chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: F
Vaccine: TDAP
Symptoms: Balance disorder, Death, JC virus infection, Progressive multifocal leukoencephalopathy
Clinical narrative: Pt experienced loss of balance after vaccine, after progression of symptoms was diagnosed with progressive multifocal leukoencephalopathy, JC Virus, Pt expired Jan 3, 2023.
Age: 20.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered, Product administration error
Clinical narrative: BIVALENT mRNA vaccine is administered in error as a primary dose.
Age: 58.0
Sex: F
Vaccine: COVID19-2, FLUC4
Symptoms: Administration site inflammation, Arthralgia, Bone disorder, Dermal filler reaction, Inflammation
Clinical narrative: A few weeks  after receiving the vaccines, I began to have inflammation in several parts of my body where I?d either received injections of ?Sculptra?, and dermal filler (numerous places on my legs and face wherever I?d received the injections almost exactly a year earlier), and in my left hip which I hadn?t realized before then that it was damaged. I didn?t have any initial swelling from the Sculptra when it was first injected the prior year, so in November when the swelling wasn?t going away, I went in to see the dermatologist that had administered it. She hadn?t seen this happen before and asked if I?d recently been sick or had a vaccine. That?s when we realized the connection between the two events and she told me to contact the CDC to report the reaction. Around that same time in September, I went to see an orthopedist about pain in my hip. It wasn?t until the pain hot so bad in January of 2033 that I got an MRI and they noted a lot of sweeping and edema in my hip bone and surrounding tissue.
Age: 58.0
Sex: F
Vaccine: COVID19-2, FLUC4
Symptoms: Injection site inflammation, Joint injury, Magnetic resonance imaging abnormal, Oedema
Clinical narrative: A few weeks  after receiving the vaccines, I began to have inflammation in several parts of my body where I?d either received injections of ?Sculptra?, and dermal filler (numerous places on my legs and face wherever I?d received the injections almost exactly a year earlier), and in my left hip which I hadn?t realized before then that it was damaged. I didn?t have any initial swelling from the Sculptra when it was first injected the prior year, so in November when the swelling wasn?t going away, I went in to see the dermatologist that had administered it. She hadn?t seen this happen before and asked if I?d recently been sick or had a vaccine. That?s when we realized the connection between the two events and she told me to contact the CDC to report the reaction. Around that same time in September, I went to see an orthopedist about pain in my hip. It wasn?t until the pain hot so bad in January of 2033 that I got an MRI and they noted a lot of sweeping and edema in my hip bone and surrounding tissue.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Accidental improper storage of vaccine leading to temperature excursion prior to vaccine administration
Age: 16.0
Sex: M
Vaccine: HPV9, MENB, MNQ
Symptoms: Dizziness, Pain in extremity, Somnolence, Tremor, Vaccination site pain
Clinical narrative: shaking / uncontrotably shaking / continued to shake; lightheaded; fell asleep; Left arm  pain from  injections; This spontaneous report was received from a registered nurse, via the Agency (HA # 857596), referring to a 16-year-old male patient. The patient's pertinent medical history and concomitant medications were not reported. The patient had not known drug allergies. His concurrent conditions included attention deficit disorder (ADD).     On 20-JAN-2020 at 16:30, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) intramuscularly in the right deltoid, lot # 1637641 (expiration date not reported, but upon internal validation established as 16-FEB-2022), for prophylaxis (strength and dose were not reported). Additionally, the patient was vaccinated with the first dose of meningococcal vaccine b rfhbp/nada/nhba omv(BEXSERO) intramuscularly in the left deltoid, lot # ABXA77A; and the second dose of meningococcal vaccine a/c/y/w conj (dip tox)(MENACTRA) intramuscularly in the left deltoid, lot # V6575AA (strength, dose, expiration date and indication were not reported for both suspect vaccines). The patient did not receive any other vaccine within one month prior and did not ever have any adverse event following any previous vaccination).      On 21-JAN-2020 at 05:30, while on toilet, he started shaking, he started to shower and felt lightheaded (dizziness) in tub; his mom witnessed him uncontrollably shaking for 1 hour. He did not present loss of consciousness (LOC) and was taken to bed and continued to shake (tremor), fell asleep (somnolence), had not fever. The patient was taken to the physician 's office, on the same date. He also had left arm pain from injections (vaccination site pain). He was able to walk out from physician's office. On an unspecified date, the patient recovered from the events.       The causality assessment between the events and the suspect vaccines was not provided.  Follow-up information has been received from the reporter's office, indicating that the correspondence physician was no longer available at their  practice.
Sex: U
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: No additional AE details were provided and no additional AE's were reported.; An HCP is reporting an AE on behalf of a patient. The HCP reports that a patient was administered a dose of ROTATEQ after it was involved in a temperature excursion.; This spontaneous report was received from a certified medical assistant referring to a patient (age and gender not provided). No information was provided regarding the patient's medical history, concurrent conditions, or concomitant medications.  06-JAN-2023, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, 2ml oral, lot #1837126, expiration date: 14-OCT-2023, administered for prophylaxis (strength and anatomical location were not provided) following temperature excursion (date not reported), at a temperature of 10.3 C degrees for an unknown period, it was noted that there was no other temperature excursion.  No additional adverse effects were reported to the patient.
Age: 6.0
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs; TE for vaccines and confirms that PROQUAD was administered on 2/10/2023; This spontaneous report was received from Nurse and refers to a 6-year-old female patient. Information regarding the patient's pertinent medical history, historical drugs, concurrent conditions, concomitant therapies, and previous drug reactions or allergies was not reported.   On 10-FEB-2023, the patient was vaccinated with an improperly stored dose of  measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection, 0.5ml/once, lot #W028568, expiration date: 06-MAR-2024, administered for prophylaxis (strength, and route of administration were not provided). No additional adverse event was reported.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Product storage error
Clinical narrative: No additional AE; HCP reported VARIVAX was administered after a temperature excursion.; This spontaneous report has been received from other health care professional, regarding to a 4-year-old female patient. The patient's pertinent medical history, concurrent conditions, concomitant medications, and previous drug reactions or allergies were not reported.   On 13-JAN-2023, the patient was vaccinated with improperly stored doses of varicella virus vaccine live (Oka/Merck) (VARIVAX) injection (lot number W008711 which has been verified to be valid, expiration date reported and validated as 14-MAR-2024) (strength, dose, vaccination scheme frequency, route of administration, and anatomical sites of injection were not reported) Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II)  and diphtheria vaccine toxoid (+) pertussis vaccine acellular 5-component (+) polio vaccine inact 3v (mrc 5) (+) tetanus vaccine toxoid (QUADRACEL) (strengths, doses, vaccination scheme frequencies, routes of administration, anatomical sites of injection, lot numbers, and expiration dates were not reported). All of the vaccines were administered as prophylaxis.   Administered doses were stored at a temperature of -10.5 degrees Celsius (C) during a time frame of 1 hour and 34 minutes. There was no previous temperature excursion.  No additional adverse events were reported in the patient.  This is one of several reports received from the same reporter.
Age: 21.0
Sex: F
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: Customer called for a temperature excursion and reported GARDASIL 9 that had undergone temperature excursion was administered to a patient before calling. No additional AE reported. No PQC reported. No further information was provided.  ?    N; no adverse event; This spontaneous report was received from an office manger and an administrative assistant, regarding a 21-year-old female.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 14-FEB-2023, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (dose not provided) lot #W011264, expiration date: 05-SEP-2024, administered intramuscularly in her left deltoid for prophylaxis. Previous administration the vaccine had undergone a temperature excursion with a temperature of 35.6 Fahrenheit (F) during a time frame of 5 hours and 15 minutes. No previous excursions reported. No Adverse event reported. No other vaccines were given on the same day. Additional information was not expected.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: No additional AE or PQC reported; VARIVAX was administered after a temperature excursion; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not provided.  On 20-JAN-2023, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) 0.5 ml for prophylaxis (lot# W012163 has been verified to be a valid lot number, expiration date: 12-APR-2024; strength and route were not reported) after a temperature excursion (product storage error). The vaccine had been stored at 7 degrees Fahrenheit (F) for 1 hour. It was reported that there was no previous temperature excursion. The outcome of the event was unknown. There was no additional adverse event (AE) or product quality complaint (PQC) reported.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; Inbound call from HCP who stated MMR-II was inadvertently administered after being improperly stored during a supported temp excursion. No additional AE details or PQC.         ?    Names of vaccines involved (including lot/exp) MMR-II W001598 01/1; This spontaneous report was received from a nurse and referred to a patient with unknown age and gender. Concomitant medication included sterile diluent (manufacturer unknown). The patient's concurrent conditions, pertinent medical history and drug reactions/ allergies were not provided.  On 31-JAN-2023, measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was improperly stored during a supported temp excursion (product storage error). Temperature was 8.6 Celsius degree. Time frame was 10 minutes. Previous temperature excursion did not occur. On an unknown date in 2023, the patient was inadvertently vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (rHA) (lot # W001598 has been verified to be a valid lot number, expiration date was reported as 14-JAN-2024, dose, route and anatomical location were not provided) for prophylaxis. No additional adverse event (AE) details (No adverse event).
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I've gotten two shots and they still lingering/Suspected vaccination failure; They still lingering; 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.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. The patient was treated with gabapentin. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional Information: GSK Receipt Date: 21-FEB-2023 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient gotten two shingles shots and they still lingering (shingles). The reporter also took three times a day Gabapentin. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available. The case had been linked to US2022AMR030529, reported by the same reporter, for a different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR030529:Person mentioned in the report
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: now I have shingles again / Suspected vaccination failure; now I have shingles again; 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.   The patient's past medical history included shingles (first time was in  October 2017).   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 21-FEB-2023 Reporter's comment: This case was reported by the patient via interactive digital media. The patient stated that, he/she had the shot and still got shingles.  He/She had shingles a few years ago so he/she had the shot and at the time of reporting, he/she had shingles again.  The reporter had asked if they need to take the shot yearly. Additional supportive information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible, as no contact, details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Got the vaccine, still got shingles/ vaccine doesn't work/ Suspected vaccination failure; Still got shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female 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 vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 21-FEB-2023 Reporter's comment: This case was reported by the patient via interactive digital media. The reporter stated that, the vaccine does not work. His/Her mom had got the vaccine and still she had got shingle at the time of reporting. Additional supportive information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible, as no contact, details were available.
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Expired Havrix administered; This case was reported by a other health professional and described the occurrence of expired vaccine used in a 10-year-old male patient who received HAV (Havrix) (batch number L435X, expiry date 16th February 2023) for prophylaxis.   On 20th February 2023, the patient received Havrix (intramuscular) .5 ml. On 20th February 2023, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.       Additional Information: GSK receipt date: 21-FEB-2023 Reporter's comment: This report was submitted by public reporting. The reporter was the patient.   The vaccine was administered after expiration date. No adverse reactions noted or reported at this time. The reporter consent to follow up. Additional Supportive Information: The patient received an expired dose of Havrix, which led to expired vaccine used.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: Large/big hives on both arms; This case was reported by a consumer via call center representative and described the occurrence of hives in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th October 2022, the patient received the 1st dose of Shingrix. In October 2022, 6 days after receiving Shingrix, the patient experienced hives. The patient was treated with steroids nos (Steroid (Not Specified)). On an unknown date, the outcome of the hives was recovered/resolved.   It was unknown if the reporter considered the hives to be related to Shingrix.     Additional Information: GSK receipt date: 17-Feb-2023 Reporter's comment: The patient had the reaction to her first Shingrix dose in left arm and 6 to 7 days after the shot had large (big) hives on the inside of both arms.  The pharmacist told the patient to go to urgent care (it was the weekend) because it was well past the 2 to 3 days of expected side effects. The patient was put on a steroid and given some cream and was fine after a few days. Lot and expiry date were unknown. The patient asked that she should get the second dose. One pharmacist told the patient to get the second dose. The physician was unsure.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Didnt get 2nd dose, Dr never scheduled it; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (Family History) (patient's mother had shingles in 70s) and shingles (Family History) (patient's daughter just had a significant episode of shingles last month at age of 37 year). Previously administered products included Zoster vaccine (received Zoster vaccine in 2014) and Shingrix (received first dose in January 2021).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 17-Feb-2023 Reporter's comment: The patient stated that he/she did not get the second dose of Shingrix vaccination.  The patient's physician never scheduled it. The patient asked he/she should get the second vaccination now, get both by starting over or do nothing. 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 intermediary for this case was conservatively captured as call center representative based upon the reference classification and details and for the same follow-up request was raised.
Sex: U
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose on 2022, did not come for their second or third dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in an unspecified number of patients who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix (1st dose of Twinrix received in June or July 2022) and Twinrix (2nd dose received on an unknown date).   On an unknown date, the patient did not receive the 3rd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 17-FEB-2023 Reporter's comment: The pharmacist had several patients who received first and second dose of Twinrix back in June or July 2022 and most of them did not came for their third dose. No further details about patients were provided. The reporter did not consent to follow up. Additional supportive information: Till the time of reporting, the patients did not receive the 3rd dose, which led to incomplete course of vaccination. This case had been linked with US2023027430, reported by same reporter.; Sender's Comments:  US-GSK-US2023027430:same reporter
Sex: M
Vaccine: TDAP
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a adult male patient who received DTPa (Reduced antigen) (Tdap Vaccine) for prophylaxis. On an unknown date, the patient received Tdap Vaccine. On an unknown date, unknown after receiving Tdap Vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown. It was unknown if the reporter considered the pain in arm to be related to Tdap Vaccine. Additional Information: GSK Receipt Date: 17-Feb-2023. Reporter's Comment: The patient experienced extreme soreness in his arm before, when he received a Tdap vaccine (unknown manufacturer). The patient stated that the arm soreness from the SHINGRIX vaccine lasted longer in contrast to what he experienced with the Tdap. The patient declined to provide date of birth. The reporter did not consent to follow-up. Additional Supportive Information: This case had been linked with US2023027439, reported by same reporter, for different suspect. Sender's Comments: US-GSK-US2023027439: Same reporter.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose in 2020, 2nd in October of 2022; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 75-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in 2020).   In October 2022, the patient received the 2nd dose of Shingrix. In October 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: 21-FEB-2023 Reporter's comment: The reporter was a Pharm D. The reporter stated that did a person had to restart the series if missed the 6-month window. Additional Supportive Information: The patient received 2nd dose of Shingrix later than the recommended interval, which led to lengthening of the vaccine schedule.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Achy after 1st dose; Didn't feel well after 1st dose; Possible improper reconstitution technique 2nd dose; Possible improper reconstitution technique 2nd dose; This case was reported by a physician via call center representative and described the occurrence of pain in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular). On 3rd February 2023, the patient received the 2nd dose of Shingrix. On 3rd February 2023, not applicable after receiving Shingrix and unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the patient experienced pain and feeling unwell. On an unknown date, the outcome of the pain and feeling unwell were recovered/resolved and the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   It was unknown if the reporter considered the pain and feeling unwell to be related to Shingrix.     Additional Information: GSK Receipt Date: 16-FEB-2023 Reporter's Comments: The patient self-report this case. She received her first Shingrix dose on an unknown date in 2022.  She was achy and did not feel well afterwards. Within six months, on 3rd February 2022 she received her second Shingrix dose.  She did not have any adverse effects.  She was concerned the pharmacist may have used improper reconstitution technique. She did not see the pharmacist wipe off the top of the vial or mix/swirl the vial during reconstitution. Nothing else was reported.  The reporter did not consent to follow up. Additional supportive information: The patient had concerned the pharmacist may have used improper reconstitution technique. She did not see the pharmacist wipe off the top of the vial or mix/swirl the vial during reconstitution, which led to Inappropriate reconstitution technique and Incorrect dose administered.
Sex: M
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Injection site discolouration, Injection site erythema, Injection site pruritus, Injection site rash
Clinical narrative: still little sore, legs sore/soreness in the legs; Light red rash / discoloration, 2 inches in diamater; discoloration near the injection site on the left arm; Occasional itching; Heaviness in legs; Muscle tightness in legs; Extreme Arm Soreness, cannot lift arm,; This case was reported by a consumer via call center representative and described the occurrence of injected limb mobility decreased in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 5th February 2023, the patient received the 1st dose of Shingrix. In February 2023, less than 2 weeks after receiving Shingrix, the patient experienced injected limb mobility decreased, pain in extremity, red rash, skin discoloration, pruritus, heaviness in leg and muscle tightness. On an unknown date, the outcome of the injected limb mobility decreased was recovered/resolved and the outcome of the pain in extremity was not recovered/not resolved and the outcome of the red rash and skin discoloration were recovering/resolving and the outcome of the pruritus, heaviness in leg and muscle tightness were unknown.   It was unknown if the reporter considered the injected limb mobility decreased, pain in extremity, red rash, skin discoloration, pruritus, heaviness in leg and muscle tightness to be related to Shingrix.     Linked case(s) involving the same patient:  US2023AMR028514   Additional Information: GSK receipt date: 17-Feb-2023 Reporter's comment: This case was self reported by the patient. The patient received first dose of Shingrix on left upper arm.  The patient experienced extreme arm soreness in left arm, where could not lift arm.  This subsided after 3 to 4 days, but the left arm was still a little sore.  The arm soreness from the Shingrix was lasting longer in contrast to what experienced with the Tdap.  About 4 days after receiving the Shingrix vaccine, the patient developed a very light red rash or discoloration near the injection site on the left arm, which was about 2 inches in diameter, and experienced occasional itching.  The rash or discoloration was less red now than it was last week.  Earlier this week, the patient went for a walk, and was experienced heaviness, muscle tightness and soreness in the legs.  The adverse event was file. The reporter did not consent to follow up. The patient declined to provide date of birth. After 4 day, the patient experienced red rash, skin discoloration, pruritus. This case had been linked with US2023AMR028514 same patient.; Sender's Comments:  US-GSK-US2023AMR028514:Same reporter
Sex: M
Vaccine: VARZOS
Symptoms: Limb discomfort, Muscle tightness, Pain in extremity, Pruritus, Rash erythematous
Clinical narrative: still little sore, legs sore/soreness in the legs; Light red rash / discoloration, 2 inches in diamater; discoloration near the injection site on the left arm; Occasional itching; Heaviness in legs; Muscle tightness in legs; Extreme Arm Soreness, cannot lift arm,; This case was reported by a consumer via call center representative and described the occurrence of injected limb mobility decreased in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 5th February 2023, the patient received the 1st dose of Shingrix. In February 2023, less than 2 weeks after receiving Shingrix, the patient experienced injected limb mobility decreased, pain in extremity, red rash, skin discoloration, pruritus, heaviness in leg and muscle tightness. On an unknown date, the outcome of the injected limb mobility decreased was recovered/resolved and the outcome of the pain in extremity was not recovered/not resolved and the outcome of the red rash and skin discoloration were recovering/resolving and the outcome of the pruritus, heaviness in leg and muscle tightness were unknown.   It was unknown if the reporter considered the injected limb mobility decreased, pain in extremity, red rash, skin discoloration, pruritus, heaviness in leg and muscle tightness to be related to Shingrix.     Linked case(s) involving the same patient:  US2023AMR028514   Additional Information: GSK receipt date: 17-Feb-2023 Reporter's comment: This case was self reported by the patient. The patient received first dose of Shingrix on left upper arm.  The patient experienced extreme arm soreness in left arm, where could not lift arm.  This subsided after 3 to 4 days, but the left arm was still a little sore.  The arm soreness from the Shingrix was lasting longer in contrast to what experienced with the Tdap.  About 4 days after receiving the Shingrix vaccine, the patient developed a very light red rash or discoloration near the injection site on the left arm, which was about 2 inches in diameter, and experienced occasional itching.  The rash or discoloration was less red now than it was last week.  Earlier this week, the patient went for a walk, and was experienced heaviness, muscle tightness and soreness in the legs.  The adverse event was file. The reporter did not consent to follow up. The patient declined to provide date of birth. After 4 day, the patient experienced red rash, skin discoloration, pruritus. This case had been linked with US2023AMR028514 same patient.; Sender's Comments:  US-GSK-US2023AMR028514:Same reporter
Sex: M
Vaccine: VARZOS
Symptoms: Skin discolouration
Clinical narrative: still little sore, legs sore/soreness in the legs; Light red rash / discoloration, 2 inches in diamater; discoloration near the injection site on the left arm; Occasional itching; Heaviness in legs; Muscle tightness in legs; Extreme Arm Soreness, cannot lift arm,; This case was reported by a consumer via call center representative and described the occurrence of injected limb mobility decreased in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 5th February 2023, the patient received the 1st dose of Shingrix. In February 2023, less than 2 weeks after receiving Shingrix, the patient experienced injected limb mobility decreased, pain in extremity, red rash, skin discoloration, pruritus, heaviness in leg and muscle tightness. On an unknown date, the outcome of the injected limb mobility decreased was recovered/resolved and the outcome of the pain in extremity was not recovered/not resolved and the outcome of the red rash and skin discoloration were recovering/resolving and the outcome of the pruritus, heaviness in leg and muscle tightness were unknown.   It was unknown if the reporter considered the injected limb mobility decreased, pain in extremity, red rash, skin discoloration, pruritus, heaviness in leg and muscle tightness to be related to Shingrix.     Linked case(s) involving the same patient:  US2023AMR028514   Additional Information: GSK receipt date: 17-Feb-2023 Reporter's comment: This case was self reported by the patient. The patient received first dose of Shingrix on left upper arm.  The patient experienced extreme arm soreness in left arm, where could not lift arm.  This subsided after 3 to 4 days, but the left arm was still a little sore.  The arm soreness from the Shingrix was lasting longer in contrast to what experienced with the Tdap.  About 4 days after receiving the Shingrix vaccine, the patient developed a very light red rash or discoloration near the injection site on the left arm, which was about 2 inches in diameter, and experienced occasional itching.  The rash or discoloration was less red now than it was last week.  Earlier this week, the patient went for a walk, and was experienced heaviness, muscle tightness and soreness in the legs.  The adverse event was file. The reporter did not consent to follow up. The patient declined to provide date of birth. After 4 day, the patient experienced red rash, skin discoloration, pruritus. This case had been linked with US2023AMR028514 same patient.; Sender's Comments:  US-GSK-US2023AMR028514:Same reporter
Age: 43.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Expired dose administration; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 43-year-old female patient who received HAV (Havrix) (batch number H4H53, expiry date 30th January 2023) for prophylaxis.   On 14th February 2023, the patient received Havrix. On 14th February 2023, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.    Additional Information: GSK receipt date: 17-Feb-2023 Reporter's comment:  Nurse reported the patient received an expired dose of Havrix, expiry date 30th January 2023 on 14th February 2023. Reporter consented to follow up. Additional supportive information: As patient received expired vaccine, which led to expired vaccine used.
Age: 1.0
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Expired Havrix administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 12-month-old male patient who received HAV (Havrix pediatric) (batch number LY35X, expiry date 16th February 2023) for prophylaxis.   On 17th February 2023, the patient received the 1st dose of Havrix pediatric. On 17th February 2023, unknown after receiving Havrix pediatric, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 17-FEB-2023 Reporter's Comment: The reporter was practice coordinator. The reporter reported that one of the medical assistant staff administered an expired Havrix pediatric. The reporter consented to follow up and accepted by mailing Additional Supportive Information: The reporter reported that one of the medical assistant staff administered an expired Havrix pediatric, which led to expired vaccine used.
Sex: M
Vaccine: VARZOS
Symptoms: Social problem
Clinical narrative: Due to Covid, never got 2nd shot; This case was reported by a consumer via call center representative and described the occurrence of social problem in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in 2020 or perhaps in 2019).   On an unknown date, the patient did not received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.       Additional Information: GSK Receipt Date: 17-FEB-2023 Reporter's Comment: The patient was self-reported this case. The patient first contacted GSK via Web. The patient reported that he recalled that he received his first dose of Shingrix vaccine back in early 2020, but the physician had no record.  The patient stated that due to Covid he never received 2nd dose of Shingrix vaccine.  The patient wanted to know that the new script from document shows 2 shots. The patient asked if it was OK already having the first dose more than  2 years ago. The agent made an outbound call to the patient and reported that the patient truly believed that he received the first dose in 2020 or perhaps in 2019, but did not receive the second dose. The patient physician and the patient pharmacy were unable to locate a record of the vaccination. Additional supportive information: As the patient did not receive the second dose of Shingrix vaccine due to Covid pandemic, which led to social problem.
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Incomplete course of vaccination
Clinical narrative: A 7-year-old never received Dtap fifth dose; This case was reported by a nurse via call center representative and described the occurrence of incomplete course of vaccination in a 7-year-old female patient who received DTPa-HBV-IPV (Pediarix) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Pediarix (on an unknown date patient received 1st dose), Pentacel (on an unknown date patient received 1st dose of Pentacel), Pediarix (on an unknown date patient 2nd dose) and Pentacel (on an unknown date patient received 2nd dose).   On an unknown date, the patient received the 3rd dose of Pediarix and Pediarix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 17-FEB-2023 Reporter's comment: The nurse had a patient who had never received Dtap fifth dose. The patient schedule was Pediarix, Pentacel, Pediarix and finally Pentacel. The reporter consent to follow up by email. Additional supportive information: Till the time of reporting, the patient did not receive the 3rd dose, which led to incomplete course of vaccination. Note: Interchange of vaccine product was not considered as event because both Pediarix and Pentacel had different antigen. PEDIARIX is approved for use as a 3-dose series in infants born of hepatitis B surface antigen (HBsAg)-negative mothers. PEDIARIX may be given as early as 6 weeks of age through 6 years of age (prior to the 7th birthday). As patient was 7 years at the time of reporting, thus patient had exceeded age recommendation to receive all 3 doses of PEDIARIX.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Administered only the diligent; Administered only the diligent; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 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 inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 20-FEB-2023 Reporter's Comment:  The reporter reported that the Shingrix vaccine was not mixed and only the diluent was given. The reporter wanted to know guidance on how to proceed. The healthcare professional was disconnected without providing any credentials, patient demographics or vaccine details.  The reporter did not consent to follow up. Additional supportive information: The reporter gave by error Shingrix diluent portion only ,which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose 28Dec2019, 2nd not yet; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 71-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Zostavax (first dose received many years ago from reporting of Shingles vaccine (Zostavax)) and Shingrix (first dose received on arm via intramuscularly route 3 years 2 months ago on 28th December 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: 21-Feb-2023 Reporter's comment: This case was self-reported by the patient.  The patient received the vaccine at a pharmacy facility.  The patient does not recall in which arm the vaccine was injected.  The patient had not yet received the second dose of Shingrix. The reporter did not consent to follow up.  The reporter did not provide consent to follow up with healthcare professional but welcomed follow up with him. All the information was not available.  Additional supportive information: Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination. VAERS details were reported for 1st dose.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Could have received only the adjuvant portion; Could have received only the adjuvant portion; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patients received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 22-FEB-2023 Reporter's Comment: Healthcare professional reports that the clinic was currently investigating whether or not patients could have received only the adjuvant portion of Shingrix. It was currently unknown whether one or more patients received adjuvant-only.  No further details were available at time of call. The reporter consented to follow up from safety. Additional Supportive Information: The reporter reported that the clinic was currently investigating whether or not patients could have received only the adjuvant portion of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Age: 30.0
Sex: M
Vaccine: HEPAB
Symptoms: Expired product administered
Clinical narrative: Expired Twinrix administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 30-year-old male patient who received HAB (Twinrix) (batch number P9LTP, expiry date 1st January 2023) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 3rd January 2023, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On 3rd January 2023, unknown after receiving Twinrix and Twinrix 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: 22-FEB-2023 Reporter's comment: The nurse reported that patient received an expired dose of Twinrix on 3rd Jan 2023.  The vaccine was expired on 1st Jan 2023.  The reporter consent to follow up via email. Additional Supportive Information: The patient received an expired dose of Twinrix, which led to expired vaccine used.
Age: 14.0
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Expired Havrix administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 14-year-old male patient who received HAV (Havrix) (batch number EP47E, expiry date 6th February 2023) for prophylaxis.   On 21st February 2023, the patient received Havrix. On 21st February 2023, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 22-FEB-2023 Reporter's Comment: The healthcare professional reported that the patient received a dose of Havrix, which was already expired. The HCP would provide the doctor with shared information and doctor would decide which route he would take based off GlaxoSmithKline's data versus CDC recommendations. The reporter reported that another Havrix was not administered prior to call to medical information. No reactions reported. The reporter consented to follow up by email. Additional Supportive Information: The use of Havrix, which was already expired on 6th February 2023, which led to expired vaccine used.