chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 49.0
Sex: F
Vaccine: VARZOS
Symptoms: Myelitis transverse, Product administered to patient of inappropriate age
Clinical narrative: transverse myelitis; On or about June 20, 2013, Plaintiff was administered the ZOSTAVAX; Information has been received from a lawyer regarding a case in litigation and refers to a 49-year-old female patient (pt). No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 20-JUN-2013, the pt was vaccinated at her primary care provider with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot #, and expiration date were not reported) for the long-term prevention of shingles and zoster-related conditions (product administered to patient of inappropriate age). Subsequently, on an unknown date, the pt was treated by healthcare providers for the following injuries resulting from zoster vaccine live (ZOSTAVAX) use: transverse myelitis. The outcome of the event was not reported. The reporter considered the event of transverse myelitis to be related to zoster vaccine live (ZOSTAVAX).  Upon internal review, the event of transverse myelitis was determined to be medically significant.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: Confirmed with caller no AE occurred; Caller reported an AE for MMRII. The caller said an expired dose was administered to a patient on 4/24/2023.; This spontaneous report has been received from a medical assistant, regarding a patient of unknown age and gender. The patient's pertinent medical history, previous drug reactions or allergies and concomitant medications were not reported.  On 24-APR-2023, the patient was vaccinated with an expired dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) subcutaneous injection, as prophylaxis (lot number: U011993, which was determined to be valid, with an expiration date on 15-APR-2023, therapy type rHA) (strength, dose, scheme, route and anatomical location of administration were not reported) (Expired product administered).  Caller said the product did not have any temperature excursions prior to administration. No additional adverse event was reported.
Sex: U
Vaccine: HEP
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Received Heplisav-B While Pregnant; Initial Report Received on 15-Feb-2023.  A pharmacist reported that a 37-year-old pregnant patient (race and ethnicity unknown) received a dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization while in her third trimester.  Medical history, concomitant medications, and allergies at the time of vaccination were not reported.  The patient's last menstrual period, estimated date of delivery, pregnancy history, and pregnancy risk factors were not reported.  On 13-Feb-2023 (in her third trimester), the patient received a dose of HEPLISAV-B vaccine (Lot # 941054, expiration date 23-Nov-2024, NDC # 43528-003-05) intramuscularly in the left arm from a pharmacist. No adverse effects were experienced by the patient.   No additional information was provided.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Had shingles vaccine but also bad case/ suspected vaccination failure; Shingles bad case on back and up rectum; Painful; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: had shingles vaccine but also bad case/ suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles bad case on back and up rectum) and pain (Verbatim: Painful). The outcome of the vaccination failure was unknown and the outcome of the shingles and pain were not reported.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles and pain to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 23-MAR-2023 This case was reported by patient via interactive digital media. The patient reported that he or she received Shingles vaccine and experienced bad case of shingles on his or her back and up his or her rectum. The patient stated that the shingles are very painful and he or she was experienced shingles twice. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. Follow up was not possible, as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia, Vaccination failure
Clinical narrative: Patient had shingles/ suspected vaccination failure; Shingles; Nerve soreness; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Patient had shingles/ suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles) and post herpetic neuralgia (Verbatim: Nerve soreness). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported and the outcome of the post herpetic neuralgia was not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and post herpetic neuralgia to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles and post herpetic neuralgia to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 23-MAR-2023 This case was reported by patient via interactive digital media. The patient reported that he or she received shingles vaccine and still experienced shingles. The patient still have nerve soreness where he or she had shingles. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. Follow up was not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I got shingles 2 different times/ suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   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: I got shingles 2 different times/ 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 Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 23-MAR-2023 This case was reported by patient via interactive digital media. The patient reported that he or she received Shingles vaccine and experienced shingles for two different times.  This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. Follow up was not possible, as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Had the shot and got shingles/ suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female 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: Had the shot and got shingles/ 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 Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 23-MAR-2023 This case was reported by patient via interactive digital media. The reporter reported that his or her sister received Shingles vaccine and experienced shingles This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. Follow up was not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: took the vaccine, got the shingles/Suspected vaccination failure; shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (The patient had the shingles).   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: took the vaccine, got the shingles/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 Shingles vaccine.   It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 21-APR-2023 This case was reported by a patient via interactive digital media. The patient took the shingles vaccine and got the shingles again.  The reporter stated that apparently 10 percent of the population still got shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: got shingles after the vax/Suspected vaccination failure; shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in an unspecified number of patients 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 suspected vaccination failure (Verbatim: got shingles after the vax/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 Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 21-APR-2023 The case was received from the patient via interactive digital media. The patient stated many people got shingles after the vaccine administration. In his or her opinion vaccine crashes their immune system. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Got the shot and got worse shingles/Suspected vaccination failure; worse shingles than before; 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.   The patient's past medical history included shingles.   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: Got the shot and got worse shingles/Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: worse shingles than before). 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 Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date: 25-MAR-2023 The case was received from the patient via interactive digital media. The patient got the vaccine shot and got worse shingles than before. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pain, Post herpetic neuralgia, Vaccination failure
Clinical narrative: had shots break out on head, suspected vaccination failure; didn´t stop them break out on upper left side of head; pain; pos herpetic neuralgia; 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 Shingles vaccine (received on an unknown date, 10 years ago).   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: had shots break out on head, suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: didn´t stop them break out on upper left side of head), pain (Verbatim: pain) and post herpetic neuralgia (Verbatim: pos herpetic neuralgia). The outcome of the vaccination failure was unknown and the outcome of the shingles and post herpetic neuralgia were not reported and the outcome of the pain was not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, pain and post herpetic neuralgia to be related to Shingles vaccine and Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles, pain and post herpetic neuralgia to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 22-APR-2023 This case was reported via interactive digital media. The patient reported as it has been 6 weeks and still have the pain.  Diagnosis post herpetic neuralgia. The patient had shot for shingles 10 years prior to the reporting and then had 2 shots 2 years prior to the reporting. The patient said did not stop them when they wanted to break out on the upper left side of his or her head. Most painful thing.  The patient said had ever gone though.  The patient would not wish them on his or her worst enemy. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting. Follow up would not possible, as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Pruritus, Vaccination failure
Clinical narrative: got the vaccine and it gave me/Suspected Vaccination Failure; it gave me; painful; itchy; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: got the vaccine and it gave me/Suspected Vaccination Failure) (serious criteria GSK medically significant), shingles (Verbatim: it gave me), pain (Verbatim: painful) and pruritus (Verbatim: itchy). The outcome of the vaccination failure, shingles, pain and pruritus were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, pain and pruritus to be related to Shingles vaccine.   It was unknown if the company considered the vaccination failure, shingles, pain and pruritus to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 23-APR-2023 This case was reported by a patient via interactive digital media. The patient got the shingles vaccine and it gave him/her shingles, less strong but still so painful and very itchy. 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.  The follow up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Burning sensation, Herpes zoster, Vaccination failure
Clinical narrative: Got the shot and had shingles over and over/ suspected vaccination failure; Shingles; Burning; 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.   The patient's past medical history included shingles.   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: Got the shot and had shingles over and over/ suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles) and burning sensation (Verbatim: Burning). The outcome of the vaccination failure was unknown and the outcome of the shingles was resolved and the outcome of the burning sensation was not reported.   It was unknown if the reporter considered the vaccination failure, shingles and burning sensation to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles and burning sensation to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 25-MAR-2023 This case was reported by a patient via interactive digital media. The patient reported that he or she received Shingles vaccine after cleared previously experienced shingles. The patient stated that after received Shingles vaccine did not stop anything and experienced shingles over and over for long time in the same place and then just stopped. The patient stated that the burning is the word would be used to describe the shingles. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: got it again after the shot/suspected vaccination failure; got it again after the shot; pain/pain was no where's the level of pain before the shot; 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.   The patient's past medical history included shingles.   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: got it again after the shot/suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: got it again after the shot) and pain (Verbatim: pain/pain was no where's the level of pain before the shot ). The outcome of the vaccination failure was unknown and the outcome of the shingles and pain were not reported.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles and pain to be related to Shingles vaccine.   Additional Information: GSK receipt date: 23-Apr-2023 The case was received from the patient via interactive digital media. The patient stated that true he or she got them again after the shot but the pain was no where's the level of pain before the shot. The shot definitely helped him or her. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: had vaccines still got shingles/suspected vaccination failure; shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 5 years after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: had vaccines still got shingles/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 Shingles vaccine.   It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 24-APR-2023 This case was reported by a patient via interactive digital media. The patient had the shingles vaccines and still got shingles 5 years later. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory test confirming shingles were unknown at the time of reporting.  The follow up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: received onlyadjuvant portion; received onlyadjuvant portion; 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: received onlyadjuvant portion) and inappropriate dose of vaccine administered (Verbatim: received onlyadjuvant portion). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 17-APR-2023 The pharmacist reported a patient received only the adjuvant portion of the Shingrix vaccine. The reporter consented to follow up.  The patient received only adjuvant of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. This case is linked with US2023056014, reported by same reporter.; Sender's Comments:  US-GSK-US2023056014:Same reporter
Sex: F
Vaccine: HEPA
Symptoms: No adverse event, Pain in extremity
Clinical narrative: Arm soreness; This non-serious case was reported by a nurse via other manufacturer and described the occurrence of pain in arm in a female 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 pain in arm (Verbatim: Arm soreness). The outcome of the pain in arm was not reported.   It was unknown if the reporter considered the pain in arm to be related to Havrix.     It was unknown if the company considered the pain in arm to be related to Havrix.   Additional Information: GSK Receipt Date: 21-APR-2023 Nurse who called on behalf of herself (patient).  The patient said she experienced arm soreness after receiving Havrix dose.  No additional adverse event reported.  No Pharmaceutical product complaint reported.  No further information was provided.
Sex: U
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: received vaccines after a temperature excursion; This non-serious case was reported by a other health professional and described the occurrence of incorrect storage of drug in a 55-year-old patient who received Herpes zoster (Shingles vaccine) (batch number 7KG39) for prophylaxis.   On 10-FEB-2023, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced incorrect storage of drug (Verbatim: received vaccines after a temperature excursion). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK receipt date: 14-APR-2023 The reporter consented to follow-up. This case is for one of 119 patients, reported by same reporter. The patient received unstable vaccine after a temperature excursion, which led to incorrect storage of drug; Sender's Comments:  US-GSK-US2023054677:same reporter US-GSK-US2023AMR055743:same reporter
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Acoustic stimulation tests abnormal, Deafness neurosensory, Tinnitus, Tympanometry
Clinical narrative: In March 2022 after receiving the Pfizer booster in Jan 2022 I noticed intermittent tinnitus symptoms. By August the tinnitus was constant. I still have tinnitus today. I have seen two ENTs. The first diagnosed the follow codes Sensorineural hearing loss and Tinnitus. The second said I have little to no hearing loss and saw no signs of autoimmune inflammation.
Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: NONE
Age: 0.58
Sex: F
Vaccine: COVID19-2
Symptoms: Underdose
Clinical narrative: Patient received 10 microgram bivalent dose and not the 25 microgram bivalent dose as recommended.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Breast pain, Erythema, Incomplete course of vaccination, Pain in extremity, Rash
Clinical narrative: Left arm very sore for more than one week; red  area on arm below injection site.  One month later. still have discolored area below the injection site and a redness in both cheeks and chin on my face and a discolored large area below my neck on my chest.  My personal physician advised to not get the second shot.  I went to my Dermatologist regarding the rash like discolored skin areas and was told it could take 6+weeks to clear.  The Dermatologist also advised not getting the second shot.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin discolouration
Clinical narrative: Left arm very sore for more than one week; red  area on arm below injection site.  One month later. still have discolored area below the injection site and a redness in both cheeks and chin on my face and a discolored large area below my neck on my chest.  My personal physician advised to not get the second shot.  I went to my Dermatologist regarding the rash like discolored skin areas and was told it could take 6+weeks to clear.  The Dermatologist also advised not getting the second shot.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus. Ringing in ears.  I have been to the doctor and have no hearing loss or other health issues
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: None Stated.
Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: Discontinued product administered
Clinical narrative: NONE
Age: 74.0
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19, Fatigue, Headache, Hyperhidrosis, Pyrexia
Clinical narrative: I was sweaty and had a headache. I ran a low-grade fever and fatigued. The third day I felt better. I tested positive on February 27, 2023, for COVID-19. I spoke with doctor and got Paxlovid.
Age: 74.0
Sex: M
Vaccine: COVID19-2
Symptoms: SARS-CoV-2 test positive
Clinical narrative: I was sweaty and had a headache. I ran a low-grade fever and fatigued. The third day I felt better. I tested positive on February 27, 2023, for COVID-19. I spoke with doctor and got Paxlovid.
Age: 53.0
Sex: F
Vaccine: COVID19-2
Symptoms: Abscess, Appendicectomy, Appendicitis, Appendicitis perforated, Bacterial test positive
Clinical narrative: I had a perforated appendix follow an appendectomy follow by access on the side and pneumonia in both lungs at the same time. On March 15th, 2023. I had surgical drain implanted and April 7th I had the drainage removed.
Age: 53.0
Sex: F
Vaccine: COVID19-2
Symptoms: Computerised tomogram abdomen abnormal, Computerised tomogram thorax abnormal, Drain removal, Pneumonia, Post procedural drainage
Clinical narrative: I had a perforated appendix follow an appendectomy follow by access on the side and pneumonia in both lungs at the same time. On March 15th, 2023. I had surgical drain implanted and April 7th I had the drainage removed.
Age: 53.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pseudomonal bacteraemia
Clinical narrative: I had a perforated appendix follow an appendectomy follow by access on the side and pneumonia in both lungs at the same time. On March 15th, 2023. I had surgical drain implanted and April 7th I had the drainage removed.
Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: none
Age: 73.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: COVID-19, Cough, Fatigue, Pain, SARS-CoV-2 test positive
Clinical narrative: First day cough, second day cough, Then 2 days of achiness, temperature, and fatigue.  I took a COVID-19 Home test, it was positive. I called my doctor, she prescribed Paxlovid. I had  2 days of just fatigue and the then the cough came back for 3 or 4 more days.
Age: 67.0
Sex: F
Vaccine: PNC20
Symptoms: Erythema, Influenza like illness, Nasopharyngitis, Swelling
Clinical narrative: Red raised round  skin just under size of baseball.  persisted 2 to 3 days then resolved. patient had cold/flulike symptoms before resolution.
Age: 81.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Death, Dyspnoea exertional, Fatigue, Gait disturbance
Clinical narrative: Within 3 weeks could not walk without being out of breath as far as to the mailbox. Felt weak, tired.  He died 8 months later after debilitating issues directly related to the time he received the vaccine.
Age: 81.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Leukaemia, Pulmonary fibrosis
Clinical narrative: Within 3 weeks could not walk without being out of breath as far as to the mailbox. Felt weak, tired.  He died 8 months later after debilitating issues directly related to the time he received the vaccine.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: none
Age: 36.0
Sex: F
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: Adult received a pediatric dose; Adult received a pediatric dose; This non-serious case was reported by a nurse via call center representative and described the occurrence of accidental underdose in a 36-year-old female patient who received HBV (Engerix B pediatric) (batch number DDK7K7, expiry date 31-MAR-2024) for prophylaxis.   Concomitant products included HEPATITIS B VACCINE (ENGERIX B ADULT).   On 28-FEB-2023, the patient received the 2nd dose of Engerix B pediatric .5 ml. On 28-FEB-2023, an unknown time after receiving Engerix B pediatric, the patient experienced accidental underdose (Verbatim: Adult received a pediatric dose) and adult use of a child product (Verbatim: Adult received a pediatric dose). The outcome of the accidental underdose and adult use of a child product were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 17-APR-2023 The nurse practitioner reported that the patient inadvertently received a child dose of Engerix B as the second dose. The reporter called to inquire what protocol to got to and how to proceed. The reporter did not consent to follow up. The adult patient received a dose of Engerix B pediatric, which led to accidental underdose and adult use of a child product.
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: 2nd dose given one month after 1st.; 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 male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX).   On 17-APR-2023, the patient received the 2nd dose of Shingrix. On 17-APR-2023, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too short (Verbatim: 2nd dose given one month after 1st.). The outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK receipt date: 17-APR-2023 The pharmacist reported a second dose of Shingrix was administered one month after the first dose to an immunocompetent patient. No dates available per health care professional (HCP). No additional adverse event (AE) details available per HCP.  The reporter did not consent to follow-up. The patient received 2nd dose of Shingrix earlier than recommended interval, which led to shortening of vaccination schedule.
Age: 1.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Expired Havrix adminsitered; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 18-month-old female patient who received HAV (Havrix 720) (batch number LY35X, expiry date 16-FEB-2023) for prophylaxis.   On 14-APR-2023, the patient received Havrix 720. On 14-APR-2023, an unknown time after receiving Havrix 720, the patient experienced expired vaccine used (Verbatim: Expired Havrix adminsitered). The outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 16-Apr-2023 The practice manager reported that patient demographics obtained. The permission for safety follow-up granted. The reporter consented to follow-up. The patient received an expired dose of Havrix 720, which led to expired vaccine used.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st "about a year ago", no 2nd dose yet; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 53-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received the 1st dose of Shingrix about a year ago).   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: 1st "about a year ago", no 2nd dose yet). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date:17-APR-2023 The patient would like to get the 2nd dose of shingrix. The reporter did not had an exact lot number and expiry date.  The reporter consented to follow up via email. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: U
Vaccine: HEPA, HEPAB
Symptoms: Incomplete course of vaccination, Wrong product administered
Clinical narrative: Twinrix 1st dose, 2nd dose Havrix; Twinrix 1st dose, 2nd dose Havrix; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included HAV (Havrix) for prophylaxis.   Concomitant products included hepatitis A vaccine + hepatitis B vaccine (Twinrix).   On an unknown date, the patient did not receive the 2nd dose of Twinrix and the 2nd dose of Havrix. On an unknown date, an unknown time after receiving Twinrix, the patient experienced incomplete course of vaccination (Verbatim: Twinrix 1st dose, 2nd dose Havrix) and wrong vaccine administered (Verbatim: Twinrix 1st dose, 2nd dose Havrix). The outcome of the incomplete course of vaccination and wrong vaccine administered 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: 17-Apr-2023 The pharmacist called to report that about 5 months ago (from the date of reporting) patient only one dose of Twinrix was administered and one month later Havrix was administered as a second dose. The vaccine administration facility was the same as primary reporter. Information about lot number, dates, patient were asked and declined. The reporter did not consent to follow-up.  The patient received a dose of Havrix as second dose instead of Twinrix, which led to wrong vaccine administered. Till the time of reporting, the patient did not receive second dose of Twinrix (incomplete for Hepatitis-B), which led to incomplete course of vaccination.
Age: 52.0
Sex: M
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Infanrix administered to adult patient; Patient got Infanrix instead of Tdap/Boostrix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 52-year-old male patient who received DTPa (Infanrix) (batch number LS444, expiry date 16-SEP-2023) for prophylaxis.   On 17-APR-2023, the patient received Infanrix. On 17-APR-2023, an unknown time after receiving Infanrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Infanrix administered to adult patient) and wrong vaccine administered (Verbatim: Patient got Infanrix instead of Tdap/Boostrix). The outcome of the inappropriate age at vaccine administration and wrong vaccine administered 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: 17-APR-2023 No reactions were reported. The reporter consented for follow up via email. The patient received patient received infanrix instead of the Tdap/Boostrix at an inappropriate age, which led to inappropriate age at vaccine administration and wrong vaccine administered.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: Hives on neck, shoulders, arms and abdomen; This non-serious case was reported by a other health professional via call center representative and described the occurrence of hives in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of no adverse event (She had no adverse effects after the first Shingrix dose on 12-JAN-2023).   On 14-APR-2023, the patient received the 2nd dose of Shingrix (intramuscular, unknown deltoid). On 15-APR-2023, 1 days after receiving Shingrix, the patient experienced hives (Verbatim: Hives on neck, shoulders, arms and abdomen). The patient was treated with cetirizine and prednisone. The outcome of the hives was not resolved.   It was unknown if the reporter considered the hives to be related to Shingrix.     It was unknown if the company considered the hives to be related to Shingrix.   Additional Information: Additional Information: GSK Receipt Date: 18-APR-2023 The reporter was physician's office manager who reported that, the patient had received her second dose of Shingrix. One day later, she developed hives on her neck, shoulders, arms and abdomen. She presented to the physician's office today (on the day of reporting) and the hives were treated with cetirizine and prednisone.  Nothing else was reported. The vaccine administration facility was the same as primary reporter. The reporter had consented to follow-up. This case was linked with US2023056839, which was reported by same reporter.; Sender's Comments:  US-GSK-US2023056839:Same reporter and different patients
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Possible 2nd dose late; This non-serious case was reported by a nurse via sales rep and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix  (1st dose received on an unknown date).   On 18-APR-2023, the patient received the 2nd dose of Shingrix. On 18-APR-2023, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: Possible 2nd dose late). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK receipt date: 18-Apr-2023 The reporter reported that possible adverse event on behalf of Nurse Practitioner.   The reporter reported possible late 2nd dose of Shingrix. The Vaccine Administration Facility was the same as Primary Reporter, No additional adverse event information available. Safety emailed sales information. The reporter consented to follow up. The patient administered the second dose of vaccine at time longer than the schedule, which led to lengthening of vaccination schedule.
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered, Inappropriate schedule of product administration
Clinical narrative: Got another dose 4/18/2023; 1st dose 4/24/2022, 2nd on 4/14/2023; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 52-year-old male patient who received Herpes zoster (Shingrix) (batch number YC5Y7, expiry date 25-OCT-2024) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) (batch number YA29D, expiry date 06-OCT-2023) for prophylaxis.   Previously administered products included SHINGRIX (received the 1st dose last year on 24th April 2022).   On 18-APR-2023, the patient received the 3rd dose of Shingrix. On 14-APR-2023, the patient received the 2nd dose of Shingrix. On 14-APR-2023, not applicable after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: 1st dose 4/24/2022, 2nd on 4/14/2023). On 18-APR-2023, the patient experienced extra dose administered (Verbatim: Got another dose 4/18/2023). The outcome of the drug dose administration interval too long and extra dose administered were unknown.   Additional Information: GSK receipt date:19-APR-2023 The pharmacist did not had expiration date for second dose but had verified it with the batch identifier. The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up via postal. The patient received 2nd dose of Shingrix later than the recommended interval, which led to lengthening of vaccine schedule. The patient received 3rd dose of Shingrix, which led to extra dose administered.
Sex: F
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Expired Engerix administered; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 1-week-old female patient who received HBV (Engerix B) (batch number 5295P, expiry date 27-DEC-2022) for prophylaxis.   On 19-APR-2023, the patient received Engerix B. On 19-APR-2023, an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: Expired Engerix administered). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 19-APR-2023 The reporter asked about further guidance on this situation.  The reporter consented to follow up. The patient received an expired dose of Engerix B, which led to expired vaccine used.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: Patient got a 3rd dose of Shingrix; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 53-year-old male patient who received Herpes zoster (Shingrix) (batch number C9Z43, expiry date 08-JUL-2024) for prophylaxis.   Concomitant products included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX).   On 14-APR-2023, the patient received the 3rd dose of Shingrix. On 14-APR-2023, an unknown time after receiving Shingrix, the patient experienced extra dose administered (Verbatim: Patient got a 3rd dose of Shingrix). The outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 19-APR-2023 The second dose of Shingrix received on 28th February 2023. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up.  The reporter called to inform that a patient was administered a 3rd dose of Shingrix, which led to extra dose administered.