chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Fatigue, Headache, Malaise, Rash
Clinical narrative: tachycardia; Rash, worst on left wrist and hand; Headaches; malaise; fatigue; GI issues; This is a spontaneous report from a contactable consumer (patient) from a Pfizer sponsored program . A 61-year-old female patient (not pregnant) received bnt162b2 (Pfizer Covid-19 Vaccine), dose 2 via an unspecified route of administration, administered in Arm Left on 30Apr2021 at 61 years old (Lot Number: ER8736) as single dose for covid-19 immunization. Facility type vaccine was Health Clinic. Medical history included history of complex injury: cervical spine, Traumatic brain injury (TBI); known allergies: sensitive to gluten, casein, chemicals. The patient didn't have COVID prior vaccination and COVID was not tested post vaccination. The patient's concomitant medications were not reported. No other vaccine was received in four weeks. The patient previously received the first dose of bnt162b2 on an unspecified date for covid-19 immunization. The patient experienced rash, worst on left wrist and hand. Headaches, malaise, fatigue, GI issues, tachycardia. All began 2-3 days after second dose, and took more than 2 weeks to resolve. Adverse events start date was 02May2021. Patient reported that she was still experiencing tachycardia after she got her 2nd dose. She had already reported this experience then, but it persisted until now. She wanted more information since she was having a hard time seeking healthcare in her location. No treatment was received for the events. The outcome of the events was reported as recovered with lasting effects.  Follow-up attempts are completed. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Tachycardia
Clinical narrative: tachycardia; Rash, worst on left wrist and hand; Headaches; malaise; fatigue; GI issues; This is a spontaneous report from a contactable consumer (patient) from a Pfizer sponsored program . A 61-year-old female patient (not pregnant) received bnt162b2 (Pfizer Covid-19 Vaccine), dose 2 via an unspecified route of administration, administered in Arm Left on 30Apr2021 at 61 years old (Lot Number: ER8736) as single dose for covid-19 immunization. Facility type vaccine was Health Clinic. Medical history included history of complex injury: cervical spine, Traumatic brain injury (TBI); known allergies: sensitive to gluten, casein, chemicals. The patient didn't have COVID prior vaccination and COVID was not tested post vaccination. The patient's concomitant medications were not reported. No other vaccine was received in four weeks. The patient previously received the first dose of bnt162b2 on an unspecified date for covid-19 immunization. The patient experienced rash, worst on left wrist and hand. Headaches, malaise, fatigue, GI issues, tachycardia. All began 2-3 days after second dose, and took more than 2 weeks to resolve. Adverse events start date was 02May2021. Patient reported that she was still experiencing tachycardia after she got her 2nd dose. She had already reported this experience then, but it persisted until now. She wanted more information since she was having a hard time seeking healthcare in her location. No treatment was received for the events. The outcome of the events was reported as recovered with lasting effects.  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Thrombosis
Clinical narrative: Blood clots; had strokes; This is a spontaneous report from a Pfizer-sponsored program. This is one of three reports. A non-contactable consumer reported that a patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number and expiry date not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced blood clots and had strokes on an unspecified date after vaccination. The reporter also stated that 3 members of his family experienced the same events after vaccination. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101211992 Same reporter and drug, different patient;US-PFIZER INC-202101211993 Same reporter and drug, different patient
Sex: U
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Thrombosis
Clinical narrative: received the covid vaccine and then developed blood clots; received the covid vaccine and then had strokes; This is a spontaneous report from a non-contactable consumer (family member) from a Pfizer sponsored program regulatory authority. This consumer reported similar events for three patients. This is the second of three reports. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date (Lot number was not reported) as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The reporter stated that a member of his family received the Covid vaccine and then developed blood clots and then had strokes. The reporter was wondering about FDA approval and how many deaths happened from the Covid vaccine and also wondering about vaccine shedding. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101211991 Different patients, same reporter/drug/events;US-PFIZER INC-202101211993 Different patients, same reporter/drug/events
Sex: U
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Thrombosis
Clinical narrative: Developed blood clots and then had strokes; Developed blood clots and then had strokes; This is a spontaneous report from a non-contactable consumer via a Pfizer sponsored program. This consumer reported similar events for 3 members of his family. This is the third of three reports.  A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiration date: not reported), via an unspecified route of administration, on an unspecified date, as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunization.  The patient's medical history and concomitant medications were not reported.  The reporter stated that a member of his family received the Covid vaccine and then developed blood clots and then had strokes. The reporter was wondering about FDA approval and how many deaths happened from the Covid vaccine and also wondering about vaccine shedding. The outcome of the events was unknown at time of report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101211991 Different patients, same reporter/drug/events.;US-PFIZER INC-202101211992 Different patients, same reporter/drug/events.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Muscle spasms, Neuropathy peripheral, Pain, Pain in extremity
Clinical narrative: General neuropathy in right arm; Tingling in fingers; numbness; sharp pains; cramping; My hand throbs; This is a spontaneous report from a Contactable Other Healthcare Professional (Patient). A 54-year-old female patient (not pregnant) received bnt162b2 (Pfizer BioNTech Covid 19 mRNA Vaccine), dose 2 via an unspecified route of administration, administered in Arm Right on 23Aug2021 15:00 at 54 years old (Lot Number: FA6780) as single dose for covid-19 immunization. Facility type vaccine was Doctor's office/urgent care. Medical history included diverticulosis, breast cancer, depression, anxiety; No Known Allergies; no COVID prior vaccination. COVID was not tested post vaccination. Concomitant medications in two weeks included venlafaxine taken for an unspecified indication, start and stop date were not reported; buspirone taken for an unspecified indication, start and stop date were not reported. No other vaccine was administered in four weeks. The patient previously received the first dose of bnt162b2 (Lot number: FA6780) on 02Aug2021 03:00 PM at 53 years old in right arm for covid-19 immunization. The patient experienced general neuropathy in right arm. Tingling in fingers, numbness, sharp pains. Tingling and cramping began in the fingertips and move gradually up her arm to her shoulder. Her hand throbs and she sometimes have stabbing pains while trying to complete daily tasks like holding on to things, writing or driving. Adverse events started from 27Aug2021. No treatment was received for the events. The outcome of the events was not recovered.; Sender's Comments: Based on temporal relationship the possibility of causal association between the events Peripheral Neuropathy and other reported events  and the 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: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: General neuropathy in right arm; Tingling in fingers; numbness; sharp pains; cramping; My hand throbs; This is a spontaneous report from a Contactable Other Healthcare Professional (Patient). A 54-year-old female patient (not pregnant) received bnt162b2 (Pfizer BioNTech Covid 19 mRNA Vaccine), dose 2 via an unspecified route of administration, administered in Arm Right on 23Aug2021 15:00 at 54 years old (Lot Number: FA6780) as single dose for covid-19 immunization. Facility type vaccine was Doctor's office/urgent care. Medical history included diverticulosis, breast cancer, depression, anxiety; No Known Allergies; no COVID prior vaccination. COVID was not tested post vaccination. Concomitant medications in two weeks included venlafaxine taken for an unspecified indication, start and stop date were not reported; buspirone taken for an unspecified indication, start and stop date were not reported. No other vaccine was administered in four weeks. The patient previously received the first dose of bnt162b2 (Lot number: FA6780) on 02Aug2021 03:00 PM at 53 years old in right arm for covid-19 immunization. The patient experienced general neuropathy in right arm. Tingling in fingers, numbness, sharp pains. Tingling and cramping began in the fingertips and move gradually up her arm to her shoulder. Her hand throbs and she sometimes have stabbing pains while trying to complete daily tasks like holding on to things, writing or driving. Adverse events started from 27Aug2021. No treatment was received for the events. The outcome of the events was not recovered.; Sender's Comments: Based on temporal relationship the possibility of causal association between the events Peripheral Neuropathy and other reported events  and the 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.
Sex: M
Vaccine: COVID19
Symptoms: Diplegia
Clinical narrative: has been left diplegic in a wheelchair since the Pfizer vaccine was given to him; This is a spontaneous report from a contactable consumer (wife). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), 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's medical history and concomitant medications were not reported. On an unspecified date, patient has been left diplegic in a wheelchair since the Pfizer vaccine was given to him. The outcome of the event was not recovered.   The lot number for the vaccine, [BNT162B2], was not provided and will be re-quested during follow up.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Full blood count, Full blood count abnormal
Clinical narrative: Blood count was going up; This is a spontaneous report from a contactable consumer (patient) based on the information received by Pfizer from Pharmaceutical Company (manufacturer control number: US2021AMR058338). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection), via an unspecified route of administration on 23Mar2021 (lot number was not reported) as dose 2, single for COVID-19 immunization; belantamab mafodotin via an unspecified route of administration on an unspecified date at an unspecified dose and frequency for an unspecified indication. The patient's medical history and concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date (lot number was not reported) as dose 1, single for COVID-19 immunization. The patient reported the blood count was going up on an unspecified date. The patient was doing really well (in regards to COVID-19 antibodies) - as reported. The action taken with belantamab mafodotin in response to the event was unknown. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Erectile dysfunction, Inappropriate schedule of product administration, Libido decreased, Testicular pain, Testicular swelling
Clinical narrative: I have noticed significant decrease in libido and inability to maintain an erection; I experienced swelling and pains in my testicles the day after each dose; I experienced swelling and pains in my testicles the day after each dose; I have noticed significant decrease in libido and inability to maintain an erection; Start Date/Time: [Pfizer] 24-MAR-2021 03:00 PM/Start Date/Time: [Pfizer] 4-APR-2021 01:15 PM; This is a spontaneous report from a contactable consumer (the patient). A 33-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0153) via an unspecified route of administration in Left arm on 04Apr2021 13:15 at age of 33-year-old at single dose for COVID-19 immunisation. Medical history included PTSD. No known allergies, no COVID prior vaccination. Concomitant medication (in two weeks) included finasteride taken for an unspecified indication from an unspecified date. No other vaccine in four weeks. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: ER8732) on 24Mar2021 03:00pm at age of 33-year-old in Left arm for COVID-19 immunisation and experienced swelling and pains in testicles the day after the dose, significant decrease in libido and inability to maintain an erection. The patient experienced swelling and pains in his testicles the day after the dose (05Apr2021). Since then, he have noticed significant decrease in libido and inability to maintain an erection. No treatment received for the events. No Covid tested post vaccination. The outcome of the events was unknown.   Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Shock
Clinical narrative: Shock; This is a spontaneous report from a contactable consumer. A 17-year-old female patient received BNT162B2, 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. Unknown if pregnant. The patient's medical history and concomitant medications were not reported. Unknown if received other vaccine in four weeks. Unknown if had COVID prior vaccination and if was COVID tested post vaccination. The patient experienced shock on an unspecified date. Adverse event resulted in Emergency room/department or urgent care and Hospitalization. Outcome of event was unknown.  The lot number for BNT162B2, was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Diplegia
Clinical narrative: left patient diplegic and in a wheelchair; This is a spontaneous report from a non-contactable consumer. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was left diplegic and in a wheelchair on an unspecified date. The clinical course was as follows: Received call from lady who wanted to know if Comirnaty is supposed to be component BNT162BT. She tried to look in the protein data bank which is how the scientific community speaks to each other. There is nothing on the human expression on that protein. She was left in shock. The only thing she has on the # is the protein expression of this Pfizer MrNA is based on mouse spleen cells. But she is not a mouse. There is an individual with 2 children who was left a diplegic and in a wheelchair. Prior to this, he could run 7 miles in a day. Pfizer left him in a wheelchair. He has been more than 6 months like that. She then started stating something about getting vaccinated with Moderna. The caller kept over talking call handler and would not allow call handler to ask questions or clarify information. The outcome of the event was unknown.    No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Uveitis
Clinical narrative: uveitis; This is a spontaneous report from a non-contactable consumer (parent) reporting for her son. A 14-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in Arm Left on 24Jun2021 (Batch/Lot Number: EW0196) as dose 2, single for COVID-19 immunization at a pharmacy. Medical history included COVID-19 from Jan2021. The patient was never diagnosed with autoimmune issues. The patient's concomitant medications were not reported. The patient previously received bnt162b2 (lot number: EW0202) on an unspecified date in 2021 (also reported as 24Jun2021), dose 1 in the left arm for COVID-19 immunization. No other vaccine in four weeks. On 28Aug2021, it was reported that the patient had uveitis as a result of this vaccine causing disability. The reporter added "this vaccine caused this. My son was sick with COVID in Jan2021 and had no issues. Whatever is in this vaccine caused it as my son's doctor said they are seeing an increase number of people with uveitis issues. The patient underwent lab tests and procedures which included COVID-19 PCR test: negative on 03Aug2021 (Nasal Swab). Therapeutic measures were taken as a result of uveitis which includes steroid eye drops. The event required emergency room and physician's office visit. The outcome of the event was not recovered.   No follow-up attempts are possible. No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Angioedema
Clinical narrative: Angioedema; This is a spontaneous report from a contactable other hcp (patient).  A 29-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular, administered in Deltoid Left on 28Aug2021 16:00 (Lot Number: F08498) at age of 29 years old as DOSE 1, SINGLE for covid-19 immunisation. Medical history included Penicillin Allergy in her childhood, she had a rash and hives. There were no concomitant medications. The patient did not receive any other vaccines around the time of Pfizer-BioNTech COVID-19 Vaccine vaccination. On 28Aug2021 the patient got some grapes, she washed them and ate them and was fine. The patient got the vaccine at 4:00 pm on 28Aug2021 and at 7:00 pm she ate the same grapes and then her face was itchy and her bottom lip was big so she took benadryl the swelling went down. Saturday, 11Sep2021, the patient ate a banana and her top lip got big, swollen, and firm to the touch. The patient took Benadryl and the swelling went down. Yesterday, 14Sep2021, the patient didn't have anything to eat and her lip got really itchy to the touch and her eye had hives and it. The patient took Benadryl and it helped. Her lip was big and her cheek was firm to the touch. She went to urgent care today, 15Sep2021, and they diagnosed her with angioedema and advised her not to get the second dose. The patient has eaten grapes and fruit with no problems before this and the only allergy she has is to Penicillin. 5 minutes after the vaccine (as reported), the patient's lip was swollen and big. The patient's face that was itchy improved in 24 hours. The patient has never had this problem and it has happened three times now. The first flare up was on 28Aug2021, the second flare up was on 11Sep2021 and the third flare up was on 14Sep2021. The team at urgent care gave the patient a steroid shot in her right arm and with the benadryl it has improved within 24 hours. Yesterday, 14Sep2021, the patient had swelling with her bottom lip and 2 hives on her right eyelid. Yesterday was the first time the patient has had hives on her eye with these flare ups. The face swelling and the around her mouth swelling happened the two previous events. She was scheduled for her second dose on 18Sep2021. The outcome was unknown. The causality assessment from primary reporter with Global Introspection assessment method was related.; Sender's Comments: Based on the information available and close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events . The case will be reassessed once new information is available   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Induration, Lip pruritus, Lip swelling, Pruritus, Urticaria
Clinical narrative: Angioedema; This is a spontaneous report from a contactable other hcp (patient).  A 29-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular, administered in Deltoid Left on 28Aug2021 16:00 (Lot Number: F08498) at age of 29 years old as DOSE 1, SINGLE for covid-19 immunisation. Medical history included Penicillin Allergy in her childhood, she had a rash and hives. There were no concomitant medications. The patient did not receive any other vaccines around the time of Pfizer-BioNTech COVID-19 Vaccine vaccination. On 28Aug2021 the patient got some grapes, she washed them and ate them and was fine. The patient got the vaccine at 4:00 pm on 28Aug2021 and at 7:00 pm she ate the same grapes and then her face was itchy and her bottom lip was big so she took benadryl the swelling went down. Saturday, 11Sep2021, the patient ate a banana and her top lip got big, swollen, and firm to the touch. The patient took Benadryl and the swelling went down. Yesterday, 14Sep2021, the patient didn't have anything to eat and her lip got really itchy to the touch and her eye had hives and it. The patient took Benadryl and it helped. Her lip was big and her cheek was firm to the touch. She went to urgent care today, 15Sep2021, and they diagnosed her with angioedema and advised her not to get the second dose. The patient has eaten grapes and fruit with no problems before this and the only allergy she has is to Penicillin. 5 minutes after the vaccine (as reported), the patient's lip was swollen and big. The patient's face that was itchy improved in 24 hours. The patient has never had this problem and it has happened three times now. The first flare up was on 28Aug2021, the second flare up was on 11Sep2021 and the third flare up was on 14Sep2021. The team at urgent care gave the patient a steroid shot in her right arm and with the benadryl it has improved within 24 hours. Yesterday, 14Sep2021, the patient had swelling with her bottom lip and 2 hives on her right eyelid. Yesterday was the first time the patient has had hives on her eye with these flare ups. The face swelling and the around her mouth swelling happened the two previous events. She was scheduled for her second dose on 18Sep2021. The outcome was unknown. The causality assessment from primary reporter with Global Introspection assessment method was related.; Sender's Comments: Based on the information available and close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events . The case will be reassessed once new information is available   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Investigation, Myocarditis, Pericarditis, SARS-CoV-2 test
Clinical narrative: myocarditis; pericarditis; This is a spontaneous report from a non-contactable consumer (patient).  A 33-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 09Sep2021 10:00 (Batch/Lot number was not reported) as single dose (at the age of 33-years-old) for COVID-19 immunization. Medical history included none. The patient was not pregnant. No known allergies. Not diagnosed with COVID prior to vaccination. No other vaccines in four weeks. Concomitant medications included metoprolol and piroxicam (PAXIL [PIROXICAM]). The patient reported that, "On Sunday night I was diagnosed with pericarditis but was unconfirmed. Went to the ER and was confirmed with myocarditis." The event started on 12Sep2021 04:15 AM. Adverse event resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization. The patient was hospitalized for 1 day. The patient underwent lab tests and procedures which included investigation: pericarditis on 12Sep2021, SARS-CoV-2 test: negative on 12Sep2021 (Nasal swab). Therapeutic measures were taken as a result of the event which included Tylenol and colchicine and indomethacin. The outcome of the event was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Aneurysm, Cerebrovascular accident, Headache, Migraine, Musculoskeletal disorder
Clinical narrative: thought she was having a stroke; in bed with a migraine; having an aneurysm; no one could touch her arm for 5 days; bed for 5 days with a headache; could not move her arm; This is a spontaneous report from a Pfizer sponsored Program from a contactable consumer reported for sister. A female patient of unspecified age received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. Medical history and concomitant medications were unknown. The reporter stated she knew a lot of people that had had been getting a lot sicker after getting the vaccine. She reported that the patient had an adverse event after the vaccine and was in bed for 5 days with a headache and thought she was having a stroke. The reporter said that the patient could not move her arm. The patient was in bed with a migraine, thought she was having an aneurysm, no one could touch her arm for 5 days. It was so severe and debilitating after she got her vaccine. The reporter said that she had had a bunch of family members that got the vaccine. The reporter confirmed that she had not received the vaccine. Outcome of the events was unknown.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Pseudodementia, Psychotic disorder
Clinical narrative: pseudo- dementia type symptoms; psychosis; This is a spontaneous report from a contactable consumer (patient). A 55-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number and Expiration date were not reported), via an unspecified route of administration (administered on the left arm) on 19Jun2021 at 11:00 (at the age of 55-years-old) as dose 2, single for COVID-19 immunisation. Medical history included depression, high blood pressure, severe west Nile virus, and encephalitis (7 years earlier) all from an unknown date. The patient previously took LAMICTAL and experienced allergy. Prior to vaccination, the patient has not been diagnosed with COVID-19. Concomitant medications included celecoxib (CELEXA), lisinopril and gabapentin (NEURONTIN) all taken for an unspecified indication, start and stop date were not reported. The patient was previously vaccinated with the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19, Solution for injection; Lot number and Expiration date were not reported), via an unspecified route of administration (administered on the left arm) on 22May2021 at 12:00 (at the age of 55-years-old) for COVID-19 immunisation. On 22Jun2021 at 08:00, the patient experienced pseudo- dementia type symptoms and psychosis. The events resulted in Doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization, and disability or permanent damage. Therapeutic measures were taken as a result of the events which included multiple tests, antiseizure meds, and antipsychotics. Since the vaccination the patient has not been tested for COVID-19. The patient has not recovered from the events.  The lot number for BNT162B2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Rheumatoid arthritis
Clinical narrative: RA Fare; This is a spontaneous report from a contactable nurse and a contactable consumer.  A 41-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), 2nd dose via an unspecified route of administration on an unspecified date (Batch/Lot number and expiration date were not reported) as a single dose for covid-19 immunisation; tofacitinib citrate (XELJANZ XR, strength: 11mg), orally from 2016 (Batch/Lot number and expiration date were not reported) to an unspecified date, at 11 mg, daily for rheumatoid arthritis. The patient's medical history was not reported. Concomitant medications included MODERNA COVID-19 VACCINE taken for covid-19 immunisation; spironolactone (tablet); sertraline hydrochloride (ZOLOFT, tablet); rosuvastatin calcium (CRESTOR, tablet). The patient previously received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number and expiration date were not reported) as at age of 41 years old a single dose for covid-19 immunization. The patient experienced RA fare on an unspecified date. Clinical course: reported small RA flare after receiving the second covid vaccine that lasted one day. MD told patient to hold tofacitinib citrate (XELJANZ XR) for 1 week after covid vaccine. The action taken in response to the event for tofacitinib citrate was not applicable. The outcome of the event was recovered on an unspecified date.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: Suffered a sever stroke; This is a spontaneous report received from a contactable consumer (patient's husband). A female patient of an unspecified age received BNT162B2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as unknown dose, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient a sever stroke after getting vaccine there was nothing wrong with her till she was vaccinated. The outcome of the event was unknown.  The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Hypertension
Clinical narrative: high blood pressure; This is a spontaneous report from a Pfizer sponsored program, via a contactable consumer (patient).  A 60-year-old female consumer patient 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 12Mar2021 (age at the time of vaccination 60-years-old), as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient previously received first dose of BNT162B2 vaccine, on an unspecified date, for COVID-19 immunization. On an unspecified date 2021, the patient experienced high blood pressure. Patient received medication as a treatment of adverse event. The outcome of the event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Nausea
Clinical narrative: dizziness; fatigue; extreme nausea; This is a spontaneous report from a contactable Consumer or other non-HCP reported for a patient. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection), via an unspecified route of administration on an unspecified date (Lot number was not reported), as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced dizziness, fatigue and extreme nausea. The reported stated that keep hearing and various communication sites that the side effects of the booster shot in 5 percent of the people are sore arms and swollen gland. I personally was down and out for three days with dizziness, fatigue and extreme nausea. Three of my friends had the same thing. The patient outcome of the events was unknown at the time of this report.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, Vaccination site pain
Clinical narrative: I felt just sore where the needle went in my arms; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/lot number: EW0158,) via unspecified route of administration in arm on 13Apr2021 as dose 2, single (at the age of 45-year-old) for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/lot number: EN6208) via unspecified route of administration in arm on 23Mar2021 as dose 1, single (at the age of 45-year-old) for COVID-19 immunization. The patient was calling on behalf of herself and her husband. On an unspecified date in 2021, the patient felt sore where the needle went in her arms. On 03Sep2021, they went to see their HCP and had blood work done. They both who live with vulnerable people who are older than them, tested negative for antibodies on 2 different readings. She said their antibody test came back negative with zero antibodies and were questioning why. Their doctor told them that they are not protected at all. Patient wanted to know if there was any antibody testing that they can do, since Pfizer did do testing to determine if the vaccine was effective. And also wanted to know how Pfizer determines that the vaccine was effective, or should they just take your word on the vaccine working. She said on top of that, they thought maybe the ones she got were damaged or something, and then they were both negative for antibodies. The patient underwent lab that included SARS-CoV-2 antibody test: negative on 03Sep2021. Patient reported that her antibody test was collected 03Sep2021 and results were negative. She clarified that the test results read as SARS CoV 2, IgG NUCLEOCAP, IgM SPIKE, QL as the top one, then indented on the next line it says SARS CoV 2 AB (IgG), NUCLEOCAPSID, QL then SARS CoV 2 AB IGG for specific test with negative next to that, then another title that says negative as well. Patient mentioned that their tests both said negative as well for each result and her doctor said this morning if one of the two results for the test said positive it would be good, they just don't want both results on the test to say negative. Outcome of the event was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Bedridden, Fatigue, Feeling abnormal, SARS-CoV-2 antibody test
Clinical narrative: after first dose, was totally whacked out and was in bed for 24 hours; Had absolutely no energy the following night; I stayed in bed for 24 hours because I was just totally exhausted; Well the first one totally wiped out so I expected that. I wasn't surprised. I was in bed for 24 hours; This is a spontaneous report from a contactable consumer (patient himself). An 80-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: FC3181, expiry date: unknown) via unspecified route of administration in left arm on 23Aug2021 (age at vaccination: 80-years) as dose 1, single for covid-19 immunisation. Medical history of patient included Diabetes, Moderate kidney disease, Cholesterol, High Blood pressure, blood pressure, and water pill from an unknown date and unknown if ongoing. Concomitant medications included hydrochlorothiazide 25 mg, daily as water pill, amlodipine besilate, 10 mg daily for high blood pressure, atenolol 100 mg for blood pressure, omeprazole 20 mg daily for unknown indication, atorvastatin calcium 40 mg, daily for cholesterol. After first dose, patient had absolutely no energy the following night, Wednesday night, and stayed in bed for 24 hours because he was just totally exhausted on 23Aug2021. No additional vaccines administered on same date of the Pfizer suspect. Prior Vaccinations (within 4 weeks) was administered. Here was no emergency room visit or physicians office visit due to the adverse events. Patient underwent lab test which included blood test for Covid antibodies, with results: has antibodies, on 30Jul2021. The outcome of the events was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: He had soreness in the arm after receiving the 1st, 2nd, and 3rd dose; This is a spontaneous report from a contactable consumer or other non-healthcare professional (patient). A 76-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown), via an unspecified route of administration on an unspecified date as dose 1, single and a second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown), via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Consumer said patient already received 3 doses of the Pfizer-BioNTech Covid-19 Vaccine. He said he had his 3rd dose a couple of weeks ago. However, on the 20th, he said they will be releasing the booster dose and he wanted to know if he should still receive it. He also mentioned that he had soreness in the arm after receiving the 1st, 2nd, and 3rd dose on unknow date. 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: COVID-19, Drug ineffective
Clinical narrative: My elderly mother and I were superinfected by an unvaccinated nurse at the workplace. My mother was vaccinated with your vaccine and has not had to be hospitalized and is recovering.; My elderly mother and I were superinfected by an unvaccinated nurse at the workplace; This is a spontaneous report from a Pfizer-sponsored program. A contactable Other-HCP reported similar events for 2 patients. This report is 2nd of 2 reports. A female patient of unspecified age received BNT162B2 (PFIZ-ER-BIONTEC COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number: not reported) via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. Medical history and concomitant medications were not reported. Reported stated she was a Geriatric Psychiatric Nurse Practitioner and 322 of her patients die from COVID-19. Since her patients have been vaccinated with Pfizer vaccine none of them who have been superinfected with Delta have died. Also reported said My elderly mother and I were superinfected by an unvaccinated nurse at the workplace. My mother was vaccinated with your vaccine and has not had to be hospitalized. 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 available information and a possible contributory role of suspect product BNT162B2 to the development of covid19 and drug ineffective cannot be totally excluded.,Linked Report(s) : US-PFIZER INC-202101224473 same reporter, drug, event, different patient
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Product preparation error, Pyrexia
Clinical narrative: He later found out the vaccine he received was undiluted; had a fever kind of thing; feeling under the weather or whatever; This is a spontaneous report from a contactable consumer (other health care professional). A 29-years-old male patient received second dose of bnt162b2 (Pfizer BioNTech Covid 19 vaccine, Solution for injection, Batch/Lot number was not reported, expiry date: unknown), via an unspecified route of administration in Sep2021 as DOSE 2, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient previously received first dose of bnt162b2 (Pfizer BioNTech Covid 19 vaccine, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unknown date as DOSE 1, SINGLE for covid-19 immunisation. Patient received second dose two weeks ago and for 6 hours afterward had a fever kind of thing, feeling under the weather or whatever. He later found out the vaccine he received was undiluted. The outcome of event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up. Follow-up attempts are completed. No further information was expected.
Sex: U
Vaccine: COVID19
Symptoms: Exposure to SARS-CoV-2
Clinical narrative: the patient was in a room with two other vaccinated individuals, in a meeting, without masks; This is a spontaneous report from a contactable consumer. A patient of an unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Batch/Lot number: unknown), via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 02Aug2021 the patient was in a room with two other vaccinated individuals, in a meeting, without masks. It was reported that on Thursday, 05Aug2021, the patient learned that one of the persons who had the Pfizer COVID vaccine had tested positive for Covid 19. The outcome of the event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID side effects; I am having issues; COVID side effects; I am having issues; This is a spontaneous report from a contactable consumer (patient reported for self). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown and Expiration date: unknown) via an unspecified route of administration, on an unspecified date as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced COVID side effects; patient was having issues. Reporter stated that it was because of COVID, COVID side effects, patient was having issues and there was nobody to talk to. So, the patient wanted to speak to a supervisor. 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: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Blindness transient, Dizziness, Hyperhidrosis, Pallor, SARS-CoV-2 test
Clinical narrative: Temporary partial blindness; ringing in right ear; pale skin; sweating; dizziness.; This is a spontaneous report from a contactable consumer (patient).  A 15-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 18Sep2021 15:30 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included Prior to vaccination, was the patient diagnosed with COVID-19, known allergies: numerous foods and environmental substances like trees and grass all from an unknown date and unknown if ongoing.  Since the vaccination, has the patient been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and no other medications the patient received within 2 weeks of vaccination. There were no concomitant medications. The patient was previously vaccinated with the first dose of BNT162B2 (lot number: unknown) on 27Aug2021 12:00 PM at the left arm for COVID-19 immunization. It was reported that the patient experienced Temporary partial blindness, ringing in right ear, pale skin, sweating, dizziness on 18Sep2021 03:30 PM. The patient underwent laboratory procedure which includes covid test post vaccination (unknown covid test type), which was negative in 2021. The outcome of the events was recovered on 27Sep2021 12:00 PM.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.