chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 16.0
Sex: M
Vaccine: COVID19, COVID19, HPV9, MNQ, UNK, UNK
Symptoms: Dysstasia, Fall, Foot deformity, Gait disturbance, Gait inability
Clinical narrative: 3-3-24- I noticed my son tapping his foot when seated but, it wasn't sustained. I just thought it may be a side effect to one of his medications. 3-16-24- Noticed he was guarding his right arm and hand 3-28-24 Pt was walking very unsteady and had alot of movement in his torso. Right foot rotating outward. 4-1-24- Pt unable to walk, falling down. Taken urgent care - xrays rt shoulder, rt hip, rt knee (no fx) ordered a walker for pt. to use. 4-3-24- follow up appt at peds, pt could not walk, slumping over in chair, EMS tx to Hospital CT head, neck, Xrays rt shoulder, r hip, r knee, r ankle- all normal- give 1 liter LR and felt better- legs very shaky, MD called it CLONUS-ER to follow up with neurologist- 4-4-24- pt fell 3 times, unable to stand, right sided weakness, EMS tx to Hospital, Clonus present and sustained CT head/ neck Admitted to Hospital 4-4-24 through 4-17-24 4-5-24 MRI head and spine under general anesthesia, spinal tap 4-6-24 diagnosed with Transverse Myelitis by neurologist started on 5 days of high dose IV Solumedrol Attending hospitalist pointed out that pt received 5 vaccines on 2-22-24 and he thought that was too many to give at one time. He said, "I would have spaced them out and not given the 2 Meningiococcal vaccines at the same time. That will overwhelm the immune system. The Moderna Covid has been know to cause transverse myelitis as an adverse reaction." Also, dr never had my consent for pt to receive the HPV or the Meningiococcal vaccines.  4-11-24 repeat MRI of head and spine under general anesthesia- results unchanged 4-17-24- Pt was transferred to Rehabilitation hospital.  Physical status declined and pt had another CT of his head- results normal.  Pt is still hospitalized today (5-19-24) and is finally making some physical gains. He can walk with a walker with assistance and is gaining better use of his right arm, right hand, right leg. He still remains weaker on his right side of his body. He still has clonus.   There is a VAERS report filed by on 4-15-2024. The VAERS number is 1018564.
Age: 16.0
Sex: M
Vaccine: COVID19, COVID19, HPV9, MNQ, UNK, UNK
Symptoms: General physical health deterioration, Hemiparesis, Lumbar puncture abnormal, Magnetic resonance imaging head normal, Magnetic resonance imaging spinal normal
Clinical narrative: 3-3-24- I noticed my son tapping his foot when seated but, it wasn't sustained. I just thought it may be a side effect to one of his medications. 3-16-24- Noticed he was guarding his right arm and hand 3-28-24 Pt was walking very unsteady and had alot of movement in his torso. Right foot rotating outward. 4-1-24- Pt unable to walk, falling down. Taken urgent care - xrays rt shoulder, rt hip, rt knee (no fx) ordered a walker for pt. to use. 4-3-24- follow up appt at peds, pt could not walk, slumping over in chair, EMS tx to Hospital CT head, neck, Xrays rt shoulder, r hip, r knee, r ankle- all normal- give 1 liter LR and felt better- legs very shaky, MD called it CLONUS-ER to follow up with neurologist- 4-4-24- pt fell 3 times, unable to stand, right sided weakness, EMS tx to Hospital, Clonus present and sustained CT head/ neck Admitted to Hospital 4-4-24 through 4-17-24 4-5-24 MRI head and spine under general anesthesia, spinal tap 4-6-24 diagnosed with Transverse Myelitis by neurologist started on 5 days of high dose IV Solumedrol Attending hospitalist pointed out that pt received 5 vaccines on 2-22-24 and he thought that was too many to give at one time. He said, "I would have spaced them out and not given the 2 Meningiococcal vaccines at the same time. That will overwhelm the immune system. The Moderna Covid has been know to cause transverse myelitis as an adverse reaction." Also, dr never had my consent for pt to receive the HPV or the Meningiococcal vaccines.  4-11-24 repeat MRI of head and spine under general anesthesia- results unchanged 4-17-24- Pt was transferred to Rehabilitation hospital.  Physical status declined and pt had another CT of his head- results normal.  Pt is still hospitalized today (5-19-24) and is finally making some physical gains. He can walk with a walker with assistance and is gaining better use of his right arm, right hand, right leg. He still remains weaker on his right side of his body. He still has clonus.   There is a VAERS report filed by on 4-15-2024. The VAERS number is 1018564.
Age: 16.0
Sex: M
Vaccine: COVID19, COVID19, HPV9, MNQ, UNK, UNK
Symptoms: Musculoskeletal disorder, Myelitis transverse, Posture abnormal, Product use issue, Tremor
Clinical narrative: 3-3-24- I noticed my son tapping his foot when seated but, it wasn't sustained. I just thought it may be a side effect to one of his medications. 3-16-24- Noticed he was guarding his right arm and hand 3-28-24 Pt was walking very unsteady and had alot of movement in his torso. Right foot rotating outward. 4-1-24- Pt unable to walk, falling down. Taken urgent care - xrays rt shoulder, rt hip, rt knee (no fx) ordered a walker for pt. to use. 4-3-24- follow up appt at peds, pt could not walk, slumping over in chair, EMS tx to Hospital CT head, neck, Xrays rt shoulder, r hip, r knee, r ankle- all normal- give 1 liter LR and felt better- legs very shaky, MD called it CLONUS-ER to follow up with neurologist- 4-4-24- pt fell 3 times, unable to stand, right sided weakness, EMS tx to Hospital, Clonus present and sustained CT head/ neck Admitted to Hospital 4-4-24 through 4-17-24 4-5-24 MRI head and spine under general anesthesia, spinal tap 4-6-24 diagnosed with Transverse Myelitis by neurologist started on 5 days of high dose IV Solumedrol Attending hospitalist pointed out that pt received 5 vaccines on 2-22-24 and he thought that was too many to give at one time. He said, "I would have spaced them out and not given the 2 Meningiococcal vaccines at the same time. That will overwhelm the immune system. The Moderna Covid has been know to cause transverse myelitis as an adverse reaction." Also, dr never had my consent for pt to receive the HPV or the Meningiococcal vaccines.  4-11-24 repeat MRI of head and spine under general anesthesia- results unchanged 4-17-24- Pt was transferred to Rehabilitation hospital.  Physical status declined and pt had another CT of his head- results normal.  Pt is still hospitalized today (5-19-24) and is finally making some physical gains. He can walk with a walker with assistance and is gaining better use of his right arm, right hand, right leg. He still remains weaker on his right side of his body. He still has clonus.   There is a VAERS report filed by on 4-15-2024. The VAERS number is 1018564.
Age: 16.0
Sex: M
Vaccine: COVID19, COVID19, HPV9, MNQ, UNK, UNK
Symptoms: Walking aid user, X-ray limb normal, X-ray of pelvis and hip normal
Clinical narrative: 3-3-24- I noticed my son tapping his foot when seated but, it wasn't sustained. I just thought it may be a side effect to one of his medications. 3-16-24- Noticed he was guarding his right arm and hand 3-28-24 Pt was walking very unsteady and had alot of movement in his torso. Right foot rotating outward. 4-1-24- Pt unable to walk, falling down. Taken urgent care - xrays rt shoulder, rt hip, rt knee (no fx) ordered a walker for pt. to use. 4-3-24- follow up appt at peds, pt could not walk, slumping over in chair, EMS tx to Hospital CT head, neck, Xrays rt shoulder, r hip, r knee, r ankle- all normal- give 1 liter LR and felt better- legs very shaky, MD called it CLONUS-ER to follow up with neurologist- 4-4-24- pt fell 3 times, unable to stand, right sided weakness, EMS tx to Hospital, Clonus present and sustained CT head/ neck Admitted to Hospital 4-4-24 through 4-17-24 4-5-24 MRI head and spine under general anesthesia, spinal tap 4-6-24 diagnosed with Transverse Myelitis by neurologist started on 5 days of high dose IV Solumedrol Attending hospitalist pointed out that pt received 5 vaccines on 2-22-24 and he thought that was too many to give at one time. He said, "I would have spaced them out and not given the 2 Meningiococcal vaccines at the same time. That will overwhelm the immune system. The Moderna Covid has been know to cause transverse myelitis as an adverse reaction." Also, dr never had my consent for pt to receive the HPV or the Meningiococcal vaccines.  4-11-24 repeat MRI of head and spine under general anesthesia- results unchanged 4-17-24- Pt was transferred to Rehabilitation hospital.  Physical status declined and pt had another CT of his head- results normal.  Pt is still hospitalized today (5-19-24) and is finally making some physical gains. He can walk with a walker with assistance and is gaining better use of his right arm, right hand, right leg. He still remains weaker on his right side of his body. He still has clonus.   There is a VAERS report filed by on 4-15-2024. The VAERS number is 1018564.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse event/ PQC reported.; Nurse calling to report a dose of VARIVAX was administered after experiencing a temperature excursion.; This spontaneous report was received from a nurse and refers to a unspecified age and gender patient. No information regarding the patient's medical history, previous drug reactions or allergies and concomitant medications was provided.   On 14-MAY-2024, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection, lot #X024649, expiration date: 11-OCT-2025, and lot number X025846 expiration date 31-OCT-2025 (who had been verified to be a valid lot numbers) administered for prophylaxis (strength, and route of administration were not provided).   The nurse was reported that the vaccine was administered after experiencing a temperature excursion with a temperature of -11.1C with a time frame of 1 hour 54 minutes and 0 seconds (product storage error). There was no information about previous temperature excursion. No adverse event.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Impetigo, Rash, Rash erythematous, Rash pruritic, Skin odour abnormal
Clinical narrative: Impetigo; the rash was itchy; the rash was red; had an odor to it; The rash became worse/The rash was located under the patient's breasts/the rash was painful; This non-serious case was reported by a consumer via patient support programs and described the occurrence of impetigo in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included rash. Previously administered products included COVID-19 vaccine (received a covid vaccine in September or October 2023) and Influenza vaccine (received a Flu vaccine in September or October 2023). Concurrent medical conditions included melanoma. Concomitant products included famotidine (Pepcid), montelukast sodium (Singulair), meloxicam, nebivolol hydrochloride (Nebivolol) and bupropion hydrochloride (Wellbutrin).   On 26-NOV-2023, the patient received the 1st dose of Shingrix. In NOV-2023, less than a week after receiving Shingrix, the patient experienced rash (Verbatim: The rash became worse/The rash was located under the patient's breasts/the rash was painful). On an unknown date, the patient experienced impetigo (Verbatim: Impetigo), itchy rash (Verbatim: the rash was itchy), red rash (Verbatim: the rash was red) and body odor (Verbatim: had an odor to it). The patient was treated with hydrocortisone and doxycycline hydrochloride (Doxycycline). The outcome of the impetigo, rash, itchy rash, red rash and body odor were resolved.   It was unknown if the reporter considered the impetigo, rash, itchy rash, red rash and body odor to be related to Shingrix.     It was unknown if the company considered the impetigo, rash, itchy rash, red rash and body odor to be related to Shingrix.   Additional Information: GSK receipt date: 07-MAY-2024 The patient was received the 1st dose of Shingrix vaccine. The patient was gone to her healthcare professional for a routine physical check up on or about 29th November 2023. The patient complained of a rash at the time to the healthcare professional. The patient did not notice the rash until after she received the Shingrix vaccine, the rash could have been there prior to receiving the Shingrix vaccine, but she did not notice. The rash was located under the patient's breasts.  The healthcare professional prescribed an antifungal powder, which did not help.  The rash became worse, so the patient gone to a dermatologist on 12th December 2023 for treatment of the rash, by this time, the rash was itchy, painful, red and had odor to it. The dermatologist prescribed Hydrocortisone cream and Doxycycline (100mg for 2 weeks).  The rash subsequently cleared up. The final diagnosis for the patient's rash was Impetigo. The patient returned from a cruise 9th November 2023. The reporter consent to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Therapeutic response unexpected
Clinical narrative: Shingrix appears to have eliminated cold sores; This non-serious case was reported by a consumer and described the occurrence of unexpected therapeutic effect in a 64-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included cold sores (typically have 2-3 cold sore outbreaks per year).   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced unexpected therapeutic effect (Verbatim: Shingrix appears to have eliminated cold sores). The outcome of the unexpected therapeutic effect was unknown.   Additional Information: GSK Receipt date: 08-MAY-2024  A reporter reported that Shingrix appears to have eliminated cold sores, suggest a clinical trial.
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash vesicular
Clinical narrative: itching; shingles like rash; This non-serious case was reported by a physician via sales rep and described the occurrence of pruritus in a 52-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 30-APR-2024, the patient received the 1st dose of Shingles vaccine. On 10-MAY-2024, 10 days after receiving Shingles vaccine, the patient experienced pruritus (Verbatim: itching) and vesicular rash (Verbatim: shingles like rash). The outcome of the pruritus and vesicular rash were resolving.   It was unknown if the reporter considered the pruritus and vesicular rash to be related to Shingles vaccine.     It was unknown if the company considered the pruritus and vesicular rash to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 16-MAY-2024  A reporter reported that patient reported itching and shingles like rash. Patient had no known health concerns.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Incomplete course of vaccination; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of Shingrix vaccine on 27th February 2020 from batch Y9K7L (either I or L at end)).   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: Incomplete course of vaccination). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 08-MAY-2024 The patient was come for her 2nd Shingrix shot. The physician didn't clarify if 2nd dose was given or not today (on the day of reporting). Till the time of reporting, the patient did not receive 2nd dose of Shingrix vaccine, which led to incomplete course of vaccination.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: shot hurt like hell for over a week; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain (Verbatim: shot hurt like hell for over a week). The outcome of the pain was resolved.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.     It was unknown if the company considered the pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 09-MAY-2024 This case was reported by a patient via interactive digital media. The reporter reported that he/she was so glad that he/she got the shot then although the shot hurt like hell for over a week.
Sex: U
Vaccine: RVX
Symptoms: Malaise
Clinical narrative: was sick for 2 month; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced sickness (Verbatim: was sick for 2 month). The outcome of the sickness was resolved (duration 2 months).   It was unknown if the reporter considered the sickness to be related to RSV vaccine.     It was unknown if the company considered the sickness to be related to RSV vaccine.   Additional Information: GSK Receipt Date: 09-MAY-2024 The case was received from the patient via interactive digital media. The reporter reported that he/she took the RSV shot and was sick for 2 month afterwards so would not scare people with lies to make money.
Sex: M
Vaccine: RVX
Symptoms: Malaise
Clinical narrative: sick ever since; 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 RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   In NOV-2023, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced sickness (Verbatim: sick ever since). The outcome of the sickness was not resolved.   It was unknown if the reporter considered the sickness to be related to RSV vaccine.     It was unknown if the company considered the sickness to be related to RSV vaccine.   Additional Information: GSK Receipt Date: 09-MAY-2024 This case was reported by the patient's wife via interactive digital media. The reporter stated that her husband (patient) received the dose of RSV vaccine and he had been sick ever since he got the vaccine in November. She wishes that he never got the vaccine. The reporter stated that did not anyone get the RSV shot. She saw they discontinued to adults. This case had been linked to the case US2024AMR060421 reported by the same reporter.; Sender's Comments:  US-GSK-US2024AMR060421:Same reporter different patient
Sex: F
Vaccine: RVX
Symptoms: Malaise
Clinical narrative: sick ever since; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in a female patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   In NOV-2023, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced sickness (Verbatim: sick ever since). The outcome of the sickness was not resolved.   It was unknown if the reporter considered the sickness to be related to RSV vaccine.     It was unknown if the company considered the sickness to be related to RSV vaccine.   Additional Information: GSK Receipt Date: 09-MAY-2024 This case was reported by a patient via interactive digital media. The reporter (patient) received the dose of RSV vaccine and she had been sick ever since she got the vaccine in November. She wishes that she never got the vaccine. The reporter stated that did not anyone get the RSV shot. She saw they discontinued to adults. This case had been linked to the case US2024AMR060414 reported by the same reporter.; Sender's Comments:  US-GSK-US2024AMR060414:same reporter different patient
Sex: U
Vaccine: VARZOS
Symptoms: Tenderness
Clinical narrative: tender arm; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain in arm (Verbatim: tender arm). 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 Shingles vaccine.     It was unknown if the company considered the pain in arm to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 10-MAY-2024 This case was reported by a patient via interactive digital media. The patient just had his/her 2nd shot of Shingles vaccine and had no reaction other than a tender arm.
Sex: U
Vaccine: RSV
Symptoms: Intercepted product prescribing error, Product prescribing issue
Clinical narrative: pulmonologist recently prescribed GlaxoSmithKline's new RSV vaccine for him. While he understood that the patient was under the recommended age of 60 for the vaccine; This non-serious case was reported by a consumer and described the occurrence of intercepted drug prescribing error in a 54-year-old patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   The patient's past medical history included respiratory syncytial virus infection (very sick with RSV last winter). Concurrent medical conditions included asthma.   On an unknown date, the patient did not receive Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced intercepted drug prescribing error (Verbatim: pulmonologist recently prescribed GlaxoSmithKline's new RSV vaccine for him. While he understood that the patient was under the recommended age of 60 for the vaccine). The outcome of the intercepted drug prescribing error was unknown.   Additional Information: GSK Receipt Date: 10-MAY-2024 The patient's pulmonologist recently prescribed GlaxoSmithKline's new RSV vaccine for him/her.  While he understood that the patient was under the recommended age of 60 for the vaccine, which led to intercepted drug prescribing error. The patient got very sick with RSV last winter (leading to a trip to the ER) and had asthma and other problematic conditions . So he thought the vaccine would be beneficial.  The patient received the prescription but the pharmacist told then he could not proceed it because the patient under the age of 60.  The pharmacist could not even tell the patient if his/her insurance would cover it because his pharmacy computer system would not let him get to that point in the process. The reporter was wondering if GlaxoSmithKline knew of any way for him/her to obtain that vaccine before he/she turned the age of 60.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; 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 (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, 2 days after receiving Shingrix, the patient experienced shingles (Verbatim: shingles). The outcome of the shingles was not reported.   It was unknown if the reporter considered the shingles to be related to Shingrix.     It was unknown if the company considered the shingles to be related to Shingrix.   Additional Information: GSK Receipt Date: 12-MAY-2024 The patient got the shot and 2 days later broke out with the shingles.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Missed dose; This non-serious case was reported by a pharmacist and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (had 1st dose in 2020).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: Missed dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 17-MAY-2024 Patient had 1st dose in 2020, and has not yet received 2nd dose, which led to incomplete course of vaccination.
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Consumer received first Shingrix dose in 2022 and 2nd dose January 2024.; This non-serious case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose of Shingrix in 2022).   In JAN-2024, the patient received the 2nd dose of Shingrix. In JAN-2024, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: Consumer received first Shingrix dose in 2022 and 2nd dose January 2024.). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 07-MAY-2024 The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccination schedule.
Sex: U
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: patients younger than 4 years of age recived kinrix; This non-serious case was reported by a physician via call center representative and described the occurrence of inappropriate age at vaccine administration in an unspecified number of patients who received DTPa-IPV (Kinrix) for prophylaxis.   On an unknown date, the patient received Kinrix. On an unknown date, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: patients younger than 4 years of age recived 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: 07-MAY-2024 The reporter asked a questions why Kinrix was not approved for patients younger than 4 years of age. The reporter reported that during the call the HCP mentioned that Kinrix was given to an unknown number of patients who younger than 4 years of age which led to, inappropriate age at vaccine administration. The HCP asked for expected side effects of the administration of Kinrix to these patients. The reporter did not provide patients information. The reporter did not consent to follow up.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: first Shingrix shot 6/2021 and her second one 2/2024; 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 69-year-old female patient who received Herpes zoster (Shingrix) (batch number 3dk7e, expiry date 25-JAN-2026) for prophylaxis.   Previously administered products included Shingrix (on June 2021 received 1st dose.).   In FEB-2024, the patient received the 2nd dose of Shingrix. In FEB-2024, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: first Shingrix shot 6/2021 and her second one 2/2024). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt date: 08-MAY-2024 A pharmacist reported that he/she had a patient who received her first Shingrix shot in June 2021 and her second one February 2024. The reporter wanted to know if the patient got another one now, 3 months after her 2nd one. The patient received 2nd dose of Shingrix later than the recommended interval, which led to lengthening of the vaccine schedule
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: received dose 1 of Shingrix in fall of 2022 and dose 2 of Shingrix two to three weeks ago; This non-serious case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a 73-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (on fall of 2022 received 1st dose).   In APR-2024, the patient received the 2nd dose of Shingrix. In APR-2024, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: received dose 1 of Shingrix in fall of 2022 and dose 2 of Shingrix two to three weeks ago). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt date: 08-MAY-2024  The patient self-reported. He received dose 1 of Shingrix in fall of 2022 and dose 2 of Shingrix two to three weeks ago.  The patient received 2nd dose of Shingrix later than the recommended interval, which led to lengthening of the vaccine schedule.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Inappropriate schedule of vaccine; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 86-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 23-JAN-2020 with batch number 24KZ7).   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: Inappropriate schedule of vaccine). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 08-MAY-2024  The patient received first dose of Shingrix vaccine and presented to pharmacy on the day of reporting to requesting for second dose.  The reporter stated that at the time of reporting, it had not yet been administered. The vaccine administration facility was the same as primary reporter. Till the time of reporting patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: U
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: pediatric dose of Engerix-B was administered to an adult patient; pediatric dose of Engerix-B was administered to an adult patient; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of underdose in a adult patient who received HBV (Engerix B pediatric) for prophylaxis.   On 03-APR-2024, the patient received Engerix B pediatric 10 µg. On 03-APR-2024, an unknown time after receiving Engerix B pediatric, the patient experienced underdose (Verbatim: pediatric dose of Engerix-B was administered to an adult patient) and adult use of a child product (Verbatim: pediatric dose of Engerix-B was administered to an adult patient). The outcome of the 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: 08-MAY-2024 The pharmacist reported that the pediatric dose of Engerix B was administered to an adult patient which led to underdose and adult use of a child product. The reporter knows that another pediatric dose could not be administered. He asked what was the timeline for administering the correct dose. The vaccine administration facility was the same as primary reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Antibody test negative, Pain in extremity, Rash vesicular, Skin discolouration
Clinical narrative: 6 blisters that resembled chicken pox; injected arm was a little sore; purplish marks on her skin; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of blister in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Varicella vaccine (vaccinated for chicken pox (varicella) in 1996).   On an unknown date, the patient received the 1st dose of Shingrix (unknown arm). On an unknown date, an unknown time after receiving Shingrix, the patient experienced blister (Verbatim: 6 blisters that resembled chicken pox), pain in arm (Verbatim: injected arm was a little sore) and skin discoloration (Verbatim: purplish marks on her skin). The outcome of the blister and pain in arm were resolved and the outcome of the skin discoloration was not resolved.   The reporter considered the blister and pain in arm to be related to Shingrix. It was unknown if the reporter considered the skin discoloration to be related to Shingrix.     The company considered the blister and pain in arm to be related to Shingrix. It was unknown if the company considered the skin discoloration to be related to Shingrix.   Additional Information: GSK Receipt Date: 08-MAY-2024 The pharmacist reported that she herself received first Shingrix dose a couple of months ago and then (unspecified number of days) later developed a reaction of about 6 blisters that resembled chicken pox. The reporter reported that they were all on the right side of her body. she did not get seen, so unknown diagnosis. The reporter at first she thought they were spider bites. The reporter stated that they lasted for a month or more and blistered. The blisters had resolved but had left purplish marks on her skin. she also reported that the injected arm was a little sore.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Accidental underdose, Device defective, Product complaint, Syringe issue, Underdose
Clinical narrative: Syringe leak; Product Complaint; patient only received a partial dose; This non-serious case was reported by a nurse via call center representative and described the occurrence of accidental underdose in a 6-month-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number 9P329, expiry date 06-MAR-2026) for prophylaxis. This case was associated with a product complaint.   On 07-MAY-2024, the patient received Pediarix. On 07-MAY-2024, an unknown time after receiving Pediarix, the patient experienced accidental underdose (Verbatim: patient only received a partial dose). On an unknown date, the patient experienced syringe leak (Verbatim: Syringe leak) and pharmaceutical product complaint (Verbatim: Product Complaint). The outcome of the accidental underdose, syringe leak and pharmaceutical product complaint 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: 08-MAY-2024 The registered nurse reported that when a staff member was administering a dose of Pediarix to a patient yesterday (day before reporting), the medication squirted out the side of the syringe and the patient only received a partial dose, which led to accidental underdose. The reporter stated, he/she did review product instructions for use step by step. Confirmation that all operations were performed appropriately before defect was discovered. The defect was discovered during administration. It was not known where in the multi pack the suspect dose was located. As per product instructions the mixing/shaking performed after reconstitution and/or re-suspension. The suspect product was partially administered. The HCP was an experienced user. Clearly describe which component was impacted. The pre filled syringe was the component impacted. Leaky syringe from needle connection or plunger stopper. It was unknown if where did it leak. The syringe and needle was assembled in the room with the patient. 25G1inch needle size gauge needle was used. No blister and/or carton damaged. It was unknown if leaking from plunger stopper, were there any liquid traces observed on the plunger stopper rings. No luer lok damaged and needle which was used, available. No any damage/breakage on the syringe barrel. All components and the needle would be returned to GSK and reporter requested to credit 1 dose of Pediarix.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: patients did not receive 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 an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (patients received first doses over 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: patients did not receive 2nd dose yet). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 08-MAY-2024 The reporter stated that she did not have a specific patient she was calling about, but she had patients coming in soon for 2nd doses and some patients had their first doses over a year ago, hence she wanted to know do they need to restart the series or not. Till the time of reporting, the patients did not receive second dose of Shingrix, which led to an incomplete course of vaccination. The reporter consented to follow up.
Sex: U
Vaccine: RSV
Symptoms: Product preparation issue
Clinical narrative: incorrect preparation of Arexvy vaccine/ only administered the diluent; have been an occasion that it was only administered the diluent of the product; 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 RSVPreF3 adjuvanted (Arexvy) (batch number 9RP9M, expiry date 04-OCT-2025) for prophylaxis.   In APR-2024, the patient received the 1st dose of Arexvy. In APR-2024, an unknown time after receiving Arexvy, the patient experienced inappropriate preparation of medication (Verbatim: incorrect preparation of Arexvy vaccine/ only administered the diluent) and inappropriate dose of vaccine administered (Verbatim: have been an occasion that it was only administered the diluent of the product). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 08-MAY-2024 The reporter called and reported that he/she wanted to inquire regarding the Arexvy vaccine because he/she believed that there might have been an occasion that it was only administered the diluent of the product to the patient, which led to an inappropriate preparation of medication and inappropriate dose of vaccine administered. Healthcare professional did not have patient initials, date of birth nor gender yet he provided batch number.  The administration of the adjuvant was done at the end of April 2024. The healthcare professional did not have the exact date. The reporter consented to follow up.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: pain at the injection site; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 64-year-old female patient who received Herpes zoster (Shingrix) (batch number 274YD, expiry date 15-SEP-2025) for prophylaxis.   On 23-MAR-2024, the patient received the 1st dose of Shingrix (left deltoid) .5 ml. In MAR-2024, 1 hr after receiving Shingrix, the patient experienced injection site pain (Verbatim: pain at the injection site). In MAR-2024, the outcome of the injection site pain was resolved (duration 2 days).   It was unknown if the reporter considered the injection site pain to be related to Shingrix.     It was unknown if the company considered the injection site pain to be related to Shingrix.   Additional Information: GSK receipt date: 09-MAY-2024 The patient self-reported this case. The patient had pain at the injection site 1 hour after receiving injection. Pain resolved 2 days after onset. Family physician was retired and no physician available at this time.; Sender's Comments:  US-GSK-US2024059124:Same reporter/Diffrent patient (wife)
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Product preparation error
Clinical narrative: instead of using the proper additive they may have used sterile water or diluent; he received the vaccine stating that vaccine may be deemed ineffective; This non-serious case was reported by a consumer via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 63-year-old male patient who received Herpes zoster (Shingrix) (batch number 274YD, expiry date 15-SEP-2025) for prophylaxis.   On 23-MAR-2024, the patient received Shingrix (left deltoid) .5 ml. On 23-MAR-2024, an unknown time after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution (Verbatim: instead of using the proper additive they may have used sterile water or diluent) and inappropriate dose of vaccine administered (Verbatim: he received the vaccine stating that vaccine may be deemed ineffective). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 09-MAY-2024 The patient self reported this case. The patient received his first dose of Shingrix vaccine.  He received a letter from the location he received the vaccine stating that vaccine might be deemed ineffective (lack of efficacy). The patient called the clinic and number on the letter to obtain more information. The patient reported that the manager of the clinic states, instead of using the proper additive they might had used sterile water or diluent, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.  The patient reports that the manager states, when they did their inventory they had 2 extra vials.  Two people might not have gotten the proper additive in the vaccine (wrong solution used). The patient and his wife received Shingrix vaccine at the same time with the same lot number. However wife did not receive a letter. This case had been link with US2024059122, reported by the same reporter.; Sender's Comments:  US-GSK-US2024059122:Same reporter/Diffrent patient (wife)
Age: 45.0
Sex: F
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration
Clinical narrative: A patient received the second dose of Havrix a week after having the first dose.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 45-year-old female patient who received HAV (Havrix) for prophylaxis.   Concomitant products included HEPATITIS A VACCINE INACT (HAVRIX).   On 09-MAY-2024, the patient received Havrix. On 09-MAY-2024, an unknown time after receiving Havrix, the patient experienced drug dose administration interval too short (Verbatim: A patient received the second dose of Havrix a week after having the first dose.). The outcome of the drug dose administration interval too short 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: 09-MAY-2024 The pharmacist reported that, the patient received the 2nd dose of Havrix a week after having the 1st dose which led to shortening of vaccination schedule. The vaccine administration facility was the same as primary reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: received Shingrix first dose 4 years ago and never got second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 74-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose 4 years ago in a doctor's office on 17-JAN-2020).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: received Shingrix first dose 4 years ago and never got second dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 09-MAY-2024 The reporter had an immunocompetent patient who never got second dose of Shingrix. No data available on lot number or expiration date of the first dose. Till the time of reporting, the patient did not receive the second dose of Shingrix, which led to an incomplete course of vaccination. The reporter consented to follow up.
Age: 28.0
Sex: M
Vaccine: HEPAB
Symptoms: Product storage error
Clinical narrative: Vaccine stored outside recommended conditions and administered to patient; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a 28-year-old male patient who received HAB (Twinrix) (batch number H7RF2, expiry date 17-JAN-2026) for prophylaxis.   On 29-MAR-2024, the patient received the 1st dose of Twinrix. On an unknown date, an unknown time after receiving Twinrix, the patient experienced incorrect storage of drug (Verbatim: Vaccine stored outside recommended conditions and administered to patient). 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: 09-MAY-2024 and 10-MAY-2024  The pharmacist wanted to know what the adverse events were for administering a vaccine that was recalled on some Glaxo because the product was not stored at the recommended temperature. The reporter had a patient who received the Twinrix vaccination, and he was asking what the potential adverse effects would be since he received the administration after well prior, to the recall notice, which led to an incorrect storage of drug. The reporter wanted to stay anonymous and did not consent follow-up from PV.  This case had been linked to the case US2024059164, reported by the same reporter.; Sender's Comments:  US-GSK-US2024059164:Same reporter
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Product preparation issue
Clinical narrative: inappropriate reconstitution technique; just the adjuvant for Shingrix was administered to a patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 51-year-old male patient who received Herpes zoster (Shingrix) (batch number 444N2, expiry date 25-JAN-2026) for prophylaxis.   On 09-MAY-2024, the patient received the 2nd dose of Shingrix. On 09-MAY-2024, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: inappropriate reconstitution technique) and inappropriate dose of vaccine administered (Verbatim: just the adjuvant for Shingrix was administered to a patient). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 09-MAY-2024 The nurse office manager stated that just the adjuvant for Shingrix was administered to a patient, which led to an inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter asked were there any risks and wanted to know what he/she should do from there. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.