chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 11.0
Sex: M
Vaccine: HPV9, HPV9, HPV9, HPV9, HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; temperature excursion total time: 25 mins, 3 excursions on dates: 9/9/22 for 9 mins, 9/16/22 for 5 mins, 1/3/23 for 12 mins; This spontaneous report was received from an office manager and refers to a 11-year-old male patient. No information on patient medical history, current conditions and concomitant medications was provided.  On 07-FEB-2023, the patient was vaccinated with one dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe, injection, 1 dosage form, lot # and expiration dates: 1775811, 07-DEC-2023; 1775827, 27-JUN-2024; W009829, 19-OCT-2024; U032681, 26-OCT-2023; and 1780876, 09-NOV-2023 (administration sites and routes of administration were not provided) administered for prophylaxis (product storage error and no adverse event).  Temperature excursion total time was 25 minutes. There were 3 temperature excursions: on 09-SEP-2022 for 8 minutes, on 16-SEP-2022 for 5 minutes and on 03-JAN-2023 for 12 minutes. Excursions were not noted until after the first fact due to employee error of cleaning data logger more than once a day. Patient was vaccinated in private doctor's office/hospital.  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2304USA002221:source original: 2304USA002221
Sex: U
Vaccine: MMR
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: MMR II was administered intradermally to a set of 13 month old twin patients.; No additional AE; This spontaneous report was received from a nurse refers to a 13-month-old patient. No information on patient medical history, current conditions and concomitant medications was provided.    On an unknown date the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II), intradermal for prophylaxis (exact dose, lot number and expiration date were not provided) (incorrect route of product administration and no adverse event).; Sender's Comments:  US-009507513-2305USA005015:
Sex: U
Vaccine: MMR
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: MMR II was administered intradermally to a set of 13 month old twin patients.; No additional AE; This spontaneous report was received from a nurse refers to a 13-month-old patient. No information on patient medical history, current conditions and concomitant medications was provided.    On an unknown date the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), intradermal for prophylaxis (exact dose, lot number and expiration date were not provided) (incorrect route of product administration and no adverse event).; Sender Comments: Keywords : US-009507513-2305USA005008:
Age: 65.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No Adverse Event; A consumer is calling in to report an AE on behalf of herself. The consumer reports that she received her first dose of GARDASIL 9 at the age of 65. No additional clarifying statements or AE details were provided and no additional AE's were reported; This spontaneous report was received from a consumer refers to a 65-year-old patient of unknown gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 17-APR-2023, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (lot #, expiration date, exact dose, route of administration and anatomical location were not reported) prophylaxis (product administered to patient of inappropriate age). No additional adverse events were reported (no adverse event).
Sex: U
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: No additional AEs reported; GARDASIL 9 was administered following temperature excursion.; This spontaneous report was received from a nurse regarding a patient of an unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 12-MAY-2023, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) prefilled syringe, 1 dose, lot #W014513, expiration date: 26-JAN-2025, administered as prophylaxis (strength, dosage regimen, anatomical location, and route of administration were not provided) (Product storage error).  The improperly stored vaccine underwent a temperature excursion of 52.86 degrees Fahrenheit (F) for 96 hours (reported as "worst case scenario") without previous excursions. No adverse events were reported.  This is one of five case received from the same reporter. ; Sender's Comments:  US-009507513-2305USA005550: US-009507513-2305USA005725: US-009507513-2305USA005688:
Sex: U
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: No adverse event; Nurse reported that GARDASIL 9 was administered following temperature excursion. Consent to contact obtained. No additional AEs/PQCs reported.  ?    Names of vaccines involved (including lot/exp) GARDASIL 9         ?    Temperature 52.86F; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 15-MAY-2023, the patient was administered a temperature excursion therapy with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 1 dose, lot number W014513, expiration date: 26-JAN-2025, administered for prophylaxis (strength, and route of administration were not provided) (Product storage error ). A temperature was 52.86F for time frame of 96 Hours.
Age: 65.0
Sex: U
Vaccine: VARZOS
Symptoms: Headache, Myalgia, Pyrexia
Clinical narrative: Muscle pain; Headache; Shivering fever; This non-serious case was reported by a consumer via call center representative and described the occurrence of muscle pain in a 65-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10-MAY-2023, the patient received Shingrix. In MAY-2023, less than a day after receiving Shingrix, the patient experienced muscle pain (Verbatim: Muscle pain), headache (Verbatim: Headache) and fever chills (Verbatim: Shivering fever). The outcome of the muscle pain, headache and fever chills were not resolved.   It was unknown if the reporter considered the muscle pain, headache and fever chills to be related to Shingrix.     It was unknown if the company considered the muscle pain, headache and fever chills to be related to Shingrix.   Additional Information: GSK Receipt Date: 11-MAY-2023 The patient self-reported this case. The patient reported that he/she received Shingrix shot about 24-hours ago from reporting and experienced muscle pain, headache and shivering fever. The reporter asked how long did the side effects last.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Dyspepsia, Fatigue, Gait inability, Headache, Migraine
Clinical narrative: Severe muscle pain; nonstop heartburn; nerve pain; severe headaches; severe migraine; extreme fatigue; myofascial pain syndrome; experience so much pain; that she could not walk; This non-serious case was reported by a consumer via sales rep and described the occurrence of muscle pain in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24-APR-2023, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced muscle pain (Verbatim: Severe muscle pain), heartburn (Verbatim: nonstop heartburn), nerve pain (Verbatim: nerve pain), headache (Verbatim: severe headaches), migraine (Verbatim: severe migraine), fatigue (Verbatim: extreme fatigue), myofascial pain syndrome (Verbatim: myofascial pain syndrome), pain (Verbatim: experience so much pain) and unable to walk (Verbatim: that she could not walk). The outcome of the muscle pain, heartburn, nerve pain, headache, migraine, fatigue, myofascial pain syndrome, pain and unable to walk were resolved.   It was unknown if the reporter considered the muscle pain, heartburn, nerve pain, headache, migraine, fatigue, myofascial pain syndrome, pain and unable to walk to be related to Shingrix.     It was unknown if the company considered the muscle pain, heartburn, nerve pain, headache, migraine, fatigue, myofascial pain syndrome, pain and unable to walk to be related to Shingrix.   Additional Information: GSK Receipt Date: 11-MAY-2023 The patient received 2nd dose and had severe symptoms that lasted for more than a week. The patient had experienced severe muscle pain, nonstop heartburn that was not alleviated with any medication, nerve pain, severe headaches and severe migraine, and extreme fatigue. Reported that this messed up her whole system. The patient had myofascial pain syndrome and experienced so much pain that for first few days after vaccination was not able to walk. The reporter consented to follow up.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Myofascial pain syndrome, Neuralgia, Pain
Clinical narrative: Severe muscle pain; nonstop heartburn; nerve pain; severe headaches; severe migraine; extreme fatigue; myofascial pain syndrome; experience so much pain; that she could not walk; This non-serious case was reported by a consumer via sales rep and described the occurrence of muscle pain in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24-APR-2023, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced muscle pain (Verbatim: Severe muscle pain), heartburn (Verbatim: nonstop heartburn), nerve pain (Verbatim: nerve pain), headache (Verbatim: severe headaches), migraine (Verbatim: severe migraine), fatigue (Verbatim: extreme fatigue), myofascial pain syndrome (Verbatim: myofascial pain syndrome), pain (Verbatim: experience so much pain) and unable to walk (Verbatim: that she could not walk). The outcome of the muscle pain, heartburn, nerve pain, headache, migraine, fatigue, myofascial pain syndrome, pain and unable to walk were resolved.   It was unknown if the reporter considered the muscle pain, heartburn, nerve pain, headache, migraine, fatigue, myofascial pain syndrome, pain and unable to walk to be related to Shingrix.     It was unknown if the company considered the muscle pain, heartburn, nerve pain, headache, migraine, fatigue, myofascial pain syndrome, pain and unable to walk to be related to Shingrix.   Additional Information: GSK Receipt Date: 11-MAY-2023 The patient received 2nd dose and had severe symptoms that lasted for more than a week. The patient had experienced severe muscle pain, nonstop heartburn that was not alleviated with any medication, nerve pain, severe headaches and severe migraine, and extreme fatigue. Reported that this messed up her whole system. The patient had myofascial pain syndrome and experienced so much pain that for first few days after vaccination was not able to walk. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Asthma, Back pain, Musculoskeletal pain, Neuralgia, Pain
Clinical narrative: Deep nerve pain; Lower back pain to back of thigh and buttocks.; was really exacerbated after shot; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of nerve pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included pain (She had a little bit of pain before shot).   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced nerve pain (Verbatim: Deep nerve pain), low back pain (Verbatim: Lower back pain to back of thigh and buttocks.) and exacerbation of pain (Verbatim: was really exacerbated after shot). The outcome of the nerve pain, low back pain and exacerbation of pain were not resolved.   It was unknown if the reporter considered the nerve pain, low back pain and exacerbation of pain to be related to Shingrix.     It was unknown if the company considered the nerve pain, low back pain and exacerbation of pain to be related to Shingrix.   Additional Information: GSK Receipt Date: 15-MAY-2023 The Pharmacy intern reported that the patient experienced deep nerve pain from lower back pain to back of thigh and buttocks. It was worse in the morning.  She had a little bit of pain before shot but it was really exacerbated after shot and continued to be about the same, for every day for the last 2-3 months.
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Deep nerve pain; Lower back pain to back of thigh and buttocks.; was really exacerbated after shot; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of nerve pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included pain (She had a little bit of pain before shot).   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced nerve pain (Verbatim: Deep nerve pain), low back pain (Verbatim: Lower back pain to back of thigh and buttocks.) and exacerbation of pain (Verbatim: was really exacerbated after shot). The outcome of the nerve pain, low back pain and exacerbation of pain were not resolved.   It was unknown if the reporter considered the nerve pain, low back pain and exacerbation of pain to be related to Shingrix.     It was unknown if the company considered the nerve pain, low back pain and exacerbation of pain to be related to Shingrix.   Additional Information: GSK Receipt Date: 15-MAY-2023 The Pharmacy intern reported that the patient experienced deep nerve pain from lower back pain to back of thigh and buttocks. It was worse in the morning.  She had a little bit of pain before shot but it was really exacerbated after shot and continued to be about the same, for every day for the last 2-3 months.
Sex: U
Vaccine: VARZOS
Symptoms: Feeling abnormal
Clinical narrative: I feel absolutely horrible; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of feeling miserable in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 15-MAY-2023, the patient received the 1st dose of Shingles vaccine. On 15-MAY-2023, an unknown time after receiving Shingles vaccine, the patient experienced feeling miserable (Verbatim: I feel absolutely horrible). The outcome of the feeling miserable was not reported.   It was unknown if the reporter considered the feeling miserable to be related to Shingles vaccine.     It was unknown if the company considered the feeling miserable to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 15-May-2023  The patient had first shingles vaccine on day of reporting and highly doubt he/she would get the second. The reporter felt absolutely horrible.  The reporter thought he/she would take his/her chances with shingles.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister
Clinical narrative: Small Blisters on leg, left arm and hand; This non-serious case was reported by a consumer via call center representative and described the occurrence of blister in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had shingles 4 years ago from reporting, pre existing the Shingrix vaccine, and it was painful).   On 06-MAY-2023, the patient received the 1st dose of Shingrix (injection, left arm). On 07-MAY-2023, 1 days after receiving Shingrix, the patient experienced blister (Verbatim: Small Blisters on leg, left arm and hand). The outcome of the blister was not resolved.   It was unknown if the reporter considered the blister to be related to Shingrix.     It was unknown if the company considered the blister to be related to Shingrix.   Additional Information: GSK Receipt Date: 08-MAY-2023 The case was self-reported by the patient. The patient reported that yesterday (day before reporting), a new blister showed up on patient's leg (unknown which leg). Two days later of vaccination, the patient had 2 to 3 small blisters on her left arm and hand that had now dried up and were just pink. The reporter did not consent to follow up.
Age: 65.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Incomplete course of vaccination, Pain, Pain in extremity
Clinical narrative: he started with left arm pain; it hurts to raise his arm; He has not yet gotten his second Shingrix vaccine; This non-serious case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 65-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 26-SEP-2022, the patient received the 1st dose of Shingrix (intramuscular, left arm). On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced pain in arm (Verbatim: he started with left arm pain), pain upon movement (Verbatim: it hurts to raise his arm) and incomplete course of vaccination (Verbatim: He has not yet gotten his second Shingrix vaccine). The outcome of the pain in arm and pain upon movement were not resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the pain in arm and pain upon movement to be related to Shingrix.     It was unknown if the company considered the pain in arm and pain upon movement to be related to Shingrix.   Additional Information: GSK receipt date: 11-MAY-2023 The patient self-reported this case. The patient reported that after his injection, he started with left arm pain where it hurts to raise his arm.  The patient stated that the pain was still there and getting worse.   The patient had not yet gotten his second Shingrix vaccine.   The patient did not had any further information about the vaccine itself. The reporter did not consent to follow-up. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: F
Vaccine: VARZOS
Symptoms: Muscular weakness, Purpura, Rash, Rash macular, Rash pruritic
Clinical narrative: The spots than turned into an all over body rash covering her chest, legs, forearms, and back.; Muscle weakness; rash itches; scar; rash is open, bleeding; had 3 spots that developed on her body.; This non-serious case was reported by a consumer via call center representative and described the occurrence of spot-like rash in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included diabetes.   On 16-JAN-2023, the patient received the 1st dose of Shingrix. On 27-MAR-2023, 70 days after receiving Shingrix, the patient experienced spot-like rash (Verbatim: had 3 spots that developed on her body.). On an unknown date, the patient experienced generalized rash (Verbatim: The spots than turned into an all over body rash covering her chest, legs, forearms, and back.), muscle weakness (Verbatim: Muscle weakness), itchy rash (Verbatim: rash itches), scar (Verbatim: scar) and rash hemorrhagic (Verbatim: rash is open, bleeding). The outcome of the spot-like rash, generalized rash, muscle weakness, itchy rash, scar and rash hemorrhagic were unknown.   It was unknown if the reporter considered the spot-like rash, generalized rash, muscle weakness, itchy rash, scar and rash hemorrhagic to be related to Shingrix.     It was unknown if the company considered the spot-like rash, generalized rash, muscle weakness, itchy rash, scar and rash hemorrhagic to be related to Shingrix.   Additional Information: GSK Receipt Date: 11-MAY-2023. The reporter was patient's daughter. The reporter stated that her mother had her first dose of Shingrix administered on 16 January 2023 and the second dose on 3 April 2023.  Her mother had 3 spots that developed on her body on 27 March 2023.   The spots than turned into an all over body rash covering her chest, legs, forearms, and back.  The patient also experinced Muscle weakness, rash was open, bleeding, and looks like a scar, rash itches after admistered shingrix. The patient did go to a dermatologist on 6 April 2023.  The patient also went to the hospital emergency room on 7 May 2023.   No further information was known. Emergency room Visit Required. Consent, address, and other questions were asked.   The daughter grew frustrated and disconnected the call prior to obtaining consent, address and more information.   The daughter stated how was me giving you this information going to help my mother. Something was wrong with the medication as her mother was not feeling liked this prior to vaccination with Shingrix.
Sex: F
Vaccine: VARZOS
Symptoms: Scar
Clinical narrative: The spots than turned into an all over body rash covering her chest, legs, forearms, and back.; Muscle weakness; rash itches; scar; rash is open, bleeding; had 3 spots that developed on her body.; This non-serious case was reported by a consumer via call center representative and described the occurrence of spot-like rash in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included diabetes.   On 16-JAN-2023, the patient received the 1st dose of Shingrix. On 27-MAR-2023, 70 days after receiving Shingrix, the patient experienced spot-like rash (Verbatim: had 3 spots that developed on her body.). On an unknown date, the patient experienced generalized rash (Verbatim: The spots than turned into an all over body rash covering her chest, legs, forearms, and back.), muscle weakness (Verbatim: Muscle weakness), itchy rash (Verbatim: rash itches), scar (Verbatim: scar) and rash hemorrhagic (Verbatim: rash is open, bleeding). The outcome of the spot-like rash, generalized rash, muscle weakness, itchy rash, scar and rash hemorrhagic were unknown.   It was unknown if the reporter considered the spot-like rash, generalized rash, muscle weakness, itchy rash, scar and rash hemorrhagic to be related to Shingrix.     It was unknown if the company considered the spot-like rash, generalized rash, muscle weakness, itchy rash, scar and rash hemorrhagic to be related to Shingrix.   Additional Information: GSK Receipt Date: 11-MAY-2023. The reporter was patient's daughter. The reporter stated that her mother had her first dose of Shingrix administered on 16 January 2023 and the second dose on 3 April 2023.  Her mother had 3 spots that developed on her body on 27 March 2023.   The spots than turned into an all over body rash covering her chest, legs, forearms, and back.  The patient also experinced Muscle weakness, rash was open, bleeding, and looks like a scar, rash itches after admistered shingrix. The patient did go to a dermatologist on 6 April 2023.  The patient also went to the hospital emergency room on 7 May 2023.   No further information was known. Emergency room Visit Required. Consent, address, and other questions were asked.   The daughter grew frustrated and disconnected the call prior to obtaining consent, address and more information.   The daughter stated how was me giving you this information going to help my mother. Something was wrong with the medication as her mother was not feeling liked this prior to vaccination with Shingrix.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Tremor
Clinical narrative: he noticed a tremor in both hands; This non-serious case was reported by a consumer via call center representative and described the occurrence of tremor in a 75-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In DEC-2022, the patient received the 1st dose of Shingrix (intramuscular). In JAN-2023, less than 2 months after receiving Shingrix, the patient experienced tremor (Verbatim: he noticed a tremor in both hands). The outcome of the tremor was not resolved.   It was unknown if the reporter considered the tremor to be related to Shingrix.     It was unknown if the company considered the tremor to be related to Shingrix.   Additional Information: GSK receipt date: 11-MAY-2023. The patient was self-reported this case. The patient had his first Shingrix dose in DEC 2022.  In January he noticed a tremor in both hands. The tremor comes and goes.  The patient noticed it at rest and while holding a golf club.  The tremor stops when he thinks about it.  On 10-MAR-2023 he received his second dose of Shingrix.  Till the time of reporting patient has not seen his HCP but plans to. Nothing else was reported. The reporter did consented to follow up.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills
Clinical narrative: chills; This non-serious case was reported by a consumer via call center representative and described the occurrence of chills in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18-JAN-2023, the patient received the 1st dose of Shingrix. On 18-JAN-2023, less than a day after receiving Shingrix, the patient experienced chills (Verbatim: chills). The outcome of the chills was resolved.   It was unknown if the reporter considered the chills to be related to Shingrix.     It was unknown if the company considered the chills to be related to Shingrix.   Linked case(s) involving the same patient:  US2023AMR070869   Additional Information: GSK Receipt Date: 12-MAY-2023 The reporter stated that she received her first dose of Shingrix and experienced chills that was resolved. The patient took Ibuprofen to treat these symptoms. The reporter did not consent to follow-up. This case had been linked with US2023AMR070869 due to same reporter and different dose.; Sender's Comments:  US-GSK-US2023AMR070869:Same reporter
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration, Pain in extremity
Clinical narrative: Arm was sore; 1st dose received on 2019 and second dose received on 26Apr2023; This non-serious case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (On 2019 received 1st dose).   On 26-APR-2023, the patient received the 2nd dose of Shingrix. On 26-APR-2023, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: 1st dose received on 2019 and second dose received on 26Apr2023). On an unknown date, the patient experienced pain in arm (Verbatim: Arm was sore). The outcome of the pain in arm was not resolved and the outcome of the drug dose administration interval too long was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.     It was unknown if the company considered the pain in arm to be related to Shingrix.   Additional Information: GSK Receipt date: 15-MAY-2023 The reporter reported the patient received Shingrix vaccine and experience the arm was sore. The reporter consented to follow up. The patient received 2nd dose of Shingrix vaccine later than the recommended interval, which led to lengthening of vaccination schedule.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Acute myeloid leukaemia, Incomplete course of vaccination
Clinical narrative: Diagnosed with AML; 1st dose received 2 years ago, 2nd dose not received yet; This serious case was reported by a other health professional via call center representative and described the occurrence of acute myeloid leukemia in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced acute myeloid leukemia (Verbatim: Diagnosed with AML) (serious criteria GSK medically significant) and incomplete course of vaccination (Verbatim: 1st dose received 2 years ago, 2nd dose not received yet). The outcome of the acute myeloid leukemia and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the acute myeloid leukemia to be related to Shingrix.     It was unknown if the company considered the acute myeloid leukemia to be related to Shingrix.   Additional Information: GSK Receipt Date: 12-MAY-2023 The reporter reported that a patient who had one dose of Shingrix two years ago and recently was diagnosed with acute myeloid leukemia (AML).  The reporter enquired can they be given the second dose of Shingrix, or should restart the series. The reporter consented to follow up via mail. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: F
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Late Engerix-B second dose; 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 female patient who received HBV (Engerix B) for prophylaxis.   Previously administered products included Engerix-B (received 1st dose on 24th January 2023).   On 05-MAY-2023, the patient received the 2nd dose of Engerix B. On 05-MAY-2023, an unknown time after receiving Engerix B, the patient experienced drug dose administration interval too long (Verbatim: Late Engerix-B second dose). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 15-MAY-2023 The pharmacist had a patient who received late Engerix-B second dose.  The reporter asked how could they proceed with third dose?  No further details were provided during the call such as lot numbers or patient´s date of birth The reporter did not consent to follow-up. The patient received 2nd dose of Engerix-B, later than the recommended interval, which led to lengthening of vaccination schedule.
Sex: M
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: The patient had not received the second dose yet; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 29-year-old male patient who received HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix (received 1st dose in December 2022 with batch no as 2KE55 and expiry date as 22nd September 2023).   On an unknown date, the patient did not receive the 2nd dose of Twinrix. On an unknown date, an unknown time after receiving Twinrix, the patient experienced incomplete course of vaccination (Verbatim: The patient had not received the second dose yet). The outcome of the incomplete course of vaccination 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: 15-MAY-2023 The pharmacist asked for information about a patient who received the first dose of Twinrix and had not received the second dose yet. The reporter asked how to proceed with patient's vaccination. The reporter consented to follow up. Till the time of reporting, the patient did not receive 2nd dose of Twinrix, which led to incomplete course of vaccination.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Neuralgia, Sciatica
Clinical narrative: nerve pain down her left leg; sciatic pain on the left side of her lower back; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of nerve pain in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20-FEB-2023, the patient received the 1st dose of Shingrix (intramuscular, left deltoid). On 22-FEB-2023, 2 days after receiving Shingrix, the patient experienced nerve pain (Verbatim: nerve pain down her left leg) and sciatica (Verbatim: sciatic pain on the left side of her lower back). The outcome of the nerve pain and sciatica were unknown.   It was unknown if the reporter considered the nerve pain and sciatica to be related to Shingrix.     It was unknown if the company considered the nerve pain and sciatica to be related to Shingrix.   Additional Information: GSK Receipt Date: 15-MAY-2023 Pharmacy Intern called to ask if sciatica and nerve pain were expected side effects of SHINGRIX. She stated that the patient came to the pharmacy today to receive her 2nd SHINGRIX dose, and asked if it was likely to happen again. She stated that "about two days" after her first dose, she experienced sciatic pain on the left side of her lower back, and nerve pain down her left leg. Consented to follow up. Permission to follow up with pharmacy intern.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: First dose of Shingrix in September 2019 and hasn't received the 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 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on September 2019 from lot number m9512).   On an unknown date, the patient did not received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: First dose of Shingrix in September 2019 and hasn't received the second dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 15-MAY-2023 The reporter requested information on how to proceed if patient did not received the second dose. The reporter did not consent to follow up. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix vaccine, which led to incomplete course of vaccination.
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Shingrix + Administration of liquid portion only.; Shingrix + Administration of liquid portion only.; 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 59-year-old male patient who received Herpes zoster (Shingrix) (batch number YC547, expiry date 25-OCT-2024) for prophylaxis.   On 15-MAY-2023, the patient received Shingrix. On 15-MAY-2023, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: Shingrix + Administration of liquid portion only.) and inappropriate dose of vaccine administered (Verbatim: Shingrix + Administration of liquid portion only.). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 15-May-2023  Medical assistant reported that another medical assistant administered the liquid portion only of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The Vaccine Administration Facility was the same as Primary Reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Social problem
Clinical narrative: he never got his 2nd dose of Shingrix; This non-serious case was reported by a consumer via call center representative and described the occurrence of social problem in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix (received 1st dose on 10-Oct-2019).   On an unknown date, the patient received the 2nd dose of Shingrix (injection). On an unknown date, an unknown time after receiving Shingrix, the patient experienced social problem (Verbatim: he never got his 2nd dose of Shingrix). The outcome of the social problem was unknown.   Additional Information: GSK Receipt Date: 15-May-2023  Reporter was the wife calling on behalf of her husband who was a male patient that reports that he received his 1st dose of Shingrix 10-OCT-2019 at his doctor's office, and then due to the covid pandemic, he never got his 2nd dose of Shingrix. The reporter did not have any further information about the patient's 1st dose, no Lot number or the location of the administered dose. The reporter had reported all the information. The reporter consented to follow up.; Sender's Comments:  US-GSK-US2023069447:Patient's wife report
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: Expired dose given; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 2-year-old female patient who received DTPa (Infanrix) (batch number 23T73, expiry date 30-APR-2023) for prophylaxis.   On 15-MAY-2023, the patient received Infanrix. On 15-MAY-2023, an unknown time after receiving Infanrix, the patient experienced expired vaccine used (Verbatim: Expired dose given). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 15-May-2023  HCP called in to report that an expired dose of Infanrix was accidentally administered, providing the vaccine, patient and event information. The reporter consented to follow up. The Vaccine Administration Facility was the same as Primary Reporter.
Sex: F
Vaccine: TDAP
Symptoms: Accidental exposure to product, Exposure via skin contact, Incorrect dose administered
Clinical narrative: Boostrix incomplete dose; vaccine run down the patient´s arm; vaccine run down the patient´s arm; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete dose administered in a 42-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number HA9CH, expiry date 13-JUL-2025) for prophylaxis.   On 15-MAY-2023, the patient received Boostrix. On 15-MAY-2023, an unknown time after receiving Boostrix, the patient experienced incomplete dose administered (Verbatim: Boostrix incomplete dose), inadvertent exposure to vaccine (Verbatim: vaccine run down the patient´s arm) and exposure via skin contact (Verbatim: vaccine run down the patient´s arm). The outcome of the incomplete dose administered, inadvertent exposure to vaccine and exposure via skin contact were unknown.   Additional Information: GSK Receipt Date: 15-May-2023  The patient reported an incomplete dose of Boostrix was administered to a patient because of leakage during administration, which led to incomplete dose administered. PQC discarded because reporter mention the needle non supplied with the vaccine was split and cause the leakage. Reporter mentioned vaccine run down the patient´s arm, which led to inadvertent exposure to vaccine and exposure via skin contact. The reporter consented to follow up via email.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Product preparation error
Clinical narrative: wrong diluent used; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 16-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA771A, expiry date 31-JAN-2024) for prophylaxis.   On 15-MAY-2023, the patient received Menveo. On 15-MAY-2023, an unknown time after receiving Menveo, the patient experienced wrong solution used in drug reconstitution (Verbatim: wrong diluent used). The outcome of the wrong solution used in drug reconstitution was unknown.   Additional Information: GSK Receipt Date: 16-May-2023  Nurse stated a patient was given a dose of Menveo that was reconstituted with sterile water instead of the liquid portion of the vaccine, which led to wrong solution used in drug reconstitution. The vaccine administration facility was the same as primary reporter. No further details provided.  The reporter consented to follow up.
Sex: F
Vaccine: FLUX
Symptoms: Abdominal discomfort, Impaired work ability
Clinical narrative: she received a flu vaccine in the past and got sick in her stomach which caused her to miss a week of work; caused her to miss a week of work.; This non-serious case was reported by a consumer via call center representative and described the occurrence of upset stomach in a 74-year-old female patient who received Flu unspecified (Flu vaccine) for prophylaxis.   On an unknown date, the patient received Flu vaccine. On an unknown date, an unknown time after receiving Flu vaccine, the patient experienced upset stomach (Verbatim: she received a flu vaccine in the past and got sick in her stomach which caused her to miss a week of work) and inability to work (Verbatim: caused her to miss a week of work.). The outcome of the upset stomach was unknown and the outcome of the inability to work was resolved (duration 1 week).   It was unknown if the reporter considered the upset stomach and inability to work to be related to Flu vaccine.     It was unknown if the company considered the upset stomach and inability to work to be related to Flu vaccine.   Additional Information: GSK receipt date: 16-MAY-2023 The reporter was the patient, who stated that she received a flu vaccine in the past and got sick in her stomach which caused her to miss a week of work.  She did not know the name of the vaccine or the manufacturer.  The reporter was consented to follow up
Sex: F
Vaccine: HEP, HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Engerix B + Early 3rd dose; Engerix B Late 2nd dose and 3rd dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too long in a 55-year-old female patient who received HBV (Engerix B) (batch number NT9X3, expiry date 09-SEP-2024) and (batch number 9JG23, expiry date 10-FEB-2025) for prophylaxis.   Co-suspect products included HBV (Engerix B) (batch number 9JG23, expiry date 10-FEB-2025) for prophylaxis.   Previously administered products included engerix B (received 1st dose in November 2021).   On 15-MAR-2023, the patient received the 2nd dose of Engerix B. On 17-APR-2023, the patient received the 3rd dose of Engerix B. On 15-MAR-2023, an unknown time after receiving Engerix B and not applicable after receiving Engerix B, the patient experienced drug dose administration interval too long (Verbatim: Engerix B Late 2nd dose and 3rd dose). On 17-APR-2023, the patient experienced drug dose administration interval too short (Verbatim: Engerix B + Early 3rd dose). The outcome of the drug dose administration interval too long and drug dose administration interval too short 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: 16-May-2023  Medical assistant reported that a female patient received a first dose of Engerix B in November 2021, a second dose on 15th March 2023, which led to later than the recommended schedule, which led to shortening of the vaccination schedule. The patient also received third dose on 17th April 2023, which led earlier than the recommended standard schedule, which led to shortening of the vaccination schedule. The reporter asked how to proceed and safety information on early 3rd dose. The reporter did not consent to follow-up. The Vaccine Administration Facility was the same as Primary Reporter.
Age: 4.0
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Expired product administered
Clinical narrative: a girl received Pediarix expired dose; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 4-year-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number Z4R9R, expiry date 14-MAY-2023) for prophylaxis.   On 16-MAY-2023, the patient received the 1st dose of Pediarix. On 16-MAY-2023, an unknown time after receiving Pediarix, the patient experienced expired vaccine used (Verbatim: a girl received Pediarix expired dose). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 16-May-2023  Nurse reported that on 16th May 2023 morning, a girl received Pediarix expired dose. This Pediarix vaccines was administer as a catch up only dose, and it was a third Dtap, IPV and hep-B dose on the series. The reporter consented to follow up by email.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: administered an expired Bexsero (exp:3/23/23) dose on 5/11/23; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 18-year-old female patient who received Men B NVS (Bexsero) (expiry date 23-MAR-2023) for prophylaxis.   On 11-MAY-2023, the patient received Bexsero. On 11-MAY-2023, an unknown time after receiving Bexsero, the patient experienced expired vaccine used (Verbatim: administered an expired Bexsero (exp:3/23/23) dose on 5/11/23). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 16-May-2023  Medical assistant reported an 18-year-old patient was inadvertently administered an expired Bexsero dose on 11th May 2023.  The reporter did not consent to follow-up. Medical assistant called to inquire if the patient should be revaccinated.
Sex: F
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: Expired dose given; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 32-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 2244CG, expiry date 15-MAY-2023) for prophylaxis.   On 07-MAY-2023, the patient received Boostrix. On 07-MAY-2023, an unknown time after receiving Boostrix, the patient experienced expired vaccine used (Verbatim: Expired dose given). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 16-May-2023  The patient was accidentally given an expired dose of Boostrix and wished to know how to proceed.  They stated that they did not know the exact status of the patient's previous vaccinations. Information about patient, vaccine and vaccination was provided.  The reporter consented to follow up. The vaccine administration facility is the same as primary reporter.