chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Pain in jaw, Pyrexia
Clinical narrative: arm pain; Fever; Chills/Shivering; Eye pain; Jaw pain; Flu symptoms; redness in her face; Headache; This non-serious case was reported by a consumer via call center representative and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included parathyroid tumor (Parathyroid tumor).   On 20-JUN-2025, the patient received the 1st dose of Shingrix. In JUN-2025, an unknown time after receiving Shingrix, the patient experienced pain in arm (Verbatim: arm pain), fever (Verbatim: Fever), chills (Verbatim: Chills/Shivering), eye pain (Verbatim: Eye pain), jaw pain (Verbatim: Jaw pain), flu symptoms (Verbatim: Flu symptoms), red face (Verbatim: redness in her face) and headache (Verbatim: Headache). The outcome of the pain in arm, fever, chills, eye pain, jaw pain, flu symptoms, red face and headache were unknown.   It was unknown if the reporter considered the pain in arm, fever, chills, eye pain, jaw pain, flu symptoms, red face and headache to be related to Shingrix.     It was unknown if the company considered the pain in arm, fever, chills, eye pain, jaw pain, flu symptoms, red face and headache to be related to Shingrix.   Additional Information: GSK Receipt Date: 27-JUN-2025 The reporter was the patient who received her first dose of Shingrix on June 20th. The reporter reported that arm pain, redness in her face, flu symptoms, fever, chills, headache, eye pain, shivering, and jaw pain. The reporter was going to get a nuclear CT on Tuesday to check for a parathyroid tumor.
Vaccine: RVX
Symptoms: Cough, Malaise, Respiratory syncytial virus infection, Respiratory syncytial virus test positive, Vaccination failure
Clinical narrative: Suspected vaccination failure; RSV infection/ RSV vaccine last fall and I have it now/cough; been very sick for about 10 days;  This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient 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 vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), respiratory syncytial virus infection (Verbatim: RSV infection/ RSV vaccine last fall and I have it now/cough) and sickness (Verbatim: been very sick for about 10 days). The patient was treated with antibiotics. The outcome of the vaccination failure was not reported and the outcome of the respiratory syncytial virus infection was not resolved and the outcome of the sickness was resolved (duration 10 days).   It was unknown if the reporter considered the vaccination failure, respiratory syncytial virus infection and sickness to be related to RSV vaccine.     The company considered the vaccination failure to be unrelated to RSV vaccine. It was unknown if the company considered the respiratory syncytial virus infection and sickness to be related to RSV vaccine.   Additional Information: GSK Receipt Date:18-JUN-2025 and 19-JUN-2025 This case was reported by a patient via interactive digital media. The patient had been very sick for 10 days and now (during the reporting days) the urgent care had sent the patient home with an antibiotic and cough pills, but the patient continued to get worse.  They did not even take an x-ray of the patient's chest and was going to the emergency room (ER) on the day of reporting and believed it was respiratory syncytial virus infection (RSV) even though the patient had the RSV shot last fall in 2024 and have it now and had been very sick for about 10 days. So, the patient hates to say it just like the covid vaccine not every vaccine was perfect to do have RSV vaccine.  The hospital did an x-ray and test for RSV covid flu and he/she was positive for RSV and felt very bad.  The cough was so bad, and his/her oxygen level stayed at about a 90 to 94.  This case was considered as suspected vaccination failure since the details regarding the time to onset and laboratory confirmation of respiratory syncytial virus infection were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, time to onset and laboratory confirmation of disease) is considered unrelated to GSK RSV vaccine.
Vaccine: RVX
Symptoms: X-ray
Clinical narrative: Suspected vaccination failure; RSV infection/ RSV vaccine last fall and I have it now/cough; been very sick for about 10 days;  This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient 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 vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), respiratory syncytial virus infection (Verbatim: RSV infection/ RSV vaccine last fall and I have it now/cough) and sickness (Verbatim: been very sick for about 10 days). The patient was treated with antibiotics. The outcome of the vaccination failure was not reported and the outcome of the respiratory syncytial virus infection was not resolved and the outcome of the sickness was resolved (duration 10 days).   It was unknown if the reporter considered the vaccination failure, respiratory syncytial virus infection and sickness to be related to RSV vaccine.     The company considered the vaccination failure to be unrelated to RSV vaccine. It was unknown if the company considered the respiratory syncytial virus infection and sickness to be related to RSV vaccine.   Additional Information: GSK Receipt Date:18-JUN-2025 and 19-JUN-2025 This case was reported by a patient via interactive digital media. The patient had been very sick for 10 days and now (during the reporting days) the urgent care had sent the patient home with an antibiotic and cough pills, but the patient continued to get worse.  They did not even take an x-ray of the patient's chest and was going to the emergency room (ER) on the day of reporting and believed it was respiratory syncytial virus infection (RSV) even though the patient had the RSV shot last fall in 2024 and have it now and had been very sick for about 10 days. So, the patient hates to say it just like the covid vaccine not every vaccine was perfect to do have RSV vaccine.  The hospital did an x-ray and test for RSV covid flu and he/she was positive for RSV and felt very bad.  The cough was so bad, and his/her oxygen level stayed at about a 90 to 94.  This case was considered as suspected vaccination failure since the details regarding the time to onset and laboratory confirmation of respiratory syncytial virus infection were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, time to onset and laboratory confirmation of disease) is considered unrelated to GSK RSV vaccine.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Ophthalmic herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; shingles into the eye; shingles on the right side of his face; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included leukemia (patient was immune compromised because of leukemia four years ago).   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), ophthalmic herpes zoster (Verbatim: shingles into the eye) (serious criteria GSK medically significant) and facial herpes zoster (Verbatim: shingles on the right side of his face). The outcome of the vaccination failure was not reported and the outcome of the ophthalmic herpes zoster and facial herpes zoster were not resolved.   It was unknown if the reporter considered the vaccination failure, ophthalmic herpes zoster and facial herpes zoster to be related to Shingles vaccine and Shingles vaccine.     The company considered the vaccination failure and ophthalmic herpes zoster to be unrelated to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the facial herpes zoster to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 27-JUN-2025 Patient was immune compromised because of leukemia four years ago.  They wiped out his immune system to get the stem cell transplant and now he had all his childhood vaccinations, and the shingle shot was a last one.  Patient had first shot 6 months ago and second one 6 weeks ago and now has shingles on the right side of his face and into the eye. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, time to onset, and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine (dose 1 and 2)  Ophthalmic herpes zoster is an unlisted event which is considered unrelated to GSK vaccine Shingles vaccine (dose 1 and 2)
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; got the shot and came down with 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.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: got the shot and came down with shingles). The outcome of the vaccination failure and shingles were not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 30-JUN-2025 This case was reported by a patient via interactive digital media. The reporter reported that two friends from work got the shot and came down with shingles.  That frightened to reporter away from any of that.  So far reporter was good, no shingles.  This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine.
Sex: M
Vaccine: VARZOS
Symptoms: Death
Clinical narrative: died in his sleep; This serious case was reported by a consumer via interactive digital media and described the occurrence of died in sleep in a 50-year-old male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In MAY-2025, the patient received Shingles vaccine. In MAY-2025, less than a day after receiving Shingles vaccine, the patient experienced died in sleep (Verbatim: died in his sleep) (serious criteria death and GSK medically significant). The patient died in MAY-2025. The reported cause of death was died in sleep.   It was unknown if the reporter considered the died in sleep to be related to Shingles vaccine.     The company considered the died in sleep to be unrelated to Shingles vaccine.   Additional Information: GSK Receipt Date: 25-JUN-2025 This case was reported by the patient's friend via interactive digital media. The reporter had a 50-year-old friend who took the Shingles vaccine about a month ago.  He had died in his sleep that night.  He had no previous health issues.  Vaccines had started to appear more and more like the real threat to our health.  It was sad to see big pharma continuing to use scare tactics to get people lined up for their products.; Sender's Comments: Death is an unlisted event which is considered unrelated to GSK''s Shingles vaccine.; Reported Cause(s) of Death: died in sleep
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient received a dose of Kinrix out of the recommended age (patient is less than 4 years old); This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 1-year-old female patient who received DTPa-IPV (Kinrix) (batch number 5H95B, expiry date 16-FEB-2026) for prophylaxis.   On 20-SEP-2024, the patient received Kinrix. On 20-SEP-2024, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Patient received a dose of Kinrix out of the recommended age (patient is less than 4 years old)). The outcome of the inappropriate age at vaccine administration was not applicable.   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: 18-JUN-2025 The nurse reported that they administered a dose of Kinrix to 6 different patients under the age of 4 years old. One year old female patient received Kinrix which led to inappropriate age at vaccine administration. The reporter wanted to know if they need to continue with the same schedule as recommended in the package insert. This is 1 of 6 linked cases, reported by the same reporter.; Sender's Comments:  GSK-US2025076584:Same reporter/Diffrent patient US-GSK-US2025076595:Same reporter/Diffrent patient US-GSK-US2025076587:Same reporter/Diffrent patient US-GSK-US2025076588:Same reporter/Diffrent patient US-GSK-US2025076583:Same reporter/Diffrent patient
Sex: F
Vaccine: MENB
Symptoms: Incomplete course of vaccination
Clinical narrative: Late Dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a adult female patient who did not receive Men B NVS (Bexsero) for prophylaxis.   Previously administered products included Bexsero (1st dose received on 06-MAR-2024).   On an unknown date, the patient did not receive the 2nd dose of Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced incomplete course of vaccination (Verbatim: Late Dose). The outcome of the incomplete course of vaccination was not applicable.   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: 23-JUN-2025 The reporter have a patient came for her second dose but were just informed that the patient was in her first trimester or 8 weeks pregnant and just wanted to get clarification that it was ok to give that vaccine. The vaccine was not administered during pregnancy. Till the time of reporting the patient had not received the second dose of Bexsero, which led to incomplete course of vaccination.
Sex: M
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: Havrix plus administration after temperature excursion; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a 18-month-old male patient who received HAV (Havrix) (batch number 42DM9, expiry date 22-JAN-2027) for prophylaxis.   On 20-JUN-2025, the patient received Havrix. On an unknown date, an unknown time after receiving Havrix, the patient experienced incorrect storage of drug (Verbatim: Havrix plus administration after temperature excursion). The outcome of the incorrect storage of drug was not applicable.   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: 24-JUN-2025 Pharmacist called to verify if doses of vaccines that had been exposed to low temperatures should be repeated. Havrix temperature was 26.5 degree fahrenheit which led to incorrect storage of drug. This case has been linked to US2025079382 reported by the same reporter different patient.; Sender's Comments:  US-GSK-US2025079382:Same reporter different patient
Sex: F
Vaccine: TDAP
Symptoms: Product storage error
Clinical narrative: Boostrix + Administration after temperature excursion; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a 11-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number EB499, expiry date 26-AUG-2027) for prophylaxis.   On 19-JUN-2025 08:30, the patient received Boostrix. On an unknown date, an unknown time after receiving Boostrix, the patient experienced incorrect storage of drug (Verbatim: Boostrix + Administration after temperature excursion). The outcome of the incorrect storage of drug was not applicable.   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: 24-JUN-2025 The pharmacist had called to verify whether doses of vaccines that had been exposed to low temperatures needed to be repeated. Patient received Boostrix after temperature excursion, which led to Incorrect storage of drug.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: totally forgot to get her Second 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 of Shingrix vaccine on 04-SEP-2023 (batch number 274YD and expiry date 15-SEP-2025)).   The patient did not receive the 2nd dose of Shingrix. The patient had incomplete course of vaccination (Verbatim: totally forgot to get her Second dose). The outcome of the incomplete course of vaccination was not applicable.   Additional Information: GSK Receipt Date: 24-JUN-2025 Pharmacist reported that there is supposed to be a series of two within 2 to 6 months from the first dose about the Shingrix vaccine. This patient they had, she received one on 2023 but she totally forgot to get her Second one which led to incomplete course of vaccination. The reporter wanted to know if she had to start over and get two or was it okay to give her just one.
Age: 3.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Wrong vaccine administration; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 3-year-old male patient who received DTPa-IPV (Kinrix) (batch number 5H95B, expiry date 16-FEB-2026) for prophylaxis.   Co-suspect products included DTPa-HBV-IPV (Pediarix) for prophylaxis.   On 21-APR-2025, the patient received the 3rd dose of Kinrix. On an unknown date, the patient did not receive Pediarix. On 21-APR-2025, an unknown time after receiving Kinrix and not applicable after receiving Pediarix, the patient experienced wrong vaccine administered (Verbatim: Wrong vaccine administration). The outcome of the wrong vaccine administered was not applicable.   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: 25-JUN-2025 On 25th June 2025, a registered nurse called to report the administration of a Kinrix shot to a 3 year and 9-month-old male patient instead of Pediarix in the DTaP immunization series which led to wrong vaccine administration. The vaccine was administered on 21st April 2025 and was for the third dose.  She called to know how to proceed, do they need to revaccinate and make a Safety report?
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: received the first Shingrix dose more than 1 year ago; 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 did not receive Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received the first Shingrix dose more than 1 year ago).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after not receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: received the first Shingrix dose more than 1 year ago). The outcome of the incomplete course of vaccination was not applicable.   Additional Information: GSK Receipt Date: 26-JUN-2025 The reporter mentioned that a patient received the first Shingrix dose more than 1 year ago. They were asking if the patient should re start the series. No further details provided. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: M
Vaccine: TDAP
Symptoms: Wrong technique in product usage process
Clinical narrative: it was not shaken vigorously before administration; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of wrong technique in product usage process in a 92-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number Y3Z9P, expiry date 27-AUG-2027) for prophylaxis.   On 26-JUN-2025, the patient received Boostrix. On 26-JUN-2025, an unknown time after receiving Boostrix, the patient experienced wrong technique in product usage process (Verbatim: it was not shaken vigorously before administration). The outcome of the wrong technique in product usage process was not applicable.   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: 26-JUN-2025 The pharmacist reported that a patient that was administered with a Boostrix vaccine and it was not shaken vigorously before administration, which led to wrong technique in product usage process The reporter asked was there any advice on this and if they need to revaccinate or so. The Vaccine Administration Facility is the same as Primary Reporter
Sex: M
Vaccine: VARZOS
Symptoms: Injection site discomfort, Injection site pain
Clinical narrative: having a b urning sensation and discomfort at the injection site.; having a b urning sensation and discomfort at the injection site.; This non-serious case was reported by a physician via call center representative and described the occurrence of burning sensation skin in a 59-year-old male patient who received Herpes zoster (Shingrix) (batch number X5T42215ZK) for prophylaxis.   On 18-APR-2025, the patient received the 1st dose of Shingrix. On 18-APR-2025, less than a day after receiving Shingrix, the patient experienced burning sensation skin (Verbatim: having a b urning sensation and discomfort at the injection site.) and injection site discomfort (Verbatim: having a b urning sensation and discomfort at the injection site.). The outcome of the burning sensation skin and injection site discomfort were unknown.   It was unknown if the reporter considered the burning sensation skin and injection site discomfort to be related to Shingrix.     It was unknown if the company considered the burning sensation skin and injection site discomfort to be related to Shingrix.   Additional Information: GSK receipt date: 27-JUN-2025 The physician called in to request data about the administration of a second dose of Shingrix after a patient reported having a burning sensation and discomfort at the injection site.
Age: 34.0
Sex: F
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: The patient did not report any adverse effects, however, we needed to report that the patient received this dose 27 days after the previous dose instead of the minimum interval of 28 days. The patient is also aware.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Patient was vaccinated in left deltoid on 7/1/25. She returned 7/3/25. roughly 48 hours later showing a large red patch of skin around the injection site. She noticed it started about the size of a nickel and upon arrival on 7/3 it was about 1.5x2.5 inches. Reports itchy, warm patch of skin, red in color but no change in range of motion. Has been using cold compresses for the swelling.
Age: 61.0
Sex: F
Vaccine: PNC20
Symptoms: Diarrhoea, Erythema, Pruritus, Swelling
Clinical narrative: Itchy, redness, swollen, loose stools. Patient uses cool compresses, antihistamiines.
Age: 74.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Rheumatoid arthritis
Clinical narrative: Patient reports he developed rheumatoid arthritis as a result of his covid vaccines.  It developed sometime after his fourth shot.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pyrexia, Syncope
Clinical narrative: Fainted during the night, fever and chills the next morning
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Echocardiogram abnormal, Ejection fraction decreased, Electrocardiogram normal, Left ventricular dysfunction
Clinical narrative: Within a month after having the second dose I started having some chest pain. It was incredibly severe but it was enough to take notice and be a little concerned. I did not have any pain in my arm so I dismissed a heart attack and continued on. On February 24, 2022 that morning I was having more chest pain than normal and the nurses line recommend I go to the ER. I don't believe the test they ran me through showed any issues one being an EKG. Long story short I still have the chest pains however not as severe since being put on dilTIAZem CD 180 mg/24 hour capsule and losartan 50 mg tablet.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Left ventricular hypertrophy, Systolic dysfunction, Ventricular hypokinesia
Clinical narrative: Within a month after having the second dose I started having some chest pain. It was incredibly severe but it was enough to take notice and be a little concerned. I did not have any pain in my arm so I dismissed a heart attack and continued on. On February 24, 2022 that morning I was having more chest pain than normal and the nurses line recommend I go to the ER. I don't believe the test they ran me through showed any issues one being an EKG. Long story short I still have the chest pains however not as severe since being put on dilTIAZem CD 180 mg/24 hour capsule and losartan 50 mg tablet.
Age: 53.0
Sex: M
Vaccine: PNC20
Symptoms: Type III immune complex mediated reaction
Clinical narrative: Possible Arthus reaction to vaccine
Age: 29.0
Sex: F
Vaccine: MMR
Symptoms: Arthralgia, Joint noise, Knee arthroplasty, Surgical failure, Tuberculosis
Clinical narrative: It started a few months after i had bad joint pain, my knees started popping, i had a left knee replacement, and the surgery went bad and i had to have a second surgery 13 years later. And now i have to live off the government, and i have to uber. The joint pain is all over my body. I went to another doctor and i found out i had tuberculosis. And i am in pain management.
Age: 4.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Patient and his twin were meant to receive the Moderna COVID vaccine indicated for patients 6 months to 11 years of age, but were instead given the Spikevax vaccine indicated for patients 12 years and older. The order was placed incorrectly by the MA (per protocol) and then barcode scanning occurred, but because the order was placed incorrectly system did not flag the vaccine as incorrect for this patient. No unexpected side effects occurred.
Age: 2.0
Sex: M
Vaccine: UNK, UNK
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 58.0
Sex: M
Vaccine: PNC20
Symptoms: Injected limb mobility decreased, Injection site pain, Injection site reaction, Muscle swelling, Ultrasound Doppler normal
Clinical narrative: Pt complains of significant bicep enlargement, pain, and reduced ROM after receiving PCV 20 injection last year.
Age: 62.0
Sex: F
Vaccine: PNC20
Symptoms: Guillain-Barre syndrome
Clinical narrative: GBS
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Presyncope
Clinical narrative: patient 1st dose Pfizer had Moderna in the past denies any reaction or side effects with Moderna patient felt "body tingling after vaccine", near syncope reported nurse (withheld name) LVN , patient was sitting on a chair in the hallway upon my arrival 1st blood pressure 200/79 hr. 69, initial blood pressure for this clinic appt 133/53. daughter was present. no local reaction to left deltoid
Age: 29.0
Sex: F
Vaccine: YF
Symptoms: Dizziness, Dyspnoea, Feeling jittery
Clinical narrative: Dizziness, Lightheaded, Jittery, Shortness of Breath approximately 15 minutes following vaccine
Age: 50.0
Sex: M
Vaccine: PNC20
Symptoms: Insomnia, Pyrexia, Tremor
Clinical narrative: fever, shakes, no sleep for at least 24 hours
Age: 21.0
Sex: F
Vaccine: MMR, TDAP, VARCEL
Symptoms: Anaphylactic reaction
Clinical narrative: Anaphylactic reaction. Seen in ER at nearest hospital after about 45 minutes to an hour. Took 50mg of OTC Benadryl before the hospital. At the hospital, I was given Pepcid, more Benadryl, and a steroid via IV.  I was discharged and prescribed Diphenhydramine HCI 25mg 2 tablets four times orally daily for 5 days, Famotidine  20 mg 1 tablet oral twice daily for 3 days, and Prednisone 20 mg 2 tablets oral daily for 5 days.
Age: 11.0
Sex: M
Vaccine: MENB
Symptoms: Wrong product administered
Clinical narrative: When I went to grab Menactra the vaccine for this patient, I noticed that the lot number for this vaccine was not in correct in OP. I proceeded to writing down the lot number and notifying the NCIR lead, so it could be added. Got vaccine ready and proceeded to go to the patient's room and administer it. Right after coming out of the room, it was realized the MenB was given instead of Menactra. NCIR lead was notified and provider was notified as well.
Age: 66.0
Sex: M
Vaccine: PNC20
Symptoms: Disorientation, Swelling
Clinical narrative: Per patient, he is experiencing swelling on one side of body as well as disorientation beginning 24 hours post vaccination.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Dizziness
Clinical narrative: lightheaded, staff gave patient crackers and juice
Age: 17.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Headache, Injection site erythema, Injection site swelling, Nausea, Vomiting
Clinical narrative: Headaches, nausea & vomiting. Redness and swelling with tenderness at injection site about 3 cm.  Advised to apply cool compress , Zofran 8 mg prescribed for nausea.
Age: 0.33
Sex: F
Vaccine: DTPPVHBHPB, PNC20, RV1
Symptoms: Diarrhoea, Eye movement disorder, Skin warm, Vomiting
Clinical narrative: Mom of patient reported symptoms started  on 06/26/2025 patient felt warm, vomit, diarrhea, eyes moving involuntary
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Dizziness
Clinical narrative: Patient stated she felt lightheaded/dizzy after administering both vaccines.
Sex: M
Vaccine: PNC21, PPV
Symptoms: Fatigue
Clinical narrative: FBE calling to report an AE on behalf on an HCP in which the HCP did not want to provide any identifying information and does not want to be contacted regarding the case. HCP stated a patient received CAPVAXIVE in April 2025 and stated that his body; "fatigued and run down more than normal; This spontaneous report was received from a healthcare professional and refers to a male patient of unknown age near 70 years old.   The patient's medical history, concurrent conditions and concomitant therapies were not reported.   In 2021, the patient was vaccinated with Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23), administered by Unknown route (lot # and expiration date were not reported).  On an unknown date, the patient experienced a reaction.  In Apr-2025, the patient was vaccinated with Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) administered by Intramuscular route (lot # and expiration date were not reported). Both vaccines were administered for Prophylaxis.  After Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) vaccination, the patient stated that his body felt like it had a "stronger reaction than in previous vaccinations and that he felt fatigued and run down more than normal since 2025. The outcome of the events was unknown.   No causality assessment was provided.
Sex: M
Vaccine: HEP
Symptoms: Product storage error
Clinical narrative: Engerix B administration after temperature excursion; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a 5-year-old male patient who received HBV (Engerix B) (batch number 7NX57, expiry date 12-DEC-2026) for prophylaxis.   On 19-JUN-2025 09:30, the patient received Engerix B. On an unknown date, an unknown time after receiving Engerix B, the patient experienced incorrect storage of drug (Verbatim: Engerix B administration after temperature excursion). The outcome of the incorrect storage of drug was not applicable.   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: 24-JUN-2025 The pharmacist called to verify if doses of vaccines that had been exposed to low temperatures (26.5° Fahrenheit) and on 19 June 2025 at 09:30 am was administered to the patient which led to incorrect storage of drug. The reporter wanted to know if the dose should be repeated. The Vaccine Administration Facility is the same as Primary Reporter.
Age: 36.0
Sex: F
Vaccine: HEP, MNQ, VARCEL
Symptoms: Wrong product administered
Clinical narrative: My wife was administered the Meningitis vaccine listed above without her knowledge and without her consent.
Age: 53.0
Sex: F
Vaccine: HEPAB, VARZOS
Symptoms: Abdominal pain upper, Electric shock sensation, Headache, Hyperhidrosis, Injected limb mobility decreased
Clinical narrative: Patient was given immunization on 6/30/25 at a different pharmacy, but approached our pharmacy on 07/03/25 to ask about her adverse reaction. The following information was parsed based from database and the patient. She stated that she felt a shock down her arm at the time of vaccination. Over the course of the next couple days, she had throbbing pain in her left arm ,originating at the site of injection and moving down to her fingers. She mentioned difficulty with moving arm during this time. Other symptoms during this period included stomach cramps, headache, and profuse sweating.  At presentation to our pharmacy on 7/3, patient stated the pain was still present but had decreased in magnitude.  She also had a rash/inflammation about 3 inches in diameter, distal to the site of injection. She stated that the rash/inflammation had remained stable in size. Patient was encouraged to continue symptom management with ice packs, over the counter medications and to contact her primary if there were changes/worsening in the pain/rash.
Age: 53.0
Sex: F
Vaccine: HEPAB, VARZOS
Symptoms: Injection site inflammation, Injection site pain, Injection site rash, Pain, Pain in extremity
Clinical narrative: Patient was given immunization on 6/30/25 at a different pharmacy, but approached our pharmacy on 07/03/25 to ask about her adverse reaction. The following information was parsed based from database and the patient. She stated that she felt a shock down her arm at the time of vaccination. Over the course of the next couple days, she had throbbing pain in her left arm ,originating at the site of injection and moving down to her fingers. She mentioned difficulty with moving arm during this time. Other symptoms during this period included stomach cramps, headache, and profuse sweating.  At presentation to our pharmacy on 7/3, patient stated the pain was still present but had decreased in magnitude.  She also had a rash/inflammation about 3 inches in diameter, distal to the site of injection. She stated that the rash/inflammation had remained stable in size. Patient was encouraged to continue symptom management with ice packs, over the counter medications and to contact her primary if there were changes/worsening in the pain/rash.
Age: 27.0
Sex: M
Vaccine: HEPA, HPV9
Symptoms: Expired product administered
Clinical narrative: Patient was given Hepatitis A vaccine that was expired on 3//23/25.
Age: 33.0
Sex: F
Vaccine: FLU3, HEP
Symptoms: Injected limb mobility decreased, Injection site pain, Shoulder injury related to vaccine administration, Tendonitis
Clinical narrative: pain at injection site at time of event and ongoing, difficulty using arm, doctor diagnosed patient with tendonitis and rotator cuff dysfunction related to vaccine administration
Age: 30.0
Sex: F
Vaccine: MENB
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Right distal redness, swelling, and warmth spreading and streaking down right arm.
Age: 17.0
Sex: M
Vaccine: MMRV
Symptoms: Anaphylactic reaction, Urticaria, Wheezing
Clinical narrative: presented with hives and wheezing consistent with anaphylaxis.  He was given benadryl and albuterol and sent to facility for observation and possible epipen
Age: 37.0
Sex: F
Vaccine: YF
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Discovered on 07/03/2025 patient on skyrizi, a drug that will compromise immune system. began med 1.5 yrs ago. Now on maintenence sched (dosed every 3 mo). Last disp 05/01/25. YF vax administered on 06/27. Spoke to pt who confirms yf was administered. Pt reports no adverse effects except for redness tenderness around vaccine site. Advised patient to not take vivotif and to contact us if she experiences side effects. Called doctor and left message explaining situation.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Local, injection site reaction --- redness and swelling.  Symptoms has improved by putting ice, still still has reaction after almost a week.  Patient to continue to put ice and monitor, seek medical attention if concerned or worsen
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, PNC20
Symptoms: Culture, Injection site bruising, Injection site discharge, Injection site induration, Injection site mass
Clinical narrative: Left thigh developed hard lump by evening. Slight bruise coloring. Lump persisted with discoloration until week of 7/3/2025 with no indication of pain. Week of 7/3/2025 showed signs of discomfort when pressure was applied. Small zit like bump appeared and afternoon of 7/3/2025 it began to leak yellow milky fluid.  Patient was brought to a walk in clinic where a sample of fluid was taken and antibiotics were prescribed.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, PNC20
Symptoms: Injection site pain
Clinical narrative: Left thigh developed hard lump by evening. Slight bruise coloring. Lump persisted with discoloration until week of 7/3/2025 with no indication of pain. Week of 7/3/2025 showed signs of discomfort when pressure was applied. Small zit like bump appeared and afternoon of 7/3/2025 it began to leak yellow milky fluid.  Patient was brought to a walk in clinic where a sample of fluid was taken and antibiotics were prescribed.
Sex: F
Vaccine: PNC21
Symptoms: Cough, Erythema, Headache, Injection site pain, Nausea
Clinical narrative: COUGH; HEADACHE; INJECTION SITE ERYTHEMA; INJECTION SITE PAIN; NAUSEA; OROPHARYNGEAL PAIN; PAIN; PAIN IN EXTREMITY; SWELLING; Information has been received from the Food Drug Administration (FDA) (agency # 2834478-1) on 16-JUN-2025 This spontaneous report refers to a 65-year-old female patient. The patient's medical history was not reported. The patient's concurrent conditions included head cold, Covid +, hypothyroidism, IBS,, asthma, reflux, and Allergy to Erythromycin. Concomitant medications included Wixela inhub (Fluticasone propionate;Salmeterol xinafoate), Levothyroxine (Levothyroxine sodium), Dicyclomine (Dicycloverine hydrochloride), Vitamin D3 Ol (Colecalciferol), Multivitamin (Ascorbic acid;Nicotinamide;Retinol;Riboflavin;Thiamine;Vitamin d nos), Calcium d (Ascorbic acid;Calcium gluconate;Calcium lactate;Calcium phosphate dibasic;Ergocalciferol), Vilazodone hcl (Vilazodone hydrochloride), Famotidine d (Famotidine), Alprazolams (Alprazolam), Clomipramine (Clomipramine hydrochloride).  On 31-Mar-2025, at private, the patient was vaccinated in her left arm with the first dose of Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) intramuscular, lot #: Y019157, expiration date not provided but upon internal validation stablished as: 23-MAY-2026; dose and anatomical location were not provided) administered for prophylaxis. On 31-Mar-2025, the patient experienced cough, body aches, headache, sore throat and nausea, sore arm, redness, tenderness at injection site. (Baseball size) Self treated with Tylenol and OTC cold medicine. arm redness, swelling went down within 24 hours. Declined office visit to assess. On unspecified date in 2025, the patient recovered from all adverse events. The causal relationship between the adverse events and suspect vaccine was not reported.; Sender's Comments: Priority : 5 , Is case serious : No , Index user : , Index date : 2025-06-17 , MNSC number : , CLIC number : , ESTAR number : , IRMS number : 2834478-1 , Central date : 2025-06-17 , Classification : DMC, Attachment description : Post Marketing Basic , Safety case number :
Sex: F
Vaccine: PNC21
Symptoms: Oropharyngeal pain, Pain, Pain in extremity, Swelling
Clinical narrative: COUGH; HEADACHE; INJECTION SITE ERYTHEMA; INJECTION SITE PAIN; NAUSEA; OROPHARYNGEAL PAIN; PAIN; PAIN IN EXTREMITY; SWELLING; Information has been received from the Food Drug Administration (FDA) (agency # 2834478-1) on 16-JUN-2025 This spontaneous report refers to a 65-year-old female patient. The patient's medical history was not reported. The patient's concurrent conditions included head cold, Covid +, hypothyroidism, IBS,, asthma, reflux, and Allergy to Erythromycin. Concomitant medications included Wixela inhub (Fluticasone propionate;Salmeterol xinafoate), Levothyroxine (Levothyroxine sodium), Dicyclomine (Dicycloverine hydrochloride), Vitamin D3 Ol (Colecalciferol), Multivitamin (Ascorbic acid;Nicotinamide;Retinol;Riboflavin;Thiamine;Vitamin d nos), Calcium d (Ascorbic acid;Calcium gluconate;Calcium lactate;Calcium phosphate dibasic;Ergocalciferol), Vilazodone hcl (Vilazodone hydrochloride), Famotidine d (Famotidine), Alprazolams (Alprazolam), Clomipramine (Clomipramine hydrochloride).  On 31-Mar-2025, at private, the patient was vaccinated in her left arm with the first dose of Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) intramuscular, lot #: Y019157, expiration date not provided but upon internal validation stablished as: 23-MAY-2026; dose and anatomical location were not provided) administered for prophylaxis. On 31-Mar-2025, the patient experienced cough, body aches, headache, sore throat and nausea, sore arm, redness, tenderness at injection site. (Baseball size) Self treated with Tylenol and OTC cold medicine. arm redness, swelling went down within 24 hours. Declined office visit to assess. On unspecified date in 2025, the patient recovered from all adverse events. The causal relationship between the adverse events and suspect vaccine was not reported.; Sender's Comments: Priority : 5 , Is case serious : No , Index user : , Index date : 2025-06-17 , MNSC number : , CLIC number : , ESTAR number : , IRMS number : 2834478-1 , Central date : 2025-06-17 , Classification : DMC, Attachment description : Post Marketing Basic , Safety case number :
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Product preparation issue
Clinical narrative: Adjuvant was given without being mixed with the active ingredient; Adjuvant was given without being mixed with the active ingredient; This non-serious case was reported by a other health professional and described the occurrence of inappropriate preparation of medication in a 54-year-old male patient who received Herpes zoster (Shingrix) (batch number 97D52, expiry date 16-SEP-2025) for prophylaxis.   On 13-FEB-2025, the patient received Shingrix (intramuscular use). On 13-FEB-2025, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: Adjuvant was given without being mixed with the active ingredient) and inappropriate dose of vaccine administered (Verbatim: Adjuvant was given without being mixed with the active ingredient). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable.   Additional Information: GSK Receipt Date: 26-JUN-2025 The reporter stated that the Shingrix adjuvant was given to the patient without being mixed with the active ingredient, which led to an inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter considered the medication error without harm.; Sender's Comments:  US-GSK-US2025061270:same reporter differnt patient
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Product preparation issue
Clinical narrative: Adjuvant was given without being mixed with the active ingredient; Adjuvant was given without being mixed with the active ingredient; This non-serious case was reported by a other health professional and described the occurrence of inappropriate preparation of medication in a 61-year-old male patient who received Herpes zoster (Shingrix) (batch number 97D52, expiry date 16-SEP-2025) for prophylaxis.   Previously administered products included Venlafaxine (received a dose on an unknown date).   On 21-APR-2025, the patient received Shingrix. On 21-APR-2025, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: Adjuvant was given without being mixed with the active ingredient) and inappropriate dose of vaccine administered (Verbatim: Adjuvant was given without being mixed with the active ingredient). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable.   Additional Information: GSK Receipt Date: 26-JUN-2025 The reporter stated that the Shingrix adjuvant was given to the patient without being mixed with the active ingredient, which led to an inappropriate preparation of medication and inappropriate dose of vaccine administered.; Sender's Comments:  US-GSK-US2025061270: