chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 55.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Crohn's disease, Feeling hot, Immunisation, Neck pain, Pain in extremity
Clinical narrative: Crohn's disease Flare up; Arm Hot; Sore Arm; Neck Ache; booster; 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): 21K-163-4216571-00.  A 55 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 15Dec2021 (Batch/Lot number: unknown) at the age of 55 years as dose number unknown (booster), single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) as citrate free for crohn's disease. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series completed but Manufacturer Unknown), for COVID-19 immunization. The following information was reported: IMMUNISATION (medically significant) with onset 15Dec2021, outcome "unknown", described as "booster"; CROHN'S DISEASE (medically significant), outcome "recovered", described as "Crohn's disease Flare up"; FEELING HOT (non-serious), outcome "recovered", described as "Arm Hot"; PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "Sore Arm"; NECK PAIN (non-serious), outcome "recovered", described as "Neck Ache". The action taken for adalimumab was unknown.  The reporter's causality for the events of arm hot, Crohn's disease flare up, sore arm and neck ache with Humira (Adalimumab) was no reasonable possibility. The reporter's causality for the events of with Crohn's disease aggravated was not reported, for the events pain in arm, neck pain and arm hot with Pfizer Biontech Covid-19 Vaccine (Tozinameran) was possible.  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 current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Crohn's disease aggravated, Immunization, pain in arm, neck pain and arm hot 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: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, Injection site haemorrhage, Myocarditis
Clinical narrative: Myocarditis; Inappropriate dose of drug administered; Injection site bleeding; 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): 21K-163-4216278-00.  A 27 year-old female patient received bnt162b2 (BNT162B2), intramuscular (Batch/Lot number: unknown) at the age of 27 years as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown). The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MYOCARDITIS (medically significant), outcome "unknown", described as "Myocarditis"; INCORRECT DOSE ADMINISTERED (non-serious), outcome "unknown", described as "Inappropriate dose of drug administered "; INJECTION SITE HAEMORRHAGE (non-serious), outcome "recovered", described as "Injection site bleeding". The action taken for adalimumab was unknown. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Causality for Humira(adalimumab)  The reporter's causality for the event(s) of blood at injection site/most of the medication ran out and lost unknown onset, blood at injection site/most of the medication ran out and lost unknown onset and covid vaccine developed myocarditis was not provided. Causality for Pfizer biontech covid-19 vaccine (tozinameran) The reporter's causality for the event(s) of blood at injection site/most of the medication ran out and lost unknown onset, blood at injection site/most of the medication ran out and lost unknown onset  was not provided and the reporter causality for the event Covid vaccine developed Myocarditis was possible. 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 information in the case, a contributory effect of the vaccine BNT162B2 to the reported events cannot be ruled out.
Sex: F
Vaccine: COVID19
Symptoms: Cough, Immunisation, Pneumonia
Clinical narrative: booster; Pneumonia; cough; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient 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: Bnt162b2 (Dose: 1), for covid-19 immunization, reaction(s): "Sick"; Bnt162b2 (Dose: 2), for covid-19 immunization, reaction(s): "Sick". The following information was reported: IMMUNISATION (medically significant), outcome "unknown", described as "booster"; PNEUMONIA (medically significant), outcome "recovered", described as "Pneumonia"; COUGH (non-serious), outcome "recovered", described as "cough". She said as well that before getting the booster shot she was sick and she had a cough now when she had her booster shot she had her Pneumonia together she claims that she got well. She wants to see if Pfizer can have a correlation between the Booster shots and Pneumonia shots/vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: caller states she developed Bell's Palsy specifically after the second dose of the Pfizer BioNTech Covid-19 vaccine; 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 female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Manufacturer Unknown, Dose 1), for COVID-19 Immunization. The following information was reported: BELL'S PALSY (medically significant), outcome "unknown", described as "caller states she developed Bell's Palsy specifically after the second dose of the Pfizer BioNTech Covid-19 vaccine".  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: currently has Covid; currently has Covid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): US-PFIZER INC-202200055821 (Pfizer).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2022, outcome "unknown" and all described as "currently has Covid". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (Jan2022) positive.  The lot number for the vaccine, [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: got covid; got covid; 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 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. They both got tested for COVID yesterday because she (the mother) ended up being sick, so her boss had asked her to go get tested. To be on the safe side she also had her daughter tested before they went to go get her vaccinated. They found out that the mother was positive, and the daughter was negative. She (mother) is hoping that the vaccine didn't trigger something completely crazy. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 11Jan2022, outcome "unknown" and all described as "got covid". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (11Jan2022) positive.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Asymptomatic COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive on 23Dec2021 but did not have symptoms; tested positive on 23Dec2021 but did not have symptoms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 5.5 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1 (tris), 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), ASYMPTOMATIC COVID-19 (medically significant) all with onset 23Dec2021, outcome "unknown" and all described as "tested positive on 23Dec2021 but did not have symptoms". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (23Dec2021) positive. The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Tested positive last night using a PCR test; Tested positive last night using a PCR test; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non healthcare professional) from a sales representative. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) as dose 2, single and administration date 2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 11Jan2022 21:00, outcome "unknown" and all described as "Tested positive last night using a PCR test". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (11Jan2022) positive.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Patient had a breakthrough infection around 12/25/2021 after completing 2 doses earlier this year.  Has had severe COVID symptoms for over 2 weeks.; Patient had a breakthrough infection around 12/25/2021 after completing 2 doses earlier this year.  Has had severe COVID symptoms for over 2 weeks.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non healthcare professional).  An adult male patient received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) as dose 2, single and administration date 2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. It was unknown if the patient receive any other vaccines within 4 weeks prior to the COVID vaccine.Prior to vaccination, the patient was not diagnosed with COVID-19. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 24Dec2021, outcome "recovered with sequelae" and all described as "Patient had a breakthrough infection around 12/25/2021 after completing 2 doses earlier this year.  Has had severe COVID symptoms for over 2 weeks.". The event "patient had a breakthrough infection around 12/25/2021 after completing 2 doses earlier this year.  has had severe covid symptoms for over 2 weeks." and "patient had a breakthrough infection around 12/25/2021 after completing 2 doses earlier this year.  has had severe covid symptoms for over 2 weeks." was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (Dec2021) positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: positive covid test; positive covid test; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group.  A 13 year-old male patient received bnt162b2 (BNT162B2), administration date 04Jun2021 (Lot number: ew0187) at the age of 13 years as dose 2, single and administration date 13May2021 (Lot number: ew0183) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), outcome "unknown", COVID-19 (medically significant) with onset 11Jan2022, outcome "unknown" and all described as "positive covid test". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (11Jan2022) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of covid-19. Clinical course: Prior to vaccination, the patient had not diagnosed with COVID-19.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Immunisation, Influenza like illness
Clinical narrative: booster vaccine; developed COVID infection with mild flu-like symptoms; developed COVID infection with mild flu-like symptoms; developed COVID infection with mild flu-like symptoms; This is a spontaneous report received from non-contactable reporter(s) (Physician) from a sales representative. The reporter is the patient.  A patient in their 40's received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1 Manufacturer Unknown), for Covid-19 Immunisation; Covid-19 vaccine (Dose 2 Manufacturer Unknown), for Covid-19 Immunisation. The following information was reported: IMMUNISATION (medically significant), outcome "unknown", described as "booster vaccine"; COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), INFLUENZA LIKE ILLNESS (non-serious), outcome "recovered" and all described as "developed COVID infection with mild flu-like symptoms".Clinical Course: HCP/consumer mentioned that his 2 children (ages and gender not available) received the Comirnaty paediatric vaccine series in Nov2021. Both kids developed COVID symptoms with mild flu-like symptoms around 1 week ago (early Jan2022) and both are almost completely recovered. Both parents ( 40s) had the booster vaccine (unclear which brand) within the past few months and also developed COVID infection with mild flu-like symptoms within the past week. They are almost fully recovered as well. HCP did not mention the type of primary vaccine series that he and his spouse received, or when they received the primary series.   The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events Immunisation, covid 19, influenza like illness, DRUG INEFFECTIVE and the suspect drug BNT162B2,Linked Report(s) : US-PFIZER INC-202200056556 same vaccine, similar AE, different patient;US-PFIZER INC-202200056557 same vaccine, similar AE, different patient;US-PFIZER INC-202200056555 same vaccine, similar AE, different patient
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Influenza like illness
Clinical narrative: developed COVID symptoms with mild flu-like symptoms; developed COVID symptoms with mild flu-like symptoms; developed COVID symptoms with mild flu-like symptoms; This is a spontaneous report received from non-contactable reporter(s) (Physician) from a sales representative. The reporter is the parent.  A child patient received bnt162b2 (COMIRNATY), administration date Nov2021 (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), INFLUENZA LIKE ILLNESS (non-serious) all with onset Jan2022, outcome "recovered" (Jan2022) and all described as "developed COVID symptoms with mild flu-like symptoms". The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the available information and a possible contributory role of the suspect product BNT162B2 to the development of events drug ineffective, covid19 cannot be totally excluded.,Linked Report(s) : US-PFIZER INC-202200056534 same vaccine, similar AE, different patient
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Influenza like illness
Clinical narrative: developed COVID symptoms with mild flu-like symptoms; developed COVID symptoms with mild flu-like symptoms; developed COVID symptoms with mild flu-like symptoms; This is a spontaneous report received from non-contactable reporter(s) (Physician) from a sales representative. The reporter is the parent.  A patient (no qualifiers provided) received bnt162b2 (COMIRNATY), administration date Nov2021 (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), INFLUENZA LIKE ILLNESS (non-serious) all with onset Jan2022, outcome "recovered" (Jan2022) and all described as "developed COVID symptoms with mild flu-like symptoms".  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the available information and a possible contributory role of the suspect product BNT162B2 to the development of events drug ineffective, covid19 cannot be totally excluded.,Linked Report(s) : US-PFIZER INC-202200056534 same vaccine, similar AE, different patient
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Immunisation, Influenza like illness
Clinical narrative: booster vaccine; developed COVID infection with mild flu-like symptoms; developed COVID infection with mild flu-like symptoms; developed COVID infection with mild flu-like symptoms; This is a spontaneous report received from non-contactable reporter(s) (Physician) from a sales representative.  A female patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose number unknown(booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Primary Immunization series complete but unknown manufacturer), for Covid-19 immunization; Covid-19 vaccine (Dose 2, Primary Immunization series complete but unknown manufacturer), for Covid-19 immunization. The following information was reported: IMMUNISATION (medically significant), outcome "unknown", described as "booster vaccine"; DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), INFLUENZA LIKE ILLNESS (non-serious), outcome "recovered" (2021) and all described as "developed COVID infection with mild flu-like symptoms". Both kids developed COVID symptoms with mild flu-like symptoms around 1 week ago (early Jan2022) and both are almost completely recovered. Both parents (? 40s) had the booster vaccine (unclear which brand) within the past few months and also developed COVID infection with mild flu-like symptoms within the past week. They are almost fully recovered as well. HCP did not mention the type of primary vaccine series that he and his spouse received, or when they received the primary series.   The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the available information and a possible contributory role of the suspect product BNT162B2 to the development of events drug ineffective, covid19 cannot be totally excluded.,Linked Report(s) : US-PFIZER INC-202200056534 same vaccine, similar AE, different patient
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea, Heart rate irregular, SARS-CoV-2 test
Clinical narrative: Chest pains; Shortness of breath; Irregular heart beat; This is a spontaneous report from a contactable reporter (consumer or other non-HCP). The reporter is the patient.  A 33-year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 21May2021 at 15:00 (Lot number: EW0169) at the age of 33 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19?: Yes. Concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot Number: ER8731; Anatomical Location: Arm Left; Administration time: 15:00; Route of administration: Unspecified), administration date: 29Apr2021, when the patient was 33 years old, for COVID-19 immunisation.  The following information was reported: CHEST PAIN (non-serious) with onset 02Jun2021, outcome "not recovered", described as "Chest pains"; DYSPNOEA (non-serious) with onset 02Jun2021, outcome "not recovered", described as "Shortness of breath"; HEART RATE IRREGULAR (non-serious) with onset 02Jun2021, outcome "not recovered", described as "Irregular heart beat". The events "Chest pains", "Shortness of breath" and "Irregular heart beat" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: It was unknown whether any therapeutic measures were taken as a result of the events. The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19 and the results were unknown.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Tested positive for Covid after completing a two dose series of the vaccine; Tested positive for Covid after completing a two dose series of the vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non healthcare professional).  A patient (no qualifiers provided) 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 had no relevant medical history. There were no concomitant medications. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "Tested positive for Covid after completing a two dose series of the vaccine". 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.
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea, Myocarditis
Clinical narrative: myocarditis; chest pain; difficulty in breathing; This is a spontaneous report received from contactable reporter(s) (Consumer or other non healthcare professional). The reporter is the patient. Other Case identifier(s): 20211256440 (0) (Janssen).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MYOCARDITIS (medically significant), outcome "unknown", described as "myocarditis"; CHEST PAIN (non-serious), outcome "recovered", described as "chest pain"; DYSPNOEA (non-serious), outcome "recovered", described as "difficulty in breathing".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: PNC13
Symptoms: Unevaluable event
Clinical narrative: When putting safety needle on the luer lock, the entire thing broke apart; This is a spontaneous report received from a contactable reporter (nurse).  A patient (no qualifiers provided) ready to receive pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) (Lot number: EN8811, Expiration Date: Sep2023) as dose number unknown, single for immunisation. The patient's relevant medical history and concomitant medications were not reported.   The following information was reported: DEVICE MATERIAL ISSUE (non-serious) with onset 11Jan2022, described as "When putting safety needle on the luer lock, the entire thing broke apart".  Additional information: One of the medical assistants was putting the safety needle on the luer lock of the vaccine and the whole thing broke apart. They were not able to give that particular vaccine.  No patient received the affected vaccine. The patient did receive the vaccine, they had to use one from their private stock.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Immunisation, SARS-CoV-2 test
Clinical narrative: Booster; The patient contracted the Omicron variant of SARS-COV-2; The patient contracted the Omicron variant of SARS-COV-2; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: IMMUNISATION (medically significant), outcome "unknown", described as "Booster"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2022, outcome "unknown" and all described as "The patient contracted the Omicron variant of SARS-COV-2". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (Jan2022) positive, notes: contracted the Omicron variant. The patient contracted the Omicron variant of SARS-COV-2 and had experienced mild symptoms.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200058699 same reporter/drug/event, different patient;US-PFIZER INC-202200058698 same reporter/drug/event, different patient;US-PFIZER INC-202200058700 same reporter/drug/event, different patient
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Immunisation, Suspected COVID-19
Clinical narrative: booster; contracted the Omicron variant of SARS-COV-2; contracted the Omicron variant of SARS-COV-2; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: IMMUNISATION (medically significant), outcome "unknown", described as "booster"; DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "contracted the Omicron variant of SARS-COV-2".  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200058493 same reporter/drug/event, different patient
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Immunisation, Suspected COVID-19
Clinical narrative: booster; contracted the Omicron variant of SARS-COV-2; contracted the Omicron variant of SARS-COV-2; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: IMMUNISATION (medically significant), outcome "unknown", described as "booster"; DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "contracted the Omicron variant of SARS-COV-2". Earlier last week, the patient contracted the Omicron variant of SARS-COV-2 and experienced mild symptoms.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200058493 same reporter/drug/event, different patient
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Eye operation, Intestinal operation, Nasopharyngitis, Pain
Clinical narrative: Eye operation; Intestinal operation; cold; Pain; MARKETING PROGRAM NOT AVAILABLE  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-163-4224022-00.  A 74 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 03Apr2021 (Batch/Lot number: unknown) at the age of 73 years as dose 1, single and intramuscular, administration date 27Apr2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) at 40 mg weekly (40 mg, weekly (citrate free, 40mg/0.4ml (40 mg,1 in 7 d)40mg/0.4ml)) for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: EYE OPERATION (medically significant), outcome "unknown", described as "Eye operation"; INTESTINAL OPERATION (medically significant), outcome "unknown", described as "Intestinal operation"; NASOPHARYNGITIS (non-serious), outcome "unknown", described as "cold"; PAIN (non-serious), outcome "unknown", described as "Pain". The action taken for adalimumab was dosage permanently withdrawn. Therapeutic measures were taken as a result of eye operation, intestinal operation. Clinical course reported as the patient was in pain because she had been out of medication for six months. She had an horrible cold and two surgeries one on her eye and the other one on her intestine. It was unknown if patient was enrolled in a COVID 19 Vaccine Trial. Primary reporter declined to be contacted.  Causality for bnt162b2: The reporter's causality for the event(s) of eye surgery, intestinal surgery, pain and cold was reported as possible, The reporter considered "eye operation", "intestinal operation", "cold" and "pain" related to bnt162b2. Causality for humira 40mg/0.4ml (adalimumab): The reporter's causality for the event(s) of eye surgery, intestinal surgery, pain and cold was not related. Agency's opinion is that there is no reasonable possibility that the events of eye surgery, intestinal surgery and pain are related to humira 40mg/0.4ml(adalimumab). Agency's opinion is that the event of cold is not assessable.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events eye operation, intestinal operation, Nasopharyngitis, Pain and the suspect drug BNT162B2.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Vaccination failure; COVID symptoms started on 12Jan22 and tested positive on 13Jan22; 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 28 year-old male patient received bnt162b2 (BNT162B2), administration date 18Mar2021 (Lot number: EN6203) at the age of 28 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: No, reaction(s): "Allergy". Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6205), administration date: 25Feb2021, when the patient was 28 years old, for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant) with onset 12Jan2022, outcome "unknown", described as "Vaccination failure"; COVID-19 (medically significant) with onset 12Jan2022, outcome "unknown", described as "COVID symptoms started on 12Jan22 and tested positive on 13Jan22". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (12Jan2022) positive, notes: Other. Therapeutic measures were not taken as a result of vaccination failure, covid-19.  Clinical course: Facility where the most recent COVID-19 vaccine was administered was pharmacy or drug store. 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 has been tested for COVID-19. No known allergies and no other medical history. COVID test post vaccination: COVID test type post vaccination was other, COVID test name post vaccination was saliva, COVID test date was 12Jan2022, COVID test result was positive.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Nausea, Psoriasis, Vaccination site pain
Clinical narrative: Nausea; Psoriasis aggravated; Vaccination site pain; Fatigue; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient.  A 59 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 20Feb2020 (Batch/Lot number: unknown) at the age of 59 years as dose 1, single and intramuscular, administration date 13Mar2020 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) at citrate free for psoriatic arthropathy. Relevant medical history included: "Hypothyroidism" (unspecified if ongoing), notes: in her early 40's. The patient's concomitant medications were not reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The following information was reported: PSORIASIS (medically significant) with onset May2020, outcome "unknown", described as "Psoriasis aggravated"; VACCINATION SITE PAIN (non-serious) with onset 13Mar2020, outcome "unknown", described as "Vaccination site pain"; FATIGUE (non-serious) with onset 13Mar2020, outcome "unknown", described as "Fatigue"; NAUSEA (non-serious), outcome "unknown", described as "Nausea". The action taken for adalimumab was unknown.  The reporter considered "vaccination site pain" and "fatigue" related to bnt162b2. The reporter's causality for the event(s) of worsening psoriasis with Humira (adalimumab) was a reasonable possibility. The reporter's causality for the event(s) of Covid vaccine related sore arm, covid vaccine related fatigue and nausea was not provided.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Follow-up (11Jan2022): This Follow-up report contains no new safety information.; Sender's Comments: Based on available information the events Psoriasis, Vaccination site pain, Fatigue, Nausea were assessed as possibly related to the suspect vaccine BNT162B2 based on temporal association. This 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 to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling of body temperature change, Headache, Immunisation, Oropharyngeal pain
Clinical narrative: Fever; Changes in body temperature (cold/hot); Chills; Headache; Runny nose; Pain teeth; Sore throat; Dose received: 3; This is a spontaneous report from a contactable reporter (other healthcare professional). The reporter is the patient.  A 15-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 10Jan2022 at 16:30 (Lot number: unknown) at the age of 15 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing) and "Multiple allergies" (unspecified if ongoing), notes: Other medical history: allergies. Concomitant medication included: PROGESTERONE taken for Birth control. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot number: unknown; Anatomical site: left arm; Administration time: 12:00), administration date: 15May2021, when the patient was 15 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE; Lot number: unknown; Anatomical site: left arm; Administration time: 15:00), administration date: 06Jun2021, when the patient was 15 years old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 10Jan2022 at 16:30, outcome "unknown", described as "Dose received: 3"; PYREXIA (non-serious) with onset 10Jan2022 at 21:00, outcome "not recovered", described as "Fever"; FEELING OF BODY TEMPERATURE CHANGE (non-serious) with onset 10Jan2022 at 21:00, outcome "not recovered", described as "Changes in body temperature (cold/hot)"; CHILLS (non-serious) with onset 10Jan2022 at 21:00, outcome "not recovered", described as "Chills"; HEADACHE (non-serious) with onset 10Jan2022 at 21:00, outcome "not recovered", described as "Headache"; RHINORRHOEA (non-serious) with onset 10Jan2022 at 21:00, outcome "not recovered", described as "Runny nose"; TOOTHACHE (non-serious) with onset 10Jan2022 at 21:00, outcome "not recovered", described as "Pain teeth"; OROPHARYNGEAL PAIN (non-serious) with onset 10Jan2022 at 21:00, outcome "not recovered", described as "Sore throat". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia, feeling of body temperature change, chills, headache, rhinorrhoea, toothache and oropharyngeal pain.  Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Treatment for the reported events included rest at home, fluids, Ibuprofen and Tylenol. Since the vaccination, the patient had 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: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rhinorrhoea, SARS-CoV-2 test, Toothache
Clinical narrative: Fever; Changes in body temperature (cold/hot); Chills; Headache; Runny nose; Pain teeth; Sore throat; Dose received: 3; This is a spontaneous report from a contactable reporter (other healthcare professional). The reporter is the patient.  A 15-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 10Jan2022 at 16:30 (Lot number: unknown) at the age of 15 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing) and "Multiple allergies" (unspecified if ongoing), notes: Other medical history: allergies. Concomitant medication included: PROGESTERONE taken for Birth control. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot number: unknown; Anatomical site: left arm; Administration time: 12:00), administration date: 15May2021, when the patient was 15 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE; Lot number: unknown; Anatomical site: left arm; Administration time: 15:00), administration date: 06Jun2021, when the patient was 15 years old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 10Jan2022 at 16:30, outcome "unknown", described as "Dose received: 3"; PYREXIA (non-serious) with onset 10Jan2022 at 21:00, outcome "not recovered", described as "Fever"; FEELING OF BODY TEMPERATURE CHANGE (non-serious) with onset 10Jan2022 at 21:00, outcome "not recovered", described as "Changes in body temperature (cold/hot)"; CHILLS (non-serious) with onset 10Jan2022 at 21:00, outcome "not recovered", described as "Chills"; HEADACHE (non-serious) with onset 10Jan2022 at 21:00, outcome "not recovered", described as "Headache"; RHINORRHOEA (non-serious) with onset 10Jan2022 at 21:00, outcome "not recovered", described as "Runny nose"; TOOTHACHE (non-serious) with onset 10Jan2022 at 21:00, outcome "not recovered", described as "Pain teeth"; OROPHARYNGEAL PAIN (non-serious) with onset 10Jan2022 at 21:00, outcome "not recovered", described as "Sore throat". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia, feeling of body temperature change, chills, headache, rhinorrhoea, toothache and oropharyngeal pain.  Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Treatment for the reported events included rest at home, fluids, Ibuprofen and Tylenol. Since the vaccination, the patient had 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: 70.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Bladder cancer recurrent
Clinical narrative: Bladder cancer recurrent; FACILITATED COLLECT  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (NOT PROVIDED). The reporter is the patient.  A 70 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date Mar2021 (Batch/Lot number: unknown) at the age of 70 years as dose 2, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose:1, Route of administration:Intramuscular), administration date: Feb2021, for Covid-19 immunization. The following information was reported: BLADDER CANCER RECURRENT (Serious,medically significant) with onset Oct2021, outcome "unknown", described as "Bladder cancer recurrent". The action taken for adalimumab was unknown. Clinical comment: The patient had event of bladder cancer and scraped it out and it had come back with humira (adalimumab). In Oct2021, the patient experienced bladder cancer and scraped it out and it had come back. Chemo in bladder after procedure was done. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. In Dec2021, the patient received third dose of BNT162B2 Vaccine. Other relevant history was not reported.  Causality for Humira (Adalimumab) The reporter's causality for the event(s) of bladder cancer and scraped it out and it had came back was not provided. abbvie's opinion is that the event of bladder cancer and scraped it out and it had came back is not assessable.  Causality for Humira (Adalimumab), unknown 1) Bladder cancer recurrent (#) (Bladder cancer recurrent (#)) [v.#] Causality as per reporter (Drug/Vaccine): Not Reported, Causality as per Mfr(Drug/Vaccine):  Not assessable  Causality for Pfizer Biontech Covid-19 Vaccine (Tozinameran) (Tozinameran),Un-Known, Unknown 1) Bladder cancer recurrent (#) (Bladder cancer recurrent (#)) [v. #] Causality as per reporter (Drug/Vaccine): possible   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 information available and close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported event. The case will be reassessed once new information is available   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.