chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; patient was given a dose of Moderna that has been expired; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient was given a dose of Moderna that has been expired) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 013H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 22-Jun-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 22-Jun-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 (patient was given a dose of Moderna that has been expired). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient was given a dose of Moderna that has been expired) 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 (patient was given a dose of Moderna that has been expired).    No concomitant medication was reported. Suspect product dosage text was reported as unknown. The expiry date was reported as 24-May-2023. The vial size was 2.5 ml. The vial was initially stored in the refrigerator on 22-Jun-2023 and was administered on the same day. The vial did not undergo any temperature excursions.  No treatment medication was reported.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Joint range of motion decreased, Neck pain, Pain
Clinical narrative: After the COVID-19 Vaccines, this has caused her so much pain; much pain, she is on the max dose of Gabapentin she can get for her neck; she couldn't move her neck; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP), Program ID:  The reporter is the patient.  A 38-year-old female patient received BNT162b2 (BNT162B2), on 31Aug2021 as dose 1, single (Lot number: FD8448) at the age of 38 years for covid-19 immunisation. The patient's relevant medical history included: "had 4 C-Sections and never needed pain medicine." (unspecified if ongoing), notes: had 4 C-Sections and never needed pain medicine. The patient's concomitant medications were not reported. The following information was reported: PAIN (non-serious) with onset 2021, outcome "unknown", described as "After the COVID-19 Vaccines, this has caused her so much pain"; NECK PAIN (non-serious) with onset 2021, outcome "unknown", described as "much pain, she is on the max dose of Gabapentin she can get for her neck"; JOINT RANGE OF MOTION DECREASED (non-serious) with onset 2021, outcome "unknown", described as "she couldn't move her neck". Therapeutic measures were taken as a result of pain, neck pain, joint range of motion decreased.  Additional Information: After the COVID-19 Vaccines, that had caused her so much pain, she was on the max dose of Gabapentin she can get for her neck. If she didn't have that, she couldn't move her neck. Had none of these conditions until after the COVID-19 vaccines. It was a big series of medicine because she was in so much pain.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101728832 same patient/drug, different event/dose;
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Inappropriate schedule of product administration, Night sweats, Overdose, Paraesthesia
Clinical narrative: tingling in fingers, arms, feet; night sweats; Numbness; other vaccine same date product Pfizer 12+; other vaccine same date product Pfizer 12+; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 26Jun2023 at 14:30 as dose 4 (booster), single (Lot number: GJ6743) at the age of 56 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Sleep apnea" (unspecified if ongoing). Concomitant medication(s) included: FIBER; MAGNESIUM. Vaccination history included: BNT162b2 (DOSE 3 (BOOSTER), SINGLE , Lot number: FP7137), administration date: 26Jun2023, when the patient was 56-year-old, for COVID-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE , Lot number and expiration date not provided.), for COVID-19 immunization; Covid-19 vaccine (DOSE 1, SINGLE , Lot number and expiration date not provided.), for COVID-19 immunization. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious), OVERDOSE (non-serious) all with onset 26Jun2023 at 14:30, outcome "unknown" and all described as "other vaccine same date product Pfizer 12+"; HYPOAESTHESIA (non-serious) with onset Jul2023, outcome "not recovered", described as "Numbness"; NIGHT SWEATS (non-serious) with onset Jul2023, outcome "not recovered"; PARAESTHESIA (non-serious) with onset Jul2023, outcome "not recovered", described as "tingling in fingers, arms, feet". The events "tingling in fingers, arms, feet", "night sweats" and "numbness" required physician office visit and emergency room visit. Therapeutic measures were not taken as a result of paraesthesia, night sweats, hypoaesthesia.  Additional Information: No allergies, no treatment, no covid prior vaccination, no covid tested post vaccination, no other vaccines in 4weeks.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine
Clinical narrative: migraines; 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 10Apr2021 at 15:00 as dose 2, single (Lot number: EN5318) at the age of 52 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "HSV2" (unspecified if ongoing); "Hashimotos" (unspecified if ongoing); "High cholesterol" (unspecified if ongoing); "herniated discs" (unspecified if ongoing); "known allergies: Sulfa" (unspecified if ongoing); "known allergies: eggs" (unspecified if ongoing); "known allergies: lactose" (unspecified if ongoing); "known allergies: Hazelnuts" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID; OMEPRAZOLE; LIVALO; VALACYCLOVIR [VALACICLOVIR]; D3; B12 [CYANOCOBALAMIN]. Past drug history included: Amoxicillin, reaction(s): "known allergies: Amoxicillin"; Ibuprofen, reaction(s): "known allergies: Ibuprofen". Vaccination history included: BNT162b2 (dose 1, is bivalent: False, lot number: EP7534, administration time: 03:00 PM, vaccine location: Left arm), administration date: 20Mar2021, when the patient was 52-year-old, for COVID-19 immunization, reaction(s): "severe lightheadedness/dizziness", "I had burning tongue syndrome beforehand", "it has gotten much worse", "tinnitus", "weakness in my left arm", "severe headache", "nausea". The following information was reported: MIGRAINE (non-serious), outcome "unknown", described as "migraines".; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300253096 same reporter/patient/product, different dose/event;US-PFIZER INC-2021367791 same reporter/patient/product, different dose/event;US-PFIZER INC-202300253122 same reporter/patient/product, different dose/event;
Age: 43.0
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 44-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19Nov2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 43 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: "Narcolepsy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "recovered" (2023) and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (17Jul2023) Positive. 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 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300253699 same reporter/patient, different product/AE;
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: he got sick/he got Covid last week; he got sick/he got Covid last week; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A 79-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), in Jan2021 as dose 1, single (Batch/Lot number: unknown), in Feb2021 as dose 2, single (Batch/Lot number: unknown) and in Oct2021 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), SUSPECTED COVID-19 (medically significant) all with onset Jul2023, outcome "unknown" and all described as "he got sick/he got Covid last week".   The caller reported that he took both of the Pfizer Covid vaccines originally and then two booster shots. He stated the first booster came out and he immediately took it and then when the bivalent came out he took that as well. He took the first Pfizer Covid vaccination in Jan2021, second Pfizer Covid Vaccination in Feb2021, Booster Pfizer Covid vaccination in Oct2021, Pfizer Bivalent Covid vaccination in Sep2022. He stated that he went on a trip/cruise and was not wearing a mask and about a week ago, halfway through the trip, he got sick. He stated he got Covid last week. He wanted information on the isolation period and testing.   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: 16.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Seizure
Clinical narrative: Seizure; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 17-year-old male patient received BNT162b2 (BNT162B2), on 22Jun2021 at 17:30 as dose 2, single (Lot number: Ew0180) at the age of 16 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Penicillin" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: Ew0180, in right arm, at 06:00 PM), administration date: 27May2021, when the patient was 16-year-old, for COVID-19 immunisation. The following information was reported: SEIZURE (medically significant) with onset 05Jan2023 at 22:30, outcome "not recovered". The event "seizure" required emergency room visit. Clinical course: No other vaccine in four weeks. No other medications in two weeks. No COVID prior vaccination. No other medical history.
Age: 16.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Seizure; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 17-year-old male patient received BNT162b2 (BNT162B2), on 22Jun2021 at 17:30 as dose 2, single (Lot number: Ew0180) at the age of 16 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Penicillin" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: Ew0180, in right arm, at 06:00 PM), administration date: 27May2021, when the patient was 16-year-old, for COVID-19 immunisation. The following information was reported: SEIZURE (medically significant) with onset 05Jan2023 at 22:30, outcome "not recovered". The event "seizure" required emergency room visit. Clinical course: No other vaccine in four weeks. No other medications in two weeks. No COVID prior vaccination. No other medical history.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Seizure
Clinical narrative: covid test result: Positive; covid test result: Positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 17-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Lot number: Ew0180), in right arm and as dose 2, single (Lot number: Ew0180), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 30Dec2022, outcome "unknown" and all described as "covid test result: Positive". The event "covid test result: positive" required emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (30Dec2022) Positive.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300253812 same reporter/patient/drug, different dose/event;
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: covid test result: Positive; covid test result: Positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 17-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Lot number: Ew0180), in right arm and as dose 2, single (Lot number: Ew0180), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 30Dec2022, outcome "unknown" and all described as "covid test result: Positive". The event "covid test result: positive" required emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (30Dec2022) Positive.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300253812 same reporter/patient/drug, different dose/event;
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache after dose; This is a spontaneous report received from non-contactable reporter(s) (Other HCP) from a sales representative.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2, bnt162b2 omi ba.4-5 (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for COVID-19 Immunization. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "Headache after dose".  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: 56.0
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) (Pharmacist). The reporter is the patient.  A 56-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Sep2022 as dose 5 (booster), single (Lot number: GH9694) at the age of 56 years, in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 17Jul2023. Patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Sep2022 at 12:00 AM.; Sender's Comments: Based on available information, a lack of efficacy with the suspect vaccine BNT162b2, BNT162b2 omi ba.4-5 in this patient cannot be completely excluded.,Linked Report(s) : US-PFIZER INC-202300254007 same patient, different drug/event;
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 a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 90-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "chronic UTIs" (unspecified if ongoing); "Bladder Disorder" (unspecified if ongoing); "Thyroid Disorder" (unspecified if ongoing); "Osteroporosis" (unspecified if ongoing); "Sleep Apnea" (unspecified if ongoing). The patient has no know allergies.  Patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative and Covid-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "CHF" (unspecified if ongoing); "GERD" (unspecified if ongoing); "known allergies: penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Positive test (Binax NOW) before starting Paxlovid. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 10Jul2023 to 15Jul2023.  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.; Sender's Comments: Based on available information, a lack of efficacy with the suspect vaccine BNT162B2 in this patient cannot be completely excluded. ,Linked Report(s) : US-PFIZER INC-202300254720 Same patient, different drug, different event;
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: I've had 3 Pfizer vaccines and 1 booster. Had 1st symptoms on 06Jul with pos. test. Started Paxlovid 07Jul and took last pills on 12Jul; I've had 3 Pfizer vaccines and 1 booster. Had 1st symptoms on 06Jul with pos. test. Started Paxlovid 07Jul and took last pills on 12Jul; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  An 82-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 06Jul2023, outcome "unknown" and all described as "I've had 3 Pfizer vaccines and 1 booster. Had 1st symptoms on 06Jul with pos. test. Started Paxlovid 07Jul and took last pills on 12Jul". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (06Jul2023) Positive, notes: Had 1st symptoms on 06Jul with pos. test. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient was an 82 yr female in very good health until Covid. She had 3 Pfizer vaccines and 1 booster. Had 1st symptoms on 06Jul with pos. test. Started Paxlovid 07Jul and took last pills on 12Jul. Initial bad symptoms cleared with Paxlovid immediately. By 14Jul symptoms began to return. Cough, nasal congestion, tiredness. She believed she stopped the med too soon. People are not reporting rebounds. The same thing happened to her husband last year. It's way more than you are recording.   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.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300253196 different patient, same drug and event;US-PFIZER INC-202300253197 same reporter, different patient, drug and event;US-PFIZER INC-202300253195 same patient, different drug and event;
Sex: F
Vaccine: COVID19
Symptoms: Injury
Clinical narrative: injuries; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from License Party.  A 13-year-old female patient received BNT162b2 (BNT162B2), in Jan2023 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE; Manufacturer Unknown), for Covid-19 immunization. The following information was reported: INJURY (non-serious) with onset 2023, outcome "unknown", described as "injuries".  Additional information: Having experienced severe symptoms following the administration of the second dose of the Pfizer-BioNTech vaccine in January. participation in a vaccine trial, a 30-second advertisement was prepared by the Vaccine Safety Research Association, which was intended to raise awareness of her injuries and to coincide with the 26Oct meeting of the FDA advisory committee meeting to review Pfizer data on its COVID vaccine for children 5-11.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  SUSPECT PRODUCT is under agreement with BIONTECH.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Unfortunately, he contracted the virus; Unfortunately, he contracted the virus; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID.  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) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history 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 "Unfortunately, he contracted the virus".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Breast pain, Fatigue, Feeling cold, Injection site pain
Clinical narrative: PATIENT REPORTED PAIN AND SORNESS IN LEFT ARM (INJECTION SITE) AND ALSO AROUND LEFT BREAST, WITH A PAIN SCORE OF 8/10, REPORTED SHE STARTED GETTING COLD AND TIRED AFTER SHINGRIX BOOSTER VACCINE WAS ADMINISTERED, SYMPTOMS STARTED AFTER 6 HOURS. PATIENT HAS TAKEN 2 ACETAMINOPHEN 500MG TABLETS TO HELP ALLEVIATE THE PAIN AND DRINKING HOT TEA(S), WHILE RESTING IN BED. WILL CONTINUE TO REST AND HYDRATE, TAKE OTC PAIN RELIEVERS AND FEVER REDUCERS UNTIL ALL THE SYMPTOMS HAVE COMPLETELY DECLINED.   PATIENT REPORTED SHE FELT THE SAME SYMPTOMS AFTER THE FIRST SHINGRIX VACCINE, HOWEVER THE SYMPTOMS WHERE WAY MILDER AND MORE TOLERABLE THAN THE SECOND TIME.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Cor pulmonale, Transient ischaemic attack
Clinical narrative: G45.9 TRANSIENT CEREBRAL ISCHEMIA 4/24/2023 COR PULMONALE G45.9 TRANSIENT CEREBRAL ISCHEMIA 4/24/2023 TRANSIENT CEREBRAL ISCHEMIA
Age: 69.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Patient received the vaccine 5 days after the beyond use date.
Age: 81.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient given the vaccine 5 days after the beyond use date. Patient denies adverse effects.
Age: 61.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient was given vaccine 5 days after the beyond use date. Patient denies adverse effects.
Age: 19.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect dose administered
Clinical narrative: Patient received only the liquid conjugate portion of the vaccine Menveo.  She was receiving this dose for entry to college. The vaccine was not reconstituted with the Lyophilized component vial 2.  We are working to contact patient. The provider administering the vaccine accidentally pulled only the liquid portion from the box.
Age: 75.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient received the shot 6 days after the beyond use date. Patient denies adverse effects.
Age: 76.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient received vaccine 6 days after beyond use date. Patient denies adverse effects.
Age: 66.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient given vaccine 10 days after beyond use date. Patient denies adverse effects.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Injection site erythema, Injection site pain, Pyrexia
Clinical narrative: Fever, chills, redness  and soreness at injection site, fatigue. Tylenol every four hours.  Effects abated 32 hours later.  Did not call dr.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; The caller said the patient received a dose of MMRII on 6/27/2023, after the product was involved in a temperature excursion that reached 48.8 F and the product was out of range for 7 hours and 45 minutes.; This spontaneous report has been received from a registered nurse referring to a patient of unknown age and gender. The patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX). Additionally, the patient's pertinent medical history, drug reactions or allergies were not provided.  On 27-JUN-2023, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, one dose, lot number was reported as W035041, which upon internal review was determined to be a valid lot number for measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), expiration date was reported and determined to be valid as 24-MAY-2024, albumin status rHA, administered as prophylaxis (strength, dose, frequency, route of administration, albumin status, and anatomical location was not provided) after a temperature excursion (product storage error) with a temperature of 48.8 degree Fahrenheits for 7 hours and 45 minutes. No adverse event reported..  This is one of the several reports from the same reporter.
Age: 0.5
Sex: M
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: No adverse effects; second dose of Rotated was given to the patient on 04-APR-2023 and the third one on 15-JUN-2023 (timeframe: 10 weeks + 1 day); Temperature excursion- vaccine not viable according to manufacturer; This spontaneous report has been received from a physician, regarding a 6-months-old male patient. The patient's pertinent medical history included pneumococcal vaccine conj 13v (PREVENAR 13), Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ)  and hepatitis B vaccine as historical drug, previous drug reactions or allergies were not reported. Concomitant medications included diphtheria vaccine toxoid (+) hib vaccine conj (tet tox) (+) pertussis vaccine acellular 5-component (+) polio vaccine inact 3v (mrc 5) (+) tetanus vaccine toxoid (PENTACEL)  On 15-JUN-2023, the patient was vaccinated with the third dose, which was improperly storage, of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) oral liquid, orally as prophylaxis (lot number: 1968386, which was determined to be valid, with an expiration date on 23-MAY-2024) (strength, dose and scheme were not reported) (Product storage error). The vaccine was bought with private funds and was administered at a private doctor's office. (inappropriate schedule of product adminsitration0  The administered dose underwent a temperature excursion during unreported amount of time on unreported temperature. There was a previous temperature excursion reported during unreported amount of time on unreported temperature as well.  It was reported that vaccine temperature excursion was not viable and occurred from a digital data logger alarm believed to be due to sensory issues. Monitoring temperature with back up logger. Temperature in range, new data logger was in use. It was also reported a storage in clinical practice.  The action taken with the vaccine was reported as "returned, waste in progress". No adverse effects.  No additional information was reported.  This is one of several cases from the same reporter.
Age: 1.83
Sex: M
Vaccine: DTAPIPV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: 22-month-old patient was given QUADRACEL vaccine formulated for a 46-year-old with no reported adverse event; Initial information was received on 14-Jul-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 22 months old male patient was given diphtheria-15/tetanus/5 hybrid ac pertussis/ipv (mrc5) (quadracel) vaccine formulated for a 4 to 6-year-old 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 hepatitis a vaccine; and pneumococcal vaccine CONJ 13V (CRM197) (Prevnar 13).  On 12-Jul-2023, the patient received a dose of 0.5 ml of suspect diphtheria-15/tetanus/5 hybrid ac pertussis/ipv (mrc5) vaccine(Suspension for injection) (strength was unknown) lot U7564AA, Expiry date : 08-Nov-2024) via intramuscular route in the right thigh for Imunization.  On 12-Jul-2023 the patient developed a non-serious event of 22-month-old patient was given quadracel vaccine formulated for a 4 to 6-year-old with no reported adverse event (wrong product administered) (latency: same day) following the administration of diphtheria-15/tetanus/5 hybrid ac pertussis/ipv (mrc5) vaccine.  Action taken with DIPHTHERIA, TETANUS, AC PERTUSSIS and ipv VACCINE (Quadracel) was not applicable.  At time of reporting, the outcome was Unknown for the event 22-month-old patient was given quadracel vaccine formulated for a 4 to 6-year-old with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 5.0
Sex: F
Vaccine: UNK
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: pentacel was administered to a 5 year old instead of the intended kinrix with no reported adverse event; pentacel given to a 5 year old patient with no reported adverse event; Initial information received on 14-Jul-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 5 years old female patient for whom vaccine Diphtheria/Tetanus/5 Hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) Vaccine [Pentacel (Vero)] was administered instead of the intended kinrix 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 Measles Vaccine, Mumps Vaccine, Rubella Vaccine, Varicella Zoster Vaccine for Immunisation.  On 14-Jul-2023, the patient of 5 year old received a dose of 0.5 ml (frequency: once) of standard strength dose 5 of suspect Diphtheria/Tetanus/5 Hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) Vaccine [Pentacel (Vero)] suspension for injection (lot: UJ851AA, Expiry date: 01-Apr-2024) via intramuscular route in the left thigh for Immunization, instead of the intended kinrix with no reported adverse event (wrong product administered) (product administered to patient of inappropriate age) (latency: same day).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for both the events.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 36.0
Sex: M
Vaccine: TD
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired TENIVAC was administered to a patient with no reported adverse event; Initial information received on 18-Jul-2023 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 36 years old male patient for whom expired Diphtheria-2/Tetanus-5 Adsorbed Toxoids No Preservative Adult [Tenivac] was administered with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 18-Jul-2023, the patient received an expired dose of 0.5 ml (1x) (Frequency = once) of standard strength suspect Diphtheria-2/Tetanus-5 Adsorbed Toxoids No Preservative Adult suspension for injection (lot: U6922AA, Expiry date:  31-Jan-2023) via intramuscular route in the right deltoid for Immunization with no reported adverse event (expired product administered) (latency: same day).  Action taken: not applicable.  At time of reporting, the outcome was 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: 0.5
Sex: F
Vaccine: UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: pentacel was administered to a patient after it experienced a temperature excursion with no reported adverse event; Initial information was received on 18-Jul-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 7 months old female patient who received diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine [Pentacel (vero)] after it experienced a temperature excursion with no reported adverse event.  The patient's past medical history, medical treatment(s), concomitant medications, vaccination(s) and family history were not provided.  On 17-Jul-2023, the patient received a dose of suspect diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine Suspension for injection at dose of 0.5 ml (lot number: UJ757AAA, expiration date: 09-Sep-2023, strength, route, administration site: Unknown) for Immunization (immunisation) after it experienced a temperature excursion with no reported adverse event (poor quality product administered).  No lab data reported.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event pentacel was administered to a patient after it experienced a temperature excursion with no reported adverse 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: 74.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient received vaccine 19 days after the beyond use date. Patient denies adverse effects.
Age: 89.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient received vaccine 26 days after beyond use date. Patient denies adverse effects.
Age: 78.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient received shot 26 days after beyond use date. Patient denies adverse effects.
Age: 77.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient was given the vaccine 27 days after the beyond use date. Patient denies adverse effects.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Blood glucose, Condition aggravated, Febrile convulsion
Clinical narrative: Febrile seizure morning after vaccine.  Seen in ED. Quickly resolved.  Only given antipyretics.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation
Clinical narrative: Atrial Fibrillation on 11/29/2021 without any family history or negative health history.  Don't cover this up Government.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Inflammation, Injection site discomfort, Injection site pain, Injection site reaction, Injection site urticaria
Clinical narrative: Received immunizations for kindergarten. One and half days later the site of injection began to welt, was hot, and painful for patient to walk. Very uncomfortable. Reached out to triage center with concerns. Sent photos to triage center. They informed me they would contact the provider (urgently). Called me to inform me that the patient is experiencing ?local reaction?  and will need to put cold compress 4x a day, 7.5ml ibuprofen for pain/inflammation, and 7.5ml Benadryl for itching.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Injection site warmth
Clinical narrative: Received immunizations for kindergarten. One and half days later the site of injection began to welt, was hot, and painful for patient to walk. Very uncomfortable. Reached out to triage center with concerns. Sent photos to triage center. They informed me they would contact the provider (urgently). Called me to inform me that the patient is experiencing ?local reaction?  and will need to put cold compress 4x a day, 7.5ml ibuprofen for pain/inflammation, and 7.5ml Benadryl for itching.
Age: 12.0
Sex: M
Vaccine: TYP
Symptoms: Swelling, Swelling face, Urticaria
Clinical narrative: Took first pill and almost exactly 8 hours later had sudden and horrific hives and had swelling of neck and face
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient given expired medication, manufacturer contacted, vaccine maintained the activity necessary to protect against Covid-19 virus at time of administration.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient given expired medication, manufacturer contacted, vaccine maintained the activity necessary to protect against Covid-19 virus at time of administration.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient given expired medication, manufacturer contacted, vaccine maintained the activity necessary to protect against Covid-19 virus at time of administration.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient given expired medication, manufacturer contacted, vaccine maintained the activity necessary to protect against Covid-19 virus at time of administration.
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Pneumonia
Clinical narrative: hospitalized for COVID infection; PNA
Sex: F
Vaccine: VARZOS
Symptoms: Gait disturbance, Impaired work ability, Neuropathy peripheral, Pain
Clinical narrative: Pain (unspecified location); hard to walk, inability to work due to neuropathy; unable to work; Neuropathy in legs; This serious case was reported by a consumer via call center representative and described the occurrence of peripheral neuropathy in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 05-MAY-2022, the patient received the 2nd dose of Shingrix. In MAY-2022, 4 days after receiving Shingrix, the patient experienced peripheral neuropathy (Verbatim: Neuropathy in legs) (serious criteria GSK medically significant). On an unknown date, the patient experienced pain (Verbatim: Pain (unspecified location)), walking difficulty (Verbatim: hard to walk, inability to work due to neuropathy) and inability to work (Verbatim: unable to work). The outcome of the peripheral neuropathy, pain and walking difficulty were unknown and the outcome of the inability to work was not reported.   It was unknown if the reporter considered the peripheral neuropathy, pain, walking difficulty and inability to work to be related to Shingrix.     It was unknown if the company considered the peripheral neuropathy, pain, walking difficulty and inability to work to be related to Shingrix.   Additional Information: GSK receipt date: 17-JUL-2023 The patient developed neuropathy within 4 days following Shingrix vaccine. The reporter reported neuropathy in legs, pain, hard to walk, inability to work due to neuropathy, had gone from doctor to doctor and no one seemed to know what to do. The reporter had called the FDA (Food and Drug Administration). There were no warnings or pamphlets warning about neuropathy. The patient was a single mom and angry that she was unable to work due to the neuropathy. The reporter consented to follow up.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: Mild physical therapy, waiting it out
Sex: M
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Vision blurred
Clinical narrative: Blurred vision; This non-serious case was reported by a nurse via sales rep and described the occurrence of blurred vision in a 72-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, immediately after receiving Shingrix, the patient experienced blurred vision (Verbatim: Blurred vision). The outcome of the blurred vision was unknown.   It was unknown if the reporter considered the blurred vision to be related to Shingrix.     It was unknown if the company considered the blurred vision to be related to Shingrix.   Additional Information: GSK receipt date: 14-JUL-2023 The reporter reported that patient received his first dose of Shingrix and immediately after complained of having blurred vision. According to reporter, the patient went to neurologist and ophthalmologist and the diagnosis was inconclusive. The patient went to the pharmacy to receive the second dose and pharmacist was concerned about side effect and did not administer second dose. The reporter consented to follow up.
Sex: F
Vaccine: TDAP
Symptoms: Wrong product administered
Clinical narrative: Neonate received Tdap vaccine instead of Hepatitis B
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Cough, Dyspnoea, Pain
Clinical narrative: Presented to ED w c/o cough, shortness of breath and body aches for 1 week; reports dx w/COVID 1 wk ago; tx w/abx, steroids, zinc; pt did not require O2; dc'd home
Age: 75.0
Sex: M
Vaccine: COVID19-2
Symptoms: Asthenia, Walking aid user
Clinical narrative: Saw dr on 7/20/23 - Received bivalent COVID vaccine several weeks ago complicated by profound weakness - to the point that he went back to using a walker and almost went to ED. Reminiscent of when he was very weak and ill with COVID. Reticent to take this again. Fully recovered now.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Dyspnoea, Pneumonia, SARS-CoV-2 test positive
Clinical narrative: Presented with shortness of breath.  COVID test was positive and admitted for pneumonia management. Tx w/remdesivir, steroids, O2, zinc, abx; weaned to RA, dc'd home
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: syncope
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Fall, Pneumonia, Rib fracture, SARS-CoV-2 test positive
Clinical narrative: Admitted s/p fall down multiple stairs with resulting rib fxs. On admission noted to have multifocal pna and subsequently + COVID-19. Tx w/remdesivir, steroids, O2, zinc;  weaned to 5 L NC. Dc'd to SNF.
Age: 91.0
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19, Encephalopathy
Clinical narrative: encephalopathy r/t COVID infection
Age: 50.0
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19, Small intestinal obstruction
Clinical narrative: partial small bowel obstruction, COVID-19 was an incidental finding
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cerebrovascular accident
Clinical narrative: CVA, COVID-19 incidental finding at discharge