chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE details; TE evaluation states vaccines have been administered; This spontaneous report was received from a medical assistant and refers to unspecified number of patients. The patients' medical history, concurrent conditions were not reported and concomitant therapies were not reported.  On an unknown date, the patients were vaccinated with improperly stored doses of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection (lot # U025790, expiration date: 19-AUG-2023, lot # U029496 with expiration date on 21-SEP-2023) administered for prophylaxis (dose and route of administration were not provided).  The vaccines underwent temperature excursion of -14 degrees Celsius up to -10 degrees Celsius during a time frame of 3 hours; -10 degrees Celsius up to 8 degrees Celsius during a time frame of 1 hour and 30 minutes. No adverse event was reported.  This is one of several reports from the same reporter.  Follow-up information has been received from the medical assistant on 24-MAY-2022, referring to a 4-year-old (also reported as 5-year-old, discrepant information) female patient.   On 25-MAR-2022, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) administered subcutaneously (SQ) as prophylaxis (dose and anatomical site of vaccination were not reported; lot number U025790 has been verified to be valid, expiration date reported and established as 19-AUG-2023).   The patient's identifiers were missing in the initial report.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2205USA003614: US-009507513-2205USA007821: US-009507513-2205USA007847: US-009507513-2205USA007852:
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered
Clinical narrative: Administrator calling to report PROQUAD dose that was administered after its expiration date. Vaccine expired: 4/11/2022. Dose administered: 4/28/2022. No PQC. No additional information.; Information has been received from other healthcare professional regarding a patient of unknown age and gender. The patient's medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medications were not reported.  On 28-APR-2022, the patient was vaccinated with an expired measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) rHA (recombinant human albumin) for prophylaxis, lot number T034828 with expiration date on 11-APR-2022 (expired product administered) (strength dose, route of administration, strength and anatomical location not reported)
Sex: M
Vaccine: HPV9
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: Healthcare provider reports GARDASIL 9 was incorrectly administered on an unspecified date via subcutaneous route instead of intramuscular route. Caller did not provide any additional information related to the AE. No further information provided. No; No adverse event; This spontaneous report was received from a medical assistant, and refers to a male patient of unknown age. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) for prophylaxis (strength, lot #, and expiry date were not provided). The vaccine was incorrectly administered via subcutaneous route instead of intramuscular route. No adverse events were reported.
Age: 6.0
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE details; vaccine stored outside of recommended range was administered; This spontaneous report as received from a registered nurse and an administrator, referring to a 6 years old male patient. Concomitant therapies included sterile diluent. The patient's historical condition and current condition were not reported.  On 20-APR-2022, the patient was vaccinated with incorrectly storge of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA (recombinant Human albumin)) (PROQUAD) (lot # U039258 with expiration date: 09-JUN-2023; dose, route and strength were unknown) for prophylaxis (product storage error). The temperature excursion below 6 Fahrenheit degrees (F) up to 14F (7.9F) for 4 hours 8 minutes 0 seconds. No previous temperature excursions reported. The reporter reported the office was unaware of the temperature excursion until she completed a data logger download on 02-MAY-2022.  No adverse events have been reported to the office at the time of the report.  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-2205USA001061: US-009507513-2205USA000973:02158506 US-009507513-2205USA001205: US-009507513-2205USA001202: US-009507513-2205USA001043: US-009507513-2205USA001271:
Sex: M
Vaccine: PPV
Symptoms: Hypersensitivity
Clinical narrative: slight allergic reaction; This spontaneous report has been received from an anonymized provider referring to a male patient of unknown age. The patient's medical history, concurrent condition, and concomitant therapy were not provided.  On an unknown date, the patient received pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) for prophylaxis (strength, dose, unit, lot #, expiry date, and route of administration were not provided). On an unknown date, the patient had a slight allergic reaction to pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) and want to be given pneumococcal vaccine conj 7v (crm197) (PREVNAR) 20. At the time of reporting, the outcome of slight allergic reaction was unknown.   It was considered the slight allergic reaction to be related to pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23).
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No additional AEs were reported; Nurse reported that an adult patient received PROQUAD instead of MMR II today 5/6/2022 due to a human error.   No additional AEs were reported, no further information provided.; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not provided.   On 06-MAY-2022, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (albumin status rHA) (PROQUAD) 0.5ml/once, lot # U028181, expiration date 08-MAR-2023 (route of administration was not provided) for prophylaxis, instead of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) due to a human error (wrong product administered). Other suspect therapies included sterile diluent, lot# t027316, expiration date 07-APR-2023 upon internal validation determined to be valid. No additional adverse events were reported (no adverse event).
Age: 0.25
Sex: U
Vaccine: HIBV
Symptoms: Product storage error
Clinical narrative: No adverse events; During temperature excursion case, customer reported that improperly stored vaccine was administered to 10 separate patients. No additional AE reported, No PQC reported.  Names of vaccines involved (including lot/exp) PEDVAX HIB T042013 exp 07/22/202; This spontaneous report was received from an office manager, and refers to a 3-month-old patient of unspecified gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 24-MAR-2022, the patient was vaccinated with haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection, lot #T042013, expiration date: 22-JUL-2023, administered for prophylaxis (strength, and route of administration were not provided).  On an unspecified date, the dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) underwent a temperature excursion of 11.43 Celsius (°C) degrees, for a time frame of 4 hours and 45 minutes. There were no previous temperature excursions.   No adverse events were reported.  This is one of 10 cases received from the same source.; Sender's Comments:  US-009507513-2205USA003131: US-009507513-2205USA002848: US-009507513-2205USA002913: US-009507513-2205USA002951: US-009507513-2205USA002965: US-009507513-2205USA002988: US-009507513-2205USA003118: US-009507513-2205USA003121: US-009507513-2205USA003266:
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Expired vaccines, with the same lot and expiration date, were administered to two different patients; This spontaneous report was received from a healthcare professional, 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 06-MAY-2022, the patient received vaccination with an expired Hepatitis A Vaccine, Inactivated (VAQTA) for prophylaxis, lot number #U003464 and expiration date 02-MAY-2022 (strength, dose, frequency and route of administration were not reported).   No adverse events were reported.   This is one of 2 reports received from the same reporter (MARRS #US-009507513-2205USA003700) ; Sender's Comments:  US-009507513-2205USA003700:Case Number: 02164360
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Diarrhoea, Fatigue
Clinical narrative: Severe all over pain in joints and muscles. Severe diarrhea. Overall tiredness.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No further adverse events; Caller is nurse reporting administered dose of expired MMR II.; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history and concomitant medications was provided.  On 17-MAY-2022, the patient was vaccinated with expired dose (expired product administered) of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant Human albumin) (M-M-R II) 1 dose, lot #: T016196, expiration date: 11-MAY-2022 (strength, site and route of administration were not provided) for prophylaxis. There was no further adverse events reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported.; Patient was administered improperly stored VARIVAX; This spontaneous report was received from a healthcare business professional and refers to a patient of unknown age and gender. The patient's concurrent conditions, concomitant therapies and medical history were not provided.  On 18-APR-2022, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, lot #U022320, expiration date: 15-JUL-2023 (strength, and route of administration were not provided) administered for prophylaxis (Product storage error).  Administered vaccine experienced the temperature excursion of -11.45 degrees Celsius for 1 hour on 18-APR-2022 and -14 up to -10 degrees Celsius for 30 minutes on 04-MAR-2022.  There was no adverse event reported (No adverse event).
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: No additional AE details; Customer calling for TE evaluation of VARIVAX. Customer states she called yesterday 5/24/2022 to report a TE but they just found out they had another TE 1 week ago and they need to report that at this time. VARIVAX has been administered to one patien; This spontaneous report was received from a customer referring to a patient of unknown age and gender. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.      On 25-MAY-2022, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot number U028164, expiration date 09-SEP-2023 (dose and route of administration not provided) for prophylaxis and that was reconstituted with a sterile diluent (product storage error). No adverse event was reported.  the excursion was between -14 degrees Celsius (°C) to 10 °C for 2 hours and 5 minutes and between -10°C to 8°C with an average of -0.4°C for 1 hour and 25 minutes. A previous temperature excursion was deteceted and was between -14°C to -10°C with an average of -12°C for 50 minutes.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE details; Customer calling for TE evaluation of VARIVAX. Customer states she called yesterday 5/24/2022 to report a TE but they just found out they had another TE 1 week ago and they need to report that at this time. VARIVAX has been administered to a total of; This spontaneous report was received from a customer referring to a patient of unknown age and gender. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.      Between 11-MAY-2022 and 24-MAY-2022, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot number U039949, expiration date 12-DEC-2023 (dose and route of administration not provided) for prophylaxis and that was reconstituted with a sterile diluent (product storage error). No adverse event was reported.  The excursion was between -14 degrees Celsius (°C) to 10 °C for 2 hours and 5 minutes and between -10°C to 8°C with an average of -0.4°C for 1 hour and 25 minutes. A previous temperature excursion was deteceted and was between -14°C to -10°C with an average of -12°C for 50 minutes.
Sex: M
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: No additional AE details; TE evaluation states vaccines have been administered to multiple patients; This spontaneous report was received from Other Health Professional and refers to unspecified number of patients.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On an unknown date, the patients were vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, unk, lot #U025790, expiration date: 19-AUG-2023 or U029496 with expiration date on 21-SEP-2023, administered for prophylaxis (strength, and route of administration were not provided). The vaccines underwent temperature excursion of -14°C up to-10 degrees C for 3 hours 0 and  -10 degrees C up to 8 degrees C for 1 hour 30 minutes. No adverse event was reported.  This is one of several reports from the same reporter. This case in non-valid due to the lack of the patients' identifiers.   Follow up information has been received from the physician's office, on 24-MAY-2022, referring to a 5 year old male patient.      On 11-APR-2022, the patient was vaccinated with an improperly storage dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # U025790 expiration date: 19-AUG-2023, subcutaneous (SQ), for prophylaxis (no previous vaccine administered) product storage error.     Temperature excursion occurred on 23-MAR-2022.      No further clarify.    ; Sender's Comments:  US-009507513-2205USA003614: US-009507513-2205USA007821: US-009507513-2205USA007847:Original Case : 2204USA009330 US-009507513-2205USA007852:Original Case : 2204USA009330
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: got both shots, still got it twice in one month/Suspected vaccination failure; got both shots, still got it twice in one month; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     Additional Information: GSK Receipt Date: 22-MAY-2022 Reporters comment: The patient self-reported the case via interactive digital media and described the occurrence of suspected vaccination failure. After receiving Shingles vaccine, the patient got shingles twice in one month. Additional supportive information: This case was considered as suspected vaccination failure, since the details regarding time to onset for event and laboratory test confirming shingles were unknown at the time of reporting. Follow up would not be possible as contact details were not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Arthralgia
Clinical narrative: I had 1st dose my knees have had severe pain since; This case was reported by a consumer via interactive digital media and described the occurrence of knee pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd May 2022, the patient received the 1st dose of Shingrix. In May 2022, less than 3 weeks after receiving Shingrix, the patient experienced knee pain. On an unknown date, the outcome of the knee pain was not recovered/not resolved.   It was unknown if the reporter considered the knee pain to be related to Shingrix.     Additional Information: GSK receipt date:23-May-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient-self reported this case. The patient had 1st dose of Shignrix on 3rd May and his/her knees have had severe pain since. Additional Supportive Information: Foll0w-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Social problem
Clinical narrative: Didn´t get the 2nd dose due to the pandemic shutdowns; 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 (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on November 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.       Additional Information: GSK Receipt Date: 23-May-2022 Reporter's Comments: This case was reported by a consumer via interactive digital media. The patient received 1st dose of shingrix and due to pandemic shutdown the patient did not received 2nd dose. Additional Supportive Information: The patient did not received 2nd dose of shingrix due to pandemic shutdown which led to social problem.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Ear discomfort, Electric shock sensation, Inappropriate schedule of product administration
Clinical narrative: got her second vaccine on 5/23/2022; dizziness/lightheadedness; brain and ear zaps; This case was reported by a consumer via call center representative and described the occurrence of dizziness in a 74-year-old female patient who received Herpes zoster (Shingrix) (batch number x2e93, expiry date 6th May 2023) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site pruritus (received 1st dose on 9th May 2022 experienced injection site pruritus refer case US2022083402) and COVID booster (received 2nd dose of COVID booster).   On 23rd May 2022, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. In May 2022, 12 hrs after receiving Shingrix, the patient experienced dizziness and brain zaps. On 23rd May 2022, the patient experienced drug administration duration too short. On an unknown date, the outcome of the dizziness and brain zaps were not recovered/not resolved and the outcome of the drug administration duration too short was unknown.   It was unknown if the reporter considered the dizziness and brain zaps to be related to Shingrix.     Linked case(s) involving the same patient: US2022083402   Additional Information: GSK Receipt Date: 24-MAY-2022 Reporter's Comments: The case was self reported by the patient. The patient received Shingrix in the left deltoid. On 24th may 2022, about 12 hours after receiving Shingrix vaccine, she started with dizziness/lightheadedness and what she described as brain and ear zaps. These symptoms were still present. The reporter consented to follow up. Additional supportive information: The patient received the Shingrix dose earlier than the recommended interval, which led to shortening of vaccination schedule.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022083402:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration, Malaise
Clinical narrative: 2nd dose in two weeks; don't feel well; This case was reported by a consumer via interactive digital media and described the occurrence of unwell in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Concomitant products included SHINGLES VACCINE (NOS) (SHINGLES VACCINE).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On 24th May 2022, unknown after receiving Shingles vaccine, the patient experienced unwell. On an unknown date, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the unwell and drug dose administration interval too short were unknown.   It was unknown if the reporter considered the unwell to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 24-May-2022 Reporter's comments: This case was reported by the patient via interactive digital media. The patient went to two different pharmacist and the pharmacist told to get the 2nd one in two weeks so the patient did. On the date of reporting, the patient did not feel well and was reading information that not to get the next one until 2 to 4 months. Since the patient received the shot too quick next. Additional Supportive Information: The patient received 2nd dose of Shingrix earlier than recommended time frame, which led to shortening of interval between vaccine doses.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: should have two injections; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date, few years ago).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 25-MAY-2022 Reporter's Comments: The case was reported by the patient via interactive digital media. The patient just found out that he/she should have received 2 injections. The patient asked if he or she should take second dose now. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: M
Vaccine: UNK, VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: shingles after having received 2 shots shingrix/Suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a 59-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis and teriflunomide (Aubagio) for multiple sclerosis.   Concurrent medical conditions included multiple sclerosis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. In January 2021, the patient started Aubagio (oral) 14 mg once daily (14 mg daily). On an unknown date, unknown after receiving Shingrix and Shingrix and an unknown time after starting Valtrex, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. The patient was treated with valaciclovir hydrochloride (Valtrex). Aubagio was continued with no change. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was recovering/resolving.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     Additional Information: GSK Receipt Date: 25-May-2022 Reporter's Comments: The patient's past medical history, medical treatments, concomitant medications and family history were not provided. In January 2021, the patient started taking AUBAGIO (TERIFLUNOMIDE) 14 mg QD (once daily) oral (with an unknown batch number and formulation, strength- 14mg) for Multiple sclerosis. On an unknown date, the patient started taking SHINGRIX vaccination. The reporter stated that the patient came down with shingles even after having received the 2 shots of the shingrix vaccination while being treated with TERIFLUNOMIDE (AUBAGIO). The patient advised to reached out to doctor office to make aware. The patient advised was prescribed a topical cream to help and valtrex and was recovering and advised to follow up with doctor to ensure aware and to see if any additional steps need to be taken. Additional Supportive Information: This case considered as suspected vaccination failure since the details regarding time to onset of shingles and laboratory confirmation of shingles were not provided
Age: 72.0
Sex: M
Vaccine: HEPAB, HEPAB
Symptoms: Inappropriate schedule of product administration, Incomplete course of vaccination
Clinical narrative: first dose in 5/21/21, second in 12/16/21.; first dose in 5/21/21, second in 12/16/21.; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 72-year-old male patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis, HAB (Twinrix) for prophylaxis and hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix (1st dose of Twinrix was received on 21st May 2021).   On 16th December 2021, the patient received the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, the patient received the 3rd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On 16th December 2021, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device and not applicable after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced drug dose administration interval too long. On an unknown date, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the 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: 20-MAY-2022 Reporter's Comments:  The reporter wanted to know that how to proceed with Twinrix series. The pharmacist reported that a patient received second dose later and 3rd dose had not received yet. The reporter did not give consent to follow up.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Cyst, Cyst removal, Hypoaesthesia, Immobile
Clinical narrative: loss of mobility; shoulder pain; excruciating pain, progressive; soft tissue cyst, surgically removed, metallic appearance; Numbness; nerve pain; tingling; did not come for the 2nd dose; This case was reported by a pharmacist via call center representative and described the occurrence of immobile in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In August 2020, the patient received the 1st dose of Shingrix. On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced immobile (serious criteria GSK medically significant), shoulder pain, pain, cyst, numbness, nerve pain, tingling and incomplete course of vaccination. On an unknown date, the outcome of the immobile, shoulder pain, pain, cyst, numbness, nerve pain, tingling and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the immobile, shoulder pain, pain, cyst, numbness, nerve pain and tingling to be related to Shingrix.   Additional Information: GSK Receipt Date: 23-MAY-2022 Reporter's Comment:  The patient did not have a good experience after first dose complained of shoulder pain.  Later a notice was sent to reporter which stated that the patient developed an excruciating pain with soft tissue cyst which was surgically removed. MRI (Magnetic resonance imaging)/X-ray showed cyst was noticeable with metallic appearance.  The progressive pain after failed consecutive treatment.  The patient also had numbness, nerve pain, tingling and loss of mobility. The patient did not come for the 2nd dose in spite of the pharmacist reminding the patient.  The vaccine administration facility was the same as primary reporter.  VAERS details were reported for 1st dose. No other information of patient or vaccine was available. Additional Supportive Information: Till the time of reporting, the patient did not receive the second dose of Shingrix, which led to incomplete course of vaccination.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Incomplete course of vaccination, Magnetic resonance imaging abnormal, Neuralgia, Pain, Paraesthesia
Clinical narrative: loss of mobility; shoulder pain; excruciating pain, progressive; soft tissue cyst, surgically removed, metallic appearance; Numbness; nerve pain; tingling; did not come for the 2nd dose; This case was reported by a pharmacist via call center representative and described the occurrence of immobile in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In August 2020, the patient received the 1st dose of Shingrix. On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced immobile (serious criteria GSK medically significant), shoulder pain, pain, cyst, numbness, nerve pain, tingling and incomplete course of vaccination. On an unknown date, the outcome of the immobile, shoulder pain, pain, cyst, numbness, nerve pain, tingling and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the immobile, shoulder pain, pain, cyst, numbness, nerve pain and tingling to be related to Shingrix.   Additional Information: GSK Receipt Date: 23-MAY-2022 Reporter's Comment:  The patient did not have a good experience after first dose complained of shoulder pain.  Later a notice was sent to reporter which stated that the patient developed an excruciating pain with soft tissue cyst which was surgically removed. MRI (Magnetic resonance imaging)/X-ray showed cyst was noticeable with metallic appearance.  The progressive pain after failed consecutive treatment.  The patient also had numbness, nerve pain, tingling and loss of mobility. The patient did not come for the 2nd dose in spite of the pharmacist reminding the patient.  The vaccine administration facility was the same as primary reporter.  VAERS details were reported for 1st dose. No other information of patient or vaccine was available. Additional Supportive Information: Till the time of reporting, the patient did not receive the second dose of Shingrix, which led to incomplete course of vaccination.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Treatment failure, X-ray abnormal
Clinical narrative: loss of mobility; shoulder pain; excruciating pain, progressive; soft tissue cyst, surgically removed, metallic appearance; Numbness; nerve pain; tingling; did not come for the 2nd dose; This case was reported by a pharmacist via call center representative and described the occurrence of immobile in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In August 2020, the patient received the 1st dose of Shingrix. On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced immobile (serious criteria GSK medically significant), shoulder pain, pain, cyst, numbness, nerve pain, tingling and incomplete course of vaccination. On an unknown date, the outcome of the immobile, shoulder pain, pain, cyst, numbness, nerve pain, tingling and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the immobile, shoulder pain, pain, cyst, numbness, nerve pain and tingling to be related to Shingrix.   Additional Information: GSK Receipt Date: 23-MAY-2022 Reporter's Comment:  The patient did not have a good experience after first dose complained of shoulder pain.  Later a notice was sent to reporter which stated that the patient developed an excruciating pain with soft tissue cyst which was surgically removed. MRI (Magnetic resonance imaging)/X-ray showed cyst was noticeable with metallic appearance.  The progressive pain after failed consecutive treatment.  The patient also had numbness, nerve pain, tingling and loss of mobility. The patient did not come for the 2nd dose in spite of the pharmacist reminding the patient.  The vaccine administration facility was the same as primary reporter.  VAERS details were reported for 1st dose. No other information of patient or vaccine was available. Additional Supportive Information: Till the time of reporting, the patient did not receive the second dose of Shingrix, which led to incomplete course of vaccination.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: received a 3rd dose fo Shingrix; This case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 80-year-old female patient who received Herpes zoster (Shingrix) (batch number 9pr2p, expiry date 17th April 2023) for prophylaxis.   Previously administered products included shingrix (1st dose and 2nd dose received on an unknown date).   On 14th March 2022, the patient received the 3rd dose of Shingrix. On 14th March 2022, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.    Additional Information: GSK Receipt Date: 24-May-2022 Reporter's Comments: The patient received a 3rd dose of Shingrix.  The reporter asked any safety information for the patient regarding this situation. The reporter consented to follow up. Additional Supportive Information: The patient received 3rd dose of Shingrix vaccine, which led to extra dose administered.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Engerix-B was administered, had expired on 09May2022; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a patient who received HBV (Engerix B) (batch number unknown, expiry date 9th May 2022) for prophylaxis.   On 24th May 2022, the patient received Engerix B. On 24th May 2022, unknown after receiving Engerix B, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.    Additional Information: GSK Receipt Date: 24-May-2022 Reporter's Comments: HCP reported a dose of Engerix-B was administered on 24th May 2022 that had expired on 9th May 2022. Chat was abandoned after attempting to collect demographics.  Additional Supportive Information: The patient received dose of Engerix B vaccine on 24th May 2022, which was already expired on 9th May 2022.
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: first and second dose four weeks apart; This case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too short in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included RECOMBINANT VARICELLA ZOSTER VIRUS SURFACE GLYCOPROTEIN E (SHINGRIX).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK Receipt Date: 24-MAY-2022  Reporter's Comment: The patient self-reported this case. The patient received first and second dose of Shingrix just four weeks apart.  The patient simply reported themselves and several of their family members was receiving the first and second dose four weeks apart instead of the recommended minimum of 2 months for the second dose, after receipt of the first dose. The reporter did not consent to follow-up. Additional supportive information: The patient received 2nd dose of Shingrix vaccine earlier than the recommended interval, which led to shortening of vaccination schedule. This case had been linked with case US2022AMR084510, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR084510:Same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: received only the diluent; received only the diluent; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a female patient who received Herpes zoster (Shingrix) (batch number 75PE7, expiry date 3rd June 2023) for prophylaxis.   On 24th May 2022, the patient received Shingrix. On 24th 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: 24-May-2022 Reporter's comments: The patient received only the diluent AS01B of Shingrix. The consent to follow up was given. Additional Supportive Information: The patient received only the diluent AS01B of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Sex: U
Vaccine: MENB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose on March 5 and the 2nd dose on March 26 of this year; This case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too short in a patient who received Men B NVS (Bexsero) (batch number Abxb58aa, expiry date 30th September 2022) 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.   Concomitant products included MENINGOCOCCAL B VACCINE (BEXSERO).   On 26th March 2022, the patient received the 2nd dose of Bexsero and Bexsero Pre-Filled Syringe Device. On 26th March 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 24-May-2022 Reporter's comment: Nurse reported that a patient received a dose of Bexsero inadvertently on 5th March and the second dose on right deltoid 26th March of this year. The expiration date was from agency.  The reporter was not able to provide additional information during the call, but consent was provided for follow-up via email. Additional Supportive Information: The patient received the second dose of Bexsero earlier than the recommended interval, which led to shortening of vaccination schedule.
Age: 86.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache
Clinical narrative: Ten days later the 1st dose began to experience headaches; This case was reported by a consumer via call center representative and described the occurrence of headache in a 86-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th May 2022, the patient received the 1st dose of Shingrix. On 16th May 2022, 10 days after receiving Shingrix, the patient experienced headache. On an unknown date, the outcome of the headache was not recovered/not resolved.   It was unknown if the reporter considered the headache to be related to Shingrix.     Additional Information: GSK Receipt Date: 24-MAY-2022 Reporter's Comment: The patient self-reported this case. The patient received dose of Shingrix vaccine and ten days later began to experience headaches. The reporter consented to follow-up.
Age: 73.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: Dose expired on 15-may-2022 and was administered on 24-may-2022.; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 73-year-old female patient who received HAV (Havrix) (batch number B23EA, expiry date 15th May 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 24th May 2022, the patient received Havrix and Havrix Pre-Filled Syringe Device. On 24th May 2022, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 24-May-2022 Reporter's Comments: The health care professional reported that the Havrix expired and was administered to the patient. The reporter asked how to proceed. No reactions reported. The reporter consented to follow up.  Additional Supportive Information: The patient received Havrix which was already expired which led to expired vaccine used.
Age: 57.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: administered an expired Havrix vaccine; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 57-year-old female patient who received HAV (Havrix) (batch number 3A22R, expiry date 24th May 2022) for prophylaxis.   On 25th May 2022, the patient received the 1st dose of Havrix. On 25th May 2022, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.       Additional Information: GSK Receipt Date: 25-May-2022 Reporter's Comments: The medical assistant reported a patient was administered an expired Havrix vaccine inadvertently. The reporter consented to follow.  Additional Supportive Information: The patient received Havrix which was already expired which led to expired vaccine used.
Age: 47.0
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: expired dose was given to patient; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 47-year-old male patient who received HAV (Havrix) (batch number J99R4, expiry date 20th May 2022) for prophylaxis.   On 24th May 2022, the patient received Havrix. On 24th May 2022, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.       Additional Information: GSK Receipt Date: 25-May-2022 Reporter's Comments: The health care professional reported expired dose was given to patient. The reporter consented to follow up. The Vaccine Administration Facility was the same as primary reporter. Additional Supportive Information: The patient received Havrix which was already expired which led to expired vaccine used.
Age: 26.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Patient received an expired dose; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 26-year-old female patient who received HAV (Havrix) (batch number J95H7, expiry date 22nd May 2022) for prophylaxis.   On 25th May 2022, the patient received Havrix. On 25th May 2022, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.       Additional Information: GSK Receipt Date: 25-May-2022 Reporter's Comments: The medical assistant supervisor reported that the patient received an expired Havrix dose. The reporter consented to follow up by email. Additional Supportive Information: The patient received Havrix which was already expired which led to expired vaccine used.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: reconstituted with non-GSK diluent, then administered; reconstituted with non-GSK diluent, then administered; This 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 16-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA584A, expiry date 31st August 2022) and (batch number AMXA584A, expiry date 30th April 2023) for prophylaxis.   On 25th May 2022, the patient received Menveo. On an unknown date, the dose was an unknown dose. On 25th May 2022, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.       Additional Information: GSK Receipt Date: 25-May-2022 Reporter's Comments: The Pharmacy Technician reported that the nurse inadvertently reconstituted Menveo lyophilized powder component with a non-GSK diluent, then administered to a patient. The Pharmacy Technician asked how to proceed with dose? The reporter did not consent to follow-up. Additional Supportive Information: The Menveo lyophilized powder component was reconstituted with a non-GSK diluent, then administered to a patient, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.