chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported; A pharmacist reported an expired GARDASIL 9 was administered to a patient. The caller declined to provide patient demographics at this time. The vaccine had no prior temperature excursions. No additional AE reported. No PQC.; Point in the process the medication error ocurred? Dispensing/The pharmacist was interrupted while checking the product/The doctor's office missed checking the expiration date before administration; This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's historical drugs, medical history, concomitant therapies and concurrent conditions were not reported.  On 01-APR-2022, the patient was vaccinated with an expired dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) 0.5 ml, lot # S023476, expiration date 26-MAR-2022, for prophylaxis (strength, route and frequency were not reported). The vaccine had no prior temperature excursions. No additional adverse events reported  This report is non-valid due to lack of identifiable patient.  Follow-up information was received from the pharmacist on 12-MAY-2022. This case was referring to a 31-year-old female patient.  On 01-APR-2022, the patient was vaccinated with an expired first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) administered intramuscularly (anatomical site of administration was not provided).  It was stated that the medication error occurred during the dispensing process as the pharmacist was interrupted while checking the product and the doctor's office missed checking the expiration date before administration (product dispensing error).   The reporter considered expired product administered to be not related to hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9).
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: Pharmacist calling to report multiple patients, a total of 70, were given PROQUAD that had been stored outside of recommended storage range with a non supported disclaimer; No additional Adverse Event details; This spontaneous report was received from a pharmacist regarding to a patient of an unknown age and gender.   The pertinent medical history, medical history, previous drug reactions or allergies were not reported. Concomitant medications included sterile diluent (MERCK STERILE DILUENT).   On an unknown date, the patient was vaccinated with an improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin (rHA)) (PROQUAD) subcutaneous injection, lot number U029147 with expiration date: 16-MAR-2023, indicated as prophylaxis (dose and route of administration were not provided). (Product storage error).    The administered dose of the vaccine experienced a temperature excursion of  menus 58 Degree Fahrenheit to 5 Degree Fahrenheit with average of menus 7 Degrees Fahrenheit for 2 hours and below menus 59 Degrees Fahrenheit with average of -65.2 Degrees Fahrenheit for 46 hours. Pharmacist would like to know when the patient could be re-vaccinated.   No additional adverse events (AE) reported.  This is one case of the several cases received from same reporter.; Sender's Comments:  US-009507513-2204USA006370: US-009507513-2204USA006506: US-009507513-2204USA006513:
Sex: F
Vaccine: HPV9
Symptoms: Incomplete course of vaccination
Clinical narrative: She reported that she received her 1st dose "sometime January 2021" but never completed the entire dosage series. She mentioned that she started the dosage series over again and got another "1st dose'' in March 2022; she did not experience any adverse effects; This spontaneous report was received from consumer, referring herself.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unspecified date in January 2021 (reported as "sometime" in January 2021"), the patient was vaccinated with the first dose of with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided), but she never completed the entire dosage series (drug dose administration interval too long). She mentioned that she started the dosage series over again and got another "1st dose" in March 2022 and was on track to receiving the next 2 doses appropriately, however, she was wondering if she should consider the January 2021 dose as the "first dose", or if she should consider the March 2022 dose as the "first dose". The caller confirmed that she did not experience any adverse effects. No additional adverse effects or details reported.
Age: 11.0
Sex: U
Vaccine: HPV4, HPV9, HPV9
Symptoms: Extra dose administered, Inappropriate schedule of product administration, No adverse event
Clinical narrative: The caller did not definitively confirm the brand name for the previous HPV vaccines that were administered in 2017 and 2018; No additional AE reported; Patient inadvertently received a third dose of GARDASIL 9 on May 3, 2022 after completing a two dose regimen.; Patient inadvertently received a third dose of GARDASIL 9 on May 3, 2022 after completing a two dose regimen. Patient received their first dose of a HPV vaccine on April 28, 2017 and their second dose on March 27, 2018.; This spontaneous report was received from a medical assistant concerning a 12-year-old patient of unknown gender. The patient's concurrent conditions, pertinent medical history and concomitant medications were not provided.   On 28-APR-2017, the patient was vaccinated with the first dose of Human Papillomavirus (HPV) vaccine (manufacturer unknown) for prophylaxis (Dose, route of administration, anatomical location, lot # and expiration date were not reported).   On 27-MAR-2018, the patient received the second dose of HPV vaccine (manufacturer unknown) for prophylaxis (Dose, route of administration, anatomical location, lot # and expiration date were not reported) (Inappropriate schedule of product administration).   On 03-MAY-2022, after completing a two dose regimen, the patient inadvertently received a third dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) 0.5 mL once, lot # U029623, expiration date 26-OCT-2023, for prophylaxis (Route of administration and anatomical location were not provided) (Extra dose administered). The reporter mentioned that no adverse effects were noted after the administration of extra dose of  HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) and no additional adverse events were reported (No adverse event).
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: VAQTA that had undergone temperature excursion was administered to a patient; No additional AE reported; This spontaneous report has been received from a healthcare worker, concerning a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions and concomitant medications was not provided.   On an unspecified date, the patient was vaccinated with an improperly stored hepatitis a vaccine, inactivated(VAQTA) for prophylaxis, lot reported as U026782 and expiration date 28-OCT-2022 (lot number U026782 is an invalid lot number for vaccine, inactivated(VAQTA), lot U026782 does not match any company product as confirmed by lot verification team) (strength, dose and route of administration were not provided). No adverse event was reported.   The temperature excursion was reported as 49.6F during a time frame of 32 minutes. There was no previous temperature excursion.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: PROQUAD  administered after an excursion that occurred on 4/25/2022.; This spontaneous report was received from a medical assistant referring to a patient of unspecified age and gender.  The patient's concurrent conditions, medical history, and concomitant therapies were not reported.  On 25-APR-2022, Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) vaccines experienced a temperature excursion for 1 hour and 12 minutes, at -2 degree Celsius (product storage error). The vaccines underwent a previous temperature excursion at -10 degree Celsius up to 8 degree Celsius (7.3C) for 2 hours and 37 minutes, and at -10 C up to 8 C (0.7 C) for 2 hours and 56 minutes.  On 27-APR-2022, the patient was vaccinated with the improperly stored dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) 0.5 ml, Lot number: U029319,  expiration date: 19-MAR-2023, (strength, vaccination scheme, frequency, route of administration, and anatomical location were not provided), for prophylaxis.   This is one of several reports received from  the same reporter.
Sex: F
Vaccine: HPV9
Symptoms: Injection site swelling, Respiratory tract oedema
Clinical narrative: Patient 1 had swelling at injection site and respiratory swelling and required and Epi-Pen injection.; Patient 1 had swelling at injection site and respiratory swelling and required and Epi-Pen injection.; This spontaneous report was received from a pharmacist referring to a female patient of unknown age. The patient's current conditions included sulfonamide (also reported as sulfa allergy). The patient's pertinent medical history and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered for prophylaxis (strength, dose description, lot number, expiration date, and route of administration were not provided). After vaccination, the patient subsequently had a reaction and experienced swelling at the injection site (vaccination site swelling) and respiratory swelling (respiratory tract oedema), an epinephrine (reported as Epi-Pen) injection was required to treat the adverse events. At the time of reporting, the outcome of the events vaccination site swelling, and respiratory tract oedema was not known.   The causal relationship between the events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not provided.   Upon internal review, the event respiratory tract oedema was determined to be medically significant.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2205USA003803:
Age: 11.0
Sex: U
Vaccine: HPV4, HPV9
Symptoms: Inappropriate schedule of product administration, Interchange of vaccine products, No adverse event
Clinical narrative: GARDASIL 9 Dosing Schedule specific to the completion of the interrupted, original GARDASIL Dose Series; No additional AE reported.; Patient who was 1st administered GARDASIL in 2010 when corresponding Patient was 11 Years Old was administered a GARDASIL 9 dose in 2016 when corresponding Patient was 17 Years Old; This spontaneous report was received from a medical assistant, referring to a currently 23-year-old patient of unknown gender. Information regarding the patient's pertinent medical history, concurrent condition, drug reactions/allergies and concomitant medication was not provided.  On an unknown date in 2010, the patient was vaccinated with the first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) (dose, strength, route, lot# and expiration date were not provided) for prophylaxis when patient was 11 years old (inappropriate schedule of product administration). On an unknown date in 2016, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (dose, strength, route, lot# and expiration date were not provided) for prophylaxis when patient was 17 years old (interchange of vaccine products). No additional adverse event reported.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Rheumatoid arthritis
Clinical narrative: rheumatoid arthritis; multiple outbreaks of herpes zoster; This initial spontaneous report was received from a lawyer and a patient of unknown age and gender regarding a case in litigation. The patient's concurrent conditions, medical history, concomitant medications, drug reactions or allergies were not reported. On an unspecified date, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot #, expiration date, route of administration, anatomical location not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unspecified date, soon after receiving zoster vaccine live (ZOSTAVAX), the patient experienced rheumatoid arthritis followed by multiple breaks of herpes zoster. As results of these symptoms, plaintiff was seen and treated by medical providers and was still under their care. As a directed and proximate result, the patient sustained severe and permanent personal injuries. Further, Patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. At the reporting time, the outcome of rheumatoid arthritis and herpes zoster were considered as not recovered.   The reporters considered rheumatoid arthritis and herpes zoster to be related to Zoster Vaccine Live (ZOSTAVAX).     The reporters considered both events to be disabling. Upon internal review rheumatoid arthritis was determined to be a medically significant event.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: multiple outbreaks of herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported.  On an unknown date, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, route of administration and anatomical location were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster).  On an unknown date, after receiving zoster vaccine live (ZOSTAVAX), the patient suffered multiple outbreaks of herpes zoster. As a result of these symptoms, patient was seen and treated by medical providers and was still under their care.  As a direct and proximate result of zoster vaccine live (ZOSTAVAX), patient's symptoms have resulted in physical limitations not present prior to using the vaccine. Patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of patient's condition. As a result of zoster vaccine live (ZOSTAVAX), patient sustained severe and permanent personal injuries. Further, as a tragic consequence of Company's wrongful conduct, patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of Company's conduct, patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash pruritic
Clinical narrative: shingles; Little rash/Mild recation on my neck/Itchy; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, 2 weeks after receiving Shingles vaccine, the patient experienced shingles and itchy rash. On an unknown date, the outcome of the shingles and itchy rash were unknown.   It was unknown if the reporter considered the shingles and itchy rash to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 9-MAY-2022 Reporter's Comment: The patient self-reported this case via interactive digital media. The patient just received dose of Shingles vaccine and 2 weeks later experienced mild reaction of shingles on his/her neck that was little rash with Itchy. The patient stated that It was rough, had a few simple side effects but it was better than getting Shingles. The patient also stated that he/she was fine and would wait to get his/her 2nd shot but definitely would do it. Additional supportive information: The follow-up would not possible, as no contact, details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Headache, Malaise, Pyrexia
Clinical narrative: Fever; Joint pain; Headache; Violent shaking chills; Violent shaking chills; This case was reported by a consumer via interactive digital media and described the occurrence of fever 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 fever, joint pain, headache, chills and tremor. On an unknown date, the outcome of the fever, joint pain, headache, chills and tremor were recovered/resolved.   It was unknown if the reporter considered the fever, joint pain, headache, chills and tremor to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 10-May-2022 Reporter's comments: This case was reported by the patient via interactive digital media. The patient got the shingles vaccine. After vaccination the patient was sick for four days fever, joint pain, headache, violent shaking chills. After the pain of it all, the patient had hope that he or she would not suffer with it.
Sex: U
Vaccine: VARZOS
Symptoms: Tremor
Clinical narrative: Fever; Joint pain; Headache; Violent shaking chills; Violent shaking chills; This case was reported by a consumer via interactive digital media and described the occurrence of fever 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 fever, joint pain, headache, chills and tremor. On an unknown date, the outcome of the fever, joint pain, headache, chills and tremor were recovered/resolved.   It was unknown if the reporter considered the fever, joint pain, headache, chills and tremor to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 10-May-2022 Reporter's comments: This case was reported by the patient via interactive digital media. The patient got the shingles vaccine. After vaccination the patient was sick for four days fever, joint pain, headache, violent shaking chills. After the pain of it all, the patient had hope that he or she would not suffer with it.
Sex: F
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: A pediatric dose of Hep B (Engerix B) was given to an adult; A pediatric dose of Hep B (Engerix B) was given to an adult; This case was reported by a nurse via sales rep and described the occurrence of underdose in a adult female patient who received HBV (Engerix B pediatric) (batch number 39A3L, expiry date 23rd February 2024) for prophylaxis.   On 10th May 2022 17:15, the patient received Engerix B pediatric. On 10th May 2022 17:15, unknown after receiving Engerix B pediatric, 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.   Additional Information: GSK Receipt Date: 11-MAY-2022 Reporters comment: The patient was 44 years of age at the time of reporting. A pediatric dose of Engerix B was given to an adult patient instead of the adult dose of Engerix B.  The patient had been informed and was scheduled next month from the date of reporting to receive the correct adult dose. The reporter consented to follow up. Additional supportive information: A pediatric dose of Engerix B was given to an adult patient instead of the adult dose of Engerix B, which led to underdose and adult use of a child product.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Fatigue
Clinical narrative: exhausted; chills; This case was reported by a consumer via interactive digital media and described the occurrence of chills in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, less than a day after receiving Shingles vaccine, the patient experienced chills and exhaustion. On an unknown date, the outcome of the chills was recovered/resolved and the outcome of the exhaustion was unknown.   It was unknown if the reporter considered the chills and exhaustion to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 11-MAY-2022 Reporter's comments: This case was reported by a patient via interactive digital media.  The patient got the chills for a day, no amounts of blankets helped, and was exhausted the day after the second shot of Shingles vaccine.  The patient would do it again in a heartbeat.
Age: 0.33
Sex: U
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Kinrix administered to a 4 month old infant; This case was reported by a physician via patient support programs and described the occurrence of inappropriate age at vaccine administration in a 4-month-old patient who received DTPa-IPV (Kinrix) (batch number d24g7, expiry date unknown) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. 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: 13-MAY-2022 Reporters comment: Kinrix was administered to a 4-month-old patient on accident. Doctor stated that, they noticed after and the patient was in office doing a checkup at the time of reporting. The reporter wanted to know the difference between Kinrix and another vaccine that was not theirs and gave the patient's parents more information. The call center representative placed the reporter on hold so he/she could get additional product adverse events information and they discontinued the call. Additional supportive information: Kinrix was administered to a 4-month-old patient on accident, which led to inappropriate age at vaccine administration.
Sex: M
Vaccine: MENB
Symptoms: Peripheral swelling, Vomiting
Clinical narrative: vomiting; Arm swollen significantly; This case was reported by a nurse via sales rep and described the occurrence of vomiting in a male 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.   On an unknown date, the patient received Bexsero .5 ml and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced vomiting and swelling arm. On an unknown date, the outcome of the vomiting and swelling arm were unknown.   The reporter considered the vomiting and swelling arm 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.   Additional Information: GSK receipt date: 12-MAY-2022 Reporter's comment: The patient's arm was swollen significantly and experienced vomiting.  The reporter believed both were related to administration of vaccine. The reporter did not consent to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Illness, Myalgia
Clinical narrative: sick; muscle aches; fatigue; headache; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 10th May 2022, the patient received Shingles vaccine. In May 2022, less than a week after receiving Shingles vaccine, the patient experienced sickness, muscle pain, fatigue and headache. On an unknown date, the outcome of the sickness, muscle pain, fatigue and headache were not recovered/not resolved.   It was unknown if the reporter considered the sickness, muscle pain, fatigue and headache to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 13-MAY-2022 Reporter's Comments: The case was reported via interactive digital media. The patient received the shingles shot on Tuesday. On the reporting date, it was Friday and the patient was still sick with muscle aches, fatigue and a headache. The patient asked how much longer he/ she suffer with these effects.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site bruising
Clinical narrative: Bruise at vaccine site on arm; This case was reported by a consumer via interactive digital media and described the occurrence of injection site bruising 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 injection site bruising. On an unknown date, the outcome of the injection site bruising was unknown.   It was unknown if the reporter considered the injection site bruising to be related to Shingles vaccine.     Additional Information: GSK receipt date: 13-MAY-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient had a bruise at the vaccination site and enquired if this was normal. Additional Supportive Information: Follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: muscle ache; This case was reported by a consumer via interactive digital media and described the occurrence of muscle pain 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 muscle pain. On an unknown date, the outcome of the muscle pain was not recovered/not resolved.   It was unknown if the reporter considered the muscle pain to be related to Shingrix.     Additional Information: GSK Receipt Date: 15-MAY-2022 Reporter's comment: The case was self reported by the patient via interactive digital media. The patient asked could he/she take Tylenol for muscle ache experienced after the Shingrix injection.  Additional Supportive Information: The follow-up would not possible, as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Social problem
Clinical narrative: I had my 1st shot Jan-2020 and due to Covid restrictions I have not had my 2nd shot.; This case was reported by a consumer via interactive digital media and described the occurrence of social problem in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included shingles vaccine (received 1st dose on an unknown date in January 2020).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.   Additional Information: GSK Receipt Date: 13-MAY-2022 Reporter's Comments: This case was reported by a consumer via interactive digital media. The patient received first shot in January 2020 and then due to Covid restrictions he/ she was not received second shot. The reporter asked Should he/ she start over with the first shot as it was over two years. Additional Supportive Information: Follow up would not be possible since no contact details provided.
Sex: F
Vaccine: VARZOS
Symptoms: Chromaturia, Erythema, Pain, Pain in extremity, Pyrexia
Clinical narrative: red arm; body aches; fever; Sore arm; urine color, pale yellow to pale tan; This case was reported by a consumer via call center representative and described the occurrence of urine discoloration in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   In April 2022, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced urine discoloration, erythema of extremities, general body pain, fever and pain in arm. On an unknown date, the outcome of the urine discoloration was recovered/resolved and the outcome of the erythema of extremities, general body pain, fever and pain in arm were unknown.   It was unknown if the reporter considered the urine discoloration, erythema of extremities, general body pain, fever and pain in arm to be related to Shingrix.     Additional Information: GSK Receipt Date: 16-MAY-2022 Reporter's Comment: The patient self-reported this case via. The patient received dose of Shingrix vaccine in April and experienced a change in urine color from pale yellow to pale tan. The patient also experienced red arm, sore arm, body aches, and fever. The color change lasted 2 days. The patient asked if she should receive the second shot given the change in urine color. The patient asked what was her protection with one shot. The patient also asked if most people do experience worse or milder side effects with the second shot. The patient asked if there was any 2nd shot data for people who experienced harsh side effects with the first shot.
Sex: M
Vaccine: VARZOS
Symptoms: Skin exfoliation
Clinical narrative: Peeling of the skin of both hands; This case was reported by a physician via sales rep and described the occurrence of skin peeling in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of skin exfoliation (1st dose received on an unknown date, refer case US2022AMR078930).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced skin peeling. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the skin peeling was unknown.   It was unknown if the reporter considered the skin peeling to be related to Shingrix.     Linked case(s) involving the same patient:  US2022AMR078930   Additional Information: GSK Receipt Date: 16-MAY-2022 Reporter's Comment: The patient received dose of Shingrix vaccine and experienced peeling of the skin in both hands. The reporter consented to follow-up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR078930:Same reporter.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Patient received only liquid portion of Menveo without reconstitution; Patient received only diluent portion and also half dose due to leakage; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 11-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMXA641A, expiry date 30th June 2023) for prophylaxis.   On 9th May 2022, the patient received Menveo. On 9th May 2022, unknown after receiving Menveo, 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: 9-May-2022 Reporter's comments: On reporting day, the patient received half dose of only liquid portion of Menveo without being reconstituted due to leakage. The reporter consented to follow up.  Additional Supportive Information: The patient received half dose of only liquid portion of Menveo without being reconstituted, which led to inappropriate dose of vaccine administered and wrong solution used in drug reconstitution.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022075741:Initial Case
Age: 17.0
Sex: M
Vaccine: HEPA
Symptoms: Incorrect dose administered
Clinical narrative: 17 year old was administered adult dose; 17 year old was administered adult dose; This case was reported by a nurse via call center representative and described the occurrence of overdose in a 17-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 10th May 2022, the patient received Havrix and Havrix Pre-Filled Syringe Device. On 10th May 2022, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced overdose and adult product administered to child. On an unknown date, the outcome of the overdose and adult product administered to child 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: 10-MAY-2022 Reporter's Comments: The nurse reported that the patient was administered adult dose of Havrix. Health care professional (HCP) wanted to know how to proceed in this situation and if there was any further information available to be sent. The reporter consented to follow up. Additional Supportive Information: The 17 years old patient received adult dose of Havrix, which led to overdose and adult product administered to child.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash erythematous
Clinical narrative: Shingles; Rash is still red and raw; The blisters are gone; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   In February 2022, the patient received the 1st dose of Shingrix. In April 2022, less than 3 months after receiving Shingrix, the patient experienced shingles, red rash and blister. On an unknown date, the outcome of the shingles and red rash were not recovered/not resolved and the outcome of the blister was recovered/resolved.   It was unknown if the reporter considered the shingles, red rash and blister to be related to Shingrix.     Additional Information: GSK receipt date: 11-May-2022 Reporter's comment: Pharmacist called to receive guidance because a patient had her Shingrix dose but a month ago she developed shingles. The patient also had rash was still red and raw and blisters were gone. Did not consent to follow-up.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Hot to the touch; Swelling at injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site warmth in a 83-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th May 2022, the patient received the 2nd dose of Shingrix (intramuscular). On 9th May 2022, 5 hrs after receiving Shingrix, the patient experienced injection site warmth and injection site swelling. On an unknown date, the outcome of the injection site warmth and injection site swelling were not recovered/not resolved.   It was unknown if the reporter considered the injection site warmth and injection site swelling to be related to Shingrix.   Additional Information: GSK Receipt Date: 11-MAY-2022 Reporter's Comment: The case was reported by the patient. The patient reported that, about 5 hours after receiving the Shingrix vaccine her left arm was hot to the touch and swelling at the injection site.  The reporter did not consent to follow-up.
Age: 95.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered, Pyrexia
Clinical narrative: received 3rd dose; fever, 102.5 degrees F; This case was reported by a consumer via call center representative and described the occurrence of fever in a 95-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date) and Shingrix (2nd dose received 6 to 9 months before the date of reporting).   On 11th May 2022, the patient received the 3rd dose of Shingrix. On 11th May 2022, unknown after receiving Shingrix, the patient experienced extra dose administered. In May 2022, the patient experienced fever. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the fever was not recovered/not resolved and the outcome of the extra dose administered was unknown.   It was unknown if the reporter considered the fever to be related to Shingrix.     Additional Information: GSK Receipt Date:12-May-2022 Reporter's comments: This case was reported by the patient's daughter. The patient already had 2 doses of Shingrix in the past and received his 3rd extra dose on the day before the date of reporting. Less than a week after vaccination, the patient started to experience a fever. Initially it was 102.5 degrees Fahrenheit but went down to 100 degrees Fahrenheit after a dose of Tylenol. Fever had not resolved. The reporter did not consent to follow-up. Additional Supportive Information: The patient received 3rd dose of Shingrix, which led to extra dose administered.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pyrexia, Tinnitus, Vaccination failure
Clinical narrative: Fever for a few days; Tinnitus, unsure if after 1st or 2nd dose; Received 2 doses, developed shingles today/Suspected vaccination failure; Shingles; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 67-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 2nd dose of Shingrix and the 1st dose of Shingrix. On 12th May 2022, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the patient experienced fever and tinnitus. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles and tinnitus were not recovered/not resolved and the outcome of the fever was recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles, fever and tinnitus to be related to Shingrix. It was unknown if the reporter considered the vaccination failure, shingles and tinnitus to be related to Shingrix.   Additional Information: GSK Receipt Date: 12-MAY-2022 Reporter's Comment: The case was reported by the patient. The patient received 2 doses of Shingrix. She stated that, after her second dose, she experienced a fever for a few days.  She also reported that, tinnitus after receiving Shingrix. The patient was unsure if it was after the first or second dose.  She stated that, tinnitus was still present but was a bit better. She also reported that, she developed shingleson the day of reporting.  She had not yet been diagnosed but stated that, she knew that it was shingles. The reporter did not consent to follow-up. 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.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose Dec2021 and 2nd in March2022; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a adult patient who received HBV (Engerix B adult) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Engerix B adult (received 1st dose in December 2021).   In March 2022, the patient received the 2nd dose of Engerix B adult and Engerix B Pre-Filled Syringe Device. In March 2022, unknown after receiving Engerix B adult and Engerix B Pre-Filled Syringe Device, 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.   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: 12-May-2022 Reporter's comment: Pharmacist was inquiring about a catch up schedule for Engerix-B for an adult patient.  The 1st dose was administered in December 2021 and 2nd dose in March 2022. The reporter did not had any additional details (no patient demographics). Consented to follow up via postal. Additional Supportive Information: The patient received 2nd dose of Engerix-B later than the recommend interval, which led to lengthening of vaccination schedule. Note: Regarding the suspect formulation query was raised by the intake team meanwhile suspect was coded as Engerix B adult with Suspension for injection in pre-filled syringe.
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash pustular
Clinical narrative: itching pustules across her back; itching pustules; This case was reported by a consumer via call center representative and described the occurrence of pustular rash in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In December 2021, the patient received the 1st dose of Shingrix. On an unknown date, 10 days after receiving Shingrix, the patient experienced pustular rash and pruritus. On an unknown date, the outcome of the pustular rash and pruritus were unknown.   It was unknown if the reporter considered the pustular rash and pruritus to be related to Shingrix.     Additional Information: GSK Receipt Date: 13-May-2022 Reporter's Comment: The patient self-reported this case. The patient received dose of Shingrix vaccine and 10 days later she experienced itching pustules across her back. The reporter did not consent to follow-up.
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: expired dose of Menveo was administered to patient; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA520A, expiry date 30th April 2022) for prophylaxis.   On 12th May 2022, the patient received Menveo. On 12th May 2022, unknown after receiving Menveo, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 13-MAY-2022 Reporter's comment: Nurse reported an expired dose of Menveo was administered to patient. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.  Additional Supportive Information: The patient received dose of Menveo that was already got expired on 30th April 2022, which led to expired vaccine used.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation error, Product preparation issue
Clinical narrative: was administered liquid portion not reconstituted with powder; was administered liquid portion not reconstituted with powder; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 60-year-old male patient who received Herpes zoster (Shingrix) (batch number 2459K, expiry date 27th May 2023) for prophylaxis.   On 13th May 2022, the patient received the 1st dose of Shingrix. On 13th May 2022, 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: 13-May-2022 Reporter's comment: Medical Assistant reported that the patient was administered the liquid diluent portion of Shingrix vaccine.   The liquid was not reconstituted with the powder portion of Shingrix.  This was the patient's first dose in the series.   The adjuvant was administered from lot number 2459K (expiration date 27May2023).   At the time of reporting, repeat dose had not been administered. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.  Additional Supportive Information: The patient was administered the liquid diluent portion of Shingrix vaccine, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Age: 5.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Product storage error
Clinical narrative: vaccines excursion, administered to patient; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a 5-year-old male patient who received DTPa-IPV (Kinrix) (batch number 237C4, expiry date 17th January 2023) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 12th May 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug 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: 13-MAY-2022 Reporters comment: Vaccine coordinator reported the vaccine excursion that was previous reported to be discarded, was administered to the patient in left thigh. The reporter did not consent to follow-up. Additional supportive information: The vaccine excursion that was previous reported to be discarded, was administered to the patient, which led to incorrect storage of drug. This was 1 of 3 linked cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022078361:Same reporter US-GLAXOSMITHKLINE-US2022078362:Same reporter
Sex: M
Vaccine: VARZOS
Symptoms: Prostatic specific antigen increased
Clinical narrative: second dose, labs drawn, PSA elevated; This case was reported by a consumer via call center representative and described the occurrence of prostate specific antigen increased in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th May 2022, the patient received the 2nd dose of Shingrix. On 12th May 2022, 2 days after receiving Shingrix, the patient experienced prostate specific antigen increased. On an unknown date, the outcome of the prostate specific antigen increased was unknown.   It was unknown if the reporter considered the prostate specific antigen increased to be related to Shingrix.     Additional Information: GSK Receipt Date: 13-May-2022 Reporter's Comment: This case was reported by the patient's wife. The patient received dose of Shingrix vaccine and when the patient went get his labs drawn for PSA (Prostate specific antigen) it was elevated. The reporter did not consent to follow-up.