chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: RSV
Symptoms: Guillain-Barre syndrome
Clinical narrative: Guillain Barre syndrome; This serious case was reported by a nurse via sales rep and described the occurrence of guillain barre syndrome in a female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   In MAR-2024, the patient received the 1st dose of Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced guillain barre syndrome (Verbatim: Guillain Barre syndrome) (serious criteria hospitalization, disability, GSK medically significant and other: serious as per reporter). The outcome of the guillain barre syndrome was resolving.   The reporter considered the guillain barre syndrome to be related to Arexvy.   The company considered the guillain barre syndrome to be related to Arexvy.   Additional Information: GSK receipt date: 02-APR-2024 The nurse practitioner (NP) told at the time of reporting that her patient had the pneumonia vaccine and the RSV vaccine and had guillain barre syndrome. The reporter did not know which RSV vaccine the patient received.  She said she would follow up with the patient in the next few weeks and try to find out and also stated that the physicians at where her patient was being treated. The reporter said that they had treated many guillain barre syndrome patients from the RSV vaccine and said she would never recommend anyone to get it. The reporter considered the guillain barre syndrome to be related to pneumonia vaccine.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Ophthalmic herpes zoster, Vaccination failure
Clinical narrative: Had both shots of vaccine still got shingles/Suspected vaccination failure; Got shingles in left eye; Got shingles twice on both sides of the scalp; 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.   Previously administered products included Varicella zoster vaccine (had both the first vaccine on an unknown date).   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: Had both shots of vaccine still got shingles/Suspected vaccination failure) (serious criteria GSK medically significant), ophthalmic herpes zoster (Verbatim: Got shingles in left eye) (serious criteria GSK medically significant) and shingles (Verbatim: Got shingles twice on both sides of the scalp). The outcome of the vaccination failure was unknown and the outcome of the ophthalmic herpes zoster and shingles were not reported.   It was unknown if the reporter considered the vaccination failure, ophthalmic herpes zoster and shingles to be related to Shingles vaccine and Shingles vaccine.     It was unknown if the company considered the vaccination failure, ophthalmic herpes zoster and shingles to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 02-APR-2024 This case was reported by a patient via interactive digital media. The patient stated that he/she had both the first vaccine and both shots of the second vaccine and still got shingles twice on both sides of the scalp.  It got into the left eye before the patient knew what it was and when it attacked the right side, the patient recognized what it was immediately and got on the antiviral immediately.  The patient knew it could had been much worse had not been vaccinated.  The patient stated that hopefully he/she will never get them again. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory confirmation regarding shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Develop shingles after previously receiving shingrix/suspected vaccination failure; Shingles; This serious case was reported by a physician via sales rep and described the occurrence of vaccination failure in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Develop shingles after previously receiving shingrix/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 reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingrix.   Additional Information: GSK Receipt Date: 03-APR-2024 The reporter stated that he/she had a couple of people who developed shingles after previously receiving Shingrix. 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.
Sex: U
Vaccine: RVX
Symptoms: Respiratory syncytial virus infection, Vaccination failure
Clinical narrative: Suspected vaccination failure; Got the shot but still got RSV; 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) and respiratory syncytial virus infection (Verbatim: Got the shot but still got RSV). The outcome of the vaccination failure was unknown and the outcome of the respiratory syncytial virus infection was not reported.   It was unknown if the reporter considered the vaccination failure and respiratory syncytial virus infection to be related to RSV vaccine.     It was unknown if the company considered the vaccination failure and respiratory syncytial virus infection to be related to RSV vaccine.   Additional Information: GSK receipt date: 02-APR-2024 This case was reported by a patient via interactive digital media. The patient got shot but still got respiratory syncytial virus infection. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccine schedule, time to onset and laboratory confirmation of respiratory syncytial virus infection were unknown at the time of reporting. The case was linked with case US2024AMR042753, reported by the same reporter for different patient.; Sender's Comments:  US-GSK-US2024AMR042753:Same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Swelling
Clinical narrative: Joint pain; Swelling; This non-serious case was reported by a other health professional via sales rep and described the occurrence of swelling in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Additional patient notes included patient was healthy.   On 19-FEB-2024, the patient received the 1st dose of Shingrix (right deltoid). On 20-FEB-2024, 1 days after receiving Shingrix, the patient experienced swelling (Verbatim: Swelling). On an unknown date, the patient experienced joint pain (Verbatim: Joint pain). On 26-FEB-2024, the outcome of the swelling was resolved (duration 6 days). The outcome of the joint pain was not reported.   The reporter considered the swelling to be related to Shingrix. It was unknown if the reporter considered the joint pain to be related to Shingrix.     The company considered the swelling to be related to Shingrix. It was unknown if the company considered the joint pain to be related to Shingrix.   Additional Information: GSK Receipt Date: 25-MAR-2024 The medical assistant reported that a patient received first dose of Shingrix vaccine and experienced swelling which was not serious. The patient also experienced joint pain. Patient did not receive any other products.
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, Product use issue, Wrong product administered
Clinical narrative: Pregnant patient received Arexvy / Gave to non indicated patient; This non-serious prospective pregnancy case was reported by a pharmacist via sales rep and described the occurrence of vaccine exposure during pregnancy in a female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received the 1st dose of Arexvy (unknown arm). On an unknown date, an unknown time after receiving Arexvy, the patient experienced vaccine exposure during pregnancy (Verbatim: Pregnant patient received Arexvy / Gave to non indicated patient). The outcome of the vaccine exposure during pregnancy was unknown.   Pregnancy exposure: Pregnancy Exposure (Arexvy): Trimester unknown Pregnancy Outcome: Pregnancy was ongoing   Additional Information: GSK receipt date: 26-MAR-2024 The pregnant patient received a dose of Arexvy, which led to vaccine exposure during pregnancy. Did not consent to follow-up.
Sex: U
Vaccine: RSV
Symptoms: Respiratory disorder
Clinical narrative: Lower respiratory symptoms; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of lower respiratory disorder in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced lower respiratory disorder (Verbatim: Lower respiratory symptoms). The outcome of the lower respiratory disorder was not reported.   It was unknown if the reporter considered the lower respiratory disorder to be related to Arexvy.     It was unknown if the company considered the lower respiratory disorder to be related to Arexvy.   Additional Information: GSK receipt date: 27-MAR-2024 This case was reported the patient via interactive digital media. The patient was received Arexvy vaccine and experienced lower respiratory symptoms. The follow-up could not be possible as no contact details were available.
Age: 69.0
Sex: M
Vaccine: RSV
Symptoms: Arthralgia, Injection site pain, Tendonitis
Clinical narrative: he feels sore in his shoulder when sleeping over his left side; Chronis tendinitis/ bicep tendinitis in left shoulder; Sore in Left bicep; This non-serious case was reported by a other health professional via call center representative and described the occurrence of tendonitis in a 69-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 24-DEC-2023, the patient received Arexvy (left deltoid). On 26-DEC-2023, 2 days after receiving Arexvy, the patient experienced tendonitis (Verbatim: Chronis tendinitis/ bicep tendinitis in left shoulder) and muscle pain (Verbatim: Sore in Left bicep). On an unknown date, the patient experienced shoulder soreness (Verbatim: he feels sore in his shoulder when sleeping over his left side). The outcome of the tendonitis, muscle pain and shoulder soreness were not resolved.   It was unknown if the reporter considered the tendonitis, muscle pain and shoulder soreness to be related to Arexvy.     It was unknown if the company considered the tendonitis, muscle pain and shoulder soreness to be related to Arexvy.   Additional Information: GSK Receipt Date: 25-MAR-2024 The patient self-reported this case. The reporter was a physician assistant who received Arexvy in his left shoulder and developed a bicep tendinitis in left shoulder. According to reporter, the vaccine was administered right over the left bicep and has been sored since day 2 after receiving the vaccine until today (on the day of reporting). Reporter stated he was a side sleeper, and he felt sore in his shoulder when sleeping over his left side. Reporter was a healthcare provider and he diagnosed himself with a chronic tendinitis.  Reporter preferred GSK to contact him regarding this event since he was a provider.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: received their first dose of Shingrix and has not had their second dose yet; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 13-MAR-2023).   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: received their first dose of Shingrix and has not had their second dose yet). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 26-MAR-2024 The registered pharmacist inquired, how long to wait to get the second dose. The reporter asked, did they had to start over on the Shingrix series. The patient received her first dose of Shingrix and not had second dose yet (till the time of reporting) and it had been over year, which led to incomplete course of vaccination. This was 1 of the 5 cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2024038678:Different patient US-GSK-US2024038682:Different patient US-GSK-US2024038680:Different patient US-GSK-US2024038681:Different patient
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: their second dose yet and it has been over year; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 11-JUL-2022).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: their second dose yet and it has been over year). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 26-MAR-2024. Pharmacist called to inquire how long patient had to wait to get the second dose. Pharmacist asked if they had to start over on the Shingrix series.  Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. RPH reported that 5 patients who received their first dose of Shingrix and not had their second dose yet and it had been over years reported by same reporter. This was 1 of 5 linked cases, reported by same reporter.; Sender's Comments:  US-GSK-US2024038679:Different patient US-GSK-US2024038680:Different patient US-GSK-US2024038681:Different patient US-GSK-US2024038682:Different patient
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: not had the second dose yet and it has been over years; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 28-NOV-2022).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: not had the second dose yet and it has been over years). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 26-MAR-2024 The RPH (registered pharmacist) reported that a patient who received their first dose of Shingrix and has not had her second dose yet and it had been over years. The reporter wanted to know how long patient need to wait to get the second dose and do the patient had to start over on the Shingrix series. Till the time of reporting the patient did not receive the second dose of Shingrix, which led to an incomplete course of vaccination. This was 1 of 5 linked cases, reported by same reporter.; Sender's Comments:  US-GSK-US2024038678:Different patient US-GSK-US2024038679:Different patient US-GSK-US2024038681:Different patient US-GSK-US2024038682:Different patient
Age: 1.0
Sex: F
Vaccine: HEPA, HIBV, MMRV, VARCEL
Symptoms: Extra dose administered
Clinical narrative: Patient was given both Varicella and MMRV
Age: 41.0
Sex: F
Vaccine: HPV9
Symptoms: Arthralgia, Chills, Migraine, Pain, Pruritus
Clinical narrative: fever 101.2, chills, joint pain, swelling, itchy hands, body aches/pain, and migraine headaches
Age: 41.0
Sex: F
Vaccine: HPV9
Symptoms: Pyrexia, Swelling
Clinical narrative: fever 101.2, chills, joint pain, swelling, itchy hands, body aches/pain, and migraine headaches
Age: 14.0
Sex: F
Vaccine: HEP, HPV9, IPV, MMR, MNQ, TDAP, VARCEL
Symptoms: Extra dose administered
Clinical narrative: I failed to verify this patients identity and gave her vaccines she did not need. The only vaccines that she needed were the Meningoccal and Varicella. The patient did not suffer any injury.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site urticaria
Clinical narrative: Patient received vaccine and then ten minutes later patient developed a hive around the injection site.
Age: 25.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Exposure during pregnancy, Premature delivery, Premature labour
Clinical narrative: Preterm labor days after receiving vaccine. Estimated due date was 1-18-24. Birth weight was 4 lbs 13 oz. Due to prematurity baby was admitted to hospital
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Audiogram, Deafness unilateral, Sudden hearing loss, Tinnitus
Clinical narrative: some sudden hearing loss in right ear and constant tinnitus
Age: 8.0
Sex: M
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Hepatitis A was given before due date. Due date is 04/19/2024. Patient was waited 30 minutes after he was given the vaccine and no symptoms.
Age: 66.0
Sex: F
Vaccine: PNC20
Symptoms: Eye discharge, Eye pruritus, Lacrimation increased
Clinical narrative: From OV after AE on 3/28/24: "Patient coming in with complaints of itchy and watery eyes since Tuesday afternoon.  States that her symptoms started about 2 hours after her office visit when she had received the Prevnar 20 vaccination.  Denies any fevers, vision changes or eye pain. Green/yellow discharge when waking up after sleeping. No other sick symptoms. Tried her granddaughters polymyxin B-TMP eye drops 3 x (Tuesday night and twice yesterday morning). No improvement. ". Patient was given prescription for antihistamine eye drops and advised to take OTC zyrtec. Patient was seen for an additional follow-up on 4/4/2024 with noted improvement in ocular symptoms.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Immunisation, Incorrect route of product administration, No adverse event
Clinical narrative: The  Dtap/IPV was inadvertently given Subcutaneously instead of IM by Nurse. The Provider was notified right away and in to discuss with family. Provider determined that re-administration was needed of Dtap/IPV. This was done in the Right Deltoid. At this time there have been no side effects or negative effects to the patient.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Breakthrough COVID-19, Death
Clinical narrative: Covid-19 Breakthrough Infection
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Glossodynia, Mass, Swollen tongue
Clinical narrative: Two weeks after I started feeling my tongue was swelling, I had a gigantic lump on my tongue. The soreness on a scale from 1-10 is a 10, and is still a 10. I may not be able to get rid of it. A big swollen lump, it's sore and sometime it raises on my tongue and i dont know.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Dyspnoea, Pruritus, Throat irritation, Urticaria
Clinical narrative: History of Present Illness Patient is a 18 yo female who presents with hives, mild SOB, itchiness for 2 days after getting meningococcal vaccine on friday morning. Reports started with mild hives. However, now spreading to her face. In the hour, feeling like itchy throat and a little SOB.History of Present Illness Patient is a 18 yo female who presents with hives, mild SOB, itchiness for 2 days after getting meningococcal vaccine on friday morning. Reports started with mild hives. However, now spreading to her face. In the hour, feeling like itchy throat and a little SOB.
Age: 70.0
Sex: F
Vaccine: PNC20
Symptoms: Erythema, Fatigue, Peripheral swelling, Pruritus
Clinical narrative: pt reports redness, swelling and itching in upper arm to elbow.  Pt also reports fatigue
Age: 43.0
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse affects
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Epilepsy, Seizure
Clinical narrative: Seizures started 9/10/2021...
Age: 68.0
Sex: F
Vaccine: COVID19-2
Symptoms: Aphasia, Asthenia, Blindness, Fatigue, Malaise
Clinical narrative: The Moderna vaccination and flu shot were given on 1/11/24 at approx. 10:45 am.  One in the rt. arm and the other in the left arm.  Both arms became sore later that day and I felt unwell.  Tired/no energy, so layed down for a few hours in the afternoon.  Was very restless during the night and did not sleep well.  Got up the next morning and took the dog out for our morning stroll.  That is when I noticed that I had partial vision loss and that I had trouble thinking.  I returned quickely to my home to report this to my significant other.  By this time my vision was back to normal, but I had difficulty telling my s.o. what was happening.  I was having trouble finding the right words to explain.  We decided that we needed to get to the ER quickly.  By the time we arrived at the ER, I was no longer having trouble with speaking.
Age: 68.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pain in extremity, Restlessness, Sleep disorder, Thinking abnormal
Clinical narrative: The Moderna vaccination and flu shot were given on 1/11/24 at approx. 10:45 am.  One in the rt. arm and the other in the left arm.  Both arms became sore later that day and I felt unwell.  Tired/no energy, so layed down for a few hours in the afternoon.  Was very restless during the night and did not sleep well.  Got up the next morning and took the dog out for our morning stroll.  That is when I noticed that I had partial vision loss and that I had trouble thinking.  I returned quickely to my home to report this to my significant other.  By this time my vision was back to normal, but I had difficulty telling my s.o. what was happening.  I was having trouble finding the right words to explain.  We decided that we needed to get to the ER quickly.  By the time we arrived at the ER, I was no longer having trouble with speaking.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, VARCEL
Symptoms: Injection site bruising, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient received vaccines 03/15/24 by that night per mother patient had large red circles around the vaccine sites that wrapped around the arm, bruising, hot to the touch, swollen, and painful.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: The patient received a third dose of Shingrix. It was not noted on the chart that he had been administered the second dose. It was later discovered after the injection that he had received a second dose.  He has had no adverse reactions noted at this time.
Sex: F
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: missed their 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 79-year-old female patient who received HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix (received first dose of Twinrix on 5th October 2023 with batch number PG39 and Expiration date 19-SEP-2025).   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: missed their second 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: 26-MAR-2024 Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination. The reporter consented to follow up.
Age: 51.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Tinnitus
Clinical narrative: I have been suffering from tinnitus in both ears since the vaccinations. I never thought about it but it doesn't go away.
Age: 0.08
Sex: M
Vaccine: RV1
Symptoms: Angiogram abnormal, Full blood count, Haematochezia, Intestinal operation, Intussusception
Clinical narrative: 1 month after vaccination pt was admitted to hospital with bloody stools and found to have intussusception requiring emergent ex-lap to reduce.
Age: 0.08
Sex: M
Vaccine: RV1
Symptoms: Laboratory test, Laparotomy, Scan normal, Ultrasound abdomen normal, X-ray gastrointestinal tract abnormal
Clinical narrative: 1 month after vaccination pt was admitted to hospital with bloody stools and found to have intussusception requiring emergent ex-lap to reduce.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Palpitations, Paraesthesia, Pruritus, Throat tightness
Clinical narrative: Pt reported to ER (on 8/6/21) stating she received her Pizer vaccine about 30 mins prior to arrival and after about 10 minutes mins she started feeling itchy over entire body and feeling like her throat was closing. Pt took 2 benadryl.  No objective evidence of angioedema.  No hives or redness.  No hypotension or nausea vomiting.  Her symptoms have improved after Benadryl and steroids and Pepcid. Prescribed prednisone taper at discharge from ED. Pt returned to ED on 8/9/21 with headache described as a "tingling sensation", palpitations, chest and throat tightness. Discharged again from ED with instructions to continue prednisone from previous visit.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine was administered past the Beyond Use Date of 3/13/24. No symptoms/reactions reported from patient in patient chart. Patient has been contacted for revaccination.
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Acoustic stimulation tests abnormal, Deafness, Sleep disorder, Tinnitus
Clinical narrative: I started noticing ringing in the ears towards the end of the summer that year.  It has progressively gotten worse over the past couple years.  I reported it to my PCP a couple years ago.  I reported it again the last time I was there - I believe it was last year, as it had gotten significantly worse.  I went to an EENT specialist and had a hearing test, which determined that I had minor hearing loss - likely due to age.  I reported the ringing in the ears and they said that a hearing aid might help.   It is now significantly loud and bothers me every day, even at night when I try to sleep.
Age: 16.0
Sex: F
Vaccine: COVID19, MENB
Symptoms: Expired product administered
Clinical narrative: Covid Vaccine was administered past the Beyond Use Date of 3/13/24. No symptoms reported from patient in patient chart. Patient has been contacted for revaccination.
Age: 4.0
Sex: M
Vaccine: COVID19, MMRV
Symptoms: Expired product administered
Clinical narrative: Covid Vaccine was administered past the Beyond Use Date of 3/13/24. No symptoms reported from patient in patient chart. Patient to be contacted for revaccination.
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus
Age: 37.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Vaccine beyond use date was passed by 3 days.  no signs or symptoms reported
Age: 1.33
Sex: F
Vaccine: DTAP, HEPA, HIBV, MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: DTaP was 2 days expired. No adverse event occurred.
Age: 16.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Vaccine beyond use date was passed by 3 days when administered.  no signs or symptoms reported
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: Pentacel given expired on 3/24/2024.  There were no adverse reactions per mom.
Age: 14.0
Sex: F
Vaccine: HEPA, MNQ, VARCEL
Symptoms: Dizziness, Nausea, Pallor
Clinical narrative: Patient went pale,  had nausea and was dizzy about 11:48. Patient was alert and could respond to questions verbally. Patient assisted to the floor with legs raised by 11:50. 11:50am: BP 85/54 , Pulse 50, O2=97% (lying) 12:00 pm: BP 96/63, Pulse 61, O2=98% (lying) 12:10 pm: BP 89/59 , Pulse 68, O2=98% (sitting) provided with some orange juice 12:20 pm: BP 80/57 , Pulse 61, O2=98% sitting.
Age: 43.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Vaccine beyond use date was passed by 3 days when administered.  no signs or symptoms reported
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Lip blister, Pain in extremity, Rash, Urticaria
Clinical narrative: BLISTERS ON INSIDE OF LOWER LIP; HIVES/RASH ON CHEST; RASH, RED STREAKS, AND PAIN IN/ON LEFT ARM.  SYMPTOMS BEGAN TO APPEAR 4/6/24 (DAY AFTER VACCINATION), AND HAVE MOSTLY RESOLVED AS OF 4/9/24 (ARM STILL PAINFUL, ALTHOUGH LESS SO, AND SOME BLISTERS ARE STILL VISIBLE ON INSIDE OF LIP). PATIENT DID NOTIFY PHYSICIAN EITHER VIA PHONE CALL OR OFFICE VISIT.
Age: 62.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Vaccine beyond use date was passed by 3 days when administered.  no signs or symptoms reported
Age: 77.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Vaccine beyond use date was passed by 3 days when administered.  no signs or symptoms reported
Age: 0.5
Sex: F
Vaccine: DTPPVHBHPB, PNC15, DTPPVHBHPB, PNC15
Symptoms: Febrile convulsion
Clinical narrative: febrile seizure.  Patient went to ED that night. Did well thereafter without sequelae
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Eyelid ptosis, Facial paralysis, Magnetic resonance imaging
Clinical narrative: 8/27/2022  - 12/4/2022 Left Facial Dropping            Left Eye Lid droop remains to current date.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, HEPA, IPV, MMRV
Symptoms: Extra dose administered
Clinical narrative: IPV and Kinrix both administered.
Age: 47.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Muscular weakness, Pain in extremity, Swelling
Clinical narrative: She stopped in the pharmacy on 4/9/24 wondering if her trip to the emergency room (ER) 2 days after her vaccinations were  caused by her vaccinations.  She reported that she had severe lower leg pain some swelling and some right arm weakness.  She also said that nothing like this has happened to her before.  She left the ER with a course of prednisone and an appointment to meet with another provider in a couple of days.  As of now she is still saying she has pain (severity?).
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: Patient present to clinic for 4 month old vaccines. Pt needed (DTAP IPV HIB) pentacel. Patient was administered vaccine without the DTAP and IPV mixed with HIB. No adverse reactions noted or reported. Mother informed of error when we found out. Pt scheduled for following week (4/27) to get hib vaccine at mom's earliest appt.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, HEPA, IPV, MMRV
Symptoms: Extra dose administered
Clinical narrative: Kinrix and IPV both administered.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Discomfort, Injection site bruising, Injection site discolouration, Injection site vesicles, Pain
Clinical narrative: bruising at the site of injection; discoloration at the site of injection; blister at the site of injection; pain; discomfort; This non-serious case was reported by a other health professional via call center representative and described the occurrence of injection site bruising in a 60-year-old male patient who received Herpes zoster (Shingrix) (batch number X5J23, expiry date 25-JAN-2026) for prophylaxis.   On 25-MAR-2024, the patient received the 1st dose of Shingrix. In MAR-2024, an unknown time after receiving Shingrix, the patient experienced pain (Verbatim: pain) and discomfort (Verbatim: discomfort). On 25-MAR-2024, the patient experienced injection site bruising (Verbatim: bruising at the site of injection), injection site discoloration (Verbatim: discoloration at the site of injection) and injection site blisters (Verbatim: blister at the site of injection). The outcome of the injection site bruising, injection site discoloration, injection site blisters, pain and discomfort were unknown.   It was unknown if the reporter considered the injection site bruising, injection site discoloration, injection site blisters, pain and discomfort to be related to Shingrix.     It was unknown if the company considered the injection site bruising, injection site discoloration, injection site blisters, pain and discomfort to be related to Shingrix.   Additional Information: GSK Receipt Date: 27-MAR-2024 The practice manager reported, after his first dose of Shingrix, on the day of the receipt of the Shingrix (healthcare professional thought the evening of receipt, less than a day after vaccination) he developed discoloration, bruising and a blister at the site of injection. Also reported pain and discomfort. Provider prescribed him antibiotics and steroids.  The HCP reported to the agent she was transferred to, that the bruising was dark purple and the injection site reaction was about 2 inches in diameter. The vaccine administration facility was the same as primary reporter.
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Tinnitus
Clinical narrative: chronic tinnitus - appeared to be a number of months later
Age: 57.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Expired product administered
Clinical narrative: The vaccine expiration date was 8/8/2023. The vaccine was administered 8/9/2023.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Hospitalization related to COVID 19 following completion of primary vaccine series
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cough, Dyspnoea, SARS-CoV-2 test positive, Sneezing
Clinical narrative: Cough;  labored breathing; sneezing started on evening of April 6.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: tinnitus began in both ears during the month following the vaccine
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Angiocardiogram, Contusion, Coronary arterial stent insertion, Coronary artery disease, Echocardiogram
Clinical narrative: MODERNA #1 4/20/2021 MODERNA #2 5/18/2021  SEPT 2022 DEVELOPED SYMPTOMATIC CAD UNDERWENT CORONARY STENTING OF LAD.  HAD PLAVIX POORLY TOLERATED DUE TO BLEEDING AND BRUISING.
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Electrocardiogram, Haemorrhage, Laboratory test
Clinical narrative: MODERNA #1 4/20/2021 MODERNA #2 5/18/2021  SEPT 2022 DEVELOPED SYMPTOMATIC CAD UNDERWENT CORONARY STENTING OF LAD.  HAD PLAVIX POORLY TOLERATED DUE TO BLEEDING AND BRUISING.
Age: 0.5
Sex: F
Vaccine: DTPPVHBHPB, PNC20, RV1
Symptoms: Extra dose administered, No adverse event
Clinical narrative: There were no adverse effects noted. Patient received an extra dose of Rotavirus.
Age: 7.0
Sex: F
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Hep A was given too soon. Dose was due 6/2/2024.
Age: 20.0
Sex: F
Vaccine: MENB
Symptoms: Expired product administered, No adverse event
Clinical narrative: RN administered outdated vaccine.  No adverse reactions.
Sex: F
Vaccine: HEP
Symptoms: Exposure via skin contact, Product administration error, Product preparation issue, Syringe issue
Clinical narrative: Liquid leaked on the patients skin.  Location of the vaccine contact with skin was the left arm. ( Accidental Exposure; The patient received two needle sticks while at office visit for one vaccine. (More than one stick/poke required for vaccine administration ); This non-serious case was reported by a nurse via call center representative and described the occurrence of accidental exposure while administering drug in a female patient who received HBV (Engerix B) (batch number 9LK2G, expiry date 21-AUG-2026) for prophylaxis.   On an unknown date, the patient received Engerix B. On an unknown date, an unknown time after receiving Engerix B, the patient experienced accidental exposure while administering drug (Verbatim: Liquid leaked on the patients skin.  Location of the vaccine contact with skin was the left arm. ( Accidental Exposure) and inappropriate reconstitution technique (Verbatim: The patient received two needle sticks while at office visit for one vaccine. (More than one stick/poke required for vaccine administration )). The outcome of the accidental exposure while administering drug and inappropriate reconstitution technique were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 27-MAR-2024 Reporter was a HCP (health care professional), reported that a pre-filled syringe dose of vaccine was prepared by using a hypodermic safety needle instead of a Luer Lok needle.   The reporter stated TIP-LOK syringes were to be used with Luer Lock compatible needles (Incorrect Preparation) stated patient was stuck with needle.   While pushing plunger to inject the liquid HCP noted leaking where the needle was connected with the syringe.   Liquid leaked on the patients skin.   Location of the vaccine contact with skin was the left arm. (Accidental Exposure).  HCP stated that no liquid was injected into the muscle.   Another dose was prepared and administered.   The patient received two needle sticks while at office visit for one vaccine (More than one stick/poke required for vaccine administration). The vaccine was prepared by using a hypodermic safety needle instead of a Luer Lok needle, which led to inappropriate Reconstitution Technique. The reporter consented to follow up.
Age: 22.0
Sex: F
Vaccine: MENB
Symptoms: Erythema, Myalgia
Clinical narrative: reported she had myalgia; erythema.; This non-serious case was reported by a other health professional via call center representative and described the occurrence of myalgia in a 22-year-old female patient who received Men B NVS (Bexsero) for prophylaxis.   On 25-MAR-2024, the patient received Bexsero. In MAR-2024, an unknown time after receiving Bexsero, the patient experienced myalgia (Verbatim: reported she had myalgia) and erythema (Verbatim: erythema.). The patient was treated with paracetamol (Tylenol). The action taken with Bexsero was unknown. The outcome of the myalgia and erythema were unknown.   It was unknown if the reporter considered the myalgia and erythema to be related to Bexsero and Bexsero Pre-Filled Syringe Device.     It was unknown if the company considered the myalgia and erythema to be related to Bexsero and Bexsero Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 28-MAR-2024 The Licensed practical nurse (LPN) wanted to report an adverse reaction following the administration of Bexsero to a 22 year old patient. Vaccine was administered on Monday and today (on the day of reporting) the patient went to the clinic and reported she had myalgia and erythema. The health care professional HCP mentioned that patient took Tylenol to ameliorate the symptoms.  The HCP did not provided information about the dose given (Lot number, exp date). The HCP preferred follow up via fax
Sex: F
Vaccine: RV1
Symptoms: Oral administration complication, Underdose, Vomiting
Clinical narrative: Vomited immediately; Vomited immediately after receiving the vaccine; This non-serious case was reported by a nurse via sales rep and described the occurrence of vomiting in a infant female patient who received Rota (Rotarix lyophilized formulation) for prophylaxis.   On an unknown date, the patient received Rotarix lyophilized formulation. On an unknown date, immediately after receiving Rotarix lyophilized formulation, the patient experienced vomiting (Verbatim: Vomited immediately) and accidental underdose (Verbatim: Vomited immediately after receiving the vaccine). The outcome of the vomiting and accidental underdose were unknown.   It was unknown if the reporter considered the vomiting to be related to Rotarix lyophilized formulation and Rotarix Oral Applicator Device.     It was unknown if the company considered the vomiting 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: 27-MAR-2024 and 28-MAR-2024 The reporter stated that she had a approximately 2 months old patient received Rotarix vaccine and vomited immediately after receiving the vaccine, which led to accidental underdose. The reporter stated she did not want to be contacted and there was limited information given. The reporter did not consent to follow up.
Age: 15.0
Sex: M
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: The vaccination happened April 1st 2024, expiration date on the vaccine 31st March 2024.; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 15-year-old male patient who received Men B NVS (Bexsero) (batch number G7KX2, expiry date 31-MAR-2024) for prophylaxis.   On 01-APR-2024, the patient received Bexsero. On 01-APR-2024, an unknown time after receiving Bexsero, the patient experienced expired vaccine used (Verbatim: The vaccination happened April 1st 2024, expiration date on the vaccine 31st March 2024.). The outcome of the expired vaccine used 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: 01-APR-2024 The nurse called wanting to know if there is information on giving a 15 year old patient an expired dose of Bexsero.  The Vaccine Administration Facility was the same as Primary Reporter The reporter consented to follow up.
Sex: M
Vaccine: MMR
Symptoms: Incorrect route of product administration
Clinical narrative: someone was injected intramuscularly; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of subcutaneous injection formulation administered by other route in a male patient who received MMR (Priorix) for prophylaxis.   On 31-MAR-2024, the patient received Priorix (intramuscular). On 31-MAR-2024, an unknown time after receiving Priorix, the patient experienced subcutaneous injection formulation administered by other route (Verbatim: someone was injected intramuscularly). The outcome of the subcutaneous injection formulation administered by other route 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: 01-APR-2024 The reporter called to report that he/she was calling about the Priorix vax, someone was injected intramuscularly, he/she did not know the safety of that and what was the recommendation, which led to subcutaneous injection formulation administered by other route. The Vaccine Administration Facility was the same as Primary Reporter. No lot number/expiration date available, no other information than gender available for patient's identifiers. The reporter did not consent to follow-up.
Sex: U
Vaccine: VARZOS
Symptoms: Product preparation issue
Clinical narrative: patient received the adjuvant component of SHINGRIX instead of the reconstituted vaccine.; patient received the adjuvant component of SHINGRIX instead of the reconstituted vaccine.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: patient received the adjuvant component of SHINGRIX instead of the reconstituted vaccine.) and inappropriate dose of vaccine administered (Verbatim: patient received the adjuvant component of SHINGRIX instead of the reconstituted vaccine.). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 01-APR-2024 The reporter who stated that a patient received the adjuvant component of Shingrix instead of the reconstituted vaccine, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter did not have any patient demographics. The reporter did not consent to follow-up.
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: a patient received the 1st dose of Shingrix on October 6th of 2022. According to reporter, 2nd one was administered on October 26th, 2023; This non-serious case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too long in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 06th October 2022).   On 26-OCT-2023, the patient received the 2nd dose of Shingrix. On 26-OCT-2023, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: a patient received the 1st dose of Shingrix on October 6th of 2022. According to reporter, 2nd one was administered on October 26th, 2023). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK receipt date: 01-APR-2024 The pharmacy technician called to inform that a patient received the 1st dose of Shingrix on October 6th of 2022. According to reporter, 2nd one was administered on October 26th, 2023, which led to lengthening of vaccination schedule. The Vaccine Administration Facility was the same as Primary Reporter.
Age: 17.0
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: they accidentally administered a dose of Pediarix to a 17 year old patient; 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 17-year-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number 473YA, expiry date 04-APR-2025) for prophylaxis.   On 04-MAR-2024, the patient received Pediarix. On 04-MAR-2024, an unknown time after receiving Pediarix, the patient experienced inappropriate age at vaccine administration (Verbatim: they accidentally administered a dose of Pediarix to a 17 year old patient). The outcome of the inappropriate age at vaccine administration 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-APR-2024 Licensed Practical Nurse explained they accidentally administered a dose of Pediarix to a 17 year old patient, which led to inappropriate age at vaccine administration The reporter consented to follow up.