chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: F
Vaccine: UNK
Symptoms: Underdose, Wrong technique in product usage process
Clinical narrative: she may not have gotten a full dose of the Flulaval because the nurse shot a good bit of it into the air before she injected it into her; nurse did not shake the Flulaval prior to administering it to her, she rolled it in her hands to warm it up; This case was reported by a consumer via call center representative and described the occurrence of underdose in a 61-year-old female patient who received Flu Seasonal QIV(FluLaval Quadrivalent 2022-2023 season) for prophylaxis.   Co-suspect products included flu seasonal qiv  pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 25th October 2022, the patient received FluLaval Quadrivalent 2022-2023 season (intramuscular) and Flulaval Tetra Pre-Filled Syringe Device. On 25th October 2022, unknown after receiving FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced underdose and wrong technique in product usage process. On an unknown date, the outcome of the underdose and wrong technique in product usage process 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: 25-Oct-2022 Reporter's comment: The reporter reported that the nurse did not shake the Flulaval prior to administering it to the patient in right arm.  When asked the nurse said she rolled it in her hands to warm it up. The reporter also reported she might not had gotten a full dose of the Flulaval because the nurse had a shot a good bit of it into the air before she injected it into the patient. The reporter would like safety to contact her to see if she needed to be revaccinated, or if she was okay to do nothing. The reporter did not give permission to contact health-care professional.   The reporter did not consent to follow-up. Additional Supportive Information: The nurse did not shake the Flulaval prior and a good bit of it into the air before she injected it into the patient, which led to underdose and wrong technique in product usage process.
Sex: F
Vaccine: VARZOS
Symptoms: Neuralgia
Clinical narrative: nerve pain in her side/pains are ongoing; This case was reported by a consumer via call center representative and described the occurrence of nerve pain in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (shingles virus on her stomach side and back). Concomitant products included RECOMBINANT VARICELLA ZOSTER VIRUS SURFACE GLYCOPROTEIN E (SHINGRIX).   In March 2018, the patient received the 2nd dose of Shingrix. On an unknown date, 1 year after receiving Shingrix, the patient experienced nerve pain. On an unknown date, the outcome of the nerve pain was not recovered/not resolved.   It was unknown if the reporter considered the nerve pain to be related to Shingrix.     Additional Information: GSK Receipt Date: 25-OCT-2022 Reporter's Comment: Reported stated that about 4 years ago patient had shingles virus on her stomach/side, and back. After it cleared patient got the Shingrix series. The patient believed the doses were administered in January and March about 4 years ago.  The patient started having nerve pain in her side where the shingles rash was years prior. The pains were ongoing. The patient does not have the exact dates of administration or lot number expiration date information. Reporter consented to follow up.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Herpes zoster
Clinical narrative: experiencing internal Shingles; shooting pain on temple areas of their head, it continues; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 55-year-old female patient who received Herpes zoster (Shingrix) (batch number LG2XJ, expiry date unknown) for prophylaxis.   On 10th September 2022, the patient received Shingrix. In September 2022, 10 days after receiving Shingrix, the patient experienced shingles and head pain. On an unknown date, the outcome of the shingles was unknown and the outcome of the head pain was not recovered/not resolved.   It was unknown if the reporter considered the shingles and head pain to be related to Shingrix.     Additional Information: GSK Receipt Date: 25-OCT-2022 Reporter's Comment: The patient self-reported this case. Concomitant products included antiviral medication. The patient received first dose of Shingrix on September 10 2022 left arm. The patient experienced upward shooting pain in the right side of the head 10 days after receiving dose.  The patient made appointment with healthcare professional and being told she was likely experiencing a case of internal Shingles.  Health care professional did not officially diagnose them with Shingles, but made the suggestion based on patient's report of her systems. Patient continue to experience shooting pain on both sides of their head, around the temple areas. Reporter consented to follow.
Age: 17.0
Sex: M
Vaccine: UNK
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Flulaval on October 25, 2022 and October 13, 2022; This case was reported by a physician via call center representative and described the occurrence of extra dose administered in a 17-year-old male patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2022-2023 season) (batch number 437BK, expiry date 30th June 2023) for prophylaxis.   Concomitant products included INFLUENZA VACCINE INACT (FLULAVAL QUADRIVALENT).   On 25th October 2022, the patient received FluLaval Quadrivalent 2022-2023 season. On 25th October 2022, unknown after receiving FluLaval Quadrivalent 2022-2023 season, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   Additional Information: GSK receipt date: 25-Oct-2022 and 26-Oct-2022 Reporter's comment: Medicine of doctor reported that they administered a Flulaval on the day of reporting to a patient, who already received a Flulaval vaccine. The reporter had reported this to vaers already. The reporter asked that they want to know what kind of effect this may had on him and the impact of next year's flu vaccine or there was anything that they need to be on the lookout for. No additional adverse event details were available outside of what was reported in the adverse report. The reporter consented to follow-up. Additional supportive information: The patient received an extra dose of Flulaval, which led to extra dose administered.
Age: 17.0
Sex: M
Vaccine: UNK
Symptoms: Incorrect route of product administration
Clinical narrative: administering intranasally; This case was reported by a nurse via call center representative and described the occurrence of intramuscular formulation administered by other route in a 17-year-old male patient who received Flu Seasonal QIV (FluLaval Quadrivalent 2022-2023 season) (batch number 3393T, expiry date 30th June 2023) for prophylaxis.   Co-suspect products included flu seasonal qiv pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 25th October 2022, the patient received FluLaval Quadrivalent 2022-2023 season (intranasal) and Flulaval Tetra Pre-Filled Syringe Device. On 25th October 2022, unknown after receiving FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the intramuscular formulation administered by other route was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 26-Oct-2022 Reporter's comment: The health department had a flu clinic one day before the reporting date. The reporter reported that they were administering Flulaval and an intranasal flu vaccine and a nurse volunteer gave Flulaval intranasally to 3 patients. The vaccine administration facility was the same as primary reporter. The facility address was also reported above in health care professional's details. The reporter consented to follow-up by phone. This was for 2 of 3 linked cases reported by same reporter. Additional supportive information: The patient received Flulaval vaccine intranasally, which led to intramuscular formulation administered by other route.; Sender's Comments:  US-GSK-US2022AMR154541:Same reporter US-GSK-US2022154655:Same reporter-Deleted US-GSK-US2022154657:Same reporter
Age: 16.0
Sex: F
Vaccine: UNK
Symptoms: Incorrect route of product administration
Clinical narrative: administered intranasally; This case was reported by a nurse via call center representative and described the occurrence of intramuscular formulation administered by other route in a 16-year-old female patient who received Flu Seasonal QIV  (FluLaval Quadrivalent 2022-2023 season) (batch number 3393T, expiry date 30th June 2023) for prophylaxis.   Co-suspect products included flu seasonal qiv pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 25th October 2022, the patient received FluLaval Quadrivalent 2022-2023 season (intranasal) and Flulaval Tetra Pre-Filled Syringe Device. On 25th October 2022, unknown after receiving FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the intramuscular formulation administered by other route was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 26-Oct-2022 Reporter's comment: The health department had a flu clinic one day before the reporting date. The reporter reported that they were administering Flulaval and an intranasal flu vaccine and a nurse volunteer gave Flulaval intranasally to 3 patients. The vaccine administration facility was the same as primary reporter. The facility address was also reported above in health care professional's details. The reporter consented to follow-up by phone. This was for 3 of 3 linked cases reported by same reporter. Additional supportive information: The patient received Flulaval vaccine intranasally, which led to intramuscular formulation administered by other route.; Sender's Comments:  US-GSK-US2022154656:Same reporter US-GSK-US2022AMR154541:Same reporter US-GSK-US2022154655:Same reporter-Deleted
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Body aches, pains; This case was reported by a consumer via call center representative and described the occurrence of general body pain in a 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a month after receiving Shingrix, the patient experienced general body pain. On an unknown date, the outcome of the general body pain was unknown.   It was unknown if the reporter considered the general body pain to be related to Shingrix.     Additional Information: GSK Receipt Date: 26-OCT-2022 Reporter's comment: The case was self reported by the patient. The patient received first dose of Shingrix into right arm about 4 weeks ago and had body aches and pains. The reporter consented to follow up. The reporter did not have health care professional address. No additional details were provided by the reporter.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, DTAPHEPBIP, DTAPHEPBIP
Symptoms: Therapeutic response decreased
Clinical narrative: Lab work showed not immune for Hepatitis B; This case was reported by a consumer via call center representative and described the occurrence of therapeutic response decreased in a 2-month-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number 7S9NK, expiry date unknown) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa-HBV-IPV (Pediarix) (batch number 3NM93, expiry date unknown) for prophylaxis, dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa-HBV-IPV (Pediarix) (batch number 35ZF9, expiry date unknown) for prophylaxis and dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included hb vaccine (received HBV pediatric/adolescent on 21st November 2016 with batch number 9Z9LN).   On 23rd May 2017, the patient received the 3rd dose of Pediarix and Pediarix Pre-Filled Syringe Device. On 21st March 2017, the patient received the 2nd dose of Pediarix and Pediarix Pre-Filled Syringe Device. On 23rd January 2017, the patient received the 1st dose of Pediarix and Pediarix Pre-Filled Syringe Device. In July 2022, more than 2 years after receiving Pediarix, Pediarix Pre-Filled Syringe Device, Pediarix, Pediarix Pre-Filled Syringe Device, Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced therapeutic response decreased. On an unknown date, the outcome of the therapeutic response decreased was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 26-Oct-2022 Reporter's comment: The patient 's mother reported that the patient had completed her series with Pediarix. In July 2022, the lab work done which showed she was not immune for Hepatitis B (low titer) and had to have a booster dose of Hepatitis B vaccine on 30th August 2022. The reporter consented to follow-up. Additional supportive information: The patient had low titer of Hepatitis B after Pediarix series, which led to therapeutic response decreased.
Sex: F
Vaccine: DTAP
Symptoms: Incomplete course of vaccination
Clinical narrative: Missed 5th dose of DTaP vaccine at 4 y/o; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a 7-year-old female patient who received DTPa (DTaP vaccine) for prophylaxis.   Previously administered products included DTap vaccine  (received 4 doses of DTaP on an unknown date (unknown manufacturer/brand)).   On an unknown date, the patient did not receive the 5th dose of DTaP vaccine. On an unknown date, unknown after receiving DTaP vaccine, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 26-Oct2022 Reporter's comment: The patient never receive the 5th dose at 4 years of age. No additional information was available regarding brand/manufacturer of previous DTaP doses. The reporter consented to follow-up. Additional supportive information: Till the time of reporting, the patient did not receive 5th dose of DTaP, which led to incomplete course of vaccination.
Age: 60.0
Sex: F
Vaccine: UNK, VARZOS
Symptoms: Headache, Injection site erythema, Injection site rash, Injection site warmth, Vision blurred
Clinical narrative: Rash at the injection site; redness at Injection site; warm to touch, 4 by 5 inches; Headache; Blurred vision; This case was reported by a consumer via call center representative and described the occurrence of injection site rash in a 60-year-old female patient who received Herpes zoster (Shingrix) (batch number 4NY45, expiry date 15th September 2023) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2022-2023 season) (batch number Y9JS7, expiry date 30th June 2023) for prophylaxis and flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Zostavax (received on an unknown date).   On 20th October 2022, the patient received Shingrix, the 1st dose of Fluarix Quadrivalent 2022-2023 season (intramuscular) and Fluarix Tetra Pre-Filled Syringe Device. In October 2022, less than a week after receiving Shingrix, Fluarix Quadrivalent 2022-2023 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced injection site erythema and injection site warmth. On 20th October 2022, the patient experienced headache. On 21st October 2022, the patient experienced blurred vision. On 24th October 2022, the patient experienced injection site rash. The patient was treated with topical steroid nos (Steroid Cream) and antibiotics nos (Oral Antibiotic (Drug Name Unknown)). On an unknown date, the outcome of the injection site rash was not recovered/not resolved and the outcome of the injection site erythema and injection site warmth were unknown and the outcome of the headache and blurred vision were recovered/resolved.   It was unknown if the reporter considered the injection site rash, injection site erythema, injection site warmth, headache and blurred vision to be related to Shingrix, Fluarix Quadrivalent 2022-2023 season and Fluarix Tetra Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 26-OCT-2022 Reporter's comment: The case was self-reported by the patient. The patient received a dose of Shingrix and Fluarix into left deltoid and experienced headache immediately. The headache resolved after 3 days. The day after vaccination, the patient experienced blurred vision that resolved after 2 days. Four days after vaccination, the patient developed a rash at the injection site. The rash was red, warm to touch and about 4 inches by 5 inches. The borders of the rash were well-defined and rectangular, not curved.  The patient's doctor initially prescribed a steroid cream to treat the rash. He then prescribed an oral antibiotic because the rash was warm to the touch. No other details were reported. The reporter consented to follow up.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Expired product administered, Exposure during pregnancy
Clinical narrative: Expired dose administered to pregnant patient; Expired dose administered to pregnant patient; This prospective pregnancy case was reported by a other health professional via call center representative and described the occurrence of vaccine exposure during pregnancy in a 38-year-old female patient who received Flu Seasonal QIV  (FluLaval Tetra 2020-2021 season) (batch number DD352, expiry date 30th June 2021) for prophylaxis.   Co-suspect products included flu seasonal qiv pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 20th October 2022, the patient received FluLaval Tetra 2020-2021 season and Flulaval Tetra Pre-Filled Syringe Device. The patient's last menstrual period was on an unknown date and estimated date of delivery was 17th March 2023. The patient received FluLaval Tetra 2020-2021 season at an unknown time during the pregnancy. On 20th October 2022, unknown after receiving FluLaval Tetra 2020-2021 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the patient experienced vaccine exposure during pregnancy. On an unknown date, the outcome of the vaccine exposure during pregnancy and expired vaccine used were unknown. The pregnancy was ongoing.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 27-Oct-2022 Reporter's comment: The office manager called to inquired that any adverse effects to look for or if the patient needs to be revaccinated. The reporter confirmed that the Flulaval was administered in their facility. The reporter consented to follow-up. Additional supportive information: The patient received an expired dose of Flulaval in right deltoid during her pregnancy, which led to vaccine exposure during pregnancy and expired vaccine used. Suspect was coded as Flulaval tetra 2020-2021 season as both Flualval tetra and Flulaval quadrivalent both are same in terms of active ingredient and also considering the expiration date.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: Received Menveo rather than Bexsero; Received a third dose of Menveo; This case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 16-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA766A, expiry date 1st December 2023) for prophylaxis.   Previously administered products included Menveo (received 1st dose in 2017) and Menveo (received 2nd dose in August 2022).   On 26th October 2022, the patient received the 3rd dose of Menveo. On 26th October 2022, unknown after receiving Menveo, the patient experienced wrong vaccine administered and extra dose administered. On an unknown date, the outcome of the wrong vaccine administered and extra dose administered were unknown.   Additional Information: GSK receipt date: 27-Oct-2022 Reporter's comment: Nothing else was reported. The vaccine administration was the same as primary reporter. The reporter consented to follow-up. Additional supportive information: The patient mistakenly received third dose of Menveo rather than the intended Boostrix, which led to wrong vaccine administered and extra dose administered.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose Dec2021, 2nd not yet; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 92-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 0.5 ml of first dose on 9th December 2021).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 27-Oct-2022 Reporter's comment: The pharmacist stated that the patient had not yet gotten the second one (past the recommended 6 months). The reporter did not had any further information about the vaccine itself. Did not consent to follow-up. Additional supportive information: Till the time of reporting the patient did not receive the second dose of Shingrix, which led to incomplete course of vaccination.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Got 1st dose and developed HZ 4 days later/now has shingles; This case was reported by a nurse via call center representative and described the occurrence of shingles in a 63-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 21st September 2022, the patient received the 1st dose of Shingrix. In September 2022, 4 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional Information: GSK Receipt Date: 27-OCT-2022 Reporter's Comment: The reporter reported that, a patient was vaccinated Shingrix and developed herpes zoster 4 days later.  The reporter did not have batch or expiration date because patient was vaccinated in a different facility (pharmacy).  The first attempt to get adverse event information was declined, patient details were share after second attempt. There was no opportunity to ask healthcare professional for follow up with team since mentioned only had a few minutes to go over the call.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Chest pain, Cryotherapy, Fatigue, Herpes zoster
Clinical narrative: Rash on the left arm, developed rashes, on Left thoracic spine and under my L breast; Pain, extremely painful; Unable to sleep at night; Unable to work, workout, do housework; Additional fatigue; Numb; Shingles; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included ankylosing spondylitis (took Humira for a very mild case of AS (Ankylosing Spondylitis) which was diagnosed when patient was 64 year old). Previously administered products included HUMIRA (took Humira for a very mild case of AS (Ankylosing Spondylitis) which was diagnosed when patient was 64 year old).   On 14th October 2022, the patient received the 1st dose of Shingrix. In October 2022, 3 days after receiving Shingrix, the patient experienced shingles, pain, difficulty sleeping, activities of daily living impaired, fatigue and numbness. On 17th October 2022, the patient experienced rash. The patient was treated with valaciclovir hydrochloride (Valacyclovir Hydrochloride), lidocaine, non-drug therapy (Cryotherapy) and triamcinolone diacetate (Triamcinolone Acetate Cream). On an unknown date, the outcome of the shingles, pain, difficulty sleeping, activities of daily living impaired, fatigue and numbness were unknown and the outcome of the rash was not recovered/not resolved.   It was unknown if the reporter considered the shingles, rash, pain, difficulty sleeping, activities of daily living impaired, fatigue and numbness to be related to Shingrix.     Additional Information: GSK Receipt Date: 27-OCT-2022 Reporter's comment: The case was self reported by the patient. The patient received first dose of Shingrix into left arm and now experiencing a rash on the left arm that she stated was diagnosed as shingles by her dermatologist. Three days later, after vaccination the patient developed rashes on left thoracic spine and under left breast. Her doctor found it strange and had no explanation for that. The patient had no discharge, no pus, but extremely painful entire thoracic/lumbar area, painful both quads to the patella area, and unable to sleep at night and obviously unable to work, workout, or even do housework due to additional fatigue. At present the patient was taking Valacyclovir HCL 1 gram tablet 3x/day for 7 days, spreading Lidocaine and applying cryotherapy to numb pain, and Triamcinolone acetate cream to help with healing. The patient stated that her entire health status could be obtained from her primary care physician, if that helps with her case. The reporter did not wish to provide health care professional information. The reporter did not consent to follow up. Additional Supportive Information: Conservatively numbness event coded.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022GSK126305:Literature case previously created for the article mentioned at narrative
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Impaired work ability, Insomnia, Loss of personal independence in daily activities, Myalgia
Clinical narrative: Rash on the left arm, developed rashes, on Left thoracic spine and under my L breast; Pain, extremely painful; Unable to sleep at night; Unable to work, workout, do housework; Additional fatigue; Numb; Shingles; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included ankylosing spondylitis (took Humira for a very mild case of AS (Ankylosing Spondylitis) which was diagnosed when patient was 64 year old). Previously administered products included HUMIRA (took Humira for a very mild case of AS (Ankylosing Spondylitis) which was diagnosed when patient was 64 year old).   On 14th October 2022, the patient received the 1st dose of Shingrix. In October 2022, 3 days after receiving Shingrix, the patient experienced shingles, pain, difficulty sleeping, activities of daily living impaired, fatigue and numbness. On 17th October 2022, the patient experienced rash. The patient was treated with valaciclovir hydrochloride (Valacyclovir Hydrochloride), lidocaine, non-drug therapy (Cryotherapy) and triamcinolone diacetate (Triamcinolone Acetate Cream). On an unknown date, the outcome of the shingles, pain, difficulty sleeping, activities of daily living impaired, fatigue and numbness were unknown and the outcome of the rash was not recovered/not resolved.   It was unknown if the reporter considered the shingles, rash, pain, difficulty sleeping, activities of daily living impaired, fatigue and numbness to be related to Shingrix.     Additional Information: GSK Receipt Date: 27-OCT-2022 Reporter's comment: The case was self reported by the patient. The patient received first dose of Shingrix into left arm and now experiencing a rash on the left arm that she stated was diagnosed as shingles by her dermatologist. Three days later, after vaccination the patient developed rashes on left thoracic spine and under left breast. Her doctor found it strange and had no explanation for that. The patient had no discharge, no pus, but extremely painful entire thoracic/lumbar area, painful both quads to the patella area, and unable to sleep at night and obviously unable to work, workout, or even do housework due to additional fatigue. At present the patient was taking Valacyclovir HCL 1 gram tablet 3x/day for 7 days, spreading Lidocaine and applying cryotherapy to numb pain, and Triamcinolone acetate cream to help with healing. The patient stated that her entire health status could be obtained from her primary care physician, if that helps with her case. The reporter did not wish to provide health care professional information. The reporter did not consent to follow up. Additional Supportive Information: Conservatively numbness event coded.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022GSK126305:Literature case previously created for the article mentioned at narrative
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Rash
Clinical narrative: Rash on the left arm, developed rashes, on Left thoracic spine and under my L breast; Pain, extremely painful; Unable to sleep at night; Unable to work, workout, do housework; Additional fatigue; Numb; Shingles; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included ankylosing spondylitis (took Humira for a very mild case of AS (Ankylosing Spondylitis) which was diagnosed when patient was 64 year old). Previously administered products included HUMIRA (took Humira for a very mild case of AS (Ankylosing Spondylitis) which was diagnosed when patient was 64 year old).   On 14th October 2022, the patient received the 1st dose of Shingrix. In October 2022, 3 days after receiving Shingrix, the patient experienced shingles, pain, difficulty sleeping, activities of daily living impaired, fatigue and numbness. On 17th October 2022, the patient experienced rash. The patient was treated with valaciclovir hydrochloride (Valacyclovir Hydrochloride), lidocaine, non-drug therapy (Cryotherapy) and triamcinolone diacetate (Triamcinolone Acetate Cream). On an unknown date, the outcome of the shingles, pain, difficulty sleeping, activities of daily living impaired, fatigue and numbness were unknown and the outcome of the rash was not recovered/not resolved.   It was unknown if the reporter considered the shingles, rash, pain, difficulty sleeping, activities of daily living impaired, fatigue and numbness to be related to Shingrix.     Additional Information: GSK Receipt Date: 27-OCT-2022 Reporter's comment: The case was self reported by the patient. The patient received first dose of Shingrix into left arm and now experiencing a rash on the left arm that she stated was diagnosed as shingles by her dermatologist. Three days later, after vaccination the patient developed rashes on left thoracic spine and under left breast. Her doctor found it strange and had no explanation for that. The patient had no discharge, no pus, but extremely painful entire thoracic/lumbar area, painful both quads to the patella area, and unable to sleep at night and obviously unable to work, workout, or even do housework due to additional fatigue. At present the patient was taking Valacyclovir HCL 1 gram tablet 3x/day for 7 days, spreading Lidocaine and applying cryotherapy to numb pain, and Triamcinolone acetate cream to help with healing. The patient stated that her entire health status could be obtained from her primary care physician, if that helps with her case. The reporter did not wish to provide health care professional information. The reporter did not consent to follow up. Additional Supportive Information: Conservatively numbness event coded.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022GSK126305:Literature case previously created for the article mentioned at narrative
Sex: M
Vaccine: VARZOS
Symptoms: Apathy, Chills, Headache, Inappropriate schedule of product administration, Muscular weakness
Clinical narrative: first dose September 22, 2022, second on October 25, 2022; Chills; Muscle weakness; Muscle soreness; Lack of motivation; Head strain (back of the head); This case was reported by a consumer via call center representative and described the occurrence of chills in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included RECOMBINANT VARICELLA ZOSTER VIRUS SURFACE GLYCOPROTEIN E (SHINGRIX).   On 25th October 2022, the patient received the 2nd dose of Shingrix. In October 2022, less than a week after receiving Shingrix, the patient experienced chills, muscle weakness, muscle soreness, lack of motivation and headache. On 25th October 2022, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the chills, muscle weakness, muscle soreness, lack of motivation, headache and drug dose administration interval too short were unknown.   It was unknown if the reporter considered the chills, muscle weakness, muscle soreness, lack of motivation and headache to be related to Shingrix.     Additional Information: GSK Receipt Date: 27-OCT-2022 Reporter's comment: The patient self-reported this case. The patient stated that he received his first dose of Shingrix on 22nd September 2022, and his second dose on 25th October 2022 (AE Inappropriate Schedule of Vaccine). The patient also stated that after receiving the second dose, he experienced chills, muscle weakness, muscle soreness, lack of motivation, and head strain (back of the head). The patient did not wish to provided date of birth. The patient did not give consent to follow-up with HCP(Health Care Professional). The reporter did not consent to follow-up. Additional Supportive Information: The patient received 2nd dose of Shingrix vaccine earlier than the recommended interval, which led to shortening of vaccination schedule.
Sex: M
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: first dose September 22, 2022, second on October 25, 2022; Chills; Muscle weakness; Muscle soreness; Lack of motivation; Head strain (back of the head); This case was reported by a consumer via call center representative and described the occurrence of chills in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included RECOMBINANT VARICELLA ZOSTER VIRUS SURFACE GLYCOPROTEIN E (SHINGRIX).   On 25th October 2022, the patient received the 2nd dose of Shingrix. In October 2022, less than a week after receiving Shingrix, the patient experienced chills, muscle weakness, muscle soreness, lack of motivation and headache. On 25th October 2022, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the chills, muscle weakness, muscle soreness, lack of motivation, headache and drug dose administration interval too short were unknown.   It was unknown if the reporter considered the chills, muscle weakness, muscle soreness, lack of motivation and headache to be related to Shingrix.     Additional Information: GSK Receipt Date: 27-OCT-2022 Reporter's comment: The patient self-reported this case. The patient stated that he received his first dose of Shingrix on 22nd September 2022, and his second dose on 25th October 2022 (AE Inappropriate Schedule of Vaccine). The patient also stated that after receiving the second dose, he experienced chills, muscle weakness, muscle soreness, lack of motivation, and head strain (back of the head). The patient did not wish to provided date of birth. The patient did not give consent to follow-up with HCP(Health Care Professional). The reporter did not consent to follow-up. Additional Supportive Information: The patient received 2nd dose of Shingrix vaccine earlier than the recommended interval, which led to shortening of vaccination schedule.
Age: 54.0
Sex: F
Vaccine: UNK
Symptoms: Incorrect route of product administration, Product administered at inappropriate site
Clinical narrative: given in the back area of the left arm; not in the deltoid/into the fat; was given a subcutaneous injection; This case was reported by a other health professional via call center representative and described the occurrence of vaccine administered at inappropriate site in a 54-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2022-2023 season) (batch number FZ453, expiry date 30th June 2023) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 25th October 2022, the patient received Fluarix Quadrivalent 2022-2023 season (subcutaneous) and Fluarix Tetra Pre-Filled Syringe Device. On 25th October 2022, unknown after receiving Fluarix Quadrivalent 2022-2023 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced vaccine administered at inappropriate site and intramuscular formulation administered by other route. The action taken with Fluarix Quadrivalent 2022-2023 season was unknown. On an unknown date, the outcome of the vaccine administered at inappropriate site and intramuscular formulation administered by other route were unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 27-Oct-2022 Reporter's comment: The quality manager reported that patient was given a subcutaneous injection of Fluarix in the back area of the left at, not in the deltoid. No symptoms were reported. The reporter stated that there might be more patients involved once she reviews all the records. The reporter consented to follow-up via email. This was 1 of 2 linked patients, reported same reporter. Additional supportive information: The patient received Fluarix injection via subcutaneous route at inappropriate site, which led to vaccine administered at inappropriate site and intramuscular formulation administered by other route. The case US2022155536 was identified as duplicate of US2022155534. The case US2022155536 was deleted and all future correspondence would be added in the present case which stands as case of record for this patient; Sender's Comments:  US-GSK-US2022155535:same reporter
Sex: M
Vaccine: UNK
Symptoms: Product administered at inappropriate site
Clinical narrative: given near the right scapula area; not in the deltoid; This case was reported by a other health professional via call center representative and described the occurrence of vaccine administered at inappropriate site in a male patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2022-2023 season) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 26th October 2022, the patient received Fluarix Quadrivalent 2022-2023 season and Fluarix Tetra Pre-Filled Syringe Device. On 26th October 2022, unknown after receiving Fluarix Quadrivalent 2022-2023 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced vaccine administered at inappropriate site. On an unknown date, the outcome of the vaccine administered at inappropriate site 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: 27-Oct-2022 Reporter's comment: The quality manager reported that patient was given Fluarix injection near right scapula area near right arm, not in the deltoid. No symptoms were reported. The reporter did not had the patient's date of birth or lot/exp at the time of report. The reporter stated that there might be more patients involved once she reviews all the records. The reporter consented to follow-up. This was for 2 of 2 linked patients, reported by same reporter. Additional supportive information: The patient received Fluarix vaccine at inappropriate site, which led to vaccine administered at inappropriate site.; Sender's Comments:  US-GSK-US2022155534:same reporter
Sex: F
Vaccine: HEP
Symptoms: Wrong product administered
Clinical narrative: Patient received Engerix-B instead of Twinrix; This case was reported by a pharmacist via call center representative and described the occurrence of wrong vaccine administered in a 46-year-old female patient who received HBV (Engerix B) (batch number K9HS5, expiry date 18th March 2024) for prophylaxis.   Previously administered products included Twinrix (1st dose received on an unknown date ).   On 27th October 2022, the patient received Engerix B. On 27th October 2022, unknown after receiving Engerix B, the patient experienced wrong vaccine administered. On an unknown date, the outcome of the wrong vaccine administered was unknown.   Additional Information: GSK Receipt Date: 27-OCT-2022 Reporter's Comment: A pharmacist called to ask for information about the administration of Twinrix. The reporter mentioned that the patient received the first dose of Twinrix and, when administering the second dose by error, Engerix-B was administered instead of Twinrix.  The reporter asked if they could combine the dose of Engerix-B already given with a dose of Havrix in order to have a complete dose against HepA-Hep-B.  The reporter did consent to follow up. Additional supportive information: The reporter mentioned that the patient received the first dose of Twinrix and, when administering the second dose by error, Engerix-B was administered instead of Twinrix, which led to wrong vaccine administered.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Did not get the second dose; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 72-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose three years ago).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 27-Oct-2022 Reporter's comment: The patient did not get the second dose. The patient indicated that he intended on getting the second dose as soon as possible. The reporter consented to follow-up. Additional supportive information: Till the time of reporting, the patient did not receive second dose of Shingrix, which led to incomplete course of vaccination. The Vaers details were reported for first dose of Shingrix.
Sex: F
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: exposed to few degree cooler; This case was reported by a consumer via call center representative and described the occurrence of incorrect storage of drug in a 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In August 2022, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, unknown after receiving Shingrix, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   Additional Information: GSK Receipt Date: 26-OCT-2022 Reporter's Comment: The case was reported by the patient. The patient who received her first Shingrix dose back in August 2022.  The patient stated that, pharmacy called her to let her know that the vaccine dose she received was exposed for half an hour to temperatures few degree cooler than the recommended storage temperatures and advised her to contact her Healthcare provider for further guidance on whether she needs to repeat the first dose in the Shingrix series given the circumstances.  The patient received her Shingrix dose at pharmacy. The patient did not know the specifics of the temperature excursions (exact temperature at which the vaccine was stored) and whether the temperature excursions happened before or after vaccine reconstitution.  The patient stated that, she contacted her healthcare professional and they referred her to the Shingrix manufacturer for further guidance.  Advised for healthcare professional and pharmacy to call and obtain thermostability data. The patient could not provide Shingrix vaccine information including Shingrix dose, volume injected, lot or expiration date when asked and suggested we contact pharmacy for this information.  The reporter was the patient, she consented for safety follow-up with both her healthcare professional and the administering pharmacy.  Additional Supportive Information: The patient received Shingrix which was exposed for half an hour to temperatures few degree cooler than the recommended storage temperatures, which led to incorrect storage of drug.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Condition aggravated, Injection site pain, Lethargy, Nausea
Clinical narrative: mild pain at injection site; fever; mild shivering; lethargy; nausea; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 79-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (On an unknown date the patient received 1st dose of Shingrix. Refer case US2022AMR156166).   On 25th October 2022, the patient received the 2nd dose of Shingrix. In October 2022, less than a week after receiving Shingrix, the patient experienced injection site pain, fever, shivering, lethargy and nausea. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site pain, fever, shivering, lethargy and nausea were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, fever, shivering, lethargy and nausea to be related to Shingrix.     Linked case(s) involving the same patient:  US2022AMR156166   Additional Information: GSK Receipt Date: 27-OCT-2022 Reporter's Comment: The reporter was the patient, who received her second dose of SHINGRIX 2 days ago.  The reporter stated that she states that since her 2nd dose, she has experienced a fever, shivering, lethargy, pain at the injection site and nausea.  The reporter also stated that states that these symptoms are worse than her first dose.  The symptoms after her second dose have not yet resolved. The reporter did not consent to follow-up.; Sender's Comments:  US-GSK-US2022AMR156166:Same reporter