chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20May2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 54 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: penicillin" (unspecified if ongoing), notes: Known allergies: penicillin. 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 "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (21Jan2023) Negative, notes: I have taken another at home COVID test which was negative. Therapeutic measures were taken as a result of drug ineffective, covid-19 for COVID 19 Treatment with Paxlovid from 07Jan2023 to 11Jan2023.  Clinical course: Patient received vaccine and other medication in 2weeks yes. patient treated with Paxlovid for event.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging, Vaccination site pain
Clinical narrative: This is a spontaneous report received from contactable reporter  A 78-year-old female patient received BNT162b2 (BNT162B2), on 18Jan2021 as dose 1, single (Lot number: EL3249, Expiration Date: May2021) at the age of 76 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Had kidney removed last year", start date: Oct2021 (unspecified if ongoing); "Sciatica" (unspecified if ongoing), notes: had to lay in bed,had sciatica,one weekend she had to go to ER three times in four days; "back surgery" (unspecified if ongoing), notes: She had back surgery in the past; "mass in her kidney" (unspecified if ongoing), notes: she does have a mass in her kidney and looks very cancerous; "They were able to take the kidney out and since cancer" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Oxycodone, reaction(s): "Nerve block", notes: heavier dose before could get nerve block Oxycodeine did not take pain away only nerve block did. Vaccination history included: Shingles (Caller and his wife had all vaccines, from shingles to whatever), for Immunization. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "sore at the injection site". Relevant laboratory tests and procedures are available in the appropriate section.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging, Vaccination site pain
Clinical narrative: sore at the injection site; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 78-year-old female patient received BNT162b2 (BNT162B2), on 27Apr2022 at 10:00 as dose 4 (booster), single (Lot number: FJ6369) at the age of 78 years intramuscular, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Had sciatica so bad" (unspecified if ongoing); "Had kidney removed last year", start date: Oct2021 (unspecified if ongoing), notes: Had kidney removed last year; "mass in her kidney" (unspecified if ongoing); "mass in her kidney and looks very cancerous" (unspecified if ongoing); "She had back surgery in the past" (unspecified if ongoing), notes: She had back surgery in the past. The patient's concomitant medications were not reported. Past drug history included: Oxycodeine, reaction(s): "nerve block". Vaccination history included: BNT162b2 (Dose 3 (Booster), Lot number: EW0185, EXP: Unknown, Route of administration: injected into right arm, Time: morning, exact time unknown), administration date: 11Oct2021, when the patient was 77-year-old, for COVID-19 immunization, reaction(s): "sore arm at the injection site"; BNT162b2 (Dose 2, single, Lot number: EN9581, Expiry date: May2021, Route of administration: injected into right arm, Time: 10AM), administration date: 08Feb2021, when the patient was 76-year-old, for COVID-19 immunization, reaction(s): "sore arm at the injection site"; BNT162b2 (Dose 1, Single, Lot number: EL3249, Expiry date: May2021, Route of administration: injected into right arm, Time: around 6-7pm Was a drive-thru vaccine facility), administration date: 18Jan2021, when the patient was 76-year-old, for COVID-19 immunization, reaction(s): "sore arm at the injection site"; Shingles (Caller and his wife had all vaccines, from shingles to whatever), for Immunization. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "sore at the injection site". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: While she had the sciatica, one weekend she had to go to ER three times in four days. The last time she was there, they did an MRI on her back. Oxycodeine: NDC/LOT/EXP/Manufacturer: Unknown Unable to confirm spelling of product name as she does not have product at time of call. Strength: 5mg, but she did have some of the heavier dose before she could get the nerve block Oxycodeine did not take the pain away, only the nerve block did.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300032197 same patient/drug/event, different dose;US-PFIZER INC-202300032249 same patient/drug/event, different dose;US-PFIZER INC-202300032250 same patient/drug/event, different dose;US-PFIZER INC-202300030721 same patient/drug, different event/dose;US-PFIZER INC-202300030735 same patient/drug/event, different dose;
Sex: M
Vaccine: COVID19
Symptoms: Ischaemic stroke
Clinical narrative: I have got a stroke/Ischemic attack; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 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. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot number: unknown), for COVID-19 immunization; Bnt162b2 (DOSE 2, SINGLE; Lot number: unknown), for COVID-19 immunization. The following information was reported: ISCHAEMIC STROKE (medically significant), outcome "unknown", described as "I have got a stroke/Ischemic attack".  Clinical course: Consumer stated that he needed to speak to whoever the doctor was because he had an adverse reaction to the vaccine. He had an ischemic event or ischemic attack was what he believed they call it. He was relatively a healthy man. When paraphrased the concern, consumer stated that he had a stroke there were reports that people might be having strokes as results of the vaccine, he got a stroke.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
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 non-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 04Nov2022 as dose 5 (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), 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: "Mast Cell Activation Syndrome" (unspecified if ongoing); "Chronic Lyme Disease" (unspecified if ongoing), notes: Chronic Lyme Disease; "Known allergies: Pennicilin" (unspecified if ongoing), notes: Known allergies: Pennicilin; "Known allergies: Dairy" (unspecified if ongoing), notes: Known allergies: Dairy. The patient's concomitant medications were not reported. Past drug history included: Lanolin, reaction(s): "Allergy_Lanolin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: Antiviral COVID-19 Treatment Paxlovid from 12Jan2023 to 17Jan2023  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroid" (unspecified if ongoing); "known allergies: NSAIDS" (unspecified if ongoing), notes: known allergies: NSAIDS. Concomitant medication(s) included: LEVOTHYROXINE. Past drug history included: Aspirin, reaction(s): "known allergies:Aspirin", notes: known allergies:Aspirin. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2023, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jan2023) positive; (17Jan2023) Negative, notes: Rebound of COVID 5 days after testing negative. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 10Jan2023 to 14Jan2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77-year-old female patient received BNT162b2 (BNT162B2), on 21Apr2021 as dose number unknown, 0.3ml single (Lot number: ER8736) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "recovered" (2021), described as "sore arm".  Additional information: With the Pfizer COVID-19 Vaccine she was administered on 21Apr2021 she reported sore arm, but that did not last terribly long; event start date and stop date unknown other than event lasted for about a week and she recovered completely.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 59-year-old male patient received BNT162b2 (BNT162B2), on 02Feb2022 at 14:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 58 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: vaccine received was reported as yes. No other medication in 2weeks. Product COVID 19 Treatment, Treatment start date 02Jan2023, Treatment stop date 06Jan2023, device timestamp 22Jan2023.  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 in the case report and a plausible temporal relationship, a possible causal relationship between the events drug ineffective, covid-19 and suspect drug BNT162B2 cannot be excluded.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Covid test positive.; Covid test positive.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 44-year-old male patient received BNT162b2 (BNT162B2), on 12Feb2021 as dose 1, single (Lot number: EL9265), in left arm, on 04Mar2021 as dose 2, single (Lot number: EN6200), in left arm and on 08Dec2021 as dose 3 (booster), single (Lot number: 33030BD) at the age of 43 years, in left arm, all intramuscular for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications.   The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 22Jan2023, outcome "unknown" and all described as "Covid test positive.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (22Jan2023) Positive. Therapeutic measures were not taken as a result of vaccination failure, covid-19.  Clinical course: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and any Other medications in two weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since vaccination, patient had tested for COVID-19.Patient did not have any known allergies and no other medical history.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: he had covid in Mar2022 / pfizer covid-19 vaccine (EUA); he had covid in Mar2022 / pfizer covid-19 vaccine (EUA); This is a spontaneous report received from contactable reporter(s) (Nurse), Program ID.  A 43-year-old 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 was not reported. Concomitant medication(s) included: FLUCELVAX QUAD taken for immunisation; VENOFER; ESCITALOPRAM OXALATE; VITAMIN D NOS. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Mar2022, outcome "not recovered" and all described as "he had covid in Mar2022 / pfizer covid-19 vaccine (EUA)".  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 given in narrative, the causal relationship between the reported events covid 19/ drug ineffective  and the suspect drug BNT162B2 cannot be excluded.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Interchange of vaccine products, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; vaccine brand other: Moderna/vaccine administration date: 08Apr2022; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Sep2022 as dose 5 (booster), single (Lot number: GJ5342) at the age of 54 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 05Mar2021 as dose 1, single (Lot number: En6205), on 26Mar2021 as dose 2, single (Lot number: Er8727) and on 11Oct2021 as dose 3 (booster), single (Lot number: Fd0810) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 08Apr2022 as dose 4 (booster), single (Lot number: 084j21A) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "diabetes" (unspecified if ongoing); "heart disease" (unspecified if ongoing); "Sulfa drugs" (unspecified if ongoing), notes: Known allergies: Sulfa drugs. The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 08Apr2022, outcome "unknown", described as "vaccine brand other: Moderna/vaccine administration date: 08Apr2022"; 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: Product: COVID 19 Treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Patient has vaccine was received  and Other medication in 2weeks Yes. patient received Paxlovid treatment for event.
Sex: F
Vaccine: COVID19
Symptoms: Cough
Clinical narrative: This is a spontaneous report received from a non-contactable reporter. A 33-year-old female patient 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. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 3; MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: COUGH (non-serious), outcome "unknown", described as "Constant cough for 6 months".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Autoimmune thyroiditis, Condition aggravated, Pancreatic failure
Clinical narrative: Worsening of Hashimoto's disease; Worsening of Hashimoto's disease; pancreatic insufficiency; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 57-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 12Apr2021 at 14:30 as dose 2, single (Lot number: Er8729) at the age of 57 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Pancreas insufficiency" (unspecified if ongoing); "Hashimoto's disease" (unspecified if ongoing). Concomitant medication (in two weeks) included: LEVOTHYROXINE. Past drug history included: Codeine, reaction: "Known allergies". Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot number: EP8729, administration time: 02:00 PM, vaccine location: right arm), administration date: 24Mar2021, when the patient was 57-year-old, for COVID-19 Immunization. The following information was reported: AUTOIMMUNE THYROIDITIS (hospitalization, disability, medically significant, life threatening), CONDITION AGGRAVATED (hospitalization, disability, medically significant, life threatening) all with onset 14May2021 at 14:00, outcome "not recovered" and all described as "Worsening of Hashimoto's disease"; PANCREATIC FAILURE (hospitalization, disability, medically significant, life threatening) with onset 14May2021 at 14:00, outcome "not recovered", described as "pancreatic insufficiency". The patient was hospitalized for autoimmune thyroiditis, condition aggravated, pancreatic failure (hospitalization duration: 1 day. The events "worsening of hashimoto's disease" and "pancreatic insufficiency" required physician office visit and emergency room visit. Therapeutic measures were taken as a result of autoimmune thyroiditis, condition aggravated, pancreatic failure, which included fluids. Clinical course: The vaccination facility was reported as the public health clinic. The patient had no other vaccine in four weeks. The patient had no covid prior vaccination and was not tested for covid post vaccination.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 49-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "HTN" (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 "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: COVID 19 Treatment; (Jan2023) Positive, notes: started having symptoms again and tested positive for Covid again on home test kit (was negative on last day of paxlovid) - runny nose, mild cough; (16Jan2023) Negative, notes: was negative on last day of paxlovid. Therapeutic measures were taken as a result of drug ineffective, covid-19. 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 known drug safety profile, there is reasonable possibility of causal association between the events DRUG INEFFECTIVE and COVID-19 and BNT162B2.
Sex: U
Vaccine: PNC13
Symptoms: Illness, Viral titre
Clinical narrative: 2 recent patients at the age of 5 years of age that have been sick and titer tests were conducted and neither patient had titers of Prevnar.; This is a spontaneous report received from contactable reporter(s) (Nurse) from a sales representative.  A 5-year-old patient received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), as dose number 4, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Hep, reaction(s): "no titer"; Prevnar 13 (dose 1), for immunization; Prevnar 13 (dose 3), for immunization; Prevnar 13 (dose 2), for immunization. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "2 recent patients at the age of 5 years of age that have been sick and titer tests were conducted and neither patient had titers of Prevnar.". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: The nurse was describing 2 recent patients at the age of 5 years of age that have been sick and titer tests were conducted and neither patient had titers of Prevnar. She felt both had 4 doses as infants. Thought was strange that they had no titers. One of the patients also had no titers of Hep B. Event took place after use of product.  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-202300027122 Same reporter/ drug /AE, different patients.;
Sex: U
Vaccine: PNC13
Symptoms: Urticaria
Clinical narrative: Hives following vaccination; This is a spontaneous report received from contactable reporter(s) (Nurse) from a sales representative.  A patient (no qualifiers provided) received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), as dose number unknown, 0.5 ml single (Lot number: FX0078, Expiration Date: 30Nov2024) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: URTICARIA (non-serious), outcome "unknown", described as "Hives following vaccination".  Additional information: Description of Event: Hives following vaccination. Name of Product: Prevnar 13, 0.5 mL, FX0078, 30Nov2024. Event took place after use of product.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Pain in extremity, Rash
Clinical narrative: Rash and/or sores on arms, stomach and inner thighs; Rash and/or sores on arms, stomach and inner thighs; Rash and/or sores on arms, stomach and inner thighs; Rash and/or sores on arms, stomach and inner thighs; This is a spontaneous report received from non-contactable reporter(s) (Other HCP) from a sales representative. The reporter is the patient.  A 50-year-old female patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Current smoker" (unspecified if ongoing), notes: Current smoker. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization completed, unknown manufacturer), for COVID-19 immunization. The following information was reported: RASH (non-serious), PAIN IN EXTREMITY (non-serious), ABDOMINAL PAIN UPPER (non-serious), PAIN IN EXTREMITY (non-serious), outcome "unknown" and all described as "Rash and/or sores on arms, stomach and inner thighs".  Additional Information: It was reported patient developed rash and/or sores on arms, stomach and inner thighs 2 days after receiving her 3rd dose of the Pfizer COVID-19 vaccine. Reports symptoms have persisted for close to 1 year. Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Carditis
Clinical narrative: The heart inflammation from the shot; 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 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: CARDITIS (medically significant), outcome "unknown", described as "The heart inflammation from the shot".  Additional information: Brief description of event: Heart inflammation from the shot.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: PNC20
Symptoms: Peripheral swelling, Urticaria
Clinical narrative: Swelling in arm; hives; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old male patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 09Jan2023 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PERIPHERAL SWELLING (non-serious) with onset Jan2023, outcome "unknown", described as "Swelling in arm"; URTICARIA (non-serious) with onset Jan2023, outcome "unknown", described as "hives".  Additional information: No other vaccines were administered when the patient received PCV 20.   The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: He still ended up getting COVID; He still ended up getting COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Nov2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), on 01Apr2021 as dose number unknown, single (Batch/Lot number: unknown) and on 04Apr2022 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. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2023, outcome "unknown" and all described as "He still ended up getting COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jan2023) Positive.  Clinical information: Patient mentioned that he is calling to let us know that he did take the vaccine and he said that he initially took the first set on 01Apr2021 and he took another booster on 04Apr2022 then took the new Bivalent booster on Nov2022. He said that he just wanted to know that he still ended up getting COVID and he said that he got relatively severe cases of cold. He said that he just wanted to know the progress. He also mentioned that he was tested positive last Friday.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Cardiac disorder
Clinical narrative: heart issues; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A female patient (unknown if pregnant) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "potential binge drinker" (unspecified if ongoing), notes: implicating her as a potential binge drinker. The patient's concomitant medications were not reported. The following information was reported: CARDIAC DISORDER (non-serious), outcome "unknown", described as "heart issues".  Additional information: Activity Category was withheld Services, Activity Subject was reported as No Subject. Activity Body reported as I am seeking a payment for evidence disproving a lawsuit by a withheld of Withheld on Withheld. She claims that your COVID vaccination caused her health issues, specifically heart issues. Reach me at Withheld As my information that I have gathered amounts even greater, I will detail what I know as follows: I have evidence of her gross irresponsibility, implicating her as a potential binge drinker and "party girl." Evidence of gross irresponsibility on day of vaccination.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Transient ischaemic attack
Clinical narrative: father had a Tia several weeks after receiving the COVID vaccine - Pfizer; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 91-year-old 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 included: "He has blood pressure issues" (unspecified if ongoing), notes: Optional Information: He has blood pressure issues and meds. He is 91. The patient took concomitant medications. The following information was reported: TRANSIENT ISCHAEMIC ATTACK (medically significant), outcome "unknown", described as "father had a Tia several weeks after receiving the COVID vaccine - Pfizer".  Clinical information: The patient's father had a Tia several weeks after receiving the COVID vaccine - Pfizer. He had blood pressure issues and meds. He was 91. The event took place after use of product.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 61.0
Sex: F
Vaccine: PNC20
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site rash
Clinical narrative: injection site had a red rash and was itching; injection site had a red rash and was itching; injection site had a red rash and was itching; This is a spontaneous report received from a contactable reporter (Nurse) from a sales representative.  A 61-year-old female patient received pneumococcal 20-valent conjugate vaccine (diphtheria CRM197 protein) (PREVNAR 20), on 06Jan2023 as dose number unknown, single (Batch/Lot number: unknown) at the age of 61 years for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE RASH (non-serious) all with onset Jan2023, outcome "recovering" and all described as "injection site had a red rash and was itching"; VACCINATION SITE PRURITUS (non-serious) with onset Jan2023, outcome "not recovered", described as "injection site had a red rash and was itching". Therapeutic measures were taken as a result of vaccination site erythema, vaccination site rash, vaccination site pruritus. Additional information: On 13Jan2023, the patient called the office and said the injection site had a red rash and was itching. She stated that those events occurred immediately after the injection. The nurse told her to take Benadryl and let her know if it did not resolve. On 19Jan2023, the patient called and stated that the rash had improved and there was only slight itching, but it had not resolved completely. The nurse and the treating physician felt that it was a moderate reaction to the vaccine. The nurse stated she did not feel it was a severe reaction. The event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: FLU3, FLUR3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: flublok inadvertently ordered, staff administered to patient. should have been fluzone with no reported adverse event; administration of flublok to patient younger than intended/ patient is 7 month infant and indication given as 18 years plus with no reported adverse event; Initial information received on 17-Jan-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 7 months old female patient and reporter sated that INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK] inadvertently ordered, staff administered to patient should have been INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE [FLUZONE] with no reported adverse event and administration of flublok to patient younger than intended/ patient is 7 month infant and indication given as 18 years plus with no reported adverse event.   The patient's past medical history, medical treatment(s), concomitant medication, vaccination(s) and family history were not provided.  On 04-Jan-2023 the patient developed a non-serious event of flublok (dose: 0.5ml via intramuscular route, administration site and strength was unknown, batch number: UJ931AA and expiry date was unknown for prophylactic vaccination)inadvertently ordered, staff administered to patient. should have been fluzone with no reported adverse event (wrong product administered) (Latency: same day) following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE and (INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE.  On 04-Jan-2023 the patient developed a non-serious event of administration of flublok to patient younger than intended/ patient is 7 month infant and indication given as 18 years plus with no reported adverse event (product administered to patient of inappropriate age) (Latency: same day) following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE and INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE.  Action taken with QUADRIVALENT RECOMBINANT INFLUENZA VACCINE (FLUBLOK) and INFLUENZA VACCINE TRIVALENT (FLUZONE) was not applicable.  Outcome: Unknown  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 6.0
Sex: F
Vaccine: FLU3, FLUR3
Symptoms: Medication error, No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: flublok inadvertently ordered, staff administered to six patients, should have been fluzone with no adverse event; flublok inadvertently ordered, staff administered to six patients, should have been fluzone with no adverse event; Initial information was received from on 17-Jan-2023 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves a 6 years old female patient to whom influenza quadrivalent recombinant vaccine [Flublok] inadvertently ordered, staff administered to six patients, should have been influenza trival A-B subvirion no preservative vaccine [Fluzone] with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant disease or risk factor and family history were not provided.   On 04-Jan-2023, the patient received 0.5 ml dose of suspect influenza quadrivalent recombinant vaccine (lot UJ93AA; strength, formulation, frequency, expiry date: unknown) via intramuscular route in unknown administration site for prophylactic vaccination.  On 04-JAN-2023 the flublok inadvertently ordered, staff administered to six patients, should have been fluzone with no adverse event (wrong product administered) (product administered to patient of inappropriate age) (latency: on same day).  It is unknown if there were lab data/results available  Action taken : not applicable.  Outcome : Unknown.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 11.0
Sex: M
Vaccine: FLU3, FLUR3
Symptoms: Medication error, No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: flublok inadvertently ordered, staff administered to six patients, should have been fluzone with no adverse event; flublok inadvertently ordered, staff administered to six patients, should have been fluzone with no adverse event; Initial information received on 17-Jan-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 11 years old male patient to whom influenza quadrivalent recombinant vaccine [Flublok] inadvertently ordered, staff administered to six patients, should have been influenza trival A-B subvirion no preservative vaccine [Fluzone] with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant disease or risk factor and family history were not provided.  On 04-Jan-2023, the patient received 0.5 ml dose of suspect influenza quadrivalent recombinant vaccine (lot UJ93AA; strength, formulation, frequency, expiry date: unknown) via intramuscular route in unknown administration site for prophylactic vaccination.  On 04-JAN-2023 the flublok inadvertently ordered, staff administered to six patients, should have been fluzone with no adverse event (wrong product administered) (product administered to patient of inappropriate age) (latency:same day).  It is unknown if there were lab data/results available  Action taken : not applicable.  Outcome : Unknown.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 11.0
Sex: F
Vaccine: FLU3, FLUR3
Symptoms: Medication error, No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: flublok inadvertently ordered, staff administered to six patients, should have been fluzone with no adverse event; flublok inadvertently ordered, staff administered to six patients, should have been fluzone with no adverse event; Initial information received on 17-Jan-2023 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves a 11 years old female patient whom influenza quadrivalent recombinant vaccine [Flublok] inadvertently ordered, staff administered to six patients, should have been influenza trival A-B subvirion no preservative vaccine [Fluzone] with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant disease or risk factor and family history were not provided.  On 04-Jan-2023, the patient received 0.5 ml dose of suspect influenza quadrivalent recombinant vaccine (lot UJ93AA; strength, formulation, frequency, expiry date: unknown) via intramuscular route in unknown administration site for prophylactic vaccination.  On 04-JAN-2023 the flublok inadvertently ordered, staff administered to six patients, should have been fluzone with no adverse event (wrong product administered) (product administered to patient of inappropriate age) (latency: on same day).  It is unknown if there were lab data/results available  Action taken : not applicable.  Outcome : Unknown.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: FLUX
Symptoms: Illness
Clinical narrative: Every time I get the flu shot I get sick.; Initial information received on 18-Jan-2023 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves an unknown age and unknown gender patient who reported every time i get the (Influenza vaccine) flu shot i get sick.  The patient's past medical treatment(s), vaccination(s) and family history were not provided. It was unknown if the patient had any medical history, concomitant disease or risk factor.  On an unknown date, the patient received a dose of suspect Influenza vaccine produced by unknown manufacturer (dose, strength, form, expiry number and lot number not reported) via unknown route in unknown administration site as flu (Influenza).  On an unknown date the patient reported every time i get the flu shot i get sick. (illness) (unknown latency).  It was also reported "This year had it for 9 weeks straight got better for 1 week and I am sick again. Next year I might think twice before getting it".  It was unknown if there were lab data/results available.  It was unknown if the patient experienced any additional symptoms/events.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event.  Outcome: Unknown
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: use to get the flu shot and would get the flu that same year; Initial information received on 18-Jan-2023 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional via social media.  This case involves a patient of unknown age and gender who used to get the flu shot and would get the flu that same year after receiving influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s), concomitant disease or risk factor and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect influenza vaccine produced by unknown manufacturer (strength, formulation, lot number, expiry date - not reported) via unknown route in unknown administration site for prophylactic vaccination (Immunization).  On an unknown date the patient had flu shot and got the flu that same year (influenza) (unknown latency) following the administration of influenza vaccine.  Reportedly,  Funny I use to get the flu shot and would get the flu that same year and now that I don't get it I haven't had the flu.  It was unknown if the patient experienced any additional symptoms/events.  It was unknown if there were lab data/results available.  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.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: got flu; Initial information received on 18-Jan-2023 regarding an unsolicited valid Social Media serious case received from a consumer/non-hcp.  This case involves an unknown age and gender patient who got flu after receiving vaccine Influenza vaccine.  The patient's past medical treatment(s), vaccination(s) and family history were not provided.  It was unknown if the patient had any medical history, concomitant disease or risk factor   On an unknown date, the patient received a  dose of suspect Influenza vaccine produced by unknown manufacturer (dose, strength, form, expiry date and lot number not reported) via unknown route in unknown administration site as prophylactic vaccination.  On an unknown date the patient got flu (influenza) (unknown latency) following the administration of Influenza vaccine.   It was unknown if there were lab data/results available.   Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (got flu).  At time of reporting, the outcome was Unknown for the event got flu.  The patient was hospitalized for this event.; Sender's Comments: Sanofi Company Comment dated 18-Jan-2023: This case involves an unknown age and gender patient who got flu after receiving vaccine Influenza vaccine. Further information regarding concurrent condition during vaccination, previous vaccination, concomitant medication and tolerance, allergic history, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the individual suspect vaccine cannot be assessed.