chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.75
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No further AE; Medical assistant calls to report ROTATEQ given at 9mo instead of 8 months  She thinks it is the 3rd dose but cannot find documentation of doses 1 and 2.  No further AE.  No PQC.  Lot# 1965569 9/18/2024 request cases 02500498,02500501; This spontaneous report was received from a medical assistant referring to a 9-month-old patient of unknown gender. The patient's historical medications, medical history, concurrent conditions and concomitant medications were not reported.      On 31-OCT-2023, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent(ROTATEQ) orally, lot number 1965569, expiration date 18-SEP-2024 (dose not reported) for prophylaxis (product administered to patient of inappropriate age). No adverse event was reported.  The reporter thought that the dose administered was the third, however, did not find the documentation the previous administration of doses 1 and 2.
Age: 9.0
Sex: F
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Inappropriate schedule of vaccine administered (first dose of Hep A vaccine administered on 27-MAR-2009, second on 08-AUG-2011); This spontaneous report has been received from a physician, via medical records from a case in litigation for quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (MARRS # 2309USA001668), concerning a 11-year-old female patient.  The patient's medical history and concurrent conditions were not reported. Historical vaccines included unspecified diphtheria vaccine toxoid (+) pertussis vaccine (+) tetanus vaccine toxoid (DPT), unspecified diphtheria vaccine toxoid (+) pertussis vaccine acellular (+) tetanus vaccine toxoid (DTaP), or unspecified diphtheria vaccine toxoid (+) tetanus vaccine toxoid (DT) (reported as DTP/DTAP/DT), unspecified polio vaccine (POLIO), unspecified haemophilus influenzae type B vaccine (HIB), unspecified hepatitis b vaccine (HEP B), unspecified pneumococcal conjugate vaccine (PCV), unspecified measles vaccine (+) mumps vaccine (+) rubella vaccine (MMR), and unspecified varicella zoster vaccine (VARICELLA). Concomitant vaccines included unspecified varicella virus vaccine live (oka/merck).  On 27-MAR-2009, the patient was vaccinated with the first dose of hepatitis a vaccine, inactivated (manufacturer unknown) intramuscular injection, administered for prophylaxis (exact dose, anatomical location, lot #, expiry date, and route of administration were not provided). On 08-AUG-2011, the patient received the second dose of hepatitis a vaccine, inactivated (manufacturer unknown) (inappropriate schedule of product administration).  This is one of several reports regarding the same patient.; Sender's Comments:  US-009507513-2309USA001668:original case
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs were reported; The physician is reporting that a patient received improperly stored vaccine.  No additional AEs were reported, no further information provided.  Names of vaccines involved (including lot/exp) PROQUAD x009730   9/30/2024 Temperature: 40F Time frame:; This spontaneous report was received from a physician and refers to a patient of unknown age and gender. The patient's concurrent conditions, concomitant therapies, historical drugs and historical conditions were not reported.  On 21-AUG-2023, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live, recombinant Human albumin (rHA) (PROQUAD) injection, 1 dose, lot #x009730, expiration date: 30-SEP-2024, administered for prophylaxis (strength, dose, anatomical site of administration and route of administration were not provided). It was showed Temperature of 40F for 336 hours occurred (Product storage error). there was no Previous temperature excursion. No additional adverse events (AEs) were reported.
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B surface antibody negative, No adverse event
Clinical narrative: Product origin unknown; HCP called to report a 19-year-old patient who received 4 doses of a hepatitis B vaccine at birth, 2-months-old, 4-months-old, and 8-months-old, but recent titers showed no immunity towards hepatitis B.; This spontaneous report was received from a registered nurse concerning a 19-year-old female patient. The patient's concurrent conditions, medical history and concomitant therapies were not reported.   The patient received 4 doses of hepatitis B vaccine (recombinant) (manufacturer unknown) intramuscular injection 0.5 mL as routine vaccination for hepatitis B prevention (lot#, expiry date, route of administration and anatomical location not reported) at birth, 2-months-old, 4-months-old, and 8-months-old, but on an unknown date in 2023 (reported as recent) titers showed no immunity towards hepatitis B (hepatitis B surface antibody negative). It was unsure of the name of the vaccine that was administered and could not confirm if it was hepatitis B vaccine (recombinant) (RECOMBIVAX HB) (product origin unknown). It was stated that since recent titers showed that the patient had no immunity towards hepatitis B, on 03-NOV-2023, the patient restarted the vaccination series and was vaccinated with hepatitis B vaccine (recombinant) (RECOMBIVAX HB) intramuscular injection 0.5 mL as routine vaccination for hepatitis B prevention (lot#, expiry date, route of administration and anatomical location not reported). Exact date that titers were drawn was unknown by reporter. The patient did not see medical attention. No additional information was provided by reporter. No additional adverse event (AE). At the reporting time, the outcome of hepatitis B surface antibody negative was unknown. The action taken with hepatitis B vaccine (recombinant) (manufacturer unknown) and hepatitis B vaccine (recombinant) (RECOMBIVAX HB) was not applicable.  The causal relationship between hepatitis B surface antibody negative and hepatitis B vaccine (recombinant) (manufacturer unknown) and hepatitis B vaccine (recombinant) (RECOMBIVAX HB) was not reported.
Age: 21.0
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Underdose
Clinical narrative: received a pediatric dose of VAQTA; no additional AE; This spontaneous report was received from a nurse via company representative referring to a 21-year-old patient of unknown gender.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, 1 dose, a pediatric dose instead of the adult dose (incorrect dose administered), administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided). No additional details were provided, and no additional adverse event was reported.
Sex: F
Vaccine: PNC15, PPV, VARZOS
Symptoms: Allergy to metals, Gait inability, Gastrointestinal disorder, Herpes zoster, Nausea
Clinical narrative: peritonitis; turpentine ate  holes in her small intestines; allergic to nickel; digestive troubles; shingles; This spontaneous report was received from a female consumer via a physician. The patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies, and concomitant therapies were not provided.  On an unknown date, the patient started therapy with pneumococcal 15v conj vaccine (crm197) (manufacturer unknown) injection, administered for prophylaxis (strength, dose description, lot #, expiry date, and route of administration were not provided); or pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) injection, administered for prophylaxis (strength, dose description, lot #, expiry date, and route of administration were not provided). Consumer developed shingles out of the blue in August 2022, didn't say it was after a vaccine or anything when in the hospital for a physical, so she attributed it to the hospital, "looked like poison ivy". Allergic to nickel, got a skin reaction and itchiness. On unknown date, the patient recovered from the event of shingles. After shingles abated, the patient was vaccinated with zoster vaccine live (manufacturer unknown) subcutaneous injection, unk, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided), 2 shots. On an unknown date, the patient experienced peritonitis, turpentine ate holes in her small intestines, allergic to nickel, digestive troubles. She was having digestive troubles and was told to put a drop of pharmaceutical turpentine drops on sugar cubes (pinus spp. oil (TURPENTINE [PINUS SPP. OIL]), (strength, formulation, dose description, lot #, expiry date, route of administration was not provided)) and she was in pain and couldn't walk and was laying on the floor in the fetal position and having nausea/vomiting. An ultrasound showed peritonitis (turpentine ate holes in her small intestines). She was hospitalized for 22 days and was only receiving IV glucose no solid food. At the reporting time, the outcome of the events was unknown. The action taken with suspect vaccines regarding the events was not applicable.  The causality between the events and suspect vaccines was not provided.   Upon internal review, the events turpentine ate holes in her small intestines and peritonitis were determined to be medically significant.
Sex: F
Vaccine: PNC15, PPV, VARZOS
Symptoms: Pain, Peritonitis, Pruritus, Skin reaction, Small intestinal perforation
Clinical narrative: peritonitis; turpentine ate  holes in her small intestines; allergic to nickel; digestive troubles; shingles; This spontaneous report was received from a female consumer via a physician. The patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies, and concomitant therapies were not provided.  On an unknown date, the patient started therapy with pneumococcal 15v conj vaccine (crm197) (manufacturer unknown) injection, administered for prophylaxis (strength, dose description, lot #, expiry date, and route of administration were not provided); or pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) injection, administered for prophylaxis (strength, dose description, lot #, expiry date, and route of administration were not provided). Consumer developed shingles out of the blue in August 2022, didn't say it was after a vaccine or anything when in the hospital for a physical, so she attributed it to the hospital, "looked like poison ivy". Allergic to nickel, got a skin reaction and itchiness. On unknown date, the patient recovered from the event of shingles. After shingles abated, the patient was vaccinated with zoster vaccine live (manufacturer unknown) subcutaneous injection, unk, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided), 2 shots. On an unknown date, the patient experienced peritonitis, turpentine ate holes in her small intestines, allergic to nickel, digestive troubles. She was having digestive troubles and was told to put a drop of pharmaceutical turpentine drops on sugar cubes (pinus spp. oil (TURPENTINE [PINUS SPP. OIL]), (strength, formulation, dose description, lot #, expiry date, route of administration was not provided)) and she was in pain and couldn't walk and was laying on the floor in the fetal position and having nausea/vomiting. An ultrasound showed peritonitis (turpentine ate holes in her small intestines). She was hospitalized for 22 days and was only receiving IV glucose no solid food. At the reporting time, the outcome of the events was unknown. The action taken with suspect vaccines regarding the events was not applicable.  The causality between the events and suspect vaccines was not provided.   Upon internal review, the events turpentine ate holes in her small intestines and peritonitis were determined to be medically significant.
Sex: F
Vaccine: PNC15, PPV, VARZOS
Symptoms: Ultrasound abdomen abnormal, Vomiting
Clinical narrative: peritonitis; turpentine ate  holes in her small intestines; allergic to nickel; digestive troubles; shingles; This spontaneous report was received from a female consumer via a physician. The patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies, and concomitant therapies were not provided.  On an unknown date, the patient started therapy with pneumococcal 15v conj vaccine (crm197) (manufacturer unknown) injection, administered for prophylaxis (strength, dose description, lot #, expiry date, and route of administration were not provided); or pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) injection, administered for prophylaxis (strength, dose description, lot #, expiry date, and route of administration were not provided). Consumer developed shingles out of the blue in August 2022, didn't say it was after a vaccine or anything when in the hospital for a physical, so she attributed it to the hospital, "looked like poison ivy". Allergic to nickel, got a skin reaction and itchiness. On unknown date, the patient recovered from the event of shingles. After shingles abated, the patient was vaccinated with zoster vaccine live (manufacturer unknown) subcutaneous injection, unk, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided), 2 shots. On an unknown date, the patient experienced peritonitis, turpentine ate holes in her small intestines, allergic to nickel, digestive troubles. She was having digestive troubles and was told to put a drop of pharmaceutical turpentine drops on sugar cubes (pinus spp. oil (TURPENTINE [PINUS SPP. OIL]), (strength, formulation, dose description, lot #, expiry date, route of administration was not provided)) and she was in pain and couldn't walk and was laying on the floor in the fetal position and having nausea/vomiting. An ultrasound showed peritonitis (turpentine ate holes in her small intestines). She was hospitalized for 22 days and was only receiving IV glucose no solid food. At the reporting time, the outcome of the events was unknown. The action taken with suspect vaccines regarding the events was not applicable.  The causality between the events and suspect vaccines was not provided.   Upon internal review, the events turpentine ate holes in her small intestines and peritonitis were determined to be medically significant.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; medical assistant who reports ROTATEQ that experienced temperature excursion was administered; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 20-NOV-2023, the patient was vaccinated with improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid (lot #1965569 was valid, expiration date: 18-SEP-2024, exact dose, route of administration and anatomical location were not provided) for prophylaxis (Product storage error).  On 02-NOV-2023, the suspect vaccine experienced a temperature excursion of above 9 degrees Celsius (C) for 6 minutes. No previous temperature excursion reported. No additional adverse event (AE) or product quality complaint (PQC) reported (No adverse event).
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; ROTATEQ that experienced temperature excursion was administered; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 08-NOV-2023, the patient was vaccinated with improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid (lot #1965569 was valid, expiration date: 18-SEP-2024, exact dose, route of administration and anatomical location were not provided) for prophylaxis (Product storage error).  On 02-NOV-2023, the suspect vaccine experienced a temperature excursion of above 9 degrees Celsius (C) for 6 minutes. No previous temperature excursion reported. No additional adverse event (AE) or product quality complaint (PQC) reported (No adverse event).
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; Caller is a medical assistant who reports ROTATEQ that experienced temperature excursion was administered. Excursion occurred 11/2/2023 and was administered 11/6/2023.  ?    Names of vaccines involved (including lot/exp) ROTATEQ  1965569  9/18/2024; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 06-NOV-2023, the patient was vaccinated with impropered storage of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, unk, lot #1965569, expiration date: 18-SEP-2024, administered orally for prophylaxis (strength was not provided). This vaccine underwent temperature excursion for 6 minutes above 9 degree Celsius (Product storage error). No additional adverse event was reported.
Sex: U
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: she had given an adult patient a vaccine intended for a child under 2; Underdose; This non-serious case was reported by a consumer via patient support programs and described the occurrence of adult use of a child product in a adult patient who received HBV (Engerix B) for prophylaxis.   On an unknown date, the patient received Engerix B. On an unknown date, an unknown time after receiving Engerix B, the patient experienced adult use of a child product (Verbatim: she had given an adult patient a vaccine intended for a child under 2) and underdose (Verbatim: Underdose). The outcome of the adult use of a child product and underdose were unknown.   Additional Information: GSK Receipt Date: 15-NOV-2023 This report was submitted via the online direct entry reporting system. The reporter called in to report that she had given an adult patient a vaccine intended for a child under 2, which led to underdose and adult use of a child product.
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Pyrexia
Clinical narrative: fever; was really tired; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of fever in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced fever (Verbatim: fever) and tiredness (Verbatim: was really tired). The outcome of the fever and tiredness were resolved.   It was unknown if the reporter considered the fever and tiredness to be related to Shingrix.     It was unknown if the company considered the fever and tiredness to be related to Shingrix.   Additional Information: GSK Receipt Date-15-NOV-2023 This case was reported by a patient via interactive digital media. The patient received second dose of Shingrix vaccine and stated that it was not fun and kinda sucked. She had fever and was really tired. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: RSV
Symptoms: Arthralgia, Body temperature increased, Headache, Mobility decreased, Pain
Clinical narrative: still have a horrible headache; from shoulders to top of head mainly right side; Cant turn my head toward the left; My whole body still achy/daily aches pains head killing me; running a temp of 100/ Temp 100 to 103; This non-serious case was reported by a consumer via call center representative and described the occurrence of headache in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, less than 3 weeks after receiving Arexvy, the patient experienced headache (Verbatim: still have a horrible headache), shoulder pain (Verbatim: from shoulders to top of head mainly right side), movement disorder (Verbatim: Cant turn my head toward the left), general body pain (Verbatim: My whole body still achy/daily aches pains head killing me) and fever (Verbatim: running a temp of 100/ Temp 100 to 103). The patient was treated with paracetamol (Tylenol) and naproxen sodium (Aleve). The outcome of the headache, shoulder pain, movement disorder, general body pain and fever were not reported.   It was unknown if the reporter considered the headache, shoulder pain, movement disorder, general body pain and fever to be related to Arexvy.     It was unknown if the company considered the headache, shoulder pain, movement disorder, general body pain and fever to be related to Arexvy.   Additional Information: GSK receipt date:15-NOV-2023 The side effects was suppose to last for long time. The patient got shot three weeks ago from the day after reporting. The patient had horrible headache from shoulders to top of head mainly right side and cant turn head towards the left. The whole body of patient achy and running a temperature 100. The patient was received sinus medicine. The follow-up could not be possible as no contact details were available.
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Pain, Pain in extremity
Clinical narrative: sore arm; aches/ pain; shivering; This non-serious case was reported by a other health professional via sales rep and described the occurrence of pain in arm in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced pain in arm (Verbatim: sore arm), pain (Verbatim: aches/ pain) and shivering (Verbatim: shivering). The outcome of the pain in arm, pain and shivering were not reported.   It was unknown if the reporter considered the pain in arm, pain and shivering to be related to Shingrix.     It was unknown if the company considered the pain in arm, pain and shivering to be related to Shingrix.   Additional Information: GSK receipt date: 15-NOV-2023 The reporter reported that patient shared his own experience after he got the 1st dose of Shingrix.  The reporter stated that patient had a sore arm, aches and pains, and shivering. The reporter did not consent to follow up.
Sex: F
Vaccine: RVX
Symptoms: Herpes zoster, Illness, Injection site pain
Clinical narrative: so severe when she tried to get up in the middle of the night she fell because she couldn't put pressure on the arm; shingles flare up a day after the vaccine; sick in bed for several days; This non-serious case was reported by a physician via sales rep and described the occurrence of injection site pain in a elderly female patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced injection site pain (Verbatim: severe pain at the injection site), shingles (Verbatim: shingles flare up a day after the vaccine) and sickness (Verbatim: sick in bed for several days). The outcome of the injection site pain was not reported and the outcome of the shingles and sickness were resolved.   It was unknown if the reporter considered the injection site pain, shingles and sickness to be related to RSV vaccine.     It was unknown if the company considered the injection site pain, shingles and sickness to be related to RSV vaccine.   Additional Information: GSK receipt date:15-NOV-2023 The reporter reported that patient received Arexvy vaccination and no other vaccine was combined. The patient had severe pain at the injection site, so severe when she tried to get up in the middle of the night she fell because she could not put pressure on the arm. The patient also had a shingles flare up a day after the vaccine and threw up several days after the vaccine. The patient was sick in bed for several days. The reporter consented to follow up.
Sex: U
Vaccine: RSV
Symptoms: Hypoacusis
Clinical narrative: my hearing to become sounding; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of hearing impaired in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced hearing impaired (Verbatim: my hearing to become sounding). The outcome of the hearing impaired was not reported.   It was unknown if the reporter considered the hearing impaired to be related to Arexvy.     It was unknown if the company considered the hearing impaired to be related to Arexvy.   Additional Information: GSK Receipt Date: 16-NOV-2023 The case was received form the consumer via (Open field AE monitoring) interactive digital media. The patient received dose arevxy and seems to had hearing to become (illegible text) sounding. The reporter asked that any information on this. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: Administered 2 arexvy vaccines 3 months apart; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Previously administered products included Arexvy (1st dose received 3 months ago prior to receiving 2nd dose).   On an unknown date, the patient received the 2nd dose of Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced extra dose administered (Verbatim: Administered 2 arexvy vaccines 3 months apart). The outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 16-Nov-2023 The reporter reported that he or she administered two doses of Arexvy vaccine three months apart. The reporter wanted to know information about giving an extra dose of Arexvy vaccine by mistake. The patient received extra dose of Arexvy in error, which led to extra dose administered. The follow up would not possible as no contact details were available.
Sex: U
Vaccine: RSV
Symptoms: No adverse event, Product preparation error
Clinical narrative: patient only received the diluent; unsure of which patient received the antigen only; This non-serious case was reported by a pharmacist via sales rep and described the occurrence of inappropriate preparation of medication in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced inappropriate preparation of medication (Verbatim: patient only received the diluent) and inappropriate dose of vaccine administered (Verbatim: unsure of which patient received the antigen only). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 15-NOV-2023 A healthcare professional (HCP) reported that they found an extra vial of Arexvy antigen in the multidose box and got to know that a patient only received the diluent. The reporter had narrowed the error down to 4 patients but was unsure which of them received the diluent only. No specific adverse events had been reported. The vaccine was approved for the older adults (60 years and older) that received the vaccine. The reporter had filed VAERS reports for all 4 patients already and validated that she had already spoken to GlaxoSmithKline (GSK) to report that as well. There was no new information to report. The reporter did not consent to follow up. The patient received only diluent part of vaccine, which led to inappropriate preparation of medication inappropriate dose of vaccine administered
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature increased, Fatigue, Headache, Oral herpes zoster
Clinical narrative: shingles outbreak in the mouth; low grade temp; tiredness; headaches; This non-serious case was reported by a consumer via call center representative and described the occurrence of oral herpes zoster in a 57-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, an unknown time after receiving Shingrix, the patient experienced oral herpes zoster (Verbatim: shingles outbreak in the mouth), slight temperature (Verbatim: low grade temp), tiredness (Verbatim: tiredness) and headache (Verbatim: headaches). The outcome of the oral herpes zoster, slight temperature, tiredness and headache were resolving.   It was unknown if the reporter considered the oral herpes zoster, slight temperature, tiredness and headache to be related to Shingrix.     It was unknown if the company considered the oral herpes zoster, slight temperature, tiredness and headache to be related to Shingrix.  Additional Information: GSK Receipt Date: 16-NOV-2023 The consumer asked how long after getting the shot could side effects show up. The patient saw a doctors and she believed she had a bad reaction from the first shot. The reporter did not asked about time frames. The patient had a shingles outbreak in the mouth, low grade temp, tiredness and headaches. The patient stated that symptoms were relieved. The reporter asked if there were any sulfur products in the vaccine. The detailed information of the side effects after Shingrix and other relevant information was provided to the patient. The consent to follow-up requested.
Sex: U
Vaccine: FLU4
Symptoms: Expired product administered
Clinical narrative: administration of expired Flulaval to employees; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2022-2023 season) (batch number J7C77, expiry date 26-JUN-2023) for prophylaxis.   On 30-OCT-2023, the patient received FluLaval Quadrivalent 2022-2023 season. On 30-OCT-2023, an unknown time after receiving FluLaval Quadrivalent 2022-2023 season, the patient experienced expired vaccine used (Verbatim: administration of expired Flulaval to employees). 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: 14-NOV-2023 The pharmacist reported that the administration of expired Flulaval to employees which led to expired vaccine used. The reporter consented to follow up. This case is 1 of 4 cases reported by same reporter.; Sender's Comments:  US-GSK-US2023157831: US-GSK-US2023AMR162065: US-GSK-US2023AMR162074:
Sex: U
Vaccine: FLU4
Symptoms: Expired product administered
Clinical narrative: administration of expired Flulaval to 4 employees; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2022-2023 season) (batch number J7C77, expiry date 26-JUN-2023) for prophylaxis.   On 03-NOV-2023, the patient received FluLaval Quadrivalent 2022-2023 season. On 03-NOV-2023, an unknown time after receiving FluLaval Quadrivalent 2022-2023 season, the patient experienced expired vaccine used (Verbatim: administration of expired Flulaval to 4 employees). 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: 14-NOV-2023 The pharmacist reported that the administration of expired Flulaval to employees which led to expired vaccine used. The reporter consented to follow up. This case is 1 of 4 cases reported by same reporter.; Sender's Comments:  US-GSK-US2023157831:1 st employee US-GSK-US2023AMR162052:2 nd employee US-GSK-US2023AMR162074:4 th employee US-GSK-US2023AMR162065:3rd  employee US-GSK-US2023AMR162065:3rd  employee US-GSK-US2023AMR162074:3 rd  employee
Sex: U
Vaccine: FLU4
Symptoms: Expired product administered
Clinical narrative: administration of expired Flulaval to employees; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a patient who received Flu Seasonal QIV (FluLaval Quadrivalent 2022-2023 season) (batch number J7C77, expiry date 26-JUN-2023) for prophylaxis.   On 03-NOV-2023, the patient received FluLaval Quadrivalent 2022-2023 season. On 03-NOV-2023, an unknown time after receiving FluLaval Quadrivalent 2022-2023 season, the patient experienced expired vaccine used (Verbatim: administration of expired Flulaval to employees). 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: 14-NOV-2023 The pharmacist reported that the administration of expired Flulaval to employees which led to expired vaccine used. The reporter consented to follow up. This case is 1 of 4 cases reported by same reporter.; Sender's Comments:  US-GSK-US2023157831:1 st employee US-GSK-US2023AMR162052:2nd  employee US-GSK-US2023AMR162065:3 rd  employee US-GSK-US2023AMR162074:4  th employee US-GSK-US2023AMR162074:4  th employee
Sex: F
Vaccine: RSV
Symptoms: Inflammation, Rash, Rash erythematous
Clinical narrative: huge red inflamed rash on my left arm; huge red inflamed rash on my left arm; This non-serious case was reported by a consumer and described the occurrence of red rash in a 78-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Concurrent medical conditions included sarcoidosis.   On 14-NOV-2023 12:55, the patient received Arexvy. In NOV-2023, an unknown time after receiving Arexvy, the patient experienced red rash (Verbatim: huge red inflamed rash on my left arm) and inflammation localized (Verbatim: huge red inflamed rash on my left arm). The outcome of the red rash and inflammation localized were not resolved.   It was unknown if the reporter considered the red rash and inflammation localized to be related to Arexvy.  It was unknown if the company considered the red rash and inflammation localized to be related to Arexvy.   Additional Information: GSK Receipt Date: 17-NOV-2023 The patient who had Sarcoidosis and she was advised to get Arexvy.  The patient received the Arexvy shot. Well she had all the terrible reactions for the first 36 hours and now she had a huge red inflamed rash on her left arm sight of the injection.  The reporter stated that not sure if your Department had any information on people with Sarcoidosis receiving the vaccine. Most medical doctors had minimal contact with sarcoidosis patients therefore their knowledge of vaccines and sarcoidosis was limited to get it.  The patient was sure the symptoms she had and still experiencing would go away but her question was the vaccine going to work in her body. The patient knew months and months of clinical studies were done therefore she thought that she would go to directly to see if had any knowledge of the vaccine and sarcoidosis.
Sex: U
Vaccine: RV1
Symptoms: Cough
Clinical narrative: coughed; This non-serious case was reported by a physician via sales rep and described the occurrence of cough in a 4-month-old patient who received Rota (Rotarix lyophilized formulation) for prophylaxis.   On an unknown date, the patient received Rotarix lyophilized formulation 1.5 ml. On an unknown date, an unknown time after receiving Rotarix lyophilized formulation, the patient experienced cough (Verbatim: coughed). The outcome of the cough was not reported.   It was unknown if the reporter considered the cough to be related to Rotarix lyophilized formulation and Rotarix Oral Applicator Device.     It was unknown if the company considered the cough to be related to Rotarix lyophilized formulation and Rotarix Oral Applicator 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: 15-NOV-2023 The physician stated that she noticed for two patients who she thought were 4 months old that the new Rotarix Liquid only did not taste the same as the old one and may be too much volume at 1.5ml. She said the babies coughed and had their back patted when she was administering it. She said that never happened with the old mixed formulation. She thought the old one maybe had a better taste and also 1ml change to 1.5ml was a lot for babies. She did not wanted to be contacted, but asked if the flavor was different.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Immediate post-injection reaction, Injection site erythema, Injection site pain
Clinical narrative: She said that she experienced pain at the injection site; Redness at the injection site; Swelling at the injection site; Fatigue; Chills; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Nucala with an associated reaction of injection site pain (received 1st dose on 24th October 2023 and for tolerance of 1st dose of Nucala, refer case US2023AMR163748).   On 02-NOV-2023, the patient received the 2nd dose of Shingrix (intramuscular, right deltoid) .5 ml. On 02-NOV-2023, immediately after receiving Shingrix, the patient experienced injection site pain (Verbatim: She said that she experienced pain at the injection site), injection site erythema (Verbatim: Redness at the injection site), injection site swelling (Verbatim: Swelling at the injection site), fatigue (Verbatim: Fatigue) and chills (Verbatim: Chills). The outcome of the injection site pain was resolved and the outcome of the injection site erythema, injection site swelling and fatigue were resolved (duration 1 week) and the outcome of the chills was resolved (duration 2 days).   It was unknown if the reporter considered the injection site pain, injection site erythema, injection site swelling, fatigue and chills to be related to Shingrix.  It was unknown if the company considered the injection site pain, injection site erythema, injection site swelling, fatigue and chills to be related to Shingrix.   Linked case(s) involving the same patient:US2023AMR163748   Additional Information: GSK Receipt Date: 14-NOV-2023 The patient also described that she received the Shingrix and experienced the following:fatigue, chills and pain, redness and swelling at the injection site. She reported these all started immediately after receiving the dose. The redness and swelling at the injection site lasted for one week. The pain at the injection site lasted for 3-4 days. Chills resolved after two days and the fatigue resolved after one week. The reporter consented to follow up.; Sender's Comments:  US-GSK-US2023AMR163748:same / different drug
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling
Clinical narrative: She said that she experienced pain at the injection site; Redness at the injection site; Swelling at the injection site; Fatigue; Chills; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Nucala with an associated reaction of injection site pain (received 1st dose on 24th October 2023 and for tolerance of 1st dose of Nucala, refer case US2023AMR163748).   On 02-NOV-2023, the patient received the 2nd dose of Shingrix (intramuscular, right deltoid) .5 ml. On 02-NOV-2023, immediately after receiving Shingrix, the patient experienced injection site pain (Verbatim: She said that she experienced pain at the injection site), injection site erythema (Verbatim: Redness at the injection site), injection site swelling (Verbatim: Swelling at the injection site), fatigue (Verbatim: Fatigue) and chills (Verbatim: Chills). The outcome of the injection site pain was resolved and the outcome of the injection site erythema, injection site swelling and fatigue were resolved (duration 1 week) and the outcome of the chills was resolved (duration 2 days).   It was unknown if the reporter considered the injection site pain, injection site erythema, injection site swelling, fatigue and chills to be related to Shingrix.  It was unknown if the company considered the injection site pain, injection site erythema, injection site swelling, fatigue and chills to be related to Shingrix.   Linked case(s) involving the same patient:US2023AMR163748   Additional Information: GSK Receipt Date: 14-NOV-2023 The patient also described that she received the Shingrix and experienced the following:fatigue, chills and pain, redness and swelling at the injection site. She reported these all started immediately after receiving the dose. The redness and swelling at the injection site lasted for one week. The pain at the injection site lasted for 3-4 days. Chills resolved after two days and the fatigue resolved after one week. The reporter consented to follow up.; Sender's Comments:  US-GSK-US2023AMR163748:same / different drug
Sex: U
Vaccine: RSV
Symptoms: Product administered to patient of inappropriate age, Product prescribing error
Clinical narrative: prescribed Arexvy, to the patient has leukemia and is younger than 60; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug prescribing error in a adult patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Concurrent medical conditions included leukemia.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced drug prescribing error (Verbatim: prescribed Arexvy, to the patient has leukemia and is younger than 60). The outcome of the drug prescribing error was unknown.   Additional Information: GSK Receipt date: 14-NOV-2023 The reporter stated that a patient was prescribed Arexvy. The patient had leukemia and was younger than 60. Reporter declined to provide more information. Reporter did not consent to follow up. Reporter stated that patient was prescribed Arexvy and patient was younger than 60, which led to drug prescribing error.
Sex: F
Vaccine: MMR
Symptoms: Device connection issue, Needle issue, Underdose
Clinical narrative: the nurse went to twist the needle onto the syringe and the little piece that you twist the needle onto is not threaded; Nurse is unsure how much of the vaccine was administered; the nurse went to twist the needle onto the syringe; This non-serious case was reported by a other health professional via call center representative and described the occurrence of accidental underdose in a adolescent female patient who received MMR (Priorix) (batch number CB979, expiry date 13-MAY-2024) for prophylaxis. This case was associated with a product complaint.   In SEP-2023, the patient received Priorix. In SEP-2023, an unknown time after receiving Priorix, the patient experienced accidental underdose (Verbatim: Nurse is unsure how much of the vaccine was administered) and needle issue (Verbatim: the nurse went to twist the needle onto the syringe). On an unknown date, the patient experienced pharmaceutical product complaint (Verbatim: the nurse went to twist the needle onto the syringe and the little piece that you twist the needle onto is not threaded). The outcome of the accidental underdose, needle issue and pharmaceutical product complaint were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date-14-NOV-2023 The reporter reported that the nurse went to twist the needle onto the syringe and the little piece that you twist the needle onto was not threaded. The product quality check involved two units of suspect product with one unit administered. The reporter stated that the nurse was unsure how much of the vaccine was administered, which led to accidental underdose, needle issue and pharmaceutical product compliant. After administration, the nurse noticed that the patient's shirt was wet. The defect was noticed during preparation and administration.  Mixing was done gently and by a swirling motion after reconstitution.  The vial was held upside down when the vaccine was being withdrawn. There was limited information at time of call. Office Manager will call back with further information. The reporter consented to follow up.
Sex: U
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: pharmacist called to inform that an adult patient had received a pediatric dose; pharmacist called to inform that an adult patient had received a pediatric dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of adult use of a child product in a 19-year-old patient who received HBV (Engerix B pediatric) (batch number KR3XD, expiry date 17-FEB-2025) for prophylaxis.   On an unknown date, the patient received Engerix B pediatric. On an unknown date, an unknown time after receiving Engerix B pediatric, the patient experienced adult use of a child product (Verbatim: pharmacist called to inform that an adult patient had received a pediatric dose) and underdose (Verbatim: pharmacist called to inform that an adult patient had received a pediatric dose). The outcome of the adult use of a child product and underdose 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: 14-NOV-2023  A pharmacist called to inform that an adult patient had received a pediatric dose of Engerix-B. The reporter consented to follow up.  The Vaccine Administration Facility was the same as Primary Reporter. Age of the patient was unknown; reporter only knew that the patient was over 19 years old. An adult patient received pediatric dose of Engerix B, which led to adult use of a child product and under dose.