chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter (Other HCP). The reporter is the patient.  A 46-year-old male patient received BNT162b2, on 04Feb2021 at 01:30 as dose 1, single (Lot number: EN5318), in left arm, on 25Feb2021 at 11:15 as dose 2, single (Lot number: EL9264), in left arm and on 04Oct2021 at 13:45 as dose 3 (booster), single (Lot number: 2389) at the age of 46 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergy: internal sulfas" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19 included pf-07321332, ritonavir (PAXLOVID).; Sender's Comments: The causal relation of reported events lack of efficacy with suspected vaccine BNT162B2 cannot be totally excluded based from temporal relation and potential varying immune response of individuals in relation to vaccines.  Case will be reassess pending investigation of this report.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Jan2021 as dose 1, single (Lot number: EL3247), on 11Feb2021 as dose 2, single (Lot number: EL3247), on 17Nov2021 as dose 3 (booster), single (Lot number: FF8841) and on 05Apr2022 as dose 4 (booster), single (Lot number: EL3197) at the age of 50 years for covid-19 immunization. The patient's relevant medical history included: "high cholesterol" (unspecified if ongoing); "overweight" (unspecified if ongoing). Concomitant medication(s) included: LIPITOR; LOVAZA; NEXIUM [ESOMEPRAZOLE MAGNESIUM]; MAGNESIUM; VITAMIN D NOS; CALCIUM; VITAMIN B NOS; TURMERIC [CURCUMA LONGA]. Past drug history included: Propranolol, reaction(s): "Rash", notes: propranolol (rash); Fluoroquinolone, reaction(s): "Rash", notes: fluoroquinolone (rash); Morphine, reaction(s): "vomit", notes: morphine (vomit). The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Report about covid treatment: Yes. Product: COVID 19 Treatment, Brand: Paxlovid. Treatment start date: 04Aug2022, Lot number: GA8851, Indication-Treatment of COVID-19, Administrator route: Oral. Known allergies: propranolol (rash), fluoroquinolone (rash), morphine (vomit). Other medical history: high cholesterol, overweight.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19 PCR test: Result: Positive; COVID-19 PCR test: Result: Positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 67-year-old female patient received BNT162b2 (BNT162B2), in Jan2021 as dose 1, single (Lot number: EK9231) intramuscular, in left arm, on 02Feb2021 as dose 2, single (Lot number: EL3247), in left arm, on 29Sep2021 as dose 3 (booster), single (Lot number: FF2589), in left arm and on 31Mar2022 as dose 4 (booster), single (Lot number: FK9893) at the age of 67 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "Depression" (unspecified if ongoing); "a lot of trouble swallowing" (unspecified if ongoing). Concomitant medication(s) included: HYDROCHLOROTHIAZIDE taken for hypertension; LOSARTAN oral taken for hypertension; ESCITALOPRAM oral taken for depression. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 01Aug2022, outcome "unknown" and all described as "COVID-19 PCR test: Result: Positive". The event "covid-19 pcr test: result: positive" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (01Aug2022) Positive; (02Aug2022) Positive. Additional information: Patient tested positive for Covid earlier this week, was prescribed Paxlovid (Lot: FW4118 and Expiry: Feb2023) at 3 tablets twice a day by mouth for 5 days  earlier today, and has now picked up the medication but has not yet started.  She has a lot of trouble swallowing, and she knows that it can't be crushed or chewed.  She'll never be able to get these down. Her pharmacist said she had to swallow them whole.  If she does that, she will end up throwing them up and the medication won't help her at all. Patient is fully vaccinated and boosted and has Covid-19 on 01Aug2022. Patient assumes she has the new Covid-19 variant because she has had all of her vaccines and she is boosted as well. She is fatigued from the Covid.
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: several strokes; This is a spontaneous report received from a contactable consumer. A male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose 1), administration date: 08Jun2022, for Covid-19 immunization. This information combined with the negative (near death) reaction that patient has suffered in Jun2022 (several strokes two weeks after receiving his second Pfizer vaccination) has any future injections on hold.  Event resulted in doctor or other healthcare professional office/Clinic Visit. It was unknown if covid prior vaccination or if covid tested positive post vaccination. The event "several strokes" required physician office visit. It was unknown if therapeutic measures were taken as a result of cerebrovascular accident. Outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: he has the Pfizer covid19 vaccine for his first, second, and booster doses. He mentioned that he recently tested positive for Covid; he has the Pfizer covid19 vaccine for his first, second, and booster doses. He mentioned that he recently tested positive for Covid; This is a spontaneous report received from a contactable consumer from medical information team. The reporter is the patient. A male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication included: ALFUZOSIN (ongoing). Patient stated that he has the Pfizer covid-19 vaccine for his first, second, and booster doses. He recently tested positive for Covid and was prescribed with nirmatrelvir; ritonavir (PAXLOVID) tablets. Outcome of the events was unknown.   No follow-up attempts are possible. Information about Lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Vaccination site pain
Clinical narrative: while receiving the injection it felt weird; as soon as the pharmacist put the needle in.....it started hurting.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): MOD22-02005, U1076693.  A female patient received BNT162b2 (BNT162B2), on 12Mar2021 as dose 1, single (Batch/Lot number: unknown), on 01Apr2021 as dose 2, single (Lot number: ER8733) and on 03Dec2021 as dose 3 (booster), single (Lot number: 330308D) for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 30Jul2022 as dose 4 (booster), single (Lot number: 011B22A) for covid-19 immunisation. The patient's relevant medical history included: "several allergies: Latex" (unspecified if ongoing); "several allergies: Penicillin" (unspecified if ongoing); "COVID", start date: 23Nov2020 (unspecified if ongoing), notes: she had COVID during the early pandemic. The patient's concomitant medications were not reported. Past drug history included: Lexapro, reaction(s): "several allergies: Lexapro"; Afron, reaction(s): "several allergies: Afron". The following information was reported: FEELING ABNORMAL (non-serious), outcome "unknown", described as "while receiving the injection it felt weird"; VACCINATION SITE PAIN (non-serious), outcome "recovered with sequelae", described as "as soon as the pharmacist put the needle in.....it started hurting.".  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, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Prior to getting covid, I had received four vaccinations by Pfizer; Prior to getting covid, I had received four vaccinations by Pfizer; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (005570). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Prior to getting covid, I had received four vaccinations by Pfizer". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: Prior to getting covid. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: Patient wanted to give feedback on the Paxlovid medication. Prior to getting covid, Patient had received four vaccinations by Pfizer. Patient found the paxlovid to Be an Effective medication. Patient was wondering if some of the rebound was caused by people stopping the medication too soon. Patient's son-in- law and daughter in (State name withheld) also took it , but patient's son-in-law had side effects and was told he could stop whenever he wanted. Patient thought it should be treated the same as an antibiotic.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 63.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: COVID-19; COVID-19; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4488613-00.   A 64-year-old male patient received BNT162b2 (BNT162B2), on 04Aug2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 63 years intramuscular for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 01Mar2021 as dose 1, single (Batch/Lot number: unknown) and on 20Apr2021 as dose 2, single (Batch/Lot number: unknown), all intramuscular for covid-19 immunisation; risankizumab (SKYRIZI [RISANKIZUMAB]), (Batch/Lot number: unknown), subcutaneous for psoriasis, psoriatic arthropathy. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset Jul2022, outcome "unknown" and all described as "COVID-19". The action taken for risankizumab was unknown.  The reporter considered "covid-19" related to BNT162b2.  Clinical course: In Jul2022, the patient experienced COVID-19. MODERNA COVID-19 VACCINE (ELASOMERAN) and PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN) were also considered suspect. In Jul2022, the patient had covid-19 and was unable to contact dermatologist so on 27Jul2022, he made his own decision to take Skyrizi shot. The reporter's causality for the event(s) of COVID-19 with SKYRIZI(RISANKIZUMAB) was no reasonable possibility.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on available information a contributory role of BNT162B2 to the reported events suspected Covid-19 and Drug ineffective cannot be totally excluded as efficacy of a drug varies from individual to individual depending upon the immune status. As with any vaccine, vaccination with BNT162B2 may not protect all vaccine recipients, so the expectedness of suspected covid-19 and drug ineffective is : expected. The case will be reassessed further upon receipt of additional information.
Sex: M
Vaccine: COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: the patient experienced an anaphylactic reaction; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 2022NVX-US-000002628 (Novavax).  A male patient received BNT162b2 (BNT162B2), on 05Feb2021 as dose number unknown, single (Lot number: EN6201) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ANAPHYLACTIC REACTION (medically significant), outcome "unknown", described as "the patient experienced an anaphylactic reaction".  Clinical course: On 14Jul2022, it was reported that a patient started treatment on 05Feb2021 with Pfizer BioNTech COVID-19 vaccine at an unreported dose/frequency for an unreported indication. It was reported the patient experienced an anaphylactic reaction.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Just now testing positive for COVID and am finding weird effects.; Just now testing positive for COVID and am finding weird effects; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", described as "Just now testing positive for COVID and am finding weird effects."; COVID-19 (medically significant), outcome "unknown", described as "Just now testing positive for COVID and am finding weird effects". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Just now testing positive for COVID.  The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Antineutrophil cytoplasmic antibody, Antinuclear antibody, Blood glucose, Blood test
Clinical narrative: This is a literature report for the following literature source(s): "Subungual hematomas after mRNA Covid-19 vaccine administration", Journal of Travel Medicine, 2022. A 42-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "migrant" (unspecified if ongoing); "numbness" (unspecified if ongoing), notes: on palms and fingers, bilaterally; "tingling" (unspecified if ongoing), notes: on palms and fingers, bilaterally; "excruciating pain" (unspecified if ongoing); "prickling" (unspecified if ongoing), notes: 3 hours afterwards; "generalized distal finger phalanx pain" (unspecified if ongoing), notes: 3 hours afterwards. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization. The following information was reported: TRAUMATIC HAEMATOMA (medically significant), 1 week after the suspect product(s) administration, outcome "recovering", described as "She developed multiple large, polymorphic subungual hemorrhages in several fingers". The patient underwent the following laboratory tests and procedures: Antibody test: Normal; Antineutrophil cytoplasmic antibody: Normal; Antinuclear antibody: Normal; Blood glucose: Normal, notes: fasting glycemia; 125 mg/dl; Blood test: Normal; Coagulation time: Normal; Full blood count: Normal; Immune complex assay: Normal; A1c: Normal; 10%; clinical evaluation: ruled out any significant, notes: active cardiovascular and pulmonary abnormalities; normal; Red blood cell sedimentation rate: Normal; SARS-CoV-2 antibody test: negative, notes: against SARS-Cov-2 by an immunoassay; negative, notes: against SARS-Cov-2 by an immunoassay; Total complement activity test: Normal; Ultrasound Doppler: failed to reveal deep, notes: or superficial vein thrombosis. Therapeutic measures were taken as a result of traumatic haematoma. Sender's Comments: Based on the information provided in the narrative, a causal association between the suspect drug and the event cannot be completely 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.
Sex: F
Vaccine: COVID19
Symptoms: Coagulation time, Full blood count, Immune complex assay, Investigation, Laboratory test
Clinical narrative: This is a literature report for the following literature source(s): "Subungual hematomas after mRNA Covid-19 vaccine administration", Journal of Travel Medicine, 2022. A 42-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "migrant" (unspecified if ongoing); "numbness" (unspecified if ongoing), notes: on palms and fingers, bilaterally; "tingling" (unspecified if ongoing), notes: on palms and fingers, bilaterally; "excruciating pain" (unspecified if ongoing); "prickling" (unspecified if ongoing), notes: 3 hours afterwards; "generalized distal finger phalanx pain" (unspecified if ongoing), notes: 3 hours afterwards. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization. The following information was reported: TRAUMATIC HAEMATOMA (medically significant), 1 week after the suspect product(s) administration, outcome "recovering", described as "She developed multiple large, polymorphic subungual hemorrhages in several fingers". The patient underwent the following laboratory tests and procedures: Antibody test: Normal; Antineutrophil cytoplasmic antibody: Normal; Antinuclear antibody: Normal; Blood glucose: Normal, notes: fasting glycemia; 125 mg/dl; Blood test: Normal; Coagulation time: Normal; Full blood count: Normal; Immune complex assay: Normal; A1c: Normal; 10%; clinical evaluation: ruled out any significant, notes: active cardiovascular and pulmonary abnormalities; normal; Red blood cell sedimentation rate: Normal; SARS-CoV-2 antibody test: negative, notes: against SARS-Cov-2 by an immunoassay; negative, notes: against SARS-Cov-2 by an immunoassay; Total complement activity test: Normal; Ultrasound Doppler: failed to reveal deep, notes: or superficial vein thrombosis. Therapeutic measures were taken as a result of traumatic haematoma. Sender's Comments: Based on the information provided in the narrative, a causal association between the suspect drug and the event cannot be completely 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.
Sex: F
Vaccine: COVID19
Symptoms: Red blood cell sedimentation rate, SARS-CoV-2 antibody test, Total complement activity test, Traumatic haematoma, Ultrasound Doppler
Clinical narrative: This is a literature report for the following literature source(s): "Subungual hematomas after mRNA Covid-19 vaccine administration", Journal of Travel Medicine, 2022. A 42-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "migrant" (unspecified if ongoing); "numbness" (unspecified if ongoing), notes: on palms and fingers, bilaterally; "tingling" (unspecified if ongoing), notes: on palms and fingers, bilaterally; "excruciating pain" (unspecified if ongoing); "prickling" (unspecified if ongoing), notes: 3 hours afterwards; "generalized distal finger phalanx pain" (unspecified if ongoing), notes: 3 hours afterwards. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization. The following information was reported: TRAUMATIC HAEMATOMA (medically significant), 1 week after the suspect product(s) administration, outcome "recovering", described as "She developed multiple large, polymorphic subungual hemorrhages in several fingers". The patient underwent the following laboratory tests and procedures: Antibody test: Normal; Antineutrophil cytoplasmic antibody: Normal; Antinuclear antibody: Normal; Blood glucose: Normal, notes: fasting glycemia; 125 mg/dl; Blood test: Normal; Coagulation time: Normal; Full blood count: Normal; Immune complex assay: Normal; A1c: Normal; 10%; clinical evaluation: ruled out any significant, notes: active cardiovascular and pulmonary abnormalities; normal; Red blood cell sedimentation rate: Normal; SARS-CoV-2 antibody test: negative, notes: against SARS-Cov-2 by an immunoassay; negative, notes: against SARS-Cov-2 by an immunoassay; Total complement activity test: Normal; Ultrasound Doppler: failed to reveal deep, notes: or superficial vein thrombosis. Therapeutic measures were taken as a result of traumatic haematoma. Sender's Comments: Based on the information provided in the narrative, a causal association between the suspect drug and the event cannot be completely 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.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: a patient who might benefit from the Paxlovid; a patient who might benefit from the Paxlovid; This is a spontaneous report received from a contactable reporter(s) (Physician), Program ID.  A female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "a patient who might benefit from the Paxlovid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of drug ineffective, suspected covid-19. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received. Additional information: The patient got the booster dose a week ago.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebral thrombosis, Diabetes mellitus, Thrombosis, Trisomy 21
Clinical narrative: Non-Serious Down Syndrome; diabetes; 14 Inches Long Blood Clot in the Femoral Brain; Blood Clot; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 2K-163-4265157-00.  A 19-year-old female patient received BNT162b2 (BNT162B2), on 01Apr2021 as dose 2, single (Batch/Lot number: unknown) at the age of 18 years intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown) at citrate free, subcutaneous for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE: 1, Route of Admin: Intramuscular), administration date: 09Mar2021, when the patient was 18-year-old, for COVID-19 Immunization. The following information was reported: THROMBOSIS (disability) with onset May2021, outcome "recovered", described as "Blood Clot"; CEREBRAL THROMBOSIS (disability) with onset 29Jun2021, outcome "recovering", described as "14 Inches Long Blood Clot in the Femoral Brain"; TRISOMY 21 (disability), outcome "unknown", described as "Non-Serious Down Syndrome"; DIABETES MELLITUS (disability), outcome "recovering", described as "diabetes". The action taken for adalimumab was unknown. Additional information: 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 disabled, 14 inches long blood clot in the femoral brain, blood clot, down syndrome, diabetes was not provided. Company's opinion is that there is no reasonable possibility that the events of disabled, 14 inches long blood clot in the femoral brain, down syndrome, diabetes are related to Humira (Adalimumab). Company's opinion is that the event of Blood Clot is not assessable. Causality for vaccine Clot blood (Thrombosis) Causality as per reporter (Drug/Vaccine): Possible.  The reporter's assessment of the causal relationship of "14 inches long blood clot in the femoral brain", "non-serious down syndrome" and "diabetes" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. The reporter considered "blood clot" related to BNT162b2.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the available clinical data, reported events were most likely from an intercurrent medical condition considered unrelated to vaccination with BNT162B2. This case will be re-evaluated upon receipt of additional information.
Sex: F
Vaccine: COVID19
Symptoms: Myocarditis
Clinical narrative: myocarditis; This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative.  A female patient in her 30's received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "asthma" (unspecified if ongoing), notes: Patient was asthmatic. The patient's concomitant medications were not reported. The following information was reported: MYOCARDITIS (medically significant), outcome "unknown". The patient received the first dose of COVID vaccine (did not specifically state it was Pfizer's) and developed myocarditis so did not receive second dose. Event took place after use of product.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information in the case, an association between the reported event myocarditis and bnt162b2 cannot be ruled out.  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.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Nausea, Pain in extremity
Clinical narrative: This is a spontaneous report received from a contactable pharmacist from a sales representative. An 8-year-old female patient received BNT162b2 (COMIRNATY), as dose number unknown, single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history included: "Well-controlled asthma" (unspecified if ongoing); "Constipations" (unspecified if ongoing). Concomitant medication(s) included: SINGULAIR oral; MAGNESIUM OXIDE. The following information was reported: FATIGUE (non-serious), outcome "unknown"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Sore arm"; NAUSEA (non-serious), outcome "unknown". Additional Information: Events took place after use of product. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: died a week after getting the Pfizer shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death), 1 week after the suspect product(s) administration, outcome "fatal", described as "died a week after getting the Pfizer shot". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Reported Cause(s) of Death: died a week after getting the Pfizer shot
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Injection site erythema, Injection site pain
Clinical narrative: At injection site: swelling, redness, extreme itching, severe pain. Nausea, chills, severe headache, fatigue, body aches.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site swelling, Nausea, Pain
Clinical narrative: At injection site: swelling, redness, extreme itching, severe pain. Nausea, chills, severe headache, fatigue, body aches.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Additional Details: patient felt a little dizzy and light head. we assisted him to floor, and call rescue. He began to feel better and left on his on
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Injected limb mobility decreased, Injection site pain, Injection site swelling
Clinical narrative: Site: Pain at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Joint Pain-Severe, Systemic: Weakness-Severe, Additional Details: pt came to pharmacy to pick up prescription and in passing mentioned that after his vaccine on 4/21/22 he could not raise his arm at all. Patient stated that his doctor told him it was the vaccine that caused this. Patient stated that he has been going to physical therapy and has regained some motion to left his left arm again.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Lethargy, Lymphadenopathy, Pain, Rash
Clinical narrative: Systemic: Allergic: Rash Generalized-Medium, Systemic: Body Aches Generalized-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Lymph Node Swelling-Medium
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Rash, Rash erythematous
Clinical narrative: Systemic: Allergic: Rash Generalized-Mild, Systemic: Fever-Medium, Additional Details: had a high temperature of 102/103 an hour after the vaccination followed by a non-itchy reddish rash covering whole body
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Error: Improper Storage (ex. temp./location).
Age: 24.0
Sex: U
Vaccine: UNK
Symptoms: COVID-19
Clinical narrative: Diagnosed with Covid.  Had Covid Vaccine.
Age: 70.0
Sex: U
Vaccine: UNK
Symptoms: COVID-19
Clinical narrative: Had Covid Vaccine.  Diagnosed with Covid
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: covid positive pt, hospitalized, vaccinated
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Neuralgia
Clinical narrative: Pt had nerve pain reaction to the vaccine.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, Dyspnoea, Hypersensitivity, Laboratory test
Clinical narrative: Allergies occurred after being vaccinated. Before vaccination no allergies were had. After being vaccinated, severe hives and rash occurred all over body and trouble breathing occurred.  A year after being vaccinated, symptoms are still occurring, severe rash, allergies and trouble breathing (tightness in chest). Inhaler was given but does not always help with breathing problems or chest pains.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Urticaria
Clinical narrative: Allergies occurred after being vaccinated. Before vaccination no allergies were had. After being vaccinated, severe hives and rash occurred all over body and trouble breathing occurred.  A year after being vaccinated, symptoms are still occurring, severe rash, allergies and trouble breathing (tightness in chest). Inhaler was given but does not always help with breathing problems or chest pains.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Janssen 3/5/21, 11/3/21. Positive on 8/9/22
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: covid positive pt, fully vaccinated, hospitalized
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebral infarction, Cerebrovascular accident, Computerised tomogram head abnormal, Fall
Clinical narrative: Readmitted with new Left temporal lobe infarct (new stroke) after an unwitnessed fall at Skilled Care Facility
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Janssen 6/2/21. Positive on 8/9/22
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Janssen 4/2/21. Positive on 8/9/22
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Acute respiratory failure
Clinical narrative: Admitted to hospital with acute hypoxemic respiratory failure
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Acute respiratory failure, Aspergillus test positive, COVID-19, Chemotherapy, Chest tube insertion
Clinical narrative: Presented to ED on 7/19 for respiratory distress. COVID + in February, 2 weeks before admission and on admission. On Chemo therapy since December 2021. Admitted on Vapotherm to maintain O2 level. 7/28 critical care consulted and patient was intubated for acute onset chronic hypoxic respiratory failure. Sputum culture on 7/22 showed pulmonary aspergillus. Treated with cresemba for funagal infection and broad spectrum antibiotics and COVID treatment. Became infected with pseudomonas which was treated with cefepime. Developed right-sided tension pneumothorax which was relieved by chest tube placed to wall suction.Final sputum culture showed extended spectrum cephalosporin resistant pseudomomas aerginosa. Pressor requirments included norepinephrine, epinephrine, vasopressin to maintain mean arterial pressure greater than 65. Ventilator settings increased to 100% FiO2. Cefepime changed to meropenum on 8/4, however patinet was in multi organ failure from septic shock. Changed from full code to intubate only. Due to continued deterioration family decided on comfort care on 8/4.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Endotracheal intubation, Fungal infection, General physical health deterioration, Mechanical ventilation, Multiple organ dysfunction syndrome
Clinical narrative: Presented to ED on 7/19 for respiratory distress. COVID + in February, 2 weeks before admission and on admission. On Chemo therapy since December 2021. Admitted on Vapotherm to maintain O2 level. 7/28 critical care consulted and patient was intubated for acute onset chronic hypoxic respiratory failure. Sputum culture on 7/22 showed pulmonary aspergillus. Treated with cresemba for funagal infection and broad spectrum antibiotics and COVID treatment. Became infected with pseudomonas which was treated with cefepime. Developed right-sided tension pneumothorax which was relieved by chest tube placed to wall suction.Final sputum culture showed extended spectrum cephalosporin resistant pseudomomas aerginosa. Pressor requirments included norepinephrine, epinephrine, vasopressin to maintain mean arterial pressure greater than 65. Ventilator settings increased to 100% FiO2. Cefepime changed to meropenum on 8/4, however patinet was in multi organ failure from septic shock. Changed from full code to intubate only. Due to continued deterioration family decided on comfort care on 8/4.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Pneumothorax, Pseudomonas infection, Pseudomonas test positive, Respiratory distress, Respiratory failure
Clinical narrative: Presented to ED on 7/19 for respiratory distress. COVID + in February, 2 weeks before admission and on admission. On Chemo therapy since December 2021. Admitted on Vapotherm to maintain O2 level. 7/28 critical care consulted and patient was intubated for acute onset chronic hypoxic respiratory failure. Sputum culture on 7/22 showed pulmonary aspergillus. Treated with cresemba for funagal infection and broad spectrum antibiotics and COVID treatment. Became infected with pseudomonas which was treated with cefepime. Developed right-sided tension pneumothorax which was relieved by chest tube placed to wall suction.Final sputum culture showed extended spectrum cephalosporin resistant pseudomomas aerginosa. Pressor requirments included norepinephrine, epinephrine, vasopressin to maintain mean arterial pressure greater than 65. Ventilator settings increased to 100% FiO2. Cefepime changed to meropenum on 8/4, however patinet was in multi organ failure from septic shock. Changed from full code to intubate only. Due to continued deterioration family decided on comfort care on 8/4.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive, Septic shock, Sputum culture positive
Clinical narrative: Presented to ED on 7/19 for respiratory distress. COVID + in February, 2 weeks before admission and on admission. On Chemo therapy since December 2021. Admitted on Vapotherm to maintain O2 level. 7/28 critical care consulted and patient was intubated for acute onset chronic hypoxic respiratory failure. Sputum culture on 7/22 showed pulmonary aspergillus. Treated with cresemba for funagal infection and broad spectrum antibiotics and COVID treatment. Became infected with pseudomonas which was treated with cefepime. Developed right-sided tension pneumothorax which was relieved by chest tube placed to wall suction.Final sputum culture showed extended spectrum cephalosporin resistant pseudomomas aerginosa. Pressor requirments included norepinephrine, epinephrine, vasopressin to maintain mean arterial pressure greater than 65. Ventilator settings increased to 100% FiO2. Cefepime changed to meropenum on 8/4, however patinet was in multi organ failure from septic shock. Changed from full code to intubate only. Due to continued deterioration family decided on comfort care on 8/4.
Age: 64.0
Sex: F
Vaccine: UNK
Symptoms: Fatigue, Injection site erythema, Injection site swelling, Pain, Pain in extremity
Clinical narrative: fatigue, aches, sore arm, large red bump where injection was, fever
Age: 64.0
Sex: F
Vaccine: UNK
Symptoms: Pyrexia
Clinical narrative: fatigue, aches, sore arm, large red bump where injection was, fever
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Eye pain, Facial pain, Injection site pain, Injection site swelling, Jaw clicking
Clinical narrative: I received my injection in my left arm and had pain and swelling at the injection site, but I also experienced pain from my jaw through the left side of my face. The left side of my lip up into my eye was all in pain. When I woke up the next morning, I could feel pain all in that area and it felt like my jaw was set to the right. I heard a cracking sound at some point. When I was eating that morning, I felt a crack and it felt like my jaw shattered. I'm still feeling pain in my face, and it looks asymmetrical. I took a picture. I also developed a red rash on both legs from above my knees and up into my thighs. About 7 inches above my knee, I have been seeing red spots and itchy patches that have been raised. I was taking over the counter non drowsy allergy medication because I was already experiencing some allergy issues, yet I was still seeing the rash on my legs. I went to the doctor who gave me a shot of MEDROL and prescribed prednisone for 10 days and advised that I continue taking BENADRYL and non-drowsy allergy medication and come back in two weeks, unless things get worse, in which case he wants to see me immediately. I have also been experiencing an itching sensation all over in random places.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Lip pain, Pain in jaw, Rash, Rash erythematous, Rash papular
Clinical narrative: I received my injection in my left arm and had pain and swelling at the injection site, but I also experienced pain from my jaw through the left side of my face. The left side of my lip up into my eye was all in pain. When I woke up the next morning, I could feel pain all in that area and it felt like my jaw was set to the right. I heard a cracking sound at some point. When I was eating that morning, I felt a crack and it felt like my jaw shattered. I'm still feeling pain in my face, and it looks asymmetrical. I took a picture. I also developed a red rash on both legs from above my knees and up into my thighs. About 7 inches above my knee, I have been seeing red spots and itchy patches that have been raised. I was taking over the counter non drowsy allergy medication because I was already experiencing some allergy issues, yet I was still seeing the rash on my legs. I went to the doctor who gave me a shot of MEDROL and prescribed prednisone for 10 days and advised that I continue taking BENADRYL and non-drowsy allergy medication and come back in two weeks, unless things get worse, in which case he wants to see me immediately. I have also been experiencing an itching sensation all over in random places.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: I received my injection in my left arm and had pain and swelling at the injection site, but I also experienced pain from my jaw through the left side of my face. The left side of my lip up into my eye was all in pain. When I woke up the next morning, I could feel pain all in that area and it felt like my jaw was set to the right. I heard a cracking sound at some point. When I was eating that morning, I felt a crack and it felt like my jaw shattered. I'm still feeling pain in my face, and it looks asymmetrical. I took a picture. I also developed a red rash on both legs from above my knees and up into my thighs. About 7 inches above my knee, I have been seeing red spots and itchy patches that have been raised. I was taking over the counter non drowsy allergy medication because I was already experiencing some allergy issues, yet I was still seeing the rash on my legs. I went to the doctor who gave me a shot of MEDROL and prescribed prednisone for 10 days and advised that I continue taking BENADRYL and non-drowsy allergy medication and come back in two weeks, unless things get worse, in which case he wants to see me immediately. I have also been experiencing an itching sensation all over in random places.
Age: 83.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Cerebral haemorrhage
Clinical narrative: Patient was admitted to the hospital for COVID-19.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Bacteraemia, Bile duct stent insertion, Biliary dilatation
Clinical narrative: Brought to ED on 8/3 from skilled nursing facility for altered mental status and Covid +. Had been admitted to Medical Center in July with septic shock, cholangitis requiring ERCP/biliary stenting and bacteremia. There was concern for Cholangiocarcinoma but unable to peform EUS and was to f/u OP. He was then sent to facility. On arrival to ED he was hypotensive. Labs- creatinine 1.4, alk phos 976, AST 224 and ALT 224. WBC s elveated at 26. Hemoglobin 8.7. Had  UTI with blood cultures positive for kebsiella. Underwent CT of thorax , abdomen and pelvis showing cholelithiasis with gallbadder distentions concerning for cholecystitis. Biliary stent appeared in good position with dilatation concerning for cholangitis. General surgery consulted. After discussion with wife she decided to transition to comfort care. Palliative care and hospice were consulted. Comfort measures were initiated .
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Blood alkaline phosphatase increased, Blood creatinine increased, Blood culture positive, COVID-19, Cholangitis
Clinical narrative: Brought to ED on 8/3 from skilled nursing facility for altered mental status and Covid +. Had been admitted to Medical Center in July with septic shock, cholangitis requiring ERCP/biliary stenting and bacteremia. There was concern for Cholangiocarcinoma but unable to peform EUS and was to f/u OP. He was then sent to facility. On arrival to ED he was hypotensive. Labs- creatinine 1.4, alk phos 976, AST 224 and ALT 224. WBC s elveated at 26. Hemoglobin 8.7. Had  UTI with blood cultures positive for kebsiella. Underwent CT of thorax , abdomen and pelvis showing cholelithiasis with gallbadder distentions concerning for cholecystitis. Biliary stent appeared in good position with dilatation concerning for cholangitis. General surgery consulted. After discussion with wife she decided to transition to comfort care. Palliative care and hospice were consulted. Comfort measures were initiated .
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Cholelithiasis, Computerised tomogram abdomen abnormal, Computerised tomogram thorax abnormal, Endoscopic retrograde cholangiopancreatography, Gallbladder disorder
Clinical narrative: Brought to ED on 8/3 from skilled nursing facility for altered mental status and Covid +. Had been admitted to Medical Center in July with septic shock, cholangitis requiring ERCP/biliary stenting and bacteremia. There was concern for Cholangiocarcinoma but unable to peform EUS and was to f/u OP. He was then sent to facility. On arrival to ED he was hypotensive. Labs- creatinine 1.4, alk phos 976, AST 224 and ALT 224. WBC s elveated at 26. Hemoglobin 8.7. Had  UTI with blood cultures positive for kebsiella. Underwent CT of thorax , abdomen and pelvis showing cholelithiasis with gallbadder distentions concerning for cholecystitis. Biliary stent appeared in good position with dilatation concerning for cholangitis. General surgery consulted. After discussion with wife she decided to transition to comfort care. Palliative care and hospice were consulted. Comfort measures were initiated .