date and metoprolol at 25 mg, 1x/day from an unspecified date. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: ECUO153) on 07Jul2021 at 08:00 at single dose on right arm. The patient was found to have decreased hemoglobin, decreased hematocrit and Iron saturation decreased. Treatment received included started on FE supplement.The patient underwent lab test which included 30Jul2021: HGB 14; 26Aug21: HGB: 12.1; 08Sep2021: HGB: 10.8; 30Jul2021: HCT 40; 26Aug2021: HCT: 35.8; 08Sep2021: HCT: 31.9; 08Sep2021: Iron 20; Iron Sat 8. At the time of the reporting events outcome was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Condition aggravated, Hypoaesthesia
Clinical narrative: Lost feeling in my left arm from the shot site to the tip of my thumb; Got the second shot and it got worse; I cannot even push buttons on my telephone with my thumbs; This is a spontaneous report from a contactable consumer or other non hcp.   A patient of unspecified age and gender received bnt162b2 (BNT162B2) solution for injection, dose 2 (Lot number expiry date was not reported) via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine dose 1 BNT162B2 (lot number and expiry date was unknown) via unspecified route of administration on an unspecified date as a single dose for covid-19 immunisation. Consumer stated, "To report adverse side effect, patient need help from Pfizer, patient need (sentence incomplete). The day after patient first shot, patient lost feeling in left arm from the shot site to the tip of patient thumb. Patient got the second shot and it got worse. Now, patient cannot even push buttons on patient telephone with thumbs. Patient need arm back, what do we get to reverse this thing?. Consumer was informed about the role of Pfizer Drug Safety. Mailing address: Consumer stated, "No, why? You know, patient worked for Pfizer for 5 years, you have patient mailing address (further clarification unknown). This was going nowhere; patient will do something else." And hung up abruptly. Further probing could not be done as consumer hung up abruptly. Hence, product details (LOT#, expiration date, NDC#, UPC#), purchase details and other details were unknown and limited information was available over the call     The lot number for the vaccine, [BNT162B2] was not provided and will be requested during follow-up.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Feeling abnormal, Illness, Rhinorrhoea
Clinical narrative: Friend tested positive for Covid virus; Friend tested positive for Covid virus; runny nose; sneezing; feeling terrible; got very sick; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient's friend) reported that a 5-decade-old (in her early 40's) female patient received bnt162b2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN, Formulation: Solution for injection, Batch/Lot number and expiry date was not reported), via an unspecified route of administration in Mar2021 (age at the time of vaccination was not provided) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The medical history included unspecified allergies from an unknown date and unknown if ongoing (does have allergies). The patient's concomitant medications were not reported.  The reporter was at a friend's house on Saturday night, and her friend (patient), was in her early 40's, and was vaccinated in Mar2021. The reporter later clarified that she was not sure which Covid vaccine her friend received. The reporter stated that her friend was very healthy, and they ate outside. The reporter stated her friend was sneezing and had a runny nose at the time, but her friend does have allergies. The reporter's friend (the patient) started feeling ill and went to the doctor and tested positive for Covid. The reporter stated on Sunday, her friend woke up feeling terrible and on Monday in 2021, her friend (the patient), tested positive for Covid (medically significant). The reporter declined to complete a safety report. Full details not obtained. The patient was tested positive for Covid virus after being vaccinated with unspecified Covid vaccine: had runny nose, sneezing, feeling terrible on an unspecified date in 2021. The patient got very sick in 2021, and the reporter thought that the booster should be recommended to not only older people but younger people as well. The reporter stated there was no reason for someone as healthy as her friend, to have a breakthrough case. Reporter seriousness for tested positive for Covid virus after being vaccinated with unspecified Covid vaccine: had runny nose, sneezing, feeling terrible was unspecified. The sample of the product was not available to be returned, if requested. Reason for no lot number: of Covid vaccine, unspecified manufacturer: Caller unwilling to complete the report. The patient underwent lab tests and procedures which included SARS-COV-2 TEST: positive in 2021. The outcome of the events was reported as unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Sneezing
Clinical narrative: Friend tested positive for Covid virus; Friend tested positive for Covid virus; runny nose; sneezing; feeling terrible; got very sick; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient's friend) reported that a 5-decade-old (in her early 40's) female patient received bnt162b2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN, Formulation: Solution for injection, Batch/Lot number and expiry date was not reported), via an unspecified route of administration in Mar2021 (age at the time of vaccination was not provided) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The medical history included unspecified allergies from an unknown date and unknown if ongoing (does have allergies). The patient's concomitant medications were not reported.  The reporter was at a friend's house on Saturday night, and her friend (patient), was in her early 40's, and was vaccinated in Mar2021. The reporter later clarified that she was not sure which Covid vaccine her friend received. The reporter stated that her friend was very healthy, and they ate outside. The reporter stated her friend was sneezing and had a runny nose at the time, but her friend does have allergies. The reporter's friend (the patient) started feeling ill and went to the doctor and tested positive for Covid. The reporter stated on Sunday, her friend woke up feeling terrible and on Monday in 2021, her friend (the patient), tested positive for Covid (medically significant). The reporter declined to complete a safety report. Full details not obtained. The patient was tested positive for Covid virus after being vaccinated with unspecified Covid vaccine: had runny nose, sneezing, feeling terrible on an unspecified date in 2021. The patient got very sick in 2021, and the reporter thought that the booster should be recommended to not only older people but younger people as well. The reporter stated there was no reason for someone as healthy as her friend, to have a breakthrough case. Reporter seriousness for tested positive for Covid virus after being vaccinated with unspecified Covid vaccine: had runny nose, sneezing, feeling terrible was unspecified. The sample of the product was not available to be returned, if requested. Reason for no lot number: of Covid vaccine, unspecified manufacturer: Caller unwilling to complete the report. The patient underwent lab tests and procedures which included SARS-COV-2 TEST: positive in 2021. The outcome of the events was reported as unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Acoustic stimulation tests, Deafness unilateral, Magnetic resonance imaging
Clinical narrative: Hearing loss in right ear; This is a spontaneous report from a contactable consumer (patient). A 20-year-old female patient received the first dose of bnt162b2 (BNT162B2, Lot Number: ER8737), via an unspecified route of administration on 31Mar2021 (received at the age of 20-years-old) as DOSE 1, SINGLE for COVID-19 immunisation. The COVID-19 vaccine was administered in a Pharmacy or Drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient medical history was not reported. The patient was not pregnant at the time of vaccination and adverse event. There was no relevant past drug history or known allergies to report. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included fluoxetine (FLUOXETINE) taken for an unspecified indication, start and stop date were not reported. The patient experienced hearing loss in right ear on 01May2021. The event resulted into a Physician Office Visit. The patient underwent hearing test and MRI (magnetic resonance imaging) on an unspecified date. Therapeutic measures were taken as a result of hearing loss in right ear which included steroids. Outcome of the event was not recovered. The reporting consumer assessed the event as serious (disability). The patient has not been tested for COVID-19 since the vaccination.   Follow-up attempts are completed. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Fall, Loss of consciousness, Nasopharyngitis
Clinical narrative: unable to take deep breath's; cold; fell to the floor; nausea; dizzy; passed out; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in left arm on 17Sep2021 14:30 (Batch/Lot Number: Ff2587) (at the age of 51 years old) as dose 2, single for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. Medical history included celiacs, primary biliary cirrhosis, lupus, Sjogren's syndrome and allergy: gluten. Concomitant medication included ibuprofen (IBUP) taken for an unspecified indication, start and stop date were not reported; hydroxychloroquine taken for an unspecified indication, start and stop date were not reported; Tyl; and Ursodial gabe. The patient previously received BNT162B2 in left arm on 27Aug2021 15:00 (lot number Ff2588) dose 1 for COVID-19 immunisation. The first dose was ok however she did have more dizzy spells than she normally do. Facility where the most recent COVID-19 vaccine was administered in Pharmacy or Drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. After the second dose approximately 8 hours later she was experiencing nausea and very dizzy. On 17Sep2021 (time reported as 12:00), the patient experienced passed out, nausea and dizzy. On 18Sep2021 07:30, patient had cold and fell to the floor. On 19Sep2021 14:30, patient was unable to take deep breath's. At 17 hours post vaccine, she passed out cold (as reported) and fell to the floor for approximately 1 minute. She did not go to the ER because she hate it, but called the pharmacy and was told that fainting can happen. She was told to go to ER if it happens again. She was at 48 plus hours post vaccine and she felt like she was unable to take deep breath's, still very dizzy. She will call the doctor tomorrow to be seen. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. There were no treatment for the events. The report is serious - medically significant. The outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: unable to take deep breath's; cold; fell to the floor; nausea; dizzy; passed out; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in left arm on 17Sep2021 14:30 (Batch/Lot Number: Ff2587) (at the age of 51 years old) as dose 2, single for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. Medical history included celiacs, primary biliary cirrhosis, lupus, Sjogren's syndrome and allergy: gluten. Concomitant medication included ibuprofen (IBUP) taken for an unspecified indication, start and stop date were not reported; hydroxychloroquine taken for an unspecified indication, start and stop date were not reported; Tyl; and Ursodial gabe. The patient previously received BNT162B2 in left arm on 27Aug2021 15:00 (lot number Ff2588) dose 1 for COVID-19 immunisation. The first dose was ok however she did have more dizzy spells than she normally do. Facility where the most recent COVID-19 vaccine was administered in Pharmacy or Drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. After the second dose approximately 8 hours later she was experiencing nausea and very dizzy. On 17Sep2021 (time reported as 12:00), the patient experienced passed out, nausea and dizzy. On 18Sep2021 07:30, patient had cold and fell to the floor. On 19Sep2021 14:30, patient was unable to take deep breath's. At 17 hours post vaccine, she passed out cold (as reported) and fell to the floor for approximately 1 minute. She did not go to the ER because she hate it, but called the pharmacy and was told that fainting can happen. She was told to go to ER if it happens again. She was at 48 plus hours post vaccine and she felt like she was unable to take deep breath's, still very dizzy. She will call the doctor tomorrow to be seen. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. There were no treatment for the events. The report is serious - medically significant. The outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Fear, Hypotension, Loss of consciousness, Tremor
Clinical narrative: she "was terrified and passed out."; she "was terrified and passed out."; blood pressure was low; she was shaking; This is a spontaneous report from a contactable pharmacist. A 21-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Unknown, Expiry date: Unknown), via an unspecified route of administration on 14Sep2021 (at age of 21-year-old), as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included flu vaccine on an unspecified date and never had a reaction. On 14Sep2021, after first dose of vaccine, the patient "was terrified and passed out" and fell and was taken to the ER due to the fall. Patient was flat on the floor and opened her eyes, no lip swelling and was breathing. Patient was not given epi pen. The patient was shaking and blood pressure was low. Reporter made her lay flat on her back in case she needed to do CPR. Reporter was hesitant to give the epi pen so did not. The clinical outcome of all the events was unknown.  The lot number for the vaccine [BNT162B2] was not provided and will be requested during follow up.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Headache, Muscle twitching, Muscular weakness, Pain
Clinical narrative: warning stroke; left side of face was tingling and prickly/left arm was weak and tingled; left side of face was tingling and prickly/left arm still is tingling, has prickly feeling; bad headache; left arm was twitching; left arm was weak; This is a spontaneous report from a contactable consumer or other non health care professional (patient). A 51-year-old non pregnant female patient of an unspecified age received second dose of bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number- EW0202) via an unspecified route of administration, administered in arm left on 01Jul2021 16:15 (age at vaccination 51 years) as dose 2, single for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered was reported. The patient medical history included colitis ulcerative. Concomitant medications included infliximab (REMICADE), bupropion hcl and amlodipine besylate. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EW0186) via an unspecified route of administration, administered in arm left on 07Jun2021 14:45 (age at vaccination 50 years) as dose 1, single for COVID-19 immunization. The patient previously took anaprox, Compazine [prochlorperazine maleate], flagyl [metronidazole], amoxicillin, prednisone and experienced allergy. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and Since the vaccination, the patient has not been tested for COVID-19. It was reported that month after 2nd shot on 04Aug2021 13:15 left side of face was tingling and prickly also had a bad headache. Went to emergency room. Was diagnosed with a warning stroke on 04Aug2021 13:15. Month and half after second shot on Aug2021 while having Remicade infusion treatment left arm was twitching. After infusion, left arm was weak and tingled on 04Aug2021 13:15. Two weeks later infusion left arm still was tingling, has prickly feeling and twitches. Her husband who received his shots a month before her was experiencing tingling and twitching in his arm where he received his shot too. Adverse events resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Seriousness of the event warning stroke was medically significant and all other events were reported as non serious. The patient underwent lab tests and procedures which included Nasal swab: negative on 05Aug2021 and 10Sep2021. The patient did not receive any treatment for the adverse events. The outcome of all the events was not recovered.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, SARS-CoV-2 test
Clinical narrative: warning stroke; left side of face was tingling and prickly/left arm was weak and tingled; left side of face was tingling and prickly/left arm still is tingling, has prickly feeling; bad headache; left arm was twitching; left arm was weak; This is a spontaneous report from a contactable consumer or other non health care professional (patient). A 51-year-old non pregnant female patient of an unspecified age received second dose of bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number- EW0202) via an unspecified route of administration, administered in arm left on 01Jul2021 16:15 (age at vaccination 51 years) as dose 2, single for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered was reported. The patient medical history included colitis ulcerative. Concomitant medications included infliximab (REMICADE), bupropion hcl and amlodipine besylate. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EW0186) via an unspecified route of administration, administered in arm left on 07Jun2021 14:45 (age at vaccination 50 years) as dose 1, single for COVID-19 immunization. The patient previously took anaprox, Compazine [prochlorperazine maleate], flagyl [metronidazole], amoxicillin, prednisone and experienced allergy. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and Since the vaccination, the patient has not been tested for COVID-19. It was reported that month after 2nd shot on 04Aug2021 13:15 left side of face was tingling and prickly also had a bad headache. Went to emergency room. Was diagnosed with a warning stroke on 04Aug2021 13:15. Month and half after second shot on Aug2021 while having Remicade infusion treatment left arm was twitching. After infusion, left arm was weak and tingled on 04Aug2021 13:15. Two weeks later infusion left arm still was tingling, has prickly feeling and twitches. Her husband who received his shots a month before her was experiencing tingling and twitching in his arm where he received his shot too. Adverse events resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Seriousness of the event warning stroke was medically significant and all other events were reported as non serious. The patient underwent lab tests and procedures which included Nasal swab: negative on 05Aug2021 and 10Sep2021. The patient did not receive any treatment for the adverse events. The outcome of all the events was not recovered.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Haemorrhage, Heavy menstrual bleeding, Menstruation irregular, Vaccination site rash
Clinical narrative: severe bleeding; Menstrual irregularity; very itchy rash after second vaccine at injection site for several days; severe bleeding/passing lots of large clots with heaviest bleeding than ever experienced in my life; This is a spontaneous report from a contactable consumer (patient). A 24-years-old (Pregnant: Unknown) female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number was not reported), via an unspecified route of administration on an unspecified date in 2021 (at the age of 24-years-old) as DOSE 2, SINGLE for COVID-19 immunisation at Pharmacy or Drug Store. The patient's medical history included epilepsy from an unknown date and unknown if ongoing. The patient had known allergies from skin lotions. The patient concomitant medications included levetiracetam (KEPPRA [LEVETIRACETAM]). The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: FC3181), via an unspecified route of administration, administered in left arm on 10Aug2021 at 16:00 (at the age of 24-years-old) as DOSE 1, SINGLE for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On an unspecified date in 2021, the patient experienced severe bleeding, menstrual irregularity, very itchy rash after second vaccine at injection site for several days, and severe bleeding/passing lots of large clots with heaviest bleeding than ever experienced in my life. The patient did not received treatment for the adverse events. Outcome of events was not recovered.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement
Clinical narrative: My blood pressure has shot up; This is a spontaneous report from a contactable consumer or other non-health professional (patient). A 72-years-old female patient second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EP7533), via an unspecified route of administration, administrated in Left upper arm on 08Jun2021 (age at the time of vaccination 72-years-old), as a single dose for COVID-19 immunization. The patient medical history and concomitant medication were not reported. Patient previously received first dose of BNT162B2 (COMIRNATY COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: ER2613), via an unspecified route of administration on 18May2021 (age at the time of vaccination 72-years-old), as a single dose for COVID-19 immunization. On 21Jul2021, the patient experienced My blood pressure has shot up. On 21Jul2021, the patient underwent lab tests and procedures which included Blood pressure measurement: shot up, my blood pressure has shot up. Patient stated that, I have never had a blood pressure issue before, I am on Losartan Potassium 15mg medication now for my high blood pressure I just came from my doctor's office. The outcome of the event was unknown.  Follow-up (22Sep2021): Follow-up attempts are completed. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Abortion spontaneous, Bell's palsy
Clinical narrative: I had a miscarriage at 4 months; Bell's palsy; This is a Spontaneous report received from a contactable other HCP (patient).  A 27-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 intramuscular on 28Apr2021 (Batch/Lot number was not reported) age at vaccination of 27-years-old, as single dose, for covid-19 immunisation.  Medical history was none. No known allergies. The patient was not pregnant and was not pregnant at the time of vaccination. The patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 on an unspecified date in 2021 (Batch/Lot number was not reported), age at vaccination of 27-years-old, as single dose, for covid-19 immunisation. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced miscarriage at 4 months on 26Jul2021 and bell's palsy on 26Jul2021; the events were serious as congenital anomaly. The events resulted in emergency room/department or urgent care. Therapeutic measures were taken as a result of the events and included D&C (as reported), antiviral medicine and steroids. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events were recovered with sequelae on an unspecified date in 2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, the causal relationship between the event Miscarriage, Bell's palsy and suspect drug BNT162B2 cannot be excluded.  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: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Dizziness, Fatigue, Headache
Clinical narrative: Feeling very nauseous and she threw up; Feeling very nauseous and she threw up; feeling dizzy and tired; feeling dizzy and tired; Headache; Blood pressure was higher than normal; This is a spontaneous report from a contactable pharmacist. A 17-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Solution for injection), intramuscular in the left arm, on 08Sep2021 16:15 (Lot number: FE3592), at age 17 years old, as dose 1, single, for COVID-19 immunisation, at a pharmacy or drug store. It was unknown if the patient was pregnant at the time of vaccination. Relevant medical history was not reported. The patient has no known allergies. It was unknown if the patient was diagnosed with COVID-19 prior to vaccination and if she has been tested for COVID-19 since the vaccination. Concomitant medication included prazosin, trazodone and lithium all taken for unknown indications, start and stop dates were not reported. The patient did not receive any other vaccines within 4 weeks prior to BNT162B2. On 08Sep2021, the patient had a headache. On 09Sep2021 00:00 (also reported as 12:00 AM), the patient was feeling dizzy and tired. On 10Sep2021, the patient started feeling very nauseous and she threw up. Over the next few days, the vomiting intensified. It was also reported that in Sep2021, after the vaccine, her blood pressure was higher than normal. The patient ended up going to the hospital on 13Sep2021 and was discharged on 18Sep2021. It was unknown if the patient received treatment for the events. The patient recovered from the headache on 18Sep2021. The patient was recovering from the remaining events.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vomiting
Clinical narrative: Feeling very nauseous and she threw up; Feeling very nauseous and she threw up; feeling dizzy and tired; feeling dizzy and tired; Headache; Blood pressure was higher than normal; This is a spontaneous report from a contactable pharmacist. A 17-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Solution for injection), intramuscular in the left arm, on 08Sep2021 16:15 (Lot number: FE3592), at age 17 years old, as dose 1, single, for COVID-19 immunisation, at a pharmacy or drug store. It was unknown if the patient was pregnant at the time of vaccination. Relevant medical history was not reported. The patient has no known allergies. It was unknown if the patient was diagnosed with COVID-19 prior to vaccination and if she has been tested for COVID-19 since the vaccination. Concomitant medication included prazosin, trazodone and lithium all taken for unknown indications, start and stop dates were not reported. The patient did not receive any other vaccines within 4 weeks prior to BNT162B2. On 08Sep2021, the patient had a headache. On 09Sep2021 00:00 (also reported as 12:00 AM), the patient was feeling dizzy and tired. On 10Sep2021, the patient started feeling very nauseous and she threw up. Over the next few days, the vomiting intensified. It was also reported that in Sep2021, after the vaccine, her blood pressure was higher than normal. The patient ended up going to the hospital on 13Sep2021 and was discharged on 18Sep2021. It was unknown if the patient received treatment for the events. The patient recovered from the headache on 18Sep2021. The patient was recovering from the remaining events.