chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Investigation, SARS-CoV-2 test, Vaccination failure
Clinical narrative: had Covid; had Covid; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 79-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Jun2024 as dose 1, single (Batch/Lot number: unknown) at the age of 79 years for covid-19 immunisation. The patient's relevant medical history included: "dry cough" (ongoing); "bad back" (ongoing), notes: suffering with for a number of years. The patient took concomitant medications. Vaccination history included: Bnt162b2 nos (DOSE NUMBER UNKNOWN, SINGLE), for COVID-19 immunisation. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 04Jul2024, outcome "unknown" and all described as "had Covid". The patient underwent the following laboratory tests and procedures: test: (unspecified date) abnormal, notes: back; SARS-CoV-2 test: (04Jul2024) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid. Clinical course: This report was not related to a study or programme. Traveled earlier this year, and caller had gotten the current COVID vaccine then, but stated maybe caller didn't get soon enough because caller got Covid again, clarified caller has had two rounds of Covid, fortunately Paxlovid has taken care of both of them. Clarified and confirmed caller has taken Paxlovid twice. Attempted to clarify how many Pfizer COVID vaccines doses caller has had, caller unknown, however many were put out, caller had each one, but caller was not sure how many total doses. Dates of prior doses were unknown, only recalls the date for the COVID vaccine caller had prior to the dose caller had 13Sep2024, and that dose prior this current dose was in early Jun2024. This year when caller got back from trip started coughing on 04Jul, caller has dry cough normally, but wondered if was okay, was feeling strange, had test kit at home, and was positive. Caller took some medications and over the counter products, but stated nothing different than what caller has been taking, no additional information provided. Latest test results were on caller's back, if reads report says abnormal, but caller talked to doctor, doctor suggested pain management, and caller said caller was going to go to acupuncturist to see if would help. When caller saw acupuncturist who is a RN, they went over results with caller, and said caller's back looks like the back of most when aging, was not concerned, and gave caller the information on what caller needed to do based on what the tests showed.   The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400258225 same patient, product/ different dose/event;US-PFIZER INC-202400258476 same patient, product/ different dose/event;
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Vaccination site pain
Clinical narrative: Pain on in injection site; fatigue; dizzy; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 75-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 15Sep2024 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: WARFARIN. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "Pain on in injection site"; FATIGUE (non-serious), outcome "unknown"; DIZZINESS (non-serious), outcome "unknown", described as "dizzy".  Batch/lot number is not provided, and it cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: I know two more personally who died; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: DEATH (death), outcome "fatal", described as "I know two more personally who died". The reporter stated that he/she knew six people who lost loved ones directly to the shot, and the reporter knew two more personally who died. The reporter stated, "That's eight people I know in my circle who died directly from it. If I know eight, there are millions." The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed.   No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202200104641 same reporter/drug/event, different patient;; Reported Cause(s) of Death: I know two more personally who died
Sex: F
Vaccine: TDAP
Symptoms: Multiple sclerosis
Clinical narrative: Multiple sclerosis; Initial information received on 04-Sep-2024 regarding an unsolicited valid social media serious case received from a consumer/Non-Healthcare Professional.  This case involves an unknown age female patient who had multiple sclerosis after receiving diphtheria-2/tetanus/5 ac pertussis vaccine [adacel].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received 0.5 ml (x1 (once)) dose of suspect diphtheria-2/tetanus/5 ac pertussis vaccine Suspension for injection via unknown route in unknown administration site for Prophylactic vaccination (Immunisation) (strength, batch number and expiry date unknown).  Information on batch number corresponding to the one at time of event occurrence was requested.  On an unknown date the patient had multiple sclerosis (unknown latency).  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (Multiple sclerosis).  At time of reporting, the outcome was Unknown for the event multiple sclerosis.  Seriousness criteria-Medically significant for event; Sender's Comments: Sanofi Company Comment dated 17-Sep-2024: This case involves an unknown age female patient who had multiple sclerosis after receiving diphtheria-2/tetanus/5 ac pertussis vaccine [adacel].Further information regarding concurrent condition during vaccination, previous vaccination, concomitant medication and tolerance, allergic history, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the individual suspect vaccine cannot be assessed
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: HCP called to report temperature excursion for GARDASIL 9.  Caller reports product was administered.  No symptoms reported.  Consent to correspond was granted.  This case is related to AE cases: 02669899, 02669980, 02669985, 02669992 and 02669997.; No symptoms reported; This spontaneous report was received from a nurse and refers to a currently 12-year-old patient of an unspecified gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with an improperly stored dose of of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5 milliliter, lot #1965046, expiration date: 22-JAN-2026, administered for prophylaxis (strength, and route of administration were not provided).  There were no adverse effects reported. Administered dose of vaccine experienced the temperature excursion of 8.6 degrees Celsius for 10 minutes. There were no previous excursions reported.  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2409USA004203: US-009507513-2409USA003853: US-009507513-2409USA004119: US-009507513-2409USA004156: US-009507513-2409USA004145:
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Sjogren's syndrome
Clinical narrative: Sjogren's disease; This serious case was reported by a consumer via call center representative and described the occurrence of sjogren's disease in a 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In JAN-2023, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced sjogren's disease (Verbatim: Sjogren's disease) (serious criteria GSK medically significant). The outcome of the sjogren's disease was not resolved.   It was unknown if the reporter considered the sjogren's disease to be related to Shingrix.     The company considered the sjogren's disease to be unrelated to Shingrix.   Linked case(s) involving the same patient:  US2024113759   Additional Information: GSK Receipt Date: 12-SEP-2024 The patient self reported this case for herself.  The patient received the first dose of Shingrix. The patient reported that a couple of weeks ago, she was diagnosed with Sjogren's disease. For tolerance of 2nd dose refer linked case US2024113759.; Sender's Comments: Sjogren's syndrome is an unlisted event which is considered unrelated to GSK vaccine Shingrix. US-GSK-US2024113759:Same patient/Diff event
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered
Clinical narrative: was given 2 times dose of 1mL instead of 0.5mL; This non-serious case was reported by a consumer and described the occurrence of overdose in a 56-year-old female patient who received Herpes zoster (Shingrix) (batch number 53XH9) for prophylaxis.   On 06-SEP-2024, the patient received Shingrix 1 ml. On 06-SEP-2024, an unknown time after receiving Shingrix, the patient experienced overdose (Verbatim: was given 2 times dose of 1mL instead of 0.5mL). On 08-SEP-2024, the outcome of the overdose was not applicable.   Additional Information: GSK Receipt Date: 09-SEP-2024 The patient asked advise if there were any additional potential issues with being given incorrect dose of vaccine and when/if she should have 2nd dose administered. It appeared she was given 2 times dose of 1mL instead of 0.5mL which led to overdose.
Sex: F
Vaccine: VARZOS
Symptoms: Allergy to metals, Discomfort, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: swelling; itching; pain; Allergy/sensitivity to Nickel; Uncomfortable; This non-serious case was reported by a consumer via call center representative and described the occurrence of swelling in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included injection site swelling and injection site warmth. Concurrent medical conditions included nickel allergy.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced swelling (Verbatim: swelling), pruritus (Verbatim: itching), pain (Verbatim: pain), nickel allergy (Verbatim: Allergy/sensitivity to Nickel) and discomfort (Verbatim: Uncomfortable). The outcome of the swelling, pruritus, pain, nickel allergy and discomfort were resolved.   It was unknown if the reporter considered the swelling, pruritus, pain, nickel allergy and discomfort to be related to Shingrix.     It was unknown if the company considered the swelling, pruritus, pain, nickel allergy and discomfort to be related to Shingrix.   Additional Information: GSK Receipt Date: 09-SEP-2024 The patient stated that with 1st shingles shot she had caused swelling, itching and some pain. She had an allergy or sensitivity to nickel that lasted a almost a week. She did not know it was Shingrix. She took the 1st dose right before Covid hit. She did not wanted to go through the misery of that reaction. She was able to check her pharmacy portal and confirmed that she did receive brand name Shingrix. She was unable to find the exact date of administration or the lot number. She said the date of Shingrix shot 1st was sometime before the Covid epidemic and thus 2 to 3 years ago. She had not yet received Shingix shot 2nd. She indicated that she went back to pharmacy to get Shingrix shot 2nd. She confirmed that the swelling, itching and pain that she experienced after the first Shingrix shot was at the injection site, the upper arm. She iced the arm for a couple of days and also took oral Benadryl to help because it was uncomfortable. The Benadryl did not seem to help. Eventually the events resolved. Medical history reported were known sensitivity to nickel (ie: cannot wear any jewelry with nickel). Injectable diabetic medication, Trulicity, prescribed by an endocrinologist was injected in her thigh but she would swell up at the injection site with about 2 inches of swelling and the area was hot to the touch. She discontinued this and later learned that the needles that were used for administration had a nickel coating. No further prescriber details provided. This case is linked with US2024112042, same reporter; Sender's Comments:  US-GSK-US2024112042:Same reporter/2nd case
Sex: U
Vaccine: MNQ
Symptoms: Wrong product administered
Clinical narrative: wrong vaacine administered; This non-serious case was reported by a other health professional via other manufacturer and described the occurrence of wrong vaccine administered in two patients who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   Co-suspect products included MENINGOCOCCAL VACCINE B RFHBPA/FHBPB (TRUMENBA) for prophylaxis.   On an unknown date, the patients received Menveo and TRUMENBA. On an unknown date, an unknown time after receiving Menveo, the patients experienced wrong vaccine administered (Verbatim: wrong vaacine administered). The outcome of the wrong vaccine administered was not applicable.   Additional Information: GSK Receipt Date: 09-SEP-2024 Nurse reported another nurse at her facility administered the wrong vaccine to two patients. Trumenba was ordered by the physician, and the nurse administered Menveo which led to wrong vaccine administered. No further information provided.; Sender's Comments:  US-GSK-US2024AMR112862:PATIENT 1
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 2nd dose not received yet; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in 2022).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: 2nd dose not received yet). The outcome of the incomplete course of vaccination was not applicable.   Additional Information: GSK Receipt Date: 09-SEP-2024 HCP called on behalf of consumer. The HCP stated consumer received first dose of Shingrix in 2022.  Consumer presented to pharmacy on day of reporting for second vaccination (late dose). No other information was known including any demographic information for the consumer,HCP information or pharmacy information. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Age: 4.0
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Wrong product administered
Clinical narrative: after a 4 year old patient had received Pediatrics instead of Kinrix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 4-year-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number X9DP5, expiry date 09-MAR-2026) for prophylaxis.   Previously administered products included Pediarix (received 1st dose on 16th July 2020), Pediarix (received 1st dose on 16th September 2020) and Pediarix (received 3rd dose on 16th November 2020).   On 05-SEP-2024, the patient received the 4th dose of Pediarix. On 05-SEP-2024, an unknown time after receiving Pediarix, the patient experienced wrong vaccine administered (Verbatim: after a 4 year old patient had received Pediatrics instead of Kinrix). The outcome of the wrong vaccine administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 09-SEP-2024 A medical assistant contacted GSK and requested information and clinical recommendations after a 4 year old patient had received Pediatrics instead of Kinrix as their 4th dose in the Dtap series, which led to wrong vaccine administration. They did mention that the previous doses were with Pediatrics. The Vaccine Administration Facility was the same as Primary Reporter Did not consent to follow-up.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Extra dose administered, Inappropriate schedule of product administration
Clinical narrative: got a total of 3 Shingrix doses; several people (friends/relatives) who missed the 6 month window for Shingrix and so they ended up having to re-start the series; This non-serious case was reported by a consumer via call center representative and described the occurrence of extra dose administered in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix (1st dose received on an unknown date).   On an unknown date, the patient received the 3rd dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced extra dose administered (Verbatim: got a total of 3 Shingrix doses) and drug dose administration interval too long (Verbatim: several people (friends/relatives) who missed the 6 month window for Shingrix and so they ended up having to re-start the series). The outcome of the extra dose administered and drug dose administration interval too long were unknown.   Additional Information: GSK Receipt Date: 09-SEP-2024 The reporter stated that she knew several people (friends/relatives) who missed the 6 month window for Shingrix and so they ended up having to re-start the series and got a total of 3 Shingrix doses, which led to extra dose administered. She wanted to get off the phone therefore no further questions were asked such as the specific number of patients, their genders or ages. The reporter was not aware that a report was being filed regarding her statement pertaining to her friends/relatives. The reporter did not consent to follow-up. The case had been linked with the case US2024AMR112227, reported by same reporter. The patient received 2nd dose of Shingrix later than the recommended schedule, which led to lengthening of vaccination schedule.; Sender's Comments:  US-GSK-US2024AMR112227:Same reporter/2nd case
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Late second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in 2018).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: Late second dose). The outcome of the drug dose administration interval too long was not applicable.   Additional Information: GSK Receipt Date: 09-SEP-2024 Pharmacist asked about advise/recommendations for a late second dose. The patient received a first dose in 2018.  Vaccine details and patient demographics were not provided from the pharmacist´s end No further information was given during this call. The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccinations schedule.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: an active outbreak of Shingles; This non-serious case was reported by a consumer via sales rep and described the occurrence of shingles in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 1 month after receiving Shingrix, the patient experienced shingles (Verbatim: an active outbreak of Shingles). The outcome of the shingles was not reported.   It was unknown if the reporter considered the shingles to be related to Shingrix.     It was unknown if the company considered the shingles to be related to Shingrix.   Additional Information: GSK Receipt Date: 10-SEP-2024  The GlaxoSmithKline medical representative called to reported that one of her providers (reporter) informed her and it was regarding Shingrix, he said that he had over a dozen patients that get an active outbreak of Shingles within a month receiving the Shingrix vaccine. The GSK medical representative reported that after receiving Shingrix, more than 12 patients presented an outbreak of shingles.  GSK employee (medical representative) did not have lot number, patients information nor HCP's (health care professionals) email but reported because she consider important to give follow-up.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Internal haemorrhage
Clinical narrative: Had internal bleeding and had surgery in June to remove the problem; This spontaneous case was reported by a patient and describes the occurrence of INTERNAL HAEMORRHAGE (Had internal bleeding and had surgery in June to remove the problem) in an 84-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     Concomitant products included PREDNISONE.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. In June 2024, the patient experienced INTERNAL HAEMORRHAGE (Had internal bleeding and had surgery in June to remove the problem) (seriousness criteria hospitalization and medically significant). The patient was treated with Surgery for Internal haemorrhage. At the time of the report, INTERNAL HAEMORRHAGE (Had internal bleeding and had surgery in June to remove the problem) outcome was unknown.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.       No concomitant medications were provided. Dosage text for suspect product was reported as unknown. No treatment medication was provided.  Company Comment: This is a Spontaneous case reported by a patient, concerning an 84-year-old female patient, with no medical history reported, who experienced the unexpected and serious (due to hospitalization and medically significant) event of Internal haemorrhage, which occurred on a date after an unspecified dose of SPIKEVAX NOS vaccine. Since no vaccination dates were provided, temporal association and latency cannot be properly assessed. As reported, the patient had surgery for internal bleeding. One month later she was able to get off Prednisone. No information disclosed about diagnostic tests performed or clinical course. The benefit-risk relationship of SPIKEVAX NOS is not affected by this report.
Age: 34.0
Sex: F
Vaccine: RSV
Symptoms: Erythema, Exposure during pregnancy
Clinical narrative: Erythemia redness; This is a spontaneous report received from a nurse from a sales representative.  A 34-year-old female patient (pregnant) received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 09Sep2024 as dose number unknown, single (Batch/Lot number: unknown) at the age of 34 years for maternal immunisation. The patient's relevant medical history included: "Drug allergy" (unspecified if ongoing), notes: Name of drug reported as 'No'. The patient was 36 weeks pregnant at the event onset. Concomitant medication(s) included: LABETALOL, start date: 01Aug2023. The following information was reported: ERYTHEMA (non-serious) with onset 09Sep2024 at 21:00, outcome "recovering", described as "Erythemia redness". Therapeutic measures were taken as a result of erythema.  Causality for "erythemia redness" was determined associated to device constituent of rsv vaccine prot.subunit pref 2v (malfunction).  Additional Information: The patient did not receive any other vaccines within 4 weeks prior to the suspect vaccine. The patient did not receive any other vaccines on the same date as the suspect vaccine. Treatment received for the adverse event included antibiotics.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: One time when realized had Covid, thinks was last year; One time when realized had Covid, thinks was last year; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 77-year-old female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "bad back" (ongoing), notes: suffering with for a number of years; "dry cough" (ongoing), notes: caller has dry cough normally. The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "One time when realized had Covid, thinks was last year". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Ever since Covid came around, caller has had all of the Pfizer COVID vaccines. caller has had two rounds of Covid, One time when caller realized caller had Covid, caller thinks was last year, unknown what month. Fortunately Paxlovid has taken care of both of them. Clarified and confirmed caller has taken Paxlovid twice. Caller unknown, that how many Pfizer COVID vaccines doses caller has had, however many were put out, caller had each one, but caller was not sure how many total doses. Unknown for all prior doses of Pfizer COVID vaccines, caller does not have that information at time of call. The Paxlovid products caller took. Concomitant products: Caller takes some medications and over the counter products, but stated nothing different than what caller has been taking, no additional information provided. Medical conditions: Caller has a bad back which caller has been suffering with for a number of years.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400258475 same patient/product, different dose/event;US-PFIZER INC-202400258225 same patient/product, different dose/event;US-PFIZER INC-202400258225 Same patient, different vaccine dose and event;
Sex: F
Vaccine: COVID19
Symptoms: Acute myocardial infarction
Clinical narrative: My mom died of NSTEMI; This is a spontaneous report received from a Consumer or other non HCP.  A 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Apr2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Chronic obstructive pulmonary disease" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), administration date: Mar2021, for COVID-19 immunization. The following information was reported: ACUTE MYOCARDIAL INFARCTION (death, hospitalization, disability, life threatening) with onset 24Jun2021, outcome "fatal", described as "My mom died of NSTEMI". The patient was hospitalized for acute myocardial infarction (hospitalization duration: 12 day(s)). Therapeutic measures were taken as a result of acute myocardial infarction. The patient date of death was 24Jun2024. Reported cause of death: "NSTEMI". The dose 2 vaccine administration date was reported as 08Apr2021/ 18Apr2021. The patient did not have other vaccine in four weeks. The patient had no known allergies. It was reported the patient died because of the vaccine.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Reported Cause(s) of Death: NSTEMI
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Movement disorder, Pain in extremity, Peripheral swelling
Clinical narrative: R foot pain at the #1 MetaTarsal-phalanges joint when weight bearing; Swelling of my big toe; I was unable to curl my toes when I tried; This is a spontaneous report received from a Consumer or other non HCP.  A 42-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 17Sep2024 at 14:45 as dose 1, single (Batch/Lot number: unknown) at the age of 42 years, in left deltoid for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ADDERALL, start date: 01Sep2022. The following information was reported: MOVEMENT DISORDER (non-serious) with onset 17Sep2024 at 19:00, outcome "recovering", described as "I was unable to curl my toes when I tried"; PAIN IN EXTREMITY (non-serious) with onset 17Sep2024 at 19:00, outcome "recovering", described as "R foot pain at the #1 MetaTarsal-phalanges joint when weight bearing"; PERIPHERAL SWELLING (non-serious) with onset 17Sep2024 at 19:00, outcome "recovering", described as "Swelling of my big toe". Therapeutic measures were not taken as a result of pain in extremity, peripheral swelling, movement disorder.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Pain in extremity
Clinical narrative: arm killing him/ pain; Whole body feels like he was playing football or something; This is a spontaneous report received from a Consumer or other non HCP.  A 63-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 17Sep2024 as dose 1, single (Batch/Lot number: unknown) at the age of 63 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FEELING ABNORMAL (non-serious) with onset 17Sep2024, outcome "unknown", described as "Whole body feels like he was playing football or something"; PAIN IN EXTREMITY (non-serious) with onset 17Sep2024, outcome "unknown", described as "arm killing him/ pain".  Additional information: the patient specified that he knows that is normal. He was wondering what he can take, like a couple aspirin or something. He also stated that he is fine and he will just go to therapist, they know about him.  The information on the batch/lot number for [BNT162B2 OMICRON (KP.2)] will be requested and submitted if and when received.
Age: 13.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Circumstance or information capable of leading to medication error, Extra dose administered
Clinical narrative: Nurse gave vaccines off of a school's needed list prior to consulting patient's chart. Patient had received both vaccines the year prior.
Age: 24.0
Sex: F
Vaccine: RSV, TDAP
Symptoms: Exposure during pregnancy, No adverse event, Product use issue
Clinical narrative: Arexvy Vaccine given to pregnant female inadvertently, estimated date of delivery 9/21/24.  No adverse event to our knowledge.
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Injection site swelling, Skin swelling
Clinical narrative: 11:05 am - Mother reported, patient had a nickel sized elevated area of skin below injection site after administering MMR to left arm. Patient given 4mL of Children's Benadryl. Patient waited 15 minutes after medication administered. Re-assessed site and patient did not have redness but still had an elevated skin area. Advise to apply ice pack for 15 minutes and remove once at home. Called mother to follow up and mother stated that patient was doing better and the elevated area has gone down.
Age: 0.33
Sex: F
Vaccine: DTAP
Symptoms: Injection site induration, Injection site swelling
Clinical narrative: Hardening of fat layer causing permanent bulge in left thigh.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain, Pyrexia
Clinical narrative: 7 days post still have headache, body aches, low grade temps throughout the day, extreme fatigue
Age: 77.0
Sex: F
Vaccine: RSV
Symptoms: Injection site pain, Injection site pruritus, Injection site rash, Injection site reaction, Injection site swelling
Clinical narrative: Patient stated reaction at injection site, rash, swollen, itching, tenderness. It calmed down but still experience itching.
Age: 77.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Erythema, Swelling
Clinical narrative: PT REPORTED TO RPH 4 DAYS POST IMZ REDNESS AND SWELLING OF LEFT ARM. RPH COUNSELED PT TO APPLY COLD COMPRESS FOR 5-10 MINUTES AT A TIME AND TAKE ACETAMINOPHEN FOR DISCOMFORT.
Age: 85.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Seizure
Clinical narrative: Patient had a seizure around 10:30 pm on 09/11/2024. He was transferred to the hospital by ambulance. He suffered another seizure about 6 hours later.
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Circumstance or information capable of leading to medication error, Extra dose administered
Clinical narrative: Nurse gave vaccines off of a school's needed list prior to consulting patient's chart. Patient had received the vaccine the year prior.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Borrelia test, C-reactive protein, Differential white blood cell count, Full blood count
Clinical narrative: Symptoms began on 9/1/2024 in afternoon with leg aches.  9/2/2024 & 9/3/2024 Severe aching from waist down. Worsening by each evening. Difficulty ambulating due to pain and shuffled gait. Saw MD on 9/4/2024 with same symptoms. Labs done. & WNL. 9/5/24- bilateral leg pain gone but now seemed to localize to L hip/groin and shooting to Quad/upper thigh. Severe pain with every step. Returned to MD on 9/6/2024- Dexamethasone IM. 9/7- 9/11/2024- pain constant and no relief with steroid injection or prednisone pack. Motrin 800 mg 3x daily and Tylenol in between and pain continued to worsen. 9/112024- while ambulating pain severe and traveled from hip/groin, down quad and into knee. Ambulating increasingly difficult due to severe pain. 9/12/24- admitted to hospital x 2 days.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Gait disturbance, Groin pain, Laboratory test, Laboratory test normal, Magnetic resonance imaging
Clinical narrative: Symptoms began on 9/1/2024 in afternoon with leg aches.  9/2/2024 & 9/3/2024 Severe aching from waist down. Worsening by each evening. Difficulty ambulating due to pain and shuffled gait. Saw MD on 9/4/2024 with same symptoms. Labs done. & WNL. 9/5/24- bilateral leg pain gone but now seemed to localize to L hip/groin and shooting to Quad/upper thigh. Severe pain with every step. Returned to MD on 9/6/2024- Dexamethasone IM. 9/7- 9/11/2024- pain constant and no relief with steroid injection or prednisone pack. Motrin 800 mg 3x daily and Tylenol in between and pain continued to worsen. 9/112024- while ambulating pain severe and traveled from hip/groin, down quad and into knee. Ambulating increasingly difficult due to severe pain. 9/12/24- admitted to hospital x 2 days.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Metabolic function test, Myalgia, Pain, Pain in extremity
Clinical narrative: Symptoms began on 9/1/2024 in afternoon with leg aches.  9/2/2024 & 9/3/2024 Severe aching from waist down. Worsening by each evening. Difficulty ambulating due to pain and shuffled gait. Saw MD on 9/4/2024 with same symptoms. Labs done. & WNL. 9/5/24- bilateral leg pain gone but now seemed to localize to L hip/groin and shooting to Quad/upper thigh. Severe pain with every step. Returned to MD on 9/6/2024- Dexamethasone IM. 9/7- 9/11/2024- pain constant and no relief with steroid injection or prednisone pack. Motrin 800 mg 3x daily and Tylenol in between and pain continued to worsen. 9/112024- while ambulating pain severe and traveled from hip/groin, down quad and into knee. Ambulating increasingly difficult due to severe pain. 9/12/24- admitted to hospital x 2 days.
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: PATIENT CAME IN 2 DAYS LATER TO REPORT ARM IS WARM TO THE TOUCH AND SWOLLEN, RED FROM INJECTION SITE TRAVELING ALL THE WAY TO ELBOW AND UNDERNEATH. RECOMMENDED. SHE NOTED SHE TOOK TYLENOL. I TOLD HER TO CONTINUE THAT AND SHE COULD USE A COOL WASHCLOTH TO DRAW HEAT TO THE SURFACE. SINCE SHE IS ALLERGIC TO ALL OTHER OTC MEDS I CAN RECCOMMEND I DEFERRED TO HER DOCTOR. SHE ALREADY PUT A CALL INTO HER DOCTOR'S OFFICE AND IS AWAITING A PHONE CALL. SHE SAW HER NEUROLOGIST TODAY AND HE CONTACTED HER PRIMARY PHYSICIAN.
Age: 69.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Erythema
Clinical narrative: patient's entire face is red (like a sunburn, but is not painful or itchy). patient does not feel any other adverse reaction.
Age: 55.0
Sex: M
Vaccine: FLU3
Symptoms: Extra dose administered
Clinical narrative: Patient received 2 flu shots on 8/9/24 and 9/13/24
Age: 60.0
Sex: F
Vaccine: COVID19, FLU3, RSV
Symptoms: Blood test, Computerised tomogram, Drug hypersensitivity
Clinical narrative: Thunderclap headache (radiated from above the eyebrow all around head),-this started 4 days after receiving the RSV vaccine. Patient went to the ER and received: Morphine, Benadryl and Zofran IV. Patient was in the hospital over night and was discharged the next morning (9/17/24).
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: No S/S of adverse reactions noted. Resident found expired within 24 hrs. of vaccine administration.
Age: 76.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Patient complained of redness, swelling and soreness in arm with a red streak running down her arm
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: pain to left arm, started at the time of the vaccine, persisting 10 days
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, MNQ, PNC20, RV1
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: 2 month old infant given MenQuadfi vaccine instead of HiB. MenQuadfi not FDA approved for age of infant at the time of administration.
Age: 14.0
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered
Clinical narrative: Pt received 2 flu shots - one at pharmacy on 9/13/24 and one at doctor's office on 9/11/24
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Asthma, Chest discomfort, Condition aggravated, Wheezing
Clinical narrative: Participant received COVID vaccine on 9/12/2024. Participant endorsed chest tightness starting on 9/13/2024. Participant endorses that they are "not sure" if it is related to vaccine or asthma or environment as participant is traveling to area of higher altitude. Participant reports not taking medication for symptoms nor seeking medical attention. On 9/17/2024, participant endorses new symptom of wheezing that started this morning of 9/17/2024. Participant says they are "unsure if it is related to the vaccine" and adds "I think it is my asthma and I just don't have my albuterol." RN advised participant to seek medical attention if needed. Participant acknowledges that they will seek treatment when needed.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, IPV
Symptoms: Extra dose administered, Product administration error
Clinical narrative: patient received both Kinrix containing polio and separate polio (IPV) vaccine leading to double dose today.  Patient's mother was contacted and informed of the error and that this would be reported to VAERS. Informed to monitor for fever, headache and arm pain in particular as well as any other symptoms and to contact clinic for any concerning symptoms.
Age: 6.0
Sex: F
Vaccine: TDAP
Symptoms: Wrong product administered
Clinical narrative: Administered wrong dose. Administered TDAP instead DTAP.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Headache, Lethargy, Malaise, Pain in extremity
Clinical narrative: I developed pain and severe itching on the back of my right thigh on 09/15/24. The next day I developed a raised red rash that followed the nerve root. I had received Singrex vaccine approx 5 years ago. This rash continues to burn and I feel I?ll with lethargy, headache and general malaise.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash erythematous, Rash papular
Clinical narrative: I developed pain and severe itching on the back of my right thigh on 09/15/24. The next day I developed a raised red rash that followed the nerve root. I had received Singrex vaccine approx 5 years ago. This rash continues to burn and I feel I?ll with lethargy, headache and general malaise.
Age: 74.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Chills, Pain, Sleep disorder
Clinical narrative: Patient reported not being able to sleep at all night of the day she got the vaccines. She reported feeling chills. The day after the vaccines, she said she had a low grade fever (about 99.5 F) and she said that she was sore over the body. She has took Tylenol the night of and the day after the vaccines, and she said that the Tylenol was helping.
Age: 65.0
Sex: F
Vaccine: COVID19, PNC20
Symptoms: Vaccination site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: patient had 2in by 3 in raised area around vaccine site- red and warm to touch. advised patient to seek medical help if it got worse or if she had a high fever. patient ended up going to urgent care where they prescribed cephalexin and stated vaccine could of been administered too low
Age: 77.0
Sex: F
Vaccine: TDAP
Symptoms: Bedridden, Migraine, Pain
Clinical narrative: Patient experience constant migraines and severe body aches causing her to become bedridden
Age: 65.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Cellulitis
Clinical narrative: Cellulitis spreading over arm; five to six inches long and about 3.5 inches wide, still expanding on arm. Patient received cephalexin 500mg for treatment from physician.
Age: 88.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site haemorrhage, Injection site mass
Clinical narrative: On 9/19/2024 at 2 pm I gave pt her flu shot. Patient had very thin skin and barely any muscle. After injection to the deltoid muscle, patient started bleeding at injection site. I immediately put some gauze and a bandaid. I also put pressure and the bleeding stopped pretty quick. However, a lump formed. I informed the patient what had happened ( that I hit a blood vessel) and told her to keep arm elevated and avoid exercise for that day. At 7:30 pm the same day I called patient to follow up. She reported that the lump had gone down .
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Joint swelling
Clinical narrative: Patient reported swelling, redness  and heat on inside of left arm, from near armpit to just below elbow.  Little to no swelling or redness in deltoid region where injection was given. Patient informed pharmacist on duty on 09/15/24.  Pharmacist spoke to patient on phone 09/19/24 and he stated the swelling had reduced greatly and was nearly gone.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort
Clinical narrative: The participant reported chest tightness during a scheduled phone call on 9/16/2024. She had several episodes over several days, starting on 9/14/24. The episodes are very quick and happen sporadically. Sometimes it starts when she is lying and bed, and other times it happens when she is sitting in her chair at work. The study team recommended she get medical treatment during the phone call on 9/16/24, and she did so later that day. The results are listed on the continuation page.   As of 9/19/24, the participant reports the last day of experiencing these symptoms are 9/17/24.
Age: 24.0
Sex: F
Vaccine: HEP
Symptoms: Wrong product administered
Clinical narrative: The patient received  Engerix but was supposed to get her 2nd  dose  of  Hepslisav.
Age: 72.0
Sex: F
Vaccine: RSV
Symptoms: Injection site bruising, Pain, Pain in extremity
Clinical narrative: 9-19-24 patient came in and complained pain, severity of 10, after RSV injection on 9-9-24.  Patient doesn't know exactly what day/time pain started. Patient showed small dime sized bruise next to the injection site. She said for sure it was from the injection. She only suffers pain on the back of right arm and not injection site or surrounding areas. She said that she might go ER today or next week.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache
Clinical narrative: Chills, headache
Age: 55.0
Sex: M
Vaccine: UNK
Symptoms: Balance disorder, Dizziness, Heart rate irregular, Muscle twitching, Pulse abnormal
Clinical narrative: On 3/24/24, I had the first Shingrix vaccine.  The 3th day after, I felt a bit dizzy.  On the 4th day, I woke up with severe Vertigo.  The room-spinning Vertigo finally stopped after about 10 days.  Then, my heart started beating strongly, but not faster.  Each pulse was strong enough to cause my head and hands to shift (or flicker) back & forth to each heartbeat.  I can feel the pulsing radiating inside my head.  My equilibrium and balance have not been right.  My head feels like it?s in a constant plane turbulence.   My left hand and left foot have also started twitching every few minutes.
Age: 55.0
Sex: M
Vaccine: UNK
Symptoms: Sensory disturbance, Tinnitus, Vertigo
Clinical narrative: On 3/24/24, I had the first Shingrix vaccine.  The 3th day after, I felt a bit dizzy.  On the 4th day, I woke up with severe Vertigo.  The room-spinning Vertigo finally stopped after about 10 days.  Then, my heart started beating strongly, but not faster.  Each pulse was strong enough to cause my head and hands to shift (or flicker) back & forth to each heartbeat.  I can feel the pulsing radiating inside my head.  My equilibrium and balance have not been right.  My head feels like it?s in a constant plane turbulence.   My left hand and left foot have also started twitching every few minutes.
Age: 68.0
Sex: F
Vaccine: PNC20
Symptoms: Fatigue, Headache, Nausea, Pyrexia, Tremor
Clinical narrative: Fever,  headache, shaking at times, vomiting twice, nausea and exhaustion. Bad for 24 hours. Gradually improving the second day,.
Age: 68.0
Sex: F
Vaccine: PNC20
Symptoms: Vomiting
Clinical narrative: Fever,  headache, shaking at times, vomiting twice, nausea and exhaustion. Bad for 24 hours. Gradually improving the second day,.
Age: 16.0
Sex: F
Vaccine: HPV9, MENB
Symptoms: Generalised tonic-clonic seizure
Clinical narrative: 1:30 appointment for immunizations, immunization checklist for contraindications done by medical assistant and this nurse. Mothe denies seizure activity or disorder twice when asked but said patient faints. Placed patient on exam table lying down for safety. Administered Gardasil 9 and Meningitis B in left deltoid. Patient closed eye and benin to seize and had grand mal seizure that lasted 15-20 sec. Mother said "see she is fainting". Mother then states she "fained" when she got a piercing and states she went to ER last year with same issue and Mother was instructed to have child evaluated.