chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 74.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Myalgia, Polymyalgia rheumatica
Clinical narrative: Three days after the injection, I experienced severe muscle pain in my shoulders, thighs and around my hips. I took Tylenol for two weeks and when pains persisted, I went to urgent care. Blood was taken and it showed there was no infection, but the 3 markers for inflammation were high. I was told to wait another week to see if the pain passed. They did not, so I went to my doctor and he gave me a 10 day regime of Prednisone. After 10 days, the pains returned. I went to another doctor and he diagnosed that I had Polymyalgia Rheumatica. He believes the Covid vaccine kicked-off this condition. I am now on a regime of slowly reduced doses of Prednisone which could go on for 6 months to a year.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Confusional state, Death, Heart rate increased, Influenza like illness
Clinical narrative: UNKNOWN CAUSE OF DEATH; ELEVATED HEART RATE; HYPER RESPIRATIONS; FLU LIKE SYMPTOMS; MENTAL CONFUSION; WEAKNESS WORSENED; This spontaneous report received from a consumer concerned a 63 year old male. The patient's height and weight were not reported. The patient's pre-existing medical conditions included the patient did not had medical and underlying condition and was healthy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: 041A21A, expiry: Unknown) frequency one total, dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. The patient was not taking any concomitant medications. On 03-APR-2021, the patient experienced elevated heart rate, hyper respiration, flu like symptoms including chills, weakness, fatigue, cough; the patient also had mental confusion and nausea. He was called in urgent care centre and they treated him with over the counter medications, Tylenol (paracetamol). On 16-APR-2021, the patient died due unknown cause. The daughter stated that she was taking him to emergency room the day he passed away. It was unknown if the autopsy was performed. The cause of death was not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of unknown cause on 16-APR-2021, had not recovered from mental confusion, and the outcome of weakness worsened, elevated heart rate, hyper respirations and flu like symptoms was not reported. This report was serious (Death).; Sender's Comments: 20210439259-COVID-19 VACCINE AD26.COV2.S -Unknown Cause Of Death. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Respiratory rate increased
Clinical narrative: UNKNOWN CAUSE OF DEATH; ELEVATED HEART RATE; HYPER RESPIRATIONS; FLU LIKE SYMPTOMS; MENTAL CONFUSION; WEAKNESS WORSENED; This spontaneous report received from a consumer concerned a 63 year old male. The patient's height and weight were not reported. The patient's pre-existing medical conditions included the patient did not had medical and underlying condition and was healthy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: 041A21A, expiry: Unknown) frequency one total, dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. The patient was not taking any concomitant medications. On 03-APR-2021, the patient experienced elevated heart rate, hyper respiration, flu like symptoms including chills, weakness, fatigue, cough; the patient also had mental confusion and nausea. He was called in urgent care centre and they treated him with over the counter medications, Tylenol (paracetamol). On 16-APR-2021, the patient died due unknown cause. The daughter stated that she was taking him to emergency room the day he passed away. It was unknown if the autopsy was performed. The cause of death was not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of unknown cause on 16-APR-2021, had not recovered from mental confusion, and the outcome of weakness worsened, elevated heart rate, hyper respirations and flu like symptoms was not reported. This report was serious (Death).; Sender's Comments: 20210439259-COVID-19 VACCINE AD26.COV2.S -Unknown Cause Of Death. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: WAS DOWN FOR 4 SOLID DAYS; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch number. No concomitant medications were reported. On an unspecified date, the subject experienced feeling unwell. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from feeling unwell. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, SARS-CoV-2 antibody test, Therapy non-responder
Clinical narrative: SUSPECTED IMMUNOLOGICAL VACCINE FAILURE; LITTLE TIRED; INTERMITTENT CHILLS OVER 2-3  WEEKS; This spontaneous report received from a consumer concerned a 75 year old male. The patient's height, and weight were not reported. The patient's blood type was A positive. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A/43A27A expiry: unknown) dose was not reported, 1 total administered on 01-APR-2021 to right arm for prophylactic vaccination. No concomitant medications were reported. On 01-APR-2021 after vaccination, the patient experienced some tiredness which he thought might have been due to the weather or the pandemic. The patient also had slight chills intermittently over three weeks after vaccination before this report. The patient was unsure about the lot number that it could be 043A21A or 043A27A. On 24-APR-2021, the patient took IGG (Immunoglobin G) antibody test and got a negative result. On 25-APR-2021, the patient took another IGG (Immunoglobin G) antibody test and the result was negative. It was reported that the patient had been eating a higher than normal amount of protein. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from little tired on 03-APR-2021, and the outcome of suspected immunological vaccine failure and intermittent chills over 2-3 weeks was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210451243 -Covid-19 vaccine ad26.cov2.s- suspected immunological vaccine failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: ADVERSE EVENT NOS; This spontaneous report received from a patient concerned multiple patients. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure no follow up will be requested. No concomitant medications were reported. On an unspecified date, the subject experienced adverse event nos. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of adverse event nos was not reported. This report was non-serious. This case, from the same reporter .
Sex: U
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: HIT INJECTION LOT HARDER THAN EXPECTED; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced hit injection lot harder than expected. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of hit injection lot harder than expected was not reported. This report was non-serious.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Gastrointestinal disorder, Pharyngeal swelling, Productive cough, Therapeutic response unexpected
Clinical narrative: EXPELLED PEA SIZED MUCUS BOLUS WITH BLACK CENTER WHEN COUGHING OR BLOWING NOSE; UNEXPECTED THERAPEUTIC BENEFIT; TIRED; GASTROINTESTINAL TRACT PAINFUL; BLURRED VISION; THROAT SWELLING REQUIRING MOUTH BREATHING; This spontaneous report received from a patient concerned a 73 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid 19/covid cough, and concurrent conditions included migranes, osteoarthritis, irritable bowel, constipation, reactive asthma, malaise, exhaustion, brain fog, migrating joint pain, disturbed sleep pattern, mold allergy, pollen grass allergy, raynaud's syndrome, alcohol use, memory disturbances, non smoker, sulfonamide allergy, tetracycline allergy, barbiturate allergy, and penicillin allergy, and other pre-existing medical conditions included the patient was not pregnant at the time of reporting. the patient had no history of drug abuse or illicit drug usage. the patient increased the use of normal nebulizer from sporadically to daily for months that caused a trip to the emergency room in apr-2020. The patient was previously treated with butalbital/caffeine/paracetamol; and experienced cut off vital organs to brain shut down blood vessels when treated with cimetidine for migraine, and low blood pressure when treated with pethidine hydrochloride, tachycardia when treated with oxycodone hydrochloride/paracetamol, and throat swelling when treated with capsaicin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. Concomitant medications included epinephrine. On 09-APR-2021, the subject experienced blurred vision. On 09-APR-2021, the subject experienced throat swelling requiring mouth breathing. On 10-APR-2021, the subject experienced gastrointestinal tract painful. On 11-APR-2021, the subject experienced tired. On 13-APR-2021, the subject experienced unexpected therapeutic benefit. On 20-APR-2021, the subject experienced expelled pea sized mucus bolus with black center when coughing or blowing nose. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from blurred vision, and throat swelling requiring mouth breathing on 09-APR-2021, and tired on 12-APR-2021, was recovering from unexpected therapeutic benefit, had not recovered from gastrointestinal tract painful, and the outcome of expelled pea sized mucus bolus with black center when coughing or blowing nose was not reported. This report was non-serious.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: EXPELLED PEA SIZED MUCUS BOLUS WITH BLACK CENTER WHEN COUGHING OR BLOWING NOSE; UNEXPECTED THERAPEUTIC BENEFIT; TIRED; GASTROINTESTINAL TRACT PAINFUL; BLURRED VISION; THROAT SWELLING REQUIRING MOUTH BREATHING; This spontaneous report received from a patient concerned a 73 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid 19/covid cough, and concurrent conditions included migranes, osteoarthritis, irritable bowel, constipation, reactive asthma, malaise, exhaustion, brain fog, migrating joint pain, disturbed sleep pattern, mold allergy, pollen grass allergy, raynaud's syndrome, alcohol use, memory disturbances, non smoker, sulfonamide allergy, tetracycline allergy, barbiturate allergy, and penicillin allergy, and other pre-existing medical conditions included the patient was not pregnant at the time of reporting. the patient had no history of drug abuse or illicit drug usage. the patient increased the use of normal nebulizer from sporadically to daily for months that caused a trip to the emergency room in apr-2020. The patient was previously treated with butalbital/caffeine/paracetamol; and experienced cut off vital organs to brain shut down blood vessels when treated with cimetidine for migraine, and low blood pressure when treated with pethidine hydrochloride, tachycardia when treated with oxycodone hydrochloride/paracetamol, and throat swelling when treated with capsaicin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. Concomitant medications included epinephrine. On 09-APR-2021, the subject experienced blurred vision. On 09-APR-2021, the subject experienced throat swelling requiring mouth breathing. On 10-APR-2021, the subject experienced gastrointestinal tract painful. On 11-APR-2021, the subject experienced tired. On 13-APR-2021, the subject experienced unexpected therapeutic benefit. On 20-APR-2021, the subject experienced expelled pea sized mucus bolus with black center when coughing or blowing nose. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from blurred vision, and throat swelling requiring mouth breathing on 09-APR-2021, and tired on 12-APR-2021, was recovering from unexpected therapeutic benefit, had not recovered from gastrointestinal tract painful, and the outcome of expelled pea sized mucus bolus with black center when coughing or blowing nose was not reported. This report was non-serious.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue
Clinical narrative: chills; feeling tired; This is a spontaneous report received by Pfizer from Company via product quality complaint from a contactable other HCP reported for her mother-in-law (patient).  A 70-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 23Mar2021 as single dose for COVID-19 immunisation.  The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced chills, feeling tired on an unspecified date. Outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site mass
Clinical narrative: got a bump on injection site; This is a spontaneous report received from a contactable consumer (reporting for her husband) from a Pfizer-sponsored program. A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number not provided), via an unspecified route of administration on 29Mar2021 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the vaccine on 29Mar2021 and got a bump on injection site on an unspecified date. The outcome of the event was unknown.     No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: fever; This is a spontaneous report from a contactable consumer (the patient) from a Pfizer-sponsored program. A male patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number not provided), via an unspecified route of administration in Mar2021 (age at vaccination unknown) as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient stated he just had his second shot last night. He had a fever since yesterday (Mar2021). The outcome of fever was not recovered.     No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: light headache; This is a spontaneous report from a contactable consumer (the patient) from a Pfizer-sponsored program. A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number not provided), via an unspecified route of administration on an unspecified date (age at vaccination unknown) as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the first dose and had a light headache. He would like to know if he can take paracetamol (TYLENOL). The outcome of light headache was unknown.     No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: PNC13
Symptoms: Pain in extremity
Clinical narrative: arm pain; This is a spontaneous report from a contactable consumer. A 68-year-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration on an unspecified date as single dose for immunisation. The patient's medical history and concomitant medications were not reported. Clinical course: Flu shot was early Dec2020. patient never had a problem with any vaccines. Worst arm pain from the newer pneumonia shot. She thought it was the pneumococcal 13-val conj vac (dipht crm197 protein). The older one she did not have. No Manufacturer, lot or expiration for the Prevnar that caused arm pain. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Menstrual disorder, Pain in extremity, Pyrexia, Thrombosis
Clinical narrative: Caller states she was not due for her monthly menstrual period for another week, so she found, passing the clot, odd.; Blot clot/Very big blood clot, that passed out of body; Fever, of 102; Sore arm; This is a spontaneous report from a contactable Other HCP (patient). A 35-years-old female patient (no pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 29Mar2021 09:00 (Lot Number: ER2613) as single dose for covid-19 immunisation.  Medical history included ongoing asthma , contraception. Concomitant medication included ethinylestradiol, norgestimate (SPRINTEC) taken for contraception from an unspecified start date and ongoing.  The patient previously took bactrim and experienced drug hypersensitivity. The blood clot only was for one day on 31Mar2021, and it was one blood clot. The patient went to the bathroom and it was passed, one time.  The patient was not due for her monthly menstrual period for another week, so she found, passing the clot, odd. The patient menstrual period did happen on time and it was normal. The patient was not due for her menstrual period for another week, and she takes birth control.  The patient contacted her Gynocologist, and it was confirmed that she was not pregnant, and states her menstrual period happened on time. The clot did not happen again. The patient had Fever, of 102 on 30Mar2021, the temperature resolved in a day. The patient took Aleve, drank a lot of water and napped, reclarifies, and the temperature improved. The patient experienced sore arm on 30Mar2021. The outcome of event Clot blood was recovered on 31Mar2021; outcome of event Fever was recovered on 30Mar2021; outcome of event Sore arm was recovered on 01Apr2021, outcome of other event was unknown. No other vaccine in four weeks; No covid prior vaccination; No covid tested post vaccination.; Sender's Comments: Based on the temporal relationship, A possible contributory role of the suspect product to the development of Thrombosis and Menstrual Disorder 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: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, SARS-CoV-2 test, Thrombosis
Clinical narrative: Blood clots in colon; 2nd dose 07Jan2021; This is a spontaneous report from a contactable other hcp (patient). A 61-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19), second dose at the age of 61-years-old via an unspecified route of administration, administered in arm left on 07Jan2021 (Batch/Lot Number: Ek5730) as single dose for covid-19 immunisation. The patient medical history was not reported. The patient has no known allergies. Concomitant medication included unspecified medication. The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in the left arm on 22Dec2020 (lot number: Ek5730) at the age of 61-years-old for covid-19 immunisation. The patient experienced blood clots in colon on 14Jan2021. It was noted that the patient received the second dose on 07Jan2021. The patient was hospitalized for blood clots in colon for 30 days. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 21Jan2021. Therapeutic measures were taken as a result of blood clots in colon which included surgery. The patient was recovering from the event.; Sender's Comments: Based on event-vaccine chronological association a causal relationship between event blood clots in colon and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), cannot be completely 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: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Cerebrovascular accident, Fatigue, Headache
Clinical narrative: mild stroke; loss of taste and smell; loss of taste and smell; fatigue; headache; This is a spontaneous report from a contactable consumer (patient). A 72-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection; Lot Number: EN8732) via an unspecified route of administration on 23Mar2021 at 08:45 (at the age of 72-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure, high cholesterol, and a-fib (atrial fibrillation), all from unspecified dates and unspecified if ongoing. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had no known allergies. Concomitant medications ("other medications in two weeks") included carvedilol, hydrochlorothiazide and losartan, all taken for unspecified indications on unspecified dates. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. On 24Mar2021 the patient experienced loss of taste and smell, fatigue and headache and on 26Mar2021 the patient experienced mild stroke. All events resulted in an emergency room visit and resulted in hospitalization from 26Mar2021 to 29Mar2021. The clinical course was reported as follows: "Second dose on 23Mar2021, loss of taste and smell, fatigue, headache on 24Mar2021 and 25Mar2021. Went to (Hospital name) on Friday 26Mar2021 and diagnosed with a mild stroke. Stayed in hospital until Monday 29Mar2021. Prescribed a blood thinner (Eliqus) per already engaged cardiologist. As of 13Apr2021 still no taste or smell; gaining energy." Therapeutic measures were taken in response to the adverse events and included treatment with "medications to lower blood pressure and a blood thinner". The patient underwent a nasal swab COVID-19 test post vaccination on 26Mar2021 which was negative. The clinical outcomes of the events loss of taste and smell were not recovered; mild stroke, fatigue and headache were recovered/resolved on unspecified dates.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: mild stroke; loss of taste and smell; loss of taste and smell; fatigue; headache; This is a spontaneous report from a contactable consumer (patient). A 72-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection; Lot Number: EN8732) via an unspecified route of administration on 23Mar2021 at 08:45 (at the age of 72-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure, high cholesterol, and a-fib (atrial fibrillation), all from unspecified dates and unspecified if ongoing. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had no known allergies. Concomitant medications ("other medications in two weeks") included carvedilol, hydrochlorothiazide and losartan, all taken for unspecified indications on unspecified dates. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. On 24Mar2021 the patient experienced loss of taste and smell, fatigue and headache and on 26Mar2021 the patient experienced mild stroke. All events resulted in an emergency room visit and resulted in hospitalization from 26Mar2021 to 29Mar2021. The clinical course was reported as follows: "Second dose on 23Mar2021, loss of taste and smell, fatigue, headache on 24Mar2021 and 25Mar2021. Went to (Hospital name) on Friday 26Mar2021 and diagnosed with a mild stroke. Stayed in hospital until Monday 29Mar2021. Prescribed a blood thinner (Eliqus) per already engaged cardiologist. As of 13Apr2021 still no taste or smell; gaining energy." Therapeutic measures were taken in response to the adverse events and included treatment with "medications to lower blood pressure and a blood thinner". The patient underwent a nasal swab COVID-19 test post vaccination on 26Mar2021 which was negative. The clinical outcomes of the events loss of taste and smell were not recovered; mild stroke, fatigue and headache were recovered/resolved on unspecified dates.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Skin discolouration, Thrombosis
Clinical narrative: asked if this was a blood clot; a big black spot next to her knee, and if she touched it, it hurt; a big black spot next to her knee, and if she touched it, it hurt; This is a spontaneous report from a contactable consumer (patient). A (age: 70; unit: unspecified) female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection) via an unspecified route of administration on 12Apr2021 as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. On 12Apr2021 the patient experienced a big black spot next to her knee, and if she touched it, it hurt. The patient called to report that she received the first dose of the COVID-19 vaccine yesterday 12Apr2021 and she was supposed to receive the second dose on 03May2021. When she got home yesterday afternoon, she ended up with a big black spot next to her knee, and if she touched it, it hurt. It was a little larger than a quarter coin, about the size of a silver dollar. She stated it was next to the inner part of her knee. The patient asked if this was a blood clot. She stated that she was worried with all the information about blood clots and the COVD-19 vaccines. She stated that she did not know if it was a blood clot but asked if it was a blood clot. The clinical outcomes of the events a big black spot next to her knee, and if she touched it, it hurt were both unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fall, Inappropriate schedule of product administration, Off label use
Clinical narrative: fall; received her 1st dose on 15Jan2021 and the 2nd dose was scheduled on 12Feb2021 but she was not able to get the 2nd dose because she was hospitalized and was rehabilitated; received her 1st dose on 15Jan2021 and the 2nd dose was scheduled on 12Feb2021 but she was not able to get the 2nd dose because she was hospitalized and was rehabilitated; This is a spontaneous report from a contactable consumer (who is also the patient) via a Pfizer-sponsored program. A female patient of an unspecified age (reported as 73, unit not reported) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration, on 15Jan2021, as single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient fell on an unspecified date. This resulted to hospitalization (unspecified date) and rehabilitation. The patient reported that she received her 1st dose on 15Jan2021, and the 2nd dose was scheduled on 12Feb2021, but she was unable to get the 2nd dose because she fell and was hospitalized and rehabilitated. It was reported that the patient just got out of the hospital. The patient was asking if she should just continue with the 2nd dose or start over again with the vaccine. The outcome of the event fall was unknown.  Information about lot/batch has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fall
Clinical narrative: fall; received her 1st dose on 15Jan2021 and the 2nd dose was scheduled on 12Feb2021 but she was not able to get the 2nd dose because she was hospitalized and was rehabilitated; received her 1st dose on 15Jan2021 and the 2nd dose was scheduled on 12Feb2021 but she was not able to get the 2nd dose because she was hospitalized and was rehabilitated; This is a spontaneous report from a contactable consumer (who is also the patient) via a Pfizer-sponsored program. A female patient of an unspecified age (reported as 73, unit not reported) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration, on 15Jan2021, as single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient fell on an unspecified date. This resulted to hospitalization (unspecified date) and rehabilitation. The patient reported that she received her 1st dose on 15Jan2021, and the 2nd dose was scheduled on 12Feb2021, but she was unable to get the 2nd dose because she fell and was hospitalized and rehabilitated. It was reported that the patient just got out of the hospital. The patient was asking if she should just continue with the 2nd dose or start over again with the vaccine. The outcome of the event fall was unknown.  Information about lot/batch has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fall, Inappropriate schedule of product administration, Off label use
Clinical narrative: fall; This is a spontaneous report from a contactable consumer (patient) via Pfizer sponsored program. A 73-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: unknown), via an unspecified route of administration on 15Jan2021 at single dose for COVID-19 immunization. Medical history and concomitant medication were not reported. It was reported that the patient received her 1st dose on 15Jan2021 and the 2nd dose was scheduled on 12Feb2021 but she was not able to get the 2nd dose because she was hospitalized and was rehabilitated. she just got out of the hospital. It was reported that patient was in the hospital due to a fall. Has an appointment on the 20th with primary care. Is that too late. Asking if she should just continue with the 2nd dose or start over again with the vaccine. There were unaddressed medical questions referred or forwarded to Medical Information. The outcome of the event was recovered.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fall
Clinical narrative: fall; This is a spontaneous report from a contactable consumer (patient) via Pfizer sponsored program. A 73-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: unknown), via an unspecified route of administration on 15Jan2021 at single dose for COVID-19 immunization. Medical history and concomitant medication were not reported. It was reported that the patient received her 1st dose on 15Jan2021 and the 2nd dose was scheduled on 12Feb2021 but she was not able to get the 2nd dose because she was hospitalized and was rehabilitated. she just got out of the hospital. It was reported that patient was in the hospital due to a fall. Has an appointment on the 20th with primary care. Is that too late. Asking if she should just continue with the 2nd dose or start over again with the vaccine. There were unaddressed medical questions referred or forwarded to Medical Information. The outcome of the event was recovered.  No follow-up attempts are needed. No further information is expected.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Feeling abnormal, Nerve injury, Neurological symptom
Clinical narrative: His brain just felt like he lost nerves; weird neurological effect; makes him almost feel light headed / Like the top of his head feels more "light"/he do get lightheaded; top of his head feels really empty; This is a spontaneous report from a contactable consumer (patient). A 23-year-old male patient received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in the right arm on 07Apr2021 18:15 (Batch/Lot Number: EWO153) as single dose for covid-19 immunisation. Medical history included scoliosis. Patient previously received the first dose of BNT162B2 (lot number: ENG205), on 17Mar2021,17:30, in the left arm, fore COVID-19 immunization and experienced some lower back pain and mild chills. Concomitant medication included ibuprofen taken for an unspecified indication, start and stop date were not reported. On 09Apr2021 15:00, the patient experienced that the top of his head feels really empty. He was not light headed per se. Well, maybe the top of his head feels a bit lightheaded. His brain just felt like he lost nerves and it makes him almost feel light headed when he try to lie down and fall asleep. Like the top of his head feels more "light". He was not sure if this was some weird neurological effect. Also sometimes if he just stay still and space out on purpose, he do get lightheaded. The outcome of events was reported as "not recovered". Patient did not receive any treatment for the events.  No follow-up attempts are possible. No further information is expected. Information on the batch/lot number has been obtained.
Sex: F
Vaccine: COVID19
Symptoms: Cellulitis, Condition aggravated, Inappropriate schedule of product administration, Lymphadenopathy, Off label use
Clinical narrative: hospitalized due to chronic ongoing issues with her lymph nodes and cellulitis; hospitalized due to chronic ongoing issues with her lymph nodes and cellulitis; hospitalized due to chronic ongoing issues with her lymph nodes and cellulitis; would like to know if her friend would need to start the vaccination series over if it has been over 6 weeks since her first dose of the Pfizer COVID-19 vaccine; would like to know if her friend would need to start the vaccination series over if it has been over 6 weeks since her first dose of the Pfizer COVID-19 vaccine; This is a spontaneous report from a contactable consumer via a  female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration, on an unspecified date, as single dose, for COVID-19 immunisation. Medical history included chronic ongoing issues with her lymph nodes and cellulitis (has been in and out of the hospital over 6 times for this same issue in the past). The patient's concomitant medications were not reported. The reporter was not sure when the patient received the first vaccination, but she thinks it has been over 6 weeks at the time of the report. It was reported that on an unspecified date, the patient was hospitalized due to chronic ongoing issues with her lymph nodes and cellulitis and insisted, "this has nothing to do with the Pfizer COVID-19 vaccine and it is not worth reporting." It was reported that the patient has been in and out of the hospital over 6 times for this same issue in the past. The reporter would like to know if the patient would need to start the vaccination series over if it has been over 6 weeks since her first dose of the Pfizer COVID-19 vaccine. The outcome of the event "hospitalized due to chronic ongoing issues with her lymph nodes and cellulitis" was not recovered.   Information about the lot/batch number has been requested.; Sender's Comments: Based on the information provided by the reporter, the reported events are unrelated to BNT162B2; these are intercurrent medical conditions
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Chest scan, Pulmonary venous thrombosis
Clinical narrative: clot on the left pulmonary vein; This is a spontaneous report from a contactable nurse (patient) from a Pfizer-sponsored program COVAX US Support. A 75-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in left arm on 13Jan2021 09:30 (lot number: FL3022; expiration date: May2021) at the age of 75 years old, as single dose for COVID-19 immunisation. Medical history included high blood pressure (taking losartan), anxiety with COVID; both from an unknown date and unknown if ongoing. Concomitant medications included losartan taken for high blood pressure from Jun2020 to an unspecified stop date; escitalopram oxalate (LEXAPRO) taken for anxiety with COVID from Jun2020 to an unspecified stop date. The patient previously received first dose of bnt162b2 on 23Dec2020 at the age of 75 years old for COVID-19 immunisation (lot number: ELD140; Pfizer product; expiry date: unknown). It was the first time they found a clot on the left pulmonary vein of the patient on 17Apr2021. The patient stated that she felt this was medically significant and that she had no symptoms. She stated that her inner voice said it was related to the vaccine. She started apixaban (ELIQUIS) 5mg twice a day on 09Apr2021 for the clot. She had nothing medical and she was in denial and shock as she had never had an issue until now and she never took pills. She is waiting to get a heart monitor and after that to have a TEE as they want to be sure the clot doesn't go to her heart. She was in complete denial, that she has no symptoms and she is feeling fine. She was told no exertion for 2 weeks, that she can go for walks, she thought it may be until the apixaban kicks in. The patient underwent lab tests and procedures which included chest scan: everything came back normal on unspecified date (6 months ago she had another chest scan), chest scan: unknown result on 07Apr2021. The patient has not recovered from the event.; Sender's Comments: Based on the current available information, the event Pulmonary venous thrombosis is most likely related to an intercurrent or underlying condition which is not related to the suspected drug (weak temporal association). The case will be reassessed if additional information becomes available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Committees and Investigators, as appropriate.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Rash, SARS-CoV-2 test negative, Vaccination site pruritus, Vaccination site rash
Clinical narrative: raised rash on LEFT forearm & upper arm with itching & burning sensation; raised rash on LEFT forearm & upper arm with itching & burning sensation; raised rash on LEFT forearm & upper arm with itching & burning sensation; raised rash on RIGHT forearm; This is a spontaneous report from a non-contactable consumer (patient). A 56-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: unknown), via an unspecified route of administration in left arm on 26Mar2021 at 10:15 at single dose for COVID-19 immunization. Medical history included allergic to penicillin, tetracycline, keflex, all sulfa drugs, Diflucan. Concomitant medication was not reported. Patient was not pregnant at time of vaccination. On 18Mar2021, patient tested nasal swab and resulted negative. Since the vaccination, the patient had been tested for COVID-19. On 26Mar2021 at 11:00, the patient experienced raised rash on left forearm & upper arm with itching & burning sensation. The patient visited doctor or other healthcare professional office/clinic and emergency room/department or urgent care. Patient received treatment with steroids & Benedryl. The outcome of the events was recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Cerebrovascular accident, Computerised tomogram head, Dizziness, Magnetic resonance imaging
Clinical narrative: Diagnosed with cryptogenic posterior cerebellar CVA; severe dizziness; vomiting; arm pain; severe general back pain; This is a spontaneous report from a contactable healthcare professional (patient). A 57-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EL9261), via an unspecified route of administration, administered in left arm on 20Jan2021 13:30 (at the age of 57 years old) as single dose for COVID-19 immunisation, at a workplace clinic. Medical history included hypertension (HTN) and depression, both from an unknown date and unknown if ongoing. The patient has no history of COVID prior vaccination. The patient has no known allergies. Concomitant medications included sertraline hydrochloride (ZOLOFT); and benazepril hydrochloride, hydrochlorothiazide (BENAZEPRIL/HCTZ) both taken for an unspecified indication. On 22Jan2021 the patient experienced arm pain and severe general back pain. On 23Jan2021, the patient experienced severe dizziness and vomiting. She went to urgent care and symptoms were treated. The patient was advised to have follow-up with the patient's professional care provider; she had MRI and CT angio of head on an unknown date with unknown results. The patient was diagnosed with cryptogenic posterior cerebellar CVA on 23Jan2021. Due to the events, the patient was recommended to have full diagnostic working including cardiac and neuro workup as treatment. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, and hospitalization for three days. The patient underwent lab tests and procedures which included CT angio of head and magnetic resonance imaging (MRI): both with unknown results on an unknown date, and Nasal Swab: negative on 12Apr2021. The patient was recovering from the events.; Sender's Comments: Based on the information provided by the reporter, it appears unlikely that vaccine BNT162B2 contributed to the reported events; these are likely intercurrent medical conditions in this patient with underlying hypertension. 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: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, SARS-CoV-2 test, Vomiting
Clinical narrative: Diagnosed with cryptogenic posterior cerebellar CVA; severe dizziness; vomiting; arm pain; severe general back pain; This is a spontaneous report from a contactable healthcare professional (patient). A 57-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EL9261), via an unspecified route of administration, administered in left arm on 20Jan2021 13:30 (at the age of 57 years old) as single dose for COVID-19 immunisation, at a workplace clinic. Medical history included hypertension (HTN) and depression, both from an unknown date and unknown if ongoing. The patient has no history of COVID prior vaccination. The patient has no known allergies. Concomitant medications included sertraline hydrochloride (ZOLOFT); and benazepril hydrochloride, hydrochlorothiazide (BENAZEPRIL/HCTZ) both taken for an unspecified indication. On 22Jan2021 the patient experienced arm pain and severe general back pain. On 23Jan2021, the patient experienced severe dizziness and vomiting. She went to urgent care and symptoms were treated. The patient was advised to have follow-up with the patient's professional care provider; she had MRI and CT angio of head on an unknown date with unknown results. The patient was diagnosed with cryptogenic posterior cerebellar CVA on 23Jan2021. Due to the events, the patient was recommended to have full diagnostic working including cardiac and neuro workup as treatment. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, and hospitalization for three days. The patient underwent lab tests and procedures which included CT angio of head and magnetic resonance imaging (MRI): both with unknown results on an unknown date, and Nasal Swab: negative on 12Apr2021. The patient was recovering from the events.; Sender's Comments: Based on the information provided by the reporter, it appears unlikely that vaccine BNT162B2 contributed to the reported events; these are likely intercurrent medical conditions in this patient with underlying hypertension. 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.