chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An elderly female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Feb2021 as dose 2, single (Lot number: EN5318), in right arm, on 19Sep2021 as dose 3 (booster), single (Lot number: 30145BA), in right arm and on 13Jul2022 as dose 4 (booster), single (Lot number: FJ4991), in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's 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 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment; Negative, notes: negative for COVID; Positive, notes: COVID test positive again. Therapeutic measures were taken as a result of drug ineffective, covid-19 (Paxlovid from 11Feb2023 to 16Feb2023).
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 23Nov2022 at 09:00 as dose 5 (booster), single (Lot number: G36665) at the age of 55 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 19Mar2021 at 13:00 as dose 1, single (Lot number: EN6207), in left arm, on 09Apr2021 at 09:00 as dose 2, single (Lot number: EW0153), in right arm, on 11Oct2021 at 09:00 as dose 3 (booster), single (Lot number: 30155BA), in left arm and on 14May2022 at 09:00 as dose 4 (booster), single (Lot number: FM9992), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 07Mar2023, outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (07Mar2023) positive; (14Mar2023) Negative; (15Mar2023) Negative; (16Mar2023) Negative; (17Mar2023) Negative; (18Mar2023) positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Additional information: Patient had no known allergies. Patient tested positive 07Mar2023. Paxlovid treatment started on 08Mar2023 to 12Mar2023 as COVID 19 Treatment. Patient tested negative 14Mar2023 to 17Mar2023. Symptoms returned and tested positive on 18Mar2023.   No follow-up attempts are possible. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from contactable reporter (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 55-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Sep2022 as dose 5 (booster), single (Lot number: GH9694) at the age of 54 years, in left arm for COVID-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "diabetes" (unspecified if ongoing); "gout" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Known allergies: lantus, reaction: "Known allergies: lantus"; Known allergies: amlodipine, reaction: "Known allergies: amlodipine". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Mar2023, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, COVID-19.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 68-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (booster), single (Batch/Lot number: unknown) for COVID-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "atrial fibrillation" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Mar2023, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (12Mar2023) Negative, notes: symptom free; (14Mar2023) Negative, notes: symptom free; (18Mar2023) Positive, notes: re-developed symptoms. Therapeutic measures were taken as a result of drug ineffective, COVID-19 with Paxlovid from 06Mar2023 to 11Mar2023.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 82.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from contactable consumer. The reporter is the patient.  An 82-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Sep2022 as dose 5 (booster), single (Lot number: GH9702) at the age of 82 years, in left arm for COVID-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient had no known allergies. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Mar2023, outcome "recovered with sequelae" (Mar2023) and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Mar2023) Negative. Therapeutic measures were taken as a result of drug ineffective, COVID-19 which included nirmatrelvir/ ritonavir (PAXLOVID) from 11Mar2023 to 15Mar2023.
Sex: F
Vaccine: COVID19
Symptoms: Hypoacusis, Insomnia, Tinnitus
Clinical narrative: can't sleep at night/her good friend has the same thing happened to her; noise drives her nuts/her good friend has the same thing happened to her; affected her hearing/her good friend has the same thing happened to her; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received BNT162b2 (BNT162B2 NOS), 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: INSOMNIA (non-serious), outcome "unknown", described as "can't sleep at night/her good friend has the same thing happened to her"; TINNITUS (non-serious), outcome "unknown", described as "noise drives her nuts/her good friend has the same thing happened to her"; HYPOACUSIS (non-serious), outcome "unknown", described as "affected her hearing/her good friend has the same thing happened to her".  Additional information: Agent relayed that she had a caller on the line that had an adverse reaction to the Covid vaccine. Caller stated this was not the only time calling. She had called and wrote a letter and we had never responded, and she suffered like this with her head and ears. Does not have report numbers to provide. Wanted them to do something for her head. She can't live like this. She can't sleep at night, can't put head on pillow and the noise drives her nuts. She had wrote and called many times. She even wanted money to go to all the doctors.  Went to a specialist for her ear. It had affected her hearing. There was nothing wrong with her ears. She was not the only one, her good friend had the same thing happened to her. Caller was willing to get a lawyer. She can't go on like this. Wanted an answer something that can cure her head, it was going on like this one year. She lived with buzzing like you are by the ocean. How can she live like this. Clarified it was the Pfizer Covid vaccine. Stated the first one was ok; it was the second one she got and she never went for the booster for the same reason that it would affect her head. Stated she had nothing new to report, it's all the same. She wanted help and Pfizer had a lot of money. As call handler was providing caller with legal address caller stated she had written to legal previously and hasn't heard anything. She sent it certified. Stated she was not writing the letter because she did already, and they didn't answer. Caller doesn't know all her friend's details; she had identical thing caller had. She will have her friend call and report herself. Caller was thinking of getting a lawyer, they don't do nothing, and she won't go through this. Provided caller with phone # option 1 for friend to report. Caller declines contact details. Warm transfer to agent in Pfizer Medical Information. Upon transfer, with agent on the line caller clarified the sound in her ears, like being by the ocean was in her head.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 49-year-old patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Considering a plausible drug-event temporal association, a reasonable possibility that the events drug ineffective and Covid-19 are related to BNT162b2 (BNT162B2 NOS) cannot be excluded. This case will be reassessed should additional information become available.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Interchange of vaccine products, Vaccination failure
Clinical narrative: COVID-19; COVID-19; Pfizer- 17Apr2021/ Moderna- 09Nov2021; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35-year-old male patient received BNT162b2 (BNT162B2), on 20Mar2021 at 13:00 as dose 1, single (Lot number: ER2613), in left arm and on 17Apr2021 at 13:00 as dose 2, single (Lot number: EW0170) at the age of 33 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 09Nov2021 at 17:00 as dose 3 (booster), single (Lot number: 034F21), in left arm for covid-19 immunisation; davesomeran, elasomeran (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), on 09Sep2022 at 14:00 as dose 4 (booster), single (Lot number: AS7140C), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Colitis ulcerative". The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 09Nov2021 at 17:00, outcome "unknown", described as "Pfizer- 17Apr2021/ Moderna- 09Nov2021"; COVID-19 (medically significant) with onset 2023, outcome "unknown", VACCINATION FAILURE (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 and included treatment with nirmatrelvir/ritonavir (PAXLOVID).  No follow-up attempts are possible. No further information is expected.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Diplopia, Dizziness, Inappropriate schedule of product administration, Palpitations
Clinical narrative: Heart palpitations; Severe dizziness; Double vision; Dose 1 administered on 11Nov2021; Dose 2 administered on 02Jan2022; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 27-year-old male patient received BNT162b2 (BNT162B2), on 02Jan2022 at 14:00 as dose 2, single (Lot number: Fk9729) at the age of 26 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. Patient did not get covid prior vaccination and did not have a covid tested post vaccination. There were no Known allergies. There were no concomitant medications. There were no other medications received in two weeks. Vaccination history included: BNT162b2 (Dose number: 1, lot number: Fh8027, vaccine location: Left arm), administration date: 11Nov2021, when the patient was 26-year-old, for COVID-19 immunization. There were no other vaccines received in four weeks.  The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (disability, life threatening) with onset 02Jan2022 at 14:00, outcome "not recovered", described as "Dose 1 administered on 11Nov2021; Dose 2 administered on 02Jan2022"; DIPLOPIA (disability, life threatening) with onset 31Aug2022, outcome "not recovered", described as "Double vision"; PALPITATIONS (disability, life threatening) with onset 31Aug2022, outcome "not recovered", described as "Heart palpitations"; DIZZINESS (disability, life threatening) with onset 31Aug2022, outcome "not recovered", described as "Severe dizziness". It was reported that the reported events resulted in: [Doctor or other healthcare professional office/clinic visit, Emergency AE resulted in office/clinic visit, Emergency room/department or urgent care, Life threatening illness (immediate risk of death from the event), Disability or permanent damage]. Therapeutic measures were not taken as a result of inappropriate schedule of product administration, palpitations, dizziness, diplopia.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old male patient received BNT162b2 (BNT162B2 NOS), in Oct2022 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. Past drug history included: Zofran, reaction(s): "Known allergies: Zofran". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation, Breast mass, Breast scan, Electrocardiogram, Heart rate
Clinical narrative: atrial fib/erratic heart beat/rapid heartbeat in chest and throat/Alternating episodes of rapid heartbeat in chest and throat that were so strong; A lump in left breast that was the shape and size of a new erase on a #2 pencil; The initial case was missing the following minimum criteria: Unspecified product. Upon receipt of follow-up information on 20Mar2023, this case now contains all required information to be considered valid.   This is a spontaneous report received from contactable consumer (patient), Program ID. A 71-year-old female patient received BNT162b2 (BNT162B2), on 06Mar2021 as dose 2, single (Lot number: EN6198) at the age of 71 years 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: EL9269), administration date: 13Feb2021, when the patient was 71-year-old, for COVID-19 immunization. After many months of dealing with an erratic heart beat, following the second initial COVID shot, Patient had developed atrial fib and have been put on Eliquis. Her reaction to these vaccines resulted in a previously strong heart now requiring drugs to treat the resulting atrial fibrillation. Patient stated she could not afford Eliquis due to financial reason, which was initially prescribed for her during her emergency visit. Following the second vaccine in Mar2021, patient had the following symptoms: 1. Rapid, thumbing pulse in the back of neck at the base of the skull. 2. Alternating episodes of rapid heartbeat in chest and throat that were so strong, she felt them without using hand or an instrument. Response: Her primary care doctors conducted and electrocardiogram, results showed no problems: she ordered a brain scan, result showed no problems. 3. A Lump in left breast that was the shape and size of a new erase on a #2 pencil. Even though it had gone away before the scan, the center said it probably was a result of the second COVID shot: cancer was not indicated on the breast exam. Initial assessments: patient saw her primary care doctor with complaints of rapid pounding heartbeat in lower skull/ back of neck throbbing. The patient underwent the following laboratory tests and procedures: Breast scan: (28Apr2021) Lump in left breast temporary, notes: gone away before the scan; Electrocardiogram: (23Mar2021) no problems; Heart rate: (Mar2021) High/Rapid; Physical breast examination: (Mar2021) A Lump in left breast that was the shape, notes: and size of a new erase on a #2 pencil; Scan brain: (24Apr2021) no problems. Outcome of atrial fibrillation was not recovered, outcome of lump in left breast was recovered.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Physical breast examination, Scan brain
Clinical narrative: atrial fib/erratic heart beat/rapid heartbeat in chest and throat/Alternating episodes of rapid heartbeat in chest and throat that were so strong; A lump in left breast that was the shape and size of a new erase on a #2 pencil; The initial case was missing the following minimum criteria: Unspecified product. Upon receipt of follow-up information on 20Mar2023, this case now contains all required information to be considered valid.   This is a spontaneous report received from contactable consumer (patient), Program ID. A 71-year-old female patient received BNT162b2 (BNT162B2), on 06Mar2021 as dose 2, single (Lot number: EN6198) at the age of 71 years 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: EL9269), administration date: 13Feb2021, when the patient was 71-year-old, for COVID-19 immunization. After many months of dealing with an erratic heart beat, following the second initial COVID shot, Patient had developed atrial fib and have been put on Eliquis. Her reaction to these vaccines resulted in a previously strong heart now requiring drugs to treat the resulting atrial fibrillation. Patient stated she could not afford Eliquis due to financial reason, which was initially prescribed for her during her emergency visit. Following the second vaccine in Mar2021, patient had the following symptoms: 1. Rapid, thumbing pulse in the back of neck at the base of the skull. 2. Alternating episodes of rapid heartbeat in chest and throat that were so strong, she felt them without using hand or an instrument. Response: Her primary care doctors conducted and electrocardiogram, results showed no problems: she ordered a brain scan, result showed no problems. 3. A Lump in left breast that was the shape and size of a new erase on a #2 pencil. Even though it had gone away before the scan, the center said it probably was a result of the second COVID shot: cancer was not indicated on the breast exam. Initial assessments: patient saw her primary care doctor with complaints of rapid pounding heartbeat in lower skull/ back of neck throbbing. The patient underwent the following laboratory tests and procedures: Breast scan: (28Apr2021) Lump in left breast temporary, notes: gone away before the scan; Electrocardiogram: (23Mar2021) no problems; Heart rate: (Mar2021) High/Rapid; Physical breast examination: (Mar2021) A Lump in left breast that was the shape, notes: and size of a new erase on a #2 pencil; Scan brain: (24Apr2021) no problems. Outcome of atrial fibrillation was not recovered, outcome of lump in left breast was recovered.
Sex: U
Vaccine: COVID19
Symptoms: Angiogram retina, Maculopathy
Clinical narrative: Acute idiopathic maculopathy; This is a literature report for the following literature source(s).  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: MACULOPATHY (medically significant), 7 days after the suspect product(s) administration, outcome "unknown", described as "Acute idiopathic maculopathy". The patient underwent the following laboratory tests and procedures: Angiogram retina: showed focal staining in the late stage and, notes: diffuse pooling within the serous detachment.; Sender's Comments: This is a Literature report. Based on the currently available information, a reasonable possibility that the reported adverse event maculopathy is associated to the administration of the suspect drug COVID- 19 vaccine cannot be completely excluded in this patient.  Noteworthy, age and patient medical history are key factors to fully elucidate this report.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: She was re-infected with SARS-CoV-2; She was re-infected with SARS-CoV-2; This is a literature report for the following literature source(s):   In Mar2020, a 47-year-old physician with a history of asthma developed an acute viral illness characterized by 12 days of sore throat, fatigue, diarrhea, and myalgia while working on an inpatient COVID-19 ward. She was not tested for SARS-CoV-2 infection due to the lack of availability of nucleic acid testing and the absence of fever, cough, or recent travel, which were strict criteria for testing during this time period. While many of her acute symptoms improved and she returned to work, she subsequently experienced progressive symptoms which included worsening myalgia, trouble concentrating ("brain fog"), chest pain, chronic diarrhea, and intermittent debilitating fatigue which persisted over the subsequent 20 months; this was presumed to represent Long COVID. She received 3 doses of the BNT162b2 SARS-CoV-2 vaccine with minimal change in her symptoms, although the third dose resulted in a week of intensified chest pain. Her Long Covid symptoms continued to progress to the point that she decided to take a leave of absence from work in early Winter 2022. Two months later, she was re-infected with SARS-CoV-2 and prescribed nirmatrelvir/ritonavir given her elevated risk for severe disease. She began treatment on Day 2 of her acute re-infection. She reported that within two days of initiating therapy, she began to experience relief from her chronic Long COVID symptoms, with substantial improvement in myalgia, diarrhea, and chest pain.; Sender's Comments: Based on the information available as reported at this point, a possible contributory role of the suspect products cannot be excluded for the reported event of re-infected with SARS-CoV-2 for the lack of efficacy of the vaccine.
Sex: F
Vaccine: COVID19
Symptoms: Acute psychosis
Clinical narrative: acute psychosis; This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative.  A female patient received BNT162b2 (COMIRNATY), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Comirnaty (DOSE 1, SINGLE), for Covid-19 immunization. Three weeks after the second dose, the patient was admitted to the hospital for acute psychosis.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: The limited information provided in this report on this event of acute psychosis precludes a full assessment of the case. Medical history and concomitant medications are unknown. Clinical data and details about patient and suspect drug administration have not been provided. This case will be reassessed when 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: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: got COVID-She did take all 3 Pfizer vaccines; got COVID-She did take all 3 Pfizer vaccines; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (RA).  A 77-year-old female patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; 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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "got COVID-She did take all 3 Pfizer vaccines". She got COVID about 1.5 years ago (Sep or Oct in 2021) and still can't taste or smell about 90% of the time. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate decreased
Clinical narrative: By early 2022, the thumping pulse in the back of my neck became less and less frequent; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old female patient received BNT162b2 (BNT162B2), on 04Oct2021 as dose 3 (booster), single (Lot number: FE3590, Expiration Date: 28Feb2022) at the age of 72 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Vaccine: 1st dose COVID-19 , Product name/manufacture: Pfizer, Lot number: EL9269, Health care professional or Clinic site: Withheld), administration date: 13Feb2021, when the patient was 71-year-old, for COVID-19 immunization; BNT162b2 (Vaccine: 2nd dose COVID-19 , Product name/manufacture: Pfizer, Lot number: EN6198, Health care professional or Clinic site: Withheld), administration date: 06Mar2023, when the patient was 71-year-old, for COVID-19 immunization, reaction(s): "following my second initial COVID shot, I have developed atrial fib and have been put on Eliquis", "Rapid, thumping pulse in the back of my neck at the base of the skull", "Alternating episodes of rapid heartbeat in my chest and throat that were so strong, I felt them without using my hand or an instrument.", "A lump in my left breast that was the shape and size of a new erase on a #2 pencil. Even though it had gone away before the scan, the local breast center said it probably was a result of my second COVID shot". The following information was reported: HEART RATE DECREASED (non-serious) with onset 2022, outcome "unknown", described as "By early 2022, the thumping pulse in the back of my neck became less and less frequent". Relevant laboratory tests and procedures are available in the appropriate section.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy breast, Computerised tomogram, Multiple sclerosis
Clinical narrative: Made her MS worse; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s).  A 57-year-old female patient received BNT162b2 (BNT162B2), on 04May2021 as dose 1, single (Batch/Lot number: unknown) at the age of 55 years for covid-19 immunisation. The patient's relevant medical history included: "Allergy: Penicillin" (unspecified if ongoing); "skin cancer" (unspecified if ongoing); "lumps in right breast (had outpatient procedures twice)" (unspecified if ongoing); "irritable bowel disease (had it whole life)" (unspecified if ongoing); "60% hearing loss (left ear)" (unspecified if ongoing); "double vision (nerve damage in the right eye, use glasses with prism)" (unspecified if ongoing); "bowel problems" (unspecified if ongoing); "bladder problems (have to focus and push)" (unspecified if ongoing); "so many lesions on neck" (unspecified if ongoing); "lesions on neck, spine and brain" (unspecified if ongoing); "spine and brain (about 20 lesions per CT scan)" (unspecified if ongoing); "sleeping difficulty" (unspecified if ongoing); "headaches once in a while" (unspecified if ongoing); "occasional falls" (unspecified if ongoing); "Anxiety" (unspecified if ongoing). The patient's family history included: "multiple family members with MS (from mother's side)" (unspecified if ongoing). Concomitant medication(s) included: HYDROXYZINE; MELOXICAM; CBD & MAGNESIUM. The following information was reported: MULTIPLE SCLEROSIS (medically significant), outcome "unknown", described as "Made her MS worse". The patient underwent the following laboratory tests and procedures: Biopsy breast: Unknown results; Computerised tomogram: 20 lesions, notes: spine and brain (about 20 lesions per CT scan). Clinical course: The patient reported that she refused the booster because she felt the COVID-19 vaccines made her MS worse. Her doctor said that the COVID-19 vaccines would "probably" not help her, but recommended she get them.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300122996 same patient/AE, different drug dose;
Age: 16.0
Sex: M
Vaccine: MENB
Symptoms: Syncope
Clinical narrative: Fainted going to check out, didn't wait after vaccination; This is a spontaneous report received from contactable reporter(s) (Other HCP) from a sales representative.  A 16-year-old male patient received meningococcal group b Rlp2086 (TRUMENBA), as dose number unknown, single (Lot number: FN5547, Expiration Date: 31Jul2025) at the age of 16 years for immunisation. The patient had no relevant medical history. Concomitant medication(s) included: MENQUADFI taken for immunisation. The following information was reported: SYNCOPE (medically significant), outcome "unknown", described as "Fainted going to check out, didn't wait after vaccination". The patient underwent the following laboratory tests and procedures: Body height: 204, notes: unit unknown.; Sender's Comments: There is a reasonable possibility that the event syncope was related to TRUMENBA based on known drug safety profile.  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: U
Vaccine: COVID19
Symptoms: Allergy to vaccine, Illness
Clinical narrative: I apparently was alergic to the vaccine; The 2nd made me very ill; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (003110). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, single), for COVID-19 immunization.  The following information was reported: ALLERGY TO VACCINE (non-serious), outcome "unknown", described as "I apparently was alergic to the vaccine"; ILLNESS (non-serious), outcome "unknown", described as "The 2nd made me very ill".  Additional information: The patient wanted to let know that patient took the 2 doses of the vaccine. The 2nd made patient very ill. Patient apparently was allergic to the vaccine because patient had been very ill as a result. Patient had not taken any more since then, none of the boosters. Patient had been afraid to. Patient know it was difficult to confirm that problems were caused by the vaccine, but know it to be true. Just one of the unfortunate ones that it disagreed with. Thought should know. Patient know that patient was not the only one.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Cough, Fatigue, Muscle rupture, X-ray
Clinical narrative: I tore some chest and back muscles from severe coughing; Very exhausted; weak; Cough; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old female patient received BNT162b2 (BNT162B2), on 25Apr2022 as dose 4 (booster), single (Lot number: FK9894) at the age of 72 years intramuscular, in arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "depression" (unspecified if ongoing); "stomach acid" (unspecified if ongoing); "Type 2 Diabetes" (unspecified if ongoing). Concomitant medication(s) included: ENALAPRIL oral taken for hypertension (ongoing); IMIPRAMINE oral taken for depression (ongoing); PANTOPRAZOLE oral taken for hyperchlorhydria (ongoing); METFORMIN oral taken for type 2 diabetes mellitus, stop date: Mar2023. Vaccination history included: BNT162b2 (Dose: 01, Lot number: ER8727, Anatomical site of injection: L. Arm, Route of administration: Intramuscular), administration date: 23Mar2021, when the patient was 71-year-old, for COVID-19 Immunization; BNT162b2 (Dose: 02, Lot number: ER8731, Anatomical site of injection: Arm, Route of administration: Intramuscular), administration date: 13Apr2021, when the patient was 71-year-old, for COVID-19 Immunization; BNT162b2 (Dose: 03, Lot number: FG3527, Anatomical site of injection: Arm, Route of administration: Intramuscular), administration date: 22Nov2021, when the patient was 72-year-old, for COVID-19 Immunization. The following information was reported: COUGH (non-serious) with onset Oct2022, outcome "unknown"; MUSCLE RUPTURE (medically significant), outcome "unknown", described as "I tore some chest and back muscles from severe coughing"; FATIGUE (non-serious), outcome "unknown", described as "Very exhausted"; ASTHENIA (non-serious), outcome "unknown", described as "weak". The patient underwent the following laboratory tests and procedures: X-ray: No Pneumonia, notes: had 2 X-rays.  Clinical course: Patient started enalapril, imipramine, and metformin 20 years before. She developed a serious cough in Mid Oct2022, so severe that she tore some chest and back muscles from severe coughing. Patient had 2 X-rays but no pneumonia. Patient was very exhausted and weak from this. Patient did not know if it was RSV, not diagnosed as such. Patient talked to friends and relatives in (Name withheld) who described identical cough, relentless. Patient had 5 Pfizer vaccinations/boosters.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300039609 same patient, different vaccine doses/event;
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Nausea, Platelet count, Pyrexia, Thrombocytopenia, Vomiting
Clinical narrative: thrombocytopenia; Fever; nausea; vomiting; Initial information received on 22-Feb-2023 by health care professional  regarding an unsolicited valid serious case issued from a literature article:   This case is linked to cases 2023SA063143, 2023SA063145, 2023SA063146, 2023SA063147, 2023SA063148 and 2023SA063144 (CLUSTERS).  This case involves a 62 years old female patient who experienced thrombocytopenia, fever, nausea and vomiting while receiving vaccines MODERNA COVID-19 (corona virus 2019) VACCINE and INFLUENZA VACCINE (QUADRIVALENT).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (QUADRIVALENT) produced by unknown manufacturer lot number not reported via unknown route in unknown administration site. On an unknown date, the patient received a dose of suspect MODERNA COVID-19 VACCINE not produced by Sanofi Pasteur lot number not reported via unknown route in unknown administration site.  On an unknown date the patient developed a serious thrombocytopenia, fever (pyrexia), nausea, vomiting (latency: 5 days). The patient was hospitalized for 5 days.  Relevant laboratory test results included: Platelet count - On an unknown date:  [decrease from 102 to 76]  Seriousness criteria: hospitalization for all events, additionally medically significant for thrombocytopenia. Action taken with QUADRIVALENT INFLUENZA VACCINE (INFLUENZA VACCINE (QUADRIVALENT)) and ELASOMERAN (MODERNA COVID-19 VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the events. At time of reporting, the outcome was Unknown for the events. Reporter's causality: Related for all the events.; Sender's Comments: Sanofi company comment dated 28-FEB-2023: This case involves a 62 years old female patient (table 1) who experienced thrombocytopenia while receiving vaccine INFLUENZA VACCINE (QUADRIVALENT). Based on information received the causal role of VACCINE cannot be excluded due to compatible tem-poral relationship of ADR to the VACCINE. Further information regarding concurrent condition during vaccination, previous vaccination, tolerance, allergic history, laboratory investigations excluding alter-native etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of vaccine cannot be assessed.
Age: 16.0
Sex: M
Vaccine: MEN
Symptoms: Syncope
Clinical narrative: fainted; Initial information received on 17-Mar-2023 regarding an unsolicited valid serious case received from a Non-Healthcare Professional.  This case involves a 16-year-old male patient who experienced fainted after receiving vaccine MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE [MENQUADFI].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 16-Mar-2023, the patient received total dose of suspect MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE Solution for injection (strength, lot number and expiry date: not reported) via intramuscular route in unknown administration site for Vaccination.  On 16-Mar-2023 on the same day, the patient developed a serious event of fainted (syncope) following the administration of MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE. This event was assessed as medically significant.  It was reported, patient had received vaccines after screening questions were answered. Went to check out escorted by his father to check out window. Assessed patient and he was moved to a room to be monitored. He was monitored for about 15 minutes. After monitoring it was recommended to father to take him to emergency room (ER).   It is unknown if the patient experienced any additional symptoms/events. It is unknown if the patient had any medical history, concomitant disease or risk factor. It is unknown if there were lab data/results available.   Action taken with MENINGOCOCCAL VACCINE (MENQUADFI) was not applicable.  It was not reported if the patient received a corrective treatment for the event (fainted).  At time of reporting, the outcome was Recovered / Resolved on 16-Mar-2023 for the event fainted.; Sender's Comments: Sanofi company comment dated 20-Mar-2023: This case involves a 16-year-old male patient who experienced fainted after receiving vaccine MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE [MENQUADFI]. Based upon the reported information, the role of vaccine cannot be assessed. Additional information regarding additional risk factor, medical treatment, family history, concomitant medications, medical history excluding other predisposing etiologies would be needed for complete assessment of the case.
Age: 16.0
Sex: F
Vaccine: DTAP, TD
Symptoms: Extra dose administered, No adverse event
Clinical narrative: TENIVAC and Infanrix were administered to patient with no adverse event; Initial information regarding an unsolicited valid non-serious case received via medical assistant on 15-Mar-2023 processed along with live follow-up of same. number: 01534286, 01533938.  This case involves 16 years old female patient who experienced Diphtheria and Tetanus Toxoids (Tenivac) and Diphtheria Vaccine Toxoid, Pertussis Vaccine Acellular 3-Component, Tetanus Vaccine Toxoid (Infanrix) were administered to patient with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Last menstrual period was 26-feb-2023.  Concomitant medications included Polio Vaccine INACT 3V (Vero) (Ipol) for Prophylactic vaccination; Measles Vaccine, Mumps Vaccine, Rubella Vaccine (MMR) for Prophylactic vaccination; Varicella Zoster Vaccine (Varicella Vaccine) for Prophylactic vaccination; and Diphtheria Vaccine Toxoid, Pertussis Vaccine Acellular 5-Component, Tetanus Vaccine Toxoid (Adacel) for Prophylactic vaccination.  On 03-Mar-2023, the patient received suspect INFANRIX not produced by Sanofi Pasteur at (unknown: formulation, strength, dose, lot number, route in unknown administration site) for prophylactic vaccination and on same day, the patient received suspect Tenivac vaccine Suspension for injection at dose 0.3ml once (lot: U7092AA, expiry date: 24-Jun-2023) via intramuscular route in the left deltoid for prophylactic vaccination with no adverse event (extra dose administered) at same day latency.  Action taken with was not applicable.  No corrective treatment was received for the event.  At time of reporting, the outcome was Unknown for the event extra dose administered.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: TDAP
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: ADACEL that was expired by 9 days was given to 2 patients with no reported adverse event; Initial information received  on 15-Mar-2023 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (Non-healthcare professional).  This case involves patients of unknown age and gender and reporter reported Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine [Adacel] that was expired by 9 days was given to 2 patients with no reported adverse event.  The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patients received an unknown dose of suspect Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine Suspension for injection (lot number: Unknown, Expiry date: Unknown) (stremgth: Unknown) via unknown route in unknown administration site for immunization.  On an unknown date, the reporter reported Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine that was expired by 9 days was given to 2 patients with no reported adverse event (expired product administered) (latency: same day).  Action taken: not applicable.  Outcome: Unknown   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 8.0
Sex: F
Vaccine: FLU4
Symptoms: Induration, Skin warm, Vaccination site mass, Vaccination site warmth
Clinical narrative: her reaction was hard and warm to the touch; her reaction was hard and warm to the touch; Initial information received on 16-Mar-2023 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves 8 years old female patient who experienced her reaction was hard and warm to the touch after receiving vaccine Influenza Quadrival A-B Vaccine [Fluzone QIV].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received 0.5ml (total) dose of suspect Influenza Quadrival A-B Vaccine (strength, dose, formulation, frequency, lot number and expiry date: not reported) via unknown route in unknown administration site as prophylactic vaccination (Immunization).  On an unknown date, the patient developed non-serious her reaction was hard and warm to the touch (vaccination site mass) (vaccination site warmth) (unknown latency) following the administration of Influenza Quadrival A-B Vaccine.  No lab data was reported.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the events (her reaction was hard and warm to the touch).  At time of reporting, the outcome was Recovered / Resolved on an unknown date for the event her reaction was hard and warm to the touch.