chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.0
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE/no PQC; Manager called to report dose of PROQUAD that expired 4/6/2023 was administered to patient on 5/31/2023. No additional AE/no PQC.; This spontaneous report was received from the Manager and refers to a 12-month-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 31-MAY-2023, the patient was vaccinated with an expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) subcutaneous injection, 1 dose, lot #U031560, expiration date: 06-APR-2023, administered for prophylaxis (strength, and route of administration were not provided). No additional adverse event (AE).
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Nurse calling to report VARIVAX was administered to patient while it had a temperature excursion. Exact date of administration not provided. Patient is asymptomatic. No additional AE. No PQC. Names of vaccines involved (including lot/exp) VARIVAX W02; No additional AE; This spontaneous report was received from Physician and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date (exact date not provided), the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, 1 dose, lot #W025274, expiration date: 10-AUG-2024, administered for prophylaxis (strength, and route of administration were not provided). The vaccine underwent a temperature excursion of 24.4 F for a period of 5 hours 51 minutes. The vaccine did not undergo any previous temperature excursion. The patient was asymptomatic and did not experience any adverse event.
Age: 5.0
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; HCP called to report that an expired dose of PROQUAD was inadvertently administered to a patient.; This spontaneous report was received from a nurse referring to a  5-year-old patient of unknown gender. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported.       On 14-JUN-2023, the patient was inadvertently vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) 0.5 mL, Albumin status rHA lot # U039258 with expiration date 09-JUN-2023, for prophylaxis (strength and route of administration were not reported). No additional adverse event (AE) was reported. The reporter asked about potency of the measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) and need for revaccination.
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered
Clinical narrative: no additional AE; HCP called to state that the patient was given an expired dose of GARDASIL 9.; This spontaneous report was received from medical assistant, referring to patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent condition and concomitant medication was not provided.  On 14-JUN-2023, the patient was vaccinated with expired the dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (formulation pre-filled syringe, 0.5 mL, lot #U007667, expiration date 23-MAY-2023, route of administration and anatomical location were not provided) for prophylaxis (Expired vaccine used). No known temperature excursions. No additional adverse event (AE) (No adverse event) and product quality complaint (PQC). ; Sender's Comments:  US-009507513-2306USA008127:
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; The patient was given an expired dose of GARDASIL 9; This spontaneous report has been received from a medical assistant, concerning a patient of unknown age and gender.  The patient's medical history, concurrent conditions, historical drugs, and concomitant therapies were not reported.  On 07-JUN-2023, 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) injection, 0.5 milliliter (lot number U007667 [also reported as "UU007667"] has been verified to be valid, expiration date reported and confirmed as 23-MAY-2023), as prophylaxis (route of administration and anatomical location were not provided) (Expired product administered). A healthcare professional (HCP) was the operator of the device. There were no known temperature excursions. The expiration was supported by Post MEMO Expiry. No adverse events (AEs) nor product quality complaints were reported.  This is one of two reports received from the same reporter. ; Sender's Comments:  US-009507513-2306USA007857:
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, Product storage error
Clinical narrative: Temperature excursion; No adverse event; HCP called to report an expired dose of VARIVAX was administered to Multiple patients. Patient Demographics provided for all patients, please see notes for additional case numbers. HCP gave permission to contact. No symptoms reported. No further AE d; This spontaneous report was received from Pharmacist and refers to a 15-year-old patient of unknown gender.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 12-JUN-2023, the patient started therapy with varicella virus vaccine live (oka/merck) (VARIVAX) injection, 0.5ml/once, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided).  On 12-JUN-2023, HCP called to report an expired dose of VARIVAX was administered to Multiple patients. Patient Demographics provided for all patients, please see notes for additional case numbers. HCP gave permission to contact. No symptoms reported. No further AE details/No PQC. There was a temperature excursion previously (70 F for 9 minutes).  Lot Number W0252273 is not valid for V210.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: No further AE details; HCP called to report an expired dose of VARIVAX was administered to Multiple patients.; Improper storage of product in use; This spontaneous report was received from a pharmacist and refers to a 15-month-old patient of unknown gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 14-JUN-2023, the patient was vaccinated with expired dose varicella virus vaccine live (oka/merck) (VARIVAX) injection, 0.5 milliliter, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided) (Expired product administered). On 02-MAR-2023, the vaccines underwent temperature excursion for 9 minutes in 70 Farenheit (F) (Product storage error). No additional adverse events were reported.  This lot number #W0252273 is verified to be not valid for varicella virus vaccine live (oka/merck).
Sex: M
Vaccine: MMRV, VARCEL
Symptoms: Accidental overdose, No adverse event
Clinical narrative: Confirmed no additional AE; Nurse called to report on behalf of HCP who inadvertently administered a 12-month-old patient their first dose of VARIVAX and PROQUAD concomitantly on 06/16/2023. Confirmed no additional AE/PQC.; This spontaneous report was received from  a nurse and refers to a 12-month-old male patient.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 16-JUN-2023, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, administered subcutaneously for immunisation (strength, lot #, and expiry date were not provided); and  measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided) (Accidental overdose). No additional adverse events were reported.
Sex: F
Vaccine: HPV9
Symptoms: Body temperature increased, Vomiting
Clinical narrative: vomit profusely; low-grade temperature; This spontaneous report was received from a company employee referring to the employee's daughter, a female patient of unknown age. The patient's concomitant drugs included ondansetron (ZOFRAN). The patient's medical history, historical drugs, past drug reactions or allergies, and concurrent conditions were unknown.   On 14-JUN-2023, the patient received her second dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection (strength, dose, route of administration, lot#, and expiration date were not provided) for prophylaxis.  Within a few short hours of receiving the vaccine on 14-JUN-2023, the patient began to vomit profusely. On 16-JUN-2023, the patient's pediatrician sent her to the emergency room. The patient was prescribed ondansetron (ZOFRAN) for her symptom. On an unknown date in June 2023, the patient started to have low-grade temperature. The outcome of the events above was unknown. The patient was advised to return to the emergency room if the illness continued. The causal relationship between vomit and HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) was reported as related. The causal relationship between the pyrexia and HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) was unknown.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected Vaccination failure; I had it too and it sucks too I just had my 2nd vaccine and it sucked too; This serious 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, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected Vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: I had it too and it sucks too I just had my 2nd vaccine and it sucked too). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK receipt date: 15-JUN-2023 The case was received from the patient interactive digital media. The patient stated that he/she had it too and it sucks too, he/she just had 2nd vaccine and it sucked too. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected Vaccination Failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected Vaccination Failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 15-JUN-2023 This case was reported by a patient via interactive digital media. The reporter stated that got the shingles shot and got shingles. The reporter further stated might be not as severe as could have but who knew. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, 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.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; This non-serious 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 Shingles vaccine. On an unknown date, immediately after receiving Shingles vaccine, the patient experienced shingles (Verbatim: Shingles). The outcome of the shingles was not reported.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.     It was unknown if the company considered the shingles to be related to Shingles vaccine.   Linked case(s) involving the same patient:  US2023AMR084564   Additional Information: GSK Receipt Date: 15-JUN-2023 This case was reported by a patient via interactive digital media. It was reported that a patient who got the Shingles vaccine shot immediately got shingles. The follow-up could not be possible as no contact details were available. This case is linked with US2023AMR084564 and US2023AMR084563, same reporter.; Sender's Comments:  US-GSK-US2023AMR084564:Same reporter US-GSK-US2023AMR084563:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: little sore; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 14-JUN-2023, the patient received Shingles vaccine. On 14-JUN-2023, less than a day after receiving Shingles vaccine, the patient experienced pain (Verbatim: little sore). The outcome of the pain was not reported.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.     It was unknown if the company considered the pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 14-JUN-2023 The case was received from the patient via interactive digital media The patient got the vaccine on the day of reporting it was a little sore but all good.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Little pain in the arm; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain in arm (Verbatim: Little pain in the arm). The outcome of the pain in arm was not reported.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.     It was unknown if the company considered the pain in arm to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 14-JUN-2023 This case was reported by a patient via interactive digital media. The patient received two doses of Shingles vaccine and nothing happened. Patient had only a little pain in the arm. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: little sore; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 14-JUN-2023, the patient received Shingles vaccine. On 14-JUN-2023, less than a day after receiving Shingles vaccine, the patient experienced pain (Verbatim: little sore). The outcome of the pain was not reported.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.     It was unknown if the company considered the pain to be related to Shingles vaccine.   Additional Information: GSK receipt date:14-jun-2023 This case was reported by a patient via interactive digital media. The reporter reported that he/she got the vaccine on day of reporting, it was a little sore but all good. The follow-up could not be possible as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Limb discomfort, Pain in extremity
Clinical narrative: arm was pounding; pouring headache/pouring headache; sore arm; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of arm discomfort in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (on an unknown date received first dose of Shingrix, refer US2023AMR084833).   On 12-JUN-2023, the patient received the 2nd dose of Shingles vaccine. On 13-JUN-2023, 1 days after receiving Shingles vaccine, the patient experienced arm discomfort (Verbatim: arm was pounding), headache (Verbatim: pouring headache/pouring headache) and pain in arm (Verbatim: sore arm). The outcome of the arm discomfort and headache were resolving and the outcome of the pain in arm was resolved.   It was unknown if the reporter considered the arm discomfort, headache and pain in arm to be related to Shingles vaccine.     It was unknown if the company considered the arm discomfort, headache and pain in arm to be related to Shingles vaccine.   Linked case(s) involving the same patient:  US2023AMR084833   Additional Information: GSK Receipt Date: 14-JUN-2023 The case was received from the patient via interactive digital media. On Monday patient got her second dose of Shingles vaccine and experienced pounding arm, her arm was hurting a lot more and had pouring headache.  She was just feeling better till date. The sore arm lasted a week.  However, she said it was better than getting shingles  Her husband had shingles and did know it right away. It was awful pain and itching bad. Her husband should get the shots as she had heard shingles could hit again. Her husband was in his early fifties and now he was in his 60s Her arm hurt some after the first shot and no others affect.; Sender's Comments:  US-GSK-US2023AMR084833:Same patient/First shingles shot
Sex: U
Vaccine: VARZOS
Symptoms: Paraesthesia
Clinical narrative: Left side of my face tingled after the first shot starting; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of tingling 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, 45 min after receiving Shingles vaccine, the patient experienced tingling (Verbatim: Left side of my face tingled after the first shot starting). The outcome of the tingling was resolved.   It was unknown if the reporter considered the tingling to be related to Shingles vaccine.     It was unknown if the company considered the tingling to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 14-JUN-2023 The case was received from the patient via interactive digital media. The reporter stated his/her left side of face tingled after the first shot of Shingles vaccine. It started about the 45 minutes afterwards until he/she woke up the next day. Patient stated it was not super bad and might not be related but his/her doctor advised against the second dose.
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling
Clinical narrative: swollen arm from the shoulder to the elbow/patient's leg is swollen; This non-serious case was reported by a consumer via call center representative and described the occurrence of peripheral swelling in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (unknown arm). On an unknown date, less than 2 weeks after receiving Shingrix, the patient experienced peripheral swelling (Verbatim: swollen arm from the shoulder to the elbow/patient's leg is swollen). The outcome of the peripheral swelling was not resolved.   It was unknown if the reporter considered the peripheral swelling to be related to Shingrix.     It was unknown if the company considered the peripheral swelling to be related to Shingrix.   Additional Information: GSK Receipt Date:12-JUN-2023 The reporter also stated that the patient received her first Shingrix vaccine on unknown date, unknown arm.  After that patient reported swollen arm from the shoulder to the elbow, that resolved in 1 and half weeks. At the same time, on same side of the body the patient's leg was swollen and had not resolved. No other information known. The reporter consented to follow up
Age: 10.0
Sex: M
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: Infanrix - Administration of an expired dose.; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 10-year-old male patient who received DTPa (Infanrix) (batch number 7KM94, expiry date 10-JUN-2023) for prophylaxis.   On 13-JUN-2023, the patient received Infanrix. On 13-JUN-2023, an unknown time after receiving Infanrix, the patient experienced expired vaccine used (Verbatim: Infanrix - Administration of an expired dose.). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 13-JUN-2023 The health care professional (HCP) asked for information about adverse reactions following the administration of the expired dose. The reporter consented to follow up. The patient was administered an expired dose of Infanrix, which led to expired vaccine used.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Incorrect solution used; Inappropriate dose of vaccine administered; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution (Verbatim: Incorrect solution used) and inappropriate dose of vaccine administered (Verbatim: Inappropriate dose of vaccine administered). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 13-JUN-2023 GSK Field staff reported an adverse event that was reported to him. The reporter stated that while preparing a dose for administration, the provider used sterile solution instead of the adjuvant provided. The dose was administered to a patient.  No further information was available. The reporter consented to follow up. The patient had Shingrix reconstituted with sterile solution instead of the adjuvant, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Erythema, Peripheral swelling
Clinical narrative: Red arm down to elbow; Swollen arm down to elbow; Burning down to elbow; This non-serious case was reported by a consumer via call center representative and described the occurrence of erythema of extremities in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 09-JUN-2023, the patient received the 1st dose of Shingrix. In JUN-2023, an unknown time after receiving Shingrix, the patient experienced erythema of extremities (Verbatim: Red arm down to elbow), swelling arm (Verbatim: Swollen arm down to elbow) and burning sensation of upper limb (Verbatim: Burning down to elbow). The outcome of the erythema of extremities, swelling arm and burning sensation of upper limb were unknown.   It was unknown if the reporter considered the erythema of extremities, swelling arm and burning sensation of upper limb to be related to Shingrix.     It was unknown if the company considered the erythema of extremities, swelling arm and burning sensation of upper limb to be related to Shingrix.   Additional Information: GSK Receipt Date:14-June-2023 The patient self-reported this case.
Age: 12.0
Sex: F
Vaccine: HEPAB, HEPAB, HEPAB
Symptoms: Inappropriate schedule of product administration, Incomplete course of vaccination, Incorrect dose administered, Product administered to patient of inappropriate age
Clinical narrative: Did not received 3rd dose; 1st dose received on 18-sep-19 and 2nd dose on 14-sep-20; 2nd dose received at the age of 13 years; 1st dose received at the age of 12 years; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 16-year-old female patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included HAB (Twinrix) for prophylaxis and HAB (Twinrix) for prophylaxis.   On 14-SEP-2020, the patient received the 2nd dose of Twinrix. On 18-SEP-2019, the patient received the 1st dose of Twinrix. On an unknown date, the patient received the 3rd dose of Twinrix. On 18-SEP-2019, not applicable after receiving Twinrix and Twinrix and an unknown time after receiving Twinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: 1st dose received at the age of 12 years). On 14-SEP-2020, the patient experienced inappropriate age at vaccine administration (Verbatim: 2nd dose received at the age of 13 years) and drug dose administration interval too long (Verbatim: 1st dose received on 18-sep-19 and 2nd dose on 14-sep-20). On an unknown date, the patient experienced incomplete course of vaccination (Verbatim: Did not received 3rd dose). The outcome of the inappropriate age at vaccine administration, inappropriate age at vaccine administration, drug dose administration interval too long and incomplete course of vaccination were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 14-JUN-2023 The reporter wanted to know guidance on Twinrix dosing schedule. The reporter reported that the patient moved to here and both the physicians stated that the patient did not need to receive another dose of Twinrix vaccine, but the reporter stated their school district requires students to have three doses. The patient did not receive the 3rd dose of Twinrix as per the vaccination schedule, which led to incomplete course of vaccination. The patient received 2nd dose of Twinrix late than recommended time frame, which led to lengthening of vaccination schedule. The patient received Twinrix who was younger than the indicated age which led to inappropriate age at vaccine administration. The reporter did not consent to follow up.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Shingrix was administered intended as a first dose and was later discover a dose of shingrix may have been administered 1 month before that; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 66-year-old female patient who received Herpes zoster (Shingrix) (batch number G3T43, expiry date 07-JUL-2024) for prophylaxis.   Concomitant products included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX).   On 21-MAR-2023, the patient received the 2nd dose of Shingrix. On 21-MAR-2023, an unknown time after receiving Shingrix and an unknown time after receiving SHINGRIX, the patient experienced drug dose administration interval too short (Verbatim: Shingrix was administered intended as a first dose and was later discover a dose of shingrix may have been administered 1 month before that). The outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK Receipt Date: 14-JUN-2023 The reporter reported a dose of Shingrix was administered intended as a first dose and was later discover a dose of Shingrix might had been administered 1 month before that.  The reporter was unsure if that first dose was administered because of little documentation about it and patient was unsure if it was administered or not. The dose discovered on the patient´s record only was documented to have been administered on 22nd February 2023 but had no lot number or name of the person who administered the dose, healthcare professional also confirmed with patient and doctor office and no one had information of this dose occurring. The reporter was reporting proactively because healthcare professional was unsure if the dose was administered or not. The reporter did not consent to follow-up. The patient received 2nd dose of Shingrix earlier than the recommended schedule, which led to shortening of vaccination schedule.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Inappropriate dosing Schedule/took 2nd dose too late; This non-serious case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (On 19th July 2018, received first dose).   On 02-MAY-2023, the patient received the 2nd dose of Shingrix. On 02-MAY-2023, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: Inappropriate dosing Schedule/took 2nd dose too late). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 14-JUN-2023 The reporter was a patient. The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccinations schedule.  The reporter did not consent to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: she has patients who only receive one dose and are curious about how protected from Shingles they are; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On an unknown date, the patients did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patients experienced incomplete course of vaccination (Verbatim: she has patients who only receive one dose and are curious about how protected from Shingles they are). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 15-JUN-2023 The reporter would like to know what is the efficacy of Shingrix is for one dose only.  She stated that she had patients who only receive one dose and are curious about how protected from Shingles they are. The vaccine administration facility is the same as primary reporter. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. Details pertains to 1st dose of Shingrix in product tab.
Sex: F
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: Received expired dose of boostrix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 12-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 224CG, expiry date 07-MAY-2023) for prophylaxis.   On an unknown date, the patient received Boostrix. On an unknown date, an unknown time after receiving Boostrix, the patient experienced expired vaccine used (Verbatim: Received expired dose of boostrix). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 15-JUN-2023 The reporter was a medical assistant. The patient received a Boostrix which was already expired, which led to expired vaccine used. The reporter did consent to follow up.
Sex: M
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: Boostrix expired dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 11-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number 224CG, expiry date 07-MAY-2023) for prophylaxis.   On an unknown date, the patient received Boostrix. On an unknown date, an unknown time after receiving Boostrix, the patient experienced expired vaccine used (Verbatim: Boostrix expired dose). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 15-JUN-2023 The reporter was a medical assistant. The reporter consented to follow up. The reporter reported that a patient received an expired dose of Boostrix, which led to expired vaccine used.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: administered a dose of Shingrix adjuvant without mixing with the lyophilized Shingrix portion on 14Jun2023; administered a dose of Shingrix adjuvant without mixing with the lyophilized Shingrix portion on 14Jun2023; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) (batch number L4472, expiry date 08-OCT-2023) for prophylaxis.   On 14-JUN-2023, the patient received the 2nd dose of Shingrix. On 14-JUN-2023, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: administered a dose of Shingrix adjuvant without mixing with the lyophilized Shingrix portion on 14Jun2023) and inappropriate dose of vaccine administered (Verbatim: administered a dose of Shingrix adjuvant without mixing with the lyophilized Shingrix portion on 14Jun2023). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 15-JUN-2023 The adjuvant was given from lot number L4472 (expiration date 8th October 2023).   The reporter stated that patient was fine. The reporter stated she did not had any patient demographic information. The reporter gave permission for follow-up via email.   Declined to provide address. The patient was administered a dose of Shingrix adjuvant without mixing with the lyophilized Shingrix portion, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Age: 1.25
Sex: M
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: administration of an expired Infarix dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 15-month-old male patient who received DTPa (Infanrix) (batch number 7KM94, expiry date 10-JUN-2023) for prophylaxis.   On 14-JUN-2023, the patient received Infanrix. On 14-JUN-2023, an unknown time after receiving Infanrix, the patient experienced expired vaccine used (Verbatim: administration of an expired Infarix dose). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 15-JUN-2023 The health care professional (HCP) asked, how long does the patient had to wait in order to receive a valid dose of Infanrix. The reporter consented to follow up. The patient received an expired dose of Infanrix , which led to expired vaccine used.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Received only one dose of shingrix on 2021; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 2021).   On an unknown date, the patient did not received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: Received only one dose of shingrix on 2021). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 15-JUN-2023 Till the time of reporting, the patient did not receive the 2nd dose of Shingrix vaccine, which led to incomplete course of vaccination. The reporter did consent to follow up.
Age: 2.0
Sex: M
Vaccine: HEPA
Symptoms: Overdose, Product administered to patient of inappropriate age
Clinical narrative: Havrix adult dose administered to a child instead of Vaqta; Havrix adult dose administered to a child instead of Vaqta; This non-serious case was reported by a nurse via call center representative and described the occurrence of overdose in a 2-year-old male patient who received HAV (Havrix adult) (batch number 3J9J4, expiry date 30-AUG-2025) for prophylaxis.   On 15-JUN-2023, the patient received Havrix adult. On 15-JUN-2023, an unknown time after receiving Havrix adult, the patient experienced overdose (Verbatim: Havrix adult dose administered to a child instead of Vaqta) and adult product administered to child (Verbatim: Havrix adult dose administered to a child instead of Vaqta). The outcome of the overdose and adult product administered to child were unknown.   Additional Information: GSK Receipt Date: 15-JUN-2023 The reporter consented to follow up. The reporter reported that a 2 year old was administered an adult dose of Havrix instead of Vaqta, which led to overdose and adult product administered to child.
Age: 49.0
Sex: M
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: Engerix-B second dose pediatric formulation instead of the adult; Engerix-B second dose pediatric formulation instead of the adult; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of underdose in a 50-year-old male patient who received HBV (Engerix B 10 mcg) (batch number 25N39, expiry date 16-MAR-2024) for prophylaxis.   Previously administered products included Engerix-B (1st dose received on an unknown date).   On 09-JUN-2023, the patient received the 2nd dose of Engerix B 10 mcg. On 09-JUN-2023, an unknown time after receiving Engerix B 10 mcg, the patient experienced underdose (Verbatim: Engerix-B second dose pediatric formulation instead of the adult) and adult use of a child product (Verbatim: Engerix-B second dose pediatric formulation instead of the adult). The outcome of the underdose and adult use of a child product were unknown.   Additional Information: GSK receipt date: 15-JUN-2023 The Engerix-B first dose was administered on another pharmacy and that is why there were no details available about that dose. Follow-up declined. The reporter did not consent to follow-up. An adult patient received Engerix-B dose pediatric formulation instead of the adult, which led to underdose and adult use of a child product.
Age: 57.0
Sex: U
Vaccine: MNQ
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Administering the Menveo to a 57 yo patient; This non-serious case was reported by a physician via call center representative and described the occurrence of inappropriate age at vaccine administration in a 57-year-old patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced inappropriate age at vaccine administration (Verbatim: Administering the Menveo to a 57 yo patient). The outcome of the inappropriate age at vaccine administration was unknown.   Additional Information: GSK Receipt Date: 15-JUN-2023 The reporter wanted to know the information on the safety on administering the Menveo vaccine to the 57 years old patient that will be travelling. The reporter stated that after reviewing GlaxoSmithKline and disease control information he decided that he will follow guidance and proceed to vaccinate the patient. No additional information provided. The reporter did not consent to follow up. The patient received Menveo who was older than the indicated age which led to inappropriate age at vaccine administration.
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 2nd dose was received in January 2023; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in 2019).   In JAN-2023, the patient received the 2nd dose of Shingrix. In JAN-2023, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: 2nd dose was received in January 2023). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 16-JUN-2023 The reporter on behalf of patient. Further information was not known. The consent to follow up was not asked. The patient received 2nd dose of Shingrix later than the recommended interval, which led to lengthening of vaccine schedule.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: Patient felt sick after Shingrix/severe reaction, felt sick; This non-serious case was reported by a physician via call center representative and described the occurrence of feeling unwell in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In MAR-2023, the patient received the 1st dose of Shingrix. In MAR-2023, less than a day after receiving Shingrix, the patient experienced feeling unwell (Verbatim: Patient felt sick after Shingrix/severe reaction, felt sick). The outcome of the feeling unwell was unknown.   It was unknown if the reporter considered the feeling unwell to be related to Shingrix.     It was unknown if the company considered the feeling unwell to be related to Shingrix.   Additional Information: GSK Receipt Date: 16-JUN-2023 The reporter stated about half a day after the administration of first dose of Shingrix, the patient experienced sever reaction, felt sick. The reporter stated the reaction occurred 3 months ago from reporting. Lot number and expiration date was asked but the information was declined. The reporter did not have more information as vaccine was administered at the different facility. The reporter did not consent to follow up.
Sex: U
Vaccine: COVID19
Symptoms: Oesophageal achalasia
Clinical narrative: ACHALASIA; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient was in perfect health prior to vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced achalasia. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of achalasia was not reported. This report was non-serious. This case, from the same reporter is linked to 20230636371 and 20230636250.
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Product was expired on 06 Jun 2023, and it was stored in refrigator on 07 Jun 2023; No adverse event; patient was administered Moderna Vaccine on 08 Jun 2023, which was expired vaccine was 06 Jun 2023; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient was administered Moderna Vaccine on 08 Jun 2023, which was expired vaccine was 06 Jun 2023), PRODUCT STORAGE ERROR (Product was expired on 06 Jun 2023, and it was stored in refrigator on 07 Jun 2023) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 024H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Jun-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 08-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient was administered Moderna Vaccine on 08 Jun 2023, which was expired vaccine was 06 Jun 2023). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Product was expired on 06 Jun 2023, and it was stored in refrigator on 07 Jun 2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient was administered Moderna Vaccine on 08 Jun 2023, which was expired vaccine was 06 Jun 2023), PRODUCT STORAGE ERROR (Product was expired on 06 Jun 2023, and it was stored in refrigator on 07 Jun 2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (patient was administered Moderna Vaccine on 08 Jun 2023, which was expired vaccine was 06 Jun 2023) and PRODUCT STORAGE ERROR (Product was expired on 06 Jun 2023, and it was stored in refrigator on 07 Jun 2023).    The vial size was 2.5ml. The date the vial was initially stored in the refrigerator was 07 Jun 2023. The vial had not undergo any temperature excursions. Concomitant medications were not reported.  No treatment information was provided by the reporter. This case was for patient 3 out of 5.   This case was linked to US-MODERNATX, INC.-MOD-2023-728778 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-728778:Master case