chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Antibody test, Blood immunoglobulin G, COVID-19, Drug ineffective, Fluorescent in situ hybridisation
Clinical narrative: known PCR-confirmed diagnoses/ known SARS-CoV-2 infection between the 2-week and 6-month draws; known PCR-confirmed diagnoses/ known SARS-CoV-2 infection between the 2-week and 6-month draws; This is a literature report for the following literature source(s): (Privacy).  Authors sampled 130 NH residents and 95 HCWs 6 months after vaccination who had been previously evaluated 2 weeks following vaccination. Patients were studied from December 2020 to July 2021 from 4 NHs. The HCWs were workers at the NH buildings and medical center who all had access to the same vaccine at the same time as the NH residents. All participants received 2 doses of vaccine regardless of prior SARS-CoV-2 infection. Of 225 participants with available 6-month follow-up, 13 (6%) were excluded for presumed or known SARS-CoV-2 infection between the 2-week and 6-month draws. All of these participants were in buildings or workspaces with known outbreaks. Those with presumed infection had an increase in titer greater than 100% at 6 months from the 2 week post-vaccine level in at least 1 of the immune assays. Five participants had known PCR-confirmed diagnoses; the other presumed cases were clinically undetected. Subjects that have been excluded with documented or presumed infection in the 2 week to 6 month interval: 75-year-old male. Reason for exclusion: PCR +ve, Titer rise (Titer rise denotes an increase greater than 100% in either or all of anti-spike, anti-RBD or neutralization titers); Clinical: Symptomatic (Symptomatic denotes subjects with COVID-like symptoms).  A 75 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "known PCR-confirmed diagnoses/ known SARS-CoV-2 infection between the 2-week and 6-month draws". The patient underwent the following laboratory tests and procedures: antibody test: titer rise; blood immunoglobulin g: unknown results; fluorescent in situ hybridisation: unknown results; sars-cov-2 antibody test: titer rise; sars-cov-2 test: positive; unknown results.  No follow-up attempts are possible, information about batch number cannot be obtained.; Sender's Comments: Based on the information currently available, a lack of efficacy with BNT162B2 in this patient cannot be completely excluded,Linked Report(s) : US-PFIZER INC-202200314527 Same article/ drug/event and different patient
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, SARS-CoV-2 test
Clinical narrative: known PCR-confirmed diagnoses/ known SARS-CoV-2 infection between the 2-week and 6-month draws; known PCR-confirmed diagnoses/ known SARS-CoV-2 infection between the 2-week and 6-month draws; This is a literature report for the following literature source(s): (Privacy).  Authors sampled 130 NH residents and 95 HCWs 6 months after vaccination who had been previously evaluated 2 weeks following vaccination. Patients were studied from December 2020 to July 2021 from 4 NHs. The HCWs were workers at the NH buildings and medical center who all had access to the same vaccine at the same time as the NH residents. All participants received 2 doses of vaccine regardless of prior SARS-CoV-2 infection. Of 225 participants with available 6-month follow-up, 13 (6%) were excluded for presumed or known SARS-CoV-2 infection between the 2-week and 6-month draws. All of these participants were in buildings or workspaces with known outbreaks. Those with presumed infection had an increase in titer greater than 100% at 6 months from the 2 week post-vaccine level in at least 1 of the immune assays. Five participants had known PCR-confirmed diagnoses; the other presumed cases were clinically undetected. Subjects that have been excluded with documented or presumed infection in the 2 week to 6 month interval: 75-year-old male. Reason for exclusion: PCR +ve, Titer rise (Titer rise denotes an increase greater than 100% in either or all of anti-spike, anti-RBD or neutralization titers); Clinical: Symptomatic (Symptomatic denotes subjects with COVID-like symptoms).  A 75 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "known PCR-confirmed diagnoses/ known SARS-CoV-2 infection between the 2-week and 6-month draws". The patient underwent the following laboratory tests and procedures: antibody test: titer rise; blood immunoglobulin g: unknown results; fluorescent in situ hybridisation: unknown results; sars-cov-2 antibody test: titer rise; sars-cov-2 test: positive; unknown results.  No follow-up attempts are possible, information about batch number cannot be obtained.; Sender's Comments: Based on the information currently available, a lack of efficacy with BNT162B2 in this patient cannot be completely excluded,Linked Report(s) : US-PFIZER INC-202200314527 Same article/ drug/event and different patient
Sex: M
Vaccine: COVID19
Symptoms: Antibody test, Blood immunoglobulin G, COVID-19, Drug ineffective, Fluorescent in situ hybridisation
Clinical narrative: known PCR-confirmed diagnoses/ known SARS-CoV-2 infection between the 2-week and 6-month draws; known PCR-confirmed diagnoses/ known SARS-CoV-2 infection between the 2-week and 6-month draws; This is a literature report.  Authors sampled 130 Nursing Home (NH) residents and 95 Health Care Workers (HCWs) 6 months after vaccination who had been previously evaluated 2 weeks following vaccination. Patients were studied from December 2020 to July 2021 from 4 NHs. The HCWs were workers at the buildings and medical center who all had access to the same vaccine at the same time as the residents. All participants received 2 doses of vaccine regardless of prior SARS-CoV-2 infection. Of 225 participants with available 6-month follow-up, 13 (6%) were excluded for presumed or known SARS-CoV-2 infection between the 2-week and 6-month draws. All of these participants were in buildings or workspaces with known outbreaks. Those with presumed infection had an increase in titer greater than 100% at 6 months from the 2 week post-vaccine level in at least 1 of the immune assays. Five participants had known PCR-confirmed diagnoses; the other presumed cases were clinically undetected. Subjects that have been excluded with documented or presumed infection in the 2 week to 6 month interval: 72-year-old male. Reason for exclusion: PCR +ve, Titer rise (Titer rise denotes an increase greater than 100% in either or all of anti-spike, anti-RBD or neutralization titers); Clinical: Symptomatic (Symptomatic denotes subjects with COVID-like symptoms).  A 72 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "known PCR-confirmed diagnoses/ known SARS-CoV-2 infection between the 2-week and 6-month draws". The patient underwent the following laboratory tests and procedures: antibody test: titer rise; blood immunoglobulin g: unknown results; fluorescent in situ hybridisation: unknown results; sars-cov-2 antibody test: titer rise; sars-cov-2 test: positive; unknown results.  No follow-up attempts are possible, information about batch number cannot be obtained.; Sender's Comments: Based on the information currently available, a lack of efficacy with BNT162B2 in this patient cannot be completely excluded,Linked Report(s) : US-PFIZER INC-202200314527 Same article/ drug/event and different patient
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, SARS-CoV-2 test
Clinical narrative: known PCR-confirmed diagnoses/ known SARS-CoV-2 infection between the 2-week and 6-month draws; known PCR-confirmed diagnoses/ known SARS-CoV-2 infection between the 2-week and 6-month draws; This is a literature report.  Authors sampled 130 Nursing Home (NH) residents and 95 Health Care Workers (HCWs) 6 months after vaccination who had been previously evaluated 2 weeks following vaccination. Patients were studied from December 2020 to July 2021 from 4 NHs. The HCWs were workers at the buildings and medical center who all had access to the same vaccine at the same time as the residents. All participants received 2 doses of vaccine regardless of prior SARS-CoV-2 infection. Of 225 participants with available 6-month follow-up, 13 (6%) were excluded for presumed or known SARS-CoV-2 infection between the 2-week and 6-month draws. All of these participants were in buildings or workspaces with known outbreaks. Those with presumed infection had an increase in titer greater than 100% at 6 months from the 2 week post-vaccine level in at least 1 of the immune assays. Five participants had known PCR-confirmed diagnoses; the other presumed cases were clinically undetected. Subjects that have been excluded with documented or presumed infection in the 2 week to 6 month interval: 72-year-old male. Reason for exclusion: PCR +ve, Titer rise (Titer rise denotes an increase greater than 100% in either or all of anti-spike, anti-RBD or neutralization titers); Clinical: Symptomatic (Symptomatic denotes subjects with COVID-like symptoms).  A 72 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "known PCR-confirmed diagnoses/ known SARS-CoV-2 infection between the 2-week and 6-month draws". The patient underwent the following laboratory tests and procedures: antibody test: titer rise; blood immunoglobulin g: unknown results; fluorescent in situ hybridisation: unknown results; sars-cov-2 antibody test: titer rise; sars-cov-2 test: positive; unknown results.  No follow-up attempts are possible, information about batch number cannot be obtained.; Sender's Comments: Based on the information currently available, a lack of efficacy with BNT162B2 in this patient cannot be completely excluded,Linked Report(s) : US-PFIZER INC-202200314527 Same article/ drug/event and different patient
Sex: M
Vaccine: COVID19
Symptoms: Antibody test, Blood immunoglobulin G, COVID-19, Drug ineffective, Fluorescent in situ hybridisation
Clinical narrative: known PCR-confirmed diagnoses/ known SARS-CoV-2 infection between the 2-week and 6-month draws; known PCR-confirmed diagnoses/ known SARS-CoV-2 infection between the 2-week and 6-month draws; This is a literature report for the following literature source(s): (Privacy).   Authors sampled 130 NH residents and 95 HCWs 6 months after vaccination who had been previously evaluated 2 weeks following vaccination. Patients were studied from December 2020 to July 2021 from 4 NHs. The HCWs were workers at the NH buildings and medical center who all had access to the same vaccine at the same time as the NH residents. All participants received 2 doses of vaccine regardless of prior SARS-CoV-2 infection. Of 225 participants with available 6-month follow-up, 13 (6%) were excluded for presumed or known SARS-CoV-2 infection between the 2-week and 6-month draws. All of these participants were in buildings or workspaces with known outbreaks. Those with presumed infection had an increase in titer greater than 100% at 6 months from the 2 week post-vaccine level in at least 1 of the immune assays. Five participants had known PCR-confirmed diagnoses; the other presumed cases were clinically undetected. Subjects that have been excluded with documented or presumed infection in the 2 week to 6 month interval: 96-year-old male. Reason for exclusion: PCR +ve, Titer rise (Titer rise denotes an increase greater than 100% in either or all of anti-spike, anti-RBD or neutralization titers); Clinical: Symptomatic (Symptomatic denotes subjects with COVID-like symptoms).  A 96 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "known PCR-confirmed diagnoses/ known SARS-CoV-2 infection between the 2-week and 6-month draws". The patient underwent the following laboratory tests and procedures: antibody test: titer rise; blood immunoglobulin g: unknown results; fluorescent in situ hybridisation: unknown results; sars-cov-2 antibody test: titer rise; sars-cov-2 test: positive; unknown results.  No follow-up attempts are possible, information about batch number cannot be obtained.; Sender's Comments: Based on the information currently available, a lack of efficacy with BNT162B2 in this patient cannot be completely excluded,Linked Report(s) : US-PFIZER INC-202200314527 Same article/ drug/event and different patient
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, SARS-CoV-2 test
Clinical narrative: known PCR-confirmed diagnoses/ known SARS-CoV-2 infection between the 2-week and 6-month draws; known PCR-confirmed diagnoses/ known SARS-CoV-2 infection between the 2-week and 6-month draws; This is a literature report for the following literature source(s): (Privacy).   Authors sampled 130 NH residents and 95 HCWs 6 months after vaccination who had been previously evaluated 2 weeks following vaccination. Patients were studied from December 2020 to July 2021 from 4 NHs. The HCWs were workers at the NH buildings and medical center who all had access to the same vaccine at the same time as the NH residents. All participants received 2 doses of vaccine regardless of prior SARS-CoV-2 infection. Of 225 participants with available 6-month follow-up, 13 (6%) were excluded for presumed or known SARS-CoV-2 infection between the 2-week and 6-month draws. All of these participants were in buildings or workspaces with known outbreaks. Those with presumed infection had an increase in titer greater than 100% at 6 months from the 2 week post-vaccine level in at least 1 of the immune assays. Five participants had known PCR-confirmed diagnoses; the other presumed cases were clinically undetected. Subjects that have been excluded with documented or presumed infection in the 2 week to 6 month interval: 96-year-old male. Reason for exclusion: PCR +ve, Titer rise (Titer rise denotes an increase greater than 100% in either or all of anti-spike, anti-RBD or neutralization titers); Clinical: Symptomatic (Symptomatic denotes subjects with COVID-like symptoms).  A 96 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "known PCR-confirmed diagnoses/ known SARS-CoV-2 infection between the 2-week and 6-month draws". The patient underwent the following laboratory tests and procedures: antibody test: titer rise; blood immunoglobulin g: unknown results; fluorescent in situ hybridisation: unknown results; sars-cov-2 antibody test: titer rise; sars-cov-2 test: positive; unknown results.  No follow-up attempts are possible, information about batch number cannot be obtained.; Sender's Comments: Based on the information currently available, a lack of efficacy with BNT162B2 in this patient cannot be completely excluded,Linked Report(s) : US-PFIZER INC-202200314527 Same article/ drug/event and different patient
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pustule, Rash macular, Skin erosion, Skin irritation
Clinical narrative: he started to have some blotches with pus underneath his armpits; he started to have some blotches with pus underneath his armpits; he feel irritation and raw in his skin.; when he wears T-Shirts, he feel irritation and raw in his skin.; pain; 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 55 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 Immunization. The following information was reported: RASH MACULAR (non-serious), PUSTULE (non-serious), outcome "not recovered" and all described as "he started to have some blotches with pus underneath his armpits"; SKIN IRRITATION (non-serious), outcome "unknown", described as "he feel irritation and raw in his skin."; SKIN EROSION (non-serious), outcome "unknown", described as "when he wears T-Shirts, he feel irritation and raw in his skin."; PAIN (non-serious), outcome "unknown", described as "pain".  Additional Information: Patient also mentioned that he needed took the pus out so he can relief the pain, but like two and a half weeks ago, this started again.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19, UNK
Symptoms: COVID-19, Psoriasis, Vaccination failure
Clinical narrative: Psoriasis; COVID; COVID; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4302044-00 (Agency).  A 51 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date May2021 (Batch/Lot number: unknown) as dose 2, single and intramuscular, administration date May2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) for psoriasis. 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 Feb2022, outcome "unknown" and all described as "COVID"; PSORIASIS (non-serious), outcome "recovering", described as "Psoriasis". The action taken for adalimumab was unknown.  The reporter's did not provided causality of adalimumab for the event "covid" and "psoriasis". The reporter considered events"covid" and "psoriasis" possible to bnt162b2.; Sender's Comments: Considering the nature of the reported events and product profile, a causal role of the suspect drug cannot be denied for the reported events.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: infection with SARS-CoV-2 Omicron; infection with SARS-CoV-2 Omicron; This is a literature report for the following literature source(s):  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. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "infection with SARS-CoV-2 Omicron".; Sender's Comments: A possible contributory role of the suspect products cannot be excluded for the reported event drug ineffective based on the known safety profile and temporal association ,Linked Report(s) : US-PFIZER INC-202200256250 Same article/drug/events, different patient
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: infection with SARS-CoV-2 Omicron BA.1; infection with SARS-CoV-2 Omicron BA.1; This is a literature report.  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. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "infection with SARS-CoV-2 Omicron BA.1".; Sender's Comments: A possible contributory role of the suspect products cannot be excluded for the reported event drug ineffective based on the known safety profile and temporal association ,Linked Report(s) : US-PFIZER INC-202200256250 Same article/drug/events and different patients
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, Cough, Laryngitis, Pyrexia
Clinical narrative: Covid test result=Positive; Covid test result=Positive; feverish; cough; laryngitis; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP) from product quality group.  A 27 year-old female patient received bnt162b2 (BNT162B2), administration date 16Nov2021 (Lot number: FF2589) at the age of 27 years as dose 3 (booster), single, administration date 26Apr2021 (Lot number: EW0171) as dose 2, single and administration date 05Apr2021 (Lot number: EW0151) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 08Mar2022, outcome "unknown" and all described as "Covid test result=Positive"; LARYNGITIS (non-serious) with onset 07Mar2022, outcome "unknown", described as "laryngitis"; PYREXIA (non-serious) with onset 08Mar2022, outcome "unknown", described as "feverish"; COUGH (non-serious) with onset 08Mar2022, outcome "unknown", described as "cough". The patient underwent the following laboratory tests and procedures: body temperature: (unspecified date) unknown  results; sars-cov-2 test: (08Mar2022) positive, notes: Unknown.  No follow-up attempts are possible. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vaccination failure
Clinical narrative: Covid test result=Positive; Covid test result=Positive; feverish; cough; laryngitis; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP) from product quality group.  A 27 year-old female patient received bnt162b2 (BNT162B2), administration date 16Nov2021 (Lot number: FF2589) at the age of 27 years as dose 3 (booster), single, administration date 26Apr2021 (Lot number: EW0171) as dose 2, single and administration date 05Apr2021 (Lot number: EW0151) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 08Mar2022, outcome "unknown" and all described as "Covid test result=Positive"; LARYNGITIS (non-serious) with onset 07Mar2022, outcome "unknown", described as "laryngitis"; PYREXIA (non-serious) with onset 08Mar2022, outcome "unknown", described as "feverish"; COUGH (non-serious) with onset 08Mar2022, outcome "unknown", described as "cough". The patient underwent the following laboratory tests and procedures: body temperature: (unspecified date) unknown  results; sars-cov-2 test: (08Mar2022) positive, notes: Unknown.  No follow-up attempts are possible. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Breakthrough Covid positive case; Breakthrough Covid positive case; This is a spontaneous report received from a contactable reporter(Consumer or other non HCP). The reporter is the patient.  A 46 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 08Oct2021 (Lot number: EW0217) at the age of 46 years as dose 3 (booster), single, intramuscular, administered in arm left, administration date 09Feb2021 (Lot number: EL3247) as dose 2, single and intramuscular, administered in arm left, administration date 21Jan2021 (Lot number: EL3247) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. No covid prior vaccination. No other vaccine in four weeks. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 06Mar2022, outcome "recovering" and all described as "Breakthrough Covid positive case". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (07Mar2022) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID; again covid; COVID; MARKETING PROGRAM NAME NOT AVAILIBLE  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4296985-00 (Agency).  A 52 year-old male patient received bnt162b2 (BNT162B2), intramuscular (Batch/Lot number: unknown) as dose 3 (booster), single, intramuscular (Batch/Lot number: unknown) as dose 2, single and intramuscular (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), intramuscular (Batch/Lot number: unknown) till Oct2021 at citrate free for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant) with onset Jan2022, outcome "recovered" (2022) and all described as "COVID"; COVID-19 (medically significant) with onset Feb2022, outcome "not recovered", described as "again covid". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (Jan2022) positive; (Feb2022) positive. The action taken for adalimumab was unknown. It was unknown if patient was enrolled in a covid-19 vaccine trial. The reporters causality for Humira (adalimumab) for the event(s) of covid, again covid with Humira (adalimumab) was no reasonable possibility. The reporters causality for Pfizer BioNTech Covid-19 Vaccine (Tozinameran) for the events of COVID-19 and recurrent COVID-19 was not reported  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Considering the nature of the reported events and product profile, a causal role of the suspect drug cannot be denied for the reported events.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Drug ineffective, Pyrexia, Scar, Skin laxity
Clinical narrative: COVID; Loose skin; Scarring; COVID; Chills; Feverish; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program (MARKETING PROGRAM NAME NOT AVAILIBLE). The reporter is the patient. Other Case identifier(s): 22K-163-4302126-00 (Agency).  A 23 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date Mar2021 (Batch/Lot number: unknown) at the age of 22 years as dose 2, single and intramuscular, administration date Feb2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) at unk (citrate free) for hidradenitis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SUSPECTED COVID-19 (medically significant) with onset 02Jul2021, outcome "unknown", DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "COVID"; CHILLS (non-serious) with onset 2021, outcome "unknown", described as "Chills"; PYREXIA (non-serious) with onset 2021, outcome "unknown", described as "Feverish"; SKIN LAXITY (non-serious), outcome "unknown", described as "Loose skin"; SCAR (non-serious), outcome "unknown", described as "Scarring". The action taken for adalimumab was unknown.  The reporter's causality for the event of Chills, Loose skin, Scarring, Covid and Feverish with Adalimumab (Humira) was not provided.  The reporter's causality for the event Chills and feverish with Pfizer Biontech Covid-19 vaccine was reported as possible and for the event skin laxity, scarring and Covid-19 was not reported.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of the reported events 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."
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Suspected COVID-19
Clinical narrative: COVID; Loose skin; Scarring; COVID; Chills; Feverish; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program (MARKETING PROGRAM NAME NOT AVAILIBLE). The reporter is the patient. Other Case identifier(s): 22K-163-4302126-00 (Agency).  A 23 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date Mar2021 (Batch/Lot number: unknown) at the age of 22 years as dose 2, single and intramuscular, administration date Feb2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) at unk (citrate free) for hidradenitis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SUSPECTED COVID-19 (medically significant) with onset 02Jul2021, outcome "unknown", DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "COVID"; CHILLS (non-serious) with onset 2021, outcome "unknown", described as "Chills"; PYREXIA (non-serious) with onset 2021, outcome "unknown", described as "Feverish"; SKIN LAXITY (non-serious), outcome "unknown", described as "Loose skin"; SCAR (non-serious), outcome "unknown", described as "Scarring". The action taken for adalimumab was unknown.  The reporter's causality for the event of Chills, Loose skin, Scarring, Covid and Feverish with Adalimumab (Humira) was not provided.  The reporter's causality for the event Chills and feverish with Pfizer Biontech Covid-19 vaccine was reported as possible and for the event skin laxity, scarring and Covid-19 was not reported.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of the reported events 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."
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Chills, Dizziness, Grief reaction, Headache
Clinical narrative: Substantial pain at injection site; headache; neck pain; lower back pain; chills; fever; dizzy; 24 hours of grief; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 06Oct2021 (Batch/Lot number: unknown) at the age of 66 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose:1), for Covid-19 immunization; Bnt162b2 (Dose:2), for Covid-19 immunization. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 06Oct2021, outcome "recovering", described as "Substantial pain at injection site"; HEADACHE (non-serious) with onset 06Oct2021, outcome "recovering", described as "headache"; NECK PAIN (non-serious) with onset 06Oct2021, outcome "recovering", described as "neck pain"; BACK PAIN (non-serious) with onset 06Oct2021, outcome "recovering", described as "lower back pain"; CHILLS (non-serious) with onset 06Oct2021, outcome "recovering", described as "chills"; PYREXIA (non-serious) with onset 06Oct2021, outcome "recovering", described as "fever"; DIZZINESS (non-serious) with onset 06Oct2021, outcome "recovering", described as "dizzy"; GRIEF REACTION (non-serious) with onset 06Oct2021, outcome "recovering", described as "24 hours of grief". Therapeutic measures were not taken as a result of vaccination site pain, headache, neck pain, back pain, chills, pyrexia, dizziness, grief reaction.  Additional information included: It was significant enough to make wonder if contacting COVID would be less impactful. It was reported that batch/lot number was unavailable at the time of report completion. Patient did not received any other vaccine within 4 weeks prior to the COVID vaccine. Patient did not received any other medications within 2 weeks of vaccination. Prior vaccination patient was not diagnosed with COVID-19. Since the vaccination patient had not been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Neck pain, Pyrexia, Vaccination site pain
Clinical narrative: Substantial pain at injection site; headache; neck pain; lower back pain; chills; fever; dizzy; 24 hours of grief; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 06Oct2021 (Batch/Lot number: unknown) at the age of 66 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose:1), for Covid-19 immunization; Bnt162b2 (Dose:2), for Covid-19 immunization. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 06Oct2021, outcome "recovering", described as "Substantial pain at injection site"; HEADACHE (non-serious) with onset 06Oct2021, outcome "recovering", described as "headache"; NECK PAIN (non-serious) with onset 06Oct2021, outcome "recovering", described as "neck pain"; BACK PAIN (non-serious) with onset 06Oct2021, outcome "recovering", described as "lower back pain"; CHILLS (non-serious) with onset 06Oct2021, outcome "recovering", described as "chills"; PYREXIA (non-serious) with onset 06Oct2021, outcome "recovering", described as "fever"; DIZZINESS (non-serious) with onset 06Oct2021, outcome "recovering", described as "dizzy"; GRIEF REACTION (non-serious) with onset 06Oct2021, outcome "recovering", described as "24 hours of grief". Therapeutic measures were not taken as a result of vaccination site pain, headache, neck pain, back pain, chills, pyrexia, dizziness, grief reaction.  Additional information included: It was significant enough to make wonder if contacting COVID would be less impactful. It was reported that batch/lot number was unavailable at the time of report completion. Patient did not received any other vaccine within 4 weeks prior to the COVID vaccine. Patient did not received any other medications within 2 weeks of vaccination. Prior vaccination patient was not diagnosed with COVID-19. Since the vaccination patient had not been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Since the vaccination, has the patient been tested for COVID-19?:Yes; Since the vaccination, has the patient been tested for COVID-19?:Yes; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 46 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date Apr2021 (Batch/Lot number: unknown) at the age of 46 years as dose 2, single and intramuscular, administered in arm left, administration date Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "positive epstein barr virus" (unspecified if ongoing). There were no known allergies. The patient was not diagnosed with COVID-19 prior to vaccination.  There were no concomitant medications. There was no other vaccine in four weeks prior to the COVID vaccine. There were no other medications in the 2 weeks of vaccination.  The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset Dec2021, outcome "unknown" and all described as "Since the vaccination, has the patient been tested for COVID-19?:Yes". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (Dec2021) positive.  The lot number for bnt162b2 was not provided and will be requested during follow up.        known allergies: No; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine can not be excluded for the reported events of COVID-19 test positive and drug ineffective due to temporal relationship.  Case will be re-assessed upon the additional information provided.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Mobility decreased, Pain in extremity, Rheumatoid arthritis
Clinical narrative: different, a sensation across all the body; started having problems with her right foot/noted differences in the ability to raise and use her foot while driving and since then, this problem has been getting worse; painful and persistent problems in her legs; rheumatic arthritis/Now she has inflammation, painful and persistent problems in her legs/had health problems with her right, but not left leg.; 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 73 year-old female patient received bnt162b2 (BNT162B2), administration date Jan2022 (Batch/Lot number: unknown) at the age of 73 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "rheumatic arthritis" (unspecified if ongoing), notes: she has had health problems with her right, but not left leg. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1), when the patient was 73 years old, for COVID-19 immunization, reaction(s): "nothing happened with the first and second dose"; Covid-19 vaccine (Dose 2), when the patient was 73 years old, for COVID-19 immunization, reaction(s): "nothing happened with the first and second dose". The following information was reported: RHEUMATOID ARTHRITIS (medically significant) with onset 2022, outcome "unknown", described as "rheumatic arthritis/Now she has inflammation, painful and persistent problems in her legs/had health problems with her right, but not left leg."; FEELING ABNORMAL (non-serious) with onset Jan2022, outcome "unknown", described as "different, a sensation across all the body"; MOBILITY DECREASED (non-serious) with onset Jan2022, outcome "not recovered", described as "started having problems with her right foot/noted differences in the ability to raise and use her foot while driving and since then, this problem has been getting worse"; PAIN IN EXTREMITY (non-serious) with onset Jan2022, outcome "not recovered", described as "painful and persistent problems in her legs". Clinical course: Caller was a patient who received the booster dose of Pfizer-BioNTech COVID-19 vaccine 2 months ago (Jan2022). Within 1 hour after receiving the dose, she felt "different, a sensation across all the body". She started having problems with her right foot as she was driving to a market, and also mentioned that she had suffered from rheumatic arthritis. Caller stated she has noted differences in the ability to raise and use her foot while driving and since then, this problem has been getting worse. Now she has inflammation, painful and persistent problems in her legs. She stated that she had had health problems with her right, but not left leg. Also stated that nothing happened with the first and second dose. Caller just wanted to know if her symptoms have any correlation with the vaccine.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Impaired work ability, Pain
Clinical narrative: Pain; Not able to work; 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 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 (Unknown manufacturer., Dose: 1), for COVID-19 immunization; Covid-19 vaccine (Unknown manufacturer., Dose: 2), for COVID-19 immunization. The following information was reported: PAIN (non-serious), outcome "not recovered", described as "Pain"; IMPAIRED WORK ABILITY (non-serious), outcome "not recovered", described as "Not able to work". The events "pain" and "not able to work" were evaluated at the emergency room visit. Therapeutic measures were taken as a result of pain.  Additional information: The patient has been in pain since your vaccine 3rd shot and not able to work, no pain medication is working and all this is since vaccine and patient was getting worsed, have been in emergency room and nothing is happening.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Cataract, Influenza like illness
Clinical narrative: Bilateral cataracts; Flu like symptoms; FACILITATED COLLECT  This is a solicited report received from contactable reporter(s) (Consumer or other non-HCP) for a Pfizer sponsored program (Not Aplicable). The reporter is the patient. Other Case identifier(s): 22K-163-4297958-00 (Agency).  A 78-year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date Feb2021 (Batch/Lot number: unknown) at the age of 78 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: HUMIRA taken for psoriasis (ongoing). Vaccination history included: Bnt162b2 (Dose 2, single, Route of Administration: Intramuscular), administration date: Feb2021, when the patient was 78 years old, for Covid-19 immunization; Bnt162b2 (Dose 1, single, Route of Administration: Intramuscular), administration date: Jan2021, when the patient was 78 years old, for Covid-19 immunization. The following information was reported: CATARACT (medically significant), outcome "unknown", described as "Bilateral cataracts"; INFLUENZA LIKE ILLNESS (non-serious), outcome "recovered", described as "Flu like symptoms".  Clinical course: On unknown dates, the patient experienced cataracts in both eyes and second vaccination and booster for covid-19 made felt like having flu. On an unknown date, second vaccination and Booster for covid-19 made felt like having flu resolved. Pfizer biontech covid-19 vaccine (Tozinameran) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's assessment of the causal relationship of the events with the suspect product was provided at the time of this report. Since possible determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the available information in the case, the causal association between the events cataract, influenza like illness and the suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study 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.,Linked Report(s) : US-PFIZER_INC-202200363827 same patient/drug, different vaccine dose