chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Cardiac arrest
Clinical narrative: cardiac arrest; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 2021SA394468 (Sanofi).  A patient (no qualifiers provided) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CARDIAC ARREST (death, medically significant), outcome "fatal", described as "cardiac arrest". The patient date of death was unknown. The reported cause of death was cardiac arrest. It was not reported if an autopsy was performed. The clinical course was reported as follows: To prevent one covid-19 related death, Pfizer admits their vaccine kills at least three people by causing cardiac arrest.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101767784 same reporter/drug/event, different patients;US-PFIZER INC-202101767782 same reporter/drug/event, different patients; Reported Cause(s) of Death: cardiac arrest
Sex: U
Vaccine: COVID19
Symptoms: Cardiac arrest
Clinical narrative: cardiac arrest; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 2021SA394468 (Sanofi).  A patient (no qualifiers provided) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CARDIAC ARREST (death, medically significant), outcome "fatal", described as "cardiac arrest". The patient date of death was unknown. The reported cause of death was cardiac arrest. It was not reported if an autopsy was performed. The clinical course was reported as follows: To prevent one covid-19 related death, Pfizer admits their vaccine kills at least three people by causing cardiac arrest.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101767783 same reporter/drug/event, different patients;US-PFIZER INC-202101767782 same reporter/drug/event, different patients; Reported Cause(s) of Death: cardiac arrest
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Myocardial infarction, SARS-CoV-2 test
Clinical narrative: Diagnosed Heart Attack on 06Dec2021; initial symptom started on 02Dec2021; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 20Nov2021 09:00 (Lot number: FJ1661) at the age of 50 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "High blood pressure that was managed." (unspecified if ongoing), notes: Other medical history: High blood pressure that was managed; "known allergies: Penicillin" (unspecified if ongoing), notes: known allergies: Penicillin. Concomitant medication(s) included: MOTRIN [IBUPROFEN]; LISINOPRIL. Vaccination history included: Bnt162b2 (Dose 1, Batch/Lot No: FE3590, Location of injection: Arm Right, Vaccine Administration Time: 12:00 PM), administration date: 28Oct2021, when the patient was 50 years old, for COVID-19 immunization. The following information was reported: MYOCARDIAL INFARCTION (hospitalization, life threatening) with onset 02Dec2021 04:00, outcome "recovering", described as "Diagnosed Heart Attack on 06Dec2021; initial symptom started on 02Dec2021". The patient was hospitalized for myocardial infarction (start date: Dec2021, discharge date: Dec2021, hospitalization duration: 5 day(s)). The event "diagnosed heart attack on 06dec2021; initial symptom started on 02dec2021" was evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (06Dec2021) negative. It was unknown if therapeutic measures were taken as a result of myocardial infarction. Clinical course: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19.
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose increased, Immunisation
Clinical narrative: booster dose; her husband has been presenting high sugar levels of 395 even when he gets "quite a bit of insulin"; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 75 year-old male patient received bnt162b2 (BNT162B2), administration date 07Dec2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER: UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 2, MANUFACTURER: UNKNOWN), for Covid-19 immunization. The following information was reported: IMMUNISATION (medically significant) with onset 07Dec2021, outcome "unknown", described as "booster dose"; BLOOD GLUCOSE INCREASED (medically significant) with onset Dec2021, outcome "unknown", described as "her husband has been presenting high sugar levels of 395 even when he gets "quite a bit of insulin"". The patient underwent the following laboratory tests and procedures: blood glucose: (Dec2021) high sugar levels of 395, notes: high sugar levels of 395. Therapeutic measures were taken as a result of blood glucose increased.  Additional information: Reporter stated that since then her husband has been presenting high sugar levels of 395 even when he gets "quite a bit of insulin" She queried if this was a reported side effects and for how long will it last. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Immunisation, Pain
Clinical narrative: dose_number=3; Fatigue; headache; body aches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adult female patient received bnt162b2 (BNT162B2), administration date 05Dec2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose:1, prev_dose_brand=Pfizer), for Covid-19 immunization; Bnt162b2 (prev_dose_brand=Pfizer, Dose:2), for Covid-19 immunization.  The following information was reported: IMMUNISATION (non-serious) with onset 05Dec2021, outcome "unknown", described as "dose_number=3"; FATIGUE (non-serious) with onset 2021, outcome "recovered" (2021), described as "Fatigue"; HEADACHE (non-serious) with onset 2021, outcome "recovered" (2021), described as "headache"; PAIN (non-serious) with onset 2021, outcome "recovered" (2021), described as "body aches". It was unknown if therapeutic measures were taken as a result of fatigue, headache, pain.  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, Retinal operation
Clinical narrative: had surgery to reconnect retina early Nov2021; he had a mild case of the virus, states got the first two vaccines in Jan and Feb2021; he had a mild case of the virus, states got the first two vaccines in Jan and Feb2021; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date Feb2021 (Batch/Lot number: unknown) as dose 2, single and administration date Jan2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2021, outcome "unknown" and all described as "he had a mild case of the virus, states got the first two vaccines in Jan and Feb2021"; RETINAL OPERATION (medically significant) with onset Nov2021, outcome "unknown", described as "had surgery to reconnect retina early Nov2021".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Choking, Cough, Loss of consciousness, Seizure
Clinical narrative: She went into anaphylaxis; She had a seizure; Because looked like was choking; Wheeled out on stretcher looking unconscious; Was vomitting; Though her body at one point shook; Coughed some stuff up; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 27 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 27 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Crohn's disease" (unspecified if ongoing); "Mental health struggles (believe depression)" (unspecified if ongoing), notes: Verbatim: Mental health struggles (believe depression). The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose no: 1), when the patient was 27 years old, for COVID-19 immunization. The following information was reported: ANAPHYLACTIC REACTION (medically significant) with onset 12Dec2021 10:45, outcome "unknown", described as "She went into anaphylaxis"; SEIZURE (medically significant) with onset 12Dec2021 10:45, outcome "unknown", described as "She had a seizure"; CHOKING (medically significant) with onset 12Dec2021 10:45, outcome "unknown", described as "Because looked like was choking"; LOSS OF CONSCIOUSNESS (medically significant) with onset 12Dec2021 10:45, outcome "unknown", described as "Wheeled out on stretcher looking unconscious"; VOMITING (non-serious) with onset 12Dec2021 10:45, outcome "unknown", described as "Was vomitting"; TREMOR (non-serious) with onset 12Dec2021 10:45, outcome "unknown", described as "Though her body at one point shook"; COUGH (non-serious) with onset 12Dec2021 10:45, outcome "unknown", described as "Coughed some stuff up". The events "she went into anaphylaxis", "she had a seizure", "because looked like was choking", "wheeled out on stretcher looking unconscious", "was vomitting", "though her body at one point shook" and "coughed some stuff up" were evaluated at the emergency room visit. Therapeutic measures were taken as a result of anaphylactic reaction, seizure, choking, loss of consciousness, vomiting, tremor, cough.  Clinical course: The reporter reported that patient collapsed during 10:45 AM church service warranting emergency services to be called and to take to hospital. Rumors circulated that she went into anaphylaxis, or that she had a seizure and was vomitting. From things overheard, seems like received epinephrine and had to have chest compressions (heart stopped) prior to paramedic arrival. Reporter saw wheeled out on stretcher looking unconscious, though her body at one point shook because looked like was choking and coughed some stuff up. Know individual has Crohn's disease and has passed out before, but do not believe this may have been a similar event. Patient is 27 Years old as of Mar or late Feb (probably Mar) this year. It was unknown that the patient diagnosed with COVID-19 prior to and since vaccination.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor, Vomiting
Clinical narrative: She went into anaphylaxis; She had a seizure; Because looked like was choking; Wheeled out on stretcher looking unconscious; Was vomitting; Though her body at one point shook; Coughed some stuff up; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 27 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 27 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Crohn's disease" (unspecified if ongoing); "Mental health struggles (believe depression)" (unspecified if ongoing), notes: Verbatim: Mental health struggles (believe depression). The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose no: 1), when the patient was 27 years old, for COVID-19 immunization. The following information was reported: ANAPHYLACTIC REACTION (medically significant) with onset 12Dec2021 10:45, outcome "unknown", described as "She went into anaphylaxis"; SEIZURE (medically significant) with onset 12Dec2021 10:45, outcome "unknown", described as "She had a seizure"; CHOKING (medically significant) with onset 12Dec2021 10:45, outcome "unknown", described as "Because looked like was choking"; LOSS OF CONSCIOUSNESS (medically significant) with onset 12Dec2021 10:45, outcome "unknown", described as "Wheeled out on stretcher looking unconscious"; VOMITING (non-serious) with onset 12Dec2021 10:45, outcome "unknown", described as "Was vomitting"; TREMOR (non-serious) with onset 12Dec2021 10:45, outcome "unknown", described as "Though her body at one point shook"; COUGH (non-serious) with onset 12Dec2021 10:45, outcome "unknown", described as "Coughed some stuff up". The events "she went into anaphylaxis", "she had a seizure", "because looked like was choking", "wheeled out on stretcher looking unconscious", "was vomitting", "though her body at one point shook" and "coughed some stuff up" were evaluated at the emergency room visit. Therapeutic measures were taken as a result of anaphylactic reaction, seizure, choking, loss of consciousness, vomiting, tremor, cough.  Clinical course: The reporter reported that patient collapsed during 10:45 AM church service warranting emergency services to be called and to take to hospital. Rumors circulated that she went into anaphylaxis, or that she had a seizure and was vomitting. From things overheard, seems like received epinephrine and had to have chest compressions (heart stopped) prior to paramedic arrival. Reporter saw wheeled out on stretcher looking unconscious, though her body at one point shook because looked like was choking and coughed some stuff up. Know individual has Crohn's disease and has passed out before, but do not believe this may have been a similar event. Patient is 27 Years old as of Mar or late Feb (probably Mar) this year. It was unknown that the patient diagnosed with COVID-19 prior to and since vaccination.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Angina pectoris, Cardiac disorder, Chest pain, Inappropriate schedule of product administration, Insomnia
Clinical narrative: My lower heart was start like giving me a sort of pain; that is 21Aug and 09Dec21, dates for the first and second dose; it is hard to fall asleep; My chest was hurting; my chest and my heart bothered me; my heart bothered me; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 09Dec2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (first dose), administration date: 21Aug2021, for COVID-19 Immunization. The following information was reported: ANGINA PECTORIS (medically significant) with onset 09Dec2021, outcome "unknown", described as "My lower heart was start like giving me a sort of pain"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 09Dec2021, outcome "unknown", described as "that is 21Aug and 09Dec21, dates for the first and second dose"; INSOMNIA (non-serious) with onset 09Dec2021, outcome "unknown", described as "it is hard to fall asleep"; CHEST PAIN (non-serious) with onset 09Dec2021, outcome "unknown", described as "My chest was hurting; my chest and my heart bothered me"; CARDIAC DISORDER (non-serious) with onset 09Dec2021, outcome "unknown", described as "my heart bothered me". Patient took second dose on Thursday and same night, when the side effects were kicking in chest, it was hurting and lower heart was start like giving a sort of pain, it was hard to fall asleep and patient tried to sleep it all and going to wait for the next day which was Friday and then had to contact as early because my chest and my heart bothered me. And so patient also had this number down street because it said, when first got first shot, the number given as it says to call the number if you are experiencing any kind of side effects thats concerning you and I call this number. (voice not clear) If patient should call on today or Sunday.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: deadly; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (003110).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death), outcome "fatal", described as "deadly". The patient date of death was unknown. It was not reported if an autopsy was performed. The lot number for bnt162b2 was not provided and will be requested during follow up.; Reported Cause(s) of Death: deadly
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: After second dose in primary series, daughter re-experienced loss of taste and smell, similar as to when she was ill with Covid infection.; After second dose in primary series, daughter re-experienced loss of taste and smell, similar as to when she was ill with Covid infection.; Loss of taste; loss of taste and smell; everything tastes like nickels; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 22 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for covid 19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "After second dose in primary series, daughter re-experienced loss of taste and smell, similar as to when she was ill with Covid infection."; AGEUSIA (non-serious) with onset Oct2021, outcome "not recovered", described as "Loss of taste"; ANOSMIA (non-serious) with onset Oct2021, outcome "not recovered", described as "loss of taste and smell"; TASTE DISORDER (non-serious) with onset Oct2021, outcome "not recovered", described as "everything tastes like nickels". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (Aug2021) positive.  Clinical course: Reporter is a consumer that said that she was calling on behalf of her daughter. She reported that her daughter had a pretty severe case of Covid in Aug2021 and lost her sense of taste and smell. Reporter said that her daughter got mandated to take the vaccine by the military and after the second dose, she lost her sense of taste and smell and everything tastes like nickels. Reporter said that she is in Law enforcement and declined to provide any further contact details for her or her family. Reporter reports daughter's loss of taste and smell ongoing since October.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Taste disorder
Clinical narrative: After second dose in primary series, daughter re-experienced loss of taste and smell, similar as to when she was ill with Covid infection.; After second dose in primary series, daughter re-experienced loss of taste and smell, similar as to when she was ill with Covid infection.; Loss of taste; loss of taste and smell; everything tastes like nickels; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 22 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for covid 19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "After second dose in primary series, daughter re-experienced loss of taste and smell, similar as to when she was ill with Covid infection."; AGEUSIA (non-serious) with onset Oct2021, outcome "not recovered", described as "Loss of taste"; ANOSMIA (non-serious) with onset Oct2021, outcome "not recovered", described as "loss of taste and smell"; TASTE DISORDER (non-serious) with onset Oct2021, outcome "not recovered", described as "everything tastes like nickels". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (Aug2021) positive.  Clinical course: Reporter is a consumer that said that she was calling on behalf of her daughter. She reported that her daughter had a pretty severe case of Covid in Aug2021 and lost her sense of taste and smell. Reporter said that her daughter got mandated to take the vaccine by the military and after the second dose, she lost her sense of taste and smell and everything tastes like nickels. Reporter said that she is in Law enforcement and declined to provide any further contact details for her or her family. Reporter reports daughter's loss of taste and smell ongoing since October.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Lack of effect; tested positive for COVID-19; Lack of effect; tested positive for COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 01Mar2021 (Lot number: EL3247) at the age of 51 years as dose 2, single and administered in arm right, administration date 08Feb2021 (Lot number: EL3247) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 13Dec2021, outcome "recovering" and all described as "Lack of effect; tested positive for COVID-19". The event "lack of effect; tested positive for covid-19" and "lack of effect; tested positive for covid-19" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (12Dec2021) positive. No other vaccine was administered in four weeks. The patient was not diagnosed with COVID-19 prior vaccination.  Follow-up (16Dec2021): Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Hypersensitivity, Joint swelling, Peripheral swelling, Thrombosis
Clinical narrative: severe allergic reaction; swelling of her joints specifically on the right middle finger around the knuckle area; thrombosis; swelling of her joints specifically on the right middle finger around the knuckle area; swelling of her joints specifically on the right middle finger around the knuckle area/extreme pain in that area and was sore for weeks; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 45 year-old female patient received bnt162b2 (BNT162B2), administration date 18Oct2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunization. Relevant medical history included: "asthma" (unspecified if ongoing); "anemia" (unspecified if ongoing); "blood coagulation issues" (unspecified if ongoing); "borderline type 2 diabetes," (unspecified if ongoing); "weight gain due to pregnancy" (unspecified if ongoing); "miscarriages" (unspecified if ongoing); "weight gain due to pregnancy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: THROMBOSIS (medically significant) with onset Oct2021, outcome "unknown", described as "thrombosis"; JOINT SWELLING (non-serious), PERIPHERAL SWELLING (non-serious) all with onset Oct2021, outcome "unknown" and all described as "swelling of her joints specifically on the right middle finger around the knuckle area"; ARTHRALGIA (non-serious) with onset Oct2021, outcome "unknown", described as "swelling of her joints specifically on the right middle finger around the knuckle area/extreme pain in that area and was sore for weeks"; HYPERSENSITIVITY (non-serious) with onset 18Oct2021, outcome "unknown", described as "severe allergic reaction".  Clinical course: The Consumer wanted to know what to do as the pharmacist refused to administer the second dose of the Pfizer BioNTech Covid-19 Vaccine due to the severe allergic reaction she experienced a few minutes to 1 hour after she got the first shot.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: bell's palsy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 71 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "immune compromised" (unspecified if ongoing), notes: 71 years old patient who is immune compromised due to being a kidney transplant patient.; "kidney transplant" (unspecified if ongoing), notes: 71 years old patient who is immune compromised due to being a kidney transplant patient. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Manufacturer unknown), for Covid-19 immunization. The following information was reported: BELL'S PALSY (medically significant), outcome "unknown", described as "bell's palsy".  Clinical course: Caller was a 71-year-old patient who was immune compromised due to a kidney transplant patient. Patient was looking for information regarding, bell's palsy. Patient stated that, he was really upset, which is why this was his 3rd call. She had kidney transplant in withheld, and they administered the 2 vaccines, patient had bell's palsy, and it pretty much had cleared up "Patient got bell's palsy a couple of weeks after the 2nd dose of the vaccine again". The doctors said that patient should take a 3rd dose, and a booster dose 6 months later. Patient was just worried that he can get a worse case of bell's palsy, which she thought could be worse than the virus, being disfigured is not much fun. Patient knew that during the trials people reported bell's palsy as symptoms.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for COVID; tested positive for COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (COMIRNATY), administration date 05Jun2021 (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 12Dec2021, outcome "unknown" and all described as "tested positive for COVID". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (12Dec2021) positive.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Tardive dyskinesia
Clinical narrative: experiencing tardive dyskinesia symptoms after both doses.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 11 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: TARDIVE DYSKINESIA (medically significant), outcome "unknown", described as "experiencing tardive dyskinesia symptoms after both doses."  Clinical course: Father calling on behalf of his children who had reactions after both doses of the pediatric Pfizer-Biontech covid19 vaccine (orange cap). Seriousness of case: No.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Covid positive; Covid positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Covid positive", which was also reported as "Vaccinated Family members in same household also positive after a Covid exposure on 28Nov2021. 12 vaccinated family members now covid positive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : -PFIZER INC-202101733546 same reporter/drug/AE with different patient.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Covid positive; Covid positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Covid positive", which was also reported as "Vaccinated Family members in same household also positive after a Covid exposure on 28Nov2021. 12 vaccinated family members now covid positive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : -PFIZER INC-202101733546 same reporter/drug/event with different patient.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Covid positive; Covid positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Covid positive", which was also reported as "Vaccinated Family members in same household also positive after a Covid exposure on 28Nov2021. 12 vaccinated family members now covid positive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : PFIZER INC-202101733546 same reporter/drug/event with different patient.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Covid positive; Covid positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Covid positive", which was also reported as "Vaccinated Family members in same household also positive after a Covid exposure on 28Nov2021. 12 vaccinated family members now covid positive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101733546 same reporter/drug/event with different patient.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Immunisation, Muscle spasms
Clinical narrative: Had extreme pain in back, hips, knees; Had extreme pain in back, hips, knees; Extreme muscle spasms also at these sites; Dose number: 3; This is a spontaneous report from a contactable reporter (consumer or other non hcp). The reporter is the patient.  A 50-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in left arm, administration date 11Dec2021 at 12:30 (Lot number: 33030BD) at the age of 50 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Fibromyalgia"; "Spondylitis", notes: Arthritis of the back; "Knee arthritis", notes: Arthritis of the back, knees, and hips,; "Coxarthritis", notes: Arthritis of the back, knees, and hips and "Latex allergy", notes: Known allergies: Latex; all (unspecified if ongoing). The patient received unspecified concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot Number: EN6206; administration time: 14:00, vaccine location: left arm), administration date: 03Mar2021, when the patient was 49 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE; lot Number: EP7534, administration time: 13:30, vaccine location: right arm), administration date: 24Mar2021, when the patient was 49 years old, for COVID-19 immunisation. The following information was reported: IMMUNISATION (non-serious) with onset 11Dec2021 at 12:30, outcome "unknown", described as "Dose number: 3"; BACK PAIN (non-serious), ARTHRALGIA (non-serious); with onset 12Dec2021 at 03:00, outcome "recovering" both described as "Had extreme pain in back, hips, knees" and MUSCLE SPASMS (non-serious) with onset 12Dec2021 at 03:00, outcome "recovering" described as "Extreme muscle spasms also at these sites". Therapeutic measures were not taken as a result of back pain, arthralgia and muscle spasms.  Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. It was reported that pain was near unbearable. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Skin discolouration
Clinical narrative: Dark spot on leg below knee; This is a spontaneous report from a contactable reporter (consumer or other non hcp). The reporter is the patient.  A 49-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in right arm, administration date 08Dec2021 at 10:45 (Lot number: FG3527) at the age of 49 Years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "Allergic sinusitis" (unspecified if ongoing), notes: sinus and "Heart murmur" (unspecified if ongoing). Concomitant medications were not reported. The following information was reported: SKIN DISCOLOURATION (non-serious) with onset 09Dec2021, outcome "recovering", described as "Dark spot on leg below knee". Therapeutic measures were not taken as a result of skin discolouration.  Additional information: The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The event did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: PCR test came back positive.; PCR test came back positive.; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team. The reporter is the parent.  A 36 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "PCR test came back positive.". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive.  Clinical course: The patient had the 2 shots of Pfizer Covid-19 vaccine. He attended an event on (city/state withheld) on Thursday, started feeling bad on Saturday, PCR test came back positive. And he is still feeling bad. Patient mother was trying to see if he could get the oral medication, PAXLOVID, made by Pfizer for his treatment.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the reported information ,a causal relationship between the events and suspected drug cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Immunisation, SARS-CoV-2 test
Clinical narrative: diagnosed with Covid-19 and is currently in the hospital after getting a Comirnaty booster dose; diagnosed with Covid-19; diagnosed with Covid-19 and is currently in the hospital after getting a Comirnaty booster dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, MANUFACTURER UNKNOWN), for covid 19 immunization; Bnt162b2 (Dose 2, MANUFACTURER UNKNOWN), for covid 19 immunization. The following information was reported: IMMUNISATION (medically significant), VACCINATION FAILURE (hospitalization, medically significant), outcome "unknown" and all described as "diagnosed with Covid-19 and is currently in the hospital after getting a Comirnaty booster dose"; COVID-19 (hospitalization, medically significant), outcome "unknown", described as "diagnosed with Covid-19". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive. Clinical Course: Caller got diagnosed with Covid-19 and is currently in the hospital after getting a Comirnaty booster dose. Caller wanted to know why this has happened. Caller added his doctors don't know why this occurred.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Diplopia, Migraine with aura
Clinical narrative: Migraine with aura; Double vision - diplopia; This is a spontaneous report from a contactable consumer, the patient.   A 54-year-old female patient (not pregnant) received the first dose of COVID-19 VACCINE - MANUFACTURER UNKNOWN, administered in arm left, administration date 27Mar2021 (Lot number: unknown) at the age of 54 years as a single dose for COVID-19 immunisation. Relevant medical history included: "Migraine with aura" (unspecified if ongoing) and "Sulfonamide allergy" (unspecified if ongoing), notes: Known allergies: sulpha. There were no concomitant medications. The following information was reported: MIGRAINE WITH AURA (non-serious) with onset 30Mar2021, outcome "recovered with sequelae" on an unknown date in 2021, described as "Migraine with aura"; DIPLOPIA (non-serious) with onset 30Mar2021, outcome "recovered with sequelae" on an unknown date in 2021, described as "Double vision - diplopia". Therapeutic measures were not taken as a result of migraine with aura and diplopia.  Additional Information: The patient did not receive other vaccines within four weeks prior to COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. It was also reported the patient received the second dose of COVID-19 VACCINE - MANUFACTURER UNKNOWN administered in arm left, administration date 18Apr2021 (Lot number: unknown) at the age of 54 years as a single dose for COVID-19 immunisation.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Immunisation
Clinical narrative: Metallic taste in mouth starting on 12/13; Dose received: 3; This is a spontaneous report received from contactable reporter (consumer or other non-HCP). The reporter is the patient.  A 31-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in left arm, administration date 04Dec2021 (Lot number: unknown) at the age of 31 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Hypothyroidism" (unspecified if ongoing), notes: Hypothyroidism/Hashimotos and "Hashimoto's disease" (unspecified if ongoing), notes: Hypothyroidism/Hashimotos. Concomitant medications included: TIROSINT; PROBIOTICS NOS; FISH OIL; ZINC and VITAMIN D. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot Number: Unknown, vaccine location: Right arm), administration date: 05Mar2021, when the patient was 31 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE, Lot Number: Unknown, vaccine location: Left arm), administration date: 26Mar2021, when the patient was 31 years old, for COVID-19 immunisation. The following information was reported: IMMUNISATION (non-serious) with onset 04Dec2021, outcome "unknown", described as "Dose received: 3"; DYSGEUSIA (non-serious) with onset 13Dec2021 at 08:00, outcome "not recovered", described as "Metallic taste in mouth starting on 12/13". Therapeutic measures were not taken as a result of dysgeusia.  Additional Information: Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Immunisation, Swelling
Clinical narrative: Dose number:3; Armpit is extremely swollen even 4 days after shot; This is a spontaneous report from a non-contactable reporter (consumer or other non-HCP). The reporter is the patient.  A 25-year-old male patient received bnt162b2 (BNT162B2), administration date 11Dec2021 (Lot number: FJ8762) at the age of 25 years as dose 3 (booster), single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot Number: ER8730; Route of administration: Unspecified), for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE; Lot Number: EW0164; Route of administration: Unspecified), for COVID-19 immunisation. The following information was reported: IMMUNISATION (non-serious) with onset 11Dec2021, outcome "unknown", described as "Dose number:3"; SWELLING (non-serious) with onset an unknown date in Dec2021, outcome "not recovered", described as "Armpit is extremely swollen even 4 days after shot".  Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.