chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Malaise, Mobility decreased
Clinical narrative: Sick; bed for three days; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of bedridden in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced bedridden (Verbatim: bed for three days) and sickness (Verbatim: Sick). The outcome of the bedridden was resolved (duration 3 days) and the outcome of the sickness was not reported.   It was unknown if the reporter considered the bedridden and sickness to be related to Shingles vaccine.     It was unknown if the company considered the bedridden and sickness to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 14-MAY-2024 This case was reported by a consumer via interactive digital media. The reporter stated that if you would not have insurance there were two shots dollar 300 each.  The patient got the first one Shingles shot and he/she was in bed for three days sicker than Covid shot.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Inappropriate schedule of product administration
Clinical narrative: Shingles; 1st dose on 12th May 2023 and 2nd dose on 21st Feb 2024; This non-serious case was reported by a consumer via sales rep and described the occurrence of shingles in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of herpes zoster (1st dose received on 12th May 2023 from lot number L32MF at left deltoid, refer linked case US2024060668).   On 21-FEB-2024, the patient received the 2nd dose of Shingrix (left deltoid). On 21-FEB-2024, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: 1st dose on 12th May 2023 and 2nd dose on 21st Feb 2024). On 22-FEB-2024, the patient experienced shingles (Verbatim: Shingles). Rechallenge with Shingrix was positive. The outcome of the shingles was not reported and the outcome of the drug dose administration interval too long was unknown.   The reporter considered the shingles to be related to Shingrix.     The company considered the shingles to be related to Shingrix.   Linked case(s) involving the same patient:  US2024060668   Additional Information: GSK Receipt Date: 09-May-2024 The patient received Shingrix vaccine and 1 day after broke out with shingles. The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccination schedule. The reporter consented to follow up.; Sender's Comments:  US-GSK-US2024060668:1st dose vaccine
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Product complaint
Clinical narrative: Pharmaceutical product complaint; injection site redness; injection site swelling; injection site pain; This non-serious case was reported by a nurse via sales rep and described the occurrence of injection site erythema in a 4-year-old female patient who received DTPa-IPV (Kinrix) (batch number 34MF9, expiry date 13-FEB-2026) for prophylaxis. This case was associated with a product complaint.   On 03-MAY-2024, the patient received Kinrix. In MAY-2024, less than a week after receiving Kinrix, the patient experienced injection site erythema (Verbatim: injection site redness), injection site swelling (Verbatim: injection site swelling) and injection site pain (Verbatim: injection site pain). On an unknown date, the patient experienced pharmaceutical product complaint (Verbatim: Pharmaceutical product complaint). The outcome of the injection site erythema, injection site swelling, injection site pain and pharmaceutical product complaint were unknown.   It was unknown if the reporter considered the injection site erythema, injection site swelling and injection site pain to be related to Kinrix and Kinrix Pre-Filled Syringe Device.     It was unknown if the company considered the injection site erythema, injection site swelling and injection site pain to be related to Kinrix and Kinrix Pre-Filled Syringe Device.   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: 06-MAY-2024 The GSK (GlaxoSmithKline) field representative called in to report that he was contacted nurse. The nurse reported that the patient had received Kinrix vaccine and she concerns about Kinrix lot number. The nurse noticed patients receiving this lot number and extreme injection site redness, swelling and pain. The GSK (GlaxoSmithKline) representative did not know the injection site location or the duration of symptoms. The vaccine administration facility was the same as primary reporter. This was 2 of the 6 cases, reported by the same reporter. The reporter consent the follow up.; Sender's Comments:  US-GSK-US2024057403:Same reporter/Diffrent patient US-GSK-US2024057404:Same reporter/Diffrent patient US-GSK-US2024057402:Same reporter/Diffrent patient US-GSK-US2024057396:Same reporter/Diffrent patient
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Product complaint, Pyrexia
Clinical narrative: injection site redness; injection site swelling; injection site pain; Fever; product complaint; This non-serious case was reported by a nurse via sales rep and described the occurrence of injection site erythema in a 4-year-old female patient who received DTPa-IPV (Kinrix) (batch number 34MF9, expiry date 13-FEB-2026) for prophylaxis. This case was associated with a product complaint.   On 09-FEB-2024, the patient received Kinrix. On an unknown date, an unknown time after receiving Kinrix, the patient experienced injection site erythema (Verbatim: injection site redness), injection site swelling (Verbatim: injection site swelling), injection site pain (Verbatim: injection site pain), fever (Verbatim: Fever) and pharmaceutical product complaint (Verbatim: product complaint). The outcome of the injection site erythema, injection site swelling, injection site pain and pharmaceutical product complaint were unknown and the outcome of the fever was not reported.   It was unknown if the reporter considered the injection site erythema, injection site swelling, injection site pain and fever to be related to Kinrix and Kinrix Pre-Filled Syringe Device.     It was unknown if the company considered the injection site erythema, injection site swelling, injection site pain and fever to be related to Kinrix and Kinrix Pre-Filled Syringe Device.   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: 06-MAY-2024 The nurse had noticed patients receiving this Kinrix vaccine had extreme injection site redness, swelling, and pain. The GlaxoSmithKline field representative did not know injection site location, or duration of symptoms. The vaccine administration facility was the same as primary reporter. This was 1 of 4 cases reported by same reporter.; Sender's Comments:  US-GSK-US2024057403:Same reporter/Diffrent patient US-GSK-US2024057402:Same reporter/Diffrent patient US-GSK-US2024057401:Same reporter/Diffrent patient US-GSK-US2024057400:Same reporter/Diffrent patient US-GSK-US2024057396:Same reporter/Diffrent patient
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: patient received the 1st dose of Shingrix in 2021, and received the 2nd dose of Shingrix in March 2024; 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 male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (patient received the 1st dose of Shingrix in 2021).   In MAR-2024, the patient received the 2nd dose of Shingrix. In MAR-2024, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: patient received the 1st dose of Shingrix in 2021, and received the 2nd dose of Shingrix in March 2024). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 07-MAY-2024 The reporter had no other patient demographics to provide. The reporter was not at the pharmacy, and did not had lot, expiry, route, location of administration, or specific dates of administration but did say that the vaccines were administered at her pharmacy location. The reporter had reported all that was provided about this adverse event. The reporter consented to follow up.
Sex: U
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: patient not received 2nd dose yet; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix (on 3rd September 2023 received 1st dose).   On an unknown date, the patient did not receive the 2nd dose of Twinrix. On an unknown date, an unknown time after receiving Twinrix, the patient experienced incomplete course of vaccination (Verbatim: patient not received 2nd dose yet). The outcome of the incomplete course of vaccination 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: 07-MAY-2024 A pharmacist reported that the patient last received their first Twinrix shot in September of 2023 and the reporter wanted to see what the guidelines were regarding missing the second and the third dose. Till the time of reporting the patient did not receive the second dose of Twinrix, which led to incomplete course of vaccination.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: second shingrix dose 6 months apart but that longer time has passed.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in am unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose of Shingrix vaccine on an unknown date).   On an unknown date, the patients 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: second shingrix dose 6 months apart but that longer time has passed.). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 07-MAY-2024 The pharmacist reported that the multiple patients had not had the second dose of Shingrix vaccine 6 months apart, but that longer time had passed. The reporter did not specify how many more patients were involved. Till the time of reporting, the patients did not receive the 2nd dose, which led to incomplete course of vaccination. The vaccine administration facility was the same as primary reporter. This case had been linked to the case US2024057968 reported by the same reporter.; Sender's Comments:  US-GSK-US2024057968:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: multiple patients that hadn't got the second dose of Shingrix after 6 months but that more time had passed; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   On an unknown date, the patients did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patients experienced incomplete course of vaccination (Verbatim: multiple patients that hadn't got the second dose of Shingrix after 6 months but that more time had passed). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 07-MAY-2024 The pharmacist said he had multiple patients that had not got the second dose of Shingrix after 6 months but that more time had passed.  The vaccine administration facility was the same as primary reporter. Till the time of reporting, the patients did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination. The case was linked with case US2024057966, reported by the same reporter.; Sender's Comments:  US-GSK-US2024057966:Same reporter
Sex: U
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: Pediatric dose administered to adult patient; Pediatric dose administered to adult patient; This non-serious case was reported by a nurse via call center representative and described the occurrence of underdose in a adult patient who received HBV (Engerix B pediatric) for prophylaxis.   On an unknown date, the patient received Engerix B pediatric. On an unknown date, an unknown time after receiving Engerix B pediatric, the patient experienced underdose (Verbatim: Pediatric dose administered to adult patient) and adult use of a child product (Verbatim: Pediatric dose administered to adult patient). The outcome of the underdose and adult use of a child product were 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: 07-MAY-2024 The nurse reported that an adult patient received a pediatric dose of Engerix B a week ago (the specific date was unknown), which led to underdose and adult use of a child product.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination faliure/got shingles this year on April 14th 2024; got shingles this year on April 14th 2024; This serious case was reported by a nurse via call center representative and described the occurrence of vaccination failure in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On 14-APR-2024, more than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination faliure/got shingles this year on April 14th 2024) (serious criteria GSK medically significant) and shingles (Verbatim: got shingles this year on April 14th 2024). The outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.   It was unknown if the company considered the vaccination failure and shingles to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 09-MAY-2024 The patient a retired nurse herself would like to know if there was a Shingrix booster shot available. She had called physicians and pharmacist and wondering if there was any discussion going on for having booster shot for seniors. The patient got both her 2 shots in 2018 and got shingles this year and thought ok should she be looking for booster, other people her age called physician's and they mentioned there were no booster. By the time she came to know it was shingles, it was too late for antiviral but she had it anyway. This case was considered as suspected vaccination failure as details regarding laboratory confirmation regarding shingles were unknown at the time of reporting. This case has been linked with the case US2024059150, reported by same reporter.; Sender's Comments:  US-GSK-US2024059150:Same reporter
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a Consumer or other non HCP.  A 54-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 29Sep2023 at 13:00 as dose 1, single (Batch/Lot number: unknown) at the age of 53 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Motrin, reaction(s): "allergies". Vaccination history included: moderna (DOSE NUMBER UNKNOWN, Vaccine administration time 11:00 AM, Vaccine location Left arm), administration date: 18Nov2022, for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2024, outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of vaccination failure, covid-19 (Paxlovid treatment from 01May2024 to 05May2024).
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Got COVID; Got COVID; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 71-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 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. Vaccination history included: Bnt162b2 (DOSE 1), for COVID-19 immunization; Bnt162b2 (DOSE 2), for COVID-19 immunization; Bnt162b2 (DOSE NUMBER UNKNOWN (BOOSTER)), for COVID-19 immunization.The patient reported he got all Pfizer COVID vaccines in the past. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2024, outcome "unknown" and all described as "Got COVID". Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient was given nirmatrelvir, ritonavir (PAXLOVID) as treatment of COVID-19.  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-202400108749 same reporter, product and event, different patient;
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a Consumer or other non HCP.  A 39-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 01Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 39 years for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 3; MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset May2024, outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of vaccination failure, covid-19. The patient received PAXLOVID as COVID 19 treatment from 09May2024 to 15May2024  The lot number for BNT162b2 omi xbb.1.5, was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400108678 Same reporter and patient, different drug and event;
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a Consumer or other non HCP.  A 69-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 15Nov2023 at 13:00 as dose 1, single (Batch/Lot number: unknown) at the age of 69 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "known allergies: Sulfa" (unspecified if ongoing). Concomitant medication(s) included: LIPITOR, start date: 09Jan2004; AMLODIPINE, start date: 06May2004. Vaccination history included: pfizer / biontech (DOSE 4, vaccine administration time 01:00 PM, vaccine location Left arm), administration date: 07Oct2022, when the patient was 68-year-old, for covid-19 immunization; pfizer / biontech (DOSE 3, vaccine administration time 12:00 AM, vaccine location=Left arm), administration date: 12May2022, when the patient was 67-year-old, for covid-19 immunization; pfizer / biontech (DOSE 1, vaccine administration time 01:00 PM, vaccine lot number El1284, vaccine location Left arm), administration date: 11Jan2021, when the patient was 66-year-old, for covid-19 immunization; pfizer / biontech (DOSE 2, vaccine administration time 01:00 PM, lot number EL9261, vaccine location Left arm), administration date: 01Feb2021, when the patient was 66-year-old, for covid-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), outcome "unknown", described as "COVID 19"; COVID-19 (medically significant), outcome "unknown", described as "COVID 19 ". Therapeutic measures were taken as a result of vaccination failure, covid-19.  The information on the batch/lot number for [BNT162B2 OMI XBB.1.5] will be requested and submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Fatigue; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 38-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious), outcome "unknown".  Additional Information: Patient had Comirnaty and stated "The initial shot never had a bad side effect. However, second did had a negative side effect on me. I cannot remember all the physical symptoms it took a tool of, But I can guarantee you one thing. You will certainly remember where the spot was given for a couple days. Fatigue as well"  No follow-up attempts are possible.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Dysstasia, Fall, Musculoskeletal disorder
Clinical narrative: SHE FELL DOWN AND COULD NOT GET BACK UP.  STATES SHE COULD NOT MOVE HER ARMS OR LAGS
Age: 12.0
Sex: F
Vaccine: TDAP
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site swelling
Clinical narrative: Immediate lasting pain. Redness and significant swelling at injection site within 8 hours.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Acoustic stimulation tests, Tinnitus
Clinical narrative: I developed significant tinnitus about six hours after the Moderna booster, right worse than left.  The tinnitus has continued and is continuous.
Age: 0.33
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered
Clinical narrative: Gave patient vaccination after a second scanner. Went to put in vaccination into system to get error that it was expired. Spoke to provider and she said to let patients parents know that it was expired, patient would need to get the vaccination again and their is no harm to the patient. Manger was notified. PSA was written, note written in patients chart.
Age: 51.0
Sex: F
Vaccine: UNK
Symptoms: Breast pain, Injection site swelling, Pain, Swelling
Clinical narrative: Patient states that after zoster vaccine on 03/06/24 she felt a bump under her arm. Patient states she felt a strong sharp pain that radiates to her breast. Patient states she  also had a bump where she had the zoster vaccine. Per Dr. patient shouldn't receive second dose for zoster. Advise patient to schedule appointment for breast pain.
Age: 79.0
Sex: M
Vaccine: COVID19-2
Symptoms: Guillain-Barre syndrome
Clinical narrative: Patient received vaccine on 3/24.  On 4/22/24 he went to the hospital with s/s of guillen barre.  On 4/28 he was officially diagnoses with guillen barre syndrome
Age: 16.0
Sex: F
Vaccine: HPV9, TDAP
Symptoms: Loss of consciousness, Syncope
Clinical narrative: patient a syncopal episode in clinic about 10 minutes after injection. patient did lose consciousness for about 3 seconds. patient feet was propped up and ice pack placed on her head. patient stayed in clinic for monitoring for about 10 minutes with no further symptoms. patient was alert and oriented upon leaving the clinic with mom.
Age: 85.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Back pain, Local reaction
Clinical narrative: The pt described having a localized reaction in the arm.  It then  moved down to his back/hip... explaining pain worse in the morning.  It has been getting better since vaccine each day.  The patient described it almost as a arthritis type of pain.  He said his back/hip are sore, achy, nagging pain
Age: 9.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse events reported, vaccine for 12 years of age an older given to patient when 9 years old
Age: 7.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event
Clinical narrative: No adverse events noted
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Chest discomfort, Computerised tomogram, Computerised tomogram heart, Dizziness
Clinical narrative: Immediately after injection severe fatigue, went home and slept, woke up a few hours later with severe inflammation feeling in chest around heart and feeling like passing out and dizziness. Symptoms persisted on and off for several months and included trips to the ER for symptoms. Symptoms, mostly dizziness and feeling like passing out, still happen from time to time almost 3 years later randomly and infrequently.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Electrocardiogram, Fatigue, Immediate post-injection reaction, X-ray
Clinical narrative: Immediately after injection severe fatigue, went home and slept, woke up a few hours later with severe inflammation feeling in chest around heart and feeling like passing out and dizziness. Symptoms persisted on and off for several months and included trips to the ER for symptoms. Symptoms, mostly dizziness and feeling like passing out, still happen from time to time almost 3 years later randomly and infrequently.
Age: 52.0
Sex: F
Vaccine: UNK
Symptoms: Pain, Pain in extremity
Clinical narrative: Very sore arm for a while after vaccine. I still have pain now emanating from a single point in the upper arm. When stretching arm it really hurts.  I am in pain  if I sleep on the side of the left arm.
Age: 78.0
Sex: F
Vaccine: RSV
Symptoms: Condition aggravated, Impaired driving ability, Vertigo
Clinical narrative: baseline vertigo in patient, but stable over years.  Shortly after getting RSV vaccine September 2023, her vertigo significantly worsened and has not returned to baseline.  She is no longer able to drive.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Blood test normal, Chest X-ray normal, Culture, Generalised tonic-clonic seizure, Lethargy
Clinical narrative: Patient developed a fever the morning of 7/29/2023 that continued to rise despite being given Tylenol every 4-6hrs. At approx 2:30am on 7/30/2023, mother woke to hear patient making some abnormal sounds. Mother initially thought patient may be hungry, however, quickly realized she was having a tonic/clonic seizure and 911 was called. The seizure lasted approx 1 min, and by the time paramedics arrived, patient was lethargic and recovering from the seizure. Patient was taken to the hospital, and upon arrival, her fever was almost 105deg and heart rate of 216bpm. Patient was given both Motrin and Tylenol and monitored and then sent home after her temperature improved to normal. (Cont below) However, upon returning home at about 9am, patient's fever continued to rise despite being on medication. Mother and husband took patient back to the ER around 1:30pm, where she was monitored and then admitted with a high fever and lethargy. Patient then spent 3 days in the hospital on round the clock Tylenol and Motrin until her fever broke and she was sent home. Various tests were completed, but no diagnoses were confirmed, except that she had a high fever "potentially due to some virus." However, all of this occurred after 24hrs of receiving vaccines.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Pyrexia, SARS-CoV-2 test negative, Urine analysis normal
Clinical narrative: Patient developed a fever the morning of 7/29/2023 that continued to rise despite being given Tylenol every 4-6hrs. At approx 2:30am on 7/30/2023, mother woke to hear patient making some abnormal sounds. Mother initially thought patient may be hungry, however, quickly realized she was having a tonic/clonic seizure and 911 was called. The seizure lasted approx 1 min, and by the time paramedics arrived, patient was lethargic and recovering from the seizure. Patient was taken to the hospital, and upon arrival, her fever was almost 105deg and heart rate of 216bpm. Patient was given both Motrin and Tylenol and monitored and then sent home after her temperature improved to normal. (Cont below) However, upon returning home at about 9am, patient's fever continued to rise despite being on medication. Mother and husband took patient back to the ER around 1:30pm, where she was monitored and then admitted with a high fever and lethargy. Patient then spent 3 days in the hospital on round the clock Tylenol and Motrin until her fever broke and she was sent home. Various tests were completed, but no diagnoses were confirmed, except that she had a high fever "potentially due to some virus." However, all of this occurred after 24hrs of receiving vaccines.
Age: 1.08
Sex: F
Vaccine: MMR
Symptoms: Blood test normal, Chest X-ray normal, Cyanosis, Ear infection, Electrocardiogram normal
Clinical narrative: Patient received the MMR vaccine on 3/29/24 at approx 2:30pm. At approx 9:30am on 4/6/24, patient was sitting in her high chair eating, when all of a sudden, she slumped over and stopped breathing. Initially Mom thought she was choking, and administered back blows. After approx 45 sec of no food coming out and mom realizing she still was not breathing and her face was pale/gray and mouth gray/blue, mom administered approx 4-6 rescue breaths and then patient started breathing again. Dad called EMS as soon as patient stopped breathing, and by the time paramedics arrived, patient was breathing again on her own from the rescue breaths. (cont below) Vitals were monitored and were WNL and she did not have a temperature and her demeanor, although lethargic, was normal. Patient was then taken to the ER. While being monitored in the ER and tests obtained (chest x-ray, blood and urine draw), Patient had a febrile seizure, and after she stopped seizing, her temperature was taken and it was 102.6deg. Patient was then admitted to the hospital for 4 days with a fever. Many tests were completed including EKG and a 2hr EEG, both of which came back normal. Her bloodwork and urine was also normal. After her fever broke, patient was sent home on an antibiotic, as a small ear infection was found in one ear on day 3. Since then, patient has been seen by Neurology and Cardiology, as well as had an MRI of her brain and neck. All tests have come back normal.
Age: 1.08
Sex: F
Vaccine: MMR
Symptoms: Electroencephalogram normal, Febrile convulsion, Lethargy, Magnetic resonance imaging head normal, Magnetic resonance imaging neck normal
Clinical narrative: Patient received the MMR vaccine on 3/29/24 at approx 2:30pm. At approx 9:30am on 4/6/24, patient was sitting in her high chair eating, when all of a sudden, she slumped over and stopped breathing. Initially Mom thought she was choking, and administered back blows. After approx 45 sec of no food coming out and mom realizing she still was not breathing and her face was pale/gray and mouth gray/blue, mom administered approx 4-6 rescue breaths and then patient started breathing again. Dad called EMS as soon as patient stopped breathing, and by the time paramedics arrived, patient was breathing again on her own from the rescue breaths. (cont below) Vitals were monitored and were WNL and she did not have a temperature and her demeanor, although lethargic, was normal. Patient was then taken to the ER. While being monitored in the ER and tests obtained (chest x-ray, blood and urine draw), Patient had a febrile seizure, and after she stopped seizing, her temperature was taken and it was 102.6deg. Patient was then admitted to the hospital for 4 days with a fever. Many tests were completed including EKG and a 2hr EEG, both of which came back normal. Her bloodwork and urine was also normal. After her fever broke, patient was sent home on an antibiotic, as a small ear infection was found in one ear on day 3. Since then, patient has been seen by Neurology and Cardiology, as well as had an MRI of her brain and neck. All tests have come back normal.
Age: 1.08
Sex: F
Vaccine: MMR
Symptoms: Pallor, Posture abnormal, Pyrexia, Respiratory arrest, Resuscitation
Clinical narrative: Patient received the MMR vaccine on 3/29/24 at approx 2:30pm. At approx 9:30am on 4/6/24, patient was sitting in her high chair eating, when all of a sudden, she slumped over and stopped breathing. Initially Mom thought she was choking, and administered back blows. After approx 45 sec of no food coming out and mom realizing she still was not breathing and her face was pale/gray and mouth gray/blue, mom administered approx 4-6 rescue breaths and then patient started breathing again. Dad called EMS as soon as patient stopped breathing, and by the time paramedics arrived, patient was breathing again on her own from the rescue breaths. (cont below) Vitals were monitored and were WNL and she did not have a temperature and her demeanor, although lethargic, was normal. Patient was then taken to the ER. While being monitored in the ER and tests obtained (chest x-ray, blood and urine draw), Patient had a febrile seizure, and after she stopped seizing, her temperature was taken and it was 102.6deg. Patient was then admitted to the hospital for 4 days with a fever. Many tests were completed including EKG and a 2hr EEG, both of which came back normal. Her bloodwork and urine was also normal. After her fever broke, patient was sent home on an antibiotic, as a small ear infection was found in one ear on day 3. Since then, patient has been seen by Neurology and Cardiology, as well as had an MRI of her brain and neck. All tests have come back normal.
Age: 1.08
Sex: F
Vaccine: MMR
Symptoms: Skin discolouration, Urine analysis normal
Clinical narrative: Patient received the MMR vaccine on 3/29/24 at approx 2:30pm. At approx 9:30am on 4/6/24, patient was sitting in her high chair eating, when all of a sudden, she slumped over and stopped breathing. Initially Mom thought she was choking, and administered back blows. After approx 45 sec of no food coming out and mom realizing she still was not breathing and her face was pale/gray and mouth gray/blue, mom administered approx 4-6 rescue breaths and then patient started breathing again. Dad called EMS as soon as patient stopped breathing, and by the time paramedics arrived, patient was breathing again on her own from the rescue breaths. (cont below) Vitals were monitored and were WNL and she did not have a temperature and her demeanor, although lethargic, was normal. Patient was then taken to the ER. While being monitored in the ER and tests obtained (chest x-ray, blood and urine draw), Patient had a febrile seizure, and after she stopped seizing, her temperature was taken and it was 102.6deg. Patient was then admitted to the hospital for 4 days with a fever. Many tests were completed including EKG and a 2hr EEG, both of which came back normal. Her bloodwork and urine was also normal. After her fever broke, patient was sent home on an antibiotic, as a small ear infection was found in one ear on day 3. Since then, patient has been seen by Neurology and Cardiology, as well as had an MRI of her brain and neck. All tests have come back normal.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Sudden death
Clinical narrative: Online report of sudden death in a 62-year-old EUA medical countermeasure recipient. DOSE#1 Date 04/15/2021 LOT#EW0158. Unable to ascertain information on subsequent doses. Victim routinely traveled on long flights. According to online information his kidneys and liver were donated to three different recipients. DOD 04/22/24.
Age: 28.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Pain in extremity, Sudden death
Clinical narrative: Online report of sudden death in a 31-year-old EUA countermeasure recipient. Victim was a healthy professional dancer. Location of DOSE#1 pharmacy #unk-DOSE#1 date 02/27/21 LOT#EN6203, DATE of DOSE#2 03/21/21 LOT#UNK, ONLINE COPY of VAX CARD gives pharmacy for DOSE#2. This is a case of interstate inoculation. He was Inoculated in one state but he resided and passed away in another state. A social media post on 03/24/21 states adverse events as a sore arm and mild tiredness. Online-obituary states he died in city where he lived, that's where the death record is
Age: 12.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Papule, Rash
Clinical narrative: Rash, a few scattered papules not localized to an area
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse event; VARIVAX was administered the same day the temperature excursion occurred, 08-MAY-2024; This spontaneous report was received from a medical assistant concerning to a patient of unspecified age and gender.  The patient's medical history, concurrent conditions, concomitant therapies and drug reactions/allergies were not provided.  On 08-MAY-2024, according to data logger, improperly stored vaccine doses underwent a temperature excursion. Reporter did not have the complete information (temperature, time frame) but it was reported that there were not previous temperature excursions.  On that same date, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) 1st dose, lot #X026319, expiration date 07-NOV-2025 (anatomical location and route of administration were not provided) administered as prophylaxis (product storage error).  No other information was known by reporter. No additional adverse events were reported.  This was one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2405USA002603: US-009507513-2405USA002604:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE /PQC reported; Nurse calling to report a dose of VARIVAX was administered after experiencing a temperature excursion. Product was supported.; This spontaneous report has been received from a nurse, regarding a patient of unknown age and gender. The patient's pertinent medical history, previous drug reactions or allergies were not reported.  On 13-MAY-2024, the patient was vaccinated with an improperly storaged dose (conflicting information, two lot numbers reported) of varicella virus vaccine live (Oka/Merck) (VARIVAX) injection, as prophylaxis (lot number: X025846 and X024649, which were determined to be valid, with an expiration date on 31-OCT-2025 and 11-OCT-2025, respectively) (strength, dose, scheme, route and anatomical location of administration were not reported) (Product storage error).  The administered dose(s) underwent a temperature excursion of -11.1 degree Celsius (C) during 1 hour and 54 minutes. No previous temperature excursion was reported.  No additional information not adverse events were provided.
Age: 1.17
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects were reported/No additional AE; HCP called to report a TE with VARIVAX.  It was administered after being improperly stored.; This spontaneous report was received from a licensed practical nurse (L.P.N) and referred to a 14-month-old patient of unspecified gender. The patient's pertinent medical history, underlying concurrent conditions, previous drug reactions or allergies, and concomitant medications were not reported.  On 07-MAY-2024, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) injection, at a dose of 0.5 milliliter (mL) administered as prophylaxis (strength, dose number, vaccination scheme frequency, route of administration and anatomical location of administration were not provided; lot number W018837 with an expiration date reported and established as 14-JUN-2024) (details of temperature excursion not provided) (product storage error).  No additional adverse event or adverse effects were reported (no adverse event).  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2405USA004730:
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: confirmed no side effects or symptoms reported/No additional AE; Consumer confirmed her daughter received 2 doses of VARIVAX...today at 8am on 5/13/2024; This spontaneous report was received from a consumer (patient's mother) and referred to a 12-month-old female patient. The patient's pertinent medical history, previous drug reactions or allergies, and underlying concurrent conditions were not reported. Concomitant vaccines included measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection and hepatitis a vaccine, inactivated (VAQTA) intramuscular injection (lot numbers not reported).  On 13-MAY-2024 at 08:00, the patient received two doses (2 dosage forms) of varicella virus vaccine live (Oka/Merck) (VARIVAX) injection, administered as prophylaxis to her thigh (side unspecified) (strength, vaccination scheme frequency, exact dose quantity, route of administration, lot number, and expiration date were not reported). It was mentioned by the reporter that she could not remember if this should had been the patient's second or third dose of the vaccine (overdose). By reporter, on the same date, the patient recovered from the double varicella virus vaccine live (Oka/Merck) (VARIVAX) vaccination. It was reported that patient did not seek for medical attention and that no lab diagnostics or studies were performed.  The patient's mother also stated that she was told by her daughter health care professional (HCP) office there may just be an increased risk of soreness and swelling at injection site; however, by the reporting time she confirmed no side effects or symptoms reported, no additional adverse event (no adverse event).  Lot # is being requested and will be submitted if received
Sex: U
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: received an expired dose of acthib with no reported adverse event; Initial information received on 07-May-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves 2 patients of unknown age/gender who received an expired dose of HIB (PRP/T) VACCINE [ACT-HIB] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 11-Apr-2024, the patients received expired dose of suspect HIB (PRP/T) VACCINE, Powder and solvent for solution for injection (expiry 24-Mar-24) (expired product administered) (latency same day) (dose, lot and strength: unknown) via unknown route in unknown administration site for prophylactic vaccination (immunization).  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 and Regulatory Authority 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.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered, No adverse event
Clinical narrative: an expired PENTACEL was inadvertently administered to a patient with no reported AE; Initial information received on 09-May-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves an unknown age and gender patient to whom an expired diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (vero)] was inadvertently administered with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 08-May-2024, the patient received a 0.5 ml dose (total, once) of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine (Suspension for injection) (lot:UJ848AA, expiry date: 16-Apr-2024, Strength: standard) via unknown route in unknown administration site for Immunisation and an expired pentacel was inadvertently administered to a patient with no reported ae (expired product administered) (latency: same day).  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: No adverse event, Product storage error
Clinical narrative: patient received unsuitable Adacel after the referenced temperature excursion with no reported adverse event; Initial information received on 10-May-2024 regarding an unsolicited valid  non-serious case received from a consumer/non-healthcare professional.  The case was linked to CLUSTER (2024SA149322).  This case involves a 11 years old male patient who received unsuitable Diphtheria-2/Tetanus/5 AC Pertussis Vaccine [Adacel] after the referenced temperature excursion with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a 0.5 ml dose of suspect Diphtheria-2/Tetanus/5 AC Pertussis Vaccine Suspension for injection (lot 2CA69C1, Expiry: 20-Jul-2025 with unknown strength) via unknown route in unknown administration site as Immunization after the referenced temperature excursion with no reported adverse event (poor quality product administered) (unknown latency).  It was reported "temp excursion due to unknown cause, refrigerator got too cold with Excursion limits: 4 hours 51 minutes with a minimum temperature of -0.4A degree Celsius".   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.