chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: F
Vaccine: PNC21
Symptoms: Headache, Injection site pain, Myalgia, Pyrexia
Clinical narrative: symptoms of fever, muscle aches, injection site pain and headaches; symptoms of fever, muscle aches, injection site pain and headaches; symptoms of fever, muscle aches, injection site pain and headaches; symptoms of fever, muscle aches, injection site pain and headaches; This spontaneous report was received from a pharmacist and refers to a 60-year-old female patient. The patient's medical history included Neuropathy, and Leukemia. The patient's concurrent condition included compromised immune system. Concomitant medication included Gabapentin .  On 06-FEB-2025 (reported as last Thursday), the patient was vaccinated with Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) 0.5 mL once, (strength, lot # and expiration date were not reported) for pneumonia prevention.  On 07-FEB-2025 (also reported as the day after), the patient started having symptoms of fever, muscle aches, injection site pain and headaches. The patient hadn't seen their doctor to discuss their symptoms, but they were still dealing with the headaches and fever currently. They said that it wasn't something that was life threatening, but they were concerned because of their health history. At the reporting time, the patient had not recovered from the events. The action taken was not applicable.  The causal relationship between the events and Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) was not reported.
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional adverse event was reported; Specialist transferred Medical Assistant calling to report inadvertently administering an expired dose of GARDASIL 9 to a patient. Patient did not report any symptoms. Vaccine was supported per Post-Expiry Memo. Permission to contact HCP was granted.; This spontaneous report was received from a other health professional and refers to a patient of unknown age and gender.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On 26-Feb-2025, the patient was vaccinated with expired dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL®9), (lot #X019862, expiration date: 14-Feb-2025) for prophylaxis (Expired vaccine used).
Age: 16.0
Sex: F
Vaccine: HPV9
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: No additional AE; HCP called to report a patient received a dose of GARDASIL 9 via subcutaneous route instead of intramuscularly. No side effects or symptoms have been reported. No Additional information provided. No Additional AE/PQC.; This spontaneous report has been received from a physician assistant, regarding to a 16-year-old male patient. The patient's pertinent medical history, concurrent conditions, concomitant medications, and previous drug reactions or allergies were not reported. On 05-MAR-2025, the patient was vaccinated with a dose of human papillomavirus 9-valent vaccine, recombinant suspension for injection (GARDASIL 9) 0.5 mL (Lot No. y010656 has been verified to be a valid lot number for [human papillomavirus 9-valent vaccine, recombinant suspension for injection], expiration date reported and upon internal validation established as 29-NOV-2026) (strength, dose number, anatomical location of administration and vaccination scheme frequency were not reported) that was administered as prophylaxis by subcutaneous route instead of intramuscular route (incorrect route of product administration) No additional adverse events were reported (no adverse event).
Age: 1.0
Sex: F
Vaccine: HIBV
Symptoms: Device connection issue, Exposure via skin contact, Foreign body in skin or subcutaneous tissue, Underdose
Clinical narrative: leur lock adapters becoming loose and detaching Sometimes the leur lock adaptor spins when the cap is removed; Product complaint; Partially administered; the needle stayed in the patient; Product splashed onto patient; Product splashed onto patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of accidental needle stick in a 12-month-old female patient who received Hib (Hiberix) (batch number 3A2KF, expiry date 14-JUL-2026) for prophylaxis. This case was associated with a product complaint.   On 25-FEB-2025, the patient received Hiberix. On 25-FEB-2025, immediately after receiving Hiberix, the patient experienced accidental needle stick (Verbatim: the needle stayed in the patient), inadvertent exposure to vaccine (Verbatim: Product splashed onto patient), exposure via skin contact (Verbatim: Product splashed onto patient) and accidental underdose (Verbatim: Partially administered). On an unknown date, the patient experienced syringe connection issue (Verbatim: leur lock adapters becoming loose and detaching Sometimes the leur lock adaptor spins when the cap is removed) and pharmaceutical product complaint (Verbatim: Product complaint). The outcome of the accidental needle stick was unknown and the outcome of the inadvertent exposure to vaccine, exposure via skin contact, syringe connection issue, accidental underdose and pharmaceutical product complaint were not applicable.   The reporter considered the accidental needle stick and syringe connection issue to be related to Hiberix and Hiberix And Diluent Pre-Filled Syringe Device.     The company considered the accidental needle stick and syringe connection issue to be related to Hiberix and Hiberix And Diluent 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: 25-FEB-2025 The office manager reported the complaint of the rotating and detachment of the leur lock adapters and it was confirmed a leur lock needles were used and they had several issues with the leur lock adapters becoming loose and detaching and sometimes the leur lock adaptor spinned when the cap was removed, it spin when the needle was attached and also came completely off along with the needle during the injection. The reporter reported that during preparation for administration the defect was discovered for this current lot it was after partial use of the multipack and was partially administered, which led to accidental underdose. The luer lock adapter detached during injection and product splashed onto the HCP and the patient and the needle stayed in the patient, which led to inadvertent exposure to vaccine and exposure via skin contact. The reporter was unable to tell how much of the product was given and McKesson Thin Wall Needle 25g of 1 inch was used.
Sex: F
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: got sick again; This non-serious case was reported by a consumer via call center representative and described the occurrence of sickness in a 56-year-old female patient who received Herpes zoster (Shingrix) (batch number 9HM59, expiry date 30-SEP-2023) for prophylaxis.   On 01-DEC-2022, the patient received the 1st dose of Shingrix (intramuscular, left deltoid) .5 ml. On an unknown date, an unknown time after receiving Shingrix, the patient experienced sickness (Verbatim: got sick again). The outcome of the sickness was unknown.   It was unknown if the reporter considered the sickness to be related to Shingrix.     It was unknown if the company considered the sickness to be related to Shingrix.   Additional Information: GSK receipt date: 27-FEB-2025 The reporter was the patient she declined all demographics and her date of birth. The patient reported that she received the first dose of Shingrix and never got the second dose of Shingrix. The patient did take other chronic medications (Declined Providing Unknown Product Information), but did not remember if she took them that same day before she got the first dose of the Shingrix vaccine. The patient did had a rare health conditions, but it was unknown if these were pre-existing receiving the first dose of Shingrix (Declined Providing Medical History Information) and, the patient reported that she did not get her second dose of Shingrix per the recommended dosing schedule because her Physician wanted her to get over the acute phase of her rare health condition first, which lasted a long time. The patient reported that then she forgot to get the second dose of Shingrix once she was over the acute phase of her rare health condition, but then got sick again. No further information was provided. The patient states that she was sensitive to other medications, but not vaccines (no further information provided).
Age: 11.0
Sex: M
Vaccine: DTAPIPV, DTAPIPV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: received  1st dose of Kinrix vaccine at the age of 7 years; another nurse accidentally administered KINRIX today to a patient instead of boostrix; Inappropriate age at vaccine administration; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 11-year-old male patient who received DTPa-IPV (Kinrix) (batch number 34mf9, expiry date 13-FEB-2026) for prophylaxis.   Co-suspect products included DTPa (Reduced antigen) (Boostrix) for prophylaxis and DTPa-IPV (Kinrix) for prophylaxis.   On 28-FEB-2025, the patient received the 2nd dose of Kinrix. On an unknown date, the patient received Boostrix and the 1st dose of Kinrix. On 28-FEB-2025, an unknown time after receiving Kinrix and not applicable after receiving Boostrix and Kinrix, the patient experienced wrong vaccine administered (Verbatim: another nurse accidentally administered KINRIX today to a patient instead of boostrix) and inappropriate age at vaccine administration (Verbatim: Inappropriate age at vaccine administration). On an unknown date, the patient experienced inappropriate age at vaccine administration (Verbatim: received  1st dose of Kinrix vaccine at the age of 7 years). The outcome of the wrong vaccine administered, inappropriate age at vaccine administration and inappropriate age at vaccine administration were 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:2 8-FEB-2025 Reporter was the Health Care Professional who stated that another nurse accidentally administered KINRIX today to a patient instead of Boostrix which led to wrong vaccine administered and Inappropriate age at vaccine administration.  The patient received their first dose of KINRIX when they were 7 years old which led to inappropriate age at vaccine administration This case was one of the three case reported by the same reporter for different patient.; Sender's Comments:  US-GSK-US2025025495:same reporter US-GSK-US2025025491:same reporter US-GSK-US2023044436:same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Ageusia, Anosmia, Depression, Weight decreased
Clinical narrative: no smell; no taste; I am feeling depressed; lost weight; This non-serious case was reported by a consumer and described the occurrence of anosmia in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included anosmia (4 months of no smell).   On 07-NOV-2024, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced anosmia (Verbatim: no smell), taste absent (Verbatim: no taste), depressed mood (Verbatim: I am feeling depressed) and weight loss (Verbatim: lost weight). The outcome of the anosmia and taste absent were not resolved and the outcome of the depressed mood and weight loss were not reported.   It was unknown if the reporter considered the anosmia, taste absent, depressed mood and weight loss to be related to Shingrix.     It was unknown if the company considered the anosmia, taste absent, depressed mood and weight loss to be related to Shingrix.   Additional Information: GSK receipt date: 04-MAR-2025 The patient reported that she had recived Shingrix vaccine and experienced 4 months of no smell, no taste. Also, she was feeling depressed and had lost weight.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Lip blister
Clinical narrative: Blister lip; This non-serious case was reported by a consumer via call center representative and described the occurrence of lip blister in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included anxiety. Concomitant products included fluoxetine hydrochloride (Prozac).   On 03-MAR-2025 15:00, the patient received the 1st dose of Shingrix (left arm) .5 ml. On 04-MAR-2025, 1 days after receiving Shingrix, the patient experienced lip blister (Verbatim: Blister lip). The outcome of the lip blister was not resolved.   It was unknown if the reporter considered the lip blister to be related to Shingrix.     It was unknown if the company considered the lip blister to be related to Shingrix.   Additional Information: GSK Receipt Date: 04-MAR-2025 The patient received Shingrix vaccine and 18 hours later she woke up with a blister on her lower lip.   The reporter did not know the lot number of the vaccine.
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: fever; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of fever in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced fever (Verbatim: fever). The outcome of the fever was not reported.   It was unknown if the reporter considered the fever to be related to Shingrix.     It was unknown if the company considered the fever to be related to Shingrix.   Additional Information: GSK Receipt Date: 25-FEB-2025 This case was reported by a patient via interactive digital media. The patient had 101 fever after first shot. There was a question that 'is a 101 fever normal after the first shot'. The follow-up could not be possible as no contact details were available.
Vaccine: HEPA
Symptoms: Expired product administered, Oral herpes
Clinical narrative: fever blisters on my lips.; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of expired vaccine used in a patient who received HAV (Havrix) for prophylaxis.   On an unknown date, the patient received Havrix. On an unknown date, an unknown time after receiving Havrix, the patient experienced expired vaccine used (Verbatim: fever blisters on my lips.). The outcome of the expired vaccine used was not applicable.   Additional Information: GSK Receipt Date: 26-FEB-2025 The reporter reported that patient received the Hepatitis A vaccine which was expired 2 days ago, which led to expired vaccine used.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspeceted vaccination failure; My husband had the shot and still got shingles; 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.   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: Suspeceted vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: My husband had the shot and still got 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: 28-FEB-2025 This case was reported by a patient's wife via interactive digital media. The patient had the shingles shot and still got shingles. This case was considered as suspected vaccination failure as details regarding primary vaccination schedule, 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, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine.
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: arm hurts; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm 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 pain in arm (Verbatim: arm hurts). The outcome of the pain in arm was resolved (duration 1 week).   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.     It was unknown if the company considered the pain in arm to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 27-FEB-2025 The case was received from the patient via interactive digital media. The patient get the vax.  The patient reported that your arm hurts for a week, so what.
Sex: M
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: hurt like hell for several days; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a adult male 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 pain (Verbatim: hurt like hell for several days). The outcome of the pain was resolved.   The reporter considered the pain to be related to Shingrix.     The company considered the pain to be related to Shingrix.   Additional Information: GSK Receipt Date: 01-MAR-2025 The patient self-reported this case for himself/herself. This case was reported by a patient via interactive digital media. The Shingrix vaccine hurt like hell for several days, and it required two doses. However, it was worth it.
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; receive shingles twice; 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 (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: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: receive shingles twice). The outcome of the vaccination failure was not reported and the outcome of the shingles was resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.     The company considered the vaccination failure to be unrelated to Shingrix. It was unknown if the company considered the shingles to be related to Shingrix.   Additional Information: GSK Receipt Date: 03-MAR-2025 This case was reported by a patient via interactive digital media. The patient stated he/she received/contracted shingles twice, even with a shingles shot (Shingrix). This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, 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, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix.
Sex: M
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: received twinrix 6 months ago and skipped the 2nd dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a elderly male patient who received HAB (Twinrix adult) for prophylaxis.   Previously administered products included Twinrix adult (The patient received 1st dose on 05-SEP-2024 with batch number 4DS4N and expiry date 25-SEP-2026).   On an unknown date, the patient did not receive the 2nd dose of Twinrix adult. On an unknown date, an unknown time after receiving Twinrix adult, the patient experienced incomplete course of vaccination (Verbatim: received twinrix 6 months ago and skipped the 2nd 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: 24-FEB-2025 The pharmacist called and reported a question regarding the Twinrix vaccine. The reporter had a patient who got his 1st dose in September and knew that Twinrix was 0,1 and 6 months. However after 6 months, the patient wanted to have the Second dose and in this case the reporter asked if they should give him 2 more doses or just give 1 dose. The reporter consented to follow up. The pharmacist stated that it was a couple of husband and wife that received twinrix 6 months ago and skipped the 2nd dose. Twinrix Second late dose. VAERS details provided corresponding to the 1st dose and the case is an incomplete course of vaccination. Till the time of reporting, the patient did not receive 2nd dose of Twinrix vaccine, which led to incomplete course of vaccination.; Sender's Comments:  US-GSK-US2025023093:Same reporter different patient
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Expired product administered
Clinical narrative: administered an expired dose of Kinrix expired; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a female patient who received DTPa-IPV (Kinrix) (batch number T343J, expiry date 25-JAN-2025) for prophylaxis.   Previously administered products included Pediarix (1st dose of Pediarix received on 09th February 2022, with batch number 2AJ32 and expiry date 9 February 2022), Pediarix (2nd dose of Pediarix received on 04th August 2023, with batch number 2AJ32 and expiry date 4 August 2023), Pediarix (3rd dose of Pediarix received on 08-SEP-2021 with batch number 7P2Y3 and expiry date 4 August 2023) and Infanrix (1st dose of Infanrix received on 20-APR-2022, with batch number AK443 and expiry date 16th September 2023).   On 25-FEB-2025, the patient received the 1st dose of Kinrix. On an unknown date, an unknown time after receiving Kinrix, the patient experienced expired vaccine used (Verbatim: administered an expired dose of Kinrix expired). The outcome of the expired vaccine used 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-FEB-2025 The licensed Practical Nurse explained that a Medical Assistant administered an expired dose of Kinrix on February 25th 2025, which led to expired vaccine used. Vaccine expired on January 25th 2025.  It was the first Kinrix dose for the patient but they received 3 prior Pediarix vaccines on April 5th 2021, July 6th 2021, September 8th 2021 and 1 prior dose of Infanrix on April 20th 2022.  Pediarix dose 1 of batch number 2AJ32 received on February 9th 2022, Pediarix dose 2 of batch number 7P2Y3 and expiry date was August 4th 2023, Pediarix dose 3 of batch number 7P2Y3 and expiry date was August 4th 2023.  Infanrix dose 1 of batch number AK443 and expiry date was September 16th 2023. The Vaccine Administration Facility is the same as Primary Reporter.
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: they never finish the series; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in the unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of Shingrix on unknown date).   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: they never finish the series). The outcome of the incomplete course of vaccination was not applicable.   Additional Information: GSK Receipt Date: 26-FEB-2025 The reporter reported on 26-Feb-2025 if a patient had not finish the series and they did not had it in the last 3 to 5 years, could we restart the series or just get one more dose. The reporter mentioned that this situation was related to 4 to 5 patients, but they did not had any patients Personal Information. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Vaccine: MENB
Symptoms: Extra dose administered
Clinical narrative: two bexsero vaccines were given on the same day; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of overdose in a 11-year-old patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced overdose (Verbatim: two bexsero vaccines were given on the same day). The outcome of the overdose 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-FEB-2025 The pharmacist reported that two bexsero vaccines were given on the same day to an 11-year-old patient, which led to overdose.
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: received the second dose of Shingrix 12 days after the first dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 76-year-old male patient who received Herpes zoster (Shingrix) (batch number BP74J, expiry date 15-NOV-2026) for prophylaxis.   Concomitant products included Varicella zoster vaccine rgE (CHO) (Shingrix).   On 26-FEB-2025, the patient received the 2nd dose of Shingrix. On 26-FEB-2025, an unknown time after receiving Shingrix and Shingrix, the patient experienced drug dose administration interval too short (Verbatim: received the second dose of Shingrix 12 days after the first dose). The outcome of the drug dose administration interval too short was not applicable.   Additional Information: GSK Receipt Date: 27-FEB-2025 A pharmacist reported that a patient received the second dose of Shingrix 12 days after the first dose, which led to shortening of vaccine schedule. The reporter asked that the second dose considered was valid.
Sex: F
Vaccine: MENB
Symptoms: Injection site nodule, Injection site swelling
Clinical narrative: nodule at the injection site that is still present; patient has a swelling that it has not gone away since then; This non-serious case was reported by a other health professional via call center representative and described the occurrence of injection site nodule in a 17-year-old female patient who received Men B NVS (Bexsero) (batch number YA344, expiry date 31-JAN-2026) for prophylaxis.   On 17-MAY-2024, the patient received Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced injection site nodule (Verbatim: nodule at the injection site that is still present) and swelling (Verbatim: patient has a swelling that it has not gone away since then). The outcome of the injection site nodule and swelling were not resolved.   It was unknown if the reporter considered the injection site nodule and swelling to be related to Bexsero and Bexsero Pre-Filled Syringe Device.     It was unknown if the company considered the injection site nodule and swelling 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: 27-FEB-2025 The medical assistant report that a patient received a dose of Bexsero and had a nodule at the injection site that was still present, patient had a swelling that it had not gone away since she received the dose. The health care professional wanted clinical advice, what they could did.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Expired product administered
Clinical narrative: expired dose administration of Kinrix; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 4-year-old male patient who received DTPa-IPV (Kinrix) (batch number T343J, expiry date 25-JAN-2025) for prophylaxis.   On 27-FEB-2025, the patient received Kinrix. On 27-FEB-2025, an unknown time after receiving Kinrix, the patient experienced expired vaccine used (Verbatim: expired dose administration of Kinrix). The outcome of the expired vaccine used 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: 28-FEB-2025 The Vaccine Administration Facility is the same as Primary Reporter. The registered nurse reported an expired dose administration of Kinrix which led to expired vaccine used.  The Health Care Provider mentioned that they received three expired doses of Kinrix from another clinic and they were doing an investigation.  Only reported one expired dose administration.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: has not yet received the 2nd one; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 71-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose in July 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: has not yet received the 2nd one). The outcome of the incomplete course of vaccination was not applicable.   Additional Information: GSK receipt date: 28-FEB-2025 The pharmacist reported that the patient had not yet received the 2nd one. The vaccine administration facility was the same as primary reporter. The reporter stated follow-up via postal. Till the time of reporting, the patient did not receive second dose of Shingrix, which led to incomplete course of vaccination.
Age: 21.0
Sex: F
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: expired vaccine used; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 21-year-old female patient who received HBV (Engerix B) (batch number 9JG23, expiry date 10-FEB-2025) for prophylaxis.   On 01-MAR-2025, the patient received the 1st dose of Engerix B. On 01-MAR-2025, an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: expired vaccine used). The outcome of the expired vaccine used 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: 03-MAR-2025 Reporter had question regarding a vaccine, the hepatitis B vaccine, Engerix-B, they had a patient that received an expired vaccine, it had expired on February Tenth and the vaccine was given on March First. The patient received expired vaccine, which led to expired vaccine used.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: never completed the series; This non-serious case was reported by a nurse 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 (Patient received first dose on 28-DEC-2020).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: never completed the series). The outcome of the incomplete course of vaccination was not applicable.   Additional Information: GSK Receipt Date: 03-MAR-2025 Patient received her last Shingrix vaccine in 2020 and she never completed the series. Reporter asked if they can we give that to her now. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Vaccine: COVID19
Symptoms: Anxiety, Chills, Hypokinesia, Illness, Pyrexia
Clinical narrative: could barely move; temors; fever; chills; could barely talk; patient felt like they were dying; The Vaccine was the sickest I have ever felt in my life.; This spontaneous report received from a patient concerned a patient of unspecified age and sex. This is reported via JnJ mediated social media site The patient's height and weight were not reported. Age at time of vaccination was unknown.  The patient's past medical history included: covid-19 infection.  The patient received janssen covid-19 vaccine (suspension for injection, route of admin not reported, batch number not reported) dose, frequency and therapy dates not reported, for covid-19 prophylaxis. dose number series 1. The batch number was not reported. The company is unable to perform follow-up to request for batch or lot number. No concomitant medications were reported.  On an unspecified date, the patient experienced could barely move, temors, fever, chills, could barely talk, patient felt like they were dying, and the vaccine was the sickest i have ever felt in my life..(dose number series 1)  The action taken with janssen covid-19 vaccine was not applicable.  The outcome of could barely move, temors, fever, chills, could barely talk, patient felt like they were dying and the vaccine was the sickest i have ever felt in my life. was not reported.  This report was non-serious.
Vaccine: COVID19
Symptoms: Speech disorder, Tremor
Clinical narrative: could barely move; temors; fever; chills; could barely talk; patient felt like they were dying; The Vaccine was the sickest I have ever felt in my life.; This spontaneous report received from a patient concerned a patient of unspecified age and sex. This is reported via JnJ mediated social media site The patient's height and weight were not reported. Age at time of vaccination was unknown.  The patient's past medical history included: covid-19 infection.  The patient received janssen covid-19 vaccine (suspension for injection, route of admin not reported, batch number not reported) dose, frequency and therapy dates not reported, for covid-19 prophylaxis. dose number series 1. The batch number was not reported. The company is unable to perform follow-up to request for batch or lot number. No concomitant medications were reported.  On an unspecified date, the patient experienced could barely move, temors, fever, chills, could barely talk, patient felt like they were dying, and the vaccine was the sickest i have ever felt in my life..(dose number series 1)  The action taken with janssen covid-19 vaccine was not applicable.  The outcome of could barely move, temors, fever, chills, could barely talk, patient felt like they were dying and the vaccine was the sickest i have ever felt in my life. was not reported.  This report was non-serious.
Age: 51.0
Sex: F
Vaccine: COVID19, PNC21
Symptoms: Chills, Erythema, Pain in extremity, Pyrexia, Skin abrasion
Clinical narrative: Distal patch with excoriation started day after receiving vaccine; Warmth to site; Chills; Fever; Erythematic patches on left arm; Left arm pain; This spontaneous case was reported by an other health care professional and describes the occurrence of SKIN ABRASION (Distal patch with excoriation started day after receiving vaccine), VACCINATION SITE WARMTH (Warmth to site), CHILLS (Chills), PYREXIA (Fever) and ERYTHEMA (Erythematic patches on left arm) in a 51-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch no. 3043836) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product Pneumococcal vaccine conj 21v (CRM197) (Capvaxive) for an unknown indication.    The patient's past medical history included Palpitations, Pain in hip (Bilateral chronic hip pain), Hiatal hernia and Esophageal spasm (Esophageal spasms). Previously administered products included for Drug use for unknown indication: Celebrex. Past adverse reactions to the above products included Allergy with Celebrex. Concurrent medical conditions included Schizoaffective disorder, Obesity, Tobacco user, Insomnia, GERD, Adrenal adenoma, Dyslipidemia and Allergy to NSAIDs (Celebrex allergy). Concomitant products included Bupropion hydrochloride (Wellbutrin), Hydroxyzine hydrochloride (Atarax), Omeprazole (Prilosec), Ziprasidone hydrochloride (Geodon) and Hyoscyamine sulfate (Anaspaz) for an unknown indication.   On 19-Dec-2024, the patient received second dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form and first dose of Pneumococcal vaccine conj 21v (CRM197) (Capvaxive) (Intramuscular use) 1 dosage form. On 20-Dec-2024, the patient experienced SKIN ABRASION (Distal patch with excoriation started day after receiving vaccine), VACCINATION SITE WARMTH (Warmth to site), CHILLS (Chills), PYREXIA (Fever), ERYTHEMA (Erythematic patches on left arm) and PAIN IN EXTREMITY (Left arm pain). At the time of the report, SKIN ABRASION (Distal patch with excoriation started day after receiving vaccine), VACCINATION SITE WARMTH (Warmth to site), CHILLS (Chills), PYREXIA (Fever), ERYTHEMA (Erythematic patches on left arm) and PAIN IN EXTREMITY (Left arm pain) had not resolved.        For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use), the reporter did not provide any causality assessments.   It was reported that after the day of vaccination, patient experienced reported events. Lad data was reported as vital signs were recorded. Current illness was reported as unknown. Patient was started on antibiotics on day 4 post vaccination after patient went to clinic again.
Age: 51.0
Sex: F
Vaccine: COVID19, PNC21
Symptoms: Vaccination site warmth
Clinical narrative: Distal patch with excoriation started day after receiving vaccine; Warmth to site; Chills; Fever; Erythematic patches on left arm; Left arm pain; This spontaneous case was reported by an other health care professional and describes the occurrence of SKIN ABRASION (Distal patch with excoriation started day after receiving vaccine), VACCINATION SITE WARMTH (Warmth to site), CHILLS (Chills), PYREXIA (Fever) and ERYTHEMA (Erythematic patches on left arm) in a 51-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch no. 3043836) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product Pneumococcal vaccine conj 21v (CRM197) (Capvaxive) for an unknown indication.    The patient's past medical history included Palpitations, Pain in hip (Bilateral chronic hip pain), Hiatal hernia and Esophageal spasm (Esophageal spasms). Previously administered products included for Drug use for unknown indication: Celebrex. Past adverse reactions to the above products included Allergy with Celebrex. Concurrent medical conditions included Schizoaffective disorder, Obesity, Tobacco user, Insomnia, GERD, Adrenal adenoma, Dyslipidemia and Allergy to NSAIDs (Celebrex allergy). Concomitant products included Bupropion hydrochloride (Wellbutrin), Hydroxyzine hydrochloride (Atarax), Omeprazole (Prilosec), Ziprasidone hydrochloride (Geodon) and Hyoscyamine sulfate (Anaspaz) for an unknown indication.   On 19-Dec-2024, the patient received second dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form and first dose of Pneumococcal vaccine conj 21v (CRM197) (Capvaxive) (Intramuscular use) 1 dosage form. On 20-Dec-2024, the patient experienced SKIN ABRASION (Distal patch with excoriation started day after receiving vaccine), VACCINATION SITE WARMTH (Warmth to site), CHILLS (Chills), PYREXIA (Fever), ERYTHEMA (Erythematic patches on left arm) and PAIN IN EXTREMITY (Left arm pain). At the time of the report, SKIN ABRASION (Distal patch with excoriation started day after receiving vaccine), VACCINATION SITE WARMTH (Warmth to site), CHILLS (Chills), PYREXIA (Fever), ERYTHEMA (Erythematic patches on left arm) and PAIN IN EXTREMITY (Left arm pain) had not resolved.        For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use), the reporter did not provide any causality assessments.   It was reported that after the day of vaccination, patient experienced reported events. Lad data was reported as vital signs were recorded. Current illness was reported as unknown. Patient was started on antibiotics on day 4 post vaccination after patient went to clinic again.
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: SARS-CoV-2 infection; SARS-CoV-2 infection; This is a literature report for the following literature source(s).  An adult patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "solid organ transplant recipients" (unspecified if ongoing), notes: with a functional graft. The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "SARS-CoV-2 infection". Additional information: the patient age was over 18 years. SOT recipients with a functional graft, recipients beyond one month of transplant. At least one-month post second dose of BNT162b2 vaccine. The patient received the 3rd dose of BNT162b2 then got SARS-COV-2 infection before 6th month blood draw after dose 3.; Sender's Comments: Vaccine efficacy varies from person to person and is affected by many factors. The association between the event lack of effect/drug ineffective (CoVID-19) with the suspect product BNT162B2 cannot be fully excluded. Linked Report(s): US-PFIZER INC-PV202500025503 Same article/event and different patient;
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: SARS-CoV-2 infection; SARS-CoV-2 infection; This is a literature report for the following literature source(s).  An adult patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "solid organ transplant recipients" (unspecified if ongoing), notes: with a functional graft. The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "SARS-CoV-2 infection". Additional information: the patient age was over 18 years. SOT recipients with a functional graft, recipients beyond one month of transplant. At least one-month post second dose of BNT162b2 vaccine. The patient received the 3rd dose of BNT162b2 then got SARS-COV-2 infection before 6th month blood draw after dose 3.; Sender's Comments: Vaccine efficacy varies from person to person and is affected by many factors. The association between the event lack of effect/drug ineffective (CoVID-19) with the suspect product BNT162B2 cannot be fully excluded. Linked Report(s) : US-PFIZER INC-PV202500025503 Same article/event and different patient;
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Blood test, Dyspnoea, Dysuria, Investigation
Clinical narrative: he went that night because he could not pee; his vision comes and goes; anxiety got 10 times worse; out breath suddenly; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 65-year-old male patient received BNT162b2 (BNT162B2), on 08Sep2021 as dose 2, single (Lot number: 301308A) at the age of 62 years, in arm for covid-19 immunisation. The patient's relevant medical history included: "Anxiety", start date: 2005 (ongoing), notes: Anxiety diagnosed about 20 years ago after his father died; "COPD" (unspecified if ongoing), notes: a lot of years ago; "double pneumonia" (unspecified if ongoing), notes: a lot of years ago. Concomitant medication(s) included: CLONAZEPAM taken for anxiety (ongoing). Vaccination history included: pfizer COVID19 vaccine (Lot number: EW0172), administration date: 06Aug2021, for Covid-19 Immunization. The following information was reported: ANXIETY (non-serious) with onset 2021, outcome "unknown", described as "anxiety got 10 times worse"; DYSURIA (non-serious) with onset 2021, outcome "unknown", described as "he went that night because he could not pee"; VISUAL IMPAIRMENT (non-serious) with onset 2021, outcome "unknown", described as "his vision comes and goes"; DYSPNOEA (non-serious) with onset 2021, outcome "unknown", described as "out breath suddenly". The events "he went that night because he could not pee", "his vision comes and goes", "anxiety got 10 times worse" and "out breath suddenly" required emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Visual impairment
Clinical narrative: he went that night because he could not pee; his vision comes and goes; anxiety got 10 times worse; out breath suddenly; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 65-year-old male patient received BNT162b2 (BNT162B2), on 08Sep2021 as dose 2, single (Lot number: 301308A) at the age of 62 years, in arm for covid-19 immunisation. The patient's relevant medical history included: "Anxiety", start date: 2005 (ongoing), notes: Anxiety diagnosed about 20 years ago after his father died; "COPD" (unspecified if ongoing), notes: a lot of years ago; "double pneumonia" (unspecified if ongoing), notes: a lot of years ago. Concomitant medication(s) included: CLONAZEPAM taken for anxiety (ongoing). Vaccination history included: pfizer COVID19 vaccine (Lot number: EW0172), administration date: 06Aug2021, for Covid-19 Immunization. The following information was reported: ANXIETY (non-serious) with onset 2021, outcome "unknown", described as "anxiety got 10 times worse"; DYSURIA (non-serious) with onset 2021, outcome "unknown", described as "he went that night because he could not pee"; VISUAL IMPAIRMENT (non-serious) with onset 2021, outcome "unknown", described as "his vision comes and goes"; DYSPNOEA (non-serious) with onset 2021, outcome "unknown", described as "out breath suddenly". The events "he went that night because he could not pee", "his vision comes and goes", "anxiety got 10 times worse" and "out breath suddenly" required emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section.