chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Acute respiratory failure, Deep vein thrombosis, Imaging procedure
Clinical narrative: Vaccine induced DVT; acute hypoxic respiratory failure; This is a literature report.  A 73 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "COPD" (unspecified if ongoing), notes: on 2 L home oxygen. The patient's concomitant medications were not reported. The following information was reported: DEEP VEIN THROMBOSIS (hospitalization, medically significant), outcome "recovered", described as "Vaccine induced DVT"; ACUTE RESPIRATORY FAILURE (hospitalization, medically significant), outcome "recovered", described as "acute hypoxic respiratory failure". The patient underwent the following laboratory tests and procedures: imaging procedure: revealed right interlobar pulmonary embolism and, notes: right superficial femoral vein thrombosis without any provoking factors. Therapeutic measures were taken as a result of deep vein thrombosis, acute respiratory failure.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: As there is limited information in the case provided, the causal association between the event Deep Vein Thrombosis and Acute Respiratory Failure and the suspect drug cannot be excluded. The case will be reassessed once new information is available.,Linked Report(s) : US-PFIZER INC-202200349264 Same article/drug/patient and different dose/event
Sex: F
Vaccine: COVID19
Symptoms: Biopsy bone marrow, Skin test, Throat tightness, Urticaria
Clinical narrative: throat closing sensation; minor hives; This is a literature report.  A 48 year-old female patient (unknown if pregnant) 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. Past drug history included: Belimumab, reaction(s): "anaphylaxis"; Rituximab, reaction(s): "IgE-mediated reaction". Vaccination history included: Bnt162b2 (first dose), for COVID-19 immunisation, reaction(s): "Anaphylaxis - developing dyspnea, wheezing, throat closing sensation and an erythematous rash in her upper extremities". The following information was reported: THROAT TIGHTNESS (medically significant), outcome "unknown", described as "throat closing sensation"; URTICARIA (medically significant), outcome "unknown", described as "minor hives". The patient underwent the following laboratory tests and procedures: skin testing to vaccine components (PEG3350, polysorbate 80, polysorbate 20) and the vaccine itself were negative. Therapeutic measures were taken as a result of throat tightness, urticaria. Clinical course: Authors presented a case of a successful graded-dose administration of the second dose of the Pfizer-mRNA vaccine for SARS-CoV-2 in a patient with previous anaphylaxis to the first dose. The use of skin testing to the vaccine and its components remains controversial. Graded-dose administration of vaccines may improve vaccination rates in patients with high-risk of hypersensitivity reactions to these vaccines. She successfully completed a five-step graded-dose administration of the COVID-19 vaccine (1. Dose: 0.05ml, Dilution: 1:10 Dilution, Time: 0 min; 2. Dose: 0.05ml, Dilution: Full-strength, Time: 15 min; 3. Dose: 0.1ml, Dilution: Full-strength. Time: 30 min; 4. Dose: 0.15ml, Dilution: Full-strength; Time: 45 min; 5. Observation, Time: 75 min), presenting only throat closing sensation and minor hives, which were treated with IM diphenhydramine.; Sender's Comments: Based on the temporal association, a possible contributory role of BNT162B2 to the development of throat closing sensation and minor hives 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: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Peripheral swelling, Thrombosis
Clinical narrative: blood clots in both legs; swelling in both legs; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 15 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 03Jul2021 14:00 (Lot number: EW0198) at the age of 15 years 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: THROMBOSIS (caused and prolonged hospitalization, medically significant, life threatening) with onset 05Jul2021 13:00, outcome "recovered with sequelae", described as "blood clots in both legs"; PERIPHERAL SWELLING (hospitalization, life threatening) with onset 05Jul2021 13:00, outcome "recovered with sequelae", described as "swelling in both legs". The patient was hospitalized and prolonged hospitalization for thrombosis (hospitalization duration: 7 day(s)); for peripheral swelling (hospitalization duration: 7 day(s)). The events "blood clots in both legs" and "swelling in both legs" were evaluated at the physician office visit and emergency room visit. Therapeutic measures were taken as a result of thrombosis, peripheral swelling. Clinical course: Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No List of any other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19 and not tested for COVID-19 since vaccination. Once properly diagnosed after swelling in both legs had to undergo surgery to remove blood clots in both legs just in time before clots moved to his heart or brain. Surgery to rmove blood clots. The patient had no known allergy.
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Breakthrough COVID confirmed by PCR; Breakthrough COVID confirmed by PCR; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group.  A 11 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 17Jan2022 (Lot number: FE3594) at the age of 11 years as dose 3 (booster), single, administration date 02Jun2021 (Lot number: EW0179) as dose 2, single and administration date 14May2021 (Lot number: EW0179) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 19Feb2022, outcome "recovering" and all described as "Breakthrough COVID confirmed by PCR". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (21Feb2022) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19. No covid prior vaccination.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Diarrhoea, Stool analysis, Vomiting
Clinical narrative: like vomiting and diarrhea after the second dose of vaccination; like vomiting and diarrhea after the second dose of vaccination; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 38 year-old male patient received bnt162b2 (BNT162B2), administration date 12May2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), administration date: 15Apr2021, for Covid-19 Immunization, reaction(s): "Throwing up"; Bnt162b2 (Dose 1), administration date: 15Apr2021, for Covid-19 immunization, reaction(s): "Diarrhea", "he got really sick". The following information was reported: DIARRHOEA (non-serious) with onset 2021, outcome "unknown", VOMITING (non-serious), outcome "unknown" and all described as "like vomiting and diarrhea after the second dose of vaccination". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: tested positive for covid; tested positive for covid; Serious: No This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team and product quality group for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 05Dec2021 (Lot number: FJ1620) as dose 3 (booster), single, administration date 10Apr2021 (Lot number: EW0162) as dose 2, single and administration date 20Mar2021 (Lot number: EN6955) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant), outcome "unknown" and all described as "tested positive for covid". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive, notes: I have tested positive for covid. I dont understand how.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: not very effective; not very effective; 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 child (patient's age reported as will be 7 y/o in a week and half) male patient received BNT162B2 (COMIRNATY, solution for injection) (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 patient was not immunocompromised. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "not very effective".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200342370 Same reporter, suspect drug and events; different patient
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: not very effective; not very effective; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from medical information team. The reporter is the parent.  An 11 year-old female patient received BNT162B2 (COMIRNATY) (Batch/Lot number: unknown) as dose number unknown, single for COVID-19 immunization. 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 "not very effective". The reporter stated she read an article today that Pfizer covid vaccine for 5-11 years old is not very effective. She stated that article says as of 30Jan, efficacy in 12 years old is 67 % and in 11 y/o is 11%. She stated it was very disturbing. She stated the vaccine her children got was not very effective. She also stated as per the article the vaccine is not effective in preventing hospitalization and protection in general. The reporter wanted to know if there were any booster for these kids, and if Pfizer was going to do some trials or come up with booster dose for this age group (not immunocompromised).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200342154 Same reporter/drug/event, different patient.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, COVID-19, Drug ineffective, Unevaluable event
Clinical narrative: back pain; congestion; COVID-19; COVID-19; 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-163-4283582-00.  A 49 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 15Mar2021 (Batch/Lot number: unknown) at the age of 49 years as dose 2, single and intramuscular (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous, administration date Feb2022 (Batch/Lot number: unknown) as unk unk, daily. 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 "recovered" (2022) and all described as "COVID-19"; BACK PAIN (non-serious), outcome "not recovered", described as "back pain"; UNEVALUABLE EVENT (non-serious), outcome "not recovered", described as "congestion". The action taken for adalimumab was dosage permanently withdrawn.  Additional information: It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporter's assessment of the causal relationship of reported adverse events VACCINATION FAILURE, COVID-19, BACK PAIN and UNEVALUABLE EVENT with the bnt162b2 (BNT162B2) was provided as possible.  Reporters assessment for causal relationship of reported adverse events VACCINATION FAILURE, COVID-19, BACK PAIN and UNEVALUABLE EVENT with adalimumab (HUMIRA) was not reported.   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 drug ineffective, COVID-19, back pain, unevaluable event and the suspect drug BNT162B2
Sex: M
Vaccine: COVID19, UNK
Symptoms: COVID-19, Drug ineffective, Inflammation, Vaccination complication
Clinical narrative: COVID-19; COVID-19; Vaccination adverse reaction; Inflammation; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (Not aplicable). The reporter is the patient. Other Case identifier(s): 22K-163-4292525-00 (Agency).  A 47 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date Mar2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous from 2020 (Batch/Lot number: unknown) to 2021 at citrate free for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 24Jan2022, outcome "unknown" and all described as "COVID-19"; VACCINATION COMPLICATION (non-serious) with onset Mar2021, outcome "unknown", described as "Vaccination adverse reaction"; INFLAMMATION (non-serious) with onset Mar2021, outcome "unknown", described as "Inflammation". The action taken for adalimumab was dosage permanently withdrawn on 2021.  Causality for HUMIRA (ADALIMUMAB) The reporter's causality for the event(s) of COVID-19 VACCINE TRIGGERED SOMETHING, INFLAMMATION WITH COVID-19 VACCINE and CONTRACTED COVID was not provided.  The reporter's assessment of the causal relationship of the events with the suspect product BNT162B2 was Possible at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment  Clinical course:Solicited report by a consumer of a 47 year old male with events of non-serious COVID-19 VACCINE TRIGGERED SOMETHING, INFLAMMATION WITH COVID-19 VACCINE and CONTRACTED COVID with HUMIRA (ADALIMUMAB). There was no reported medical history. In Mar2021, the patient experienced COVID-19 VACCINE TRIGGERED SOMETHING and INFLAMMATION WITH COVID-19 VACCINE. On 24Jan2022, the patient experienced CONTRACTED COVID. PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on possible temporal association the causal role of BNT162B2 Vaccine cannot be excluded for reported events .Case will be reviewed further on receipt of FU information  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: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Haematochezia
Clinical narrative: 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-163-4289395-00 (RA). A 63 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 01Mar2021 (Batch/Lot number: unknown) at the age of 63 years as dose 1, single and intramuscular, administration date 01Apr2021 (Batch/Lot number: unknown) as dose 2, single for Covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) for colitis ulcerative. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HAEMATOCHEZIA (medically significant) with onset Apr2021, outcome "recovered" (May2021), described as "Bloody stool"; DIARRHOEA (non-serious) with onset Mar2021, outcome "not recovered", described as "Diarrhea". Causality for Pfizer BioNTech Covid-19 vaccine (tozinameran), Unknown: The reporter causality for the events Bloody stool & Diarrhea were reported as Possible. Causality for HUMIRA (ADALIMUMAB): The reporter causality for the events Bloody stool & Diarrhea were not reported. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Sender's Comments: Based on available information, there is reasonable possibility of causal association between the event bloody stools and diarrhea and the suspect drug BNT162B2. 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: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Rheumatoid arthritis
Clinical narrative: Rheumatoid arthritis flare up; Fatigue; headache; 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-163-4290285-00.  A 47 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date May2021 (Batch/Lot number: unknown) at the age of 47 years as dose 2, single and intramuscular, administration date Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) at unk (citrate free) for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The following information was reported: RHEUMATOID ARTHRITIS (medically significant), outcome "unknown", described as "Rheumatoid arthritis flare up"; FATIGUE (non-serious), outcome "unknown", described as "Fatigue"; HEADACHE (non-serious), outcome "unknown", described as "headache". The action taken for adalimumab was unknown.  Causality for Humira (adalimumab): The reporter's causality for the events of rheumatoid arthritis flare, fatigue and headache was Not Related.  Causality for Pfizer Biontech covid-19 vaccine: The reporter's causality for the events of Rheumatoid arthritis as not related and Fatigue and Headache as 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 available information in the case, the causal association between the events rheumatoid arthritis, fatigue, headache and the suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Covid-19; Covid-19; 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-163-4293116-00.  A 67 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 27Feb2021 (Batch/Lot number: unknown) at the age of 66 years as dose 2, single and intramuscular, administration date 06Feb2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) for psoriatic arthropathy. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (hospitalization, medically significant), VACCINATION FAILURE (hospitalization, medically significant) all with onset Aug2021, outcome "unknown" and all described as "Covid-19". The patient was hospitalized for covid-19, vaccination failure (hospitalization duration: 1 day(s)). The patient underwent the following laboratory tests and procedures: covid-19: (Aug2021) positive. The action taken for adalimumab was unknown. Causality for Humira(Adalimumab): The reporter's causality for the event of covid was not provided. Causality for BNT162B2: The reporter's causality for the event of covid was not provided. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the information in the case report, contributory role of BNT162B2 to the development of vaccination failure, Covid-19 cannot be ruled out.
Sex: M
Vaccine: COVID19
Symptoms: Brain neoplasm, Vaccination site papule
Clinical narrative: Injection site papule; Brain tumor; 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-163-4283169-00 (AbbVie).  A 74 year-old male patient received bnt162b2 (BNT162B2), intramuscular (Batch/Lot number: unknown) as dose 3 (booster), single, intramuscular (Batch/Lot number: unknown) as dose 2, single and intramuscular (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; leuprorelin acetate (LUPRON DEPOT) (Batch/Lot number: unknown) as unk, single. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BRAIN NEOPLASM (medically significant) with onset Oct2021, outcome "unknown", described as "Brain tumor"; VACCINATION SITE PAPULE (non-serious), outcome "unknown", described as "Injection site papule". Clinical comment: The patient diagnosed with a brain tumor and had surgery in Dec2021.  Causality for Lupron depot (Leuprolide acetate depot): The reporter's causality for the event(s) of brain tumor and bump at injection site was not provided. Abbvie's opinion is that the event of brain tumor is not assessable. Abbvie's opinion is that there is a reasonable possibility that the event of bump at injection site is related to Lupron depot (Leuprolide acetate Depot).  Causality for PFIZER BIONTECH COVID-19 VACCINE: The reporter's causality for the event(s) of brain tumor and bump at injection site 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 temporal association, there is reasonable possibility of causal association between the Reported events and the suspect drug BNT162B2   The impact of this report on the benefit/risk profile of the Pfizer drug 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: 62.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; 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 63 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 2021 (Batch/Lot number: unknown) at the age of 62 years as dose 3 (booster), single, intramuscular, administration date 2020 (Batch/Lot number: unknown) as dose 2, single and intramuscular, administration date 2020 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) for colitis ulcerative. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2020, outcome "recovered" and all described as "COVID-19". Patient reported events of non-serious COVID and bad reaction to the Booster vaccine shot with HUMIRA (ADALIMUMAB). There was no reported medical history. In 2020, the patient experienced COVID. In 2021, the patient experienced bad reaction to the booster vaccine shot and covid. PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporter considered event COVID-19 causality not reported for bnt162b2 and Humira, and event Vaccination adverse reaction/ Vaccination complication causality Possible for bnt162b2 and not reported for Humira. The action taken for adalimumab was unknown.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on temporal association, there is reasonable possibility of causal association between the Reported events and the suspect drug BNT162B2.  The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Sex: M
Vaccine: COVID19, UNK
Symptoms: Drug ineffective, SARS-CoV-2 test, SARS-CoV-2 test positive, Skin discolouration
Clinical narrative: Skin discoloration; COVID-19 virus test positive; COVID-19 virus test positive; 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-163-4289413-00.  A 50 year-old male patient received bnt162b2 (BNT162B2), intramuscular (Batch/Lot number: unknown) as dose 3 (booster), single, intramuscular (Batch/Lot number: unknown) as dose 2, single and intramuscular (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; risankizumab (SKYRIZI [RISANKIZUMAB]), subcutaneous (Batch/Lot number: unknown) for psoriasis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset Jan2022, outcome "unknown", SARS-COV-2 TEST POSITIVE (medically significant) with onset Jan2022, outcome "recovered" (2022) and all described as "COVID-19 virus test positive"; SKIN DISCOLOURATION (non-serious), outcome "recovering", described as "Skin discoloration". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (Jan2022) positive. The action taken for risankizumab was unknown.  Clinical course: It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The event COVID-19 was reported as non-serious. The reporter's causality for the event(s) of COVID-19 POSITIVE with SKYRIZI (RISANKIZUMAB) was not provided and for the event(s) of Scaling Down Considerably, But Still Remains Marks/ Discoloration with SKYRIZI (RISANKIZUMAB) was a reasonable possibility. The reporter's causality for the event(s) COVID-19 and Scaling Down Considerably, But Still Remains Marks/ Discoloration with PFIZER BIONTECH COVID-19 VACCINE was probable.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the currently available information the possibility of causal association between the reported events and the suspect drug BNT162B2  cannot be ruled out. The case will be reassessed once new information is available.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID test date: 13Jan2022, COVID test result: Positive; COVID test date: 13Jan2022, COVID test result: Positive; This is a spontaneous report received from contactable reporter(s) (Other HCP) from product quality group. The reporter is the patient.  A 44 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 19Jan2021 (Lot number: EL3248) as dose 2, single and administered in arm left, administration date 29Dec2020 (Lot number: EK5730) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Known allergies: Sulfa" (unspecified if ongoing), notes: Known allergies: Sulfa. Concomitant medication(s) included: TIROSINT; JUNEL; VITAMIN D [COLECALCIFEROL]; PANTOPRAZOLE. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 13Jan2022, outcome "unknown" and all described as "COVID test date: 13Jan2022, COVID test result: Positive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (13Jan2022) positive. Clinical course:No prior vaccination within 4 weeks. No covid-19 prior vaccination.; Sender's Comments: As there is limited information in the case provided, the causal association between the event and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Amenorrhoea, Heavy menstrual bleeding, Uterine spasm
Clinical narrative: COVID test date: 13Jan2022, COVID test result: Positive; COVID test date: 13Jan2022, COVID test result: Positive; This is a spontaneous report received from contactable reporter(s) (Other HCP) from product quality group. The reporter is the patient.  A 44 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 19Jan2021 (Lot number: EL3248) as dose 2, single and administered in arm left, administration date 29Dec2020 (Lot number: EK5730) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Known allergies: Sulfa" (unspecified if ongoing), notes: Known allergies: Sulfa. Concomitant medication(s) included: TIROSINT; JUNEL; VITAMIN D [COLECALCIFEROL]; PANTOPRAZOLE. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 13Jan2022, outcome "unknown" and all described as "COVID test date: 13Jan2022, COVID test result: Positive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (13Jan2022) positive. Clinical course:No prior vaccination within 4 weeks. No covid-19 prior vaccination.; Sender's Comments: As there is limited information in the case provided, the causal association between the event and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Fatigue, Hypotension
Clinical narrative: After booster dose patient had low blood pressure and fatigue.; After booster dose patient had low blood pressure and fatigue; This is a spontaneous report from a contactable reporter (Physician) received . A 23-year-old female patient (unknown if pregnant) received bnt162b2 (BNT162B2), administration date an unknown date in Oct2021 (Lot number: unknown) at the age of 23 years as dose 3 (booster), single for COVID-19 immunisation. The patient's relevant medical history was unknown. It was unknown whether the patient received any concomitant medication. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunisation and Covid-19 vaccine (DOSE 2;MANUFACTURER UNKNOWN), for COVID-19 immunisation.  The following information was reported: HYPOTENSION (non-serious) with onset an unknown date in Oct2021, outcome "recovered", described as "Low blood pressure"; FATIGUE (non-serious) with onset an unknown date in Oct2021, outcome "recovered", described as "Fatigue". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of hypotension and fatigue.  Additional information: It was unknown whether the patient had any known allergies. It was unknown if the patient had received any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to vaccination, it was unknown if the patient was diagnosed with COVID-19. Since the vaccination, it was unknown if the patient had been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Deep vein thrombosis, Echocardiogram, Imaging procedure
Clinical narrative: This is a literature report for the following literature source(s): "Covid-19 Pfizer- BioNTech vaccine induced VTA.", Journal of Investigative Medicine, 2022; Vol:70(2), pgs:563-564, 10.1136/jim-2022-SRMC.227. A 73 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for Covid-19 immunisation. Relevant medical history included: "COPD" (unspecified if ongoing), notes: on 2 L home oxygen. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 IMMUNIZATION, reaction(s): "acute hypoxic respiratory failure". The following information was reported: DEEP VEIN THROMBOSIS (hospitalization, medically significant), outcome "unknown", described as "Vaccine induced DVT". The patient underwent the following laboratory tests and procedures: echocardiogram: revealed a round mass in the left atrial appendage, notes: which was likely a thrombus, she was discharged on warfarin; imaging procedure: revealed right interlobar pulmonary embolism and, notes: right superficial femoral vein thrombosis without any provoking factors. Therapeutic measures were taken as a result of deep vein thrombosis. The treatment received as warfarin. Sender's Comments: As there is limited information in the case provided, the causal association between the event Deep Vein Thrombosis and the suspect drug cannot be excluded. The case will be reassessed once new information is available. Linked Report(s): US-PFIZER INC-202200333581 Same article/drug/patient and different dose/event.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Genital herpes, Malaise, Migraine, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report from a contactable reporter (consumer or other non-HCP). The reporter is the patient. A 44-year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administered in arm left, administration date 04Jun2021 (Lot number: EW0150) at the age of 44 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "Penicillin allergy" (unspecified if ongoing), notes: Known allergies: Penicillin. The patient did not receive any concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot number: EW0150, Anatomical location: Left arm, Route of administration: Unspecified), administration date: 14May2021, for COVID-19 immunisation. The following information was reported: DIARRHOEA (non-serious) with onset 05Jul2021, outcome "recovered" (an unknown date in 2021), described as "After receiving first two doses of vaccine, experienced diarrhea for 4 straight weeks"; MIGRAINE (non-serious) with onset 05Jul2021, outcome "not recovered", described as "I have had migraines every day since vaccination. I have to take daily migraine medication"; GENITAL HERPES (non-serious) with onset 05Jul2021, outcome "not recovered", described as "I had an unexplained case of genital herpes."; WEIGHT DECREASED (non-serious) with onset 05Jul2021, outcome "not recovered", described as "I lost 40 pounds"; MALAISE (non-serious) with onset 05Jul2021, outcome "not recovered", described as "I have not felt good since vaccination". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of diarrhoea, migraine, genital herpes, weight decreased and malaise. Additional Information: Prior to the 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 patient reported that she now had to take a daily medication to prevent herpes outbreaks. The patient stated that She and her husband were faithful and have had been for 18 years. She had no other way to explain genital herpes. The patient received unspecified medication for the reported events. Since the vaccination, the patient had been tested for COVID-19 and the result was negative. The events resulted in doctor or other healthcare professional office/clinic visit. The patient also received (BNT162B2), administered in left arm, administration date 10Dec2021 (Lot number: FE3594) at the age of 45 years as dose 3 (booster), single for COVID-19 immunisation.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Weight decreased
Clinical narrative: This is a spontaneous report from a contactable reporter (consumer or other non-HCP). The reporter is the patient. A 44-year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administered in arm left, administration date 04Jun2021 (Lot number: EW0150) at the age of 44 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "Penicillin allergy" (unspecified if ongoing), notes: Known allergies: Penicillin. The patient did not receive any concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot number: EW0150, Anatomical location: Left arm, Route of administration: Unspecified), administration date: 14May2021, for COVID-19 immunisation. The following information was reported: DIARRHOEA (non-serious) with onset 05Jul2021, outcome "recovered" (an unknown date in 2021), described as "After receiving first two doses of vaccine, experienced diarrhea for 4 straight weeks"; MIGRAINE (non-serious) with onset 05Jul2021, outcome "not recovered", described as "I have had migraines every day since vaccination. I have to take daily migraine medication"; GENITAL HERPES (non-serious) with onset 05Jul2021, outcome "not recovered", described as "I had an unexplained case of genital herpes."; WEIGHT DECREASED (non-serious) with onset 05Jul2021, outcome "not recovered", described as "I lost 40 pounds"; MALAISE (non-serious) with onset 05Jul2021, outcome "not recovered", described as "I have not felt good since vaccination". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of diarrhoea, migraine, genital herpes, weight decreased and malaise. Additional Information: Prior to the 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 patient reported that she now had to take a daily medication to prevent herpes outbreaks. The patient stated that She and her husband were faithful and have had been for 18 years. She had no other way to explain genital herpes. The patient received unspecified medication for the reported events. Since the vaccination, the patient had been tested for COVID-19 and the result was negative. The events resulted in doctor or other healthcare professional office/clinic visit. The patient also received (BNT162B2), administered in left arm, administration date 10Dec2021 (Lot number: FE3594) at the age of 45 years as dose 3 (booster), single for COVID-19 immunisation.
Sex: U
Vaccine: DTAP, DTAPIPV, DTAPIPVHIB, IPV, MNQ
Symptoms: Product storage error
Clinical narrative: refrigerator door being left open with no reported adverse event; Initial information received on 01-Mar-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a patient with unknown demographics whos refrigerator door being left open with no reported adverse event while receiving vaccines MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA], DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL], DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL], DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] and IPV (VERO) [IPOL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect IPV (VERO) with unknown dosing lot T1E872M via unknown route in unknown administration site for immunization.  On an unknown date, the patient received a  dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE with unknown dosing lot number not reported via unknown route in unknown administration site for immunization.  On an unknown date, the patient received a  dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE with unknown dosing lot number not reported via unknown route in unknown administration site for immunization.  On an unknown date, the patient received a  dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE lot number not reported via unknown route in unknown administration site for immunization.  On an unknown date, the patient received a  dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE for unknown dosing lot number not reported via unknown route in unknown administration site for immunization.  On an unknown date the patient refrigerator door was being left open with no reported adverse event (product temperature excursion issue) (unknown latency) following the administration of IPV (VERO), (unknown latency) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE, (unknown latency) following the administration of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE, (unknown latency) following the administration of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE and (unknown latency) following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (refrigerator door being left open with no reported adverse event).  At time of reporting, the outcome was Unknown for the event refrigerator door being left open with no reported adverse event.
Sex: U
Vaccine: IPV, TD, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: experienced excursion at temperature of 48 degrees F lasting for 96 hours due to the refrigerator being left openwith no reported adverse event; Initial information received on 01-Mar-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a patient with unknown demographics who had excursion at temperature of 48 degrees f lasting for 96 hours due to the refrigerator being left openwith no reported adverse event while receiving vaccines DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] and IPV (VERO) [IPOL] and while treated with TUBERCULIN TEST [TUBERSOL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient started taking TUBERSOL (TUBERCULIN TEST) Solution for injection dosage unknown (with an unknown batch number) for Immunization.  On an unknown date, the patient received a  dose of suspect IPV (VERO)with unknown dosing, lot T1D481M via unknown route in unknown administration site for immunization.  On an unknown date, the patient received a  dose of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT with unknown dosing,lot number not reported via unknown route in unknown administration site for immunization.  On an unknown date the patient had excursion at temperature of 48 degrees f lasting for 96 hours due to the refrigerator being left openwith no reported adverse event (product temperature excursion issue)(unknown latency) following the administration of IPV (VERO) and (unknown latency) following the administration of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (experienced excursion at temperature of 48 degrees F lasting for 96 hours due to the refrigerator being left openwith no reported adverse event).  At time of reporting, the outcome was Unknown for the event experienced excursion at temperature of 48 degrees f lasting for 96 hours due to the refrigerator being left openwith no reported adverse event.