chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Coagulation time, Headache, Investigation, Platelet count
Clinical narrative: after the first vaccine he had a headache for a few days also but it was not bad at all; This is a spontaneous report from a contactable consumer or other non-HCP (patient's mother). A 14-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EWO177), via an unspecified route of administration, in Arm Right on 01Jun2021 (age at the time of vaccination 14-years-old), as a single dose for COVID-19 immunization. The patient's medical history included allergies. The patient's concomitant medications included Cetirizine Hydrochloride (Zyrtec Allergy) for allergies, one tablet, 10 mg, as needed, He has been taking it since he was six about; and Ferrous Fumarate, Vitamins Nos (Flintstone Vitamins with Iron), 2 gummies once a day, He started taking last year for health. On an unspecified date the patient experienced after the first vaccine he had a headache for a few days also, but it was not bad at all. On an unspecified date, the patient underwent lab tests and procedures which included clotting, Coagulation time: Unknown result; took some blood they are checking, Investigation: Unknown result; and Platelet count: Unknown result. The patient visited to physician office. Caller stated, when the headaches got bad, he would take Tylenol the first few days and then he took Motrin. Caller corrects this and states he took Ibuprofen, not Motrin. The outcome of the event was unknown.  VACCINE SUPPLEMENTAL FORM 1.: Patient details, dose details, concomitant, adverse events, visited to Physician Office, patient did not receive any other vaccinations within four weeks prior to the first administration date of the suspect vaccine, Patient's Medical History, and Relevant Tests was included.  The information about lot umber was provided. No further information expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021868617 similar report from same reporter
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Chest X-ray, Echocardiogram, Electrocardiogram ambulatory normal, Mammogram, Pain of skin
Clinical narrative: bleeding; burning; itching; sores; raised patches; This is a spontaneous report received from a contactable consumer (patient).  A 53-year-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in arm left on 14May2021 12:30 PM (Batch/Lot Number: EW0177) as single dose for COVID-19 immunisation, administered at church.  Medical history included psoriasis on her scalp since childhood and ongoing, C-sections in 1997 and 2001, hypothyroidism from 2005 and ongoing, Lupus anticoagulant from 2012 and ongoing, hysterectomy from 2012 to Dec2020 (as reported), hernia repair from 2012 to Dec2020 (as reported), anxiety, gastrooesophageal reflux disease (GERD). Concomitant medication(s) included levothyroxine sodium (SYNTHROID) at 50 mcg taken for hypothyroidism from an unspecified start date and ongoing; rivaroxaban (XARELTO) at 10 mg taken for lupus anticoagulant from an unspecified start date and ongoing; pantoprazole (PANTOPRAZOLE) at 20 mg taken for gastrooesophageal reflux disease from an unspecified start date and ongoing; escitalopram (ESCITALOPRAM) at 10 mg taken for anxiety from an unspecified start date and ongoing. The patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in arm left on 16Apr2021 12:30 PM (Batch/Lot Number: EW0161) as single dose for COVID-19 immunisation, administered at church, and on 17Apr2021 her scalp started to itch significantly (no treatment received).  On 15May2021 the patient experienced bleeding (medically significant) with outcome of not recovered, burning (non-serious) with outcome of not recovered, itching (non-serious) with outcome of not recovered, sores (non-serious) with outcome of not recovered, raised patches (non-serious) with outcome of not recovered.  The course of events was as follows: The patient had psoriasis on her scalp since she was a child. It went into remission on her 20's and returned in mild form in her late 40's. After her first COVID vaccine her scalp started to itch significantly. After her second shot her scalp has gotten significantly worse with raised patches, bleeding, sores, and burning and itching. She saw a dermatologist and then prescribed clobetasol. The patient underwent lab tests and procedures which included chest X-ray: normal on 17Mar2021, echocardiogram: normal in Mar2021, electrocardiogram ambulatory: normal   on 25Mar2021, mammogram: normal on 17Mar2021.  New med clobetasol for scalp was given as treatment.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Skin burning sensation, Skin haemorrhage
Clinical narrative: bleeding; burning; itching; sores; raised patches; This is a spontaneous report received from a contactable consumer (patient).  A 53-year-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in arm left on 14May2021 12:30 PM (Batch/Lot Number: EW0177) as single dose for COVID-19 immunisation, administered at church.  Medical history included psoriasis on her scalp since childhood and ongoing, C-sections in 1997 and 2001, hypothyroidism from 2005 and ongoing, Lupus anticoagulant from 2012 and ongoing, hysterectomy from 2012 to Dec2020 (as reported), hernia repair from 2012 to Dec2020 (as reported), anxiety, gastrooesophageal reflux disease (GERD). Concomitant medication(s) included levothyroxine sodium (SYNTHROID) at 50 mcg taken for hypothyroidism from an unspecified start date and ongoing; rivaroxaban (XARELTO) at 10 mg taken for lupus anticoagulant from an unspecified start date and ongoing; pantoprazole (PANTOPRAZOLE) at 20 mg taken for gastrooesophageal reflux disease from an unspecified start date and ongoing; escitalopram (ESCITALOPRAM) at 10 mg taken for anxiety from an unspecified start date and ongoing. The patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in arm left on 16Apr2021 12:30 PM (Batch/Lot Number: EW0161) as single dose for COVID-19 immunisation, administered at church, and on 17Apr2021 her scalp started to itch significantly (no treatment received).  On 15May2021 the patient experienced bleeding (medically significant) with outcome of not recovered, burning (non-serious) with outcome of not recovered, itching (non-serious) with outcome of not recovered, sores (non-serious) with outcome of not recovered, raised patches (non-serious) with outcome of not recovered.  The course of events was as follows: The patient had psoriasis on her scalp since she was a child. It went into remission on her 20's and returned in mild form in her late 40's. After her first COVID vaccine her scalp started to itch significantly. After her second shot her scalp has gotten significantly worse with raised patches, bleeding, sores, and burning and itching. She saw a dermatologist and then prescribed clobetasol. The patient underwent lab tests and procedures which included chest X-ray: normal on 17Mar2021, echocardiogram: normal in Mar2021, electrocardiogram ambulatory: normal   on 25Mar2021, mammogram: normal on 17Mar2021.  New med clobetasol for scalp was given as treatment.
Age: 32.0
Sex: U
Vaccine: COVID19
Symptoms: Partial seizures
Clinical narrative: I started having simple partial seizures the day after I got the first vaccine; This is a spontaneous report from a contactable consumer (patient). A 32-years-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: EWO198) via an unspecified route of administration, administered in Arm Right on 15Jul2021 15:00 (at the age of 32-year-old) as dose 1, single for covid-19 immunisation. Medical history included epilepsy. The patient concomitant medications were not reported. It was reported that patient did not receive other vaccine in four weeks. Patient had no COVID prior vaccination and patient had not tested COVID post vaccination. On 16Jul2021 16:00, the patient reported that this might be just a HUGE coincidence but, patient started having simple partial seizures the day after patient got the first vaccine. Patient said HUGE coincidence because patient have not had a single issue with seizures in over 5 years. No treatment received for event. The outcome of event was recovering.  No follow-up attempts are needed. No further information is expected.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Anaemia, Aphasia, Bedridden, Cognitive disorder, Colitis
Clinical narrative: very disoriented; neurologically and cognitively there has been a continuous decline; neurologically and cognitively there has been a continuous decline; bed confined; unable to talk; forgetful; lightheartedness; unable to sleep; diarrhea; fell; colitis; anemia; dehydration; PE in lungs; DVT right leg; Decrease level of consciousness; Could not walk without assistance; This is a spontaneous report received from a contactable consumer via a consumer (patient). A 75-year-old female patient received second dose of bnt162b2 (Batch/Lot Number: El9265), via an unspecified route of administration, administered in Arm Left on 26Feb2021 at age of 75-year-old as single dose for covid-19 immunisation. The patient was not pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered was doctor's office/ urgent care. The patient didn't 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 previously received first dose of bnt162b2 (Batch/Lot Number: El9265), via an unspecified route of administration, administered in Arm Left on 05Feb2021 at age of 75-year-old as single dose for covid-19 immunisation. Medical history included High blood pressure, high cholesterol. No known allergies. Concomitant medications included lisinopril, ranolazine (RANEXA), simvastatin, ubidecarenone (COQ10), calcium. On Mar2021, two weeks after 2nd vaccine, the patient started being very forgetful, lightheartedness. 4 weeks following 2nd vaccine, patient was unable to sleep, diarrhea and fell on 3 different occasions. By Apr2021 became very disoriented, diarrhea continued. Was taken to emergency room and was diagnosed colitis, anemia, dehydration, pulmonary embolism (PE) in lungs and deep venous thrombosis (DVT) right leg. Patient was admitted into hospital for 3 days. Discharged 3 days later, could not walk without assistance and experience decrease level of consciousness. Hospital discharge doctor stated that Physical therapy and hydration will offer her a full recovery. Since the beginning of Apr2021 neurologically and cognitively there had been a continuous decline. Before Apr2021 patient was independent, living on her own, paying Bill's, driving, and preparing her own meals. Now she was bed confined, unable to talk. In early Jun2021, while she was still able to move via walker assistance she was referred to neurologist, MD. He performed MRI, EEG, and MR venagram. He ruled out stroke, and blood clot to brain. The patient received pednisone as treatment. The adverse events result in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Seriousness criteria were reported as life threatening, caused/ prolonged hospitalization and disabling/ incapacitating. COVID test (Nasal Swab) post vaccination on 05Apr2021 with result negative. The outcome of events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Electroencephalogram, Fall, Gait disturbance, Insomnia
Clinical narrative: very disoriented; neurologically and cognitively there has been a continuous decline; neurologically and cognitively there has been a continuous decline; bed confined; unable to talk; forgetful; lightheartedness; unable to sleep; diarrhea; fell; colitis; anemia; dehydration; PE in lungs; DVT right leg; Decrease level of consciousness; Could not walk without assistance; This is a spontaneous report received from a contactable consumer via a consumer (patient). A 75-year-old female patient received second dose of bnt162b2 (Batch/Lot Number: El9265), via an unspecified route of administration, administered in Arm Left on 26Feb2021 at age of 75-year-old as single dose for covid-19 immunisation. The patient was not pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered was doctor's office/ urgent care. The patient didn't 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 previously received first dose of bnt162b2 (Batch/Lot Number: El9265), via an unspecified route of administration, administered in Arm Left on 05Feb2021 at age of 75-year-old as single dose for covid-19 immunisation. Medical history included High blood pressure, high cholesterol. No known allergies. Concomitant medications included lisinopril, ranolazine (RANEXA), simvastatin, ubidecarenone (COQ10), calcium. On Mar2021, two weeks after 2nd vaccine, the patient started being very forgetful, lightheartedness. 4 weeks following 2nd vaccine, patient was unable to sleep, diarrhea and fell on 3 different occasions. By Apr2021 became very disoriented, diarrhea continued. Was taken to emergency room and was diagnosed colitis, anemia, dehydration, pulmonary embolism (PE) in lungs and deep venous thrombosis (DVT) right leg. Patient was admitted into hospital for 3 days. Discharged 3 days later, could not walk without assistance and experience decrease level of consciousness. Hospital discharge doctor stated that Physical therapy and hydration will offer her a full recovery. Since the beginning of Apr2021 neurologically and cognitively there had been a continuous decline. Before Apr2021 patient was independent, living on her own, paying Bill's, driving, and preparing her own meals. Now she was bed confined, unable to talk. In early Jun2021, while she was still able to move via walker assistance she was referred to neurologist, MD. He performed MRI, EEG, and MR venagram. He ruled out stroke, and blood clot to brain. The patient received pednisone as treatment. The adverse events result in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Seriousness criteria were reported as life threatening, caused/ prolonged hospitalization and disabling/ incapacitating. COVID test (Nasal Swab) post vaccination on 05Apr2021 with result negative. The outcome of events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Venogram
Clinical narrative: very disoriented; neurologically and cognitively there has been a continuous decline; neurologically and cognitively there has been a continuous decline; bed confined; unable to talk; forgetful; lightheartedness; unable to sleep; diarrhea; fell; colitis; anemia; dehydration; PE in lungs; DVT right leg; Decrease level of consciousness; Could not walk without assistance; This is a spontaneous report received from a contactable consumer via a consumer (patient). A 75-year-old female patient received second dose of bnt162b2 (Batch/Lot Number: El9265), via an unspecified route of administration, administered in Arm Left on 26Feb2021 at age of 75-year-old as single dose for covid-19 immunisation. The patient was not pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered was doctor's office/ urgent care. The patient didn't 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 previously received first dose of bnt162b2 (Batch/Lot Number: El9265), via an unspecified route of administration, administered in Arm Left on 05Feb2021 at age of 75-year-old as single dose for covid-19 immunisation. Medical history included High blood pressure, high cholesterol. No known allergies. Concomitant medications included lisinopril, ranolazine (RANEXA), simvastatin, ubidecarenone (COQ10), calcium. On Mar2021, two weeks after 2nd vaccine, the patient started being very forgetful, lightheartedness. 4 weeks following 2nd vaccine, patient was unable to sleep, diarrhea and fell on 3 different occasions. By Apr2021 became very disoriented, diarrhea continued. Was taken to emergency room and was diagnosed colitis, anemia, dehydration, pulmonary embolism (PE) in lungs and deep venous thrombosis (DVT) right leg. Patient was admitted into hospital for 3 days. Discharged 3 days later, could not walk without assistance and experience decrease level of consciousness. Hospital discharge doctor stated that Physical therapy and hydration will offer her a full recovery. Since the beginning of Apr2021 neurologically and cognitively there had been a continuous decline. Before Apr2021 patient was independent, living on her own, paying Bill's, driving, and preparing her own meals. Now she was bed confined, unable to talk. In early Jun2021, while she was still able to move via walker assistance she was referred to neurologist, MD. He performed MRI, EEG, and MR venagram. He ruled out stroke, and blood clot to brain. The patient received pednisone as treatment. The adverse events result in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Seriousness criteria were reported as life threatening, caused/ prolonged hospitalization and disabling/ incapacitating. COVID test (Nasal Swab) post vaccination on 05Apr2021 with result negative. The outcome of events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Asymptomatic COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: The date of PCR COVID test was 06Jul2021 and she was positive for COVID; The date of PCR COVID test was 06Jul2021 and she was positive for COVID/ she had no symptoms at all; This is a spontaneous report from a contactable consumer, the patient. This report is for the reporter herself (wife). A 57-years-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 deltoid area on 12Feb2021 (at the age of 57-years-old) (Batch/Lot Number: EN6201; Expiration Date: 30Jun2021) as dose 2, 0.3 ml single and dose 1 via an unspecified route of administration, administered in left arm deltoid area on 22Jan2021 (at the age of 57-years-old) (Batch/Lot Number: EL3302; Expiration Date: 31May2021) as DOSE 1, 0.3 ML SINGLE for covid-19 immunization. Vaccine administered at Military Facility reported as no. Medical history reported as none. There were no concomitant medications. Family Medical History Relevant to AE: Not Provided. Prior Vaccinations (within 4 weeks): none. AE following prior vaccinations: Not Provided. Additional Vaccines Administered on Same Date of the Pfizer Suspect: None. Caller was reporting side effect to Pfizer COVID Vaccine. Caller and her husband both travelled to (privacy) where they got COVID19 infection and they both had received both doses of COVID19 Vaccine, wife (patient) said she had no symptoms at all after getting the infection. The caller was pleased that the vaccine worked with her not having symptoms and she just wanted to make sure it got documented because they got COVID19 infection when in the (privacy). The date of PCR COVID test was 06Jul2021 and she was positive for COVID. She stayed in quarantine for 10 days. Stop date would be the 16Jul2021 and she recovered completely. The patient underwent lab tests and procedures which included sars-cov-2 test which was positive on 06Jul2021. Description of Product Complaint: Traveled to (privacy) where she got COVID19 infection. She had received both doses of COVID19 Vaccine. she had no symptoms at all after getting the infection. The caller is pleased that the vaccine worked with her not having symptoms. She just wanted to make sure it got documented because she got COVID19 infection when in the (privacy). The date of PCR COVID test was 06Jul2021 and she was positive for COVID. The events had not resulted in emergency room/ physician office visit. The outcome of the event Asymptomatic COVID-19 was recovered on 16Jul2021 and vaccination failure was unknown.  Information on the lot/ batch number is available. Additional information has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Bell's palsy, Investigation
Clinical narrative: I just wanted to report that, after receiving the Covid vaccine, I got the Bell's palsy so, that was the reaction I received.; 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 mRNA VACCINE, formulation: Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 03Jul2021 (Batch/Lot number was not reported) as dose 2, single for covid-19 immunisation. Medical history included Cancer. There were no concomitant medications. The patient previously received first dose of bnt162b2 (BNT162B2, formulation: Solution for injection), via an unspecified route of administration, on an unspecified date (Batch/Lot number was not reported), as single dose for covid-19 immunisation. On 03Jul2021, the after the vaccination, the patient experienced bell's palsy. Patient just wanted to report that, after receiving the Covid vaccine, patient got the Bell's palsy so, that was the reaction received. Patient stated just wanted to report that, after receiving the Covid vaccine, patient got the Bell's palsy so, that was the reaction received. The patient did not receive treatment for the event. It was reported that the patient has to take medications after the vaccine because of the side effect (Not further clarify). The patient underwent lab tests and procedures which included unknown investigation with unknown results on an unspecified date in 2021. It was reported that the patient was basically being treated by the doctor. The outcome of the event was unknown at the time of this report.
Sex: F
Vaccine: COVID19
Symptoms: Frustration tolerance decreased, Loss of personal independence in daily activities, Muscle spasms, Pain in extremity, Thrombosis
Clinical narrative: blood clot in her leg; severe leg pain and cramps; severe leg pain and cramps; she can't even stand long enough to brush her teeth; my sister continually cries from pain and frustration; This is a spontaneous report from a contactable consumer. A female patient of unknown  age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), second dose via an unspecified route of administration at unknown dose single for COVID-19 immunization. No medical history reported. No concomitant medication reported. The patient start experiencing blood clot in her leg, then severe leg pain and cramps, continually cries from pain and frustration. The outcome of Events was unknown.  Information about lot/batch number has been requested.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Adverse event, COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: positive for COVID; he had mild symptoms; breakthrough of COVID infection; This is a spontaneous report from a contactable consumer. This report is for caller's husband. This consumer (patient's wife) reported for patient (Reporter's husband) that a 67-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, batch/lot number: EN6201, expiration date: 30Jun2021) via an unspecified route of administration, administered in arm right on 12Feb2021 as DOSE 2, 0.3 ML SINGLE for COVID-19 immunisation. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, batch/lot number: EL3302, expiration date: 31May2021) (Age at vaccination 67 years) via an unspecified route of administration, administered in arm right on 22Jan2021 as DOSE 1, 0.3 ML SINGLE for COVID-19 immunisation. The patient did not have medical history. No concomitant medications. On an unknown date, the patient experienced positive for COVID. On 05Jul2021, breakthrough of COVID infection and on an unknown date, he had mild symptoms. The patient underwent lab tests and procedures which included SARS-COV-2 test: positive on 05Jul2021. It was reported that the reporter was calling to report that my husband and I both had two doses of my Pfizer COVID-19 vaccine. We both had a breakthrough of COVID infection while traveling to the UK. My husband had mild symptoms. I had no symptoms after the infection so the vaccine did it's job. I saw the doctor in UK and not in the US. I wanted to make sure it's reported in the United States. Caller and her husband both traveled to UK where they got COVID19 infection and they both had received both doses of COVID19 Vaccine. Husband said he had mild symptoms where as the wife said she had no symptoms at all after getting the infection. The caller was pleased that the vaccine worked with her not having symptoms and she just wanted to make sure it got documented because they got COVID19 infection when in the UK. It was reported that COVID19 infection: he was diagnosed on 05Jul2021. He quarantined for 10 days. Stop date would be 15Jul2021 and he recovered completely. Patient did not administered additional vaccine on same date of the Pfizer suspect. Patient was not visited to emergency room and physician office. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The clinical outcome of event breakthrough of COVID infection was recovered on 15Jul2021, while other events were unknown.  Follow-up attempts are completed. No further information was expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: Chest pain 1 week after first dose; This is a spontaneous report from a contactable consumer. A 43-years-old non-pregnant female patient received bnt162b2 (PFIZER COVID19 VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 2021(Age at vaccination 43-years-old) as DOSE 1, SINGLE for covid-19 immunisation. Pregnancy at time of Vaccination was reported as unknown. Medical history included ehlers-danlos syndrome, autonomic nervous system imbalance from an unknown date and unknown if ongoing Dysautonomia and Ehlers Danlos syndrome, Concomitant medications included hydroxyzine (HYDROXYZINE), diphenhydramine hydrochloride (BENADRYL), thyroid (ARMOUR THYROID), clonazepam (KLONOPIN), curcuma longa (TURMERIC [CURCUMA LONGA], ginger [zingiber officinale rhizome] (GINGER [ZINGIBER OFFICINALE RHIZOME]), ibuprofen taken for an unspecified indication, start and stop date were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine, serious no for Results in death, Life threatening, Caused/prolonged hospitalization, Disabling/Incapacitating, Congenital anomaly/birth defect. patient was not diagnosed with COVID-19. On 2021 the patient experienced chest pain 1 week after first dose. Therapeutic measures were taken as a result of chest pain 1 week after first dose (chest pain). The adverse event result in Emergency room/department or urgent care and also reported no hospitalization prolonged. Outcome of events was recovered on unspecified date of 2021. Information on the lot/batch number has been requested.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Measles, Rash
Clinical narrative: has a bad rash on the front of her face and behind both ears that "looks like measles."; has a bad rash on the front of her face and behind both ears that "looks like measles."; This is a spontaneous report from a contactable consumer or other non hcp.     A 15-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Batch/Lot Number: unknown), via an unspecified route of administration, administered on 19Jul2021 16:00 as single dose for covid-19 immunisation.  The patient medical history was not reported. The patient's concomitant medications were not reported. Caller states her daughter has a bad rash on the front of her face and behind both ears that "looks like measles."  on Jul2021. The outcome of events was not recovered.    Information about lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: vomited on and off for 15 hrs; This is a spontaneous report from a contactable consumer. A child patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number and expiry date not reported), via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. After receiving the second dose of COVID vaccine the patient vomited on and off for 15 hrs. The patient recovered from the event on an unspecified date.  The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Positive test results of covid-19; Positive test results of covid-19; This is a spontaneous report from a contactable consumer (patient). A 6-decade-old male patient who was in his 50's received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via an unspecified route of administration on 25Jan2021 (Batch/Lot number was not reported) as dose 1, single and dose 2 via an unspecified route of administration on 17Feb2021 (Batch/Lot number was not reported) as dose 2, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced positive test results of covid-19 after two doses of vaccine. The patient underwent lab tests and procedures which included covid-19: positive on an unspecified date in 2021. The outcome of the event was unknown.   Information on Lot/Batch number has been requested.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Body temperature increased, Epilepsy, Seizure
Clinical narrative: started to increment the temperature 37.3 C under arm to 37.8 during that period of 5 hours he increment the number of seizures to 27 total; Patients with a rare neurological condition with epilepsy; 12 hours after the COVID vaccine second shot started to increment the temperature 37.3 C under arm to 37.8 during that period of 5 hours he increment the number of seizures to 27 total; This is a spontaneous report from a contactable physician. A 15-years-old male patient received bnt162b2 (BNT162B2), dose 2 intramuscular, administered in Arm Left on 17Jul2021 14:00 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included Rare Neurological Condition with epilepsy, global developmental delay and hypotonia. Patient was allergic to Pneumococcal vaccine and Penicillin. Concomitant medication(s) included calcium folinate (LEUCOVORINE), levetiracetam (KEPPRA XR) taken , clobazam (ONFI) and rufinamide (BANZEL)-all taken for an unspecified indication, start and stop date were not reported. Previously patient received bnt162b2 (BNT162B2), dose 1 intramuscular, administered in Arm Left on 26Jun2021 02:45 PM (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 18Jul2021 at 09:00, 12 hours after the COVID vaccine second shot, patient started to increment the temperature 37.3 C under arm to 37.8 during that period of 5 hours he increment the number of seizures to 27 total, he received Tylenol to control the fever and seizure rescue medicine and the seizures were controlled. This happened from 09:00 to 14:30. Patient has not tested for covid post vaccination. The patient was treated with Tylenol and Keppra (rescue dose). The outcome of the events was recovered on 18Jul2021.  Information about Lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of Bnt162b2 cannot be excluded for the reported events .  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 RAs, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Cardiac disorder, Cardiac valve disease, Heart injury, Lung disorder, Near death experience
Clinical narrative: Reported her friend was almost killed by the COVID-19 Vaccine; The COVID-19 Vaccine damaged her friend's heart by 50% more; Attack the heart and lungs.; She lost 40 lbs., and looked like walking death; Had severe heart valve issues now.; Attack the heart and lungs.; This is a spontaneous report from a contactable consumer (patient friend). A female consumer of unknown age received BNT162B2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN) in Jan2021 at single dose for COVID-19 immunization. Medical history included heart valve issue. Concomitant medication was not reported. The patient was almost killed by the vaccine (clarified as the COVID-19 Vaccine). The patient lost 40 lbs., and had severe heart valve issues now. Reported vaccines (clarified as COVID-19 Vaccines) attack the heart and lungs. The patient was a nurse who got the COVID-19 Vaccine in Jan2021, and the COVID-19 Vaccine damaged the patient's heart by 50% more, and she lost 40 lbs., and looked like walking death. The patient had the same heart valve issue she had. No further details provided. The outcome of all events was unknown.  Pfizer is marketing authorization holder of COVID-19 Vaccine in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of COVID-19 Vaccine has submitted the same report to the regulatory authorities.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Weight, Weight decreased
Clinical narrative: Reported her friend was almost killed by the COVID-19 Vaccine; The COVID-19 Vaccine damaged her friend's heart by 50% more; Attack the heart and lungs.; She lost 40 lbs., and looked like walking death; Had severe heart valve issues now.; Attack the heart and lungs.; This is a spontaneous report from a contactable consumer (patient friend). A female consumer of unknown age received BNT162B2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN) in Jan2021 at single dose for COVID-19 immunization. Medical history included heart valve issue. Concomitant medication was not reported. The patient was almost killed by the vaccine (clarified as the COVID-19 Vaccine). The patient lost 40 lbs., and had severe heart valve issues now. Reported vaccines (clarified as COVID-19 Vaccines) attack the heart and lungs. The patient was a nurse who got the COVID-19 Vaccine in Jan2021, and the COVID-19 Vaccine damaged the patient's heart by 50% more, and she lost 40 lbs., and looked like walking death. The patient had the same heart valve issue she had. No further details provided. The outcome of all events was unknown.  Pfizer is marketing authorization holder of COVID-19 Vaccine in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of COVID-19 Vaccine has submitted the same report to the regulatory authorities.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test positive
Clinical narrative: received a positive COVID test, after being fully vaccinated; received a positive COVID test, after being fully vaccinated; This is a spontaneous report from a contactable consumer (patients' mother). A male patient of an unspecified age received bnt162b2 (BNT162B2, formulation: Solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE, and dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. Reporter became aware last night on 21Jul2021 that a friend's son, Name withheld received a positive COVID test, after being fully vaccinated with Pfizer's COVID Vaccine BNT162B2. He had severe cold symptoms, body aches, sore neck, burning nose and loss of smell and taste. His mother, Name withheld states that he felt better now and can be reached for further information. The patient had covid test positive on 21Jul2021. The outcome of the events was recovering.  Information on the lot/batch number has been requested.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Culture urine, Headache
Clinical narrative: Chills; Headach; This is a spontaneous report from a contactable consumer. A 83-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EW0196, Expiration date was not reported), via intramuscular route of administration, in Arm left, on 26Jun2021 at 13:00 (at the age of 83-year-old), as a single dose for covid-19 immunization. The patient medical history included UTI from 19Jun2021 to 29Jun2021. Concomitant medications included Levofloxacin 500mg for UTI from 19Jun2021 to 29Jun2021. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EW0186, Expiration date was not reported), via intramuscular route of administration, in right Arm, on 02Jun2021 at 13:00, as a single dose for covid-19 immunization and experienced rash, dizzy. Vaccination facility type was reported as Pharmacy or drug store. There was no prior vaccination. On 27Jun2021, the patient experienced chills and headache. Relevant tests included Urine culture on 19May2021 with a result of UTI (Units: 500 mg). Outcome of the events was unknown.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Abortion spontaneous, Exposure during pregnancy, SARS-CoV-2 test
Clinical narrative: I miscarried my healthy pregnancy two days after vaccination. I want to report this event for data collection and reporting purposes for future studies. I do not know if the vaccine caused the miscarr; I miscarried my healthy pregnancy two days after vaccination.; This is a spontaneous report from a contactable consumer(patient) reported for herself that: A 32-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Right on 19Jul2021 18:15 (Batch/Lot Number: EW0181) as DOSE 1, SINGLE for covid-19 immunization. The patient past Medical history was not reported. Concomitant medication included ascorbic acid, betacarotene, calcium sulfate, colecalciferol, cyanocobalamin, ferrous fumarate, folic acid, nicotinamide, pyridoxine hydrochloride, retinol acetate, riboflavin, thiamine mononitrate, tocopheryl acetate, zinc oxide (PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE]) taken for an unspecified indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. There were no allergies reported. The patient did not receive any other vaccine within 4 weeks prior to covid-19 vaccination. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 11Nov2020. On 21Jul2021 at 11:45 PM, she miscarried her healthy pregnancy two days after vaccination. she wants to report this event for data collection and reporting purposes for future studies. she does not know if the vaccine caused the miscarriage. The events result in doctor or other healthcare professional office/clinic visit. No treatment was reported. Since the vaccination, the patient had been tested for COVID-19. The event outcome was resolving.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Lack of efficacy for the COVID vaccine.; 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, formulation solution for injection; Batch/Lot Number: Unknown, Expiration date: Unknown) via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date the patient experienced lack of efficacy for the COVID vaccine; very mild symptoms several months after full vaccination confirmed by a rapid test. The patient underwent lab tests and procedures which included SARS-COV-2 test: positive on an unspecified date. The clinical outcome of the events was unknown.   Information on the lot/batch number has been requested.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Axillary pain, Swelling
Clinical narrative: left arm pit is swollen; left arm pit is hurting; This is a spontaneous report from a contactable consumer (patient's wife). A 47-years-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534), via an unspecified route of administration, administered in left arm on 20Jul2021 15:50 at age of 47-year-old as dose 1, single dose for covid-19 immunisation. The patient had no medical history and no family medical history relevant to event. The patient's concomitant medications were reported as none not reported. The patient did not receive any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. The patient on the day before reporting, on 22Jul2021 began having a swollen and painful area in the left armpit. The patient did not go to physician office or emergency room due to these events. The patient did not do any investigation. The reporter stated that it was staying about the same and wanted like to know if this was a common side effect with the vaccine and if it would go away. The reporter asked if the patient should get the second dose of the vaccine after having this side effect with the first dose. The outcome of the events was not recovered.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: tested positive for COVID-19; tested positive for COVID-19; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EW0164, Expiry date: not reported, age at vaccination: 49-year-old), dose 2 via an unspecified route of administration on 01Jun2021 as dose 2, single, and dose 1 via an unspecified route of administration, administered in Arm Left on 14May2021 (Batch/Lot Number: ER2613) as dose 1, single for covid-19 immunisation. Medical history includes she does have some health issues which are hereditary. There were no concomitant medications. No Additional Vaccines Administered on Same Date of the Pfizer Suspect. No other vaccination taken with 4 weeks of covid-19 vaccination. No AE following prior vaccination. The patient reported that she had both doses of the Pfizer COVID-19 Vaccine and had no side effects. But she and her husband, who is not vaccinated, tested positive for COVID-19 on 19July2021 and as she was experiencing some symptoms like started feeling a runny nose and stuffiness in the head and a headache. Her runny nose was ongoing, and no treatment was received for it, so she got tested and one test showed that she passed the POCT internal QC COVID-19 AG. But the POCT COVID-19 Allergen test showed it was detected. She was wondering if she is showing detected because she has the antibodies in her body from the vaccine. Her 17-year-old daughter is also in the house was also vaccinated and her boyfriend was not. And she was referred to her HCP for further interpretation of the results as well as contacting the manufacture or laboratory that performed the testing for interpretation of results. The patient reported that she went back to where she went for her primary last Thursday and showed him her card, it was a normal check-up. He asked if she was vaccinated, and she said yes and showed him the date. And when he saw 01Jun2021 he said she should have a lot of antibodies still left in her. She got her results back and her husband came in contact with someone and found out that he was positive. The patient did not visit emergency room or physician office due to AE. The patient underwent lab tests and procedures which included COVID-19 AG results showed passed and POCT COVID-19 Allergen test and results showed positive on 19Jul2021. The outcome of event was not recovered.
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, COVID-19, Cough, Drug ineffective
Clinical narrative: she tested positive for COVID even after getting the Pfizer vaccine; she tested positive for COVID even after getting the Pfizer vaccine; lost sense of smell and taste; lost sense of smell and taste; cough; sniffles; body aches; This is a spontaneous report from a contactable consumer (Pfizer colleague) reported for a female patient.  An adult non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number, Expiry Date: Unknown), via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. It was not known if the patient had received any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient had been tested for COVID-19. Prior to vaccination, the patient was not diagnosed with COVID-19. Reporter's friend told her that on an unspecified date, she was tested positive for COVID even after getting the Pfizer vaccine. She lost sense of smell and taste, cough, sniffles, body aches. Patient visited doctor or other healthcare professional office/clinic. It was unknown whether the patient received treatment for the events or not. The outcome of events were not recovered.  Information about lot/batch number has been requested.