chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pain, Pyrexia
Clinical narrative: I haven't been able to eat anything because I am super Nauseous; Im in Just total pain; dizziness; I haven't been able to eat anything because I am super Nauseous; Fever of 102; Excruciating headaches; body aches; Extreme stiffness; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Extreme stiffness), FEEDING DISORDER (I haven't been able to eat anything because I am super Nauseous), PAIN (Im in Just total pain), DIZZINESS (dizziness) and NAUSEA (I haven't been able to eat anything because I am super Nauseous) in a  patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 08-Nov-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 08-Nov-2023, the patient experienced MUSCULOSKELETAL STIFFNESS (Extreme stiffness), PAIN (Im in Just total pain), DIZZINESS (dizziness), NAUSEA (I haven't been able to eat anything because I am super Nauseous), PYREXIA (Fever of 102), HEADACHE (Excruciating headaches) and MYALGIA (body aches). On an unknown date, the patient experienced FEEDING DISORDER (I haven't been able to eat anything because I am super Nauseous). At the time of the report, MUSCULOSKELETAL STIFFNESS (Extreme stiffness), FEEDING DISORDER (I haven't been able to eat anything because I am super Nauseous), DIZZINESS (dizziness), NAUSEA (I haven't been able to eat anything because I am super Nauseous), PYREXIA (Fever of 102), HEADACHE (Excruciating headaches) and MYALGIA (body aches) had not resolved and PAIN (Im in Just total pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102.     The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown Route) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown Route), the reporter did not provide any causality assessments.   Concomitant medication was not reported. Patient got Moderna vaccine on 08-Nov-2023 and had severe side effects to it. Excruciating headaches, body aches, Dizziness. Extreme Stiffness. Patient haven't Left since yesterday. Patient haven't been able to eat anything because patient was super Nauseous. Patient was in just total pain and had a fever of 102. Treatment medication was not reported.   Reporter did not allow further contact
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Oesophageal discomfort, Palpitations
Clinical narrative: esophageal discomfort; heart palpitation; This spontaneous case was reported by a consumer and describes the occurrence of OESOPHAGEAL DISCOMFORT (esophageal discomfort) and PALPITATIONS (heart palpitation) in a 37-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. AU3919B) for COVID-19 prophylaxis.     The patient had no other medical history, concomitant disease or risk factor.  The patient's past medical history included COVID-19 on 01-Jun-2022.    On 20-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. On 21-Oct-2023, the patient experienced OESOPHAGEAL DISCOMFORT (esophageal discomfort) and PALPITATIONS (heart palpitation). At the time of the report, OESOPHAGEAL DISCOMFORT (esophageal discomfort) and PALPITATIONS (heart palpitation) had not resolved.            No concomitant medication was reported.  Reportedly, patient claimed to have felt esophageal discomfort and heart palpitation the day after the vaccination while performing routine exercise. Patient said he could still feel the palpitation every time he worked out ever since. Patient had taken Moderna shots before and each time had gotten sick and had felt the palpitations.  It was unknown if the patient experienced any additional symptoms/events.  No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-749038 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-749038:Same reporter (SPIKEVAX NOS)
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Interchange of vaccine products, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; Vaccine brand other: Moderna; Vaccine brand: Pfizer/BioNTech; 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, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Sep2022 as dose 5 (booster), single (Lot number: Gh9693), in left arm and on 15Jun2023 as dose 6 (booster), single (Lot number: 616796) at the age of 65 years, in left arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 13May2022 as dose 4 (booster), single (Lot number: Fn2908), in left arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 16Feb2021 as dose 1, single (Lot number: El3248), in left arm, on 09Mar2021 as dose 2, single (Lot number: En6199), in left arm and on 29Oct2021 as dose 3 (booster), single (Lot number: Fd0809), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 02Oct2023 as dose 7 (booster), single (Lot number: 8057658), in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "known allergies: Sulfa" (unspecified if ongoing); "Cholesterol" (unspecified if ongoing); "gout" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Codeine, reaction(s): "Allergy". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 02Oct2023, outcome "unknown", described as "Vaccine brand other: Moderna; Vaccine brand: Pfizer/BioNTech"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19, interchange of vaccine products.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Pfizer vaccines dose 1,2,3,4,5 and Moderna vaccine; Caller reports all her prior COVID-19 vaccinations were Pfizer but one may have been Moderna/she tested positive on 26Oct2023 while in the hospital; Caller reports all her prior COVID-19 vaccinations were Pfizer but one may have been Moderna/she tested positive on 26Oct2023 while in the hospital; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team and product quality group. The reporter is the patient.  An 80-year-old female patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Oct2022 as dose 5 (booster), single (Lot number: GJ6665) for covid-19 immunisation; bnt162b2 (BNT162B2), on 09May2022 as dose 4 (booster), single (Lot number: FJ4991) for covid-19 immunisation; bnt162b2 (BNT162B2), on 29Jan2021 as dose 1, single (Lot number: EN6202), on 17Mar2021 as dose 2, single (Lot number: EN6208) and on 11Oct2021 as dose 3 (booster), single (Lot number: FE3292) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), as dose 6 (booster), single (Lot number: RA5325) for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), in Sep2023 as dose number unknown, single (Batch/Lot number: unknown) for influenza immunisation. The patient's relevant medical history included: "High cholesterol" (unspecified if ongoing). Concomitant medication(s) included: SIMVASTATIN taken for blood cholesterol increased. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 26Oct2023, outcome "unknown" and all described as "Caller reports all her prior COVID-19 vaccinations were Pfizer but one may have been Moderna/she tested positive on 26Oct2023 while in the hospital"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "Pfizer vaccines dose 1,2,3,4,5 and Moderna vaccine". The patient underwent the following laboratory tests and procedures: Blood test: (26Oct2023) Normal; SARS-CoV-2 test: (26Oct2023) Positive, notes: when she tested positive on 26Oct2023. Therapeutic measures were taken as a result of drug ineffective, covid-19.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Visual acuity reduced
Clinical narrative: worsened eye sight; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 44-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Herpes" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "Penicillin allergy" (unspecified if ongoing); "red food dye" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Sulfameth, reaction(s): "known allergies: Sulfameth". Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Location of injection: Arm Left), for covid-19 immunisation; Bnt162b2 (DOSE 2, SINGLE, Location of injection: Arm Left), for covid-19 immunisation. The following information was reported: VISUAL ACUITY REDUCED (disability) with onset 01Nov2021 at 12:00, outcome "not recovered", described as "worsened eye sight". The event "worsened eye sight" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (24Nov2022) Positive, notes: Nasal Swab. Therapeutic measures were taken as a result of visual acuity reduced. Clinical course: The reporter now needed glasses to see her computer screen. It was not much of a prescription and her ophthalmologist said old age but she noticed it right after shot and her vision was perfect for 20 years. Patient did not had covid prior vaccination. Patient covid tested post vaccination.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information available, the causal relationship between the reported events and suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate,Linked Report(s) : US-PFIZER INC-202300357366 Same reporter/ SD/ AE, different patients.;US-PFIZER INC-202300360600 Same patient, different dose/ AE;
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: Vaccine brand=Other, Vaccine brand other=Moderna; 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 32-year-old female patient received bnt162b2 (BNT162B2 NOS), 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; elasomeran (MODERNA COVID-19 VACCINE), as dose 4 (booster), single (Batch/Lot number: unknown) and on 06Oct2023 at 12:00 as dose 5 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Anxiety" (unspecified if ongoing); "depression" (unspecified if ongoing); "migraine" (unspecified if ongoing); "asthma" (unspecified if ongoing); "seasonal allergies" (unspecified if ongoing); "sub clinical hypothyroidism" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 06Oct2023 at 12:00, outcome "unknown", described as "Vaccine brand=Other, Vaccine brand other=Moderna"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received Paxlovid treatment from 29Oct2023 to 03Nov2023. Patient had no known allergies. Patient's LMP was 03Jun2023.  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-202300356874 same patient, different drug/event;
Age: 56.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: covid test result=Positive; covid test result=Positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old male patient received bnt162b2 (BNT162B2), on 04Mar2021 at 12:00 as dose 1, single (Batch/Lot number: unknown), in right arm and on 08Dec2021 at 09:00 as dose 3 (booster), single (Lot number: CUS2096) at the age of 56 years, in right arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), on 25Mar2021 at 13:00 as dose 2, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "arhritis" (unspecified if ongoing). Concomitant medication(s) included: XELJANZ. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 27Oct2022, outcome "unknown" and all described as "covid test result=Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (27Oct2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient did not had covid prior vaccination. The patient had no known allergies.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Age: 56.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Magnetic resonance imaging, Mobility decreased
Clinical narrative: covid test result=Positive; covid test result=Positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old male patient received bnt162b2 (BNT162B2), on 04Mar2021 at 12:00 as dose 1, single (Batch/Lot number: unknown), in right arm and on 08Dec2021 at 09:00 as dose 3 (booster), single (Lot number: CUS2096) at the age of 56 years, in right arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), on 25Mar2021 at 13:00 as dose 2, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "arhritis" (unspecified if ongoing). Concomitant medication(s) included: XELJANZ. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 27Oct2022, outcome "unknown" and all described as "covid test result=Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (27Oct2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient did not had covid prior vaccination. The patient had no known allergies.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Angioedema, Contusion, Nasal congestion, Pain, Pyrexia
Clinical narrative: angioedema in her lips and up her face; pain; fevery feel; hives/ urticaria; nose became extremely stuffy; bruise on left arm and just now turning yellowish; 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 female patient received bnt162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "allergy" (unspecified if ongoing); "hives" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Prednisone, notes: She just was off of Prednisone on the past week. The following information was reported: ANGIOEDEMA (medically significant), outcome "unknown", described as "angioedema in her lips and up her face"; PAIN (non-serious), outcome "unknown"; PYREXIA (non-serious), outcome "unknown", described as "fevery feel"; URTICARIA (non-serious), outcome "recovered", described as "hives/ urticaria"; NASAL CONGESTION (non-serious), outcome "recovered", described as "nose became extremely stuffy"; CONTUSION (non-serious), outcome "unknown", described as "bruise on left arm and just now turning yellowish". Therapeutic measures were taken as a result of pyrexia, urticaria, nasal congestion. Clinical course: Patient was actually afraid of taking the Pfizer Covid vaccine 2023-2024 formula as she had a history of allergy and hives. She just was off of prednisone on the past week. She had the previous Pfizer Covid vaccines, had all the dose and had no reactions on that. She's afraid because recently she had hives and wanted to know if she would go for the shot or not. Patient had urticaria recently. She was eating ice cream at (withheld), then her nose became extremely stuffy. She took antihistamine and it was cleared up instantly. She's due for her flu and COVID vaccines. Her doctor told her she needed to get the epi pen. She's concerned on how long does she have to wait before taking Comirnaty. She was told that chocolates and dairy products are a no-no. She's been trying to google and found out every person different reactions. She was told keep wearing mask until she get the allergy test on December. She's asking if Comirnaty had IgE (Immunoglobulin E). She's eating tomatoes and it has the same kind of proteins. She was told by her doctor to cover up her arms and legs. She's basically just been taking water and bread. She said she had a bad case in Sep (unspecified year), thought it was mosquito bites, had bruise on left arm and just now turning yellowish. She also had angioedema in her lips and up her face which she have never seen before. She said she didn't have any reactions to the previous Pfizer Covid vaccines except pain and fevery feel in which she took paracetamol (TYLENOL).   The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: angioedema in her lips and up her face; pain; fevery feel; hives/ urticaria; nose became extremely stuffy; bruise on left arm and just now turning yellowish; 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 female patient received bnt162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "allergy" (unspecified if ongoing); "hives" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Prednisone, notes: She just was off of Prednisone on the past week. The following information was reported: ANGIOEDEMA (medically significant), outcome "unknown", described as "angioedema in her lips and up her face"; PAIN (non-serious), outcome "unknown"; PYREXIA (non-serious), outcome "unknown", described as "fevery feel"; URTICARIA (non-serious), outcome "recovered", described as "hives/ urticaria"; NASAL CONGESTION (non-serious), outcome "recovered", described as "nose became extremely stuffy"; CONTUSION (non-serious), outcome "unknown", described as "bruise on left arm and just now turning yellowish". Therapeutic measures were taken as a result of pyrexia, urticaria, nasal congestion. Clinical course: Patient was actually afraid of taking the Pfizer Covid vaccine 2023-2024 formula as she had a history of allergy and hives. She just was off of prednisone on the past week. She had the previous Pfizer Covid vaccines, had all the dose and had no reactions on that. She's afraid because recently she had hives and wanted to know if she would go for the shot or not. Patient had urticaria recently. She was eating ice cream at (withheld), then her nose became extremely stuffy. She took antihistamine and it was cleared up instantly. She's due for her flu and COVID vaccines. Her doctor told her she needed to get the epi pen. She's concerned on how long does she have to wait before taking Comirnaty. She was told that chocolates and dairy products are a no-no. She's been trying to google and found out every person different reactions. She was told keep wearing mask until she get the allergy test on December. She's asking if Comirnaty had IgE (Immunoglobulin E). She's eating tomatoes and it has the same kind of proteins. She was told by her doctor to cover up her arms and legs. She's basically just been taking water and bread. She said she had a bad case in Sep (unspecified year), thought it was mosquito bites, had bruise on left arm and just now turning yellowish. She also had angioedema in her lips and up her face which she have never seen before. She said she didn't have any reactions to the previous Pfizer Covid vaccines except pain and fevery feel in which she took paracetamol (TYLENOL).   The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Illness
Clinical narrative: got sick for a week "with like, COVID symptoms"; fatigue; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 2023NVX-US-000001361 (Novavax).  A 64-year-old female patient received bnt162b2 (BNT162B2), in Apr2021 as dose 2, single (Batch/Lot number: unknown) at the age of 64 years for covid-19 immunisation. The patient's relevant medical history included: "COVID symptoms" (unspecified if ongoing), notes: The patient reported she had COVID-19 prior to receiving any COVID-19 vaccines. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), administration date: Mar2021, when the patient was 64 years old, for COVID-19 immunization, reaction(s): "Fatigue", "Sickness". The following information was reported: FATIGUE (non-serious) with onset 2021, outcome "unknown"; ILLNESS (non-serious) with onset 2021, outcome "unknown", described as "got sick for a week "with like, COVID symptoms"".  Additional information: On 23Oct2023, it was reported that a patient started treatment with Pfizer BioNTech COVID-19 vaccine dose 1 in Mar2021 and dose 2 in Apr2021 (primary series), and dose 3 (booster) in in Nov2022 "before holiday" but was unsure of exact dates, for COVID-19 vaccination. It was reported that each time the patient got a vaccine or booster, she got sick for a week "with like, COVID symptoms" and fatigue. The patient reported she had COVID-19 prior to receiving any COVID-19 vaccines and stated that her doctor said it could be because she had COVID-19, and the long-term antibodies could be making her ill.   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-PV202300182857 same patient/ event, different vaccine dose number;US-PFIZER INC-202300358321 same patient/ event, different vaccine dose number;
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Illness
Clinical narrative: got sick for a week "with like, COVID symptoms"; fatigue; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 2023NVX-US-000001361 (Novavax).  A 66-year-old female patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Nov2022 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "COVID-19" (unspecified if ongoing), notes: had COVID-19 prior to receiving any COVID-19 vaccines. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Single), administration date: Mar2021, when the patient was 64 years old, for COVID-19 Immunization, reaction(s): "fatigue", "sick"; Bnt162b2 (Dose 2, Single), administration date: Apr2021, for COVID-19 Immunization, reaction(s): "fatigue", "sick". The following information was reported: ILLNESS (non-serious), outcome "recovered", described as "got sick for a week "with like, COVID symptoms""; FATIGUE (non-serious), outcome "unknown".  Additional information: On 23Oct2023, it was reported that a patient started treatment with Pfizer BioNTech COVID-19 vaccine dose 1 in Mar2021 and dose 2 in Apr2021 (primary series), and dose 3 (booster) in in Nov2022 "before holiday," but was unsure of exact dates, for COVID-19 vaccination. It was reported that each time the patient got a vaccine or booster, she got sick for a week "with like, COVID symptoms" and fatigue. The patient reported she had COVID-19 prior to receiving any COVID-19 vaccines and stated that her doctor said it could be because she had COVID-19, and the long-term antibodies could be making her ill.   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-202300358320 same patient/ event, different vaccine dose number;US-PFIZER INC-PV202300182857 same patient/ event, different vaccine dose number;
Age: 79.0
Sex: M
Vaccine: COVID19, COVID19, 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 80-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Sep2022 at 12:00 as dose 5 (booster), single (Lot number: GH9694) at the age of 79 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, single (Batch/Lot number: unknown) and as dose 4, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Gillian Barre Syndrome", start date: 2000 (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 2023, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Known allergies were reported as No.
Age: 79.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood pressure measurement, Blood test, Cardiac stress test, Computerised tomogram, Diarrhoea
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 80-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Sep2022 at 12:00 as dose 5 (booster), single (Lot number: GH9694) at the age of 79 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, single (Batch/Lot number: unknown) and as dose 4, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Gillian Barre Syndrome", start date: 2000 (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 2023, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Known allergies were reported as No.
Age: 79.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dizziness, Echocardiogram, Electrocardiogram, Heart rate, Hernia
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 80-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Sep2022 at 12:00 as dose 5 (booster), single (Lot number: GH9694) at the age of 79 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, single (Batch/Lot number: unknown) and as dose 4, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Gillian Barre Syndrome", start date: 2000 (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 2023, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Known allergies were reported as No.
Age: 79.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Laboratory test, Nausea, Pericarditis
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 80-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Sep2022 at 12:00 as dose 5 (booster), single (Lot number: GH9694) at the age of 79 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, single (Batch/Lot number: unknown) and as dose 4, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Gillian Barre Syndrome", start date: 2000 (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 2023, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Known allergies were reported as No.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 62-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 04Nov2022 at 10:00 as dose 5 (booster), single (Lot number: GH9703) at the age of 61 years, in right arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 19Nov2021 at 11:30 as dose 3 (booster), single (Lot number: 33026BD), in right arm and on 06May2022 at 11:00 as dose 4 (booster), single (Lot number: FJ4991), in right arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 13Apr2021 at 14:00 as dose 1, single (Lot number: EP7533), in left arm and on 07May2021 at 12:00 as dose 2, single (Lot number: EW0169), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Fibromyalgia" (unspecified if ongoing); "migraines" (unspecified if ongoing); "Brain lesions (not MS)" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin; "Known allergies: Sulfa" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Keflex, reaction(s): "Known allergies: Keflex"; Velocef, reaction(s): "Known allergies: Velocef"; Ergotamine, reaction(s): "Known allergies: Ergotamine"; Dexamethasone, reaction(s): "Known allergies: Dexamethasone". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: initial positive Covid test. Therapeutic measures were taken as a result of vaccination failure, covid-19. The patient received nirmatrelvir, ritonavir (PAXLOVID, lot number: GJ5186) from 15Sep2023 to 18Sep2023 as treatment of COVID-19. No follow-up attempts are possible. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19, 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) from product quality group. The reporter is the patient.  A 72-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 27Sep2022 as dose 5 (booster), single (Lot number: GH9694) at the age of 71 years, in left arm for covid-19 immunisation; COVID-19 Vaccine - Manufacturer Unknown, as dose 4 (booster), single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and 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: 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. Covid 19 Treatment: Paxlovid with treatment start date 25Oct2023 and treatment stop date 30Oct2023.   The information on the batch/lot number for COVID-19 Vaccine - Manufacturer Unknown has been requested and will be submitted if and when received.
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pain, SARS-CoV-2 test
Clinical narrative: COVID 19; 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 72-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 27Sep2022 as dose 5 (booster), single (Lot number: GH9694) at the age of 71 years, in left arm for covid-19 immunisation; COVID-19 Vaccine - Manufacturer Unknown, as dose 4 (booster), single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and 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: 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. Covid 19 Treatment: Paxlovid with treatment start date 25Oct2023 and treatment stop date 30Oct2023.   The information on the batch/lot number for COVID-19 Vaccine - Manufacturer Unknown has been requested and will be submitted if and when received.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Dry skin, Hypoaesthesia, Skin exfoliation
Clinical narrative: Tip of fingers in both hands became shriveled and partially insensitive, skin peeled; Tip of fingers in both hands became shriveled and partially insensitive, skin peeled; Tip of fingers in both hands became shriveled and partially insensitive, skin peeled; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 27Oct2023 at 18:00 as dose 1, single (Lot number: hg9497) at the age of 61 years, in left arm for covid-19 immunisation; for covid-19 immunisation. The patient's relevant medical history included: "none outside moderate high blood pressure and triglycerides" (unspecified if ongoing), notes: none outside moderate high blood pressure and triglycerides; "none outside moderate high blood pressure and triglycerides" (unspecified if ongoing), notes: none outside moderate high blood pressure and triglycerides. Concomitant medication(s) included: AMLODIPINE BENAZEPRIL; ROSUVASTATIN. Vaccination history included: Covid-19 vaccine (Dose 1, manufacturer unknown), for COVID-19 immunisation; Covid-19 vaccine (Dose 2, manufacturer unknown), for COVID-19 immunisation; Covid-19 vaccine (Dose 3, manufacturer unknown), for COVID-19 immunisation; Covid-19 vaccine (Dose 4, manufacturer unknown), for COVID-19 immunisation. The following information was reported: HYPOAESTHESIA (non-serious), SKIN EXFOLIATION (non-serious), DRY SKIN (non-serious) all with onset 03Nov2023, outcome "not recovered" and all described as "Tip of fingers in both hands became shriveled and partially insensitive, skin peeled". Therapeutic measures were not taken as a result of hypoaesthesia, skin exfoliation, dry skin.  Addition information: The most recent COVID-19 vaccine was administered on pharmacy or drug Store. The patient did not receive other vaccines within 4 weeks prior to the COVID vaccine. Impossible to know if caused by the vaccine, but never had this before. Tip of fingers in both hands became shriveled and partially insensitive, skin peeled. Started exactly one week after the vaccine. Prior to vaccination, the patient did not diagnose with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  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: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Diabetes mellitus, Paraesthesia, SARS-CoV-2 test, Vomiting projectile
Clinical narrative: parenthesis left upper lower body; Last booster parenthesis left upper lower body projectile vomitting developed DM type II post vaccines; Last booster parenthesis left upper lower body projectile vomitting developed DM type II post vaccines; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 54-year-old male patient received bnt162b2 (COMIRNATY), on 07Jul2023 at 13:00 as dose 1, single (Batch/Lot number: unknown) at the age of 54 years 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: VOMITING PROJECTILE (prolonged hospitalization, life threatening), DIABETES MELLITUS (prolonged hospitalization, life threatening) all with onset 07Jul2023 at 13:00, outcome "unknown" and all described as "Last booster parenthesis left upper lower body projectile vomitting developed DM type II post vaccines"; PARAESTHESIA (prolonged hospitalization, life threatening), outcome "unknown", described as "parenthesis left upper lower body". The events "last booster parenthesis left upper lower body projectile vomitting developed dm type ii post vaccines" and "parenthesis left upper lower body" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (01Nov2023) Negative, notes: Nasal Swab. Therapeutic measures were taken as a result of vomiting projectile, diabetes mellitus, paraesthesia.  Additional information:  adverse event: Last booster (as reported) parenthesis (as reported) left upper lower body projectile vomitting developed DM type II post vaccines  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the close temporal relationship, the association between the life threatening events vomiting projectile, diabetes mellitus, and paresthesia with COMIRNATY can not be fully excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: dizzy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID:. The reporter is the patient.  A female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 06Nov2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Moderna (DOSE NUMBER UNKNOWN, SINGLE; Lot number: unknown), for Covid-19 Immunization. The following information was reported: DIZZINESS (non-serious), outcome "unknown", described as "dizzy".  Additional information: The patient mentioned she had the Pfizer vaccine yesterday and mentioned that she was feeling dizzy today. She was asking if it was normal to feel a "little dizzy" after getting the Pfizer Covid-19 vaccine. She hardly had anything last night so it might be that that caused her dizziness. She's very relieved to hear that dizziness was a common side effect of Comirnaty then asked for how long could it last. Caller mentioned she usually had Moderna and had no reactions with it so this was a very unusual thing to happen to her.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: I got sick; 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)), 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: ILLNESS (non-serious), outcome "unknown", described as "I got sick".  Additional information: When the patient got the COVID shots there was Moderna, there was Johnson and Johnson and the Pfizer shot. He happened to take the Pfizer shot because that was what his doctors told him to take. For a day or two he got sick but he did not pick up the phone and call Pfizer and say shot made him sick.  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: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: I got really sick last time; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  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: ILLNESS (non-serious), outcome "unknown", described as "I got really sick last time".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: RSV
Symptoms: International normalised ratio fluctuation
Clinical narrative: the patient's INR was fluctuating; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  An 85-year-old female patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Lot number: HF5024, Expiration Date: 28Feb2025) for immunisation. The patient's relevant medical history was not reported. Concomitant medications included: WARFARIN; COUMADIN. The following information was reported: INTERNATIONAL NORMALISED RATIO FLUCTUATION (non-serious), outcome "unknown", described as "the patient's INR was fluctuating". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of international normalised ratio fluctuation.  Additional information: INR has been fluctuating a lot since she received the RSV vaccine; INR was 1.8 today when it has been holding steady between 2.2 and 2.3 for the last four weeks. She takes Warfarin or Coumadin as other Medical Conditions and Concomitant medications.
Sex: M
Vaccine: COVID19
Symptoms: Interchange of vaccine products, Pulmonary embolism
Clinical narrative: Saddlebag Pulmonary Embolism; Interchange of vaccine products; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative.  An adult male patient received bnt162b2 (BNT162B2), on 27Feb2021 as dose 2, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 24Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "TBI" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Location of injection: Arm Right), administration date: Feb2021, for COVID-19 immunization. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (hospitalization, medically significant, life threatening) with onset 24Oct2021, outcome "unknown"; PULMONARY EMBOLISM (hospitalization, medically significant, life threatening), outcome "recovered", described as "Saddlebag Pulmonary Embolism". The patient was hospitalized for pulmonary embolism, interchange of vaccine products (hospitalization duration: 7 day(s)). The event "saddlebag pulmonary embolism" required emergency room visit. Therapeutic measures were taken as a result of pulmonary embolism.AE treatment: Surgery. No covid prior vaccination. Not covid tested post vaccination.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.