chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: M
Vaccine: COVID19-2
Symptoms: Chest discomfort, Cough, Photopsia, Productive cough, SARS-CoV-2 test negative
Clinical narrative: In late February, I noticed I was feeling heavy in my chest. I began coughing and coughed really hard. It was not a dry cough, and it did cough up a bit of mucus that was green in color. It created floaters that were like spider webs in my eyes and light flashes behind my eyes. I went to the emergency department on February 26, 2023. They gave me some pills that were cough suppressant pearls, benzonatate (TESSALON PERLES). They made an appointment with my eye doctor regarding the issues with my eyes. I visited with the eye doctor on March 30, 2023. There was not a true diagnosis. I am no longer having the flashes of lights and the floaters are much less frequent.
Age: 65.0
Sex: M
Vaccine: COVID19-2
Symptoms: Sputum discoloured, Vitreous floaters
Clinical narrative: In late February, I noticed I was feeling heavy in my chest. I began coughing and coughed really hard. It was not a dry cough, and it did cough up a bit of mucus that was green in color. It created floaters that were like spider webs in my eyes and light flashes behind my eyes. I went to the emergency department on February 26, 2023. They gave me some pills that were cough suppressant pearls, benzonatate (TESSALON PERLES). They made an appointment with my eye doctor regarding the issues with my eyes. I visited with the eye doctor on March 30, 2023. There was not a true diagnosis. I am no longer having the flashes of lights and the floaters are much less frequent.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Acute respiratory failure, Femoral neck fracture, Fracture displacement, Humerus fracture, Ulna fracture
Clinical narrative: J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 2/11/2022 LEFT OLECRANON FX, W INTRAARTICULAR EXTENSION DISPL ROUT SUBSEQ J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 2/11/2022 RIGHT PROXIMAL HUMERUS UNSPECIFIED TYPE FX, INIT J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 2/11/2022 RIGHT FEMORAL NECK UNSPECIFIED TYPE FX, INIT
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Diabetic dyslipidaemia, Hypotension, Neuropathy peripheral, Type 2 diabetes mellitus
Clinical narrative: G62.9 PERIPHERAL NEUROPATHY 7/8/2022 DM 2 W DYSLIPIDEMIA I95.9 HYPOTENSION 4/22/2022 DM 2 W DYSLIPIDEMIA
Age: 8.0
Sex: M
Vaccine: UNK
Symptoms: Product storage error
Clinical narrative: Storage and Handling Incident
Age: 5.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Storage and Handling Incident.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Haematoma
Clinical narrative: hematoma; This spontaneous report was received from a physician and referred to a 4-year-old female patient. The patient's medical history, concurrent conditions, concomitant therapies and drug reaction/allergies were unknown by reporter.   On 05-APR-2023, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, lot #W016746, expiration date: 23-MAY-2024, administered subcutaneously for prophylaxis (strength and dose were not provided); and received therapy with sterile diluent solution for injection/infusion, lot #U034538, expiration date: 14-MAY-2024 (strength, dose, frequency, route of administration, and indication were not provided).  On 05-APR-2023, the patient experienced hematoma after the subcutaneous administration. It was unknown whether the patient sought medical attention, or any treatment was given. Information about lab diagnostics/studies was unknown by the reporter. At the time of reporting, the outcome of the event hematoma was not known. The causal relationship between hematoma and both suspect products was not provided.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported.; temperature excursion; This spontaneous report was received from a medical assistant referring to a 4-year-old female patient. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.      On 20-JAN-2023, measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) was stored in the range 6 degrees Fahrenheit to 14 degrees Fahrenheit for 1 hour 0 minute 0 second. On 07-FEB-2023 (also reported as 15-FEB-2023, contradictory information), the patient was vaccinated with the improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection (rHA), lot #W019627, expiration date: 19-DEC-2023, administered intramuscularly at right thigh for prophylaxis at private doctor's office/hospital (dose and strength were not provided) (product storage error). No additional adverse event was reported (no adverse event).  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2303USA002114:
Sex: U
Vaccine: VARZOS
Symptoms: Disability, Injury
Clinical narrative: Vaccine injured, i am seriously disable from shingles vaccine; This serious case was reported by a consumer via interactive digital media and described the occurrence of injury 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 injury (Verbatim: Vaccine injured, i am seriously disable from shingles vaccine) (serious criteria disability). The outcome of the injury was not reported.   It was unknown if the reporter considered the injury to be related to Shingles vaccine.     It was unknown if the company considered the injury 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 injured from shingles shot. The patient seriously disables from shingles vaccine. The patient stated that it's not for everyone. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Electric shock sensation, Herpes zoster, Ophthalmic herpes zoster, Tympanic membrane disorder, Vaccination failure
Clinical narrative: did have shingles shot had shingles/suspected vaccination failure; Shingles affected vision; shingles on head/Shingles affected one ear drum; shock waves in head; 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: did have shingles shot had shingles/suspected vaccination failure) (serious criteria GSK medically significant), ophthalmic herpes zoster (Verbatim: Shingles affected vision) (serious criteria GSK medically significant), shingles (Verbatim: shingles on head/Shingles affected one ear drum) and electric shock sensation in head (Verbatim: shock waves in head). The outcome of the vaccination failure was unknown and the outcome of the ophthalmic herpes zoster and shingles were resolved and the outcome of the electric shock sensation in head was not resolved.   It was unknown if the reporter considered the vaccination failure, ophthalmic herpes zoster, shingles and electric shock sensation in head to be related to Shingles vaccine.  It was unknown if the company considered the vaccination failure, ophthalmic herpes zoster, shingles and electric shock sensation in head to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 24-MAR-2023 This case was reported by a patient via interactive digital media. The patient had shingles on his/her head and affected his/her vision and one ear drum.  The patient stated that over 2 months to heal.  A year later he/she still had shock waves in his/her head and the patient did have a shingles shot 6 months before. 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: Visual impairment
Clinical narrative: did have shingles shot had shingles/suspected vaccination failure; Shingles affected vision; shingles on head/Shingles affected one ear drum; shock waves in head; 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: did have shingles shot had shingles/suspected vaccination failure) (serious criteria GSK medically significant), ophthalmic herpes zoster (Verbatim: Shingles affected vision) (serious criteria GSK medically significant), shingles (Verbatim: shingles on head/Shingles affected one ear drum) and electric shock sensation in head (Verbatim: shock waves in head). The outcome of the vaccination failure was unknown and the outcome of the ophthalmic herpes zoster and shingles were resolved and the outcome of the electric shock sensation in head was not resolved.   It was unknown if the reporter considered the vaccination failure, ophthalmic herpes zoster, shingles and electric shock sensation in head to be related to Shingles vaccine.  It was unknown if the company considered the vaccination failure, ophthalmic herpes zoster, shingles and electric shock sensation in head to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 24-MAR-2023 This case was reported by a patient via interactive digital media. The patient had shingles on his/her head and affected his/her vision and one ear drum.  The patient stated that over 2 months to heal.  A year later he/she still had shock waves in his/her head and the patient did have a shingles shot 6 months before. 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: Eye disorder, Herpes zoster, Pruritus, Vaccination failure
Clinical narrative: Shingles / Suspected vaccination failure; Had shingles; Some of the itching; Eye issues; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Had shingles), pruritus (Verbatim: Some of the itching) and eye disorder (Verbatim: Eye issues). The outcome of the vaccination failure was unknown and the outcome of the shingles, pruritus and eye disorder were not reported.   It was unknown if the reporter considered the vaccination failure, shingles, pruritus and eye disorder to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles, pruritus and eye disorder 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, when you have had shingles, you darn sure know what it was.  Took them awhile to admit, no guaranteed shots prevent, no guarantee or for sure how long the side effects continue, and on and on. The reporter just did not know enough about it.   The reporter stated that, still got side effects, some of the itching, eye issues etc. some of the symptoms mirror other medical issues but everything seems to overlap these days. 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 could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Abdominal discomfort, COVID-19, Emotional distress, Herpes zoster, Illness
Clinical narrative: had 2 sets of shots and backside was breaking out/ suspected vaccination failure; Pneumonia; Backside was breaking out with shingles; Fever; Upset stomach; Sick; Upset , like you're into the MRI Machine Head first; Covid; 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.   The patient's past medical history included shingles (had first time in 1954 patient was 6 years old). Additional patient notes included for 56 years patient had been got hysterical shingles below the waist on his or her Sciatica.   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 2 sets of shots and backside was breaking out/ suspected vaccination failure) (serious criteria GSK medically significant), pneumonia (Verbatim: Pneumonia) (serious criteria GSK medically significant), shingles (Verbatim: Backside was breaking out with shingles), fever (Verbatim: Fever), upset stomach (Verbatim: Upset stomach), sickness (Verbatim: Sick), emotional distress (Verbatim: Upset , like you're into the MRI Machine Head first) and covid-19 (Verbatim: Covid). The outcome of the vaccination failure was unknown and the outcome of the pneumonia, shingles, fever, upset stomach, sickness, emotional distress and covid-19 were not reported.   It was unknown if the reporter considered the vaccination failure, pneumonia, shingles, fever, upset stomach, sickness, emotional distress and covid-19 to be related to Shingles vaccine and Shingles vaccine.     It was unknown if the company considered the vaccination failure, pneumonia, shingles, fever, upset stomach, sickness, emotional distress and covid-19 to be related to Shingles vaccine and 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 two doses of Shingles vaccine and slowed shingles down but he or she experienced fever, upset stomach sick and felt upset like he or she is in the MRI machine as head first. The patient stated that at the time he or she got home his or her backside was breaking out. The patient was bad at last summer when he or she experienced Covid followed by Pneumonia. 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, VARZOS
Symptoms: Pneumonia, Pyrexia, Rash, Vaccination failure
Clinical narrative: had 2 sets of shots and backside was breaking out/ suspected vaccination failure; Pneumonia; Backside was breaking out with shingles; Fever; Upset stomach; Sick; Upset , like you're into the MRI Machine Head first; Covid; 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.   The patient's past medical history included shingles (had first time in 1954 patient was 6 years old). Additional patient notes included for 56 years patient had been got hysterical shingles below the waist on his or her Sciatica.   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 2 sets of shots and backside was breaking out/ suspected vaccination failure) (serious criteria GSK medically significant), pneumonia (Verbatim: Pneumonia) (serious criteria GSK medically significant), shingles (Verbatim: Backside was breaking out with shingles), fever (Verbatim: Fever), upset stomach (Verbatim: Upset stomach), sickness (Verbatim: Sick), emotional distress (Verbatim: Upset , like you're into the MRI Machine Head first) and covid-19 (Verbatim: Covid). The outcome of the vaccination failure was unknown and the outcome of the pneumonia, shingles, fever, upset stomach, sickness, emotional distress and covid-19 were not reported.   It was unknown if the reporter considered the vaccination failure, pneumonia, shingles, fever, upset stomach, sickness, emotional distress and covid-19 to be related to Shingles vaccine and Shingles vaccine.     It was unknown if the company considered the vaccination failure, pneumonia, shingles, fever, upset stomach, sickness, emotional distress and covid-19 to be related to Shingles vaccine and 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 two doses of Shingles vaccine and slowed shingles down but he or she experienced fever, upset stomach sick and felt upset like he or she is in the MRI machine as head first. The patient stated that at the time he or she got home his or her backside was breaking out. The patient was bad at last summer when he or she experienced Covid followed by Pneumonia. 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, Vaccination failure
Clinical narrative: Got Shingrix, got shingles/Suspected vaccination failure; Shingles every 4 months; This serious case was reported by a nurse via sales rep and described the occurrence of vaccination failure in a 48-year-old 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: Got Shingrix, got shingles/Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles every 4 months). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.   It was unknown if the company considered the vaccination failure and shingles to be related to Shingrix.   Additional Information: GSK Receipt Date: 19-APR-2023 The patient had already been vaccinated with Shingrix. The patient had been experiencing shingles episodes frequently (around every 4 months). 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 reporter did not agree to follow up from GlaxoSmithKline.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; 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: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Got 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: 28-APR-2023 This case was reported by the patient via interactive digital media. The patient experienced shingles after receiving the shot. The follow-up could not be possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Steady constant outbreaks, this is with vaccination, Suspected vaccination failure; Steady outbreaks, some heavier; 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. In JUN-2020, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Steady constant outbreaks, this is with vaccination, Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Steady outbreaks, some heavier). 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: 28-APR-2023 This case was reported by the patient via interactive digital media. The patient received a dose of Shingles vaccine and stated that had steady outbreaks since June 2020 and stated that some heavier than others but constant and reported that this was with vaccination. This case was considered as suspected vaccination failure as details regarding completion of vaccination schedule, 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, Vaccination failure
Clinical narrative: 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 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 vaccination failure (Verbatim: 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: 28-APR-2023 This case was reported via interactive digital media. The reporter stated that everyone he/she know who got this Shingles shot 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 could not be possible as no contact details were available. This case had been linked with US2023AMR063830, reported by same reporter.; Sender's Comments:  US-GSK-US2023AMR063830:Same reporter. Flux vx case
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: had the shots, had shingles / Suspected vaccination failure; had 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: had the shots, had shingles / Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: had 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: 28-APR-2023 Reporter's comment: This case was reported by a patient via interactive digital media. The patient had the Shingles shots and had shingles since Christmas.  Things work to awhile and then he or she try something else.  Now rotating several treatments. 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. Follow up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Got them after; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced shingles (Verbatim: Got them after). The outcome of the shingles was not reported.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.     It was unknown if the company considered the shingles 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 also had the Shingles shot and got them after. The patient had another shot since then and he/she hoped that he/she never had them again. Follow up was not possible, as no contact details were available. As per narrative it seems patient experienced AE after 1st dose only, hence captured conservatively
Sex: U
Vaccine: VARZOS
Symptoms: Illness
Clinical narrative: got sick; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness 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 sickness (Verbatim: got sick). The outcome of the sickness was unknown.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.     It was unknown if the company considered the sickness to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 23-APR-2023. Case was reported by a consumer via interactive digital media. The reporter stated that If have diabetes, the vaccine was not highly recommended, and when defenses were low, remember that it was the virus that you were injected with,  The reporter stated he/she worked with people who got sick immediately after they got the vaccine.
Sex: U
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: knocked me; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of feeling unwell in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced feeling unwell (Verbatim: knocked me). The outcome of the feeling unwell was not reported.   It was unknown if the reporter considered the feeling unwell to be related to Shingles vaccine.     It was unknown if the company considered the feeling unwell to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 23-APR-2023. Case was reported by a consumer via interactive digital media. The reporter stated that, he/she had the vaccine, and knocked him/her on ass. The patient would get the second dose.
Age: 32.0
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: The dose was expired; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 32-year-old male patient who received HAV (Havrix) (batch number H4H53, expiry date 30-JAN-2023) for prophylaxis.   On 24-APR-2023, the patient received Havrix. On 24-APR-2023, an unknown time after receiving Havrix, the patient experienced expired vaccine used (Verbatim: The dose was expired). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 24-APR-2023 and 26-APR-2023 The nurse reported that a patient was vaccinated with Havrix. The dose was expired on January 30th 2023 and the nurse asked how to proceed?. The Vaccine Administration Facility is the same as Primary Reporter. The reporter did not consented to follow up. This case was found to be duplicate of US2023060925 and all the future correspondence would be added in case US2023AMR060812 which stands as case of record for this patient and the case US2023060925 would be deleted.
Sex: U
Vaccine: DTAPHEPBIP
Symptoms: Product storage error
Clinical narrative: Temp excursion, unknown if administered; This non-serious case was reported by a other health professional via other manufacturer and described the occurrence of incorrect storage of drug in a patient who received DTPa-HBV-IPV (Pediarix) for prophylaxis.   On an unknown date, the patient received Pediarix. On an unknown date, an unknown time after receiving Pediarix, the patient experienced incorrect storage of drug (Verbatim: Temp excursion, unknown if administered). The outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 25-APR-2023 The reporter was the medical assistant, reported that on April 19, 2023, excursion of the product was occurred, which was not too long, it was for short time. The reporter hung up the call abruptly, thus limited information. The product was excursed, which led to incorrect storage of drug. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Illness
Clinical narrative: Sick; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness 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 sickness (Verbatim: Sick). The outcome of the sickness was not reported.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.     It was unknown if the company considered the sickness to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 26-MAR-2023 This case was reported by a patient via interactive digital media. The reporter reported that he or she have a man in there church that he received Shingles vaccine and he experienced so sick with the vaccine. Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: TDAP
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 32-year-old patient who received DTPa (Reduced antigen) (Tdap Vaccine) (batch number 397B5) for prophylaxis.   On 24-FEB-2023, the patient received Tdap Vaccine. On an unknown date, an unknown time after receiving Tdap 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 patient received unstable vaccines after a temperature excursion. The patient received unstable vaccines after a temperature excursion, which led incorrect storage of drug.; Sender's Comments:  US-GSK-US2023054677:same reporter US-GSK-US2023AMR055743:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Feeling abnormal, Pain in extremity
Clinical narrative: Hurt my arm; Felt lousy; 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.   The patient's past medical history included shingles (Had shingles bad in scalp and neck) and pain (Horrid pain).   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: Hurt my arm) and feeling bad (Verbatim: Felt lousy). The outcome of the pain in arm was resolved and the outcome of the feeling bad was not reported.   It was unknown if the reporter considered the pain in arm and feeling bad to be related to Shingles vaccine.     It was unknown if the company considered the pain in arm and feeling bad to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 25-APR-2023 This case was reported by a patient via interactive digital media. The patient received the shingles vaccine a year later of pervious shingles episode and had pain in arm for days, and felt lousy but that was not as bad as shingles was. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: TDAP
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 52-year-old patient who received DTPa (Reduced antigen) (Tdap Vaccine) (batch number YR7AA) for prophylaxis.   On 03-JAN-2023, the patient received Tdap Vaccine. On an unknown date, an unknown time after receiving Tdap 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 patient received unstable vaccines after a temperature excursion, which led incorrect storage of drug. The reporter consented to follow-up. This case was for one of 119 patients, reported by same reporter.; Sender's Comments:  US-GSK-US2023054677:same reporter US-GSK-US2023AMR055743:same reporter
Sex: U
Vaccine: TDAP
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 61-year-old patient who received DTPa (Reduced antigen) (Tdap Vaccine) (batch number YR7AA) for prophylaxis.   On 04-JAN-2023, the patient received Tdap Vaccine. On an unknown date, an unknown time after receiving Tdap 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 patient received unstable vaccines after a temperature excursion, which led incorrect storage of drug. The reporter consented to follow-up. This case was for one of 119 patients, reported by same reporter.; Sender's Comments:  US-GSK-US2023054677:same reporter US-GSK-US2023AMR055743:same reporter
Sex: U
Vaccine: TDAP
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 57-year-old patient who received DTPa (Reduced antigen) (Tdap Vaccine) (batch number YR7AA) for prophylaxis.   On 04-JAN-2023, the patient received Tdap Vaccine. On an unknown date, an unknown time after receiving Tdap 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 patient received unstable vaccines after a temperature excursion, which led incorrect storage of drug. The reporter consented to follow-up. This case was for one of 119 patients, reported by same reporter.; Sender's Comments:  US-GSK-US2023054677:same reporter US-GSK-US2023AMR055743:same reporter
Sex: U
Vaccine: TDAP
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 22-year-old patient who received DTPa (Reduced antigen) (Tdap Vaccine) (batch number YR7AA) for prophylaxis.   On 05-JAN-2023, the patient received Tdap Vaccine. On an unknown date, an unknown time after receiving Tdap 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 patient received unstable vaccines after a temperature excursion, which led incorrect storage of drug. The reporter consented to follow-up. This case was for one of 119 patients, reported by same reporter.; Sender's Comments:  US-GSK-US2023054677:same reporter US-GSK-US2023AMR055743:same reporter
Sex: U
Vaccine: TDAP
Symptoms: Product storage error
Clinical narrative: This non-serious case was reported by a other health professional and described the occurrence of incorrect storage of drug in a 44-year-old patient who received DTPa (Reduced antigen) (Tdap Vaccine) (batch number YR7AA) for prophylaxis.   On 10-JAN-2023, the patient received Tdap Vaccine. On an unknown date, an unknown time after receiving Tdap 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 patient received unstable vaccines after a temperature excursion, which led incorrect storage of drug. The reporter consented to follow-up. This case was for one of 119 patients, reported by same reporter.; Sender's Comments:  US-GSK-US2023054677:same reporter US-GSK-US2023AMR055743:same reporter
Sex: U
Vaccine: DTAPHEPBIP
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 patient who received DTPa-HBV-IPV (DTPa-HBV-IPV) (batch number TS425) for prophylaxis.   On 20-FEB-2023, the patient received DTPa-HBV-IPV. On an unknown date, an unknown time after receiving DTPa-HBV-IPV, 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 patient received unstable vaccines after a temperature excursion. The patient received unstable vaccines after a temperature excursion, which led incorrect storage of drug.; Sender's Comments:  US-GSK-US2023054677:same reporter US-GSK-US2023AMR055743:same reporter
Sex: U
Vaccine: DTAPHEPBIP
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 patient who received DTPa-HBV-IPV (DTPa-HBV-IPV) (batch number TS425) for prophylaxis.   On 21-FEB-2023, the patient received DTPa-HBV-IPV. On an unknown date, an unknown time after receiving DTPa-HBV-IPV, 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 patient received unstable vaccines after a temperature excursion. The patient received unstable vaccines after a temperature excursion, which led incorrect storage of drug.; Sender's Comments:  US-GSK-US2023054677:same reporter US-GSK-US2023AMR055743:same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Chills
Clinical narrative: Chills; This non-serious case was reported by a pharmacist via sales rep and described the occurrence of chills in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.  In MAR-2023, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced chills (Verbatim: Chills). The outcome of the chills was not reported.  It was unknown if the reporter considered the chills to be related to Shingrix.  It was unknown if the company considered the chills to be related to Shingrix.  Additional Information: GSK Receipt Date: 27-APR-2023 The patient self-reported that, she had experienced chills with dose 1 of Shingrix and was concerned if the dose 2 side effects would be as severe . The reporter had consented to follow-up.
Sex: U
Vaccine: TDAP
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 51-year-old patient who received DTPa (Reduced antigen) (Tdap Vaccine) (batch number YR7AA) for prophylaxis.   On 27-JAN-2023, the patient received Tdap Vaccine. On an unknown date, an unknown time after receiving Tdap 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
Sex: U
Vaccine: TDAP
Symptoms: Product storage error
Clinical narrative: received vaccines after a temperature excursion; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a 52-year-old patient who received DTPa (Reduced antigen) (Tdap Vaccine) (batch number YR7AA) for prophylaxis.   On 25-JAN-2023, the patient received Tdap Vaccine. On an unknown date, an unknown time after receiving Tdap 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: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Accidental exposure to product, Exposure via skin contact, Incorrect dose administered, Syringe issue
Clinical narrative: Vaccine leaked from luer-lok, unk amount given; Vaccine went down the patient's arm; Vaccine went down the patient's arm; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete dose administered in a 66-year-old male patient who received Herpes zoster (Shingrix) (batch number 2A54M, expiry date 21-MAY-2024) for prophylaxis.   On 19-APR-2023, the patient received the 2nd dose of Shingrix. On 19-APR-2023, an unknown time after receiving Shingrix, the patient experienced incomplete dose administered (Verbatim: Vaccine leaked from luer-lok, unk amount given), exposure via skin contact (Verbatim: Vaccine went down the patient's arm) and inadvertent exposure to vaccine (Verbatim: Vaccine went down the patient's arm). The outcome of the incomplete dose administered, exposure via skin contact and inadvertent exposure to vaccine were unknown.   Additional Information: GSK Receipt Date: 24-APR-2023 The pharmacist administered Shingrix vaccine to a patient, and some of the vaccine leaked from the luer-lok so that the patient did not receive the full dose.  The pharmacist was unable to determine how much of the dose the patient received.  The pharmacist asked that what is the recommendation in this case, should the dose be repeated?  The pharmacist added that some of the vaccine went down the patient's arm. No product quality complaint (PQC) as leaking was from the syringe. The reporter did not consent to follow-up. The patient did not received full dose of Shingrix as some of the vaccine leaked from the luer-lok to the patient's arm, which led to incomplete dose administered, inadvertent exposure to vaccine and exposure via skin contact.
Age: 0.92
Sex: M
Vaccine: DTAPIPV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 11 MO received Kinrix; 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 11-month-old male patient who received DTPa-IPV (Kinrix) (batch number G9N2M, expiry date 14-APR-2024) for prophylaxis.   On 22-APR-2023, the patient received Kinrix. On 22-APR-2023, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: 11 MO received Kinrix). The outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 24-APR-2023  The health care professional (HCP) reported that an 11 month old received the Kinrix as the 3rd vaccination in the Dtap/IPV series.  No reactions reported. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up via email. The patient received Kinrix at inappropriate age, which led to inappropriate age at vaccine administration.