chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Immunisation, Malaise, SARS-CoV-2 test
Clinical narrative: After the booster, the patient got COVID; After the booster, the patient got COVID; Sick; booster; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 45 year-old male patient received bnt162b2 (BNT162B2), administration date 22Dec2021 (Lot number: 331308A) at the age of 45 years as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: IMMUNISATION (medically significant) with onset 22Dec2021, outcome "unknown", described as "booster"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 23Dec2021, outcome "unknown" and all described as "After the booster, the patient got COVID"; MALAISE (non-serious) with onset 23Dec2021, outcome "unknown", described as "Sick". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (23Dec2021) positive. Therapeutic measures were taken as a result of drug ineffective, covid-19, malaise. Clinical course: The nurse called because her husband (patient) received the 3rd vaccine yesterday (22Dec2021), and the husband has COVID today (23Dec2021). After the booster, the patient got COVID. The patient started developing symptoms after the vaccine yesterday and today was very sick, so he was tested positive. The nurse called to check if there were any reports of people getting actual COVID after the vaccine. No prior vaccination (within four weeks). As a treatment, the nurse stated that the patient just taken vitamin C, zinc, Tylenol, and Motrin but not treatment like medicine. The nurse further stated, "It is just confusing because he got COVID after the second shot as well and now (third dose), and that time he was tested positive and now today he was tested positive again. So, it is every time he gets the shot the second and the booster, he got the COVID." The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the drug ineffective (LOE) cannot be ruled out.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Immunisation, Pain, Pyrexia, Syncope
Clinical narrative: Fainted initially second and third dose; third dose; chest pains and persisting achiness and fever at night; chest pains and persisting achiness and fever at night; chest pains and persisting achiness and fever at night; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 25-year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 21Dec2021 17:00 (Batch/Lot number: unknown) at the age of 25 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "no" (unspecified if ongoing). The patient did not receive any other vaccines within 4 weeks prior to the vaccine. Prior to vaccination the patient was not diagnosed with COVID-19. There were no concomitant medications. Vaccination history included: Bnt162b2 (dose 1, arm left), administration date: 01Mar2021, when the patient was 25 years old, for Covid-19 Immunization; Bnt162b2 (dose 2, arm left), administration date: 21Mar2021, when the patient was 25 years old, for Covid-19 Immunization, reaction(s): "Fainted initially second and third dose". The following information was reported: SYNCOPE (medically significant) with onset 21Dec2021, outcome "not recovered", described as "Fainted initially second and third dose"; IMMUNISATION (medically significant) with onset 21Dec2021, outcome "unknown", described as "third dose"; CHEST PAIN (non-serious), PAIN (non-serious), PYREXIA (non-serious) all with onset 21Dec2021, outcome "not recovered" and all described as "chest pains and persisting achiness and fever at night". Therapeutic measures were not taken as a result of syncope, chest pain, pain, pyrexia. It was also reported that since the vaccination the patient was not diagnosed with COVID-19.  The lot number for bnt162b2 was not provided and will be requested during follow-up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101858912 same patient, different vaccine dose/AE.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: Fainted initially second and third dose; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 25 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 21Mar2021 17:00 (Batch/Lot number: unknown) at the age of 25 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Location of injection: Arm Left), administration date: 01Mar2021, when the patient was 25 years old, for Covid-19 Immunization. The following information was reported: SYNCOPE (medically significant) with onset 2021, outcome "unknown", described as "Fainted initially second and third dose".  Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Bedridden, Dizziness, Limb injury, Loss of personal independence in daily activities, Nausea
Clinical narrative: He had complete loss of his legs in twilight zone; he had a car accident getting home; first day nothing and second day so dizzy at work; couldn't even type and had to call off; he had to stay in bed 24 hours; Nausea; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): MOD21-174666 (Moderna).  A male patient 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: LIMB INJURY (disability), outcome "unknown", described as "He had complete loss of his legs in twilight zone"; DIZZINESS (non-serious), outcome "unknown", described as "first day nothing and second day so dizzy at work"; ROAD TRAFFIC ACCIDENT (disability), outcome "unknown", described as "he had a car accident getting home"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious), outcome "unknown", described as "couldn't even type and had to call off"; BEDRIDDEN (non-serious), outcome "unknown", described as "he had to stay in bed 24 hours"; NAUSEA (non-serious), outcome "unknown", described as "Nausea".  Clinical Course: She was talking to people about her husband's AE and some people described being very dizzy and having nausea. A lady told her "That happened to me the same night of getting the vaccine. She was so dizzy, couldn't do anything at all, she had to stay in bed 24 hours. She had to call off work." Someone else had Pfizer and same thing "first day nothing and second day so dizzy at work, couldn't even type and had to call off, then he had a car accident getting home". He had complete loss of his legs in twilight zone. If this is a common side effects, shouldn't it be listed. She's doubtful we are giving half a dose. She's trying to find out what caused this.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Road traffic accident
Clinical narrative: He had complete loss of his legs in twilight zone; he had a car accident getting home; first day nothing and second day so dizzy at work; couldn't even type and had to call off; he had to stay in bed 24 hours; Nausea; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): MOD21-174666 (Moderna).  A male patient 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: LIMB INJURY (disability), outcome "unknown", described as "He had complete loss of his legs in twilight zone"; DIZZINESS (non-serious), outcome "unknown", described as "first day nothing and second day so dizzy at work"; ROAD TRAFFIC ACCIDENT (disability), outcome "unknown", described as "he had a car accident getting home"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious), outcome "unknown", described as "couldn't even type and had to call off"; BEDRIDDEN (non-serious), outcome "unknown", described as "he had to stay in bed 24 hours"; NAUSEA (non-serious), outcome "unknown", described as "Nausea".  Clinical Course: She was talking to people about her husband's AE and some people described being very dizzy and having nausea. A lady told her "That happened to me the same night of getting the vaccine. She was so dizzy, couldn't do anything at all, she had to stay in bed 24 hours. She had to call off work." Someone else had Pfizer and same thing "first day nothing and second day so dizzy at work, couldn't even type and had to call off, then he had a car accident getting home". He had complete loss of his legs in twilight zone. If this is a common side effects, shouldn't it be listed. She's doubtful we are giving half a dose. She's trying to find out what caused this.  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, Immunisation, Malaise, Oropharyngeal pain
Clinical narrative: positive for COVID 19; positive for COVID 19; SHE WAS NOT TRUTHFUL WHEN I ASKED her if she was feeing well and meeting the site requirements to be at work and then she felt worse on 23Dec; did have a ST; Dose Number:3; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP) from product quality group.  An adult female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in deltoid left, administration date 21Dec2021 (Lot number: FF2589) as dose 3 (booster), single, (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: IMMUNISATION (medically significant) with onset 21Dec2021, outcome unknown, described as Dose Number:3; DRUG INEFFECTIVE (medically significant) with onset 23Dec2021, outcome unknown, COVID-19 (medically significant) with onset 23Dec2021, outcome recovering and all described as positive for COVID 19; MALAISE (non-serious) with onset 21Dec2021, outcome recovering, described as SHE WAS NOT TRUTHFUL WHEN I ASKED her if she was feeing well and meeting the site requirements to be at work and then  she felt worse on 23Dec; OROPHARYNGEAL PAIN (non-serious) with onset 21Dec2021, outcome recovering, described as did have a ST. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (23Dec2021) positive. It was unknown if therapeutic measures were taken as a result of covid-19, malaise. At Workplace clinic facility where the most recent COVID-19 vaccine was administered. The patient receives any other vaccines within 4 weeks prior to the COVID vaccine was unknown. Prior to vaccination, the patient diagnosed with COVID-19 was unknown. Since the vaccination, the patient has been tested for COVID-19. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events immunization, drug ineffective and covid-19 and the suspect drug BNT162B2.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: positive for COVID 19; positive for COVID 19; SHE WAS NOT TRUTHFUL WHEN I ASKED her if she was feeing well and meeting the site requirements to be at work and then she felt worse on 23Dec; did have a ST; Dose Number:3; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP) from product quality group.  An adult female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in deltoid left, administration date 21Dec2021 (Lot number: FF2589) as dose 3 (booster), single, (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: IMMUNISATION (medically significant) with onset 21Dec2021, outcome unknown, described as Dose Number:3; DRUG INEFFECTIVE (medically significant) with onset 23Dec2021, outcome unknown, COVID-19 (medically significant) with onset 23Dec2021, outcome recovering and all described as positive for COVID 19; MALAISE (non-serious) with onset 21Dec2021, outcome recovering, described as SHE WAS NOT TRUTHFUL WHEN I ASKED her if she was feeing well and meeting the site requirements to be at work and then  she felt worse on 23Dec; OROPHARYNGEAL PAIN (non-serious) with onset 21Dec2021, outcome recovering, described as did have a ST. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (23Dec2021) positive. It was unknown if therapeutic measures were taken as a result of covid-19, malaise. At Workplace clinic facility where the most recent COVID-19 vaccine was administered. The patient receives any other vaccines within 4 weeks prior to the COVID vaccine was unknown. Prior to vaccination, the patient diagnosed with COVID-19 was unknown. Since the vaccination, the patient has been tested for COVID-19. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events immunization, drug ineffective and covid-19 and the suspect drug BNT162B2.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Immunisation
Clinical narrative: still i got covid again in 11 months; still i got covid again in 11 months; booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Covid-19" (unspecified if ongoing), notes: I had covid -19. The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "still i got covid again in 11 months"; IMMUNISATION (non-serious), outcome "unknown", described as "booster". The patient got the COVID-19 in 11 months.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Back injury, Hypersensitivity
Clinical narrative: My back is like broken or something; I have many allergic reaction from vaccine; 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 23Dec2021 (Lot number: FF2593) 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: BACK INJURY (non-serious) with onset 26Dec2021, outcome "unknown", described as "My back is like broken or something"; HYPERSENSITIVITY (non-serious) with onset 26Dec2021, outcome "unknown", described as "I have many allergic reaction from vaccine".   No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19 confirmed by positive COVID-19 test; COVID-19 confirmed by positive COVID-19 test; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP).  An adult female patient (not pregnant) 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) all with onset Dec2021, outcome "recovering" and all described as "COVID-19 confirmed by positive COVID-19 test". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (23Dec2021) positive, notes: PCR. The clinical course was reported as follows: "she did not know she was exposed to covid but did have a ST on the day of the vaccine and she was not truthful when I asked her if she was feeling well and meeting the site requirements to be at work and then she felt worse on 23Dec2021 tested with PCR and the result was positive for COVID 19 so that is a vaccine failure and she got the booster when she should not have as she was having symptoms but denied it".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the Drug ineffective (LOE) cannot be ruled out.
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: Drug ineffective; has covid; This is a spontaneous report received from a contactable reporter.  An adult male patient received 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), outcome unknown; SUSPECTED COVID-19 (medically significant), outcome unknown. The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Cough, Drug ineffective, Immunisation, Nasal congestion
Clinical narrative: I have had both my shots and the booster; I tested positive for covid today; I tested positive for covid today; I had a stuffy nose; sore throat; a slight cough; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 54 year-old patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single, (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 was not reported. There were no concomitant medications. The following information was reported: IMMUNISATION (medically significant), described as "I have had both my shots and the booster"; COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "I tested positive for covid today"; NASAL CONGESTION (non-serious), outcome "unknown", described as "I had a stuffy nose"; OROPHARYNGEAL PAIN (non-serious), outcome "unknown", described as "sore throat"; COUGH (non-serious), outcome "unknown", described as "a slight cough". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (24Dec2021) positive.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Oropharyngeal pain, SARS-CoV-2 test
Clinical narrative: I have had both my shots and the booster; I tested positive for covid today; I tested positive for covid today; I had a stuffy nose; sore throat; a slight cough; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 54 year-old patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single, (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 was not reported. There were no concomitant medications. The following information was reported: IMMUNISATION (medically significant), described as "I have had both my shots and the booster"; COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "I tested positive for covid today"; NASAL CONGESTION (non-serious), outcome "unknown", described as "I had a stuffy nose"; OROPHARYNGEAL PAIN (non-serious), outcome "unknown", described as "sore throat"; COUGH (non-serious), outcome "unknown", described as "a slight cough". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (24Dec2021) positive.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: Stroke; This is a spontaneous report received from a contactable consumer. The reporter is the patient.  A 41 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 30Jun2021 (Lot number: EW0191) at the age of 41 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "Immune deficiency" (unspecified if ongoing). The patient took concomitant medications includes: IMMUNOGLOBULIN G HUMAN. Vaccination history included: BNT162B2 (dose 1, lot number: EW0191), administration date: 09Jun2021, for COVID-19 immunisation. The following information was reported: CEREBROVASCULAR ACCIDENT (hospitalization, medically significant), outcome "unknown", described as "Stroke". The patient was hospitalized for cerebrovascular accident. The event "stroke" was evaluated at the physician office visit. Therapeutic measures were taken as a result of cerebrovascular accident. Additional information: The patient stated, "I'm the one who got the stroke; I got the stroke like literally a couple weeks after, so I never got a booster shot, I was told not to get one. I have had been in hospital, in ICU the for 3 days. Now I have to get all kind of therapies physical therapy, occupational therapy and speech therapy."  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: we wanted did a home test for COVID the PCR that you bring home /my test is positive.; we wanted did a home test for COVID the PCR that you bring home /my test is positive.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient 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, COVID-19, outcome unknown. The patient wanted to know they got the COVID booster from Pfizer on Tuesday. She wasn't feeling good up until today like the body ache, cold chills and headache the whole night. So, they wanted did a home test for COVID the PCR that you bring home and her husband same symptoms, his test was negative, her test was positive. The patient wanted to know could that be a false positive. The patient reported body ache, cold chills, bad cough, sore throat but did not have any symptoms up until got the booster. She just wants to know if they could be a false positive and those are really symptoms neither just all side effects from the shot. The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Immunisation, Nasopharyngitis, SARS-CoV-2 test
Clinical narrative: Covid test and it's showing positive; Covid test and it's showing positive; Booster; Had a cold; This is a spontaneous report received from a contactable reporter. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 2021 (Lot number: FE3594) as dose 3 (booster), single, (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: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 2021, outcome unknown and all described as Covid test and it's showing positive; IMMUNISATION (non-serious) with onset 2021, outcome unknown, described as Booster; NASOPHARYNGITIS (non-serious) with onset 2021, outcome unknown, described as Had a cold. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (2021) positive.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 43.0
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Immunisation, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Positive Covid PCR test; Positive Covid PCR test; booster; This is a spontaneous report received from a contactable consumer.  A 43-year-old patient received bnt162b2 (COMIRNATY), administration date Nov2021 (Batch/Lot number: unknown) at the age of 43 years as dose 3 (booster), single, administration date Mar2021 (Batch/Lot number: unknown) as dose 2, single and administration date Mar2021 (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: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 20Dec2021, outcome "unknown" and all described as "Positive Covid PCR test"; IMMUNISATION (medically significant) with onset Nov2021, outcome "unknown", described as "booster". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (20Dec2021) positive, notes: Asymptomatic.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation
Clinical narrative: Atrial Fibrillation. Waiting for Booster, before going to Emergency Room. Omicron variant has me concerned about waiting in ER waiting room.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49 year-old male patient received bnt162b2 (BNT162B2), administration date 14Apr2021 08:45 (Lot number: ER8729) at the age of 49 years 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 Number: 1, Batch/Lot No: er8732), administration date: 28Mar2021, for COVID-19 immunization. The following information was reported: ATRIAL FIBRILLATION (medically significant) with onset Nov2021, outcome "not recovered", described as "Atrial Fibrillation. Waiting for Booster, before going to Emergency Room. Omicron variant has me concerned about waiting in ER waiting room.". The event "atrial fibrillation. waiting for booster, before going to emergency room. omicron variant has me concerned about waiting in er waiting room." was evaluated at the physician office visit.  Clinical information: Patient did not receive any other vaccines within 4 weeks. Prior to the COVID vaccine, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Pyrexia, Urticaria, Vomiting
Clinical narrative: Fever; vomiting; welts that appeared on his hands and feet; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 7 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "covid-19" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "Fever"; VOMITING (non-serious), outcome "unknown", described as "vomiting"; URTICARIA (non-serious), outcome "unknown", described as "welts that appeared on his hands and feet". Relevant laboratory tests and procedures are available in the appropriate section.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Exposure to SARS-CoV-2
Clinical narrative: Exposed to the COVID; This is a spontaneous report received from a contactable reporter(s) (Other HCP) for a Pfizer sponsored program (005570). The reporter is the parent.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Stents" (unspecified if ongoing), notes: he has a couple of stents . The patient's concomitant medications were not reported. The following information was reported: EXPOSURE TO SARS-COV-2 (non-serious), outcome "unknown", described as "Exposed to the COVID".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Covid-19 positive; Covid-19 positive; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from product quality group.  A female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 01May2021 (Lot number: EW0153) asdose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose product: COVID 19, dose brand: Pfizer BNT162B2, dose brand unknown: False, dose lot number: ER8736, dose lot unknown: False, dose administrator route: Intra muscular, dose administration date: 10Apr2021,dose number: 1, dose vaccine location: Left arm), administration date: 10Apr2021, for COVID-19 Immunization. The following information was reported: VACCINATION FAILURE, COVID-19 (medically significant) all with onset 27Dec2021, outcome "recovering". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (27Dec2021) positive, notes: Nasal swab. Therapeutic measures were taken as a result of vaccination failure, covid-19. It was reported that, the patient had not received other vaccine in four weeks. No Other medications in two weeks. It was reported that, the patient did not diagnosed with COVID-19 Prior to vaccination. It was reported that, the patient had been tested for COVID-19 Since the vaccination.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on the  information in the case report, a possible causal relationship between the events Vaccination failure, Covid-19  and suspect drug BNT162B2 cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Anxiety, Blood test, COVID-19, Chest pain, Insomnia
Clinical narrative: Covid-19 positive; Covid-19 positive; passed out; near death experience; sleeplessness for a night; chest pain; anxiety; palpitation; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 01May2021 (Batch/Lot number: unknown) as dose 2, single and administration date 10Apr2021 (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: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 25Dec2021, outcome "recovering" and all described as "Covid-19 positive". The patient underwent the following laboratory tests and procedures: blood test: (26Dec2021) unknown; sars-cov-2 test: (26Dec2021) positive. Clinical information: On the night December 25th, the patient suddenly feel ill. The patient passed out and had a near death experience and was rushed to the ER. Blood samples and nasal swab for Covid-19 testing was collected early hours of 26Dec2021. After some hours, the Doctor came back with a Covid-19 positive test result. Other events that the patient experienced were headache, dizziness, light headedness, loss of appetite, loss of sense of smell, sleeplessness for a night, coughing, chest pain, anxiety, palpitation.   The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the vaccination failure (LOE) cannot be ruled out.Based on the currently available information the possibility of causal association between the events near death experience and passed out and the suspect drug BNT162B2  cannot be ruled out. 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: U
Vaccine: COVID19
Symptoms: Loss of consciousness, Near death experience, Palpitations, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Covid-19 positive; Covid-19 positive; passed out; near death experience; sleeplessness for a night; chest pain; anxiety; palpitation; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 01May2021 (Batch/Lot number: unknown) as dose 2, single and administration date 10Apr2021 (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: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 25Dec2021, outcome "recovering" and all described as "Covid-19 positive". The patient underwent the following laboratory tests and procedures: blood test: (26Dec2021) unknown; sars-cov-2 test: (26Dec2021) positive. Clinical information: On the night December 25th, the patient suddenly feel ill. The patient passed out and had a near death experience and was rushed to the ER. Blood samples and nasal swab for Covid-19 testing was collected early hours of 26Dec2021. After some hours, the Doctor came back with a Covid-19 positive test result. Other events that the patient experienced were headache, dizziness, light headedness, loss of appetite, loss of sense of smell, sleeplessness for a night, coughing, chest pain, anxiety, palpitation.   The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the vaccination failure (LOE) cannot be ruled out.Based on the currently available information the possibility of causal association between the events near death experience and passed out and the suspect drug BNT162B2  cannot be ruled out. 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: Exposure to SARS-CoV-2
Clinical narrative: Exposed to the COVID; This is a spontaneous report received from a contactable reporter(s) (Other HCP) for a Pfizer sponsored program. The reporter is the parent.  A 64 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Stents" (not ongoing), notes: he has a couple of stents. The patient's concomitant medications were not reported. The following information was reported: EXPOSURE TO SARS-COV-2 (non-serious), outcome "unknown", described as "Exposed to the COVID".   The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19 pneumonia
Clinical narrative: I'm currently being treated for COVID pneumonia and have been symptomatic for about 2 weeks now; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  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: COVID-19 PNEUMONIA (medically significant), outcome "unknown", described as "I'm currently being treated for COVID pneumonia and have been symptomatic for about 2 weeks now".  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: fully vaccinated with the Pfizer-BioNTech COVID-19 Vaccine and tested positive for COVID-19; fully vaccinated with the Pfizer-BioNTech COVID-19 Vaccine and tested positive for COVID-19; 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 16 year-old patient received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) as dose 2, single and administration date 2021 (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, COVID-19, outcome unknown and all described as fully vaccinated with the Pfizer-BioNTech COVID-19 Vaccine and tested positive for COVID-19.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Condition aggravated, Seizure
Clinical narrative: seizure activity had increased; seizure activity had increased; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation; ofatumumab (KESIMPTA) (Batch/Lot number: unknown). Relevant medical history included: "Seizure disorder" (ongoing). The patient's concomitant medications were not reported. The following information was reported: SEIZURE (medically significant), CONDITION AGGRAVATED (medically significant), outcome "unknown" and all described as "seizure activity had increased". The action taken for ofatumumab was unknown. The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Illness, Immunisation, Suspected COVID-19
Clinical narrative: booster dose; I have COVID; I have COVID; I'm sick; 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 (BNT162B2) (Batch/Lot number: unknown) as dose 3, (booster) single, (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 was not reported. The patient took concomitant medications. The following information was reported: IMMUNISATION (medically significant), outcome "unknown", described as "booster dose"; DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 25Dec2021, outcome "unknown" and all described as "I have COVID"; ILLNESS (non-serious) with onset 25Dec2021, outcome "unknown", described as "I'm sick". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19, illness.  Additional information: Do you have any information of the availability of PAXLOVID?"  Response: Responded as per attached SRD. Informed caller: "Paxlovid has not been approved, but has been authorized for emergency use by FDA , for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are at high-risk for progression to severe COVID-19, including hospitalization or death. Under the Emergency Use Authorization, Department of Health and Human Services is overseeing the fair and equitable distribution of nirmatrelvir tablets; ritonavir tablets. Individuals should visit their healthcare provider to determine eligibility for treatment. Pfizer Medical Information does not have additional information on product availability".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Drug ineffective, Immunisation, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: Pfizer booster shot; got infected with Covid; got infected with Covid; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: IMMUNISATION (medically significant), outcome "unknown", described as "Pfizer booster shot"; DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "got infected with Covid". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: got infected with covid. Reporter reported that three of his friends had the Pfizer booster shot and got infected with Covid. 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-202101863869 same drug and patient, different event and drug dose;US-PFIZER_INC-202101863870 same drug and patient, different event and drug dose.
Sex: U
Vaccine: COVID19
Symptoms: Drug ineffective, Immunisation, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: Pfizer booster shot; got infected with Covid; got infected with Covid; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3, single, (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: IMMUNISATION (medically significant), outcome "unknown", described as "Pfizer booster shot"; DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "got infected with Covid". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: got infected with covid.  Clinical Course: Consumer reported the vaccine was a killer and was killing the people. Created 1 AE form because there was no patient's information gathered.  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-202101863868 same drug and patient, different event and drug dose;US-PFIZER_INC-202101863870 same drug and patient, different event and drug dose
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Immunisation, SARS-CoV-2 test
Clinical narrative: Pfizer booster shot; got infected with Covid; got infected with Covid; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (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 (MANUFACTURE UNKNOWN, Dose 01), for Covid-19 Immunization; Bnt162b2 (Dose 02), for Covid-19 immunization. The following information was reported: IMMUNISATION (medically significant), outcome "unknown", described as "Pfizer booster shot"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "got infected with Covid". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive, notes: Infected with Covid.  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) : -PFIZER_INC-202101863868 ;-PFIZER_INC-202101863869