chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Received COVID-19 vaccination late Dec2020 or early Jan2021/contracted COVID-19 infection in a foreign country; Received COVID-19 vaccination late Dec2020 or early Jan2021/contracted COVID-19 infection in a foreign country; This is a spontaneous report from a contactable physician. A 58-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot/batch number and expiration date not available to reporter), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was unknown if other vaccine received in four weeks or if covid prior vaccination. It was reported that physician received COVID-19 vaccination late Dec2020 or early Jan2021. Traveled to another country (where he was originally from) sometime in early 2021, contracted COVID-19 infection in Apr2021, and unfortunately died sometime in Apr2021 while still in a foreign country. He had no known comorbidities. The patient underwent lab test which included covid tested post vaccination with unknown results on an unspecified date. It was unknown if any treatment received. The outcome of the events was fatal. The patient died in Apr2021. It was unknown if an autopsy was performed.  The events Drug ineffective and COVID-19 occurred in a country different from that of the reporter. This may be a duplicate report if another reporter from the country where the events occurred has submitted the same information to his/her local agency.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Drug ineffective and COVID-19 cannot be totally excluded.  The case will be reassessed if additional information becomes available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to agency, as appropriate.; Reported Cause(s) of Death: Received COVID-19 vaccination late Dec2020 or early Jan2021/contracted COVID-19 infection in a foreign country; Received COVID-19 vaccination late Dec2020 or early Jan2021/contracted COVID-19 infection in a foreign country.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: she got diagnosed with Covid-19; This is a spontaneous report from a contactable consumer (pharmacist). A 21-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: unknown, Expiry Date: unknown) on 12Apr2021 via an unspecified route of administration at 1ST DOSE, SINGLE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an 22Apr2021, about ten days later, the patient got diagnosed with Covid-19. Later, on an unknown date in 2021, the patient was tested negative for the COVID-19 Virus, and the patient wanted to get her second COVID-19 Vaccine dose. The outcome of the event was recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Nasopharyngitis, SARS-CoV-2 test positive
Clinical narrative: he as diagnosed with covid on that day; he as diagnosed with covid on that day; cold; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient himself) of an unspecified age received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: ER8727; Expiration date: unknown), intramuscular, administered in Arm Left on 06Apr2021 14:00 as 1ST DOSE, 0.3 ML SINGLE for COVID-19 immunization.  Medical history included diabetes mellitus from 1997 and ongoing, myocardial infarction from an unknown date and unknown if ongoing, heart attack from 1979 unknown if ongoing , issues associated with orange ongoing. The patient had not any other vaccine 4 weeks prior to COVID-19 vaccine and not had any adverse events. The patient had not Family Medical History Relevant to adverse events. The patient's concomitant medications were not reported.  The patient experienced as he was diagnosed with COVID on that day (COVID-19), drug ineffective and cold on 27Apr2021 with outcome of recovered.  On 06APR2021 he got his first dose. He said he was supposed to go back and get his second dose on 27Apr 2021 but he got a positive result of COVID. He stated that he went through 14 days of quarantine and Tuesday of this week was the 14th day. He stated that on 11MAY2021 that his quarantine was ended. Caller clarified that he tested positive for COVID on 27APR2021 and that he received the first vaccine on 06APR02. He states that he original second dose was scheduled for 27Apr2021 but he could not take it because he was diagnosed with COVID. He stated that he has not been doing anything because he has been under a 14 day quarantine. He states he has just been sitting there waiting. The patient underwent lab tests and procedures which included SARS-COV-2 test positive: positive on 27Apr2021.  No follow up attempt are needed: No further Information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Blood test, COVID-19, Endoscopy, Nausea, Tinnitus
Clinical narrative: Intense nausea; Ringing in ears; This is a spontaneous report from contactable consumer. A female patient of unknown age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EW0162, expiry date: unknown) via unknown route of administration on 09Apr2021 at 16:10 as 0.3ml, single dose for COVID-19 immunization. Patient's medical history included hypersensitive esophagus (Feb2020), diabetes, Parkinson's, Lupus nephritis, Leukemia (Dec2000). For hypersensitive esophagus the patient took Amitriptyline 10mg, start date: Apr2020- ongoing, Nexium 20mg (1 per day), Start date: Mar2020, ongoing. The patient underwent lab test for blood test which was normal, covid-19 as negative, and endoscopy on 12Mar2020 that was not too bad; patient's gastro doctor told her it looked like some kind of virus infected me possible covid? he said other than that it didn't look too bad. Concomitant medications included Multi, vit c, vit D 2000, Calcium, on and off for 2 to 3 years ongoing, Levothyroxine 50ml for Underactived thyroid, start date: Taken for 10 to 15 years- ongoing. After vaccination, the patient experienced, In-tense nausea and Ringing in ears on 10Apr2021 at 14: 00. The outcome of event was recovered approximately on 20Apr2021 without treatment.   No follow-up attempts are needed. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Multiple sclerosis, SARS-CoV-2 test
Clinical narrative: left side of body went numb; they thought she had MS (multiple sclerosis); This is a spontaneous report from a contactable consumer (patient). A 32-year-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in arm left on 03May2021 15:30 (Lot Number: EW0167) as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was not pregnant. 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. The patient previously administered first dose of bnt162b2 in left arm on 12Apr2021 14:30 (Lot Number: EW0162) for COVID-19 immunisation. The patient experienced left side of body went numb. Spent a week in the hospital- they thought she had MS (multiple sclerosis) but it was all from the covid vaccine. There's documentation that the prognosis was from the vaccine. The events onset date and time was 04May2021 09:30. The adverse events result in any of the following doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Treatment steroids received for the adverse events. But she was still numb on the left side. The events were reported as serious, due to hospitalization and life threatening. Hospitalized for 5 days. The patient underwent lab tests and procedures which included nasal swab: negative on 05May2021. The outcome of events was not recovered.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Fatigue, Pyrexia
Clinical narrative: Fatigue; Fever; Gastro intestinal discomfort; This is a spontaneous report received from a contactable consumer(patient) from a Pfizer sponsored program. A Female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number and Expiration date not reported) via an unspecified route of administration, on 06May2021, as a single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient had experienced fatigue, fever, and gastrointestinal discomfort on an unknown date and now inquiring if it would be okay to eat. Outcome of the events was reported as unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Pulmonary embolism, SARS-CoV-2 test, Viral myelitis
Clinical narrative: pulmonary embolism; Also developed flare of viral myelitis symptoms; dyspnea; This is a spontaneous report. A 37-year-old female patient (non-pregnant at time of vaccination) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in right arm on 17Apr2021 at 12:00 PM as single dose for COVID-19 immunisation. Medical history included hypothyroid, migraines, viral myelitis from Nov2019, allergies to bee stings. Concomitant medications included levothyroxine sodium (SYNTHROID); magnesium glycinate; ascorbic acid, calcium pantothenate, calcium phosphate dibasic, colecalciferol, copper sulfate, cyanocobalamin, dl-alpha tocopheryl acetate, ferrous fumarate, magnesium oxide, manganese sulfate, nicotinamide, potassium iodide, potassium sulfate, pyridoxine hydrochloride, retinol acetate, riboflavin, thiamine mononitrate, zinc oxide (MULTIVITAMIN AND MINERAL) . The patient previously took prochlorperazine (COMPAZINE SPANSULE) and experienced allergies. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No covid prior vaccination. Prior to vaccination, the patient did not diagnose with COVID-19. Since the vaccination, the patient has been tested for COVID-19. The patient developed dyspnea 4 days after vaccine (on 21Apr2021 at 12:00 PM) and diagnosed with pulmonary embolism 2 wks later. Also developed flare of viral myelitis symptoms which had been improving and almost resolved for 2mos prior. The adverse event result in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, hospitalization (with one day hospitalization), life threatening illness (immediate risk of death from the event). Lab data included covid tested post vaccination, SARS-CoV-2 test (Nasal Swab) on 06May2021 was negative. Treatment received for the adverse event including blood thinners. The outcome of the events was recovering.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of reported events cannot be excluded.  The case will be reassessed if additional information becomes available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: death; This is a spontaneous report from a consumer. A 39 years old male patient (brother in law, sister's husband) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 05May2021 (Batch/Lot number was not reported) as 2nd dose, Single for covid-19 immunisation. The patient medical history and concomitant medications were not reported.  The patient experienced death on 06May2021. He received his second pfizer vaccination shot less than 24 hours before his death. Official cause of death hasn't been determined. He simply never woke up the next day and reporter's sister found him cold and blue in their bedroom. The patient died on 06May2021. An autopsy was performed and results were not provided.  Information on the lot/batch number has been requested.; Reported Cause(s) of Death: unknown cause of death
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac tamponade, Culture, Cytology, Inappropriate schedule of product administration, Off label use
Clinical narrative: large pericardial effusion with early signs of tamponade physiology; large pericardial effusion with early signs of tamponade physiology; dose 1, 04Mar2021/dose 2, 04Mar2021; dose 1, 04Mar2021/dose 2, 04Mar2021; This is a spontaneous report from a contactable other health care professional. A 58-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular, administered in Arm Right on 04Mar2021 (Lot Number: EN6203) as 1ST DOSE, SINGLE, dose 2, administered in Arm Left on 04Mar2021 (Lot Number: EP6955) as 2ND DOSE, SINGLE for covid-19 immunization.  Medical history included Stage IV colorectal adenocarcinoma, Shellfish (rash), Peanuts (rash) and rash. 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. Concomitant medication(s) included cetuximab; acetylsalicylic acid (ASPIRIN); atorvastatin; cholecalciferol; levothyroxine.  The patient experienced large pericardial effusion with early signs of tamponade physiology on 01Apr2021. Malignancy and infection were ruled out by cytology which showed only mesothelial cells; cultures were negative. The adverse event result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Pericardiocentesis treatment received. The patient hospitalized for 6 days. The patient underwent nasal swab COVID test negative on 08May2021. The outcome was recovered.; Sender's Comments: Reported 'large pericardial effusion with early signs of tamponade physiology', occurred 28 days after bnt162b2 vaccination, is considered unrelated to bnt162b2 but more likely an intercurrent medical condition. Patient's underlying malignancy, concurrent medical condition for which levothyroxine was administered, concomitant medication cetuximab may have contributed to reported event.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Pericardial effusion, SARS-CoV-2 test
Clinical narrative: large pericardial effusion with early signs of tamponade physiology; large pericardial effusion with early signs of tamponade physiology; dose 1, 04Mar2021/dose 2, 04Mar2021; dose 1, 04Mar2021/dose 2, 04Mar2021; This is a spontaneous report from a contactable other health care professional. A 58-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular, administered in Arm Right on 04Mar2021 (Lot Number: EN6203) as 1ST DOSE, SINGLE, dose 2, administered in Arm Left on 04Mar2021 (Lot Number: EP6955) as 2ND DOSE, SINGLE for covid-19 immunization.  Medical history included Stage IV colorectal adenocarcinoma, Shellfish (rash), Peanuts (rash) and rash. 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. Concomitant medication(s) included cetuximab; acetylsalicylic acid (ASPIRIN); atorvastatin; cholecalciferol; levothyroxine.  The patient experienced large pericardial effusion with early signs of tamponade physiology on 01Apr2021. Malignancy and infection were ruled out by cytology which showed only mesothelial cells; cultures were negative. The adverse event result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Pericardiocentesis treatment received. The patient hospitalized for 6 days. The patient underwent nasal swab COVID test negative on 08May2021. The outcome was recovered.; Sender's Comments: Reported 'large pericardial effusion with early signs of tamponade physiology', occurred 28 days after bnt162b2 vaccination, is considered unrelated to bnt162b2 but more likely an intercurrent medical condition. Patient's underlying malignancy, concurrent medical condition for which levothyroxine was administered, concomitant medication cetuximab may have contributed to reported event.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Ectopic pregnancy
Clinical narrative: ectopic pregnancy; This is a spontaneous report from a contactable consumer (patient). A 30-years-old female patient (not pregnant at the vaccination) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 23Mar2021 (Batch/Lot number was not reported) as UNKNOWN, 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. The patient previously took biaxin and experienced allergies.  It was reported the Pfizer covid shot caused the patient to have an ectopic pregnancy. She ovulated the day before her shot while trying to get pregnant and just found out due to the shot she had an ectopic pregnancy on 04May2021.  Event resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event). No treatment received. Since the vaccination, the patient has not been tested for COVID-19. The outcome was recovering.   Information on batch number has been requested
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Electromyogram, Guillain-Barre syndrome, Magnetic resonance imaging head, Magnetic resonance imaging spinal
Clinical narrative: AIDP (Acute Inflammatory Demyelinating Polyradiculopathy); This is a spontaneous report from a contactable Physician. A 59-years-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular on an unspecified date (Batch/Lot number was not reported) vaccination at the age of 59 years old as 1ST DOSE, SINGLE for covid-19 immunisation.  Medical history included bunion surgery between CCPD and vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient had acute onset peripheral and central demyelination as confirmed on MRI (magnetic resonance imaging) brain and spine with and without contrast. AIDP (Acute Inflammatory Demyelinating Polyradiculopathy) confirmed with two NCC/EMG (NCC Electromyography). Patient presented with lower extremity weakness, upper and lower motor neuron signs, somnolence, upper extremity dysmetria, and right lower facial droop.  This occurred 22 days after first vaccine. The event resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Prolongation of existing hospitalization (vaccine received during existing hospitalization), Life threatening illness (immediate risk of death from the event), Disability or permanent damage. Treatment received for the adverse event included PLEX (Plasmapheresis) x 5 treatments, and methylprednisone x 5 days followed by prednisone taper. The outcome was recovering.   Information of the lot/batch number has been requested.; Sender's Comments: Based on temporal association, a contributory role of bnt162b2 to the event AIDP (Acute Inflammatory Demyelinating Polyradiculopathy) cannot be excluded completely. The case will be reassessed once more information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Headache
Clinical narrative: upset stomach; her head was throbbing with a really bad headache; This is a spontaneous report received from a non-contactable consumer (Patient).  A 70-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on Apr2021 (unsure of the date but about 3 weeks ago) at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in Apr2021, with the first vaccine she developed upset stomach and her head was throbbing with a really bad headache. This developed about 12 hours later. She is still having stomach issues and head hurts. Patient was scheduled to receive her second dose of the vaccine. She inquired whether the vaccine work with the spike protein and also inquired whether she can take an antinausea medicine or a xanax before the vaccine to help with her stomach. The outcome of events was not recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder, Myalgia, Nausea
Clinical narrative: Muscle sore; When caller period started there was a spotty brown; On and off nausea; This is a spontaneous report from a contactable consumer (patient) via Pfizer Sponsored Program. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE ; lot number and expiration date were not reported), via an unspecified route of administration on 06May2021 at 1ST DOSE, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced muscle sore, 'on and off nausea' and feels nauseous even if she eats or not and additionally when the patient was started with periods, there was a spotty brown observed in May2021 after the first dose of vaccination. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Gait inability, Inappropriate schedule of product administration, Inflammation, Malaise, Off label use
Clinical narrative: unwell feeling; unable to move an inch; it had inflamed every cell in my body; ears, teeth, gums, hair, and especially brain; AS patient. First shot began electric shocks in lower back. Second vaccine after 24 hours gave me blinding siezures in my entire left back muscle. Saw stars blacked out. Laid on wooden floor for 5 hou; Saw stars blacked out; Inappropriate schedule of vaccine administered; Inappropriate schedule of vaccine administered; This is a spontaneous report from a contactable consumer (patient himself). A 67-year-old male consumer received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number unknown) via an unspecified route of administration in left arm on 22Apr2021 13:30 at single dose for COVID-19 immunisation. First dose of BNT162b2 was administered via an unspecified route of administration in left arm on 02Mar2021 13:30. Relevant medical history included hepatitis C, and ankylosing spondylitis. The patient had allergy to levothyroxine sodium (SYNTHROID). Concomitant medications were not reported. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. Second vaccine after 24 hours gave him blinding seizures in his entire left back muscle. Saw stars blacked out (as reported). Laid on wooden floor for 5 hours unable to move an inch without triggering seizure. 20 hours later he was able to get to bed. Have had overwhelming unwell feeling every single day since. Doctor suggested one Valium twice a day and 2 at bed. Seizures have stopped. The biggest problem is it had inflamed every cell in his body: ears, teeth, gums, hair, and especially brain (as reported). The patient had a concussion 8 years ago and this is triggering swollen brain synapse genius, followed by overwhelming guilt/anxiety/depression/anger (as reported). He got these daily attacks on his entire cellular being (as reported). His wife is freaked out because she had to hear the patient scream at the top of his lungs (even in his sleep if turning wrong) and they don't know how to turn off these full body cellular attacks (as reported). The patient have seen 4 top doctors and they basically have no answers.Onset date for all events was 23Apr2021, unwell feeling, unable to move an inch and inflammation to every cell in his body started at 12:00. All events were life-threatening and emergency room visit was required. Seizure resolved on an unspecified date, while the other events were not resolved. Outcome for inappropriate schedule of vaccine administered and off label use was unknown. The patient was not diagnosed with COVID-19 prior to vaccination, while he was tested for COVID-19 since the vaccination: nasal swab was negative on 10May2021.  Information on lot/ batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Seizure, Visual impairment
Clinical narrative: unwell feeling; unable to move an inch; it had inflamed every cell in my body; ears, teeth, gums, hair, and especially brain; AS patient. First shot began electric shocks in lower back. Second vaccine after 24 hours gave me blinding siezures in my entire left back muscle. Saw stars blacked out. Laid on wooden floor for 5 hou; Saw stars blacked out; Inappropriate schedule of vaccine administered; Inappropriate schedule of vaccine administered; This is a spontaneous report from a contactable consumer (patient himself). A 67-year-old male consumer received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number unknown) via an unspecified route of administration in left arm on 22Apr2021 13:30 at single dose for COVID-19 immunisation. First dose of BNT162b2 was administered via an unspecified route of administration in left arm on 02Mar2021 13:30. Relevant medical history included hepatitis C, and ankylosing spondylitis. The patient had allergy to levothyroxine sodium (SYNTHROID). Concomitant medications were not reported. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. Second vaccine after 24 hours gave him blinding seizures in his entire left back muscle. Saw stars blacked out (as reported). Laid on wooden floor for 5 hours unable to move an inch without triggering seizure. 20 hours later he was able to get to bed. Have had overwhelming unwell feeling every single day since. Doctor suggested one Valium twice a day and 2 at bed. Seizures have stopped. The biggest problem is it had inflamed every cell in his body: ears, teeth, gums, hair, and especially brain (as reported). The patient had a concussion 8 years ago and this is triggering swollen brain synapse genius, followed by overwhelming guilt/anxiety/depression/anger (as reported). He got these daily attacks on his entire cellular being (as reported). His wife is freaked out because she had to hear the patient scream at the top of his lungs (even in his sleep if turning wrong) and they don't know how to turn off these full body cellular attacks (as reported). The patient have seen 4 top doctors and they basically have no answers.Onset date for all events was 23Apr2021, unwell feeling, unable to move an inch and inflammation to every cell in his body started at 12:00. All events were life-threatening and emergency room visit was required. Seizure resolved on an unspecified date, while the other events were not resolved. Outcome for inappropriate schedule of vaccine administered and off label use was unknown. The patient was not diagnosed with COVID-19 prior to vaccination, while he was tested for COVID-19 since the vaccination: nasal swab was negative on 10May2021.  Information on lot/ batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: got coronavirus after having the Covid-19 vaccine shots; got coronavirus after having the Covid-19 vaccine shots; This is a spontaneous report from a Pfizer-sponsored program. This spontaneous report from a contactable consumer reporting same events under the same suspect product for 10 patients. This is one of 10 reports. A patient of unspecified age and gender received BNT162B2 (Pfizer BioNTech Covid 19 vaccine), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization.  The medical history and concomitant medications were not reported. The reporter had talked to 10 people that got coronavirus after having the Covid-19 vaccine shots.  The reporter stated that she doesn't believe in this stuff and doesn't trust it.  The reporter did not provide details for any of the patients that got coronavirus after having the Covid-19 vaccine. The outcome of the events was unknown.   Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021527957 same drug/AE, different patient
Sex: U
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: got coronavirus after having the Covid-19 vaccine shots; got coronavirus after having the Covid-19 vaccine shots; This is a spontaneous report from a Pfizer-sponsored program. This spontaneous report from a contactable consumer reporting same events under the same suspect product for 10 patients. This is one of 10 reports. A patient of unspecified age and gender received BNT162B2 (Pfizer BioNTech Covid 19 vaccine), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization.  The medical history and concomitant medications were not reported. The reporter had talked to 10 people that got coronavirus after having the Covid-19 vaccine shots.  The reporter stated that she doesn't believe in this stuff and doesn't trust it.  The reporter did not provide details for any of the patients that got coronavirus after having the Covid-19 vaccine. The outcome of the events was unknown.   Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : PFIZER INC-2021527957 same drug/AE, different patient
Sex: U
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: got coronavirus after having the Covid-19 vaccine shots; got coronavirus after having the Covid-19 vaccine shots; This is a spontaneous report from a Pfizer-sponsored program. This spontaneous report from a contactable consumer reporting same events under the same suspect product for 10 patients. This is one of 10 reports. A patient of unspecified age and gender received BNT162B2 (Pfizer BioNTech Covid 19 vaccine), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization.  The medical history and concomitant medications were not reported. The reporter had talked to 10 people that got coronavirus after having the Covid-19 vaccine shots.  The reporter stated that she doesn't believe in this stuff and doesn't trust it.  The reporter did not provide details for any of the patients that got coronavirus after having the Covid-19 vaccine. The outcome of the events was unknown.  No follow-up attempts are possible; information about batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021527957 same drug/AE, different patient
Sex: U
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: got coronavirus after having the Covid-19 vaccine shots; got coronavirus after having the Covid-19 vaccine shots; This is a spontaneous report from a Pfizer-sponsored program. This spontaneous report from a contactable consumer reporting same events under the same suspect product for 10 patients. This is one of 10 reports. A patient of unspecified age and gender received BNT162B2 (Pfizer BioNTech Covid 19 vaccine), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization.  The medical history and concomitant medications were not reported. The reporter had talked to 10 people that got coronavirus after having the Covid-19 vaccine shots.  The reporter stated that she doesn't believe in this stuff and doesn't trust it.  The reporter did not provide details for any of the patients that got coronavirus after having the Covid-19 vaccine. The outcome of the events was unknown.   No follow-up attempts are possible; information about batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021527957 same drug/AE, different patient
Sex: U
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: got coronavirus after having the Covid-19 vaccine shots; got coronavirus after having the Covid-19 vaccine shots; This is a spontaneous report from a Pfizer-sponsored program. This spontaneous report from a contactable consumer reporting same events under the same suspect product for 10 patients. This is one of 10 reports. A patient of unspecified age and gender received BNT162B2 (Pfizer BioNTech Covid 19 vaccine), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization.  The medical history and concomitant medications were not reported. The reporter had talked to 10 people that got coronavirus after having the Covid-19 vaccine shots.  The reporter stated that she doesn't believe in this stuff and doesn't trust it.  The reporter did not provide details for any of the patients that got coronavirus after having the Covid-19 vaccine. The outcome of the events was unknown.   No follow-up attempts are possible; information about batch number cannot be obtained.; Sender's Comments: Linked Report(s) : PFIZER INC-2021527957 same drug/AE, different patient
Sex: F
Vaccine: COVID19
Symptoms: Muscular weakness
Clinical narrative: Leg weakness; This is a spontaneous report from a contactable physician (patient).   An 84-year-old female patient received the second dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine) intramuscularly, at single dose, on 13Apr2021, at 12:15, for COVID-19 immunization. Relevant medical history and concomitant medications were unknown. The patient previously, on 23Mar2021, at 12:15, received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine) intramuscularly, at single dose, for COVID-19 immunization. After the first dose, on 23Mar2021 at night she could not move her legs. She was not able to stand up on her own and could not navigate her legs. She rushed to the emergency room. It was reported that the patient experienced leg weakness on 23Mar2021 at 01:00. The patient recovered from leg weakness on 23Mar2021. On 13Apr2021, after the second dose, the patient experienced leg weakness. The adverse event was assessed as serious (hospitalization and disability). It was unknown if treatment was received. Clinical outcome of the adverse event (after second dose) was unknown at time of this report.   No follow-up attempts are needed, information about lot number cannot be obtained.; Sender's Comments: Based on the close temporal relationship, the association between the event leg weakness with BNT162b2 can not be fully excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: FLU4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: high risk patient who is under age 65 was administered Fluzone HD with no adverse event; Initial information regarding an unsolicited valid non-serious case from consumer /non-health professional via Information (Reference number- 00578828).  This case involves a 55-year old female patient who was in high risk patient and who was under age 65 was administered INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (product administered to patient of inappropriate age) (lot number: unknown and expiration date: unknown] at an 0.7 ml total dose via unknown route in unknown administration site for prophylactic vaccination.  Medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant vaccination was not reported.  It was an actual medication error due to inappropriate age at vaccine administration (latency: unknown).  At the time of report, no adverse event was reported.  It was not reported if the patient received a corrective treatment.  Disclaimer: This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available regarding batch number in this case.
Age: 0.42
Sex: F
Vaccine: HIBV
Symptoms: Medication error, Product preparation issue
Clinical narrative: The patient was administered a dose of ACT-HIB that was reconstituted with sterile water, no AE; Initial information regarding an unsolicited valid non-serious case was received from a physician via inbound (reference number- 00579444) and transmitted to Sanofi on 27-Apr-2021.  This case involves a five month old female patient who was administered a 0.5 ml dose of suspect HIB (PRP/T) VACCINE [ACT-HIB] (lot number and expiry date: not reported) via intramuscular route in unknown administration site for prophylactic vaccination on 20-APR-2021 that was reconstituted with sterile water (product preparation error).  The patient's past vaccination included DIPHTHERIA VACCINE TOXOID, HIB VACCINE CONJ (TET TOX), PERTUSSIS VACCINE ACELLULAR 5-COMPONENT, POLIO VACCINE INACT 3V (MRC 5), TETANUS VACCINE TOXOID (PENTACEL) in FEB-2021 (dose 2) for prophylactic vaccination.  The patient's medical history, past medical treatment(s) and family history were not provided.  Concomitant medications included ROTAVIRUS VACCINE LIVE ORAL 1V (ROTARIX) and PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for prophylactic vaccination.  It was a case of an actual medication error due to wrong diluent used (latency same day).  The reporter wanted to know, whether dose needs repeating.  At the time of reporting no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/3/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. (compulsory)  There will be no information available on the batch number for this case.
Sex: F
Vaccine: TDAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient received a dose of ADACEL on 28Apr2021, that was expired on 26Apr2021 with no adverse event; Initial information regarding an unsolicited valid non-serious case was received from other healthcare professional via Medical Information (Reference number- 00582362) and transmitted to Sanofi on 29-Apr-2021.  This case involves a 12 years old female patient who experienced patient received a 0.5 mL expired dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (lot U6272AA and expiry date: 26-Apr-2021) via intramuscular route in the left deltoid (expired product administered) for prophylactic vaccination on 28-Apr-2021.  The patient's medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.   It was an actual medication error case due to expired vaccine used (latency: same day).   It was reported that they administered expired vaccine. The vaccine expired on exp 4/26/2021 and was administered on yesterday. They wanted to know if they needed to redose the patient at some point or is okay since the time frame was so close. Reporter asked if it would be okay since it was just a few days past the expiration date. They stated that they had a plan to repeat the ADACEL dose in three months and is asking if that would be okay. They asked if it would be okay since it was just a few days past the expiration date. They stated that they had a plan to repeat the ADACEL dose in three months and is asking if that would be okay.  At the time of reporting, the patient experienced no specific adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: Product exposed to highest temperature of 17.6 degrees Celsius with no adverse event; This case was considered as non-case as temperature excursion reported without stability data and no patient involved.
Age: 2.0
Sex: F
Vaccine: IPV
Symptoms: Extra dose administered, Inappropriate schedule of product administration
Clinical narrative: a two years old patient received fourth dose of Ipol vaccine/ No AE; Initial information received on 06-May-2021 regarding an unsolicited valid non-serious case received from a Nurse via physician.  This case involves a two years old female patient who received a 0.5 ml fourth dose of IPV (VERO) [IPOL] (batch number R1F8O1M, expiry date: 28-Sep-2021) frequency: once, strength: standard via intramuscular route in the right thigh for prophylactic vaccination and patient also received third dose at 6 to 18 months of age (Inappropriate schedule of product administration).  The patient's past vaccination included IPOL [POLIO VACCINE INACT 3V (VERO)] at 2 and 4 months of age for prophylactic vaccination.  The patient's medical history, medical treatments and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE for prophylactic vaccination.  It was an actual medication error due to drug dose administration interval too short (latency same day).   Potential Product Technique Complain: No. A nurse wanting to know how to proceed after a 2-year old received an extra dose of Ipol described as getting a dose of Ipol at age 2-years old after getting doses at 2 months, 4 months, and 6 to 18 months.   At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 1.0
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: Patient received an expired dose of DAPTACEL with no adverse event; Initial information was received on 10-May-2021 regarding an unsolicited valid non-serious case from other health professional.  This case involves a 1 years old female patient who received a 0.5 mL expired dose of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (lot C5611BA and expiry date: 03-Apr-2021) via intramuscular route in the left thigh (expired product administered) for prophylactic vaccination on 10-May-2021.  The patient's medical history, past medical treatment, past vaccination, concomitant medication and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE (HEPATITIS A VACCINE) for Immunisation.  The reporter asked whether dose needs repeating.  At the time of reporting, the patient experienced no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.