chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 56.0
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 non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28May2022 as dose 4 (booster), single (Lot number: FM9993) 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: "HBP" (unspecified if ongoing); "Penicillin allergy" (unspecified if ongoing); "Percocet allergy" (unspecified if ongoing). 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 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 03Apr2023 to 08Apr2023.   No follow-up attempts are possible. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; Pfizer, Date: 25Nov2022 / Moderna, Date: 10Sep2021; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from product quality group. The reporter is the patient.  A 45-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 25Nov2022 as dose 4 (booster), single (Lot number: 6J3R275) at the age of 45 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 27Jan2021 as dose 1, single (Lot number: 041L20A), in left arm, on 24Feb2021 as dose 2, single (Lot number: 011A21A), in left arm and on 10Sep2021 as dose 3 (booster), single (Lot number: 052E21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). Patient has no known allergies. The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 25Nov2022, outcome "unknown", described as "Pfizer, Date: 25Nov2022 / Moderna, Date: 10Sep2021"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 03Apr2023, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (03Apr2023) Positive; (07Apr2023) Negative; (12Apr2023) Positive, notes: Tested with at home COVID test and it was positive again. Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient received Paxlovid on 03Apr2023 within 24 hours of first symptoms and positive COVID test. Symptoms were nasal and sinus congestion, sore throat. Completed all doses and felt much better in day 3 of Paxlovid. Tested negative 07Apr2023. Then 12Apr2023 in the late afternoon started to feel sinus pain and nasal congestion. Symptoms continued to escalate rapidly to include body aches and sore throat. Tested with at home COVID test and it was positive again.; Sender's Comments: Based on available information, a lack of efficacy under interchange of vaccine products with the suspect vaccine BNT162B2, BNT162B2 OMI BA.4-5 in this patient cannot be completely excluded.
Age: 37.0
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 38-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 01Sep2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 37 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), 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 was not reported. Concomitant medication(s) included: LEVOTHYROXINE, start date: 01Jan2012. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), 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 01Apr2023 to 05Apr2023.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: COVID-19; COVID-19; Moderna, Dose Number: 4 / Pfizer, Dose Number: 1, 2, 3; 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 43-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07Jan2021 as dose 1, single (Lot number: EL1283), in left arm, on 28Jan2021 as dose 2, single (Lot number: EL3247), in left arm and on 13Oct2021 as dose 3 (booster), single (Lot number: FE3590) at the age of 42 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 26Sep2022 as dose 4 (booster), single (Lot number: A57163B), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hashimoto's disease" (unspecified if ongoing); "Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 26Sep2022, outcome "unknown", described as "Moderna, Dose Number: 4 / Pfizer, Dose Number: 1, 2, 3"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 13Apr2023, outcome "not recovered" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.
Sex: F
Vaccine: 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 non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (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) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ATORVASTATIN, stop date: 04Apr2023. 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: faint red line. Therapeutic measures were taken as a result of drug ineffective, covid-19, Paxlovid from 04Apr2023 to 08Apr2023. The patient has no known allergies.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 66.0
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 contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19Oct2022 at 13:00 as dose 4 (booster), single (Lot number: GJ6665) at the age of 66 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 05Apr2022 at 13:00 as dose 3 (booster), single (Lot number: FK9896), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), 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 was not reported. No known allergies. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16May2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 63 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 20Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 02Apr2021 as dose 2, single (Batch/Lot number: unknown), in left arm, on 09Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm and on 22Jan2022 as dose 4 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "known allergies: shellfish" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Iodine, reaction(s): "Drug allergy"; Sulphur, reaction(s): "Drug allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 including Paxlovid from 06Apr2023 to 10Apr2023.  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: 53.0
Sex: M
Vaccine: 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.  A 53-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 18Nov2022 as dose 5 (booster), single (Lot number: GJ5342) at the age of 53 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: "penicillin allergy" (unspecified if ongoing); "Keflex allergy" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXIN, start date: 01Dec2016; OMEPRAZOLE, start date: 01Dec2019. The following information was reported: DRUG INEFFECTIVE (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: (13Apr2023) positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 04Apr2023 to 09Apr2023.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Glomerular filtration rate, Renal function test, Renal impairment
Clinical narrative: had significant decline in kidney function/ went from GFR 63 to 39/ GFR 27 stage 4; This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative.  A 58-year-old female patient received BNT162b2 (BNT162B2), on 11Jan2021 as dose 2, single (Batch/Lot number: unknown) at the age of 56 years for covid-19 immunisation. The patient's relevant medical history included: "Kidney transplant", start date: 1998 (not ongoing). Concomitant medication(s) included: ACT [ACETYLCYSTEINE]; AMLODIPINE BESYLATE; CARVEDILOL ADICO; CYCLOBENZAPRINE HCL; CYCLOSPORINE; LOSARTAN; MYCOPHENOLATE MOFETIL; NASONEX nasal; POTASSIUM CHLORIDE; PRAVASTATIN SODIUM; PREDNISONE; RYBELSUS oral; VITAMIN D3. Vaccination history included: BNT162b2 (DOSE 1, SINGLE), administration date: 21Dec2020, for COVID-19 immunisation. The following information was reported: RENAL IMPAIRMENT (medically significant), outcome "unknown", described as "had significant decline in kidney function/ went from GFR 63 to 39/ GFR 27 stage 4". The patient underwent the following laboratory tests and procedures: Glomerular filtration rate: (04Mar2021) Declined from 63 to 39, notes: GFR Declined from 63 to 39; (11Apr2021) Declined from 39 to 27, notes: GFR declined from 39 to 27; Renal function test: (11Apr2023) Unknown results, notes: Labs drawn today to check function. Waiting on results. Clinical course: Since getting vaccine has had significant decline in kidney function. Patient received Dose 3 (Booster), Single on 23Sep2021 for COVID-19 immunisation.  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 available information, a possible contributory role of the subject product BNT162B2 vaccine  cannot be excluded for the reported event of renal impairment due to temporal relationship. However, the reported event may possibly represent intercurrent medical condition in this patient with history of renal transplantation. There is limited information provided in this report. Additional information, including complete medical history, diagnostics including renal function tests at baseline prior to vaccination, renal ultrasound, CT/MRI of abdomen/pelvis, kidney biopsy, chemistry panel and serum toxicology screen, counteractive treatment measures and concomitant medications, are needed to better assess the case.  This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: Got sick every time; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "Got sick every time".  Additional information: I got sick every time.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: Got covid after booster; Got covid after booster; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An elderly male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Got covid after booster".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Blood thyroid stimulating hormone, Blood thyroid stimulating hormone abnormal
Clinical narrative: My horomones and thyroid became messed up; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID:. The reporter is the patient.  An adult female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BLOOD THYROID STIMULATING HORMONE ABNORMAL (non-serious), outcome "unknown", described as "My horomones and thyroid became messed up". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient reported, her hormones and thyroid became messed up after getting the vaccine. So, she didn't want it to mess anything up again.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: got covid after receiving three shots; got covid after receiving three shots; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An elderly male patient 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; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "got covid after receiving three shots".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: Allergic reaction to the first two vaccines; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An elderly female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HYPERSENSITIVITY (non-serious), outcome "unknown", described as "Allergic reaction to the first two vaccines".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300154689 same patient/drug/AE, different dose;
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: Don't think the boosters are safe and neither was the initial 2 vaccinations I received. Still got Covid and a bad case; Don't think the boosters are safe and neither was the initial 2 vaccinations I received. Still got Covid and a bad case; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An elderly female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Don't think the boosters are safe and neither was the initial 2 vaccinations I received. Still got Covid and a bad case".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: heart palpitations; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: . The reporter is the patient.  An elderly male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary series completed; unknown manufacturer), for COVID-19 immunization. The following information was reported: PALPITATIONS (non-serious), outcome "unknown", described as "heart palpitations".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: Sick from shots; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An elderly female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "Sick from shots".  Additional information: Patient reported that getting sick from previous shots and I protect myself vigilantly.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: does not work; does not work; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An elderly male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "does not work". Clinical course: Nothing and it was reported that patient would never get the vaccine because it did not work and would cause more harm than if he did catch a cold.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: Drug ineffective; Got covid after shots; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP. The reporter is the patient.  An adult female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown"; SUSPECTED COVID-19 (medically significant), outcome "unknown", described as "Got covid after shots". Clinical Course: Patient also reported that she had 2 shots and she still got covid twice.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: a lot of pain; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN (non-serious), outcome "unknown", described as "a lot of pain".  Additional information: The patient experienced a lot of pain during the initial shots so that was preventing him.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Inflammation, Toxic neuropathy
Clinical narrative: had a bad reaction that looks like a non-specific systemic inflammation and developed toxic neuropathy; had a bad reaction that looks like a non-specific systemic inflammation and developed toxic neuropathy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (Unknown).  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: TOXIC NEUROPATHY (medically significant), INFLAMMATION (non-serious), outcome "unknown" and all described as "had a bad reaction that looks like a non-specific systemic inflammation and developed toxic neuropathy". The events "had a bad reaction that looks like a non-specific systemic inflammation and developed toxic neuropathy" required physician office visit. Therapeutic measures were taken as a result of toxic neuropathy, inflammation. Clinical course: The patient took the Pfizer booster about a year ago and had a bad reaction that looks like a non-specific systemic inflammation and developed toxic neuropathy, the specialist suggested the Evu shot, so she took it and was subsequently shown that it was ineffective, and then she was looking to take Novavax. She was worried about taking Novavax.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Angioedema
Clinical narrative: angioedema; This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, UNKNOWN MANUFACTURER), for COVID-19 Immunization. The following information was reported: ANGIOEDEMA (medically significant), outcome "unknown". The event "angioedema" required physician office visit. The patient was seeing an allergist. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the available information and known product profile, a possible causal relationship cannot be excluded between the suspect vaccine bnt162b2 and the reported event "angioedema". The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Hypertension
Clinical narrative: Hypertension/HTN; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 68-year-old female patient received BNT162b2 (BNT162B2), on 17Aug2021 at 17:00 as dose 3 (booster), single (Lot number: FC3181) at the age of 68 years intramuscular for covid-19 immunisation. The patient's relevant medical history included: "Asthma", start date: 1990 (ongoing), notes: Lung Disease (Asthma: requiring more frequent albuterol); "GERD", start date: 2014 (ongoing); "Insomnia", start date: 02Jul2002 (ongoing); "Former smoker" (unspecified if ongoing), notes: Social smoker for 10 Year, Quit: 1983; "Daytime somnolence" (ongoing); "NASH" (unspecified if ongoing), notes: Liver disease; "Hypertension" (unspecified if ongoing). Concomitant medication(s) included: FLOVENT taken for asthma (ongoing); LOSARTAN/HCTZ oral taken for hypertension (ongoing); PANTOPRAZOLE oral taken for gastrooesophageal reflux disease (ongoing); ZOLPIDEM oral taken for insomnia (ongoing); ALBUTEROL [SALBUTAMOL SULFATE] taken for asthma. Vaccination history included: BNT162b2 (Dose Number: 1st, Date: 06Jan2021, Site of injection: Left Deltoid, Route: IM, COVID-19 Vaccine Name: Pfizer , Batch/Lot number: EM9899), administration date: 06Jan2021, when the patient was 67-year-old, for COVID-19 immunization; BNT162b2 (Dose Number: 2nd, Date: 27Jan2021, Site of injection: Left Deltoid, Route: IM, COVID-19 Vaccine Name: Pfizer , Batch/Lot number: EL1283), administration date: 27Jan2021, when the patient was 68-year-old, for COVID-19 immunization. The following information was reported: HYPERTENSION (non-serious) with onset 22Dec2021, outcome "not recovered", described as "Hypertension/HTN".  Additional information: The patient received booster dose due to high risk of frequent institutional or occupational exposure to coronavirus (and at risk of serious COVID-19 complications). Vaccination Facility Type was reported as Pharmacy or Drug Store.  They did not considered the Pfizer product had a causal effect to the adverse event hypertension.
Sex: U
Vaccine: MEN
Symptoms: No adverse event, Product storage error
Clinical narrative: patients that were given MENQUADFI after they found out that the vaccine is not suitable for use with  no reported adverse event; The excursion happened last 17 March 2023 and was reported 24 March 2023 with no reported adverse event; Initial information was received on 11-Apr-2023 regarding an unsolicited valid non-serious case received from a nurse.  This case involves an 12 patients of unknown age and gender patient who stated the excursion happened last 17 march 2023 and was reported 24 march 2023 and patients that were given menquadfi after they found out that the vaccine is not suitable for use with no reported adverse event after receiving meningococcal A-C-Y-W135 (T CONJ) vaccine [Menquadfi].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 17-Mar-2023, the patient received dose of suspect meningococcal A-C-Y-W135 (T CONJ) vaccine Solution for injection (lot U7459AE, expiration date: 03-Nov-2024) (strength, frequency was unknown) via unknown route in unknown administration site for Immunisation.  On 17-Mar-2023 the patient developed a non-serious event of the excursion happened last 17 march 2023 and was reported 24 march 2023 with no reported adverse event (product storage error) same day following the administration of meningococcal A-C-Y-W135 (T CONJ) vaccine.   On an unknown date (in between 17-Mar-2023 to 24-Mar-2023), patients were given menquadfi after they found out that the vaccine is not suitable for use with no reported adverse event (poor quality product administered) (unknown latency) following the administration of meningococcal A-C-Y-W135 (T CONJ) vaccine.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was Unknown for the events.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 0.92
Sex: F
Vaccine: UNK
Symptoms: Inappropriate schedule of product administration, Medication error, Product administered to patient of inappropriate age
Clinical narrative: patient received PENTACEL at 4 months, at 6 months and at 9 months with no reported adverse event; Initial information received  on 11-Apr-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 11 months old female patient and it was reported that patient received diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (vero)] at 4 months, 6 months and at 9 months with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitants and family history were not provided.   On 17-Jan-2023, the patient received 0.5 mL of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine Suspension for injection (batch/lot number: UJ754AB and expiry date: 26-Sep-2023; strength: standard) via intramuscular route in the left thigh for immunization. On 17-Oct-2022, she also received a dose of the same vaccine. On 29-Aug-2022 she also received a dose of the same vaccine (Product administered to patient of inappropriate age) (latency: same day).  It was reported that patient was administered 4 DTAP components by the age of 9 months. Caller confirmed that they have a patient who received DAPTACEL at 2 months, PENTACEL at 4 months, 6 months, and 9 months.  Action taken: Not applicable.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 0.75
Sex: F
Vaccine: DTAP, UNK
Symptoms: Extra dose administered, Inappropriate schedule of product administration, No adverse event
Clinical narrative: receiving an extra dose of DTAP in dose 3 of PENTACEL at 9 months no adverse event; Initial information received on 11-Apr-2023 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves a 9 months old female patient who received an extra dose of dtap in dose 3 of pentacel no adverse event after receiving diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [pentacel (VERO)] and diphtheria-15/tetanus/5 AC pertussis vaccine [Daptacel].  The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided.   On 06-Jun-2022, the patient received 0.5 ml of suspect diphtheria-15/tetanus/5 AC pertussis vaccine, suspension for injection (With unknown strength, lot number, expiration and at unknown administration site) via intramuscular route for immunization.  On 17-Jan-2023, the patient received a dose 3 of diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine, suspension for injection (With unknown strength, route, lot number, expiration and at unknown administration site) for immunization. Before this dose, patient also received doses  of same vaccine on 29-Aug-2022 and17-Oct-2023 respectively.  On 17-Jan-2023 the patient received an extra dose of dtap in dose 3 of pentacel at 9 months no adverse event (inappropriate schedule of product administration) (latency: same day).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 0.67
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered, Poor quality product administered
Clinical narrative: ACT-HIB was mixed with an expired diluent and was administered to a patient with no reported AE; Initial information was received on 12-Apr-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 8 months old female patient who stated act-hib was mixed with an expired diluent and was administered to a patient with no reported ae after receiving HIB (PRP/T) vaccine [ACT-HIB].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included POLIO VACCINE INACT 3V (VERO) (Ipol [POLIO VACCINE INACT 3V (VERO)]) and pneumococcal vaccine 13V (PNEUMOCOCCAL 13 VALENT VACCINE) for Immunisation.  On 28-Mar-2023, the patient received a Dose 2 of 0.5 ml Total of suspect HIB (PRP/T) vaccine Powder and solvent for solution for injection (lot U7251AA/UJ647AA, expiration date: 05-Mar-2023/30-Mar-2023) Strength: standard via intramuscular route in Left Quadracipe for prophylactic vaccination (Immunisation).  On 28-Mar-2023, the patient developed a non-serious event of ''act-hib was mixed with an expired diluent and was administered to a patient with no reported ae'' (Poor quality product administered) (same day) following the administration of HIB (PRP/T) vaccine.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 1.33
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: expired ACT-HIB was given to a patient with no reported adverse event; Initial information received on 12-Apr-2023 regarding an unsolicited valid non-serious case received from Nurse.  This case involves a 16 months old female patient to whom an expired haemophilus type B (HIB) vaccine [ACT-HIB] was given with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided.  Concomitant medications included varicella zoster vaccine (Varicella Vaccine) for immunisation.  On 11-Apr-2023, the patient received 0.5 ml (dose 4) of expired haemophilus type B (HIB) vaccine, powder and solvent for solution for injection (lot U7261AA, U7261AA, expiry date: 07-Apr-0223, 05-Jun-2023) (unknown strength) via intramuscular route in the left thigh for immunization with no reported adverse event (expired product administered) (latency: same day).  No lab data were reported.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for an event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 0.92
Sex: M
Vaccine: HIBV
Symptoms: Expired product administered
Clinical narrative: administered an ACTHIB last week and the diluent expired 30mar2023 with no reported adverse event; Initial information received on 12-Apr-2023 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 11 months old male patient to whom an HIB (PRP/T) vaccine [ACT-HIB] was administered last week with expired diluent with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) concomitant(s) and family history were not provided.   On 06-Apr-2023, the patient received 0.5 ml (dose 4) of suspect HIB (PRP/T) vaccine with expired diluent, powder and solvent for solution for injection (Lot number Diluent: U7260AA; expiry date: 30-Mar-2023 and  lot number Powder: UJ652AA; expiry date- 04-Apr-2023) (strength: standard) via intramuscular route in the left thigh for immunization with no reported adverse event (expired product administered) (latency: same day).  No lab data were reported.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 55.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: none Patient given expired covid vaccine: expired 11-22-2022 given 12-12-2022
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Hypotonic-hyporesponsive episode, Seizure
Clinical narrative: THREE TO FOUR MINUTES AFTER VACCINATION THE PATIENT HAD A HYPOTONIC/HYPORESPONSIVE EVENT WHILE SITTING IN A CHAIR IN THE LOBBY. THE PATIENT WAS BROUGHT GENTLY TO THE FLOOR AND WHILE STILL HYPORESPONSIVE HAD  A SHORT SEIZURE LASTING 5-10 SECONDS. THE PATIENT REMAINED ON THE GROUND FOR ANOTHER 5-7 MINUTES. BLOOD PRESSURE AND HEART RATE WERE MONITORED AND NORMAL GIVEN THE SITUATION.
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Tremor
Clinical narrative: Tremors
Age: 32.0
Sex: M
Vaccine: MENB
Symptoms: Joint range of motion decreased, Myalgia, Pain, Tenderness
Clinical narrative: Severe Left deltoid pain: throbbing, achy, constant pain without much swelling. Severe tenderness to palpation, limiting range of motion of L arm. Had same reaction within 6 hours following the first dose in the series and pain lasted for 3 days.
Sex: U
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: Little fever; Body pain; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of fever in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced fever (Verbatim: Little fever) and general body pain (Verbatim: Body pain). The outcome of the fever and general body pain were resolved.   The reporter considered the fever and general body pain to be related to Shingles vaccine.     The company considered the fever and general body pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 09-APR-2023 This case was reported by the patient via interactive digital media. The patient received first dose of Shingles vaccine and it caused him/her little fever and body pain and the patient was already recovered and he/she prefer to felt the symptoms of the vaccine that he/she would suffer from shingles in the future. The patient reported that he/she missing the second dose in one month. The patient reported that if you're over 50 as he/she recommend, get the vaccine. The patient reported that this was a lifelong vaccine, he/she would already be protected from shingles. The patient reported that if he/she were to get it, he/she would not suffer the same as if he/she had not been vaccinated. The patient reported that for your good, protect yourself. Follow-up would not possible, as no contact details were available.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Pain in extremity
Clinical narrative: Sore arm; Dizziness, ran into a wall; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 51-year-old female patient who received Herpes zoster (Shingrix) (batch number 4993L) for prophylaxis.   In NOV-2022, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced pain in arm (Verbatim: Sore arm) and dizziness (Verbatim: Dizziness, ran into a wall). The outcome of the pain in arm was unknown and the outcome of the dizziness was resolved (duration 3 hrs).   It was unknown if the reporter considered the pain in arm and dizziness to be related to Shingrix.     It was unknown if the company considered the pain in arm and dizziness to be related to Shingrix.   Additional Information: GSK receipt date: 12-APR-2023 The pharmacist reported that a coworker (patient) took the first dose of Shingrix and developed dizziness about 15 to 16 hours after receiving it.  She was able to get up but ran into a wall.  She was also able to take a shower and went to work that lasted about 3 hours.  The dizziness was not debilitating. The vaccine administration facility was the same as primary reporter. The expiry date of the vaccine was not available.  The reporter consented to follow up by postal. The present case US2023053375 was found to be duplicate of the case US2023053376. All the future information corresponding to the US2023053376 (case of deletion) to be submitted in the case of the record (US2023053375).
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Injection site pain, Insomnia, Myalgia, Neck pain
Clinical narrative: Site: Pain at Injection Site-Medium, Systemic: Body Aches Generalized-Mild, Systemic: muscle pain in upper shoulder/neck area-Medium, Systemic: Unable to Sleep-Medium
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Site: Pain at Injection Site-Medium, Systemic: Body Aches Generalized-Mild, Systemic: muscle pain in upper shoulder/neck area-Medium, Systemic: Unable to Sleep-Medium
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site erythema, Injection site swelling
Clinical narrative: Site: Bruising at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Additional Details: advise to see his doctor
Age: 32.0
Sex: F
Vaccine: MNQ
Symptoms: Chest discomfort, Chest pain
Clinical narrative: Systemic: Chest Tightness / Heaviness / Pain-Severe, Additional Details: patient reported having tightness of chest at front of store after receiving vaccine.  asked for us to call ambulance and we did.