chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Tremor, Walking aid user, Wheelchair user, X-ray abnormal
Clinical narrative: He got his vaccine he stated having body pain and weakness that night, and some dizziness.  He went to bed and when he woke up the next morning he could hardy get out of bed.  He was really weak, shaky and dizzy.  he crawled on his hands to go to the bathroom and urinated blood.  He then started walk to the living room to sit down in his recliner and then he came to and was on the floor and was unable to use his legs.  He drugged himself into his chair, and 911.  The ambulance came and he was tonic and semi-unconscience.  They got him to the hospital, and the doctor came in and spoke to him, stroke protocol and other stuff.  They had him in for 3-4 days in the hospital and they tried to get him to walk and he could not stand up.  The timeline went back to the vaccination and had no protocol to help him.  He suggested going to a nursing home for rehab before Christmas.  He went there and was pushed in a wheelchair and taken by transport by ambulance to then.  They tried to do PT and he never recovered and went to Nursing home and rehab and was there 11/29/21 to 1/5/2022, about 30 days, had some outbreaks of COVID and told them he had to get out of there.  He had home health nurse worker that came and took care of him and did PT at home and he still could not walk and was in a wheelchair for a year.  He started to do PT with PT for a year.  They finally got him up to where he can use a walker and a cane, which he has to use the cane all the time.  He is still having dizzy spells, has trouble with his breath, walks a short period of time and runs out of breath and has falled 6 times.  His legs get real weak and give away on him, and that is current condition.  He fell 5 times and finally he injured his shoulder and they wanted to do surgery on him for that, and they denied his shoulder surgery at Hospital and the medical facility said they could not do it.  He was in stage III kidney failure and had to get clearance from his vascular surgeon and fell again 3 days ago in the parking lot.  He has to get a referral from his PCP.   Back 2002 he had a stoke and was paralyzed on the right side.  He then had the first 2 vaccines on 1/19/21 and 2/16/21, and was fine after those.  In fact he had just walked his dog for 5 miles the day before the vaccine and now he cannot walk much at all.   He is going start back on PT on 7/19/2024.  He did have lower back pain after the vaccine, and they finally did x-rays and found out that he has stage III kidney disease.  He does not know if it's due to not able to walk much so is going back for strength training.  He seems to have plateaued and is going back to PT to see if they can improve his situation.
Age: 71.0
Sex: F
Vaccine: RSV
Symptoms: Dizziness, Headache, Injection site erythema, Injection site induration, Injection site mass
Clinical narrative: Hard red lump about the size of a hard boiled egg at admin site. The arm remained swollen and red for a few days. It has decreased in size now (5 days post-vaccine) and is only a little red. The patient also experienced lightheadedness several minutes after she had left the pharmacy, and she continues to have sporadic lightheadedness. The patient experienced headaches beginning the evening after the vaccine, and continues to have intermittent headaches (5 days post-vaccine).
Age: 71.0
Sex: F
Vaccine: RSV
Symptoms: Injection site swelling
Clinical narrative: Hard red lump about the size of a hard boiled egg at admin site. The arm remained swollen and red for a few days. It has decreased in size now (5 days post-vaccine) and is only a little red. The patient also experienced lightheadedness several minutes after she had left the pharmacy, and she continues to have sporadic lightheadedness. The patient experienced headaches beginning the evening after the vaccine, and continues to have intermittent headaches (5 days post-vaccine).
Age: 72.0
Sex: M
Vaccine: TD
Symptoms: Product storage error
Clinical narrative: Patient was administered a vaccine that had went through an excursion. Once the excursion was detected, we contacted manufacturers to determine viability of vaccines. We then received the notice that TDVAX was considered non-viable, and we had to revaccinate the patients.
Age: 22.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Injection site nodule, Injection site pruritus, Injection site urticaria
Clinical narrative: On the drive home experienced itching at vaccination site. When band aid was removed noticed hives and a nodule formation from the injection site. Donor applied Calamine lotion she had at home and the hives and itchiness was relieved within the hour.
Age: 22.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Pruritus, Urticaria
Clinical narrative: On the drive home experienced itching at vaccination site. When band aid was removed noticed hives and a nodule formation from the injection site. Donor applied Calamine lotion she had at home and the hives and itchiness was relieved within the hour.
Age: 38.0
Sex: F
Vaccine: TD
Symptoms: Product storage error
Clinical narrative: Patient was administered a vaccine that had went through an excursion. Once the excursion was detected, we contacted manufacturers to determine viability of vaccines. We then received the notice that TDVAX was considered non-viable, and we had to revaccinate the patients.
Age: 21.0
Sex: F
Vaccine: HEP
Symptoms: Erythema, Pruritus, Skin warm, Swelling
Clinical narrative: Constant redness, swelling, itching, warm to touch. They report applying ice pack for relief, and states that it helped with the swelling.
Age: 22.0
Sex: F
Vaccine: TD
Symptoms: Product storage error
Clinical narrative: Patient was administered a vaccine that had went through an excursion. Once the excursion was detected, we contacted manufacturers to determine viability of vaccines. We then received the notice that TDVAX was considered non-viable, and we had to revaccinate the patients.
Age: 70.0
Sex: M
Vaccine: HEP, HEPA, MMR
Symptoms: Contraindication to vaccination, No adverse event
Clinical narrative: Pt. was taking chemotherapy for prostate cancer and received MMR vaccine. Pt. was notified. Pt. notified provider. No adverse effects at this time.
Age: 30.0
Sex: F
Vaccine: TD
Symptoms: Product storage error
Clinical narrative: Patient was administered a vaccine that had went through an excursion. Once the excursion was detected, we contacted manufacturers to determine viability of vaccines. We then received the notice that TDVAX was considered non-viable, and we had to revaccinate the patients.
Age: 24.0
Sex: M
Vaccine: TD
Symptoms: Product storage error
Clinical narrative: Patient was administered a vaccine that had went through an excursion. Once the excursion was detected, we contacted manufacturers to determine viability of vaccines. We then received the notice that TDVAX was considered non-viable, and we had to revaccinate the patients.
Age: 61.0
Sex: M
Vaccine: TD
Symptoms: Product storage error
Clinical narrative: Patient was administered a vaccine that had went through an excursion. Once the excursion was detected, we contacted manufacturers to determine viability of vaccines. We then received the notice that TDVAX was considered non-viable, and we had to revaccinate the patients.
Age: 67.0
Sex: F
Vaccine: PNC20, VARZOS
Symptoms: Erythema, Immunisation reaction, Pruritus, Rash
Clinical narrative: Pt called pharmacy on 7/12 to report adverse event from vaccines received on 7/9. She said she has experienced itching/redness/bumps from her hands to elbows on both arms that started about 2 hours post vaccination. She has been using creams and tylenol for the symptoms.
Age: 75.0
Sex: M
Vaccine: TD
Symptoms: Product storage error
Clinical narrative: Patient was administered a vaccine that had went through an excursion. Once the excursion was detected, we contacted manufacturers to determine viability of vaccines. We then received the notice that TDVAX was considered non-viable, and we had to revaccinate the patients.
Age: 49.0
Sex: M
Vaccine: TD
Symptoms: Product storage error
Clinical narrative: Patient was administered a vaccine that had went through an excursion. Once the excursion was detected, we contacted manufacturers to determine viability of vaccines. We then received the notice that TDVAX was considered non-viable, and we had to revaccinate the patients.
Age: 79.0
Sex: F
Vaccine: TD
Symptoms: Product storage error
Clinical narrative: Patient was administered a vaccine that had went through an excursion. Once the excursion was detected, we contacted manufacturers to determine viability of vaccines. We then received the notice that TDVAX was considered non-viable, and we had to revaccinate the patients.
Age: 23.0
Sex: F
Vaccine: HEP
Symptoms: Chest pain, Dizziness, Dyspnoea, Feeling hot, Nausea
Clinical narrative: About 10 mins after Hepatitis B was given she reported nausea, warmth, dizziness, feeling SOB, and  sharp chest pain that coming intermittently . Symptoms are ongoing after 3:44PM. Did not want EMS called. States she seek medical attention on her own
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash pruritic
Clinical narrative: Patient presented to Urgent Care due to having a neck and chest itchy rash that  started a few minutes after getting a dose of the shingles vaccine. Treated with diphenhydramine 25mg q6h prn #30 tablets and Prednisone 20mg daily for 3 days.
Age: 54.0
Sex: M
Vaccine: TD
Symptoms: Product storage error
Clinical narrative: Patient was administered a vaccine that had went through an excursion. Once the excursion was detected, we contacted manufacturers to determine viability of vaccines. We then received the notice that TDVAX was considered non-viable, and we had to revaccinate the patients.
Age: 50.0
Sex: M
Vaccine: TD
Symptoms: Product storage error
Clinical narrative: Patient was administered a vaccine that had went through an excursion. Once the excursion was detected, we contacted manufacturers to determine viability of vaccines. We then received the notice that TDVAX was considered non-viable, and we had to revaccinate the patients.
Age: 72.0
Sex: F
Vaccine: HEPAB
Symptoms: Dizziness
Clinical narrative: Customer states that she felt light headed from the time she left the pharmacy in the morning after getting the vaccine until later that night.
Age: 49.0
Sex: F
Vaccine: IPV
Symptoms: Underdose
Clinical narrative: When injecting the shot, less than half of the vaccine entered the arm. Dose had to be repeated.
Age: 7.0
Sex: M
Vaccine: HEP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse outcomes
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Reactivation of Herpes Zoster after vaccination. Shingles outbreak on right chest and back.
Age: 13.0
Sex: M
Vaccine: HEPA, HPV9, MNQ, TDAP, VARCEL
Symptoms: Nausea, Pallor
Clinical narrative: Patient became pale, and nauseated.  Patient stated I need to vomit.  I placed patient a wet cloth on forehead and behind neck.  Patient stayed in a sitting position.  Patient had not eaten breakfast.  Patient given a lollipop.
Sex: F
Vaccine: PPV
Symptoms: Vaccination failure
Clinical narrative: impaired response to Pneumovax-23 (vaccine failure); This literature marketed report has been received from the authors of a published article, titled as stated below, and refers to a  The patient's medical history and concomitant therapies were not reported. The patient's concurrent conditions included specific antibody deficiency (SAD) characterized by normal IgG, IgA, IgM and IgG subclasses.  On an unknown date, the patient was vaccinated with pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection, administered for prophylaxis (strength, dose, lot #, expiry date, and route of administration were not provided).  On an unknown date, the patient experienced impaired response to pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23). At the time of reporting, the outcome of the event was not provided.  The authors considered the event to be related to pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23).  A copy of the published article is attached as further documentation of the patient's experience.   Lot is being requested and will be submitted if received.  This is one the five reports derived from the same literature article (cross referenced with # 2407USA001987, 2407USA003226, 2407USA003227 and 2407USA003228).; Sender's Comments:  US-009507513-2407USA001987: US-009507513-2407USA003226: US-009507513-2407USA003227: US-009507513-2407USA003228:
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     The company considered the vaccination failure to be related to Shingles vaccine and Shingles vaccine. The company considered the shingles to be unrelated to Shingles vaccine and Shingles vaccine.   Additional Information: GSK receipt date 07 Jul 2024 This case was reported by patient via interactive digital media. The patient have had two shingles vaccinations and had shingles right now (at the time of reporting). This case was considered as suspected vaccination failure since the details regarding the time to onset and laboratory confirmation of shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which is considered related to GSK Shingles vaccine.  Herpes zoster is an unlisted event which is considered unrelated to GSK  Shingles vaccine.
Sex: U
Vaccine: RVX
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: administered in error to infants and children aged younger; This non-serious case was reported by a consumer via other manufacturer and described the occurrence of inappropriate age at vaccine administration in an unspecified number of patients who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced inappropriate age at vaccine administration (Verbatim: administered in error to infants and children aged younger). The outcome of the inappropriate age at vaccine administration was unknown.   Additional Information: GSK Receipt Date: 03-JUL-2024 The reporter reported respiratory syncytial virus vaccines from GSK administered in error to infants and children aged than 2 years were infrequently reported, which led inappropriate age at vaccine administered.
Sex: M
Vaccine: TDAP
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site pain
Clinical narrative: Injection site soreness; Injection site redness; Patient can not move the arm; This non-serious case was reported by a physician via call center representative and described the occurrence of injection site pain in a adult male patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On an unknown date, the patient received Boostrix. On an unknown date, an unknown time after receiving Boostrix, the patient experienced injection site pain (Verbatim: Injection site soreness), injection site erythema (Verbatim: Injection site redness) and mobility decreased (Verbatim: Patient can not move the arm). The outcome of the injection site pain and injection site erythema were resolved and the outcome of the mobility decreased was resolved (duration 1 month).   It was unknown if the reporter considered the injection site pain, injection site erythema and mobility decreased to be related to Boostrix.     It was unknown if the company considered the injection site pain, injection site erythema and mobility decreased to be related to Boostrix.   Additional Information: GSK receipt date: 02-JUL-2024 Doctor reported that on 2014 a patient received Boostrix on a different clinic, and suffered severe reaction on the injection side for a month: soreness, redness.  patient could not move the arm for a month.  The patient had received 3 shots before without issues.  Consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: the patient may not have received the 2nd dose/patient may not have received the 2nd dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on March 2020).   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: the patient may not have received the 2nd dose/patient may not have received the 2nd dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 01-JUL-2024 The pharmacist reported that, the patient got her 1st dose of shingrix back in 2020. The patient swears she got the 2nd dose, but can't find record of it. The pharmacist asked should she get another dose, restart there series, or get no more doses. The pharmacist reported that, they found record of one dose in march 2020. The patient said she checked all the pharmacies she thought she would have gone to. The patient felt as though she did get it, but doesn't remember where to confirm. The patient might not received the 2nd dose,which led to incomplete course of vaccination. The reporter consented to follow up via phone.
Sex: U
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: they start the Twinrix series but sometimes they miss a dose; 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 HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix (received unknown dose at unknown date).   On an unknown date, the patients did not receive Twinrix. On an unknown date, an unknown time after receiving Twinrix, the patient experienced incomplete course of vaccination (Verbatim: they start the Twinrix series but sometimes they miss a dose). 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: 02-JUL-2024 The pharmacist stated that they saw a lot of the patients who travelled at the pharmacy and they started the Twinrix series but sometimes they missed a dose. No further information provided regarding past patients who have missed doses. Till the time of reporting, the patients did not receive doses of Twinrix, which led to incomplete course of vaccination.
Sex: F
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: not yet received dose two; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix (1st dose received in April 2024).   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: not yet received dose two). 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: 02-JUL-2024 Pharmacist states the patient came to the pharmacy stating she received dose one of the Twinrix series but has not yet received dose two because she has been traveling. Till the time of reporting the patient had not received the second dose of Twinrix , which led to incomplete course of vaccination. The reporter did not consent to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain, Paraesthesia
Clinical narrative: pain in her abdomen; dermatologic tingling in her left upper arm, left flank, and abdomen; This non-serious case was reported by a physician via call center representative and described the occurrence of abdominal pain in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14-JUN-2024, the patient received Shingrix (left deltoid). On an unknown date, an unknown time after receiving Shingrix, the patient experienced abdominal pain (Verbatim: pain in her abdomen) and tingling skin (Verbatim: dermatologic tingling in her left upper arm, left flank, and abdomen). The outcome of the abdominal pain and tingling skin were unknown.   It was unknown if the reporter considered the abdominal pain and tingling skin to be related to Shingrix.     It was unknown if the company considered the abdominal pain and tingling skin to be related to Shingrix.   Additional Information: GSK Receipt Date: 02-JUL-2024 The reporter was a medical doctor calling to report that a 60 year old, female patient received the Shingrix vaccine in her left deltoid, and within a couple of days experienced dermatologic tingling in her left upper arm, left flank, and abdomen. The reporter stated that the patient also experienced pain in her abdomen. The reporter did not know for sure if this was the patient's 1st or 2nd dose of Shingrix.  The reporter did not have Lot/Expiry or route of administration to provide. The reporter only provided the gender and age for the patient. The reporter reported all that was provided about these adverse events.
Age: 25.0
Sex: F
Vaccine: TDAP
Symptoms: Product storage error
Clinical narrative: Product Storage Error; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a 25-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 9935H, expiry date 03-JUL-2026) for prophylaxis.   On 28-JUN-2024, the patient received Boostrix. On 28-JUN-2024, an unknown time after receiving Boostrix, the patient experienced incorrect storage of drug (Verbatim: Product Storage Error). The outcome of the incorrect storage of drug 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: 02-JUL-2024 The reporter requested stability data for Bexsero, Havrix, Kinrix, Pediarix, Boostrix, Infanrix stored at 35.2 Fahrenheit by 43 mins. No prior excursion. Boostrix administered to patient on 28 June 2024 which led to incorrect storage error.; Sender's Comments:  US-GSK-US2024AMR086714:Same reporter
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, DTAP, DTAPHEPBIP, DTAPIPV, HEPA, MENB, TDAP
Symptoms: Product storage error
Clinical narrative: Product Storage Error; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a 2-month-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number X9EP3, expiry date 09-MAR-2026) for prophylaxis.   On 01-JUL-2024, the patient received Pediarix. On an unknown date, an unknown time after receiving Pediarix, the patient experienced incorrect storage of drug (Verbatim: Product Storage Error). The outcome of the incorrect storage of drug 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: 02-JUL-2024 The reporter requested stability data for Bexsero, Havrix, Kinrix, Pediarix, Boostrix, Infanrix stored at 35.2 Fahrenheit by 43 mins. No prior excursion. Pediarix administered to patient on July 1, 2024 which led to incorrect storage error.; Sender's Comments:  US-GSK-US2024AMR086714:Same reporter
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, DTAP, DTAPHEPBIP, DTAPIPV, HEPA, MENB, TDAP
Symptoms: Intercepted product storage error, Product storage error
Clinical narrative: Product Storage Error; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a 2-month-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number X9EP3, expiry date 09-MAR-2026) for prophylaxis.   On 01-JUL-2024, the patient received Pediarix. On an unknown date, an unknown time after receiving Pediarix, the patient experienced incorrect storage of drug (Verbatim: Product Storage Error). The outcome of the incorrect storage of drug 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: 02-JUL-2024 The reporter requested stability data for Bexsero, Havrix, Kinrix, Pediarix, Boostrix, Infanrix stored at 35.2 Fahrenheit by 43 mins. No prior excursion. Pediarix administered to patient on July 1, 2024 which led to incorrect storage error.; Sender's Comments:  US-GSK-US2024AMR086714:Same reporter
Sex: U
Vaccine: DTAPHEPBIP, DTAP, DTAPHEPBIP, DTAPIPV, HEPA, MENB, TDAP
Symptoms: Product storage error
Clinical narrative: Bexsero, Havrix, Kinrix, Pediarix, Boostrix, Infanrix stored at 35.2 Fahrenheit by 43 mins; This non-serious case was reported by a other health professional via call center representative and described the occurrence of intercepted product storage error in a patient who received DTPa-HBV-IPV (Pediarix) for prophylaxis.   Co-suspect products included Men B NVS (Bexsero) for prophylaxis, HAV (Havrix) for prophylaxis, DTPa-IPV (Kinrix) for prophylaxis, DTPa (Reduced antigen) (Boostrix) for prophylaxis and DTPa (Infanrix) for prophylaxis.   On an unknown date, the patient did not receive Pediarix, Bexsero, Havrix, Kinrix, Boostrix and Infanrix. On an unknown date, an unknown time after receiving Pediarix, Bexsero, Havrix, Kinrix, Boostrix and Infanrix, the patient experienced intercepted product storage error (Verbatim: Bexsero, Havrix, Kinrix, Pediarix, Boostrix, Infanrix stored at 35.2 Fahrenheit by 43 mins). The outcome of the intercepted product storage error 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: 02-JUL-2024 The reporter requested stability data for Bexsero, Havrix, Kinrix, Pediarix, Boostrix, Infanrix stored at 35.2 Fahrenheit by 43 mins intercepted product storage error. No prior excursion. The case is linked with US2024083131, US2024083133, same reporter.; Sender's Comments:  US-GSK-US2024083131:Same reporter US-GSK-US2024083133:Same reporter
Sex: U
Vaccine: DTAPHEPBIP, DTAP, DTAPHEPBIP, DTAPIPV, HEPA, MENB, TDAP
Symptoms: Intercepted product storage error, Product storage error
Clinical narrative: Bexsero, Havrix, Kinrix, Pediarix, Boostrix, Infanrix stored at 35.2 Fahrenheit by 43 mins; This non-serious case was reported by a other health professional via call center representative and described the occurrence of intercepted product storage error in a patient who received DTPa-HBV-IPV (Pediarix) for prophylaxis.   Co-suspect products included Men B NVS (Bexsero) for prophylaxis, HAV (Havrix) for prophylaxis, DTPa-IPV (Kinrix) for prophylaxis, DTPa (Reduced antigen) (Boostrix) for prophylaxis and DTPa (Infanrix) for prophylaxis.   On an unknown date, the patient did not receive Pediarix, Bexsero, Havrix, Kinrix, Boostrix and Infanrix. On an unknown date, an unknown time after receiving Pediarix, Bexsero, Havrix, Kinrix, Boostrix and Infanrix, the patient experienced intercepted product storage error (Verbatim: Bexsero, Havrix, Kinrix, Pediarix, Boostrix, Infanrix stored at 35.2 Fahrenheit by 43 mins). The outcome of the intercepted product storage error 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: 02-JUL-2024 The reporter requested stability data for Bexsero, Havrix, Kinrix, Pediarix, Boostrix, Infanrix stored at 35.2 Fahrenheit by 43 mins intercepted product storage error. No prior excursion. The case is linked with US2024083131, US2024083133, same reporter.; Sender's Comments:  US-GSK-US2024083131:Same reporter US-GSK-US2024083133:Same reporter
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Early 3rd dose; This non-serious case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too short in an unspecified number of patients who received HBV (Engerix B) for prophylaxis.   Previously administered products included Engerix B (on an unknown date received 1st dose) and Engerix B (on an unknown date received 2nd dose).   On an unknown date, the patient did not receive the 3rd dose of Engerix B. On an unknown date, an unknown time after receiving Engerix B, the patient experienced drug dose administration interval too short (Verbatim: Early 3rd dose). The outcome of the drug dose administration interval too short 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 03 Jul 2024 A nurse reported that at the facility where they work, we have some students that are getting 3rd dose 4 months after the initial dose of Engerix-B.  Reporter also mentioned some of them have gotten it up to 4 days before those 16 weeks.  Reporter mentioned that this had been done since CDC guidelines state that it was fine to give the third dose of Engerix-B 4 months after the initial dose. Reporter mentioned as well that MMR catch up doses have also been administered to students who received early doses.  However, for MMR it was confirmed to 2nd line agent that the vaccines were from. The vaccine administration facility was the same as primary reporter. The patient received 3rd dose of Engerix B earlier than the recommended interval, which led to shortening of the vaccine schedule.
Sex: M
Vaccine: COVID19
Symptoms: Cardiac arrest
Clinical narrative: Cardiac arrest; This spontaneous case was reported by a patient family member or friend and describes the occurrence of CARDIAC ARREST (Cardiac arrest) in a male patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced CARDIAC ARREST (Cardiac arrest) (seriousness criteria death and medically significant). The patient died on 11-May-2022. The reported cause of death was Cardiac arrest. It is unknown if an autopsy was performed.            Concomitant medication information was not provided.  Patient did not have any type of heart problem till that apparent cardiac arrest occurred. He liked to eat healthy foods and he never complained of or had any heart problems.  It was reported that the patient's death was sudden and completely unexpected to everyone who knew the patient. Patient died on 11-May-2022 at 09:31 A.M in the emergency room of the hospital. After requesting and reviewing his medical records, it showed that he did take Moderna vaccine and emergency room notes were revealing.  Treatment information was not reported.  Company comment: This spontaneous case concerns a male patient of unknown age, with no relevant medical history reported (Patient did not have any type of heart problem till that apparent cardiac arrest occurred. He liked to eat healthy foods and he never complained of or had any heart problems), who experienced the unexpected fatal serious (death and medically significant) event of cardiac arrest. The events occurred after a dose of SPIKEVAX NOS. Temporal relationship with a dose of SPIKEVAX NOS is unclear. As reported, the patient's death was sudden and completely unexpected to everyone who knew the patient. Patient died in the emergency room of the hospital. After requesting and reviewing his medical records, it showed that he did take Moderna vaccine and emergency room notes were revealing. No further information about the events was provided. The benefit-risk relationship of SPIKEVAX NOS is not affected by this report.; Reported Cause(s) of Death: Cardiac arrest
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: Chills; This spontaneous case was reported by a patient and describes the occurrence of CHILLS (Chills) in a 74-year-old male patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     Concurrent medical conditions included Diabetes.   On an unknown date, the patient received second dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, received first dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CHILLS (Chills). At the time of the report, CHILLS (Chills) outcome was unknown.            It was reported that patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. The concomitant medication was not reported by reporter. It was reported that patient had his all shots from Moderna and the very second one, the only thing he had was the chills out of it, nothing else. The treatment medication was not reported by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2024-771206 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-771206:Same patient different moderna product
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Covid-19; This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (Covid-19) in a 41-year-old male patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.   On 13-Feb-2021, the patient received first dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On 19-Mar-2021, received second dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form. On 11-Jan-2022, received third dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form. On 17-Aug-2022, received fourth dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form. On 28-Feb-2023, received fifth dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form. On 20-Jun-2023,  after starting SPIKEVAX NOS (SPIKEVAX NOS), the patient experienced COVID-19 (Covid-19). At the time of the report, COVID-19 (Covid-19) outcome was unknown.        For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment medication was reported.  This case contains information about patient 2(Other dose case).   This case was linked to US-MODERNATX, INC.-MOD-2024-771214 ( Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-771214:master case
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (COVID) in a 77-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 vaccine (7 Moderna vaccine). Past adverse reactions to the above products included No adverse effect with Moderna COVID-19 vaccine.    In October 2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In January 2024, the patient experienced COVID-19 (COVID). At the time of the report, COVID-19 (COVID) had resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. Patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. Patient received 7 doses of Moderna covid-19 vaccine. She had no reaction whatsoever or nothing. No treatment medication was reported.   This case was linked to US-MODERNATX, INC.-MOD-2024-771206 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-771206:husband case
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Brain fog, COVID-19
Clinical narrative: COVID; Brain fog; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (COVID) and BRAIN FOG (Brain fog) in a 74-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     Concurrent medical conditions included Diabetes.    In October 2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In January 2024, the patient experienced COVID-19 (COVID) and BRAIN FOG (Brain fog). At the time of the report, COVID-19 (COVID) and BRAIN FOG (Brain fog) had not resolved.            No concomitant medication was reported. Patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. Patient had 7 doses of Moderna covid-19 vaccine. The only thing patient got from the COVID; he got the damn runny nose. The chills lasted for 24 hours. He always got COVID vaccine at least 4 weeks before he got the flu shot and that he never got any shots together. No treatment medication was reported.   This case was linked to US-MODERNATX, INC.-MOD-2024-771202, US-MODERNATX, INC.-MOD-2024-771211 (Linked Report). This case was linked to US-MODERNATX, INC.-MOD-2024-771208 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-771202:People case US-MODERNATX, INC.-MOD-2024-771211:wife case
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Product preparation issue
Clinical narrative: administered two vials of the same/two of the same one which is the lyophilized conjugate; administered two vials of the same/two of the same one which is the lyophilized conjugate; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 18-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA987A, expiry date 31-OCT-2024) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: administered two vials of the same/two of the same one which is the lyophilized conjugate) and inappropriate dose of vaccine administered (Verbatim: administered two vials of the same/two of the same one which is the lyophilized conjugate). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 02-JUL-2024 The pharmacist called and reported that by error she administered the patient two vials of the same lyophilized component of Menveo 2 vial presentation, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter insisted that lyophilized component was a liquid. This case had been linked to US2024AMR083380, reported by same reporter, for a different patient.; Sender's Comments:  US-GSK-US2024AMR083380:another patient case
Sex: U
Vaccine: RV1
Symptoms: Infantile spitting up, Oral administration complication, Underdose
Clinical narrative: received a rotavirus vaccine and spit it up; received a rotavirus vaccine and spit it up; This non-serious case was reported by a physician via call center representative and described the occurrence of regurgitation of medication in a patient who received Rota (Rotarix lyophilized formulation) for prophylaxis.   On an unknown date, the patient received Rotarix lyophilized formulation. On an unknown date, an unknown time after receiving Rotarix lyophilized formulation, the patient experienced regurgitation of medication (Verbatim: received a rotavirus vaccine and spit it up) and accidental underdose (Verbatim: received a rotavirus vaccine and spit it up). The outcome of the regurgitation of medication was not reported and the outcome of the accidental underdose was unknown.   It was unknown if the reporter considered the regurgitation of medication to be related to Rotarix lyophilized formulation and Rotarix Oral Applicator Device.     It was unknown if the company considered the regurgitation of medication to be related to Rotarix lyophilized formulation and Rotarix Oral Applicator 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: 02-JUL-2024 The doctor of medicine (MD) stated that years ago they had a situation where a patient received a rotavirus vaccine and spit it up, which led to accidental underdose. The MD wasn't sure if it was Rotarix or Rotateq vaccine. They called in to company at the time and asked how to proceed. The reporter did not consent to follow-up.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Sleep disorder, Vaccination site pain
Clinical narrative: debilitating; wake up late at night in pain; my arm has hurt me / in pain all the time; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  An 83-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 03Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 83 years, in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (medically significant) with onset 03Oct2023, outcome "not recovered", described as "my arm has hurt me / in pain all the time"; ASTHENIA (non-serious), outcome "not recovered", described as "debilitating"; SLEEP DISORDER (non-serious), outcome "not recovered", described as "wake up late at night in pain". Therapeutic measures were taken as a result of vaccination site pain. Clinical course: The patient arm hurt since vaccination and got worse and became debilitating. The physician was going to send the patient to physical therapy as pain was present all day. The patient mentioned woke up late at night in pain. The patient could not find any medication that helped. Also, patient mentioned received RSV vaccine the next day on the other arm.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Pancreatic failure, Pancreatitis
Clinical narrative: pancreatic insufficiency; pancreatitis; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A patient (age and gender not provided) 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: Covid-19 vaccine (Dose 1, single, unknown manufacturer), for COVID-19 Immunization; Covid-19 vaccine (Dose 2, single, unknown manufacturer), for COVID-19 Immunization. The following information was reported: PANCREATIC FAILURE (disability, medically significant), outcome "unknown", described as "pancreatic insufficiency"; PANCREATITIS (disability, medically significant), outcome "unknown". The patient specified that Covid vaccine caused pancreatitis and pancreatic insufficiency and other problems after 3rd shot. The patient hasn't been able to function since and even got covid after the shot.   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-202400213085 same patient and reporter, different dose and event;
Age: 13.0
Sex: F
Vaccine: TDAP
Symptoms: Pallor, Throat tightness
Clinical narrative: Patient complaint of fingers turning white, and throat felt like it was pinching. Patient states symptoms were intermittent. Vital signs normal range. Patient seen by Dr. No swelling of throat, lung sounds clear, no difficulty speaking.  MD advised to go to ER to be observed for several hours.
Age: 65.0
Sex: M
Vaccine: COVID19-2, PNC20, RSV
Symptoms: Extra dose administered
Clinical narrative: Patient received listed vaccinations at a facility vaccine clinic on 6/27/2024. Patients' paperwork was received from facility a second time for the second vaccine clinic and the patient received the listed vaccines for a second time on 7/10/2024.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: C-reactive protein increased, Electrocardiogram, Headache, Palpitations, Pruritus
Clinical narrative: Presented to UC for heart racing, HA to right side temporal area.  Reported Itchiness the evening the COVID booster was given and it resolved with Benadryl .  EKG showed sinus tachycardia and CRP is mildly elevated
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Sinus tachycardia
Clinical narrative: Presented to UC for heart racing, HA to right side temporal area.  Reported Itchiness the evening the COVID booster was given and it resolved with Benadryl .  EKG showed sinus tachycardia and CRP is mildly elevated
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Arthralgia, Impaired work ability, Injected limb mobility decreased, Injection site pain, Pain
Clinical narrative: Arm Pain   Upper left arm pain, s/p Men B vaccine on 7/8/24, consistent pain - worse in AM, taking Ibuprofen & Tylenol, icing Pt had meningococcal B vaccine on 07/08/2024 administered in this clinic by MA as a clinical support visit.  States that when the vaccine was given it was almost immediately uncomfortable. Did not feel like a typical vaccine administration. She states it looked like it was given higher in arm than other vaccines.  That day within a few hours started to developed painful shoulder ROM which has persisted and it not improving. Sx worse in the morning.  Ice, heat slightly helpful.  Ibuprofen OTC - 2 tabs Q 6-8 hours does not seem to be helping very much.  No fevers, local swelling.  Painful and difficult to put on bra, shirt, move the shoulder around Painful at rest as well.  Of note prior to the vaccine on 07/08/2024 she had no shoulder issues.    She is a karate instructor this summer and having difficulty doing this job since the vaccine was administered.    ? Shoulder injury related to vaccine administration (SIRVA) Yes Her findings today are c/w vaccine administration. Site of injection appears superior to deltoid muscle. Pt having pain and decreased painful ROM starting the day of the vaccine and persisting now 3 d after the vaccine. Does not seem to be improving.   Plan: Will start with conservative treatment at this time.  Recommend regular nsaid for now.  Recommend aleve 2 pills BID with food or ibuprofen 3 pills TID (one or the other). Take with food. GI, renal, CV potential effects d/w her.  Ice to area.  Gentle shoulder exercises reviewed.  Recommend f/u in 1-2 weeks. Pending f/u would consider PT.  Imaging such as MRI not needed at this time but could be considered in the future.