chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Depersonalisation/derealisation disorder, Gait disturbance, Headache, Loss of personal independence in daily activities
Clinical narrative: Seizures; I was having trouble focusing; my eyes had trouble focusing; Big headache; Depersonalization; My legs lost function and I could hardly walk; My legs lost function and I could hardly walk; The rest of my body felt weak but kept doing involuntary movements (like hand opening and closing); I struggled to think or talk, and it felt like my body was forgetting how to work; This is a spontaneous report from a contactable consumer (patient). A 23-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: EW0171), via an unspecified route of administration, administered in the left arm on 25Apr2021 (at the age of 23-years-old) as dose 1, single for COVID-19 immunization at other. Medical history included depression, anxiety, lactose intolerance, temporal lobe seizure, migraines, post-traumatic stress disorder (ptsd); all from an unknown date and unknown if ongoing. Patient had known allergy to Lithium. Concomitant medications within 2 weeks of vaccination included fluoxetine hydrochloride (PROZAC), pyridoxine hydrochloride (B6 supplement), cannabidiol (CBD OIL); all taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was diagnosed with COVID-19 and Since the vaccination, patient has been tested negative for COVID-19. On 09May2021, after receiving the first dose of the vaccine, the patient experienced trouble focusing and developed a big headache, eyes had trouble focusing, and patient was experiencing severe depersonalization. The patient legs lost function and could hardly walk, and the rest of her body felt weak but kept doing involuntary movements (like hand opening and closing). Patient struggled to think or talk, and it felt like her body was forgetting how to work. The patient was brought to an Emergency Room (ER). Since then, patient had seizures. The events resulted in to Emergency room/department or urgent care (ER visit) and Doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included sars-cov-2 test (covid test, Nasal Swab) post vaccination which resulted negative on 06Jul2021 and MRI with unknown results on an unspecified date in 2021. The patient received treatment for events with IV fluids, Benadryl, Reglan, Heart monitor and MRI (Magnetic resonance imaging). The outcome of the events was not recovered at the time of report.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging, Musculoskeletal disorder, SARS-CoV-2 test, Seizure, Vision blurred
Clinical narrative: Seizures; I was having trouble focusing; my eyes had trouble focusing; Big headache; Depersonalization; My legs lost function and I could hardly walk; My legs lost function and I could hardly walk; The rest of my body felt weak but kept doing involuntary movements (like hand opening and closing); I struggled to think or talk, and it felt like my body was forgetting how to work; This is a spontaneous report from a contactable consumer (patient). A 23-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: EW0171), via an unspecified route of administration, administered in the left arm on 25Apr2021 (at the age of 23-years-old) as dose 1, single for COVID-19 immunization at other. Medical history included depression, anxiety, lactose intolerance, temporal lobe seizure, migraines, post-traumatic stress disorder (ptsd); all from an unknown date and unknown if ongoing. Patient had known allergy to Lithium. Concomitant medications within 2 weeks of vaccination included fluoxetine hydrochloride (PROZAC), pyridoxine hydrochloride (B6 supplement), cannabidiol (CBD OIL); all taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was diagnosed with COVID-19 and Since the vaccination, patient has been tested negative for COVID-19. On 09May2021, after receiving the first dose of the vaccine, the patient experienced trouble focusing and developed a big headache, eyes had trouble focusing, and patient was experiencing severe depersonalization. The patient legs lost function and could hardly walk, and the rest of her body felt weak but kept doing involuntary movements (like hand opening and closing). Patient struggled to think or talk, and it felt like her body was forgetting how to work. The patient was brought to an Emergency Room (ER). Since then, patient had seizures. The events resulted in to Emergency room/department or urgent care (ER visit) and Doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included sars-cov-2 test (covid test, Nasal Swab) post vaccination which resulted negative on 06Jul2021 and MRI with unknown results on an unspecified date in 2021. The patient received treatment for events with IV fluids, Benadryl, Reglan, Heart monitor and MRI (Magnetic resonance imaging). The outcome of the events was not recovered at the time of report.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chest discomfort, Fatigue, Heart rate increased, Hypertension
Clinical narrative: my heart rate starting climbing and fast; My blood pressure, when first taken was very high; chest discomfort; whole body aches; general feeling of being exhausted and weak; general feeling of being exhausted and weak; respiratory rate climbed; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A 36-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: FA6780 and expiry date: unknown), dose 1 via an unspecified route of administration, administered in Arm Left on 26Jul2021 at 19:30 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced my heart rate starting climbing and fast, my blood pressure, when first taken was very high, chest discomfort, whole body aches, general feeling of being exhausted and weak and respiratory rate climbed on 27Jul2021 at 13:30 (After almost 24hrs from the first shot). The event resulted in Emergency room/department or urgent care. The patient received treatment for the adverse events as Ativan, nitrostat and Zofran with IV. Outcome of the events was recovered on an unknown date in 2021.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Respiratory rate increased
Clinical narrative: my heart rate starting climbing and fast; My blood pressure, when first taken was very high; chest discomfort; whole body aches; general feeling of being exhausted and weak; general feeling of being exhausted and weak; respiratory rate climbed; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A 36-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: FA6780 and expiry date: unknown), dose 1 via an unspecified route of administration, administered in Arm Left on 26Jul2021 at 19:30 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced my heart rate starting climbing and fast, my blood pressure, when first taken was very high, chest discomfort, whole body aches, general feeling of being exhausted and weak and respiratory rate climbed on 27Jul2021 at 13:30 (After almost 24hrs from the first shot). The event resulted in Emergency room/department or urgent care. The patient received treatment for the adverse events as Ativan, nitrostat and Zofran with IV. Outcome of the events was recovered on an unknown date in 2021.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Off label use, Product use issue, Suppressed lactation
Clinical narrative: milk supply decreased to nearly zero.; breastfeeding mother; breastfeeding mother; This is a spontaneous report from a contactable consumer (patient). A 38-year-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Left Arm on an unspecified date (lot Number: FC3180) as DOSE 2, SINGLE for covid-19 immunisation.  The patient medical history was not reported. The patient is not pregnant at the time of vaccination. There were no concomitant medications. Historical vaccine includes dose 1 of BNT162B2, lot number: FA6780. The patient did not have COVID-19 prior vaccination. The patient is a breastfeeding mother and had her son on 30Jun2021. After I received the second dose of the vaccine, her milk supply decreased to nearly zero. The onset of the events was reported as 09Aug2021. The events involved physician office visit. The event her milk supply decreased to nearly zero was assessed as serious, disabling. The patient has not been tested for COVID-19 post vaccination. The outcome of the events was not recovered.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101051671 same reporter/drug, different patient/event (son case)
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Heart rate, Heart rate increased, Investigation, Rectal haemorrhage
Clinical narrative: heavy bleeding from rectum; being totally exhausted; very high (for me) heart rates; lab results showed that I had irregularities in my blood; This is a spontaneous report from a contactable consumer (patient). A 80-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number and Expiry date was not reported), (age 80 year at the time of vaccination) via an unspecified route of administration, administered in Arm Left on 03Mar2021 12:00 as dose 2, single for COVID-19 immunisation. Medical history included several chronic autoimmune conditions, known allergies: Penicillin, Known allergies: Sulfa, from an unknown date and unknown if ongoing. Concomitant medication includes medications prescribed in two weeks was yes. Historical vaccine includes bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number and Expiry date was not reported), via an unspecified route of administration, administered in Arm Left on Feb2021as dose 1, single for COVID-19 immunization. On Mar2021, patient experienced heavy bleeding from rectum, being totally exhausted, very high (for me) heart rates, lab results showed that i had irregularities in my blood. No other vaccine in four weeks. No covid prior vaccination was reported. No covid tested post vaccination. Adverse event was resulted in Emergency room/department or urgent care. No treatment received for adverse event. The patient underwent lab tests and procedures which included heart rate was higher than normal (sleeping heart rate of 84 average) and lab investigation was irregularities in my blood on an unspecified date. The outcome of the event for heavy bleeding from rectum was recovered on an unspecified date 2021 where as rest all events was unknown.  Information on lot/ batch number has been requested.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Eating disorder, Gastroenteritis, SARS-CoV-2 test, Weight
Clinical narrative: Been having acute gastroentinitis for over 4 weeks.  From 7/17/21 to present (8/14/21); Can't eat regular yet; Uneasy stomach; Lost 21 lbs; This is a spontaneous report from a contactable consumer, the patient.  A 16-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: EW0182), via an unspecified route of administration, administered in Left arm on 28May2021 as dose 2, single (at the age of 16 years), for covid-19 immunization, at Hospital. Medical history and concomitant medications were not reported. There were no known allergies. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: EW0173), via an unspecified route of administration, administered in Left arm on 07May2021 as dose 1, single (at the age of 16 years), for covid-19 immunization, at Hospital. There were no other vaccine in four weeks and no other medications in two weeks. The patient reported that, since 17Jul2021, he had been having acute gastroenteritis (for over 4 weeks to present 14Aug2021) and since unknown dates in 2021, he could not eat regular yet, had uneasy stomach and lost 21 lbs. Adverse events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The patient did not have Covid prior to vaccination. The patient was tested for covid post vaccination. The patient underwent lab tests and procedures which included Covid-19 virus test (sars-cov-2 test) via Nasal Swab, Nasopharyngeal on 07Aug2021 with negative result and on an unknown date in 2021, measured weight in which realized he lost 21 lbs. Therapeutic measure for Acute gastroenteritis was taken, received IV for dehydration (IV drug was not specified). The outcome for the event Acute gastroenteritis was not recovered at the time of report, however the outcome for the rest of the events was unknown.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Weight decreased
Clinical narrative: Been having acute gastroentinitis for over 4 weeks.  From 7/17/21 to present (8/14/21); Can't eat regular yet; Uneasy stomach; Lost 21 lbs; This is a spontaneous report from a contactable consumer, the patient.  A 16-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: EW0182), via an unspecified route of administration, administered in Left arm on 28May2021 as dose 2, single (at the age of 16 years), for covid-19 immunization, at Hospital. Medical history and concomitant medications were not reported. There were no known allergies. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: EW0173), via an unspecified route of administration, administered in Left arm on 07May2021 as dose 1, single (at the age of 16 years), for covid-19 immunization, at Hospital. There were no other vaccine in four weeks and no other medications in two weeks. The patient reported that, since 17Jul2021, he had been having acute gastroenteritis (for over 4 weeks to present 14Aug2021) and since unknown dates in 2021, he could not eat regular yet, had uneasy stomach and lost 21 lbs. Adverse events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The patient did not have Covid prior to vaccination. The patient was tested for covid post vaccination. The patient underwent lab tests and procedures which included Covid-19 virus test (sars-cov-2 test) via Nasal Swab, Nasopharyngeal on 07Aug2021 with negative result and on an unknown date in 2021, measured weight in which realized he lost 21 lbs. Therapeutic measure for Acute gastroenteritis was taken, received IV for dehydration (IV drug was not specified). The outcome for the event Acute gastroenteritis was not recovered at the time of report, however the outcome for the rest of the events was unknown.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Heavy menstrual bleeding, Intermenstrual bleeding
Clinical narrative: had stopped my period 6 days prior to 1st dose & 24 hours post-injection: menstrual cycle began'; menstrual cycle began and lasted for 2 weeks. Patient had consistent, normal cycles and had stopped, patient's period 6 days prior to 1st dose; the metallic taste in mouth, lasted for 24 hours; This is a spontaneous report from a contactable consumer (the patient). A 31-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; lot number: EW0177), via an unspecified route of administration, in the left arm, on 25Jul2021 at 11:00 (at the age of 31-year-old) as dose 1 ,single for COVID-19 immunization. The patient's relevant medical history included bipolar II, ADHD (Attention deficit hyperactivity disorder), general anxiety disorder and relevant past drug history included Oxycodone and Maxalt. The concomitant medications included lamotrigine, bupropion hcl and amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (AMPHETAMIN SALTS). On 25Jul2021 at 12:30, 1.5 hours post-injection, patient experienced the metallic taste in mouth, lasted for 24 hours. On 26Jul2021 at 14:00, 24 hours post-injection, menstrual cycle began and lasted for 2 weeks. Patient had consistent, normal cycles and had stopped, patient's period 6 days prior to 1st dose. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Adverse event resulted in doctor or other healthcare professional office/clinic visit. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. No treatment received for the events. Outcome of the event taste metallic was recovered on Jul2021 and outcome of the rest events was recovered on an unknown date in 2021.   Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: got vaccine 18Dec2020.Got COVID infection 30Dec2020; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 18Dec2020 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation.  Medical history included rheumatoid arthritis (RA) from an unknown date, had been off medication since Jan2021, covid-19 from 25Sep2020 to an unknown date. The patient's concomitant medications were not reported.  The patient got vaccine on 18Dec2020 and got COVID infection 30Dec2020, the patient received monoclonal therapy on 05Jan2021 and out of work for over 100 days. 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: Headache, Muscle twitching, Nail discolouration
Clinical narrative: Muscle twitching; Headache; some wired discoloration on my nail; This is a spontaneous report from a contactable consumer (patient). A 24-years-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot Number: EA6780) as dose 1, single and dose 2 (Batch/Lot Number: EW0178) as dose 2, single for covid-19 immunization. The patient medical history and concomitant medications were not reported.  The patient reported side effect that not going away from the Pfizer vaccine. Patient experienced muscle twitching and headache and there is like some wired discoloration on patient nail. The patient does not  know if the events are the vaccine. Treatment was not taken for events. The outcome of the events was not recovered.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Patient has tested positive for COVID-19 following the completion of the COVID-19 vaccine series.; Patient has tested positive for COVID-19 following the completion of the COVID-19 vaccine series.; This is a spontaneous report from a non-contactable other hcp.   A 49-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VAC-CINE, formulation: Solution for injection, Lot Number: EN5318, and Expiration date: Unknown), via an unspecified route of administration on 15Feb2021 (at the age of 48-year-old) as dose 2, single for COVID-19 immunization. Medical history and concomitant medications were not reported. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown if the patient was diagnosed with COVID-19, prior to vaccination. Previously patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EN5318, and Expiration date: Unknown), via an unspecified route of administration on 25Jan2021 (at the age of 48-year-old), as dose 1, single for COVID-19 immunization (No reaction on previous exposure to vaccine). It was reported that on 13Aug2021, "Patient has tested positive for COVID-19 following the completion of the COVID-19 vaccine series" and it resulted in doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included SARS-CoV-2 test (COVID-19 test): positive, on 13Aug2021. The type of the COVID test was unknown. It was unknown if the patient received treatment for the events. The outcome of the events was reported as not resolved.   No follow up attempts were possible. No further information was expected.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the reported events and suspect drug BNT162B2 cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Positive for Covid-19 Infection; positive for Covid-19 Infection; This is a spontaneous report from a contactable consumer. A patient (reporter roommate) of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), in Mar2021 (Lot number: EP7534, Expiration date: not reported) as dose 1, single and on 08Apr2021 (Lot number: EW0153, Expiration date: 31Jul2021) as dose 2, single, both via Intramuscular for covid-19 immunization. Medical history and concomitant medications were not reported. On 11Apr2021, the patient had symptomatic and positive for Covid-19 Infection after being fully vaccinated with the Pfizer BioNTech Covid-19 Vaccine. The outcome of events was unknown.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Angina pectoris, Blood pressure measurement, Bradycardia, Dizziness, Echocardiogram
Clinical narrative: completely lost feeling in his left leg from the knee down; Arm soreness after receiving the shots; dose 1 24Mar2021; dose 2 24Mar2021; Irregular heartbeats; Hypervitaminosis B6; paresthesia; palpitations; Tremors; Bradycardia; Uncontrolled hypertension; Peroneal neuropathy; Blurry vision; Dizziness; Angina; Tinnitus; lameness; limp in his left leg; allergies; This is a spontaneous report from a contactable consumer (patient). A 45-year-old male patient received bnt162b2 (BNT162B2), via an unspecified route of administration, administered in right arm on 24Mar2021 11:30 (Batch/Lot Number: ER8730), at the age of 45 years old, as dose 1, single, and then via an unspecified route of administration, administered in left arm on 24Mar2021 (Batch/Lot Number: ER8371), at the age of 45 years old, as dose 2, single for covid-19 immunisation administered in a pharmacy of drug store. Medical history included attention deficit hyperactivity disorder (ADHD) from an unknown date and unknown if ongoing. No covid prior to vaccination and was not tested for covid post vaccination. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) and losartan taken for an unspecified indication, start and stop date were not reported. No other vaccine received in four weeks. The patient was healthy and athletic with no known allergies to vaccines, 45 years old, male, 160 lbs. He had no immediate reaction other than arm soreness after receiving the shots on 24Mar2021. He never felt any sickness or immune response after the 2nd shot. He walked 8 miles after receiving the 2nd dose. He takes his BP regularly and began detecting irregular heartbeats on both his BP monitor and on his smartwatch during Mar2021-Jun2021. His doctor ordered an echocardiogram and 72 hour holter monitor in 2021 and neither showed anything alarming. On 20Jun2021, he completely lost feeling in his left leg from the knee down. He was sitting with his left leg crossed over his right leg, and his left leg went to sleep. It never woke up. After vaccination, on an unspecified date in 2021, he had been diagnosed with hypervitaminosis B6, parasthesia, palpitation, tremors, bradycardia, uncontrolled hypertension, peroneal neuropathy, blurry vision, dizziness, angina, tinnitus, lameness, irregular heartbeats. He was perfectly healthy before the vaccine. Now he has a limp in his left leg. Known allergies: Pfizer Covid Vaccine. The events resulted in doctor clinic visit and emergency room/department or urgent care. The events were reported as serious - life threatening illness (immediate risk of death from the event), and disability or permanent damage. Treatment included acute care, medication, and physical therapy stress ma (as reported). The patient has not recovered from the events.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Electrocardiogram ambulatory, Gait disturbance, Heart rate irregular, Hypersensitivity, Hypertension
Clinical narrative: completely lost feeling in his left leg from the knee down; Arm soreness after receiving the shots; dose 1 24Mar2021; dose 2 24Mar2021; Irregular heartbeats; Hypervitaminosis B6; paresthesia; palpitations; Tremors; Bradycardia; Uncontrolled hypertension; Peroneal neuropathy; Blurry vision; Dizziness; Angina; Tinnitus; lameness; limp in his left leg; allergies; This is a spontaneous report from a contactable consumer (patient). A 45-year-old male patient received bnt162b2 (BNT162B2), via an unspecified route of administration, administered in right arm on 24Mar2021 11:30 (Batch/Lot Number: ER8730), at the age of 45 years old, as dose 1, single, and then via an unspecified route of administration, administered in left arm on 24Mar2021 (Batch/Lot Number: ER8371), at the age of 45 years old, as dose 2, single for covid-19 immunisation administered in a pharmacy of drug store. Medical history included attention deficit hyperactivity disorder (ADHD) from an unknown date and unknown if ongoing. No covid prior to vaccination and was not tested for covid post vaccination. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) and losartan taken for an unspecified indication, start and stop date were not reported. No other vaccine received in four weeks. The patient was healthy and athletic with no known allergies to vaccines, 45 years old, male, 160 lbs. He had no immediate reaction other than arm soreness after receiving the shots on 24Mar2021. He never felt any sickness or immune response after the 2nd shot. He walked 8 miles after receiving the 2nd dose. He takes his BP regularly and began detecting irregular heartbeats on both his BP monitor and on his smartwatch during Mar2021-Jun2021. His doctor ordered an echocardiogram and 72 hour holter monitor in 2021 and neither showed anything alarming. On 20Jun2021, he completely lost feeling in his left leg from the knee down. He was sitting with his left leg crossed over his right leg, and his left leg went to sleep. It never woke up. After vaccination, on an unspecified date in 2021, he had been diagnosed with hypervitaminosis B6, parasthesia, palpitation, tremors, bradycardia, uncontrolled hypertension, peroneal neuropathy, blurry vision, dizziness, angina, tinnitus, lameness, irregular heartbeats. He was perfectly healthy before the vaccine. Now he has a limp in his left leg. Known allergies: Pfizer Covid Vaccine. The events resulted in doctor clinic visit and emergency room/department or urgent care. The events were reported as serious - life threatening illness (immediate risk of death from the event), and disability or permanent damage. Treatment included acute care, medication, and physical therapy stress ma (as reported). The patient has not recovered from the events.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Hypervitaminosis B, Hypoaesthesia, Inappropriate schedule of product administration, Neuropathy peripheral, Pain in extremity
Clinical narrative: completely lost feeling in his left leg from the knee down; Arm soreness after receiving the shots; dose 1 24Mar2021; dose 2 24Mar2021; Irregular heartbeats; Hypervitaminosis B6; paresthesia; palpitations; Tremors; Bradycardia; Uncontrolled hypertension; Peroneal neuropathy; Blurry vision; Dizziness; Angina; Tinnitus; lameness; limp in his left leg; allergies; This is a spontaneous report from a contactable consumer (patient). A 45-year-old male patient received bnt162b2 (BNT162B2), via an unspecified route of administration, administered in right arm on 24Mar2021 11:30 (Batch/Lot Number: ER8730), at the age of 45 years old, as dose 1, single, and then via an unspecified route of administration, administered in left arm on 24Mar2021 (Batch/Lot Number: ER8371), at the age of 45 years old, as dose 2, single for covid-19 immunisation administered in a pharmacy of drug store. Medical history included attention deficit hyperactivity disorder (ADHD) from an unknown date and unknown if ongoing. No covid prior to vaccination and was not tested for covid post vaccination. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) and losartan taken for an unspecified indication, start and stop date were not reported. No other vaccine received in four weeks. The patient was healthy and athletic with no known allergies to vaccines, 45 years old, male, 160 lbs. He had no immediate reaction other than arm soreness after receiving the shots on 24Mar2021. He never felt any sickness or immune response after the 2nd shot. He walked 8 miles after receiving the 2nd dose. He takes his BP regularly and began detecting irregular heartbeats on both his BP monitor and on his smartwatch during Mar2021-Jun2021. His doctor ordered an echocardiogram and 72 hour holter monitor in 2021 and neither showed anything alarming. On 20Jun2021, he completely lost feeling in his left leg from the knee down. He was sitting with his left leg crossed over his right leg, and his left leg went to sleep. It never woke up. After vaccination, on an unspecified date in 2021, he had been diagnosed with hypervitaminosis B6, parasthesia, palpitation, tremors, bradycardia, uncontrolled hypertension, peroneal neuropathy, blurry vision, dizziness, angina, tinnitus, lameness, irregular heartbeats. He was perfectly healthy before the vaccine. Now he has a limp in his left leg. Known allergies: Pfizer Covid Vaccine. The events resulted in doctor clinic visit and emergency room/department or urgent care. The events were reported as serious - life threatening illness (immediate risk of death from the event), and disability or permanent damage. Treatment included acute care, medication, and physical therapy stress ma (as reported). The patient has not recovered from the events.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Palpitations, Paraesthesia, Tinnitus, Tremor, Vision blurred
Clinical narrative: completely lost feeling in his left leg from the knee down; Arm soreness after receiving the shots; dose 1 24Mar2021; dose 2 24Mar2021; Irregular heartbeats; Hypervitaminosis B6; paresthesia; palpitations; Tremors; Bradycardia; Uncontrolled hypertension; Peroneal neuropathy; Blurry vision; Dizziness; Angina; Tinnitus; lameness; limp in his left leg; allergies; This is a spontaneous report from a contactable consumer (patient). A 45-year-old male patient received bnt162b2 (BNT162B2), via an unspecified route of administration, administered in right arm on 24Mar2021 11:30 (Batch/Lot Number: ER8730), at the age of 45 years old, as dose 1, single, and then via an unspecified route of administration, administered in left arm on 24Mar2021 (Batch/Lot Number: ER8371), at the age of 45 years old, as dose 2, single for covid-19 immunisation administered in a pharmacy of drug store. Medical history included attention deficit hyperactivity disorder (ADHD) from an unknown date and unknown if ongoing. No covid prior to vaccination and was not tested for covid post vaccination. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) and losartan taken for an unspecified indication, start and stop date were not reported. No other vaccine received in four weeks. The patient was healthy and athletic with no known allergies to vaccines, 45 years old, male, 160 lbs. He had no immediate reaction other than arm soreness after receiving the shots on 24Mar2021. He never felt any sickness or immune response after the 2nd shot. He walked 8 miles after receiving the 2nd dose. He takes his BP regularly and began detecting irregular heartbeats on both his BP monitor and on his smartwatch during Mar2021-Jun2021. His doctor ordered an echocardiogram and 72 hour holter monitor in 2021 and neither showed anything alarming. On 20Jun2021, he completely lost feeling in his left leg from the knee down. He was sitting with his left leg crossed over his right leg, and his left leg went to sleep. It never woke up. After vaccination, on an unspecified date in 2021, he had been diagnosed with hypervitaminosis B6, parasthesia, palpitation, tremors, bradycardia, uncontrolled hypertension, peroneal neuropathy, blurry vision, dizziness, angina, tinnitus, lameness, irregular heartbeats. He was perfectly healthy before the vaccine. Now he has a limp in his left leg. Known allergies: Pfizer Covid Vaccine. The events resulted in doctor clinic visit and emergency room/department or urgent care. The events were reported as serious - life threatening illness (immediate risk of death from the event), and disability or permanent damage. Treatment included acute care, medication, and physical therapy stress ma (as reported). The patient has not recovered from the events.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Walking disability
Clinical narrative: completely lost feeling in his left leg from the knee down; Arm soreness after receiving the shots; dose 1 24Mar2021; dose 2 24Mar2021; Irregular heartbeats; Hypervitaminosis B6; paresthesia; palpitations; Tremors; Bradycardia; Uncontrolled hypertension; Peroneal neuropathy; Blurry vision; Dizziness; Angina; Tinnitus; lameness; limp in his left leg; allergies; This is a spontaneous report from a contactable consumer (patient). A 45-year-old male patient received bnt162b2 (BNT162B2), via an unspecified route of administration, administered in right arm on 24Mar2021 11:30 (Batch/Lot Number: ER8730), at the age of 45 years old, as dose 1, single, and then via an unspecified route of administration, administered in left arm on 24Mar2021 (Batch/Lot Number: ER8371), at the age of 45 years old, as dose 2, single for covid-19 immunisation administered in a pharmacy of drug store. Medical history included attention deficit hyperactivity disorder (ADHD) from an unknown date and unknown if ongoing. No covid prior to vaccination and was not tested for covid post vaccination. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) and losartan taken for an unspecified indication, start and stop date were not reported. No other vaccine received in four weeks. The patient was healthy and athletic with no known allergies to vaccines, 45 years old, male, 160 lbs. He had no immediate reaction other than arm soreness after receiving the shots on 24Mar2021. He never felt any sickness or immune response after the 2nd shot. He walked 8 miles after receiving the 2nd dose. He takes his BP regularly and began detecting irregular heartbeats on both his BP monitor and on his smartwatch during Mar2021-Jun2021. His doctor ordered an echocardiogram and 72 hour holter monitor in 2021 and neither showed anything alarming. On 20Jun2021, he completely lost feeling in his left leg from the knee down. He was sitting with his left leg crossed over his right leg, and his left leg went to sleep. It never woke up. After vaccination, on an unspecified date in 2021, he had been diagnosed with hypervitaminosis B6, parasthesia, palpitation, tremors, bradycardia, uncontrolled hypertension, peroneal neuropathy, blurry vision, dizziness, angina, tinnitus, lameness, irregular heartbeats. He was perfectly healthy before the vaccine. Now he has a limp in his left leg. Known allergies: Pfizer Covid Vaccine. The events resulted in doctor clinic visit and emergency room/department or urgent care. The events were reported as serious - life threatening illness (immediate risk of death from the event), and disability or permanent damage. Treatment included acute care, medication, and physical therapy stress ma (as reported). The patient has not recovered from the events.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Muscle twitching, Sensory disturbance, Suicidal ideation
Clinical narrative: Talking about committing suicide; Twitching and vibrating sensation throughout her whole body; Twitching and vibrating sensation throughout her whole body; This is a spontaneous report from a contactable consumer (patient's fiance). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose number unknown, via an unspecified route of administration, administered in the left arm on 13Jul2021 (Batch/Lot Number: FA6780, at the age of 60-years-old at vaccination) as a single dose for COVID-19 immunisation. Medical history included ITP (Immune thrombocytopenic purpura). Concomitant medications were not reported. On 13Jul2021, the patient received the BNT162B2 vaccine. Two days later (on 15Jul2021), she started getting a twitching and vibrating sensation throughout her whole body. She has been to numerous doctors but it won't stop and she was talking about committing suicide now because the twitching and vibrating sensation is constant and it doesn't let up. She describes it as- like sitting on a washing machine that never stops. She was in extremely bad shape now.  The fiance stated that he needed to get her some kind of help because she was ready to commit suicide. It was extremely bad now and the patient needs to get help because this side effect was about killing her. She just can't cope anymore because the twitching and vibrating sensation doesn't stop. She was having an extremely hard time coping. The patient had some blood test and was awaiting the results. The outcome of the events talking about committing suicide and twitching and vibrating sensation was not recovered.  Follow-up (17Aug2021): Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: I am break through patient of your Pfizer vaccine, I think I got Covid 19; I am break through patient of your Pfizer vaccine, I think I got Covid 19; This is a spontaneous report from a contactable consumer or other non-HCP (Patient).   A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), 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. It was reported that, the patient was going to give an advice, the patient was break through patient of Pfizer vaccine (Unspecified Vaccine). The patient thought, the patient got Covid 19 on an unspecified date, and she (the girl) was asking me questions, when patient was fill out with some kind of stuff. The patient asked can you put that into the system and see who the patient was taking to.The outcome of Suspected COVID-19 was unknown  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pericarditis
Clinical narrative: Pericarditis; This is a spontaneous report from a contactable consumer (patient). A 59-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) Dose 2 via an unspecified route of administration, administered in the right arm on 12Apr2021 at 16:00 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. There were no medical history or concomitant medications. The patient previously received the first dose of BNT162b2 on 12Mar2021 (Lot Number: EN6208) via an unspecified route of administration in the right arm for COVID-19 immunisation. The patient experienced pericarditis on 28Apr2021, for which he was hospitalized from 29Apr2021 to 01May2021. The patient stated that on 12Apr2021, he had his second shot of the vaccine. The patient stated he is very thankful for the vaccine and he was over the moon to receive it. The patient stated on 29Apr2021, he ended up in the hospital and he had pericarditis, an inflammation of the lining around his heart. The patient stated when it first happened, it was a feeling like indigestion at night and when he went to bed, he had sharp pains in his chest. The patient stated at 2:00a.m. he started looking up symptoms of a heart attack and by 3:00a.m., he woke his husband up, who is a doctor, and he took him to the hospital at 4:00a.m. The patient stated his cardiologist told him it may be a side effect of the vaccine. The patient stated he has never had any issues with his heart. The patient stated they did complete research of his heart and said it was in great shape, it was weird why the lining swelled up. There were no relevant tests reported. The patient recovered from the event on 01May2021.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pericarditis
Clinical narrative: he ended up in the hospital with Paracydis/The side effect listed should be:  Pericarditis; This is a spontaneous report from a Pfizer-sponsored program reported by a contactable consumer (patient). A male patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution injection; Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution injection; Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. On an unspecified date, after the 2nd dose the patient ended up in the hospital with pericarditis which was supposedly a common side effect of the vaccine. The patient wanted to know what Pfizer recommends and if this should be reported. 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: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal, Pain, Pyrexia, Suspected COVID-19
Clinical narrative: I have the COVID symptoms; Like I have the COVID; Fever; Breaking fever; Chills; Body Ache; I don't feel good right now; I feel like I want throw up; My arm is swollen; and my arm is swollen at the site; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 47-year-old female patient received first dose of bnt162b2 (Pfizer covid-19 vaccine, Solution for injection, Batch/lot number: Unknown, Expiry date: Unknown), via an unspecified route on 11Aug2021 (age at vaccination: 47-year-old), as a single dose for covid-19 immunization. Medical history included type 2 Diabetes, vitamin D deficiency and cholesterol. Concomitant medications included Vitamin D because she is vitamin D deficient, she took most of Vitamins, statins for cholesterol and she takes regular medicine/every day. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 12Aug2021, patient started having fever, breaking fever, started having Chills, body ache. Patient did the Pfizer the first shot experienced covid symptoms because she was having fever, chills; on an unspecified date in Aug2021, her arm was swollen at the site, like she has the covid, she doesn't feel good right now. She felt like she wants to throw up. Patient will go back in three weeks for the second dose. Therapeutic measures taken as a result of the events included Tylenol for fever. The clinical outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling, Vomiting
Clinical narrative: I have the COVID symptoms; Like I have the COVID; Fever; Breaking fever; Chills; Body Ache; I don't feel good right now; I feel like I want throw up; My arm is swollen; and my arm is swollen at the site; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 47-year-old female patient received first dose of bnt162b2 (Pfizer covid-19 vaccine, Solution for injection, Batch/lot number: Unknown, Expiry date: Unknown), via an unspecified route on 11Aug2021 (age at vaccination: 47-year-old), as a single dose for covid-19 immunization. Medical history included type 2 Diabetes, vitamin D deficiency and cholesterol. Concomitant medications included Vitamin D because she is vitamin D deficient, she took most of Vitamins, statins for cholesterol and she takes regular medicine/every day. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 12Aug2021, patient started having fever, breaking fever, started having Chills, body ache. Patient did the Pfizer the first shot experienced covid symptoms because she was having fever, chills; on an unspecified date in Aug2021, her arm was swollen at the site, like she has the covid, she doesn't feel good right now. She felt like she wants to throw up. Patient will go back in three weeks for the second dose. Therapeutic measures taken as a result of the events included Tylenol for fever. The clinical outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Itching; This is a spontaneous report from a contactable consumer (patient).   A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EY0584, expiry date: not reported), via an unspecified route of administration on 24Jul2021 as dose 2, single for COVID-19 immunisation.  The patient's medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EY0587), via an unspecified route of administration on 05Jul2021, as single dose for COVID-19 immunization. On 24Jul2021, after second dose,the patient experienced itching and had a doctor visit, took some unspecified medications in response to the event. It was reported that the medication gave some relief temporarily, but keep on coming back again. At the time of report, still it did not go away. The outcome of the event was not recovered.