chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased, Palpitations
Clinical narrative: 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 1, 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: PALPITATIONS (hospitalization), outcome "unknown", described as "heart palpitations"; HEART RATE INCREASED (hospitalization), outcome "unknown", described as "patient's heart was racing very fast". Clinical course: caller was calling because caller's friend got the first Pfizer COVID-19 vaccine and had a reaction to the shot. Caller's friend is a nurse. Caller's friend, the patient, was in the hospital because it affected the patient's heart. Caller mentions heart palpitations, but doesn't know what it was, maybe heart palpitations, patient's heart was racing very fast. Patient was scared to get the second shot, now they threatened the patient's job and the patient hasn't worked in 5 weeks. Patient got an exemption from the doctor that the patient was exempt from getting the second shot. There were other coworkers that have not gotten the shot at all. Patient was admitted to the hospital where the patient works so they have the patient's medical records. The patient underwent the following laboratory tests and procedures: Heart rate: Increased. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chronic tonsillitis, Fatigue, Illness, Pyrexia
Clinical narrative: 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-163-4339439-00 (RA). A 20-year-old female patient received BNT162b2 (BNT162B2), on 04Jan2021 as dose 1, single (Batch/Lot number: unknown) at the age of 20 years intramuscular for Covid-19 immunisation; risankizumab (SKYRIZI [RISANKIZUMAB]), (Lot number: 1156892) at unknown (1 in once), subcutaneous for psoriasis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CHRONIC TONSILLITIS (medically significant), outcome "recovered", described as "chronic tonsillitis of tonsils"; ILLNESS (non-serious), outcome "recovered", described as "COVID vaccine caused sick"; PYREXIA (non-serious), outcome "recovered", described as "COVID vaccine caused fever"; FATIGUE (non-serious), outcome "recovered", described as "COVID vaccine caused fatigue". The patient underwent the following laboratory tests and procedures: Body temperature: 101-102. The action taken for risankizumab was unknown. Additional information: Patient experienced events of non-serious COVID vaccine caused sick, fever, fatigue and chronic tonsillitis of tonsils with Skyrizi (Risankizumab). PFIZER BIONTECH COVID-19 vaccine (Tozinameran) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Causality for Skyrizi (Risankizumab): The reporter's causality for the event(s) of COVID vaccine caused sick, COVID vaccine caused fever, COVID vaccine caused fatigue and chronic tonsillitis of tonsils was not provided. Causality for PFIZER BIONTECH COVID-19 vaccine (Tozinameran): The reporter's causality for the event(s) Sickness, Fever, Fatigue, was Possible and for Chronic tonsillitis was Not Reported. The reporter's assessment of the causal relationship of "chronic tonsillitis of tonsils", "Covid vaccine caused sick", "Covid vaccine caused fever" and "Covid vaccine caused fatigue" 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. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Sender's Comments: As there is limited information in the case provided, the causal association between the event Chronic tonsillitis, sickness, fever, fatigue and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: Reports sore arm and fatigue today, that does not interfere with ability to work.; Reports sore arm and fatigue today, that does not interfere with ability to work.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 05Apr2022 (Batch/Lot number: unknown) as dose 4 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete;  unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Booster dose number unknown, manufacturer unknown), for COVID-19 immunization. The following information was reported: FATIGUE (non-serious), PAIN IN EXTREMITY (non-serious) all with onset 06Apr2022, outcome "unknown" and all described as "Reports sore arm and fatigue today, that does not interfere with ability to work.".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Guillain-Barre syndrome, Rash
Clinical narrative: Guillain Barre syndrome; Rash; 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-163-4339008-00 (AbbVie).  A 71 year-old male patient received bnt162b2 (BNT162B2), intramuscular (Batch/Lot number: unknown) at the age of 71 years as dose number unknown, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown). The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: GUILLAIN-BARRE SYNDROME (hospitalization, medically significant) with onset Dec2021, outcome "not recovered", described as "Guillain Barre syndrome"; RASH (non-serious), outcome "recovered", described as "Rash". The action taken for adalimumab was unknown. Therapeutic measures were taken as a result of guillain-barre syndrome. Clinical course: It was reported that patient's wife stated that he stopped Humira in 2021 because he kept getting rashes. In dec2021, he got guillain Barre syndrome and he was in a nursing home on a ventilator. It was unknown if patient was enrolled in a COVID-19 Vaccine trial.  The reporter's assessment of the causal relationship of events with suspect product Humira (adalimumab) for Guillain Barre syndrome was no reasonable possibility and for rash was reasonable possibility.  The reporter's assessment of the causal relationship of events with suspect product (Bnt162b2) 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 limited information in the case , a possible causal association between   the reported  events and the suspect drug BNT162B2 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: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: each dose gave her 'a rush of energy not felt since childhood' within about 15 minutes, and in the days that followed her chronic back pain went away, food irritations, and other complications eased.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 37 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 02Nov2021 (Lot number: fe3590) at the age of 36 years as dose 3 (booster), single, administration date 27Apr2021 (Lot number: er7533) as dose 2, single and administration date 06Apr2021 (Lot number: er8734) as dose 1, single for covid-19 immunisation; covid-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE) (Batch/Lot number: unknown) as dose 4  (booster), single. Relevant medical history included: "Known allergies: allergic to penicillin" (unspecified if ongoing), notes: Known allergies: allergic to penicillin; "adrenal insufficiency" (unspecified if ongoing), notes: patient has mixed adrenal insufficiency (prior to vaccines) and suffered from convulsions, neuropathy, migraines, and more for most of her life.; "convulsions" (unspecified if ongoing), notes: patient has mixed adrenal insufficiency (prior to vaccines) and suffered from convulsions, neuropathy, migraines, and more for most of her life.; "neuropathy" (unspecified if ongoing), notes: patient has mixed adrenal insufficiency (prior to vaccines) and suffered from convulsions, neuropathy, migraines, and more for most of her life.; "migraines" (unspecified if ongoing), notes: patient has mixed adrenal insufficiency (prior to vaccines) and suffered from convulsions, neuropathy, migraines, and more for most of her life. Concomitant medication(s) included: TOPAMAX; AYGESTIN; CBD OIL; NAC [ACETYLCYSTEINE]. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "each dose gave her 'a rush of energy not felt since childhood' within about 15 minutes, and in the days that followed her chronic back pain went away, food irritations, and other complications eased.". Therapeutic measures were not taken as a result of therapeutic response unexpected.  Additional Information: Facility type vaccine was Pharmacy or Drug Store. No other vaccine in four weeks. No covid prior to vaccination. Patient had mixed adrenal insufficiency (prior to vaccines) and suffered from convulsions, neuropathy, migraines, and more for most of her life. each dose gave her 'a rush of energy not felt since childhood' within about 15 minutes, and in the days that followed her chronic back pain went away, food irritations, and other complications eased.   No follow-up attempts are possible. No further information is expected.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, SARS-CoV-2 test, Tinnitus, Vertigo
Clinical narrative: Within a week of getting the 2nd Covid shot I started having vertigo; Dizziness; Extreme ringing in my left ear; This is a spontaneous report from a contactable reporter (Consumer or other non-HCP). The reporter is the patient.   A 59-year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 01Apr2021 at 12:00 (Lot number: EW0150) at the age of 59 years 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, SINGLE, Lot Number: EN6207, Anatomical site: left arm, Administration time: 12:00), administration date: 11Mar2021 when the patient was 59 years old for COVID-19 immunisation.  The following information was reported: VERTIGO (non-serious) with onset 01Apr2021, outcome "not recovered", described as "Within a week of getting the 2nd Covid shot I started having vertigo"; DIZZINESS (non-serious) with onset 01Apr2021, outcome "not recovered", described as "Dizziness"; TINNITUS (non-serious) with onset 01Apr2021, outcome "not recovered", described as "Extreme ringing in my left ear". Relevant laboratory tests and procedures are available in the appropriate section. The events within a week of getting the 2nd Covid shot I started having vertigo, dizziness and extreme ringing in my left ear resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of vertigo, dizziness and tinnitus.  Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient received thyroid medication as treatment for the reported events. Since the vaccination, the patient had been tested for COVID-19 and the result was negative. The patient also received bnt162b2 (BNT162B2), administered in arm left, administration date 05Oct2021 at 12:00 (Lot number: FF2587) at the age of 59 years as dose 3, booster single for COVID-19 immunisation.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Coronary artery occlusion, Dyspnoea
Clinical narrative: Slight blockage in heart; Shortness of breath; 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-163-4338136-00.  A 53 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date 01Aug2021 (Batch/Lot number: unknown) at the age of 52 years as dose 3 (booster), single, intramuscular, administration date 02Apr2021 (Batch/Lot number: unknown) as dose 2, single and intramuscular, administration date 01Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) for ankylosing spondylitis. Relevant medical history included: "Ankylosing Spondylitis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: CORONARY ARTERY OCCLUSION (medically significant), outcome "unknown", described as "Slight blockage in heart"; DYSPNOEA (non-serious) with onset Aug2021, outcome "unknown", described as "Shortness of breath". The action taken for adalimumab was unknown. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Causality for Humira: The reporter's causality for the event(s) of SLIGHT BLOCKAGE IN HEART with HUMIRA(ADALIMUMAB) was no reasonable possibility. The reporter's causality for the event(s) of SHORTNESS OF BREATH was not provided.  The reporter considered "slight blockage in heart" and "shortness of breath" related to bnt162b2. 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, there is a reasonable possibility of a causal relationship between the suspect vaccine BNT162B2 (COMIRNATY) and reported events which cannot be fully assessed/excluded. The case will be reassessed if additional information becomes available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: M
Vaccine: COVID19
Symptoms: Myocarditis
Clinical narrative: his son developed myocarditis after Covid shot; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A male patient 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: MYOCARDITIS (medically significant), outcome "unknown", described as "his son developed myocarditis after Covid shot".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles; This is a spontaneous report received from non-contactable reporter(s) (Nurse). Other Case identifier(s): MOD-2022-530729 (Moderna).  A female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "COVID-19", start date: 24Oct2021 (unspecified if ongoing), notes: Has the patient ever been diagnosed with/tested positive for COVID-19? Yes; "Multiple sclerosis" (unspecified if ongoing); "Deficiency" (unspecified if ongoing); "Cough" (unspecified if ongoing). Concomitant medication(s) included: BETASERON subcutaneous taken for multiple sclerosis, start date: 10Jul2021 (ongoing); VITAMIN D 2000 oral taken for hypovitaminosis (ongoing); FLUTICASONE PROPIONATE nasal taken for cough (ongoing). The following information was reported: HERPES ZOSTER (non-serious), outcome "unknown", described as "Shingles". Additional information: MODERNA COVID-19 VACCINE Information: Received Dose 1 on 28Mar2022 at 16:00Pm, Lot: 030H21B, Route and Body site: L deltoid, Dos/Volume:0.25ml. Dose 2,3,4 not received. Patient was pregnant. Allergies to medications, Food, and other products were reported as NKDA. Patient was diagnosed with/tested positive for COVID-19 on 24Oct2021. Acute illnesses at the time of vaccination and up to one month before was reported as None. Patient was given Expired vaccine on 28Mar2022 at 16:00 PM. Event did not cause the patient to seek medical care. It was unknown if the adverse event was most likely caused by mRNA-1273. Event outcome was reported as Recovered on 29Mar2022. Pt received expired vaccine for booster dose on 28Mar2022 Pt was called the next day, who stated she had experienced very mild sx after vaccination, much less than her first two Pfizer where she developed Shingles. She stated she developed a mild fever, HA, some body aches but these went away in about 24 hours. Pt notified, provider notified, Moderna communicated that adequate coverage was still maintained despite expiration.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: I have now tested positive 3 times; I have now tested positive 3 times; 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), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) 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), SARS-COV-2 TEST POSITIVE (medically significant), outcome "unknown" and all described as "I have now tested positive 3 times". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: I have now tested positive 3 times, being vaccinated (before the 1st) and boosted (before the 2nd and 3rd).  Clinical course: I am interested in signing up for the research study with COVID.I was vaccinated with Pfizer. Please let me know how I can be of service.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Myelitis transverse
Clinical narrative: transverse myelitis; This is a spontaneous report received from a contactable reporter(s) (Nurse).  A male patient 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: MYELITIS TRANSVERSE (medically significant), outcome "unknown", described as "transverse myelitis".  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 temporal association, the causal relationship between BNT162B2 and the event, Transverse myelitis cannot be completely 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, UNK
Symptoms: Back pain, Body temperature, Body temperature abnormal, Contusion, Crohn's disease
Clinical narrative: crohn's flare up; temperature between ninety nine point one and ninety nine point seven; bruising on top of thighs; nausea; back pain; This is a solicited report from a Study (Marketing Program Name Not Available) received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4340356-00 (AbbVie).  A 29 year-old female patient received bnt162b2 (BNT162B2), intramuscular (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Lot number: 1159670) till Nov2021 at unk (citrate free) for crohn's disease. 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. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: CROHN'S DISEASE (medically significant) with onset Mar2022, outcome "not recovered", described as "crohn's flare up"; BODY TEMPERATURE ABNORMAL (non-serious) with onset Mar2022, outcome "unknown", described as "temperature between ninety nine point one and ninety nine point seven"; CONTUSION (non-serious) with onset Mar2022, outcome "unknown", described as "bruising on top of thighs"; NAUSEA (non-serious) with onset Mar2022, outcome "unknown", described as "nausea"; BACK PAIN (non-serious) with onset Mar2022, outcome "unknown", described as "back pain". The patient underwent the following laboratory tests and procedures: body temperature: (Mar2022) between 99.1 and 99.7; weight: (Mar2022) loss of 3 lbs. The action taken for adalimumab was dosage permanently withdrawn on Nov2021 and dechallenge was negative. The reporter's causality for the events of temperature between ninety nine point one and ninety nine point seven, bruising on top of thighs, nausea and back pain was not provided while event of crohn's flare up was a reasonable possibility with Humira (adalimumab). The reporter considered "crohn's flare up", "temperature between ninety nine point one and ninety nine point seven", "bruising on top of thighs", "nausea" and "back pain" related to bnt162b2.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information provided there is a reasonable possibility of causal association between the events with the suspect product 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 RAs, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Nausea, Weight
Clinical narrative: crohn's flare up; temperature between ninety nine point one and ninety nine point seven; bruising on top of thighs; nausea; back pain; This is a solicited report from a Study (Marketing Program Name Not Available) received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4340356-00 (AbbVie).  A 29 year-old female patient received bnt162b2 (BNT162B2), intramuscular (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Lot number: 1159670) till Nov2021 at unk (citrate free) for crohn's disease. 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. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: CROHN'S DISEASE (medically significant) with onset Mar2022, outcome "not recovered", described as "crohn's flare up"; BODY TEMPERATURE ABNORMAL (non-serious) with onset Mar2022, outcome "unknown", described as "temperature between ninety nine point one and ninety nine point seven"; CONTUSION (non-serious) with onset Mar2022, outcome "unknown", described as "bruising on top of thighs"; NAUSEA (non-serious) with onset Mar2022, outcome "unknown", described as "nausea"; BACK PAIN (non-serious) with onset Mar2022, outcome "unknown", described as "back pain". The patient underwent the following laboratory tests and procedures: body temperature: (Mar2022) between 99.1 and 99.7; weight: (Mar2022) loss of 3 lbs. The action taken for adalimumab was dosage permanently withdrawn on Nov2021 and dechallenge was negative. The reporter's causality for the events of temperature between ninety nine point one and ninety nine point seven, bruising on top of thighs, nausea and back pain was not provided while event of crohn's flare up was a reasonable possibility with Humira (adalimumab). The reporter considered "crohn's flare up", "temperature between ninety nine point one and ninety nine point seven", "bruising on top of thighs", "nausea" and "back pain" related to bnt162b2.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information provided there is a reasonable possibility of causal association between the events with the suspect product 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 RAs, Ethics Committees, and Investigators, as appropriate.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Vomiting
Clinical narrative: Vomiting; covid; covid; 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-163-4339756-00.  A 43-year-old male patient received BNT162b2 (BNT162B2), on 16Apr2021 as dose 1, single (Batch/Lot number: unknown) and on 07May2021 as dose 2, single (Batch/Lot number: unknown) at the age of 43 years, all intramuscular for covid-19 immunisation; risankizumab (SKYRIZI [RISANKIZUMAB]), (ongoing) (Lot number: 1160234), 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), COVID-19 (medically significant) all with onset 2021, outcome "unknown" and all described as "covid"; VOMITING (non-serious), outcome "recovering". The action taken for risankizumab was dosage not changed. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.The patient had covid. He had first two doses of vaccine but not booster and in 2021, he had a serious reaction to the second vaccine. He had covid several weeks ago and had myocarditis and a heart attack when he had the vaccine.  The reporter's assessment of the causal relationship of "covid" with the suspect product(s) BNT162b2 was not related and causal relationship of "vomiting" 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 information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.  Follow-up (08Apr2022): This is a solicited Follow-up report based on information received by Pfizer (Manufacturer Control Number: 22K-163-4339756-00). A contactable consumer (patient) reported that:  Updated information included: Suspect dose 1 and dose 2 information, Co-suspect ''SKYRIZI' lot number and new event Vomiting' were added. Clinical information and causal assessment added in narrative.  The lot number for [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of  events, Drug Ineffective, COVID-19 and vomiting  cannot be totally excluded
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
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-163-4339657-00 (AbbVie).  A 77 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 18Nov2021 (Batch/Lot number: unknown) at the age of 77 years as dose 3 (booster), single, intramuscular, administration date 08Feb2021 (Batch/Lot number: unknown) as dose 2, single and intramuscular, administration date 18Jan2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) for psoriasis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The action taken for adalimumab was unknown.  Additional Information: Solicited report from the RA by a consumer of an elderly female with an event of non-serious COVID with Humira (Adalimumab). There was no reported medical history. On an unknown date, the patient experienced Covid. Pfizer BioNTech Covid-19 Vaccine (Tozinameran) was also considered suspect. 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 COVID was not provided as Reaction: Covid-19 (Covid-19). Causality for Covid-19 (Covid-19), Causality as per reporter (Drug/Vaccine): Not Reported. Drug: Pfizer BioNTech Covid-19 Vaccine(Tozinameran)(Tozinameran), Unknown, Unknown. Causality for Covid-19 (Covid-19), Causality as per reporter (Drug/Vaccine): Possible. Did event abate after stopping drug reported as N/A. Concomitant Drugs and Dates of Administration (Exclude those used to treat event): Concomitant Drugs Not reported.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on plausible dose -event relationship post vaccination and no other alternate explanation the causal role of BNT162B2 cannot be excluded for the reported LOE events
Sex: U
Vaccine: COVID19
Symptoms: Myocarditis
Clinical narrative: Myocarditis Secondary to COVID-19 mRNA Vaccine; This is a literature report.  A patient (no qualifiers provided) received COVID-19 Vaccine - Manufacturer Unknown, 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: MYOCARDITIS (medically significant), outcome "unknown", described as "Myocarditis Secondary to COVID-19 mRNA Vaccine".  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 and the drug temporal relationship, the causality between the event "Myocarditis" and the suspect drug "BNT162B2" 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, UNK
Symptoms: Body temperature, Drug ineffective, Therapeutic response shortened
Clinical narrative: Wearing off effect; Wearing off effect; 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-163-4336281-00.  A 65-year-old female patient received BNT162b2 (BNT162B2), on 05Jul2021 as dose 1, single (Batch/Lot number: unknown) and on 16Dec2021 as dose 2, single (Batch/Lot number: unknown), all intramuscular for covid-19 immunisation; risankizumab (SKYRIZI [RISANKIZUMAB]), (Batch/Lot number: unknown), subcutaneous for psoriasis. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), THERAPEUTIC RESPONSE SHORTENED (medically significant) all with onset 2021, outcome "recovered" (2021) and all described as "Wearing off effect". The patient underwent the following laboratory tests and procedures: Body temperature: 104. The action taken for risankizumab was unknown.  The reporter's assessment of the causal relationship of "wearing off effect" 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.  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 and the known product safety profile, a causal relationship between the reported events, Drug Ineffective, therapeutic response shortened and BNT162B2 is considered possible
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Colonoscopy, Large intestinal haemorrhage
Clinical narrative: bleeding in colon; MARKETING PROGRAM  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-163-4339989-00.  A 31 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date 06Dec2020 (Batch/Lot number: unknown) at the age of 31 years as dose 1 , single, intramuscular, administration date 21Jan2021 (Batch/Lot number: unknown) as dose 2, single and intramuscular, administration date 04Apr2021 (Batch/Lot number: unknown) as dose 3 (booster) , single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) at citrate free for crohn's disease. The patient's relevant medical history and concomitant medications were not reported.The following information was reported: LARGE INTESTINAL HAEMORRHAGE (medically significant), outcome "not recovered", described as "bleeding in colon". The patient underwent the following laboratory tests and procedures: colonoscopy: unknown result, notes: Bleeding in colon. The action taken for adalimumab was unknown.  The reporter considered "bleeding in colon" related to bnt162b2.  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 reported information, the causal association between the event large intestinal haemorrhage and the suspect drug BNT162B2 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: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Enuresis
Clinical narrative: started wetting the bed on the night; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 26 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 26 years as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ENURESIS (non-serious), outcome "unknown", described as "started wetting the bed on the night".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Pfizer-BioNTech Vaccine administered/ Paxlovid: Treatment of COVID-19; Pfizer-BioNTech Vaccine administered/ Paxlovid: Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose number un-known, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Hypertension" (unspecified if ongoing); "Thyroid disease" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "Pfizer-BioNTech Vaccine adminis-tered/ Paxlovid: Treatment of COVID-19". Therapeutic measures were taken as a result of covid-19, drug ineffective.   Clinical Information as reported: Patient did not receive other medication in 2 weeks. Anti viral details: product=COVID 19 Treatment, brand=Paxlovid, treatment start date=04Apr2022, Indication=Treatment of COVID-19. Adverse event Headache within 1/2 hr to 1 hour of taking dose. Chalky sensation in mouth. No appetite adverse event start date: 04Apr2022 if treatment AE was Unknown.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site pain
Clinical narrative: The soreness is always there and it really bothers me; Left arm where they gave him injection has been sore since vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) from medical information team, Program ID: (005570). The reporter is the patient.  A 52-year-old male patient received BNT162b2 (BNT162B2), on 09Feb2022 as dose 3 (booster), single (Lot number: FL3198) at the age of 52 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose 2, single, Lot Number: EC3180, caller uncertain of anatomical location of the vaccine, thinks it was his left arm.), administration date: 09Aug2021, when the patient was 51-year-old, for COVID-19 immunization; BNT162b2 (Dose 1, single, Lot Number: FA6780, caller uncertain of anatomical location of the vaccine, thinks it was his left arm.), administration date: 19Jul2021, when the patient was 51-year-old, for COVID-19 immunization. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset Feb2022, outcome "not recovered", described as "Left arm where they gave him injection has been sore since vaccine"; PAIN IN EXTREMITY (non-serious) with onset Feb2022, outcome "unknown", described as "The soreness is always there, and it really bothers me".  Additional information: They advised him to take Ibuprofen and put ice on it. Caller states that's not what he needed. Says he just wants to know if he should be concerned and if there is any information related to this. Caller states it has been ongoing since 09Feb2022 and even holding the handle on his zero-turn lawnmower causes pain.    No follow-up attempts are possible . No further information is expected.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: my temperature is increasing and going; up to 103 degrees; I have got a 103 fever; body ache; I have got chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 62-year-old male patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 62 years for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing), notes: Asthma. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1 single, Unknown Manufacturer), for Covid-19 immunization; Covid-19 vaccine (Dose 2, single  Unknown Manufacturer), for Covid-19 immunization; Covid-19 vaccine (Dose 3(Booster), single Unknown Manufacturer), for Covid-19 immunization. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "my temperature is increasing and going; up to 103 degrees; I have got a 103 fever"; PAIN (non-serious), outcome "unknown", described as "body ache"; CHILLS (non-serious), outcome "unknown", described as "I have got chills". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, pain, chills. Additional information Reporter stated, I got my second COVID booster shot today, and my temperature is increasing and going up and now up to 103 degrees, the temperature, I have got body ache, I have got chills. Is there anything I can do for this. Other medical condition- he stated, Well I have Asthma, but this is not bothering my breathing. Other medication: patient stated, I have an inhaler. Name of Inhaler: patient stated, I think it is Albuterol, I am not able to get up and 'pull up' right now (Further clarification unknown hence not captured in tab).  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Supraventricular tachycardia
Clinical narrative: developed supra ventricular tachycardia 2 months after my booster shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old patient received BNT162b2 (BNT162B2), 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. Vaccination history included: Bnt162b2 (DOSE 1, I also had a reaction to the first vaccine which did disappear after 3 days), for Covid-19 immunization, reaction(s): "I also had a reaction to the first vaccine".  The following information was reported: SUPRAVENTRICULAR TACHYCARDIA (medically significant), 2 months after the suspect product(s) administration, outcome "unknown", described as "developed supra ventricular tachycardia 2 months after my booster shot". Clinical information:I've developed supra ventricular tachycardia 2 months after my booster shot I am 66 years old could that have been from the vaccine I know super ventricular tachycardia has occurred directly after the vaccine could it have had occurred later on I also had a reaction to the first vaccine which did disappear after 3 days  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Influenza like illness, Pain in extremity, Pyrexia
Clinical narrative: Arm pain; flu-like symptoms; low grade fever (99.8-100.1); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Apr2022 at 11:30 as dose 4 (booster), single (Lot number: FL3197) at the age of 53 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: shellfish" (unspecified if ongoing), notes: Known allergies: yes - shellfish. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 immunization; Bnt162b2 (DOSE 2, SINGLE), for Covid-19 immunization; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for Covid-19 immunization.  The following information was reported: OFF LABEL USE (non-serious) with onset 05Apr2022 at 11:30, outcome "unknown", described as "dose received More than 3 / dose number: 4"; PAIN IN EXTREMITY (non-serious) with onset 05Apr2022 at 16:00, outcome "recovered" (2022), described as "Arm pain"; INFLUENZA LIKE ILLNESS (non-serious) with onset 05Apr2022 at 16:00, outcome "recovered" (2022), described as "flu-like symptoms"; PYREXIA (non-serious) with onset 05Apr2022 at 16:00, outcome "recovered" (2022), described as "low grade fever (99.8-100.1)". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pain in extremity, influenza like illness, pyrexia.  Additional Information: No other vaccine in four weeks. No COVID prior to the vaccination. No COVID tested post vaccination.  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: have had a tinnitus ever since; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP), Program ID:. The reporter is the patient.  A 61-year-old patient received BNT162b2 (BNT162B2), in Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: TINNITUS (non-serious), outcome "unknown", described as "have had a tinnitus ever since".  Additional Information: Subject: Patient Assistance. Customer Verbatim: I received the third Pfizer vaccine in Dec2021 and have had a tinnitus ever since, I am a healthy 61-year-old and do not have any health issues. I will not be getting another COVID vaccine due to this. Forwarded as an Adverse Event by the regulatory authority on 07Apr2022. Reporter provided verification of contact address on 06Apr2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.