chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.25
Sex: F
Vaccine: MMR
Symptoms: Discomfort, Erythema, Rash
Clinical narrative: generalized rash; red cheeks, and a red face / facial rash, and her face is really really red.; Consumer's granddaughter was really uncomfortable; This spontaneous report was received from a consumer referring to her granddaughter, a 15-month-old (also reported as "one year and four months old") female patient. Information regarding the patient's medical history, concurrent conditions, concomitant therapies and previous drug reactions or allergies was not provided.   On 11-NOV-2022 (reported as "about ten days ago"), the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneously (dose, anatomical site of vaccination, lot number and expiration date were not reported) for the prevention of measles, mumps, and rubella.   On 20-NOV-2022, the patient experienced a generalized rash like the measles itself (rash), red cheeks and red face (erythema). The reporter stated that they reached out to the patient's doctor and was told to take diphenhydramine hydrochloride (BENADRYL). In addition, the reporter stated that the patient was really uncomfortable (discomfort).   At the time of reporting, the patient had not recovered from the events. The reporter considered the events as a "really bad reaction" to the measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II); therefore, the causal relationship between the events and the vaccine was considered to be related.
Age: 1.08
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE details; A patient was administered a dose of VAQTA past it's expiration date; This spontaneous report was received from a health business professional referring to a 13-month-old (reported as 1 year and 1 month) patient of unspecified gender. Information regarding the patient's medical history, concurrent conditions, concomitant therapies and previous drug reactions or allergies was not provided.   On 15-NOV-2022, the patient was vaccinated with an expired dose of hepatitis A vaccine, inactivated (VAQTA) as prophylaxis (dose, route of administration, and anatomical site of vaccination were not reported; lot number U031911 has been verified to be valid, expiration date reported and established as 11-NOV-2022) (expired product administered).  No additional adverse event reported (no adverse event).
Age: 0.33
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE details were provided and no additional AE's were reported; patients that were administered vaccines after they were involved in a TE.; This spontaneous report was received from a licensed practical nurse and referred to a 4-month-old patient of unspecified gender. The patient's medical history, concurrent conditions, concomitant therapies were not reported.  On 07-NOV-2022 03:07 PM, the patient was vaccinated with the second dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 2 milliliter, oral liquid, lot # 1879861, expiration date: 20-OCT-2023, administered orally for prophylaxis (dose, strength was not provided) after the vaccine was involved in a temperature excursion (Product storage error). The storage temperature of the rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was 11.4 degrees Celcius for a time frame of 1 hour 30 minutes. There was no previous temperature excursion.  No additional adverse effect (AE) details were provided (no adverse event).   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2212USA000032: US-009507513-2212USA000033: US-009507513-2212USA000034: US-009507513-2212USA000035: US-009507513-2212USA000036: US-009507513-2212USA000037: US-009507513-2212USA000038: US-009507513-2211USA004171:
Age: 42.0
Sex: F
Vaccine: MMR, UNK
Symptoms: Expired product administered, No adverse event
Clinical narrative: The patient has reported no adverse events to this reporter at this time; patient received an MMRII vaccine that was mixed with expired diluent; This spontaneous report has been received from a nurse practitioner, concerning a 42-years-old female patient. The patient's medical history, concurrent conditions, concomitant medications, previous drug reactions, and allergies were not provided.   On 03-DEC-2022, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (recombinant Human albumin) (M-M-R II) subcutaneous injection, in her right arm as prophylaxis (lot number U013035 has been verified to be valid; expiration date reported and established as 23-APR-2023) (strength, dose, frequency, vaccination scheme, and route of administration were not provided), diluted with sterile diluent solution for injection (lot number U035268 has been verified to be valid; expiration date reported and established as 09-NOV-2022) (expired product administered). The patient had reported no adverse events.
Sex: U
Vaccine: HEP
Symptoms: Unevaluable event
Clinical narrative: Received HEPLISAV-B for Second Dose and 3-Dose Hepatitis-B Vaccine for Third Dose; Initial Report Received on 02-Sep-2022  A registered nurse reported that a 23-year-old female patient (race and ethnicity unknown) received a dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization as a second dose and a 3-dose hepatitis-B vaccine (unspecified) for the third dose.   Medical history and concomitant medications at the time of vaccination were not reported. The patient was allergic to sulfa and azithromycin.  In 1999, the patient received a 3-dose hepatitis-B vaccine (unspecified) for the first dose (Lot #, expiration date, NDC #, route, and injection site unknown).  On 21-Jul-2022, the patient received the second dose with HEPLISAV-B (Lot # 937230, expiration date 25-Sep-2023, NDC # 43528-003-05, route not specified) in the right deltoid. The patient did not report any adverse reactions.  On 20-Aug -2022, 31 days after having been vaccinated with HEPLISAV-B, the patient received an unspecified 3-dose hepatitis-B vaccine (unspecified) for the third dose (details unknown).   No further information was provided.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Product storage error
Clinical narrative: Product Temperature Excursion Issue; Initial Report Received on 06-Sep-2022, 07-Sep-2022, 09-Sep-2022, 12-Sep-2022, 13-Sep-2022 and 15-Sep-2022  A pharmacist reported that a 28-year-old patient (gender, race, and ethnicity unknown) received a dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization that had a temperature excursion issue. Follow-up information was provided by a different pharmacist from the same pharmacy.  Medical history, concomitant medications, and allergies at the time of vaccination were unknown.  On 03-Sep-2022, the patient received a dose of HEPLISAV-B (Lot # 937783, expiration date 29-Sep-2023, NDC # 43528-0003-05) intramuscularly in the left arm. It was discovered later that "over the past 10 days, the thermometer record showed that occasionally, the temperature of the HEPLISAV-B vaccine went up to 50°F and then went back down again." This patient was given the HEPLISAV-B vaccine during this time. The initial reporter was unaware of any adverse effects reported.    Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Antibody test abnormal, Therapy non-responder
Clinical narrative: Received Both Doses of Heplisav-B, Patient Titer Shows Nonresponder; Initial Report Received on 28-SEP-2022  This is a spontaneous report, received from a physician regarding a patient who received HEPLISAV-B for hepatitis B immunisation.   There was no medical history reported for the patient.  Concomitant medications were not reported.  On unknown dates, patient received both doses of HEPLISAV-B.   The physician reported that the titer showed patient was a nonresponder.   The outcome of the adverse event was not reported.  No further information was available at the time of the report.   Company Comment: The company assessed the event as non-serious. Since the dosing interval, time to serological marker testing, titer and clinical manifestations of hepatitis B were not provided, the case does not qualify for confirmed immunological failure or confirmed clinical failure.; Sender's Comments: The company assessed the event as non-serious. Since the dosing interval, time to serological marker testing, titer and clinical manifestations of hepatitis B were not provided, the case does not qualify for confirmed immunological failure or confirmed clinical failure.
Sex: F
Vaccine: HEP
Symptoms: Occupational exposure to product, Syringe issue
Clinical narrative: Vaccine Landing On My Arm Instead of It Going Into The Patient's Deltoid; Initial Report Received on 28-Sep-2022, 03-Oct-2022, 04-Oct-2022 and 18-Nov-2022  This is a spontaneous report, received via a MedWatch 3500A from the FDA MedWatch Program.  The report was reported by a patient safety specialist regarding a patient who received HEPLISAV-B for hepatitis B immunization. This case captures the occupation exposure for the Medical Assistant who administered the vaccine.  There was no medical history reported for the patient.  Concomitant medications were not reported.  On 09-Sep-2022, a dose of HEPLISAV B (Lot #937783, expiration date Dec 2025, NDC #43528-003-01), route not specified, was administered in the left deltoid for hepatitis B immunization by the medical assistant.  During administration, when attempting to administer HEPLISAV-B into a patient's left deltoid, the liquid of the vaccine shot out of where the syringe's plain tip and the needle's hub meet, causing the vaccine to land on the medical assistant's arm instead of going into the patient's deltoid. The needle was inserted into the arm, and when medical assistant pressed the plunger to administer the vaccine, a large amount of clear fluid squirted out the side between the hub of the needle and pre-filled syringe. It was reported that it appeared to be the full 0.5 ml as it was dripping from the medical assistant's arm and on her scrubs. This was immediately reported to provider, who advised new vaccine be administered and this was done with no issues.  The outcome of the adverse event was not reported.  The lot was investigated. No lot impact was found.  No further information was available at the time of the report.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Suspected vaccination failure; Shingles on left hand; Very painful; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. In November 2022, more than 2 years after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.     Additional Information: GSK receipt date: 30-Nov-2022 Reporter's comment: This case was reported by a patient via interactive digital media. The patient had the shingles shot two years ago.  Last week, the patient got shingles on left hand and was very painful. Additional Supportive Information: The follow up would not possible, as no contact, details were available. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. This case was linked with the case US2022AMR180047 reported by same reporter.; Sender's Comments:  US-GSK-US2022AMR180047:Same reporter
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: Given 3 doses; This case was reported by a physician via sales rep and described the occurrence of extra dose administered in a 52-year-old male patient who received Herpes zoster (Shingrix) (batch number T5T79, expiry date 24th November 2023) for prophylaxis.   Previously administered products included Shingrix (received first dose on 10th May 2022). Concomitant products included RECOMBINANT VARICELLA ZOSTER VIRUS SURFACE GLYCOPROTEIN E (SHINGRIX).   On 28th November 2022, the patient received the 3rd dose of Shingrix. On 28th November 2022, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   Additional Information: GSK receipt date: 28-Nov-2022 and 29-Nov-2022 Reporter's comment: No adverse events currently but wanted to report. The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up. Additional supportive information: The patient was inadvertently administered third dose of Shingrix, which led to extra dose administered.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Mobility decreased
Clinical narrative: Unable to lift arm for 4 days; This case was reported by a consumer via call center representative and described the occurrence of mobility decreased in a 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, unknown after receiving Shingrix, the patient experienced mobility decreased. On an unknown date, the outcome of the mobility decreased was recovered/resolved.   It was unknown if the reporter considered the mobility decreased to be related to Shingrix.     Linked case(s) involving the same patient:  US2022177868   Additional Information:  GSK Receipt Date: 28-Nov-2022. Reporter's Comment:  The reporter stated that  the first dose of Shingrix she was unable to lift her arm for 4 days. Patient date of birth and lot number and expiry date was not requested. The reporter gave consent to follow up. Additional supportive information: For tolerance to the 2nd dose refer case US2022177868.; Sender's Comments:  US-GSK-US2022177868:Same reporter
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain in extremity
Clinical narrative: Unable to lift arm for 4 days; This case was reported by a consumer via call center representative and described the occurrence of mobility decreased in a 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, unknown after receiving Shingrix, the patient experienced mobility decreased. On an unknown date, the outcome of the mobility decreased was recovered/resolved.   It was unknown if the reporter considered the mobility decreased to be related to Shingrix.     Linked case(s) involving the same patient:  US2022177868   Additional Information:  GSK Receipt Date: 28-Nov-2022. Reporter's Comment:  The reporter stated that  the first dose of Shingrix she was unable to lift her arm for 4 days. Patient date of birth and lot number and expiry date was not requested. The reporter gave consent to follow up. Additional supportive information: For tolerance to the 2nd dose refer case US2022177868.; Sender's Comments:  US-GSK-US2022177868:Same reporter
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Injection site discolouration, Injection site induration, Skin exfoliation
Clinical narrative: induration near the spots; This case was reported by a other health professional via call center representative and described the occurrence of injection site induration in a 18-year-old female patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Bexsero with an associated reaction of injection site discolouration (The patient received 1st dose on 31st Mar 2022 for tolerance to the 1st dose refer case US2022177893.).   On 26th May 2022, the patient received the 2nd dose of Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, several months after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced injection site induration. On an unknown date, the outcome of the injection site induration was not recovered/not resolved.   It was unknown if the reporter considered the injection site induration to be related to Bexsero and Bexsero Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Linked case(s) involving the same patient:  US2022177893   Additional Information: GSK Receipt Date: 28-Nov-2022. Reporter's Comment:  The reporter wasthe patient's mother and also an unspecified healthcare provider.  On 26-MAY-2022 she received her second Bexsero dose and a few months after the second dose the dark spots became scaly and lighter in color (AE: scaly skin).  The reporter stated that some induration was now noted near the spots of discoloration. Nothing else was reported. The reporter did not consent to follow-up.; Sender's Comments:  US-GSK-US2022177893:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Pain persist severe; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.     Additional Information: GSK receipt date :28-NOV-2022 Reporters comment: This case was reported by a consumer via interactive digital media. The patient he/she received shingle vaccine and had pain. The patient stated that the pain persists severe for long. Additional supportive information: Follow-up would not possible as no contact details were available.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Incomplete course of vaccination
Clinical narrative: shingles; got 1 dose years ago; This case was reported by a consumer via call center representative and described the occurrence of shingles in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, more than 2 years after receiving Shingles vaccine and not applicable after receiving Shingles vaccine, the patient experienced shingles and incomplete course of vaccination. On an unknown date, the outcome of the shingles and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.     Additional Information: GSK receipt date: 28-NOV-2022 Reporter's comment: The reporter was the patient. The patient received a dose of a shingles vaccine about 2-3 years ago.  He did not know which shingles vaccine he received but thought he got 1 dose.  The patient recently developed shingles.  The reporter did not consent to follow-up. Additional Supportive Information: Till the time of reporting the patient did not receive 2nd dose of vaccine, which led to incomplete course of vaccination.
Age: 8.0
Sex: F
Vaccine: DTAP
Symptoms: Extra dose administered, Product administered to patient of inappropriate age
Clinical narrative: Infanrix as the 6th dose of DTap; 8 year old received Infanrix/ last one at 2 years-old; This case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 8-year-old female patient who received DTPa (Infanrix) (batch number 23T73, expiry date 30th April 2023) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included DTaP (received 5 doses of DTaP on an unknown date).   On 23rd November 2022, the patient received the 6th dose of Infanrix and Infanrix Pre-Filled Syringe Device. On 23rd November 2022, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced extra dose administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the extra dose administered and inappropriate age at vaccine administration 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: 28-Nov-2022 Reporter's comment: Medical assistant inquired that how to proceed and any guidance. This dose was the patient's 6th dose of DTaP. The patient had not the Infanrix since 2 years of age. No other details were provided. The reporter did not consent to follow-up. Additional supportive information: The patient received Infanrix as 6th dose of DTaP at inappropriate age, which led to extra dose administered and inappropriate age at vaccine administration. Suspect dose number was captured as per reported information.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose on 2019, never received 2nd; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose on 29th April 2019).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 28-Nov-2022 Reporter's comment: The pharmacy student reporting about a patient from this pharmacy students.  The patient never received a second Shingrix dose. The reporter was  unable to provide any more information about the patient to the agent. Unknown if the reporter granted consent, this was not asked.   Additional supportive information: Till the time of reporting, the patient did not receive second dose of Shingrix, which led to incomplete course of vaccination.
Age: 0.33
Sex: F
Vaccine: UNK
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: FluLaval administered to a 4-month-old; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 4-month-old female patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2022-2023 season) (batch number 95ZA7, expiry date 30th June 2023) for prophylaxis.   Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 15th November 2022, the patient received FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device. On 15th November 2022, unknown after receiving FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. The action taken with FluLaval Quadrivalent 2022-2023 season was unknown. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 28-Nov-2022 Reporter's comment: The reporter gave permission for follow-up. Additional supportive information: The patient received a dose of FluLaval at inappropriate age, which led to inappropriate age at vaccine administration.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered
Clinical narrative: Incomplete dose administered/Needle leakage (needle loose at administration); This case was reported by a pharmacist via call center representative and described the occurrence of incomplete dose administered in a 54-year-old female patient who received Herpes zoster (Shingrix) (batch number 23E5G, expiry date 11th February 2024) for prophylaxis.   On 28th November 2022, the patient received the 1st dose of Shingrix. On 28th November 2022, unknown after receiving Shingrix, the patient experienced incomplete dose administered. On an unknown date, the outcome of the incomplete dose administered was unknown.   Additional Information: GSK receipt date: 28-Nov-2022 Reporter's comment: The report was not shared because the reporter mentioned that the needle was loose at the moment of administration and that could be the leakage reason.  For the exposure via skin contact, it was not mentioned during the call. The reporter asked to remain anonymous and denied follow-up Did not consent to follow-up. Additional supportive information: A dose of Shingrix had been administered to a patient, but due to needle leakage the dose was incomplete, which led to incomplete dose administered.
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Received 2nd dose 11 months after 1st; This 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 Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose 11 months prior to the vaccination).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK receipt date: 28-Nov-2022 Reporter's comment: A pharmacist called to ask for information about a patient who had received two doses of Shingrix. The reporter asked if the patient needs a third dose of Shingrix. The reporter neither provided patient identifiers nor data about the vaccines administered. Did not consent to follow-up. Additional supportive information: The patient received second dose of Shingrix later than recommended interval, which led to lengthening of vaccine schedule.
Sex: M
Vaccine: VARZOS
Symptoms: Illness
Clinical narrative: Got sick; This case was reported by a consumer via call center representative and described the occurrence of sickness in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown.   It was unknown if the reporter considered the sickness to be related to Shingrix.     Additional Information: GSK receipt date: 28-NOV-2022 Reporter's comment: The reporter reported that her brother in law got sick after getting the shingrix shot.  No other information was reported to the agent by the caller.  The reporter did not consent to follow-up.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injected limb mobility decreased, Loss of personal independence in daily activities
Clinical narrative: Unable to lift arm, as bad as 1st time,injected into left arm and since injection, patient has been unable to lift left arm; difficulty putting on jacket; This case was reported by a consumer via call center representative and described the occurrence of injected limb mobility decreased in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of mobility decreased (received 1st on an unknown date, refer link case US2022AMR178393).   On 23rd September 2022, the patient received the 2nd dose of Shingrix. On 23rd September 2022, less than a day after receiving Shingrix, the patient experienced injected limb mobility decreased and activities of daily living impaired. On an unknown date, the outcome of the injected limb mobility decreased and activities of daily living impaired were not recovered/not resolved.   It was unknown if the reporter considered the injected limb mobility decreased and activities of daily living impaired to be related to Shingrix.     Linked case(s) involving the same patient:  US2022AMR178393   Additional Information: GSK receipt date: 28-NOV-2022 Reporter's comment: The patient reported that after the 2nd dose she was been unable to lift her left arm.  The patient date of birth and lot number, expiry date was not requested.  The 2nd dose was injected into left arm and since injection, patient had been unable to lift left arm, stated she had difficulty putting on jacket.  The patient also stated that the 2nd time was just as bad as the 1st time but was still ongoing.  The reporter consented to follow-up. Additional Supportive Information: This case linked with case US2022AMR178393 reported by same reporter.; Sender's Comments:  US-GSK-US2022AMR178393:Same reporter
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain, Pain in extremity
Clinical narrative: Unable to lift arm, as bad as 1st time,injected into left arm and since injection, patient has been unable to lift left arm; difficulty putting on jacket; This case was reported by a consumer via call center representative and described the occurrence of injected limb mobility decreased in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of mobility decreased (received 1st on an unknown date, refer link case US2022AMR178393).   On 23rd September 2022, the patient received the 2nd dose of Shingrix. On 23rd September 2022, less than a day after receiving Shingrix, the patient experienced injected limb mobility decreased and activities of daily living impaired. On an unknown date, the outcome of the injected limb mobility decreased and activities of daily living impaired were not recovered/not resolved.   It was unknown if the reporter considered the injected limb mobility decreased and activities of daily living impaired to be related to Shingrix.     Linked case(s) involving the same patient:  US2022AMR178393   Additional Information: GSK receipt date: 28-NOV-2022 Reporter's comment: The patient reported that after the 2nd dose she was been unable to lift her left arm.  The patient date of birth and lot number, expiry date was not requested.  The 2nd dose was injected into left arm and since injection, patient had been unable to lift left arm, stated she had difficulty putting on jacket.  The patient also stated that the 2nd time was just as bad as the 1st time but was still ongoing.  The reporter consented to follow-up. Additional Supportive Information: This case linked with case US2022AMR178393 reported by same reporter.; Sender's Comments:  US-GSK-US2022AMR178393:Same reporter
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose in 2018, 2nd on 25Nov2022; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 68-year-old male patient who received Herpes zoster (Shingrix) (batch number B97G2, expiry date 26th January 2024) for prophylaxis.   Previously administered products included Shingrix (received first dose in 2018).   On 25th November 2022, the patient received the 2nd dose of Shingrix. On 25th November 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK receipt date: 28-Nov-2022 Reporter's comment: The reporter asked if the patient needs a third dose of Shingrix. The lot number and expiration date correspond to the second dose administered. The reporter consented to follow-up. Additional supportive information: The patient received second dose of Shingrix, which led to lengthening of vaccine schedule.
Age: 2.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Inappropriate schedule of product administration, Product administered to patient of inappropriate age
Clinical narrative: 2 yr old was administered Kinrix; Kinrix as 3rd dose of DTaP and IPV; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 2-year-old male patient who received DTPa-IPV (Kinrix) (batch number 2kl4k, expiry date 9th November 2023) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Pentacel (The first dose was received on an unknown date) and Pediarix (The second dose was received on an unknown date).   On 15th November 2022, the patient received the 3rd dose of Kinrix and Kinrix Pre-Filled Syringe Device. On 15th November 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and inappropriate schedule of vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and inappropriate schedule of vaccine administered 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: 28-NOV-2022. Reporter's comment: The medical assistant (MA) had reported that, a child patient was administered with Kinrix. The Healthcare Professional (HCP) had also reported that patient had received Pentacel as their first dose and Pediarix as their second, so the Kinrix was their third dose of DTaP and IPV vaccine schedule. The reporter had consented to follow-up. Additional supportive information: The patient who had received Kinrix as their third dose was younger than 4 years, which had led to inappropriate age at vaccine administration and inappropriate schedule of vaccine administered.
Age: 39.0
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Expired Havrix administered; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 39-year-old male patient who received HAV (Havrix) (batch number 7YA99, expiry date 30th September 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 25th November 2022, the patient received Havrix and Havrix Pre-Filled Syringe Device. On 25th November 2022, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, 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: 28-NOV-2022 Reporter's Comments:  The pharmacist reported that the patient was administered an expired dose of Havrix.  The reporter consented to follow up. The adverse event contains all reported information. Additional supportive information: The patient was administered an expired dose of Havrix, which led to expired vaccine used.
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: 3rd Shingrix administered.; This case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 63-year-old male patient who received Herpes zoster (Shingrix) (batch number CS2ZE, expiry date 10th September 2023) for prophylaxis.   Previously administered products included Shingrix (received 2 doses on an unknown date).   On 14th September 2022, the patient received Shingrix. On 14th September 2022, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   Additional Information: GSK receipt date: 28-Nov-2022 Reproter;'s comment: The vaccine administration facility was the same as primary reporter. The reporter gave consent to follow up via phone. Additional supportive information: The patient received the third dose of Shingrix vaccine, which led to extra dose administered.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Patient misses the 2-6 month window; This case was reported by a other health professional via sales rep and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose on an unknown date).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 28-Nov-2022 Reporter's comment: The customer relationship management (CRM) request sent by sales representative on behalf of health care professional, would  like to know if the shingrix should re-started if patient misses the 2 to 6 month second dose window. The representative was unable to confirm if a specific patient was involved or if this was only a general inquiry.  This may be a duplicate adverse event. No other information available.  Could not confirm mailing address was current in health care professional's profile or if follow up was permissible.  Additional supportive information: Till the time of reporting, the patient did not receive the second dose of Shingrix, which led to incomplete course of vaccination. The case was kept valid with worst approach considering that the patient was involved and missed the second dose.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose in 2021, 2nd 26Nov2022; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 51-year-old female patient who received Herpes zoster (Shingrix) (batch number Z7GH5, expiry date 25th January 2024) for prophylaxis.   Previously administered products included Shingrix (had received their first dose of Shingrix in 2021).   On 26th November 2022, the patient received the 2nd dose of Shingrix. On 26th November 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 29-NOV-2022 Reporter's Comment: The reporter called in to report that, a patient wished to know, under these circumstances, how to proceed with the vaccine schedule and if the doses were still valid.  The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up. Additional Supportive Information: The patient received the 2nd dose of Shingrix later than the recommended schedule which led to lengthening of vaccination schedule.
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 2nd dose 2 weeks after 1st dose; This case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too short in a elderly male patient who received Herpes zoster (Shingrix) (batch number 4H5MY, expiry date 11th May 2023) for prophylaxis.   Concomitant products included RECOMBINANT VARICELLA ZOSTER VIRUS SURFACE GLYCOPROTEIN E (SHINGRIX).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK Receipt Date: 29-NOV-2022  Reporter's comment: The nurse reported that the patient received second dose of Shingrix in 2021 only two weeks after the first dose of Shingrix. The reporter consented to follow up. Additional Supportive Information: The patient received a dose of Shingrix earlier than the recommended interval, which led to shortening of vaccination schedule.
Age: 68.0
Sex: M
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Expired Engerix-B administered; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 68-year-old male patient who received HBV (Engerix B) (batch number T2S4Z, expiry date 20th November 2022) for prophylaxis.   On 29th November 2022, the patient received Engerix B. On 29th November 2022, unknown after receiving Engerix B, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 29-NOV-2022 Reporter's comment: The reporter reported that administered expired Engerix-B to adult patient on 29th November 2022. The vaccine dose expired on 20th November 2022.  Dose from vial- batch number T2S4Z verified.  The reporter was consented to follow up. Additional Supportive Information: The Engerix-B vaccine was already expired and was administered to the patient, which led to expired vaccine used.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: not yet received her second dose; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in August 2019).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.      Additional Information: GSK receipt date: 29-NOV-2022 Reporters comment: The reporter was the patient.  She mentioned she had not yet received her second dose because she didn't know it was a two-dose series. Nothing else was reported. The reporter did not consent to follow-up. Additional Supportive information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Age: 73.0
Sex: F
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: Adult received pediatric dose; 10 mcg administered instead of adult dose/Adult received pediatric dose; This case was reported by a other health professional via call center representative and described the occurrence of underdose in a 73-year-old female patient who received HBV (Engerix B pediatric) (batch number K329E, expiry date 24th April 2023) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 8th June 2022, the patient received the 2nd dose of Engerix B pediatric 10 µg and Engerix B Pre-Filled Syringe Device. On 8th June 2022, unknown after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product were unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 1-Dec-2022 Reporter's comment: Practice manager called to inquired that the patient need to restart the series or just administer the other half of the dose. The reporter confirmed that the vaccine dose was administered in their facility. No additional details were provided. The reporter did not consent to follow-up. Additional supportive information: An adult patient was inadvertently administered a pediatric dose of Engerix as the second dose in the series, instead of the full adult dose, which led to underdose and adult use of a child product.
Sex: U
Vaccine: RV1
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Received Rotarix 2nd dose at 3 weeks; This case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too short in a patient who received Rota (Rotarix lyophilized formulation) (batch number 322CM, expiry date 15th February 2024) for prophylaxis.   Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis.   Concomitant products included LIVE ATTENUATED HUMAN ROTAVIRUS G1 STRAIN (ROTARIX).   On 21st October 2022, the patient received the 2nd dose of Rotarix lyophilized formulation and Rotarix Oral Applicator Device. On 21st October 2022, unknown after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator Device, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 5 Dec 2022 Reporter's comment: Licensed practical nurse called to inquired that the dose need to be repeated. The reporter was unable to provide any patient details. Did not consent to follow-up. Additional supportive information: The patient received second dose of Rotarix at 3 weeks instead of the series recommended 4 weeks in the reporter's facility, which led to shortening of vaccine schedule.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: received by error a Shingrix third dose; This case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 2 doses on an unknown date). Concurrent medical conditions included immunocompromised.   On 1st December 2022, the patient received the 3rd dose of Shingrix. On 1st December 2022, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   Additional Information: GSK receipt date: 1-Dec-2022 Reporter's comment: The reporter had not provided permission to storage personal information in medical information database.  Data was sent to safety via email. The reporter consented to follow-up via email. Additional supportive information: The patient received third dose of Shingrix, which led to extra dose administered.