chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 21.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Inappropriate schedule of product administration, Nasal congestion, SARS-CoV-2 test
Clinical narrative: Contracted COVID; Contracted COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 22-year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 30Jun2021 13:00 (Batch/Lot number: unknown) at the age of 21 years as dose 2, single and intramuscular, administered in arm right, administration date 23Jun2021 (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 (medically significant) all with onset 23Dec2021, outcome recovered (2021). Therapeutic measures were not taken as a result of drug ineffective, covid-19. Clinical course: No other vaccine in four weeks. It was unknown if the patient had Covid prior vaccination. Patient had covid tested post vaccination. No Known allergies.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 68.0
Sex: M
Vaccine: COVID19, HEP
Symptoms: Death, Immunisation, Off label use, Product use issue
Clinical narrative: off label use; Other vaccine same date vaccine date 27Dec2021; Patient died within 24 hrs of vaccination; booster; This is a spontaneous report received from contactable reporter(s) (Other HCP).  A 68 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 27Dec2021 (Lot number: FL3197) at the age of 68 years as dose 3 (booster), single for covid-19 immunisation; hepatitis b vaccine rhbsag (yeast) (ENGERIX-B), administration date 27Dec2021 (Lot number: 5397F) as unk, single. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid (Dose Number: 2, Batch/Lot No: EN6204, Location of injection: Arm Right, Route of Administration: Intramuscular), administration date: 19Mar2021, when the patient was 67 years old, for Covid-19 immunization; Covid (Dose Number: 1, Batch/Lot No: EN6203, Location of injection: Arm Right, Route of Administration: Intramuscular), administration date: 26Feb2021, when the patient was 67 years old, for Covid-19 immunization. The following information was reported: IMMUNISATION (death, medically significant) with onset 27Dec2021, outcome fatal; OFF LABEL USE (death, medically significant) with onset 28Dec2021, outcome fatal; PRODUCT USE ISSUE (death, medically significant) with onset 28Dec2021, outcome fatal; DEATH (death, medically significant) with onset 28Dec2021, outcome fatal. It was unknown if therapeutic measures were taken as a result of immunisation, off label use, product use issue, death. The patient date of death was 28Dec2021. The reported cause of death was Unknown cause of death. It was not reported if an autopsy was performed. Additional Information: Patient died within 24 hrs of vaccination.; Sender's Comments: Based on the available information in the case, the causal association between the events immunization, off label use, product use issue, death and the suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: Unknown cause of death
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Dizziness, Immunisation
Clinical narrative: Booster; Anaphylactic reaction; dizziness; 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 20 year-old female patient received bnt162b2 (BNT162B2), administered in arm (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FLU VACCINE VII. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 Immunization, reaction(s): "Dizzy"; Bnt162b2 (DOSE 2, SINGLE), for Covid-19 immunization, reaction(s): "Dizzy". The following information was reported: IMMUNISATION (medically significant), outcome "unknown", described as "Booster"; ANAPHYLACTIC REACTION (medically significant), outcome "unknown", described as "Anaphylactic reaction"; DIZZINESS (non-serious), outcome "unknown", described as "dizziness". The event "anaphylactic reaction" was evaluated at the emergency room visit. Caller states her daughter experienced an anaphylactic reaction 1 week after the booster dose and had to go to the ER for treatment. Caller does not know the dates for any the Covid shots her daughter received. After each dose of the vaccine, her daughter experienced dizziness within 8-10 minutes. She reports she received a flu shot around the same time and did not experience dizziness.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Seizure
Clinical narrative: seizure; Dose 1 was on 04Sep2021 and Dose 2 was on 06Nov2021; 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 15 year-old male patient received bnt162b2 (BNT162B2), administration date 06Nov2021 (Lot number: FF2590) as dose 2, single for covid-19 immunisation. Relevant medical history included: "autism" (unspecified if ongoing), notes: Her son is a 15 year old male with Autism. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1, Lot: FD8448, he got an ear infection on both ears with perforation and bleeding after the first dose), administration date: 04Sep2021, for COVID-19 immunization, reaction(s): "ear infection", "got an ear infection on both ears with perforation and bleeding ", "may have been getting sick cause of the vaccine". The following information was reported: SEIZURE (medically significant) with onset 10Dec2021, outcome "unknown", described as "seizure"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 06Nov2021, outcome "unknown", described as "Dose 1 was on 04Sep2021 and Dose 2 was on 06Nov2021".    No follow-up attempts are possible. No further information is expected.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: I came down with COVID / I tested positive; I came down with COVID / I tested positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 53 year-old male patient received bnt162b2 (BNT162B2), administration date 18Feb2021 (Lot number: EL3247) at the age of 52 years as dose 2, single and administration date 28Jan2021 (Lot number: EL3247) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. No known allergies and no other medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 26Dec2021, outcome "recovering" and all described as "I came down with COVID / I tested positive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (26Dec2021) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19. Neither received other vaccine in four weeks nor other medications in two weeks.Did not had covid prior vaccination. covid tested post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Immunisation, SARS-CoV-2 antibody test
Clinical narrative: Drug ineffective; Breakthrough COVID case; dose received: 3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 18Oct2021 (Lot number: FF258) at the age of 59 years as dose 3 (booster), single, administered in arm left, administration date 24Mar2021 (Lot number: EP6955) as dose 2, single and administered in arm left, administration date 03Mar2021 (Lot number: EL3248) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Past drug history included: No, reaction(s): "Allergy". The following information was reported: IMMUNISATION (medically significant) with onset 18Oct2021, outcome "unknown", described as "dose received: 3"; DRUG INEFFECTIVE (medically significant) with onset 25Dec2021, outcome "recovering", described as "Drug ineffective"; COVID-19 (medically significant) with onset 25Dec2021, outcome "recovering", described as "Breakthrough COVID case". The patient underwent the following laboratory tests and procedures: sars-cov-2 antibody test: (27Dec2021) positive, notes: Nasal Swab Covid test name post vaccination: BinaxNOW antigen self-test. Therapeutic measures were not taken as a result of immunisation, drug ineffective, covid-19. The patient did not take other vaccine in four weeks and other medications in two weeks.  No follow-up attempts are possible. No further information is expected.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Immunisation, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Breakthrough COVID infection - positive test; Breakthrough COVID infection - positive test; Booster dose; This is a spontaneous report received from a contactable reporter from product quality group.  A 43 year-old male patient received bnt162b2, intramuscular, administration date 03Nov2021 (Lot number: FF2593) at the age of 43 years as dose 3, single, administration date 24Feb2021 (Lot number: EM9810) as dose 2, single and administration date 01Feb2021 (Lot number: EM9810) 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 with onset 03Nov2021, outcome unknown; COVID-19, VACCINATION FAILURE all with onset 27Dec2021, outcome unknown and all described as Breakthrough COVID infection - positive test. Therapeutic measures were not taken as a result of immunisation, covid-19, vaccination failure. Patient had not received covid prior vaccination and tested positive post vaccination.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: may have been exposed to covid-19 and is symptomatic; may have been exposed to covid-19 and is symptomatic; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team for a Pfizer sponsored program (159558).  A 65 year-old female patient received bnt162b2 (BNT162B2), administration date Dec2021 (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 "unknown" and all described as "may have been exposed to covid-19 and is symptomatic".  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on available information a contributory role of BNT162B2 to the reported events Covid-19 and Drug ineffective cannot be totally excluded as efficacy of a drug varies from individual to individual depending upon the immune status. As with any vaccine, vaccination with BNT162B2 may not protect all vaccine recipients, so the expectedness of covid-19 and drug ineffective is : expected. The case will be reassessed further upon receipt of additional information.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Headache, SARS-CoV-2 test
Clinical narrative: tested positive to covid; tested positive to covid; Headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team and product quality group for a Pfizer sponsored program (159558). The reporter is the patient.  A 66 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 11Mar2021 11:30 (Lot number: EN6199) at the age of 65 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "allergic to Penicillin" (unspecified if ongoing); "Bell's Palcy" (unspecified if ongoing), notes: Patient had Bell's palsy in late 90's. There were no concomitant medications. Past drug history included: Prednisone, reaction(s): "allergy: Prednisone", notes: He is allergic to Penicillin and all steroid medications.; Methylprednisone, reaction(s): "Allergy: Methylprednisone"; Meclizine, reaction(s): "spider veins in eyes", notes: He is also allergic to Meclizine, an anti-inflammatory medication. It gave him spider veins in eyes, the floaty things. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 22Dec2021 18:30, outcome "unknown" and all described as "tested positive to covid"; HEADACHE (non-serious) with onset 13Mar2021, outcome "recovered" (2021), described as "Headache". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (22Dec2021) negative; (Dec2021) negative; (22Dec2021) positive, notes: 18:30; (22Dec2021) negative. Therapeutic measures were taken as a result of headache.  Additional information: Patient did not received other Vaccinations four weeks prior to the first administration date of the suspect vaccine. He had headaches for about 8 weeks. He tested positive last Wednesday, so he was on Day 6.The only symptoms he had were headache and nausea, but was not very bad. So, on day 6, and he feels kind of normal. He had headaches for about 8 weeks, which deterred him from 2nd shot and scared him a little. After he had headaches, a couple of days later, he took Tylenol and it did not seem to do anything.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: I was confirmed positive for Covid-19; I was confirmed positive for Covid-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 25 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 18Feb2021 (Lot number: EL3247) at the age of 25 years as dose 2, single and intramuscular, administered in arm left, administration date 28Jan2021 (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, COVID-19 all with onset 23Dec2021, outcome recovered (2021). Therapeutic measures were not taken as a result of vaccination failure, covid-19. No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Aphonia, Computerised tomogram, Dyspnoea, Immunisation, Pericarditis
Clinical narrative: After receiving his booster dose; pericarditis; short of breathe; losing his voice; 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 24 year-old male patient 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 "After receiving his booster dose"; PERICARDITIS (medically significant), outcome "unknown", described as "pericarditis"; DYSPNOEA (non-serious), outcome "unknown", described as "short of breathe"; APHONIA (non-serious), outcome "unknown", described as "losing his voice". The events "after receiving his booster dose", "pericarditis", "short of breathe" and "losing his voice" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: computerised tomogram: nothing was found; x-ray: nothing was found. Therapeutic measures were taken as a result of pericarditis, dyspnoea, aphonia.  Additional information: It was reported that, about 7-8 days after receiving his booster dose began losing his voice while trying to just talk because he was short of breathe. Reporter states her son was placed on antibiotics prophylactically and given an inhaler. Caller states her son has a condition that requires him to take immunosuppressant infusions once per month and due to this he often becomes symptomatic of things later than normal. Caller states her son has begun to make slow improvements over the last few weeks. Caller says they are seeing a Cardiologist today and she wants to make sure he considers pericarditis. Caller states her son is not in danger now, but she would like to know what the timing is and the side effect comes about.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: X-ray
Clinical narrative: After receiving his booster dose; pericarditis; short of breathe; losing his voice; 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 24 year-old male patient 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 "After receiving his booster dose"; PERICARDITIS (medically significant), outcome "unknown", described as "pericarditis"; DYSPNOEA (non-serious), outcome "unknown", described as "short of breathe"; APHONIA (non-serious), outcome "unknown", described as "losing his voice". The events "after receiving his booster dose", "pericarditis", "short of breathe" and "losing his voice" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: computerised tomogram: nothing was found; x-ray: nothing was found. Therapeutic measures were taken as a result of pericarditis, dyspnoea, aphonia.  Additional information: It was reported that, about 7-8 days after receiving his booster dose began losing his voice while trying to just talk because he was short of breathe. Reporter states her son was placed on antibiotics prophylactically and given an inhaler. Caller states her son has a condition that requires him to take immunosuppressant infusions once per month and due to this he often becomes symptomatic of things later than normal. Caller states her son has begun to make slow improvements over the last few weeks. Caller says they are seeing a Cardiologist today and she wants to make sure he considers pericarditis. Caller states her son is not in danger now, but she would like to know what the timing is and the side effect comes about.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Deafness, Tinnitus
Clinical narrative: after the 2nd shot wound up losing his hearing; had a terrible tinnitus; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP, patient's friend) from medical information team.  A male patient received bnt162b2 (COMIRNATY) (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: DEAFNESS (medically significant), outcome "unknown", described as "after the 2nd shot wound up losing his hearing "; TINNITUS (non-serious), outcome "unknown", described as "had a terrible tinnitus".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Having received 2 doses of Pfizer covid vaccine at 7 months I contracted covid; Having received 2 doses of Pfizer covid vaccine at 7 months I contracted covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (005570). The reporter is the patient.  A female 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) with onset 2021, outcome "unknown", COVID-19 (medically significant) with onset Dec2021, outcome "unknown" and all described as "Having received 2 doses of Pfizer covid vaccine at 7 months I contracted covid". The patient was enquiring that how long after having covid she could receive the booster vaccine.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Myocarditis
Clinical narrative: heart inflammation; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date Dec2021 (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: MYOCARDITIS (medically significant) with onset 2021, outcome "unknown", described as "heart inflammation". Clinical course: A review of the Prescribing Information for Pfizer BioNtech Covid vaccine failed to find any information regarding finding a facility and a cardiologist.    The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Drug ineffective, Suspected COVID-19
Clinical narrative: she found out she has covid about 2 hours ago; she found out she has covid about 2 hours ago; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team and product quality group. The reporter is the patient.  A 64-year-old female patient received bnt162b2 (BNT162B2), administration date 27Apr2021 (Batch/Lot number: unknown) at the age of 64 years as dose 2, single and administration date 05Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation (consumer provided lot number "ER8734" and expiration date "Jul2021", unspecified to which dose). Relevant medical history included: "high blood pressure" (unspecified if ongoing). The patient took concomitant medications for for high blood pressure. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 28Dec2021, outcome "unknown" and all described as "she found out she has covid about 2 hours ago". The patient stated she had both doses of the Pfizer covid 19 vaccine on 5Apr2021 and 27Apr2021. She found out she has covid about 2 hours ago before the report (28Dec2021).  The patient underwent the following laboratory tests and procedures: blood test: (2021) unknown result. When probed regarding the name of test, the patient stated, "I don't know my doctor did it. I had the blood test."  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Breast pain, Immunisation, Pain in extremity, Postmenopausal haemorrhage
Clinical narrative: Dose Number: 3; Vaginal bleeding(post menopausal); Breast pain; Arm pain; Armpit pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 10Dec2021 (Lot number: FF8841) at the age of 57 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: SYNTHROID; LEXAPRO; VIT D [COLECALCIFEROL] and Multi vitamin. Past drug history included: Omnicef, reaction(s): "Known allergies: Omnicef". Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EP7534, Location of injection: Arm Left), administration date: 22Apr2021, when the patient was 57 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EP7534, Location of injection: Arm Left), administration date: 30Mar2021, when the patient was 57 years old, for COVID-19 immunization.  The following information was reported: IMMUNISATION (medically significant) with onset 10Dec2021, outcome "unknown", described as "Dose Number: 3"; POSTMENOPAUSAL HAEMORRHAGE (medically significant) with onset 10Dec2021, outcome "not recovered", described as "Vaginal bleeding(post menopausal)"; BREAST PAIN (non-serious) with onset 10Dec2021, outcome "not recovered", described as "Breast pain"; PAIN IN EXTREMITY (non-serious) with onset 10Dec2021, outcome "not recovered", described as "Arm pain"; AXILLARY PAIN (non-serious) with onset 10Dec2021, outcome "not recovered", described as "Armpit pain". Therapeutic measures were not taken as a result of postmenopausal haemorrhage, breast pain, pain in extremity, axillary pain.  Additional information: The adverse event did not result in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Eye disorder, Facial paralysis
Clinical narrative: had her left side of her face paralyzed and she couldn't shut her eye to sleep and she has to tape her eye shut; had her left side of her face paralyzed and she couldn't shut her eye to sleep and she has to tape her eye shut; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  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: FACIAL PARALYSIS (medically significant), EYE DISORDER (non-serious), outcome "unknown" and all described as "had her left side of her face paralyzed and she couldn't shut her eye to sleep and she has to tape her eye shut".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: loss of taste and texture; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). 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: DYSGEUSIA (medically significant), outcome "unknown", described as "loss of taste and texture".  Clinical Information: It was reported that, the patient received the dose of covid vaccine and experienced loss of taste and texture in 9 months.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chest discomfort, Cough, Dyspnoea, Fatigue
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 58 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 28Nov2021 12:00 (Lot number: 320308D) at the age of 58 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: ZOLPIDEM. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: ER8729, Location of injection: Arm Left, Vaccine Administration Time: 02:30 PM), administration date: 08Apr2021, when the patient was 58 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: ER2613, Location of injection: Arm Left, Vaccine Administration Time: 10:30 AM), administration date: 19Mar2021, when the patient was 58 years old, for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 28Nov2021 12:00, outcome "unknown", described as "Dose Number: 3"; FATIGUE (non-serious) with onset 29Nov2021 02:00, outcome "not recovered", described as "Extreme fatigue"; COUGH (non-serious) with onset 29Nov2021 02:00, outcome "not recovered", described as "chronic cough"; HEADACHE (non-serious) with onset 29Nov2021 02:00, outcome "not recovered", described as "headache"; RALES (non-serious) with onset 29Nov2021 02:00, outcome "not recovered", described as "chest/lung rattles"; DYSPNOEA (non-serious) with onset 29Nov2021 02:00, outcome "not recovered", described as "shortness of breath at times"; SINUS CONGESTION (non-serious) with onset 29Nov2021 02:00, outcome "not recovered", described as "sinus congestion"; ASTHENIA (non-serious) with onset 29Nov2021 02:00, outcome "not recovered", described as "general weakness"; SNEEZING (non-serious) with onset 29Nov2021 02:00, outcome "not recovered", described as "occasional sneezing"; LACRIMATION INCREASED (non-serious) with onset 29Nov2021 02:00, outcome "not recovered", described as "eyes tearing up"; CHEST DISCOMFORT (non-serious) with onset 29Nov2021 02:00, outcome "not recovered", described as "chest tightness". The events "extreme fatigue", "chronic cough", "headache", "chest/lung rattles", "shortness of breath at times", "sinus congestion", "general weakness", "occasional sneezing", "eyes tearing up" and "chest tightness" were evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of fatigue, cough, headache, rales, dyspnoea, sinus congestion, asthenia, sneezing, lacrimation increased, chest discomfort. Additional information: Patient did not receive any other vaccines within 4 weeks PRIOR to the COVID-19 vaccine. Patient had no allergy. Prior to vaccination, was the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. The patient received treatment with Steroids, antibiotics, nebulizer, inhaler.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Immunisation, Lacrimation increased, Rales, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 58 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 28Nov2021 12:00 (Lot number: 320308D) at the age of 58 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: ZOLPIDEM. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: ER8729, Location of injection: Arm Left, Vaccine Administration Time: 02:30 PM), administration date: 08Apr2021, when the patient was 58 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: ER2613, Location of injection: Arm Left, Vaccine Administration Time: 10:30 AM), administration date: 19Mar2021, when the patient was 58 years old, for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 28Nov2021 12:00, outcome "unknown", described as "Dose Number: 3"; FATIGUE (non-serious) with onset 29Nov2021 02:00, outcome "not recovered", described as "Extreme fatigue"; COUGH (non-serious) with onset 29Nov2021 02:00, outcome "not recovered", described as "chronic cough"; HEADACHE (non-serious) with onset 29Nov2021 02:00, outcome "not recovered", described as "headache"; RALES (non-serious) with onset 29Nov2021 02:00, outcome "not recovered", described as "chest/lung rattles"; DYSPNOEA (non-serious) with onset 29Nov2021 02:00, outcome "not recovered", described as "shortness of breath at times"; SINUS CONGESTION (non-serious) with onset 29Nov2021 02:00, outcome "not recovered", described as "sinus congestion"; ASTHENIA (non-serious) with onset 29Nov2021 02:00, outcome "not recovered", described as "general weakness"; SNEEZING (non-serious) with onset 29Nov2021 02:00, outcome "not recovered", described as "occasional sneezing"; LACRIMATION INCREASED (non-serious) with onset 29Nov2021 02:00, outcome "not recovered", described as "eyes tearing up"; CHEST DISCOMFORT (non-serious) with onset 29Nov2021 02:00, outcome "not recovered", described as "chest tightness". The events "extreme fatigue", "chronic cough", "headache", "chest/lung rattles", "shortness of breath at times", "sinus congestion", "general weakness", "occasional sneezing", "eyes tearing up" and "chest tightness" were evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of fatigue, cough, headache, rales, dyspnoea, sinus congestion, asthenia, sneezing, lacrimation increased, chest discomfort. Additional information: Patient did not receive any other vaccines within 4 weeks PRIOR to the COVID-19 vaccine. Patient had no allergy. Prior to vaccination, was the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. The patient received treatment with Steroids, antibiotics, nebulizer, inhaler.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Sinus congestion, Sneezing
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 58 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 28Nov2021 12:00 (Lot number: 320308D) at the age of 58 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: ZOLPIDEM. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: ER8729, Location of injection: Arm Left, Vaccine Administration Time: 02:30 PM), administration date: 08Apr2021, when the patient was 58 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: ER2613, Location of injection: Arm Left, Vaccine Administration Time: 10:30 AM), administration date: 19Mar2021, when the patient was 58 years old, for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 28Nov2021 12:00, outcome "unknown", described as "Dose Number: 3"; FATIGUE (non-serious) with onset 29Nov2021 02:00, outcome "not recovered", described as "Extreme fatigue"; COUGH (non-serious) with onset 29Nov2021 02:00, outcome "not recovered", described as "chronic cough"; HEADACHE (non-serious) with onset 29Nov2021 02:00, outcome "not recovered", described as "headache"; RALES (non-serious) with onset 29Nov2021 02:00, outcome "not recovered", described as "chest/lung rattles"; DYSPNOEA (non-serious) with onset 29Nov2021 02:00, outcome "not recovered", described as "shortness of breath at times"; SINUS CONGESTION (non-serious) with onset 29Nov2021 02:00, outcome "not recovered", described as "sinus congestion"; ASTHENIA (non-serious) with onset 29Nov2021 02:00, outcome "not recovered", described as "general weakness"; SNEEZING (non-serious) with onset 29Nov2021 02:00, outcome "not recovered", described as "occasional sneezing"; LACRIMATION INCREASED (non-serious) with onset 29Nov2021 02:00, outcome "not recovered", described as "eyes tearing up"; CHEST DISCOMFORT (non-serious) with onset 29Nov2021 02:00, outcome "not recovered", described as "chest tightness". The events "extreme fatigue", "chronic cough", "headache", "chest/lung rattles", "shortness of breath at times", "sinus congestion", "general weakness", "occasional sneezing", "eyes tearing up" and "chest tightness" were evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of fatigue, cough, headache, rales, dyspnoea, sinus congestion, asthenia, sneezing, lacrimation increased, chest discomfort. Additional information: Patient did not receive any other vaccines within 4 weeks PRIOR to the COVID-19 vaccine. Patient had no allergy. Prior to vaccination, was the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. The patient received treatment with Steroids, antibiotics, nebulizer, inhaler.
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Suspected COVID-19
Clinical narrative: Pregnant lady I know has told story about passing out during epidural (had seen on social media); not sure which individual has covid on the podcast; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient (pregnant) received bnt162b2 (BNT162B2) (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: MATERNAL EXPOSURE DURING PREGNANCY (non-serious), outcome "unknown", described as "Pregnant lady I know has told story about passing out during epidural (had seen on social media)"; SUSPECTED COVID-19 (non-serious), outcome "unknown", described as "not sure which individual has covid on the podcast". The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: Diagnosed with covid; Diagnosed with covid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): PFIZER INC-202200000007 (pfizer), PFIZER INC-202101886107 (pfizer).  An adult male patient received bnt162b2 (BNT162B2) (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), SUSPECTED COVID-19 (medically significant) all with onset 2021, outcome "unknown" and all described as "Diagnosed with covid".Reporter stated today (was nurse but was not involved/was not told in a professional setting). Males, all mid-late 20s (public figures - can find all info including birthdays online. withheld reporter think was almost 30.). This was a recent event. Not sure what vaccines are provided, but they are likely all vaccinated. Saw this article yesterday regarding withheld, last updated 24Dec2021 (includes people telling him to get well soon). Other medical history withheld had shoulder surgery last year or early this year to treat a longstanding injury  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101858742 same reporter/vaccine/event, different patient; US-PFIZER INC-202101872620 same reporter/vaccine/event, different patient.
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: Diagnosed with covid; Diagnosed with covid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).   A male patient in his 20's received bnt162b2 (BNT162B2) (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), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Diagnosed with covid". The event did not Results in death, life threatening, Caused/prolonged hospitalization, Disabling/Incapacitating, Congenital anomaly/birth defect. The patient has been diagnosed with covid. Individual told the reporter today (is nurse but is not involved/was not told in a professional setting). A male patient mid-late 20s (public figures - can find all info including birthdays online. withheld the reporter think is almost 30.). This is a recent event. Not sure what vaccines are provided in (withheld) but the patient is likely vaccinated. Saw this article yesterday, last updated 24Dec2021 (includes people telling him to get well soon).  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101858742 same reporter/vaccine/event, different patient;US-PFIZER INC-202101872619 same reporter/vaccine/event, different patient
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Death, Immunisation, Malaise, Vomiting
Clinical narrative: Death after my mom took the booster shot; Stomach pain; Vomiting; Death after my mom took the booster shot; not feeling well; This is a spontaneous report received from a contactable reporter.  A 79-year-old female patient received bnt162b2, administered in arm, administration date 10Nov2021 (Lot number: FG3527) at the age of 79 years as dose number unknown, single for covid-19 immunisation. The patient took concomitant medications. Vaccination history included: Covid-19 vaccine (MANUFACTURER UNKNOWN, Dose number unknown), for COVID-19 Immunization. The following information was reported: IMMUNISATION (death) with onset 10Nov2021, outcome fatal, DEATH (death) with onset 13Nov2021, outcome fatal and all described as Death after my mom took the booster shot; ABDOMINAL PAIN UPPER (death) with onset 11Nov2021, outcome fatal, described as Stomach pain; MALAISE (death) with onset 10Nov2021, outcome fatal, described as not feeling well; VOMITING (death) with onset 11Nov2021, outcome fatal, described as Vomiting. The patient date of death was 13Nov2021. The reported cause of death was Death after my mom took the booster shot. It was not reported if an autopsy was performed.  No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Death after my mom took the booster shot
Age: 5.0
Sex: M
Vaccine: COVID19
Symptoms: Decreased appetite, Diarrhoea, Pyrexia, Urticaria, Vomiting
Clinical narrative: Hives/were all over his body; Diarrhea; Fever; Vomiting; Lack of appetite; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 6 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 19Dec2021 09:30 (Batch/Lot number: unknown) at the age of 5 years as dose 1 (tris), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: URTICARIA (non-serious) with onset 22Dec2021 14:00, outcome "recovered" (26Dec2021), described as "Hives/were all over his body"; DIARRHOEA (non-serious) with onset 22Dec2021 14:00, outcome "recovered" (26Dec2021), described as "Diarrhea"; PYREXIA (non-serious) with onset 22Dec2021 14:00, outcome "recovering", described as "Fever"; VOMITING (non-serious) with onset 22Dec2021 14:00, outcome "recovering", described as "Vomiting"; DECREASED APPETITE (non-serious) with onset 22Dec2021 14:00, outcome "recovered" (26Dec2021), described as "Lack of appetite". The events "hives/were all over his body", "diarrhea", "fever", "vomiting" and "lack of appetite" were evaluated at the physician office visit. Therapeutic measures were taken as a result of urticaria, diarrhoea, pyrexia, vomiting, decreased appetite.  Additional information: Hives were managed with Benadryl but continued until 26Dec2021 and were all over his body including his face. The patient did not have Covid prior vaccination. The patient does not tested for Covid post vaccination. The patient given privacy policy consent. Device timestamp: 28Dec2021.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Product administration error, Vaccination site haemorrhage
Clinical narrative: booster shot; when the needle put out there is lot of blood; when the needle put out there is lot of blood/vaccine on her right arm but the problem is the needle a lot of blood coming out; there is bleeding issue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 17 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 28Dec2021 17:00 (Lot number: FL3198) at the age of 17 years as dose number unknown (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (DOSE X; MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 28Dec2021 17:00, outcome "unknown", described as "booster shot"; PRODUCT ADMINISTRATION ERROR (non-serious) with onset 28Dec2021 17:00, outcome "unknown", described as "when the needle put out there is lot of blood"; VACCINATION SITE HAEMORRHAGE (non-serious) with onset 28Dec2021 17:00, outcome "unknown", described as "when the needle put out there is lot of blood/vaccine on her right arm but the problem is the needle a lot of blood coming out; there is bleeding issue".  Additional information: It was reported that the patient went walking to that hospital that afternoon around the 12 o'clock had a Pfizer vaccine shot afternoon at 5 O'clock and basically it was given on her right arm and when the needle put out there was lot of blood and basically it was slowing on. The problem was the needle, a lot of blood was coming out and the nurse had to wipe it twice and so her concern was that whether the vaccine given inside was availed. There was bleeding issue. The reporter wanted to know whether that was the cause that compromise the booster and if the needle went inside the muscle or if that could cause the bleeding issue.  No follow-up attempts are possible. No further information is expected.