chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Epilepsy
Clinical narrative: epileptic seizures; This spontaneous case was reported by a consumer and describes the occurrence of EPILEPSY (epileptic seizures) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no.) for COVID-19 prophylaxis.     Relevant medical history or conditions, allergy, concomitant diseases and risk factor were not given.    In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced EPILEPSY (epileptic seizures) (seriousness criteria hospitalization prolonged and medically significant). The patient was hospitalized from 14-Jul-2023 to 18-Jul-2023 due to EPILEPSY. The patient was treated with BRIVARACETAM (BRIVIACT) for Seizures, at a dose of 50 milligram twice a day and ESLICARBAZEPINE ACETATE (APTIOM) at a dose of 900 milligram, in the morning. At the time of the report, EPILEPSY (epileptic seizures) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient received 2 Moderna COVID-19 Vaccines between Feb 2021 and Mar 2021 with no specific dates, and she thought it was the primary series, but did not have the lot numbers on hand. About 3 weeks after the 2nd dose of the vaccine she experienced epileptic seizures with no previous history of seizures, and it happened again approximately 2 months later, once again 4 months later, again 3 months later and again 2 months later. It caused her a gigantic bill in the hospital because she needed hospitalization during 5 days from 14 Jul 2023 to 18 Jul 2023. The treatment given has been quite a few medications that did not work.  Company comment: This spontaneous case concerns a 31-year-old, female patient with no prior medical history of seizures, who experienced the unexpected serious (hospitalization and medically significant) AESI of epilepsy (epileptic seizure). The event occurred approximately 3 weeks after the second dose of mRNA-1273, with repeated occurrence of seizures (4 episodes with 2-4 months in between). As reported, about 3 weeks after the 2nd dose of the vaccine patient experienced epileptic seizures with no previous history of seizures, and it happened again approximately 2 months later, once again 4 months later, again 3 months later and again 2 months later. Reportedly, patient was treated with different medications which did not work and was currently of anticonvulsants. No further information about the events was provided. No information about any diagnostic tests results were provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 69.0
Sex: F
Vaccine: COVID19-2
Symptoms: Chills, Cough, Depressed mood, Feeling abnormal, Myalgia
Clinical narrative: her body ached; shivers; cough; runny nose; feels sad; not feeling well; This spontaneous case was reported by a patient and describes the occurrence of COUGH (cough), RHINORRHOEA (runny nose), DEPRESSED MOOD (feels sad), FEELING ABNORMAL (not feeling well) and MYALGIA (her body ached) in a 69-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 21-Aug-2023, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 21-Aug-2023, the patient experienced COUGH (cough), RHINORRHOEA (runny nose), DEPRESSED MOOD (feels sad), FEELING ABNORMAL (not feeling well) and CHILLS (shivers). On an unknown date, the patient experienced MYALGIA (her body ached). The patient was treated with PARACETAMOL (TYLENOL) for Pain, at an unspecified dose and frequency. At the time of the report, COUGH (cough) had not resolved, RHINORRHOEA (runny nose), DEPRESSED MOOD (feels sad), FEELING ABNORMAL (not feeling well) and CHILLS (shivers) had resolved and MYALGIA (her body ached) outcome was unknown.            Concomitant medication details not reported by the reporter.
Age: 69.0
Sex: F
Vaccine: COVID19-2
Symptoms: Rhinorrhoea
Clinical narrative: her body ached; shivers; cough; runny nose; feels sad; not feeling well; This spontaneous case was reported by a patient and describes the occurrence of COUGH (cough), RHINORRHOEA (runny nose), DEPRESSED MOOD (feels sad), FEELING ABNORMAL (not feeling well) and MYALGIA (her body ached) in a 69-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 21-Aug-2023, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 21-Aug-2023, the patient experienced COUGH (cough), RHINORRHOEA (runny nose), DEPRESSED MOOD (feels sad), FEELING ABNORMAL (not feeling well) and CHILLS (shivers). On an unknown date, the patient experienced MYALGIA (her body ached). The patient was treated with PARACETAMOL (TYLENOL) for Pain, at an unspecified dose and frequency. At the time of the report, COUGH (cough) had not resolved, RHINORRHOEA (runny nose), DEPRESSED MOOD (feels sad), FEELING ABNORMAL (not feeling well) and CHILLS (shivers) had resolved and MYALGIA (her body ached) outcome was unknown.            Concomitant medication details not reported by the reporter.
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; HCP vaccinated with a 3 day expired vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (HCP vaccinated with a 3 day expired vaccine) and NO ADVERSE EVENT (No adverse event) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AF7644C) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-Aug-2023, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 15-Aug-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (HCP vaccinated with a 3 day expired vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (HCP vaccinated with a 3 day expired vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (HCP vaccinated with a 3 day expired vaccine).    Concomitant medication details not reported by the reporter. Treatment details was not reported by the reporter.
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness, Somnolence
Clinical narrative: sleepy/feeling sleepy; flu like thing/flu like symptoms; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team, Program ID: (RA). The reporter is the patient.  A 75-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose: 01, single), for COVID-19 Immunization, reaction(s): "flu like thing/flu like symptoms", "sleepy/feeling sleepy". The following information was reported: SOMNOLENCE (non-serious), outcome "unknown", described as "sleepy/feeling sleepy"; INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "flu like thing/flu like symptoms".  Additional information: patient ´ve had that before with some of your earlier Pfizer vaccines.  After getting vaccine, had flu like symptoms day after, was feeling sleepy. These things pretty typical, has had this experience with Pfizer vaccines.Thinks he had four doses Covid-19 vaccine prior to this dose, all Pfizer.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Malaise
Clinical narrative: not feel well/ felt not great; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in 2023 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), in 2023 as dose number unknown, single (Batch/Lot number: unknown) for influenza immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MALAISE (non-serious) with onset 2023, outcome "unknown", described as "not feel well/ felt not great".  Additional information: Patient Had her COVID Vaccine and her Flu vaccine at the same time and she said she just did not feel well. Patient felt not great on Monday, but she felt better yesterday.  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; COVID 19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 79-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), in Jan2021 as dose 1, single (Batch/Lot number: unknown), in left arm, in Feb2021 as dose 2, single (Batch/Lot number: unknown), in left arm, in Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm and in May2022 as dose 4 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "high bp" (unspecified if ongoing); "cholesterol" (unspecified if ongoing); "over weight" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Lisinopril, reaction(s): "Known allergies: Lisinopril"; Codeine, reaction(s): "Known allergies: Codeine".  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19". The event "covid 19" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: 8 days after taking Paxlovid tested positive for covid. Therapeutic measures were taken as a result of drug ineffective, covid-19.  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: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Drug ineffective; 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 36-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Sep2022 as dose 5 (booster), single (Lot number: GH9694) at the age of 35 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: "Known allergies: Sulpha" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown"; COVID-19 (medically significant), outcome "unknown". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 14Aug2023 to 18Aug2023.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300283766 same patient, different drug/event;
Sex: M
Vaccine: 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 29-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Lupus" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2023, outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of Drug ineffective, Covid-19. Paxlovid was taken as therapeutic measures as a result of drug ineffective, Covid-19 from 16Aug2023 to 20Aug2023.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300283780 Same patient/different product, different dose/event;
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Drug ineffective; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant) with onset 2023, outcome "recovered" (2023), described as "COVID 19"; DRUG INEFFECTIVE (medically significant) with onset 2023, outcome "recovered" (2023). Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 08Aug2023 to 12Aug2023.  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-202300283782 same patient, different drug/event;
Age: 15.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Colonoscopy, Endoscopy, Magnetic resonance imaging, Migraine
Clinical narrative: Migraine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 15-year-old female patient received BNT162b2 (BNT162B2), on 06Aug2021 as dose 2, single (Lot number: EW0198) at the age of 15 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Crohns", start date: Jan2021 (ongoing), notes: Stop date: Ongoing, Pertinent Details: Colonoscopy 29Mar2021 / Endoscopy Oct2021 / MRI 12Apr2021; "a weakened immune system" (unspecified if ongoing), notes: Use of medications that suppress the immune system. The patient took concomitant medications. Past drug history included: Pentasa, start date: Jul2021, for Crohns, notes: Route: Oral. Vaccination history included: BNT162b2 (Dose 1, Anatomical site of Injection: Upper left arm, Route of administration: Intramuscular, Batch/Lot number: EW0198), administration date: 16Jul2021, when the patient was 15-year-old, for Covid-19 Immunization; Flu vaccine (Doses: 12), for Immunization; Flu vaccine (Doses: 11), for Immunization; Flu vaccine (Doses: 10), for Immunization; Flu vaccine (Doses:9), for Immunization; Flu vaccine (Doses: 8), for Immunization; Flu vaccine (Doses: 7), for Immunization; Flu vaccine (Doses: 6), for Immunization; Flu vaccine (Doses: 5), for Immunization; Flu vaccine (Doses: 4), for Immunization; Flu vaccine (Doses: 3), for Immunization; Flu vaccine (Doses: 2), for Immunization; Flu vaccine (Doses: 1), for Immunization. The following information was reported: MIGRAINE (non-serious) with onset Dec2021, outcome "not recovered". Relevant laboratory tests and procedures are available in the appropriate section.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300272460 same patient and product, different dose;
Age: 15.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Migraine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 15-year-old female patient received BNT162b2 (BNT162B2), on 06Aug2021 as dose 2, single (Lot number: EW0198) at the age of 15 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Crohns", start date: Jan2021 (ongoing), notes: Stop date: Ongoing, Pertinent Details: Colonoscopy 29Mar2021 / Endoscopy Oct2021 / MRI 12Apr2021; "a weakened immune system" (unspecified if ongoing), notes: Use of medications that suppress the immune system. The patient took concomitant medications. Past drug history included: Pentasa, start date: Jul2021, for Crohns, notes: Route: Oral. Vaccination history included: BNT162b2 (Dose 1, Anatomical site of Injection: Upper left arm, Route of administration: Intramuscular, Batch/Lot number: EW0198), administration date: 16Jul2021, when the patient was 15-year-old, for Covid-19 Immunization; Flu vaccine (Doses: 12), for Immunization; Flu vaccine (Doses: 11), for Immunization; Flu vaccine (Doses: 10), for Immunization; Flu vaccine (Doses:9), for Immunization; Flu vaccine (Doses: 8), for Immunization; Flu vaccine (Doses: 7), for Immunization; Flu vaccine (Doses: 6), for Immunization; Flu vaccine (Doses: 5), for Immunization; Flu vaccine (Doses: 4), for Immunization; Flu vaccine (Doses: 3), for Immunization; Flu vaccine (Doses: 2), for Immunization; Flu vaccine (Doses: 1), for Immunization. The following information was reported: MIGRAINE (non-serious) with onset Dec2021, outcome "not recovered". Relevant laboratory tests and procedures are available in the appropriate section.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300272460 same patient and product, different dose;
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Dose 1,2,3,4: Comirnaty; Dose 5: Moderna vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Apr2021 as dose 1, single (Lot number: ER8737), in left arm, on 25Apr2021 as dose 2, single (Lot number: EW0171), in left arm, on 06Dec2021 as dose 3 (booster), single (Lot number: FJ8757), in left arm and on 20Apr2022 at 14:00 as dose 4 (booster), single (Lot number: FJ4989) at the age of 63 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 06Nov2022 at 15:00 as dose 5 (booster), single (Lot number: 010H22A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Bronchitis chronic" (ongoing); "Known allergies: penicillin" (ongoing); "Known allergies: sumac" (ongoing). The patient's concomitant medications were not reported. Past drug history included: Erythromycin, reaction(s): "Known allergy: erythromycin". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 06Nov2022 at 15:00, outcome "unknown", described as "Dose 1,2,3,4: Comirnaty; Dose 5: Moderna vaccine"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: Patient did not receive any other medication in 2 weeks. Patient was treated with Paxlovid for COVID-19 from 15Aug2023 to 20Aug2023. The patient did not have any Adverse event. No treatment was received for AE.
Age: 33.0
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 34-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Aug2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 33 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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" (19Aug2023) and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (19Aug2023) Negative; (20Aug2023) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included received Paxlovid from 14Aug2023 to 18Aug2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 69.0
Sex: M
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 a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 11Jul2023 as dose 6 (booster), single (Batch/Lot number: unknown) at the age of 69 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), as dose 4 (booster), single (Batch/Lot number: unknown) and as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" (21Aug2023) and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (21Aug2023) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included received Paxlovid from 15Aug2023 to 19Aug2023.  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: U
Vaccine: COVID19, FLUX
Symptoms: COVID-19, Drug ineffective
Clinical narrative: I have had COVID three times now/extremely sick again for the third time/this one is really bad like I can't breathe/I feel like crap; I have had COVID three times now/extremely sick again for the third time/this one is really bad like I can't breathe/I feel like crap; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "I have had COVID three times now/extremely sick again for the third time/this one is really bad like I can't breathe/I feel like crap". Clinical course: consumer stated, "I have had COVID three times now, as you can hear extremely sick again for the third time. I just want to report to you all that whenever, I mean I took flu shots (Unspecified Flu shot) I took all that kind of crap, I can keep naming all names of vaccine (Unspecified vaccine) that I took myself." Consumer added, "I would just like to kind of see the medical files on the COVID because like I said it is the third time that I have had it and this one is really bad like I can't breathe. So, I would like to see the medical files, whatever they have printed out, I want to see what the purpose of this vaccine (Pfizer COVID 19 Vaccine) is. I have had it three times now (COVID)." Consumer stated, "I would like to see it's on the medical records, printed. I would like to read the actual reports on the symptoms, treatment. I want everything." Consumer stated, "My husband is an oncologist, should I have my husband come after you instead because I feel like crap. All I want to see is the medical reports, that's all I want to see."  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 52 years 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 and concomitant medications were not reported. The patient had no known 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 15Aug2023 to 20Aug2023.   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: 69.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Nov2022 as dose 6 (booster), single (Lot number: GJ3277) at the age of 69 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), on 19Apr2021 as dose 2, single (Lot number: EW0162), in left arm, on 10May2021 as dose 3 (booster), single (Lot number: EW0178), in left arm, on 12Nov2021 as dose 4 (booster), single (Lot number: EW0191), in left arm and on 15Jul2022 as dose 5 (booster), single (Lot number: FM7553), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Emphysema" (unspecified if ongoing); "pre-diabetes" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing); "hypothyroidism" (unspecified if ongoing). The patient's concomitant medications were not reported. The patient had no known allergy.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 including Paxlovid  from 13Aug2023 to 18Aug2023.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 50-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Sep2022 as dose 5 (booster), single (Lot number: AS7143C) at the age of 49 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: "Type 1 diabetes" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2023, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.
Age: 61.0
Sex: U
Vaccine: COVID19
Symptoms: Heavy metal test, Tinnitus
Clinical narrative: tinnitus; This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  A 61-year-old patient received BNT162b2 (BNT162B2), on 11Jun2021 at 16:08 as dose 1, single (Lot number: EW0182) at the age of 61 years intramuscular, in left deltoid for covid-19 immunisation. The patient's relevant medical history included: "Hyperlipidemia", start date: 18Apr2018 (ongoing); "Neuropathy", start date: 21May2020 (ongoing); "Hypogonadism", start date: 02Aug2018 (ongoing); "Hypertension", start date: 10Apr2018 (ongoing). The patient's concomitant medications were not reported. The following information was reported: TINNITUS (non-serious) with onset Jul2021, outcome "unknown". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: the patient had no prior vaccination within 4 weeks.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300262471 Same reporter/ patient/ product, different dose/ event.;
Sex: F
Vaccine: COVID19
Symptoms: Abortion spontaneous
Clinical narrative: miscarriage; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: (RA).  A female patient (pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), 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: ABORTION SPONTANEOUS (medically significant), outcome "unknown", described as "miscarriage". The pregnancy resulted in spontaneous abortion. Clinical course: The caller said his ex-girlfriend actually had a miscarriage.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Food allergy, Interchange of vaccine products, Off label use
Clinical narrative: Completely lost my sense of taste and smell; Completely lost my sense of taste and smell; Cant have eggs anymore since the vaccine/Egg allergy; Off label use; Interchange of vaccine products; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 2023NVX-US-000001084 (RA).  A 76-year-old female patient received BNT162b2 (BNT162B2), on 22Dec2021 as dose 2 (initial pfizer dose), single (Batch/Lot number: unknown) at the age of 76 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: moderna coviD-19 vaccine (DOSE 1, SINGLE), administration date: 25Jan2021, for COVID-19 Immunization, reaction(s): "No adverse event". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 22Dec2021, outcome "unknown"; OFF LABEL USE (non-serious) with onset 22Dec2021, outcome "unknown"; AGEUSIA (non-serious), ANOSMIA (non-serious), outcome "unknown" and all described as "Completely lost my sense of taste and smell"; FOOD ALLERGY (non-serious), outcome "unknown", described as "Cant have eggs anymore since the vaccine/Egg allergy".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 15.0
Sex: F
Vaccine: IPV
Symptoms: Medication error, No adverse event, Poor quality product administered
Clinical narrative: patient was given IPOL that was exposed to temperature excursion and is no longer suitable for use with no reported adverse event; Initial information received on 18-Aug-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 15 years old female patient to whom administered Ipv (Vero) [Ipol] that was exposed to temperature excursion with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 11-Aug-2023, the patient received a dose 2 at a dose of 0.5 ml of suspect IPV (VERO) (frequency: once, strength: standard, expiry date: unknown and lot W1A191M) via subcutaneous route in the right arm for immunization (poor quality product administered) (latency: same day).  It was reported that" caller asks if they should re-vaccinate the patients after being given IPOL that was exposed to temperature excursion and is no longer suitable for use."  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 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.; Sender's Comments:  US-SA-2023SA256871:01733160
Age: 80.0
Sex: M
Vaccine: FLU4
Symptoms: No adverse event, Wrong product administered
Clinical narrative: gave Fluzone QIV instead of the intended Fluzone HD QIV to patient with no reported adverse event; Initial information received on 21-Aug-2023 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves a 80 years old male patient who received Influenza Quadrival A-B Vaccine [Fluzone Qiv] instead of the intended Influenza Quadrival A-B High Dose Hv Vaccine [Fluzone High-Dose Quadrivalent] with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 19-Aug-2023, the patient received 0.5 ml of suspect Influenza Quadrival A-B Vaccine Suspension for injection (lot number: V80418A; Expiry date:Jun-2024) (Strength-Standard) (Frequency: Once) via intramuscular route in the left arm for immunization.  On 19-Aug-2023, the patient received Influenza Quadrival A-B Vaccine [Fluzone Qiv] instead of the intended Influenza Quadrival A-B High Dose Hv Vaccine [Fluzone High-Dose Quadrivalent] with no adverse event (wrong product administered) (Latency: same day).  It was reported, Pharmacist had an event on Saturday where they were administering flu vaccines. They gave an 80 year old patient and 67 year old patient the FLUZONE QIV instead of the intended FLUZONE HD QIV. Caller would like to know what the recommendation is since a patient that should have received the incorrect flu vaccine? Should they revaccinate? These inquiries are reported as medication errors for the administration of FLUZONE QIV instead of the intended FLUZONE HD QIV.   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 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: 11.0
Sex: F
Vaccine: DTAP, TDAP
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: accidentally gave DAPTACEL instead of ADACEL with no reported adverse event; Initial information received on 22-Aug-2023 regarding an unsolicited valid non-serious case received via other health professional.  This case involves a 11-year-old female patient, accidentally gave diphtheria-15/tetanus/5 AC pertussis vaccine [Daptacel] instead of diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel] 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 an unknown date, the patient received an unknown dose of suspect diphtheria-15/tetanus/5 AC pertussis vaccine Suspension for injection (strength: unknown) (lot: 2CA28C1, expiry date: 04-Nov-2024) via unknown route in unknown administration site for Immunization (immunization) and diphtheria-2/tetanus/5 AC pertussis vaccine Suspension for injection (strength, batch number, expiry date: unknown) via unknown route in unknown administration site for prophylactic vaccination (Immunization).  On an unknown date the patient had an event of accidentally gave daptacel instead of adacel with no reported adverse event (wrong product administered) (latency: same day) following the administration of diphtheria-15/tetanus/5 AC pertussis vaccine and -2/tetanus/5 AC pertussis vaccine.  It was unknown if any lab data/test results available.  Action taken with diphtheria, tetanus and acellular pertussis vaccine (Daptacel) and diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel] was not applicable.  Outcome: 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 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: 1.25
Sex: M
Vaccine: DTAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: administered expired doses of DAPTACEL, with no reported adverse event; Initial information received 22-Aug-2023 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves a 1 years old male patient got administered expired doses of diphtheria-15/tetanus/5 ac pertussis vaccine [Daptacel] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included pneumococcal vaccine and hib vaccine (HIB) for Prophylactic vaccination.  On 18-Aug-2023, the patient received 0.5ml (TOTAL) dose of suspect diphtheria-15/tetanus/5 ac pertussis vaccine Suspension for injection (lot C5893AA and expiration date- 21-Jun-2023) via intramuscular route in the left thigh (strength: not provided) for Immunization (expired product administered) (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 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: 1.25
Sex: M
Vaccine: DTAP
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: administration of an expired product with no reported adverse event; Initial information received on 22-Aug-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to cases 2023SA235929(CLUSTER), 2023SA257557(CLUSTER) and 2023SA258504(CLUSTER).  This case involves a 1 years old male patient who was administered with an expired product DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HIB VACCINE (HIB) for Prophylactic vaccination.  On 16-Aug-2023, the patient received 0.5 ml dose of expired vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE with no reported adverse event (expired product administered) (latency: same day) (Suspension for injection) Frequency = Once, Strength = Standard (lot C5893AA and expiry date: 21-Jun-2023) via intramuscular route in the left thigh for immunization.  It was reported that "Caller with question on whether dose needs repeating. Caller also requesting standard to be re-sent regarding expired dose of ACTHIB previously reported."  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 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: 67.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, Product storage error
Clinical narrative: Upon receiving Pfizer Bivalent, it was improperly stored in the freezer. This vaccine should have been stored in the refrigerator. Due to the incorrect storage patient received vaccine that was expired. NO ISSUES REPORTED.
Age: 0.75
Sex: M
Vaccine: PNC13
Symptoms: Urticaria
Clinical narrative: Patient developed hives to face, trunk, and all extremities
Age: 87.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, Product storage error
Clinical narrative: Upon receiving Pfizer Bivalent, it was improperly stored in the freezer. This vaccine should have been stored in the refrigerator. Due to the incorrect storage patient received vaccine that was expired. NO ISSUES REPORTED.
Age: 69.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, Product storage error
Clinical narrative: Upon receiving Pfizer Bivalent, it was improperly stored in the freezer. This vaccine should have been stored in the refrigerator. Due to the incorrect storage patient received vaccine that was expired. NO ISSUES REPORTED.
Age: 30.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Loss of consciousness, Syncope
Clinical narrative: About 10 minutes after giving patient the shot, his mom told me he passed out on his chair. I came to the waiting room to check on patient while he was waking up. He was out for about 1 minute per his mother. His skin was warm, pulse steady.  He said a few minutes after getting the shot, he felt dizzy and fainted. He was not hurt as he was sitting down .  I gave him a bottle of water and let him rest.  After 15 minutes patient was well enough to leave with his mother.  I called to check on him 1 hour later and his mother said he was fine.
Age: 70.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Vaccine error- vaccine was administered past its beyond use date. The vaccine had been stored in the refrigerator beyond the time frame recommended by the manufacture.
Age: 12.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Hot flush, Pallor, Vomiting
Clinical narrative: Client was walking out to waiting room after vaccines were given. HE had to sit down, hot flash, pale, sis not pass out. Went into the bathroom with mom and nurse and vomited, sat on floor. Taken to exam room with lights off. Felt better sat up sipped water. After resting, stood up and after a few minutes walked out with mom to go home.
Age: 87.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Vaccine error- vaccine was administered past its beyond use date. The vaccine had been stored in the refrigerator beyond the time frame recommended by the manufacture.
Age: 65.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, Product storage error
Clinical narrative: Upon receiving Pfizer Bivalent, it was improperly stored in the freezer. This vaccine should have been stored in the refrigerator. Due to the incorrect storage patient received vaccine that was expired. NO ISSUES REPORTED.
Age: 74.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: Vaccine error- vaccine was administered past its beyond use date. The vaccine had been stored in the refrigerator beyond the time frame recommended by the manufacture.
Age: 73.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: Vaccine error- vaccine was administered past its beyond use date. The vaccine had been stored in the refrigerator beyond the time frame recommended by the manufacture.
Age: 71.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: Upon receiving Pfizer Bivalent, it was improperly stored in the freezer. This vaccine should have been stored in the refrigerator. Due to the incorrect storage patient received vaccine that was expired. NO ISSUES REPORTED.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Gastrooesophageal reflux disease, Headache, Hepatic steatosis, Myalgia, Rash vesicular
Clinical narrative: Received vaccine on 9-7-22. By 11-16-22, patient said within 24 hours of 1st Shingrix dose. Patient had a severe acid reflux (until this moment 11/16/22), rash "blister" for 2-3 weeks, headache & muscle pain for 1 week.  And today 8-25-23, patient  mention she have fatty live now, still have acid reflux & rash once in a while