chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Glucose tolerance impaired, Inappropriate schedule of product administration, Menopausal symptoms, Menstrual disorder, SARS-CoV-2 test
Clinical narrative: Patient received the 2nd dose of BNT162B2, 70 days after the 1st dose; Pre-diabetes/Diabetes 2; Pre-diabetes/Diabetes 2; Menstrual cycle disruption - post-menopausal symptoms; Menstrual cycle disruption - post-menopausal symptoms; This is a spontaneous report received from a contactable consumer. The reporter is the patient.  A 47-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection), administered in the right arm, administration date 01Apr2021 (Lot number: EW0175) at the age of 47 years as dose 2, single for COVID-19 immunization. Relevant medical history included: "Soybean oil allergy" (unspecified if ongoing). Concomitant medication(s) included: NP THYROID. Vaccination history included: BNT162B2 (dose 1, single; lot number: ER8733; site: left arm), administration date: 22Jan2021 11:15, when the patient was 47 years old, for COVID-19 immunization. The patient did not receive any other vaccines 4 weeks prior to the COVID-19 vaccine. The following information was reported: TYPE 2 DIABETES MELLITUS (disability, medically significant), GLUCOSE TOLERANCE IMPAIRED (disability) all with onset Apr2021, outcome "not recovered" and all described as "Pre-diabetes/Diabetes 2"; MENSTRUAL DISORDER (disability), MENOPAUSAL SYMPTOMS (disability) all with onset Apr2021, outcome "not recovered" and all described as "Menstrual cycle disruption - post-menopausal symptoms"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 01Apr2021, outcome "unknown", described as "Patient received the 2nd dose of BNT162B2, 70 days after the 1st dose". The events "pre-diabetes/diabetes 2", "pre-diabetes/diabetes 2", "menstrual cycle disruption - post-menopausal symptoms" and "menstrual cycle disruption - post-menopausal symptoms" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (Aug2021) negative. Therapeutic measures were taken as result of type 2 diabetes mellitus, glucose tolerance impaired, menstrual disorder, menopausal symptoms.  No follow-up attempts are possible. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Type 2 diabetes mellitus
Clinical narrative: Patient received the 2nd dose of BNT162B2, 70 days after the 1st dose; Pre-diabetes/Diabetes 2; Pre-diabetes/Diabetes 2; Menstrual cycle disruption - post-menopausal symptoms; Menstrual cycle disruption - post-menopausal symptoms; This is a spontaneous report received from a contactable consumer. The reporter is the patient.  A 47-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection), administered in the right arm, administration date 01Apr2021 (Lot number: EW0175) at the age of 47 years as dose 2, single for COVID-19 immunization. Relevant medical history included: "Soybean oil allergy" (unspecified if ongoing). Concomitant medication(s) included: NP THYROID. Vaccination history included: BNT162B2 (dose 1, single; lot number: ER8733; site: left arm), administration date: 22Jan2021 11:15, when the patient was 47 years old, for COVID-19 immunization. The patient did not receive any other vaccines 4 weeks prior to the COVID-19 vaccine. The following information was reported: TYPE 2 DIABETES MELLITUS (disability, medically significant), GLUCOSE TOLERANCE IMPAIRED (disability) all with onset Apr2021, outcome "not recovered" and all described as "Pre-diabetes/Diabetes 2"; MENSTRUAL DISORDER (disability), MENOPAUSAL SYMPTOMS (disability) all with onset Apr2021, outcome "not recovered" and all described as "Menstrual cycle disruption - post-menopausal symptoms"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 01Apr2021, outcome "unknown", described as "Patient received the 2nd dose of BNT162B2, 70 days after the 1st dose". The events "pre-diabetes/diabetes 2", "pre-diabetes/diabetes 2", "menstrual cycle disruption - post-menopausal symptoms" and "menstrual cycle disruption - post-menopausal symptoms" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (Aug2021) negative. Therapeutic measures were taken as result of type 2 diabetes mellitus, glucose tolerance impaired, menstrual disorder, menopausal symptoms.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Dizziness, Pulmonary fibrosis
Clinical narrative: Pulmonary fibrosis; Dizzy spells; FACILITATED COLLECT  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 21K-163-4190337-00.  A 69 year-old female patient received bnt162b2 (BNT162B2), intramuscular (Batch/Lot number: unknown) as dose 1, single and intramuscular (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) at citrate free for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PULMONARY FIBROSIS (medically significant), outcome "unknown", described as "Pulmonary fibrosis"; DIZZINESS (non-serious), outcome "recovered" (2021), described as "Dizzy spells". The action taken for adalimumab was unknown. Therapeutic measures were taken as a result of pulmonary fibrosis with Ofev 150 milligrams.It was unknown if she was enrolled in a COVID-19 vaccine trial. The reporter considered "dizzy spells" not associated to bnt162b2. The reporter's assessment of the causal relationship of the event Pulmonary fibrosis with the suspect product was not provided at the time of this report.The reporter's causality for the event(s) of pulmonary fibrosis and dizzy spells with HUMIRA(ADALIMUMAB) was no reasonable possibility. Manufacturer opinion is that the event of pulmonary fibrosis is not assessable. Manufacturer opinion is that there is no reasonable possibility that the event of dizzy spells is related to HUMIRA(ADALIMUMAB).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the  information in the case report, a possible causal relationship between the events Pulmonary fibrosis, Dizziness  and 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: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Bone contusion, Immunisation, Pain of skin, Rheumatoid arthritis
Clinical narrative: Booster Dose; Rheumatoid arthritis flare ups in hips; Bruise on both sided of the hip bone; Sore spot on left arm below the elbow; FACILITATED COLLECT  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 21K-163-4193509-00.  A 57 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 05Feb2021 (Batch/Lot number: unknown) as dose 1, single, (at age 56 years), intramuscular, administration date 06Mar2021 (Batch/Lot number: unknown) as dose 2, single (at age 56 years), and intramuscular, administration date 2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) at citrate free for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The following information was reported: IMMUNISATION (medically significant) with onset 2021, outcome "unknown", described as "Booster Dose"; RHEUMATOID ARTHRITIS (medically significant) with onset 2021, outcome "not recovered", described as "Rheumatoid arthritis flare ups in hips"; BONE CONTUSION (non-serious) with onset 2021, outcome "unknown", described as "Bruise on both sided of the hip bone"; PAIN OF SKIN (non-serious) with onset 2021, outcome "not recovered", described as "Sore spot on left arm below the elbow". The action taken for adalimumab was unknown.  The reporter's causality for the event(s) with (HUMIRA) Adalimumab of 'Bruise on both sides of the hip bone, Rheumatoid Arthritis Flare ups in Hips and sore on left arm below the elbow' was not provided. The reporter's causality for the event(s) with PFIZER BIONTECH COVID-19 VACCINE of 'Bruise on both sides of the hip bone, Rheumatoid Arthritis Flare ups in Hips and sore on left arm below the elbow' was possible.  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 IMMUNISATION, RHEUMATOID ARTHRITIS, BONE CONTUSION, PAIN OF SKIN and the suspect vaccine 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: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Immunisation
Clinical narrative: Booster; Feeling bad; This is a spontaneous report received from contactable reporter(s) (Other HCP) for a Pfizer sponsored program (002611).  A 37 year-old female patient received bnt162b2 (BNT162B2), administration date 18Dec2021 (Batch/Lot number: unknown) at the age of 37 years as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Manufacturer Unknown), for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 18Dec2021, outcome "unknown", described as "Booster"; FEELING ABNORMAL (non-serious) with onset Dec2021, outcome "unknown", described as "Feeling bad".  Additional information: (Feeling bad): Patient reported gaps in therapy because she took it out then falls asleep and dose ruined. Did not take med after COVID booster on 18Dec because of feeling bad. Also after labs Oct2021 her IGF levels were elevated. No additional information available. Feeling bad was not serious adverse event. (Feeling bad) reporter consider event caused by suspect product was not known.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Deafness unilateral, Loss of consciousness, Nerve injury, Vomiting
Clinical narrative: went unconscious for 2.5 days; deaf in one ear; vomiting; permanent nerve damage; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose), for COVID-19 Immunization, reaction(s): "spells of dizziness after the first dose". The following information was reported: After two weeks of second dose of vaccination, VOMITING (non-serious), outcome "unknown", described as "vomiting"; and then LOSS OF CONSCIOUSNESS (medically significant), outcome "recovered", described as "went unconscious for 2.5 days". When patient woke DEAFNESS UNILATERAL (medically significant), outcome "unknown", described as "deaf in one ear". The doctor informed that, the patient had NERVE INJURY (non-serious), outcome "unknown", described as "permanent nerve damage". The events "vomiting", "went unconscious for 2.5 days", "deaf in one ear" and "permanent nerve damage" were evaluated at the physician office visit.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Asthenia, COVID-19, Dizziness, Drug ineffective
Clinical narrative: she was going to pass out; positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; Weakness; Dizziness; Throwing up; Fever; abdominal pain; she didn't go back to work until 24Sep2021; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56 year-old female patient received bnt162b2 (BNT162B2), administration date 09Aug2021 (Lot number: EW0179) at the age of 56 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: LOSS OF CONSCIOUSNESS (medically significant) with onset 27Aug2021, outcome "recovered" (24Sep2021), described as "she was going to pass out"; COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 27Aug2021, outcome "unknown" and all described as "positive COVID-19 test with symptoms"; ASTHENIA (non-serious) with onset 27Aug2021, outcome "recovered" (24Sep2021), described as "Weakness"; DIZZINESS (non-serious) with onset 27Aug2021, outcome "recovered" (24Sep2021), described as "Dizziness"; VOMITING (non-serious) with onset 27Aug2021, outcome "recovered" (24Sep2021), described as "Throwing up"; ABDOMINAL PAIN (non-serious) with onset Aug2021, outcome "not recovered", described as "abdominal pain"; JOB DISSATISFACTION (non-serious) with onset Aug2021, outcome "recovered" (24Sep2021), described as "she didn't go back to work until 24Sep2021"; PYREXIA (non-serious) with onset 27Aug2021, outcome "recovered" (24Sep2021), described as "Fever". The events "she was going to pass out", "positive covid-19 test with symptoms", "positive covid-19 test with symptoms", "weakness", "dizziness", "throwing up", "abdominal pain", "she didn't go back to work until 24sep2021" and "fever" were evaluated at the physician office visit and emergency room visit.   The patient underwent the following laboratory tests and procedures: pyrexia: (27Aug2021) 102; sars-cov-2 test: (27Aug2021) positive; ultrasound scan: (unspecified date) unknown results.   Therapeutic measures were taken as a result of loss of consciousness, covid-19, asthenia, vomiting, abdominal pain, job dissatisfaction, pyrexia. Therapeutic measures were not taken as a result of dizziness.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101851769 same patient/product, different dose/events.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Job dissatisfaction, Loss of consciousness, Pyrexia, SARS-CoV-2 test, Ultrasound scan
Clinical narrative: she was going to pass out; positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; Weakness; Dizziness; Throwing up; Fever; abdominal pain; she didn't go back to work until 24Sep2021; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56 year-old female patient received bnt162b2 (BNT162B2), administration date 09Aug2021 (Lot number: EW0179) at the age of 56 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: LOSS OF CONSCIOUSNESS (medically significant) with onset 27Aug2021, outcome "recovered" (24Sep2021), described as "she was going to pass out"; COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 27Aug2021, outcome "unknown" and all described as "positive COVID-19 test with symptoms"; ASTHENIA (non-serious) with onset 27Aug2021, outcome "recovered" (24Sep2021), described as "Weakness"; DIZZINESS (non-serious) with onset 27Aug2021, outcome "recovered" (24Sep2021), described as "Dizziness"; VOMITING (non-serious) with onset 27Aug2021, outcome "recovered" (24Sep2021), described as "Throwing up"; ABDOMINAL PAIN (non-serious) with onset Aug2021, outcome "not recovered", described as "abdominal pain"; JOB DISSATISFACTION (non-serious) with onset Aug2021, outcome "recovered" (24Sep2021), described as "she didn't go back to work until 24Sep2021"; PYREXIA (non-serious) with onset 27Aug2021, outcome "recovered" (24Sep2021), described as "Fever". The events "she was going to pass out", "positive covid-19 test with symptoms", "positive covid-19 test with symptoms", "weakness", "dizziness", "throwing up", "abdominal pain", "she didn't go back to work until 24sep2021" and "fever" were evaluated at the physician office visit and emergency room visit.   The patient underwent the following laboratory tests and procedures: pyrexia: (27Aug2021) 102; sars-cov-2 test: (27Aug2021) positive; ultrasound scan: (unspecified date) unknown results.   Therapeutic measures were taken as a result of loss of consciousness, covid-19, asthenia, vomiting, abdominal pain, job dissatisfaction, pyrexia. Therapeutic measures were not taken as a result of dizziness.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101851769 same patient/product, different dose/events.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: she was going to pass out; positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; Weakness; Dizziness; Throwing up; Fever; abdominal pain; she didn't go back to work until 24Sep2021; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56 year-old female patient received bnt162b2 (BNT162B2), administration date 09Aug2021 (Lot number: EW0179) at the age of 56 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: LOSS OF CONSCIOUSNESS (medically significant) with onset 27Aug2021, outcome "recovered" (24Sep2021), described as "she was going to pass out"; COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 27Aug2021, outcome "unknown" and all described as "positive COVID-19 test with symptoms"; ASTHENIA (non-serious) with onset 27Aug2021, outcome "recovered" (24Sep2021), described as "Weakness"; DIZZINESS (non-serious) with onset 27Aug2021, outcome "recovered" (24Sep2021), described as "Dizziness"; VOMITING (non-serious) with onset 27Aug2021, outcome "recovered" (24Sep2021), described as "Throwing up"; ABDOMINAL PAIN (non-serious) with onset Aug2021, outcome "not recovered", described as "abdominal pain"; JOB DISSATISFACTION (non-serious) with onset Aug2021, outcome "recovered" (24Sep2021), described as "she didn't go back to work until 24Sep2021"; PYREXIA (non-serious) with onset 27Aug2021, outcome "recovered" (24Sep2021), described as "Fever". The events "she was going to pass out", "positive covid-19 test with symptoms", "positive covid-19 test with symptoms", "weakness", "dizziness", "throwing up", "abdominal pain", "she didn't go back to work until 24sep2021" and "fever" were evaluated at the physician office visit and emergency room visit.   The patient underwent the following laboratory tests and procedures: pyrexia: (27Aug2021) 102; sars-cov-2 test: (27Aug2021) positive; ultrasound scan: (unspecified date) unknown results.   Therapeutic measures were taken as a result of loss of consciousness, covid-19, asthenia, vomiting, abdominal pain, job dissatisfaction, pyrexia. Therapeutic measures were not taken as a result of dizziness.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101851769 same patient/product, different dose/events.
Sex: F
Vaccine: COVID19
Symptoms: Illness, Immunisation
Clinical narrative: booster; Pretty sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570). The reporter is the parent.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1), for COVID-19 Immunization; Bnt162b2 (DOSE 2, My daughter from her booster and her second shot was pretty sick for 2 or 3 days), for COVID-19 Immunization, reaction(s): "pretty sick". The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "booster"; ILLNESS (non-serious), outcome "recovered" (2021), described as "Pretty sick".  Additional information: The reporter stated that " I had the 2 first shots they were absolutely nothing, didn't even feel the prick. My daughter from her booster and her second shot was pretty sick for 2 or 3 days so I guess it effects everybody differently".   The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Immunisation, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19; COVID-19; booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 34 year-old female patient received bnt162b2 (BNT162B2), administration date 05Oct2021 (Lot number: EW0196) at the age of 34 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (DOSE: 1, Lot Number: EL3248, MANUFACTUERER UNKNOWN), administration date: 02Mar2021, when the patient was 33 years old, for COVID-19 immunization; Covid-19 vaccine (DOSE: 2, Lot Number: EL3248, MANUFACTUERER UNKNOWN), administration date: 23Mar2021, when the patient was 33 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (medically significant) with onset 05Oct2021, outcome unknown; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 22Dec2021, outcome unknown.  Clinical course: Says she is fully vaccinated and has had the booster shot of the Covid Vaccine and now has Covid 19. The patient verifies that her first and second doses of the vaccine have the same Lot Number. The patient had not required to visit to emergency room/physician office. The patient description of complaint was Tested positive for Covid 19 after three doses of the Covid 19 Vaccine.
Sex: M
Vaccine: COVID19
Symptoms: Investigation, Magnetic resonance imaging, Magnetic resonance imaging head, Myelitis transverse
Clinical narrative: Acute transverse myelitis; This is a literature report. Case Description: A 76-year-old right handed previously independent male with history of hypertension, dyslipidemia and myoclonus, developed sudden onset left arm weakness and paresthesia, dizziness and imbalance 20 minutes after he received the second dose of COVID-19 vaccine (BNT162b2, Pfizer- BioNTech) in his left deltoid. By the time he presented to the acute care hospital, the weakness and paresthesia had progressed to the left lower extremity. Initial MRI brain and C-spine were unremarkable. Repeat MRI C-spine 4 days later revealed interval development of T2 hyperintensity and restricted diffusion of the spinal cord at C3-C4 suggestive of demyelinating transverse myelitis. The patient received 5 days of high-dose Solumedrol and 5 rounds of plasmapheresis during his 17-day acute hospital stay before discharge to inpatient rehab. Upon admission the patient described belt sensation around his waist, left side hemiparesis and significant trunk weakness. Sensation was intact to light touch throughout. Initial activity of daily living (ADL) and mobility evaluation revealed the patient was at a dependent level for dressing, maximal assist for bathing and toileting, moderate assist with oral hygiene, dependent with bed-to-chair transfer, and unable to walk or propel a wheelchair. Setting: Acute inpatient rehabilitation hospital. Case Diagnosis: Acute transverse myelitis.  Assessment/Results: After first 18 days of the total expected 28-day inpatient rehab hospital course, the patient gradually improved his functional status to moderate assist level for most ADLs, transfer and ambulation of 40 feet with a rolling walker. Discussion: This is the first reported case, to knowledge, of inpatient rehabilitation of a patient with acute myelitis that developed shortly after a full dose of BNT162b2 COVID-19 vaccination. Conclusion: Authors described a case of acute myelitis most likely secondary to COVID-19 vaccination with the BNT162b2 vaccine that caused severe functional impairment. The ongoing inpatient rehabilitation has helped the patient to slowly improve in strength, functions of ADL and mobility.  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 close temporal relationship and lack of any other possible etiology, the association between the event acute transverse myelitis with BNT162b2 can not be fully 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: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Heavy menstrual bleeding, Menstrual disorder, Vaccination site pain
Clinical narrative: Pain at injection site; Bleeding/ Period after vaccine, I had severe cramping, clotting and bleeding; Severe cramping/ Period after vaccine, I had severe cramping, clotting and bleeding; Clotting/ Period after vaccine, I had severe cramping, clotting and bleeding; This is a spontaneous report received from a contactable reporter (other healthcare professional). The reporter is the patient.  A 24-year-old female patient (not pregnant) received the second dose of bnt162b2 (BNT162B2), via an unspecified route of administration, administered in the left arm on 22Dec2021 (batch/lot number: unknown) at the age of 24 years old, as DOSE 2, SINGLE for COVID-19 immunization. Relevant medical history included: "Fibromyalgia" (unspecified if ongoing) and "Insomnia" (unspecified if ongoing). Patient has no known allergies and had no history of COVID-19 prior to vaccination. Concomitant medications included: GABAPENTIN, CYMBALTA, and TRAZODONE. Patient did not receive other vaccines in four weeks. Vaccination history included: Bnt162b2 (first dose (batch/lot number: unknown), administered in the left arm as DOSE 1, SINGLE), administration date: 29Nov2021, when the patient was 24 years old, for COVID-19 immunization. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 22Dec2021, outcome "recovering" described as "Pain at injection site"; HEAVY MENSTRUAL BLEEDING (non-serious) with onset 22Dec2021, outcome "recovering" described as "Bleeding/ Period after vaccine, I had severe cramping, clotting and bleeding"; DYSMENORRHOEA (non-serious) with onset 22Dec2021, outcome "recovering" described as "Severe cramping/ Period after vaccine, I had severe cramping, clotting and bleeding"; MENSTRUAL DISORDER (non-serious) with onset 22Dec2021, outcome "recovering" described as "Clotting/ Period after vaccine, I had severe cramping, clotting and bleeding." Therapeutic measures were not taken as a result of vaccination site pain, heavy menstrual bleeding, dysmenorrhoea, and menstrual disorder. The patient was not tested for COVID-19 post vaccination.  The batch/lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Pain in extremity
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 53 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 19Dec2021 (Lot number: 331308A) at the age of 53 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EW0151), administration date: 13Apr2021, when the patient was 52 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: ER8735, Location of injection: Arm Left), administration date: 04May2021, when the patient was 52 years old, for Covid-19 immunization.  The following information was reported: IMMUNISATION (non-serious) with onset 19Dec2021, outcome "unknown", described as "dose_number=3"; PAIN IN EXTREMITY (non-serious) with onset Dec2021, outcome "not recovered", described as "pain in my left arm/recurring pain in my right". The event "pain in my left arm/recurring pain in my right" was evaluated at the physician office visit. Therapeutic measures were not taken as a result of pain in extremity.  Additional information: The patient had constant pain in my left arm, recurring pain in my right. It's painful to brush my hair, painful to sleep at night. In my biceps, very painful. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient had not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Immunisation, Suspected COVID-19
Clinical narrative: received 2 shots of the vaccine and the booster; diagnosed with covid/experiencing runny nose, cough, and fatigue; diagnosed with covid/experiencing runny nose, cough, and fatigue; This is a spontaneous report received from contactable reporter (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A 50 years old male patient received BNT162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: IMMUNISATION (medically significant), outcome "unknown", described as "received 2 shots of the vaccine and the booster"; DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "diagnosed with covid/experiencing runny nose, cough, and fatigue". The patient had received 2 shots of the vaccine and the booster, and was diagnosed with covid, was experiencing runny nose, cough, and fatigue. Event took place after use of product.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101852679 same reporter/product/event, different patient
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cough, Fatigue, Immunisation, Rhinorrhoea
Clinical narrative: received 2 shots of the vaccine and the booster; diagnosed with covid/experiencing runny nose, cough, and fatigue; diagnosed with covid/experiencing runny nose, cough, and fatigue; This is a spontaneous report received from contactable reporter (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A 50 years old male patient received BNT162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: IMMUNISATION (medically significant), outcome "unknown", described as "received 2 shots of the vaccine and the booster"; DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "diagnosed with covid/experiencing runny nose, cough, and fatigue". The patient had received 2 shots of the vaccine and the booster, and was diagnosed with covid, was experiencing runny nose, cough, and fatigue. Event took place after use of product.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101852679 same reporter/product/event, different patient
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Immunisation, Suspected COVID-19
Clinical narrative: booster; runny nose; cough; fatigue; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: 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: IMMUNISATION (non-serious), outcome "unknown", described as "booster"; RHINORRHOEA (non-serious), outcome "unknown", described as "runny nose"; COUGH (non-serious), outcome "unknown", described as "cough"; FATIGUE (non-serious), outcome "unknown", described as "fatigue".  Additional information: Description of Event: (Name withheld) 50, and his daughter, 12, both were diagnosed with covid. (Name withheld) is experiencing runny nose, cough, and fatigue. (Name withheld) has received 2 shots of the vaccine and the booster. His daughter had one shot. Event took place after use of product.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cough, Fatigue, Immunisation, Rhinorrhoea
Clinical narrative: booster; runny nose; cough; fatigue; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: 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: IMMUNISATION (non-serious), outcome "unknown", described as "booster"; RHINORRHOEA (non-serious), outcome "unknown", described as "runny nose"; COUGH (non-serious), outcome "unknown", described as "cough"; FATIGUE (non-serious), outcome "unknown", described as "fatigue".  Additional information: Description of Event: (Name withheld) 50, and his daughter, 12, both were diagnosed with covid. (Name withheld) is experiencing runny nose, cough, and fatigue. (Name withheld) has received 2 shots of the vaccine and the booster. His daughter had one shot. Event took place after use of product.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: diagnosed with covid; diagnosed with covid; This is a spontaneous report received from a contactable reporter from a sales representative. The reporter is the parent.  A 12-year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 12 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome unknown.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s): US-PFIZER INC-202101852633 same reporter/drug/event, different patient
Age: 17.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Condition aggravated, Frequent bowel movements, Haematochezia
Clinical narrative: blood in stools; increased stools; increased bowel movements; flare; FACILITATED COLLECT  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 21K-163-4119659-00 (AbbVie).  A 17 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date 08Dec2021 (Batch/Lot number: unknown) at the age of 17 years as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) at citrate free. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: HAEMATOCHEZIA (medically significant), outcome "unknown", described as "blood in stools"; FREQUENT BOWEL MOVEMENTS (non-serious), outcome "unknown", described as "increased stools"; FREQUENT BOWEL MOVEMENTS (non-serious), outcome "unknown", described as "increased bowel movements"; CONDITION AGGRAVATED (non-serious) with onset 13Dec2021, outcome "recovered" (2021), described as "flare". The action taken for adalimumab was unknown.  The reporter considered "blood in stools", "increased stools", "increased bowel movements" and "flare" related to bnt162b2. It was unknown if patient was enrolled in a covid-19 vaccine Trial. Primary reporters contact for lot number information was not available. On an unknown date the HUMIRA LEVEL was Low. Patient demographics, event information, reporter opinion of causality, concomitant drug information, laboratory/diagnostic procedures and narrative description updated. The event information, reporter opinion of causality, suspect drug information, concomitant drug information and narrative description. The event of "increased bowel movements" was added. Causality for adalimumab (HUMIRA)- The reporter's causality for the event(s) of flare unknown onset with adalimumab (HUMIRA) was a reasonable possibility. The reporter's causality for the event(s) of increased stools, blood in stools, , low and increased bowel movements was not provided. The reporter's causality for the event(s) of flare onset 13Dec2021 with adalimumab (HUMIRA) was no reasonable possibility.   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 in the narrative, a causal association between the suspect drug and the events 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.
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Tested positive to COVID-19; Tested positive to COVID-19; This is a spontaneous report received from a contactable consumer from medical information team. The reporter is the parent.  A 13-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection), administered in the left arm, administration date 02Dec2021 20:00 or 21:00 (Lot number: FJ8762) at the age of 13 years as dose 1, single for COVID-19 immunization. Relevant medical history included: "Seasonal allergies" (unspecified if ongoing). There were no concomitant medications. The patient had no prior vaccinations within 4 weeks of the COVID-19 vaccine. The following information was reported: The patient's mother reported that she and her son have got their first shot of Pfizer-BioNTech COVID-19 vaccine. On 23Dec2021, they had the appointment for the second dose, however, both have tested positive to COVID-19. The pharmacist told the mother to wait one month but she read on the Internet that she could get it after 10 days. The mother asked when can they get the second dose of the vaccine. The patient has not received the second dose yet. The patient underwent the following laboratory tests and procedures: COVID-19 test: (23Dec2021) positive. Therapeutic measures were taken as result of the event which included taking over the counter pills. The outcome of the event was not recovered.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101850682 same reporter, drug, and event; different patient
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Body temperature, Fatigue, Immunisation, Pyrexia
Clinical narrative: Comirnaty yesterday (booster); Fatigued; has a back ache; A slight fever 99.5 - 100.5; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 17 year-old male patient received bnt162b2 (COMIRNATY), administration date 22Dec2021 (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose unknown, MANUFACTUERER UNKNOWN), for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 22Dec2021, outcome "unknown", described as "Comirnaty yesterday (booster)"; FATIGUE (non-serious) with onset Dec2021, outcome "unknown", described as "Fatigued"; BACK PAIN (non-serious) with onset Dec2021, outcome "unknown", described as "has a back ache"; PYREXIA (non-serious) with onset Dec2021, outcome "unknown", described as "A slight fever 99.5 - 100.5". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: The reporter reported that, "My son, 17 years old received Comirnaty yesterday (booster). He told me today he is fatigued, has a back ache, and has a slight fever 99.5 - 100.5".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Immunisation, Limb discomfort
Clinical narrative: booster; covid arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (dose 1, Primary Immunization series complete but unknown manufacturer), for Covid-19 Immunization; Covid-19 vaccine (dose 2, Primary Immunization series complete but unknown manufacturer), for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "booster"; LIMB DISCOMFORT (non-serious), outcome "unknown", described as "covid arm".  Additional Information: The patient  been exposed more then once, had the vaccine and was exposed in small space for 4 - 10 hour shifts without contracting covid. Once the patient got the booster, Ithe patient got covid arm. The patient would be willing to be exposed and tested to see if they was anything in  blood that could help.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Headache, Immunisation, Nasal congestion
Clinical narrative: COVID infection, tested positive; COVID infection, tested positive; received Booster shot; Runny nose; Nasal congestion; Headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 17 year-old female patient received bnt162b2 (BNT162B2), administration date 16Dec2021 (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation in Workplace Clinic; covid-19 vaccine (COVID-19 VACCINE) (Batch/Lot number: unknown, Manufacturer Unknown) as dose number unknown, single for covid-19 immunisation. The patient had no relevant medical history(No underlying conditions). There were no concomitant medications. The following information was reported: IMMUNISATION (medically significant) with onset 16Dec2021, outcome "unknown", described as "received Booster shot"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 22Dec2021, outcome "unknown" and all described as "COVID infection, tested positive"; RHINORRHOEA (non-serious) with onset Dec2021, outcome "unknown", described as "Runny nose"; NASAL CONGESTION (non-serious) with onset Dec2021, outcome "unknown", described as "Nasal congestion"; HEADACHE (non-serious) with onset Dec2021, outcome "unknown", described as "Headache". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (14Dec2021) negative; (19Dec2021) negative; (22Dec2021) positive.  Clinical course: the patient had a PCR test and results came negative on 14Dec2021(two days before vaccination). She received the Pfizer/BioNTech booster shot on 16Dec2021. She was informed on 17Dec2021 that she had been exposed to a classmate that tested positive to COVID-19 on this same day. She performed another rapid home-test on 19Dec2021 that came again negative. She tested positive using a rapid home-test kit in the evening of 22Dec2021. She had mild symptoms included runny nose, nasal congestion and headache.  The lot number for bnt162b2 was not provided and will be requested during follow up.