chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperhidrosis, Immunisation, Nasal congestion, Oropharyngeal pain, Pyrexia
Clinical narrative: COVID Positive; Drug ineffective; sweating; Cough; runny nose; sore throat; congestion; chills; fever (up to 101.7); booster; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 46 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 14Oct2021 14:00 (Lot number: FF2589) at the age of 46 years as dose 3 (booster), single, administered in arm right, administration date 12Apr2021 09:00 (Lot number: EP6955) as dose 2, single and administered in arm right, administration date 22Mar2021 09:00 (Lot number: EP6955) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Dairy allergy" (unspecified if ongoing), notes: other medical history: dairy allergy; "known allergy: Penicillin" (unspecified if ongoing), notes: known allergy: Penicillin. Concomitant medication(s) included: LISINOPRIL; HCTZ; OMEPRAZOLE; FLONASE; ALLEGRA. The following information was reported: IMMUNISATION (medically significant) with onset 14Oct2021 02:00, outcome "unknown", described as "booster"; COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 02Jan2022, outcome "unknown" and all described as "Positive"; HYPERHIDROSIS (non-serious) with onset 31Dec2021 14:00, outcome "recovering", described as "sweating"; COUGH (non-serious) with onset 31Dec2021 14:00, outcome "recovering", described as "Cough"; RHINORRHOEA (non-serious) with onset 31Dec2021 14:00, outcome "recovering", described as "runny nose"; OROPHARYNGEAL PAIN (non-serious) with onset 31Dec2021 14:00, outcome "recovering", described as "sore throat"; NASAL CONGESTION (non-serious) with onset 31Dec2021 14:00, outcome "recovering", described as "congestion"; CHILLS (non-serious) with onset 31Dec2021 14:00, outcome "recovering", described as "chills"; PYREXIA (non-serious) with onset 31Dec2021 14:00, outcome "recovering", described as "fever (up to 101.7)". The patient underwent the following laboratory tests and procedures: body temperature: (31Dec2021) 101.7, notes: adverse event: Cough; runny nose; sore throat; congestion; chills; fever (up to 101.7); sweating; sars-cov-2 test: (02Jan2022) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of immunisation, hyperhidrosis, cough, rhinorrhoea, oropharyngeal pain, nasal congestion, chills, pyrexia.  Additional information:no other vaccine in four weeks,no COVID prior vaccination, COVID tested post vaccination  No follow-up attempts are possible. No further information is expected.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Rhinorrhoea, SARS-CoV-2 test
Clinical narrative: COVID Positive; Drug ineffective; sweating; Cough; runny nose; sore throat; congestion; chills; fever (up to 101.7); booster; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 46 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 14Oct2021 14:00 (Lot number: FF2589) at the age of 46 years as dose 3 (booster), single, administered in arm right, administration date 12Apr2021 09:00 (Lot number: EP6955) as dose 2, single and administered in arm right, administration date 22Mar2021 09:00 (Lot number: EP6955) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Dairy allergy" (unspecified if ongoing), notes: other medical history: dairy allergy; "known allergy: Penicillin" (unspecified if ongoing), notes: known allergy: Penicillin. Concomitant medication(s) included: LISINOPRIL; HCTZ; OMEPRAZOLE; FLONASE; ALLEGRA. The following information was reported: IMMUNISATION (medically significant) with onset 14Oct2021 02:00, outcome "unknown", described as "booster"; COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 02Jan2022, outcome "unknown" and all described as "Positive"; HYPERHIDROSIS (non-serious) with onset 31Dec2021 14:00, outcome "recovering", described as "sweating"; COUGH (non-serious) with onset 31Dec2021 14:00, outcome "recovering", described as "Cough"; RHINORRHOEA (non-serious) with onset 31Dec2021 14:00, outcome "recovering", described as "runny nose"; OROPHARYNGEAL PAIN (non-serious) with onset 31Dec2021 14:00, outcome "recovering", described as "sore throat"; NASAL CONGESTION (non-serious) with onset 31Dec2021 14:00, outcome "recovering", described as "congestion"; CHILLS (non-serious) with onset 31Dec2021 14:00, outcome "recovering", described as "chills"; PYREXIA (non-serious) with onset 31Dec2021 14:00, outcome "recovering", described as "fever (up to 101.7)". The patient underwent the following laboratory tests and procedures: body temperature: (31Dec2021) 101.7, notes: adverse event: Cough; runny nose; sore throat; congestion; chills; fever (up to 101.7); sweating; sars-cov-2 test: (02Jan2022) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of immunisation, hyperhidrosis, cough, rhinorrhoea, oropharyngeal pain, nasal congestion, chills, pyrexia.  Additional information:no other vaccine in four weeks,no COVID prior vaccination, COVID tested post vaccination  No follow-up attempts are possible. No further information is expected.
Age: 42.0
Sex: M
Vaccine: COVID19, FLUX
Symptoms: COVID-19, Immunisation, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Tested Positive for COVID-19/ Mild flu-like symptoms; Tested Positive for COVID-19/ Mild flu-like symptoms; Booster; This is a spontaneous report received from contactable reporter (consumer). The reporter is the patient.  A 42-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 28Oct2021 (lot number: EW0217) at the age of 42-years as dose 3 (booster), single, administered in arm right, administration date 25Jan2021 (lot number: EL3247) at the age of 41-years as dose 1, single and administered in arm right, administration date 15Feb2021 (lot number: EL3247) at the age of 42-years as dose 2, single for COVID-19 immunisation; and influenza vaccine (FLU), administered in arm right, administration date 28Oct2021 (Batch/Lot number: unknown) at the age of 42-years as dose 1, single for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: IMMUNISATION (medically significant) with onset 28Oct2021, described as "Booster"; VACCINATION FAILURE (medically significant) and COVID-19 (medically significant) all with onset 29Dec2021, outcome "recovering" and all described as "Tested Positive for COVID-19/ Mild flu-like symptoms". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (31Dec2021) positive. Therapeutic measures were not taken as a result of vaccination failure and COVID-19. Clinical course: The patient tested positive for COVID-19 on 31Dec2021. Symptoms started on 29Dec2021. Mild flu-like symptoms persisted until at least 04Jan2022 (as reported). The patient has no known allergies and was not diagnosed with COVID prior to vaccination. It was unknown if there were other vaccines in four weeks.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Asymptomatic COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Tested positive for COVID for the 3rd time - asymptomatic this time; Tested positive for COVID for the 3rd time - asymptomatic this time; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 21 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 21 years as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Anxiety" (unspecified if ongoing); "ADHD" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), ASYMPTOMATIC COVID-19 (medically significant), outcome "unknown" and all described as "Tested positive for COVID for the 3rd time - asymptomatic this time". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive, notes: Tested positive for COVID for the 3rd time; positive; positive. Therapeutic measures were not taken as a result of asymptomatic covid-19. Clinical course: It was unknown if other vaccine in four weeks. Other mediation in two weeks included medication for anxiety and ADHD (unspecified). No Covid prior vaccination.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for COVID-19 approximately 3 weeks after her second dose of COMIRNATY/Mild cold like symptoms; tested positive for COVID-19 approximately 3 weeks after her second dose of COMIRNATY/Mild cold like symptoms; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 8 year-old female patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 2 (tris), single and (Batch/Lot number: unknown) as dose 1 (tris), single for covid-19 immunisation. Relevant medical history included: "asthma" (unspecified if ongoing); "other respiratory illnesses" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "tested positive for COVID-19 approximately 3 weeks after her second dose of COMIRNATY/Mild cold like symptoms". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive. Clinical course: The patient tested positive for COVID-19 approximately 3 weeks after her second dose of COMIRNATY. Mild cold like symptoms reported. Event took place after use of product. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Cardiac disorder, Loss of consciousness, Vomiting
Clinical narrative: Blacked out; threw up; cardiac distress; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). A 52 year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 09Sep2021 (Batch/Lot number: unknown) as dose 2, single for COVID-19 immunization. Relevant medical history included: "COVID-19" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), for COVID-19 immunization. The following information was reported: LOSS OF CONSCIOUSNESS (medically significant) with onset Sep2021, outcome "recovered", described as "Blacked out"; VOMITING (non-serious) with onset Sep2021, outcome "recovered", described as "threw up"; CARDIAC DISORDER (non-serious) with onset Sep2021, outcome "recovered", described as "cardiac distress". The events "blacked out", "threw up" and "cardiac distress" were evaluated at the emergency room visit. It was unknown if therapeutic measures were taken as a result of loss of consciousness, vomiting, cardiac disorder. Since the vaccination, it was unknown if patient has been tested for COVID-19.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Tested positive for Covid; Tested positive for Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 41 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 13Apr2021 (Lot number: EP6955) at the age of 41 years as dose 2, single and (Lot number: EP6955) 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 02Jan2022, outcome "unknown" and all described as "Tested positive for Covid". The event "tested positive for covid" and "tested positive for covid" was evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (02Jan2022) positive. Therapeutic measures were taken as a result of covid-19. Clinical course: Myself and My husband both tested positive for Covid. We were both vaccinated the same time with the batch number provided. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination.   No follow-up attempts are possible. No further information is expected; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200010534 same reporter/drug/event for different patients
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Tested positive for Covid; Tested positive for Covid; This is a spontaneous report received from a contactable reporter (consumer) via Regulatory Authority.   A male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), administration date 13Apr2021 (Lot number: EP6955) as dose 2, single and (Lot number: EP6955) as dose 1, single for COVID-19 immunization. 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 following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) both with onset 02Jan2022, outcome "unknown" and both described as "Tested positive for Covid." The event "tested positive for Covid" was evaluated at the emergency room visit. The patient underwent the following laboratory test and procedure: COVID-19: (02Jan2022) positive. Therapeutic measures were taken as a result of Covid-19, which included an unspecified medication. The reporter and her husband (the patient) both tested positive for Covid. They were both vaccinated the same time with the batch number provided.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200010509 same reporter, product, and event; different patients
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: patient was tested for Covid and the rapid at home test came back positive/ Patient has congestion and cough; patient was tested for Covid and the rapid at home test came back positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 5 year-old patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "gtube", start date: 08Aug2016 (ongoing); "weaken lungs", start date: 08Aug2016 (ongoing), notes: weaken lungs since birth. The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant) with onset 03Jan2022, outcome "unknown", described as "patient was tested for Covid and the rapid at home test came back positive/ Patient has congestion and cough"; DRUG INEFFECTIVE (medically significant) with onset 03Jan2022, outcome "unknown", described as "patient was tested for Covid and the rapid at home test came back positive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (03Jan2022) positive, notes: the rapid at home test came back positive.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: positive for Covid; positive for Covid; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP).  A 60 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administration date Sep2021 (Batch/Lot number: unknown) at the age of 60 years as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history and was of good health. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 01Jan2022, outcome "unknown" and all described as "positive for Covid". The patient experienced fever, congestion, bad aches, cough, sore throat and felt weak. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (01Jan2022) positive.  The lot number for BNT162B2 was not provided and will be requested during follow up.
Age: 80.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Computerised tomogram, Thrombosis
Clinical narrative: blood clot upper left shoulder around the neck; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): LRN4441194 (Genentech).  A 80 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 80 years as dose number unknown, single for covid-19 immunisation; rivaroxaban (XARELTO) (Batch/Lot number: unknown). Relevant medical history included: "Malignant neoplasm of unspecified part of unspecified bronchus or lung" (unspecified if ongoing), notes: Malignant neoplasm of unspecified part of unspecified bronchus or lung. The patient's concomitant medications were not reported. The following information was reported: THROMBOSIS (medically significant) with onset May2021, outcome "recovered" (Jul2021), described as "blood clot upper left shoulder around the neck". On unknown date it was reported that patient experienced: May2021 the patient had a CT scan of the chest. There was a blood clot upper left shoulder around the neck. At the time the patient was taking Xarelto. They (not known if this was the HCP or the reporter) believed that this blood clot was not due to Xarelto but rather due to COVID19 vaccine Pfizer. In Jul there was a scan and no blood clots remained. The patient underwent the following laboratory tests and procedures: computerised tomogram: (May2021) blood clot upper left shoulder around the neck, notes: There was a blood clot upper left shoulder around the neck; (Jul2021) no blood clots remained, notes: In Jul there was a scan and no blood clots remained.
Age: 5.0
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Cough, Drug ineffective, Nasal congestion, SARS-CoV-2 test
Clinical narrative: tested for Covid on Jan 3 2022; tested for Covid on Jan 3 2022; cough; congestion; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 5 year-old patient received bnt162b2 (BNT162B2), administration date 20Dec2021 (Batch/Lot number: unknown) at the age of 5 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 03Jan2022, outcome "unknown" and all described as "tested for Covid on Jan 3 2022"; COUGH (non-serious) with onset 2021, outcome "unknown", described as "cough"; NASAL CONGESTION (non-serious) with onset 2021, outcome "unknown", described as "congestion". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (03Jan2022) positive. Clinical course: Patient was tested for Covid on 03Jan2022. The rapid at home test came back positive. Patient has cough and congestion, Event took place after use of product.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: breakthrough covid infection; breakthrough covid infection; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 56 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 25Mar2021 (Lot number: EP6955) at the age of 55 years as dose 2, single and administered in arm left, administration date 04Mar2021 (Lot number: EL3247) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Allery" (unspecified if ongoing). Concomitant medication(s) included: PREMARIN; RESTASIS. The following information was reported: VACCINATION FAILURE (medically significant) with onset 29Dec2021, outcome "unknown", COVID-19 (medically significant) with onset 29Dec2021, outcome "recovering", and all described as "breakthrough covid infection". The event "breakthrough covid infection" and "breakthrough covid infection" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (31Dec2021) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19. Clinical Course: It was reported that facility where the most recent COVID-19 vaccine was administered was workplace clinic. No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Immunisation, Platelet count, Platelet count decreased
Clinical narrative: Booster; platelet count drop; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): NVSC2021US300502_OS.  A 26 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 26 years 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 (dose number unknown, Manufacturer unknown), for COVID-19 Immunization. The following information was reported: IMMUNISATION (hospitalization, medically significant), outcome "unknown", described as "Booster"; PLATELET COUNT DECREASED (hospitalization, medically significant), outcome "unknown", described as "platelet count drop". The patient underwent the following laboratory tests and procedures: platelet count: count drop. The Physician told the patient that the event could be from booster shot.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Immunisation, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Breakthrough Case of Covid-19; Breakthrough Case of Covid-19; Booster; This is a spontaneous report received from a contactable reporter (Consumer) from product quality group. The reporter is the patient. A 63-year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 03Nov2021 11:00 (Lot number: EW0217) at the age of 63 years as dose 3 (booster), single, intramuscular, administered in arm left, administration date 15Feb2021 11:00 (Lot number: EL3247) as dose 2, single and intramuscular, administered in arm left, administration date 26Jan2021 11:00 (Lot number: EL3247) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Type B Diabetes" (unspecified if ongoing). The patient has no known allergies. The patient was not diagnosed with COVID-19 prior to vaccination. The patient took concomitant medications. The following information was reported IMMUNISATION (medically significant) with onset 03Nov2021 11:00, outcome "unknown", described as "Booster"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 02Jan2022 17:00, outcome "recovering" and all described as "Breakthrough Case of Covid-19". The event "breakthrough case of covid-19" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: PCR, COVID Test (02Jan2022) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19. Additional information: The most recent COVID-19 vaccine was administered from a workplace clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Colitis ulcerative, Condition aggravated, Megacolon
Clinical narrative: Colitis was then unstable needing even remicade IVs and being hospitalized with IV infusions not working; Colitis was then unstable needing even remicade IVs and being hospitalized with IV infusions not working; Ended up with toxic megacolon and had entire colon removed within 4-5 days because they couldn't save; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunization. Relevant medical history included: "Colitis ulcerative" (unspecified if ongoing), notes: ulcerative colitis for 20 years that was treated with very little medicine and GF diet. The patient's concomitant medications were not reported. The patient received any other vaccines within 4 weeks prior to the COVID vaccine was reported as unknown. Any other medications the patient received within 2 weeks of vaccination was reported as unknown. Prior to vaccination, was the patient diagnosed with COVID-19 was reported as unknown. Since the vaccination, has the patient been tested for COVID-19 was reported as unknown. The following information was reported: COLITIS ULCERATIVE (hospitalization, disability, medically significant), CONDITION AGGRAVATED (hospitalization, disability), outcome "not recovered" and all described as "Colitis was then unstable needing even remicade IVs and being hospitalized with IV infusions not working"; MEGACOLON (hospitalization, disability, medically significant), outcome "unknown", described as "Ended up with toxic megacolon and had entire colon removed within 4-5 days because they couldn't save". Therapeutic measures were taken as a result of colitis ulcerative, condition aggravated, megacolon. It was reported that, received word of a 40-year-old with ulcerative colitis for 20 years that was treated with very little medicine and GF diet. Stated that, the individual got vaxxed. Stated that, colitis was then unstable needing even remicade IVs and being hospitalized with IV infusions not working. Stated that, ended up with toxic megacolon and had entire colon removed within 4-5 days because they couldn't save. Stated that, at the time of adverse event report, it was not known whether this was Pfizer or Moderna. Hospitalization prolonged was reported as no.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: covid infection; covid infection; 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 27 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 15Feb2021 14:00 (Lot number: EL3247) at the age of 26 years as dose 2, single and administered in arm right, administration date 27Jan2021 13:45 (Lot number: EL3247) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LAMOTRIGINE. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 30Dec2021 20:00, outcome "recovering" and all described as "covid infection". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (30Dec2021) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19.  Additional information: Reporter stated  patient receive any other vaccines within 4 weeks prior to the COVID vaccine: No  No follow-up attempts are possible. No further information is expected.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Tested positive on COVID after received two doses of Pfizer COVID vaccine; Tested positive on COVID after received two doses of Pfizer COVID vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 14Sep2021 (Lot number: 301308A) at the age of 29 years as dose 2, single and intramuscular, administered in arm left, administration date 24Aug2021 (Lot number: FE3181) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant, life threatening), COVID-19 (medically significant, life threatening) all with onset 02Jan2022, outcome "not recovered" and all described as "Tested positive on COVID after received two doses of Pfizer COVID vaccine". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (02Jan2022) positive; (03Aug2021) negative, notes: Nasal Swab; (30Aug2021) negative, notes: Nasal Swab; (29Dec2021) negative, notes: Nasal Swab. Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Dayquil, nyquil, tylenol, emergen-C, mucinex, sore throat menthol candies, traditional medicine for the events. The patient did not receive any other medications in two weeks. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The adverse events resulted in life threatening illness (immediate risk of death from the event).  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: symptomatic COVID and under quarantine; symptomatic COVID and under quarantine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: PAXLOVID. The following information was reported: SUSPECTED COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "symptomatic COVID and under quarantine".  Clinical Course: It was reported that patient was nterested in taking Paxlovid personally. Patient was a fully vaxx veterans administration surgeon. Patient recently become symptomatic COVID and under quarantine.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Cardiac disorder, Death, Myocarditis
Clinical narrative: sudden death after taking the vaccine; myocarditis; real vaccine-related injuries that caused people to have heart complications; This is a spontaneous report received from contactable reporter(s) (Consumer or other non healthcare professional). Other Case identifier(s): 2080958 (Case number).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death), outcome "fatal", described as "sudden death after taking the vaccine"; MYOCARDITIS (medically significant), outcome "unknown", described as "myocarditis"; CARDIAC DISORDER (non-serious), outcome "unknown", described as "real vaccine-related injuries that caused people to have heart complications". The patient date of death was unknown. The reported cause of death was "sudden death after taking the vaccine". It was not reported if an autopsy was performed.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: sudden death after taking the vaccine
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: took the vaccine with the purple cap however she tested positive; she tested positive; This is a spontaneous report received from a non-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: DRUG INEFFECTIVE (medically significant), outcome "unknown", described as "took the vaccine with the purple cap however she tested positive"; COVID-19 (medically significant), outcome "unknown", described as "she tested positive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: I would like to know why the vaccines are not working against covid-19, my wife, 2 daughters and I have followed the recommendations and we vaccinated and even so we contracted the virus; I would like to know why the vaccines are not working against covid-19, my wife, 2 daughters and I have followed the recommendations and we vaccinated and even so we contracted the virus; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "I would like to know why the vaccines are not working against covid-19, my wife, 2 daughters and I have followed the recommendations and we vaccinated and even so we contracted the virus".  Clinical course: The reporter stated they would like to know what happens since it begins to lose confidence in the brand and although they do not have an active social life and we take great care of ourselves, they do not understand vulnerability. it's disappointing and frustrating to go on for years at this time. Where is the 95% of protection.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200015090 same reporter/event/drug, different patient.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: I would like to know why the vaccines are not working against covid-19, my wife, 2 daughters and I have followed the recommendations and we vaccinated and even so we contracted the virus; I would like to know why the vaccines are not working against covid-19, my wife, 2 daughters and I have followed the recommendations and we vaccinated and even so we contracted the virus; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) for 1 day as dose number unkown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "I would like to know why the vaccines are not working against covid-19, my wife, 2 daughters and I have followed the recommendations and we vaccinated and even so we contracted the virus". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200015090 same reporter/event/drug, different patient.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: I would like to know why the vaccines are not working against covid-19, my wife, 2 daughters and I have followed the recommendations and we vaccinated and even so we contracted the virus; I would like to know why the vaccines are not working against covid-19, my wife, 2 daughters and I have followed the recommendations and we vaccinated and even so we contracted the virus; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "I would like to know why the vaccines are not working against covid-19, my wife, 2 daughters and I have followed the recommendations and we vaccinated and even so we contracted the virus". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200015090 same reporter/event/drug, different patient.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Immunisation, Interchange of vaccine products, Off label use
Clinical narrative: has stomach cramps becoming more severe; His first two shots were Moderna; His first two shots were Moderna; booster; 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 24 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 03Jan2022 09:30 (Lot number: FL3197) at the age of 24 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Moderna (1st dose date 28May2021 Lot 047C21A, expiration is unknown. Injected in left arm), administration date: 28May2021, when the patient was 24 years old, for Covid-19 immunization; Moderna (2nd dose date 25Jun2021, Lot 033C21A, expiration is unknown.Injected in left arm.), administration date: 25Jun2021, when the patient was 24 years old, for Covid-19 immunization. The following information was reported: OFF LABEL USE (non-serious), INTERCHANGE OF VACCINE PRODUCTS (non-serious) all with onset 03Jan2022 09:30, outcome "unknown" and all described as "His first two shots were Moderna"; IMMUNISATION (non-serious) with onset 03Jan2022 09:30, outcome "unknown", described as "booster"; ABDOMINAL PAIN UPPER (non-serious) with onset 04Jan2022 10:00, outcome "not recovered", described as "has stomach cramps becoming more severe".
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Positive COVID case; Positive COVID case; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 25 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 22Feb2021 (Lot number: EL3247) at the age of 25 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Known Allergies: sulfa drugs" (unspecified if ongoing), notes: Known Allergies: sulfa drugs; "Asthma" (unspecified if ongoing), notes: Other medical history: Asthma. The patient took concomitant medications (Junel Birth Control). Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EL3247), administration date: 01Feb2021, when the patient was 25 years old, for COVID-19 Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 31Dec2021, outcome "unknown" and all described as "Positive COVID case". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (31Dec2021) positive. If Other vaccine in four weeks: No. If covid prior vaccination: No. If covid tested post vaccination: Yes
Age: 40.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Positive COVID-19 test result; Positive COVID-19 test result; This is a spontaneous report received from a contactable consumer. The reporter is the patient. A 41-year-old male patient received BNT162B2 (BNT162B2), administered in arm left, administration date 01May2021 11:00 (Lot number: EW0175) at the age of 40 years as dose 2, single and administered in arm left, administration date 14Apr2021 14:30 (Lot number: EW0164) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Cat allergy" (unspecified if ongoing). There were no concomitant medications. No other vaccine in was administered in four weeks. The patient had no other medication in two weeks. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 03Jan2022, outcome "unknown" and all described as "Positive COVID-19 test result". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (21Oct2021) negative; (03Jan2022) positive. Therapeutic measures were not taken as a result of drug ineffective, covid-19.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200015479 Same reporter and product; different events and dose
Age: 40.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Axillary pain, COVID-19, Drug ineffective, Fatigue, Inappropriate schedule of product administration
Clinical narrative: Positive COVID-19 test result; Positive COVID-19 test result; This is a spontaneous report received from a contactable consumer. The reporter is the patient. A 41-year-old male patient received BNT162B2 (BNT162B2), administered in arm left, administration date 01May2021 11:00 (Lot number: EW0175) at the age of 40 years as dose 2, single and administered in arm left, administration date 14Apr2021 14:30 (Lot number: EW0164) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Cat allergy" (unspecified if ongoing). There were no concomitant medications. No other vaccine in was administered in four weeks. The patient had no other medication in two weeks. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 03Jan2022, outcome "unknown" and all described as "Positive COVID-19 test result". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (21Oct2021) negative; (03Jan2022) positive. Therapeutic measures were not taken as a result of drug ineffective, covid-19.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200015479 Same reporter and product; different events and dose
Age: 40.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Lymph node pain, Pain in extremity, Pyrexia, SARS-CoV-2 test
Clinical narrative: Positive COVID-19 test result; Positive COVID-19 test result; This is a spontaneous report received from a contactable consumer. The reporter is the patient. A 41-year-old male patient received BNT162B2 (BNT162B2), administered in arm left, administration date 01May2021 11:00 (Lot number: EW0175) at the age of 40 years as dose 2, single and administered in arm left, administration date 14Apr2021 14:30 (Lot number: EW0164) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Cat allergy" (unspecified if ongoing). There were no concomitant medications. No other vaccine in was administered in four weeks. The patient had no other medication in two weeks. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 03Jan2022, outcome "unknown" and all described as "Positive COVID-19 test result". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (21Oct2021) negative; (03Jan2022) positive. Therapeutic measures were not taken as a result of drug ineffective, covid-19.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200015479 Same reporter and product; different events and dose
Age: 40.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Chills, Fatigue, Lymphadenopathy, Pyrexia
Clinical narrative: Positive COVID-19 test result; Positive COVID-19 test result; This is a spontaneous report received from a contactable consumer. The reporter is the patient. A 41-year-old male patient received BNT162B2 (BNT162B2), administered in arm left, administration date 01May2021 11:00 (Lot number: EW0175) at the age of 40 years as dose 2, single and administered in arm left, administration date 14Apr2021 14:30 (Lot number: EW0164) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Cat allergy" (unspecified if ongoing). There were no concomitant medications. No other vaccine in was administered in four weeks. The patient had no other medication in two weeks. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 03Jan2022, outcome "unknown" and all described as "Positive COVID-19 test result". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (21Oct2021) negative; (03Jan2022) positive. Therapeutic measures were not taken as a result of drug ineffective, covid-19.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200015479 Same reporter and product; different events and dose