chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site inflammation, Vaccination site pain, Vaccination site warmth
Clinical narrative: Major inflammation (feels size of golf ball) at sight of injection; Redness, heat and pain also at the injection site; Redness, heat and pain also at the injection site; Redness, heat and pain also at the injection site; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 28-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 11Oct2023 at 15:45 as dose 1, single (Lot number: HG4659) at the age of 28 years, in left arm for COVID-19 immunisation; for COVID-19 immunisation; influenza vaccine (INFLUENZA VACCINE), on 11Oct2023 as dose 1, single (Batch/Lot number: unknown), in right arm for immunisation. The patient's relevant medical history included: "Hashimoto" (unspecified if ongoing); "ADD combined type" (unspecified if ongoing); "Degenerative disc disease" (unspecified if ongoing). Concomitant medications included: ADDERALL; BENADRYL; GABAPENTIN; SYNTHROID; WELLBUTRIN; ZYRTEC ALLERGY. Vaccination history included: bnt162b2;bnt162b2 omi ba.4-5 (dose 4 (booster), single; lot number: unknown), administration date: 11Oct2022, when the patient was 27-year-old, for COVID-19 immunisation; bnt162b2 (dose 3 (booster), single; lot number: FJ8762), administration date: 22Nov2021, when the patient was 26-year-old, for COVID-19 immunisation; bnt162b2 (dose 2, single; lot number: EL9264), administration date: 10Feb2021, when the patient was 26-year-old, for COVID-19 immunisation; bnt162b2 (dose 1, single; lot number: EL3247), administration date: 19Jan2021, when the patient was 26-year-old, for COVID-19 immunisation. The following information was reported: VACCINATION SITE INFLAMMATION (non-serious) with onset 11Oct2023 at 23:00, outcome "not recovered", described as "Major inflammation (feels size of golf ball) at sight of injection"; VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE WARMTH (non-serious), VACCINATION SITE PAIN (non-serious) all with onset 11Oct2023 at 23:00, outcome "not recovered" and all described as "Redness, heat and pain also at the injection site". Therapeutic measures were not taken as a result of vaccination site inflammation, vaccination site erythema, vaccination site warmth, vaccination site pain. Additional information: Major inflammation (feels size of golf ball) at sight of injection. Swelling can be seen when looking at the side view from distance. Redness, heat and pain also at the injection site.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Sex: F
Vaccine: UNK
Symptoms: Magnetic resonance imaging, Neurological symptom, Paraesthesia
Clinical narrative: Had some neurological, like tingling on her face; like near her chin and cheek; Had some neurological, like tingling on her face; like near her chin and cheek; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient received bnt162b2 omi xbb.1.5 (BNT162B2 OMI XBB.1.5), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "stroke" (unspecified if ongoing), notes: he did say that, she had an MRI. Because they wanted to rule out a stroke so, she had an MRI. The patient's concomitant medications were not reported. Vaccination history included: Moderna covid-19 vaccine (Dose number unknown, Mention that she did have Moderna, prior to this (Pfizer covid vaccine)), for Covid-19 Immunization. The following information was reported: PARAESTHESIA (non-serious), NERVOUS SYSTEM DISORDER (non-serious), outcome "unknown" and all described as "Had some neurological, like tingling on her face; like near her chin and cheek". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of paraesthesia, nervous system disorder. Additional information: Patient actually did mention that, she is 65. Because she said that if she was due for the, she waited 15 years and hasn't got the Shingrix shot vaccine and she is like so, since 15 years since she was supposed to get, so, that would make her 65. She is 15 years older than, when she was supposed to get Shingrix so, that would make her 65. Her doctor told her to get it 15 years ago but she has not got it. Because they wanted to rule out a stroke so, she had an MRI. From her description it was quite a while ago, it's over a year now.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: Heart palpitations; This is a spontaneous report received from a contactable reporter (Nurse). The reporter is the patient.  A 49-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 14Oct2023 at 17:15 as dose 1, single (Lot number: HG4659) at the age of 49 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing). Concomitant medications included: LEVOTHYROXINE; OMEPRAZOLE. The following information was reported: PALPITATIONS (non-serious) with onset 15Oct2023 at 10:00, outcome "not recovered", described as "Heart palpitations". The event "heart palpitations" required physician office visit. It was unknown if therapeutic measures were taken as a result of palpitations. Additional information: The patient had no known drug allergies (NKDA). Aside from the Pfizer COVID-19 vaccine, the patient received other vaccines from Pfizer on the same date (14Oct2023): two dose number 1 and one dose number 2 of unspecified vaccines administered on the left deltoid. The vaccination facility was the pharmacy or drug store. There was no other vaccine in four weeks. The patient had no covid prior vaccination and was not tested for covid post vaccination.  The information on the batch/lot number for bnt162b2 omi xbb.1.5  has been requested and will be submitted if and when received.
Sex: M
Vaccine: PNC20
Symptoms: Arthralgia, Full blood count, Metabolic function test
Clinical narrative: I am having a lot of pain from my right hip, down; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 65-year-old male patient received pneumococcal 20-val conj vac (dipht crm197 protein) (PREVNAR 20), as dose numer unknown, single (Batch/Lot number: unknown) for immunisation; for immunisation. The patient's relevant medical history included: "Anxiety" (unspecified if ongoing), notes: Anxiety; "Depression" (unspecified if ongoing), notes: Depression; "knee replace" (unspecified if ongoing). Concomitant medication(s) included: CARBIDOPA; LEVODOPA; CEFDINIR; CELEBREX; FLEXERIL [CEFIXIME]; LEXAPRO; MINOCYCLINE; FLUMAX [AMBROXOL HYDROCHLORIDE]; BUSPIRONE. The following information was reported: ARTHRALGIA (non-serious), outcome "unknown", described as "I am having a lot of pain from my right hip, down". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of arthralgia. Additional information: The patient got his vaccine during a doctor's appointment.   The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) has been requested and will be submitted if and when received.
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation
Clinical narrative: Patient had the Pfizer booster shot on Monday of last week and within 3 hours of it she was in Afib; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  An 89-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 09Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 89 years for covid-19 immunisation. The patient's relevant medical history included: "Afib" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunisation. The following information was reported: ATRIAL FIBRILLATION (hospitalization) with onset 09Oct2023, outcome "unknown", described as "Patient had the Pfizer booster shot on Monday of last week and within 3 hours of it she was in Afib". The patient was hospitalized for atrial fibrillation (start date: 09Oct2023, discharge date: 10Oct2023, hospitalization duration: 2 day(s)). The events "patient had the pfizer booster shot on monday of last week and within 3 hours of it she was in afib" required emergency room visit. Clinical Course: Patient had Pfizer booster shot on Monday of last week and within 3 hours of it she was in Afib. She went to the hospital through ambulance, she was dismissed from the hospital after a day. She had been diagnosed with Afib before, and doctors were treating those as an episode of Afib. She had a doctor's appointment today at 10:15 AM and so, she was calling us to ask if she needed to took a Pfizer Covid vaccine again as this was what happened to her before she goes to her doctor. Advised her that signs of a severe allergic reaction can include a fast heartbeat based on the Patient Information we have for Comirnaty. He advised her to consult further with her doctor/HCP about this as Pfizer does not provide treatment recommendations. Also told her that if indeed that her doctor says this was an allergic reaction to Comirnaty, then if ever there will be a new Pfizer Covid vaccine that would come out next year that was similar to Comirnaty, then Pfizer would not recommend for her to took it as it was going to be life-threatening. She understood and agreed and will be going to her doctor today.   The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Myocarditis
Clinical narrative: myocarditis; This is a spontaneous report received from contactable reporter(s) (Pharmacist) from a sales representative.  An adult female patient (unknown if pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 2, SINGLE, Manufacturer Unknown, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for COVID-19 Immunization; Covid-19 vaccine (DOSE 1, SINGLE, Manufacturer Unknown, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for COVID-19 Immunization. The following information was reported: MYOCARDITIS (medically significant), outcome "unknown". The event "myocarditis" required physician office visit. It was unknown if therapeutic measures were taken as a result of myocarditis.  Clinical course: It was unknown if patient received any other vaccine in four weeks. Five months after getting the bivalent vaccine, a female patient experienced myocarditis. Pharmacist called Pfizer inquiry line too ask whether or not she could give the patient the monovalent omicron vaccine at patients request. The pharmacist also said the patient told her that the patients doctor advised her against getting the Omnicrion monovalent vaccine. It was unknown if patient tested covid prior and post vaccination.  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.; Sender's Comments: Based on known drug safety profile, the events of Myocarditis is assessed as related to suspect product BNT162b2. The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Moderna, Administration Dates: 04May2021, 26May2021 / Pfizer, Administration Dates: 08Dec2021, 03May2022, 13Dec2022; COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Dec2022 as dose number unknown (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 08Dec2021 as dose number unknown (booster), single (Batch/Lot number: unknown) and on 03May2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 04May2021 as dose number unknown, single (Batch/Lot number: unknown) and on 26May2021 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "small thyroid nodule" (unspecified if ongoing).  The patient had no known drug allergy. The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "Moderna, Administration Dates: 04May2021, 26May2021 / Pfizer, Administration Dates: 08Dec2021, 03May2022, 13Dec2022"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive. Therapeutic measures were taken as a result of interchange of vaccine products, drug ineffective, covid-19 which included taking PAXLOVID from 06Oct2023 to 10Oct2023.  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5, bnt162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old male patient received bnt162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient had no known drug allergies. The patient's 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". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included taking PAXLOVID from 30Sep2023 to 05Oct2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pericarditis
Clinical narrative: pericarditis; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A 62-year-old female patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in 2022 as dose number unknown (booster), single (Lot number: GH9702, Expiration Date: 05Jan2023) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series completed, Manufacturer Unknown.), for COVID-19 Immunization. The following information was reported: PERICARDITIS (medically significant), outcome "unknown". Clinical course: The pharmacist had a 62 year old patient who received the Pfizer covid-19 bivalent vaccine for adults last year, and within 5 months of receiving the vaccine, she developed pericarditis. Because of that, her primary care physician is not recommending she get Comirnaty 2023-2024 formulation. The reporter asked, "Do you have information on the incidence of pericarditis and know if it would be safe to give for this patient?"; Sender's Comments: Based on known drug safety profile, the events of Pericarditis are assessed as related to suspect product bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5). The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: COVID 19; COVID 19; Dose #1: Moderna/ Dose #2: Moderna/ Dose #3: Pfizer/ Dose #4: Pfizer/ Dose #5: Pfizer; This is a spontaneous report received from a 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), on 08Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 69 years, in right arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 01Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm and on 20Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 15Jan2021 as dose 1, single (Lot number: 013l20a), in right arm and on 12Feb2021 as dose 2, single (Lot number: 039k20a), in right arm for covid-19 immunisation. The patient's relevant medical history included: "benign enlarged prostate" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 01Nov2021, outcome "unknown", described as "Dose #1: Moderna/ Dose #2: Moderna/ Dose #3: Pfizer/ Dose #4: Pfizer/ Dose #5: Pfizer"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of covid-19. Clinical course: Treatment for COVID 19 included Paxlovid from 06Oct2023 to 10Oct2023. The patient had no known allergies.  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5, bnt162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for COVID; tested positive for COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 73-year-old female patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Jun2023 as dose 6 (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), as dose 4 (booster), single (Batch/Lot number: unknown) and as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "recovered" (Oct2023) and all described as "tested positive for COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Oct2023) Positive; (Oct2023) Negative, notes: one day before this report she tested negative. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient was treated with nirmatrelvir, ritonavir (PAXLOVID).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Muscular weakness, Nausea, Paralysis
Clinical narrative: sudden felt paralyzed; no strength in legs; weakness in legs; Saturday woke up very tired; queasy; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 13Oct2023 at 18:30 as dose 1, single (Batch/Lot number: unknown) at the age of 68 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious) with onset 14Oct2023, outcome "recovered with sequelae" (15Oct2023), described as "Saturday woke up very tired"; ASTHENIA (non-serious) with onset 14Oct2023, outcome "recovered with sequelae" (15Oct2023), described as "no strength in legs"; NAUSEA (non-serious) with onset 14Oct2023, outcome "recovered with sequelae" (15Oct2023), described as "queasy "; PARALYSIS (medically significant) with onset 14Oct2023, outcome "recovered with sequelae" (15Oct2023), described as "sudden felt paralyzed"; MUSCULAR WEAKNESS (non-serious) with onset 14Oct2023, outcome "not recovered", described as "weakness in legs". Clinical course was reported as follows: Had the vaccine at 6:30 on 13Oct2023 evening, next day he woke up very tired, was queasy, ran errands at the mall and all of a sudden felt paralyzed, went down very quickly. Had no strength in legs whatsoever, was holding onto a rail and could not stand up, caller couldn't use legs at all, no strength at all in legs. Recovered with lasting effects, still has a little weakness in legs, walks a little and feels tired very quickly in legs. The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 66-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Oct2022 as dose 5 (booster), single (Lot number: GH9693), in left arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 20Mar2021 as dose 1, single (Lot number: EN6199), in left arm, on 10Apr2021 as dose 2, single (Lot number: ER8729), in left arm, on 04Nov2021 as dose 3 (booster), single (Lot number: FE3590), in left arm and on 07Apr2022 as dose 4 (booster), single (Lot number: FK9894), in left arm for covid-19 immunisation. The patient's relevant medical history included: "history of coronary bypass" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL, stop date: 26Sep2023; ATORVASTATIN, stop date: 26Sep2023; OMEPRAZOLE; EZETIMIBE. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Sep2023, outcome "recovered" (14Oct2023) and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 included Paxlovid from 26Sep2023 to 01Oct2023.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 29Sep2023 at 13:00 as dose 1, single (Lot number: 309) at the age of 58 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). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid from 02Oct2023 to 06Oct2023.  No follow-up attempts are possible. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 29Sep2023 as dose 1, single (Batch/Lot number: unknown) at the age of 50 years 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) with onset Oct2023, outcome "not recovered", COVID-19 (medically significant) with onset Oct2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid from 07Oct2023 to 11Oct2023.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test negative
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 30Sep2023 at 17:00 as dose 1, single (Batch/Lot number: unknown) at the age of 68 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 2023, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test negative: Positive. Patient had no known allergies. Patient received Paxlovid from 05Oct2023 to 10Oct2023 for COVID 19 Treatment.  The information on the batch/lot number for [BNT162B2 OMI XBB.1.5], has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Tested positive for COVID-19 at urgent care in Aug2023.; sinus and congestion issues/Tested positive for COVID-19 at urgent care in Aug2023.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 72-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (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 included: "AFib" (ongoing), notes: before 2007, cardioversion didn't work, so lives with AFib now. Tried a medication for a year or so.; "Patient had sinus and congestion issues in the fall", start date: 2007 (unspecified if ongoing); "cardioversion" (unspecified if ongoing), notes: didn't work, lasted 2 or 3 weeks, back in AFib. The patient's concomitant medications were not reported.The following information was reported: DRUG INEFFECTIVE (medically significant) with onset Aug2023, outcome "unknown", described as "Tested positive for COVID-19 at urgent care in Aug2023."; COVID-19 (medically significant) with onset Aug2023, outcome "unknown", described as "sinus and congestion issues/Tested positive for COVID-19 at urgent care in Aug2023.". The events "tested positive for covid-19 at urgent care in aug2023." and "sinus and congestion issues/tested positive for covid-19 at urgent care in aug2023." required emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Aug2023) Positive. Additional information:Clarified and confirmed had prior Pfizer COVID vaccines, had first 2 doses and then a booster and maybe another booster. Confirmed all doses were the Pfizer COVID vaccine. Tested positive for COVID-19 at urgent care in Aug2023. Patient had sinus and congestion issues in the fall. Patient didn't test at that time, then 2 days later was getting worse, clearly had COVID, didn't get a positive COVID test until 2 days after caller did. Patient had lingering sinus things  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5, bnt162b2 has been requested and will be submitted if and when received.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 25Sep2023 at 15:15 as dose 1, single (Lot number: H09835) at the age of 72 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "sleep apnea" (unspecified if ongoing); "sulfa drugs" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Azythromicin, reaction(s): "allergies". Vaccination history included: Covid-19 vaccine (DOSE 6 (BOOSTER), SINGLE, UNKNOWN MANUFACTURER), for Covid-19 immunization; Covid-19 vaccine (DOSE 5 (BOOSTER), SINGLE, UNKNOWN MANUFACTURER), for Covid-19 immunization; Covid-19 vaccine (DOSE 4 (BOOSTER), SINGLE, UNKNOWN MANUFACTURER), for Covid-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE, UNKNOWN MANUFACTURER), for Covid-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE, UNKNOWN MANUFACTURER), for Covid-19 immunization; Covid-19 vaccine (DOSE 1, SINGLE, UNKNOWN MANUFACTURER), for Covid-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 05Oct2023, outcome "unknown", COVID-19 (medically significant) with onset 05Oct2023, outcome "recovered" (15Oct2023) and all described as "Treatment of COVID-19". The patient became ill and tested positive for COVID on 05Oct2023. He contacted his doctor and began a 5 day course of Paxlovid on 06Oct2023 and completed it on 10Oct2023 at which time he felt he had recovered from COVID. On the morning of 14Oct2023, he tested negative, but later the day, after getting his first vigorous exercise in over a week, he began feeling feverish, had a runny nose and felt fatigued. On 15Oct2023, these symptoms continued and he tested positive for COVID. Today, 17Oct2023, he still feel very fatigued, still have a runny nose, but he do not have a fever. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (05Oct2023) Positive; (14Oct2023) Negative; (15Oct2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Vaccination failure; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 28Sep2023 as dose 1, single (Batch/Lot number: unknown) at the age of 64 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 4 (BOOSTER), SINGLE, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 5 (BOOSTER), SINGLE, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 6 (BOOSTER), SINGLE, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 7 (BOOSTER), SINGLE, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 8 (BOOSTER), SINGLE, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 9 (BOOSTER), SINGLE, MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: COVID-19 (medically significant) with onset Oct2023, outcome "unknown", described as "Treatment of COVID-19"; VACCINATION FAILURE (medically significant) with onset Oct2023, outcome "unknown". Therapeutic measures were taken as a result of vaccination failure, covid-19, patient treated with Paxlovid from 10Oct2023 to 14Oct2023. The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 73 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's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 from 14Oct2023 to 18Oct2023. Patient had no known allergies.  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.
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: Flu like symptoms; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An elderly male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 10Oct2023 as dose 1, single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose received: More than 3 (UNSPECIFIED MANUFACTURER and dose number)), for COVID-19 immunization. The following information was reported: INFLUENZA LIKE ILLNESS (non-serious) with onset 10Oct2023, outcome "recovered" (Oct2023), described as "Flu like symptoms". Therapeutic measures were not taken as a result of influenza like illness. The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Body height, Rash, Skin discolouration, Vaccination site pain
Clinical narrative: severe discoloration in her skin that has not gone away, she has a different skin tone in her upper left arm, like a tan. It is like a big blob, not a perfect circle; feeling pain at the injection site the day the vaccine was administered; mentioned it is big blob not a perfect circle; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 52-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 30Sep2023 at 17:00 as dose 1, single (Batch/Lot number: unknown) at the age of 51 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Moderna (Primary immunization series completed), for COVID-19 immunization. The following information was reported: RASH (non-serious) with onset 2023, outcome "not recovered", described as "mentioned it is big blob not a perfect circle"; VACCINATION SITE PAIN (non-serious) with onset 30Sep2023, outcome "not recovered", described as "feeling pain at the injection site the day the vaccine was administered"; SKIN DISCOLOURATION (non-serious) with onset 01Oct2023, outcome "not recovered", described as "severe discoloration in her skin that has not gone away, she has a different skin tone in her upper left arm, like a tan. It is like a big blob, not a perfect circle". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of vaccination site pain, skin discolouration, rash.  Additional Information: t was reported that All her previous COVID-19 vaccination had been Moderna. She refers feeling pain at the injection site the day the vaccine was administered and putting an ice pack on her arm. The day after the vaccine, she noted severe discoloration in her skin that has not gone away, she has a different skin tone in her upper left arm, like a tan. It is like a big blob, not a perfect circle. It is not harmful. Her husband told her it was bruising but it has been three weeks and it has not gone away. She has applied coconut oil and creams with no results. Asks if this has been reported.   The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old male patient received bnt162b2 omi xbb.1.5 (BNT162B2 OMI XBB.1.5), on 20Sep2023 as dose 1, single (Lot number: HG4629) at the age of 66 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 6, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (Dose 5, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (Dose 4, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (Dose 3, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (Dose 2, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (Dose 1, MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: COVID-19 (medically significant) with onset Oct2023, outcome "unknown"; DRUG INEFFECTIVE (medically significant) with onset Oct2023, outcome "unknown", described as "COVID-19 ". Therapeutic measures were taken as a result of drug ineffective, covid-19 (PAXLOVID Treatment). The information on the batch/lot number for bnt162b2 omi xbb.1.5  has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold, Headache, Palpitations, Paraesthesia, Vertigo
Clinical narrative: bad headache; feeling like falling; skin feeling cold; heart palpitations; tingling hands and feet; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 20-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 14Oct2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset Oct2023, outcome "unknown", described as "bad headache"; VERTIGO (non-serious) with onset Oct2023, outcome "unknown", described as "feeling like falling"; PALPITATIONS (non-serious) with onset Oct2023, outcome "unknown", described as "heart palpitations"; FEELING COLD (non-serious) with onset Oct2023, outcome "unknown", described as "skin feeling cold"; PARAESTHESIA (non-serious) with onset Oct2023, outcome "unknown", described as "tingling hands and feet".  Additional information: The reporter wanted to know how long did side effects last.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300334595 same reporter/drug, different patient/AE.;US-PFIZER INC-202300334599 same reporter/drug, different patient/AE.;
Sex: F
Vaccine: RSV
Symptoms: No adverse event
Clinical narrative: she usually gets sore arm when she takes the Abrysvo vaccine for a day or two.; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 70-year-old female patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 14Oct2023 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Oct2023, outcome "unknown", described as "she usually gets sore arm when she takes the Abrysvo vaccine for a day or two.".  Additional information: Caller said that she usually gets sore arm when she takes the Abrysvo vaccine for a day or two. She took a shot on Saturday night and she doesn't feel anything. Caller is concerned and wants to know if it is normal.  The information on the batch/lot number for rsv vaccine prot.subunit pref 2v, rsv vaccine prot.subunit pref 2v  has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Contusion
Clinical narrative: Bruising; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team.  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CONTUSION (non-serious), outcome "unknown", described as "Bruising".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Feb2023 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 61 years, in right 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) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "unknown" and all described as "COVID-19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received Paxlovid treatment from 09Oct2023 to 13Oct2023. Patient had No Known allergies.  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.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300333433 same patient, different drug/event;
Age: 56.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; 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 57-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 05Oct2022 as dose 4 (booster), single (Lot number: GJ6742) at the age of 56 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) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High LDL" (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 Oct2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid on 17Oct2023. Clinical Course: Patient had no known allergies.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300333486 same patient, different drug /event;