chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: VARZOS
Symptoms: Paraesthesia, Plasmapheresis, Pulse absent, Sensory loss, Sinus rhythm
Clinical narrative: extensive longitudinal acute transverse myelitis, there is a possible argument that can be made of the link between the patient's acute transverse myelitis (ATM) and the Shingles vaccine; pulseless ventricular tachycardia, it is possible that our patient's ventricular tachycardia could also be related to the Shingles vaccine; This literature marketed report has been received from the authors of a published article, titled as stated below, and refers to a 50-year-old male patient. His concurrent conditions included psoriatic arthritis. Concomitant medications included methotrexate.  On an unknown date, the patient was vaccinated with zoster vaccine live (manufacturer unknown) subcutaneous injection (exact dose, route of administration, anatomical site, lot # and expiration date were not provided) as prophylaxis.  On an unknown date (reported as "one week following a shingles vaccine"), the patient presented to the emergency room (ER) with complaint of ascending bilateral lower extremity paresthesia. The paresthesia progressed from his feet to groin with associated loss of sensation with urination, incomplete bladder emptying, and ambulatory dysfunction due to difficulty with proprioception of both his legs. Examination was significant for diminished light touch, vibration, and temperature sensation of the bilateral lower extremities. Urinary retention was noted and was treated with a foley catheter. Magnetic resonance imaging (MRI) of the patient's spine revealed longitudinally extensive T2 hyperintensity from the lower cervical spine to the upper thoracic spine. The patient's ER course was complicated by acute onset of diaphoresis and lightheadedness followed by a syncopal episode. The patient was unresponsive and pulseless, and the telemetry was consistent ventricular tachycardia which was quickly self-limiting with return of mental awareness and normal sinus rhythm. Amiodarone was initiated and the patient remained in normal sinus rhythm. He was treated with 1 g of intravenous (IV) solumedrol for suspected extensive longitudinal acute transverse myelitis (ATM) based on clinical presentation and spinal cord appearance on MRI. After 5 days of IV steroid treatment, there was no clinical improvement and the decision was made to initiate plasmapheresis, which was well tolerated and the patient's symptoms gradually improved. Extensive blood work and cerebrospinal fluid (CSF) studies failed to determine the etiology of the ATM. The patient's symptoms continued to progress (not recovered), and on an unknown date, he was discharged to a rehab facility with long-term cardiac event monitoring.  The reporter considered myelitis transverse and ventricular tachycardia to be possibly related to zoster vaccine live (manufacturer unknown).  Upon internal review, the events of myelitis transverse and ventricular tachycardia were determined to be medically significant.  Literature Report:
Sex: M
Vaccine: VARZOS
Symptoms: Spinal cord disorder, Syncope, Unresponsive to stimuli, Urinary retention, Ventricular tachycardia
Clinical narrative: extensive longitudinal acute transverse myelitis, there is a possible argument that can be made of the link between the patient's acute transverse myelitis (ATM) and the Shingles vaccine; pulseless ventricular tachycardia, it is possible that our patient's ventricular tachycardia could also be related to the Shingles vaccine; This literature marketed report has been received from the authors of a published article, titled as stated below, and refers to a 50-year-old male patient. His concurrent conditions included psoriatic arthritis. Concomitant medications included methotrexate.  On an unknown date, the patient was vaccinated with zoster vaccine live (manufacturer unknown) subcutaneous injection (exact dose, route of administration, anatomical site, lot # and expiration date were not provided) as prophylaxis.  On an unknown date (reported as "one week following a shingles vaccine"), the patient presented to the emergency room (ER) with complaint of ascending bilateral lower extremity paresthesia. The paresthesia progressed from his feet to groin with associated loss of sensation with urination, incomplete bladder emptying, and ambulatory dysfunction due to difficulty with proprioception of both his legs. Examination was significant for diminished light touch, vibration, and temperature sensation of the bilateral lower extremities. Urinary retention was noted and was treated with a foley catheter. Magnetic resonance imaging (MRI) of the patient's spine revealed longitudinally extensive T2 hyperintensity from the lower cervical spine to the upper thoracic spine. The patient's ER course was complicated by acute onset of diaphoresis and lightheadedness followed by a syncopal episode. The patient was unresponsive and pulseless, and the telemetry was consistent ventricular tachycardia which was quickly self-limiting with return of mental awareness and normal sinus rhythm. Amiodarone was initiated and the patient remained in normal sinus rhythm. He was treated with 1 g of intravenous (IV) solumedrol for suspected extensive longitudinal acute transverse myelitis (ATM) based on clinical presentation and spinal cord appearance on MRI. After 5 days of IV steroid treatment, there was no clinical improvement and the decision was made to initiate plasmapheresis, which was well tolerated and the patient's symptoms gradually improved. Extensive blood work and cerebrospinal fluid (CSF) studies failed to determine the etiology of the ATM. The patient's symptoms continued to progress (not recovered), and on an unknown date, he was discharged to a rehab facility with long-term cardiac event monitoring.  The reporter considered myelitis transverse and ventricular tachycardia to be possibly related to zoster vaccine live (manufacturer unknown).  Upon internal review, the events of myelitis transverse and ventricular tachycardia were determined to be medically significant.  Literature Report:
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: No Adverse Event; HCP called to report inadvertent administration of an expired dose of GARDASIL 9.  Also asked about the need for potential revaccination. Post expiry Memo supported the potency of the GARDASIL 9 which expired on 4/14/2023 and was administered on 5/10; This spontaneous report was received from a physician refers to a 25-year-old patient of unknown gender.   The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 10-MAY-2023, the patient was vaccinated with expired dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot #U007477, expiration date: 14-APR-2023, 0.5 milliliter (route of administration and anatomical location were not reported) for prophylaxis (expired product administered). No additional adverse events reported (no adverse event).
Age: 13.0
Sex: F
Vaccine: HPV9, HPV9, HPV9, HPV9, HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs reported; GARDASIL 9 was administered following a temperature excursion; This spontaneous report was received from an office manager, referring to a 13-year-old female patient. The patient's concurrent conditions, concomitant therapies and medical history was not provided.  On 04-OCT-2022, the patient was vaccinated one dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe, injection, 1 dose, lot numbers and expiration dates: 1775811, 07-DEC-2023; 1775827, 27-JUN-2024; W009829, 19-OCT-2024; U032681, 26-OCT-2023; and 1780876, 09-NOV-2023, administered for prophylaxis (administration sites, and routes of administration were not provided)  The doses of vaccines experienced 3 temperature excursions: on 09-SEP-2022 for 8 minutes, on 16-SEP-2022 for 5 minutes and on 03-JAN-2023 for 12 min. Total time: 25 mins. Temperatures were reported as 8.55 Celsius degrees for 8 minutes and 9.29 Celsius degrees for 12 minutes (product storage error). Excursions were not noted until after the fact due to employee error of cleaning data logger more than once a day. There were no previous excursions reported. No additional adverse event (AE) details were reported (no adverse event).  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2304USA002221:
Age: 13.0
Sex: M
Vaccine: HPV9, HPV9, HPV9, HPV9, HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No issue. No adverse event on patient.; Temeprature excurseion total time 25 min, 3 excursion. Escursion were not noted until after the fact due to employee error of cleanning data logger more than once a day; This spontaneous report has been received from an office manager, regarding a 13-years-old male patient. The patient's pertinent medical history, previous drug reactions or allergies and concomitant medications were not reported.  On 20-OCT-2022, the patient was vaccinated with one improperly storage dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe injection, as prophylaxis (lot number and expiration dates: 1775811, 07-DEC-2023; 1775827, 27-JUN-2024; W009829, 19-OCT-2024; U032681, 26-OCT-2023; and 1780876, 09-NOV-2023, unspecified which one was administered to this patient) (Strength, dose, scheme, route and anatomical location of administration were not reported).  Temperature excursion total time was of 25 minutes, divided in 3 temperature excursions, one on 09-SEP-2022 for 8 minutes, one on 16-SEP-2022 for 5 minutes and another one on 03-JAN-2023 for 12 minutes. Excursions were not noted until after the first fact due to employee error of cleaning data logger more than once a day.  The vaccines were purchased with public, and privet founds and were given in private doctor's office/ hospital. The medication error occurred in the point of storage in clinical practice. No additional adverse event was reported.  This is one of several reports received from the same reporter.
Sex: U
Vaccine: MMR, MMRV
Symptoms: No adverse event, Overdose, Product administered to patient of inappropriate age
Clinical narrative: No additional AE/PQC; HCP called to inform a patient received MMR II and PROQUAD at the same visit and was not supposed to receive PROQUAD MIR; HCP called to inform a patient received MMR II and PROQUAD at the same visit and was not supposed to receive PROQUAD MIR; This spontaneous report has been received from a medical assistant regarding an 18-year-old patient of unknown gender. The patient's medical history, and concomitant medication were not provided.  On 09-MAY-2023, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), subcutaneous injection, at a dose of 0.5 milliliters, albumin status rHa, administered as prophylaxis, (strength, route of administration and anatomical location were not provided; upon internal review the lot number W007041 was considered as valid and expiration date was established as 29-FEB-2024). On the same date, the patient received a dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), subcutaneous injection, at a dose of 0.5 milliliters, albumin status rHa, administered as prophylaxis, (strength, route of administration and anatomical location were not provided; upon internal review the lot number W017570 was considered as valid and expiration date was established as 29-NOV-2023). It was reported that the patient was not supposed to receive the dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (product administered to patient of inappropriate age) (overdose).  No additional adverse event was reported (no adverse event).
Age: 11.0
Sex: M
Vaccine: HPV9, HPV9, HPV9, HPV9, HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; temperature excursion total time: 25 mins, 3 excursions on dates: 9/9/22 for 8 mins, 9/16/22 for 5 mins, 1/3/23 for 12 mins; This spontaneous report was received from an office manager and refers to a 11-year-old male patient. No information on patient medical history, current conditions and concomitant medications was provided.  On 04-OCT-2022, the patient was vaccinated with one dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe, injection, 1 dosage form, lot # and expiration dates: 1775811, 07-DEC-2023; 1775827, 27-JUN-2024; W009829, 19-OCT-2024; U032681, 26-OCT-2023; and 1780876, 09-NOV-2023 (administration sites and routes of administration were not provided) administered for prophylaxis (product storage error and no adverse event).  Temperature excursion total time was 25 minutes. There were 3 temperature excursions: on 09-SEP-2022 for 8 minutes, on 16-SEP-2022 for 5 minutes and on 03-JAN-2023 for 12 minutes. Excursions were not noted until after the first fact due to employee error of cleaning data logger more than once a day. Patient was vaccinated in private doctor's office/hospital.  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2304USA002221:original source: 2304USA002221
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I know who got the shingles vaccine, got shingles/suspected vaccination failure; I know who got the shingles vaccine, got 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: I know who got the shingles vaccine, got shingles/suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: I know who got the shingles vaccine, got 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: 31-MAR-2023 This case was reported by the patient via interactive digital media. The patient had stated that everyone he/she knew who got the shingles vaccine, got shingles. 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.  Follow-up would not possible, as no contact, details were available. This case was one of the three case reported by the same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2023AMR025312:Same report/Other patient US-GSK-US2023AMR025323:Same report/Other patient US-GSK-US2023AMR069107:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: still get "attacks" every couple of months/ suspected vaccination failure; still get "attacks" every couple of months/ have it reoccurring; 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.   The patient's past medical history included shingles (had reoccurring shingles).   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: still get "attacks" every couple of months/ suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: still get "attacks" every couple of months/ have it reoccurring). 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: 31-MAR-2023 The case  was received from the patient via interactive digital media. The patient got the vaccine. The patient had it reoccurring.  The patient stated that first time was something he/she would wish on his/her worst enemy. The reoccurrences were not nearly as bad but he/she still get attacks every couple of months.  The patient stated that, according to science this should not happened.  The patient guessed, that he/she was an anomaly.  This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: Hands and fingers swelling; episodic nighttime finger pain; This non-serious case was reported by a consumer and described the occurrence of hand swelling in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included lisinopril, cetirizine, vitamins nos (Vitamins) and calcium.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced hand swelling (Verbatim: Hands and fingers swelling) and pain in fingers (Verbatim: episodic nighttime finger pain). The patient was treated with ambiguous medication nos (Neurontin (Nos)) and ibuprofen. The outcome of the hand swelling and pain in fingers were not reported.   It was unknown if the reporter considered the hand swelling and pain in fingers to be related to Shingrix.     It was unknown if the company considered the hand swelling and pain in fingers to be related to Shingrix.   Additional Information: GSK Receipt Date: 13-May-2023 The patient experienced hands and fingers swelling, episodic nighttime finger pain. These symptoms were treated with Neurontin, ice packs, ibuprofen.
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Oral herpes
Clinical narrative: cold sores; This non-serious case was reported by a consumer and described the occurrence of cold sores in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included cold sores (had gotten a cold sore at least once or twice a year for many years ). Concomitant products included levothyroxine sodium (Levoxyl) and amlodipine.   On 04-JAN-2020, the patient received Shingrix. On 10-JAN-2020, 6 days after receiving Shingrix, the patient experienced cold sores (Verbatim: cold sores). The outcome of the cold sores was not resolved.   It was unknown if the reporter considered the cold sores to be related to Shingrix.     It was unknown if the company considered the cold sores to be related to Shingrix.   Additional Information: GSK Receipt Date: 14-May-2023 The patient had gotten a cold sore at least once or twice a year for many years but noticed she did not get any since she received the Shingrix vaccine. Recently, she got two cold sores and wondered if the side effects of getting the Shingrix vaccination were wearing off.  She thought there might be some cross immunity with herpes simplex after getting the Shingrix vaccination.  She saw a study where a couple of other women reported the same thing. Might be this should be studied because it would seem that it could be lucrative for the company if it could be shown that the vaccination suppresses outbreaks of cold sores (cessation of cold sores)  These symptoms were not treated. The reporter did not consent to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: pain at the injection site; This non-serious case was reported by a physician via sales rep and described the occurrence of injection site pain 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 injection site pain (Verbatim: pain at the injection site). The outcome of the injection site pain was not reported.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.   It was unknown if the company considered the injection site pain to be related to Shingrix.   Additional Information: GSK Receipt Date: 12-MAY-2023 The doctor mentioned that the patient had significant pain at the injection site following a dose of Shingrix. The reporter did not agree to follow up from GlaxoSmithKline.
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 an unspecified numbers of patients who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patients received Shingles vaccine. On an unknown date, 1 week after receiving Shingles vaccine, the patients 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.   Additional Information: GSK Receipt Date: 31-MAR-2023 This case was reported by the consumer via interactive digital media. The patient had stated that everyone he/she knew who got the shingles vaccine, got shingles in a week. Follow-up would not possible, as no contact, details were available. This case was 1 of 4 case reported by the same reporter for different patient.; Sender's Comments:  US-GSK-US2023AMR067389:same reporter/other patient US-GSK-US2023AMR025323:same reporter/other patient US-GLAXOSMITHKLINE-US2023AMR025312:same reporter/other patient
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Incomplete course of vaccination, Product administered to patient of inappropriate age
Clinical narrative: 1st dose Sep/2022, not received 2nd shot yet; Patient born in 1975 received Shingrix on Sep-2022; This non-serious case was reported by a consumer via call center representative and described the occurrence of inappropriate age at vaccine administration in a 47-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In SEP-2022, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. In SEP-2022, an unknown time after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Patient born in 1975 received Shingrix on Sep-2022). On an unknown date, the patient experienced incomplete course of vaccination (Verbatim: 1st dose Sep/2022, not received 2nd shot yet). The outcome of the inappropriate age at vaccine administration and incomplete course of vaccination were unknown.   Additional Information: GSK Receipt date: 08-MAY-2023 The patient received Shingrix vaccine who was younger than the indicated age which led to inappropriate age at vaccine administration. Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination. The reporter did consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: had not administered a second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (In 2021, received first dose.).   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: had not administered a second dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt date: 08-MAY-2023 The reporter reported that the patient did not received the second dose of Shingrix vaccine. The exact date of vaccination and lot number was not provided as register is not available because it was happened at a different facility. The reporter did consent to follow up via email. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix vaccine, which led to incomplete course of vaccination.
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Developed a rash on the chest, neck and back; This non-serious case was reported by a consumer via call center representative and described the occurrence of rash in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular, unknown deltoid). On an unknown date, 1 day after receiving Shingrix, the patient experienced rash (Verbatim: Developed a rash on the chest, neck and back). The outcome of the rash was resolved.   It was unknown if the reporter considered the rash to be related to Shingrix.   It was unknown if the company considered the rash to be related to Shingrix.   Additional Information: GSK Receipt Date: 09-MAY-2023 The reporter was patient. The patient received Shingrix and one day later developed a rash on the chest, neck and back.  Nothing else was reported.  The reporter consented to follow up with physician.
Sex: U
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: Expired Drug Used; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a patient who received Men B NVS (Bexsero) (batch number ABXC05AA, expiry date 31-MAR-2023) for prophylaxis.   On 09-MAY-2023, the patient received Bexsero. On 09-MAY-2023, an unknown time after receiving Bexsero, the patient experienced expired vaccine used (Verbatim: Expired Drug Used). 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: 09-May-2023 The vaccine administration facility was the same as primary reporter. The reporter did not have patient demographics at the time of the call. The reporter consented to follow-up via postal. The patient received an expired dose of Bexsero, which led to expired vaccine used.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Rash
Clinical narrative: itchiness at the injection site; swelling at the injection site; redness at the injection site; spread as a rash over shoulder and chest/Skin rash; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site itching in a 52-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 09-APR-2023, the patient received the 1st dose of Shingrix (intramuscular, right arm). On 10-APR-2023, 1 days after receiving Shingrix, the patient experienced injection site itching (Verbatim: itchiness at the injection site), injection site swelling (Verbatim: swelling at the injection site), injection site erythema (Verbatim: redness at the injection site) and rash (Verbatim: spread as a rash over shoulder and chest/Skin rash). The outcome of the injection site itching, injection site swelling, injection site erythema and rash were resolved (duration 10 days).   It was unknown if the reporter considered the injection site itching, injection site swelling, injection site erythema and rash to be related to Shingrix.   It was unknown if the company considered the injection site itching, injection site swelling, injection site erythema and rash to be related to Shingrix.   Additional Information: GSK Receipt Date: 09-MAY-2023 The reporter was a patient's daughter. The reporter stated that the patient received Shingrix and a day after developed redness, swelling and itchiness at the injection site that spread as a rash over shoulder and chest. The symptoms lasted for 10 days.  In April 2023, the patient was recovered from redness, swelling and itchiness at the injection site and skin rash. The reporter consented to follow up.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Decreased appetite, Fatigue, Hypersomnia, Myalgia, Pain in extremity
Clinical narrative: slept yesterday 20 hours; soreness in her arm and muscles; soreness in her arm and muscles; I had no appetite; after the injection, she was "extremely fatigue"; This non-serious case was reported by a consumer via call center representative and described the occurrence of muscle soreness in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 04-MAY-2023, the patient received the 1st dose of Shingrix (right arm). On 08-MAY-2023, 4 days after receiving Shingrix, the patient experienced sleep excessive (Verbatim: slept yesterday 20 hours). In MAY-2023, the patient experienced muscle soreness (Verbatim: soreness in her arm and muscles), pain in arm (Verbatim: soreness in her arm and muscles), appetite absent (Verbatim: I had no appetite) and fatigue (Verbatim: after the injection, she was "extremely fatigue"). The outcome of the muscle soreness, pain in arm, appetite absent and fatigue were unknown and the outcome of the sleep excessive was not reported.   It was unknown if the reporter considered the muscle soreness, pain in arm, appetite absent, fatigue and sleep excessive to be related to Shingrix.     It was unknown if the company considered the muscle soreness, pain in arm, appetite absent, fatigue and sleep excessive to be related to Shingrix.   Additional Information: GSK Receipt Date: 09-MAY-2023 The case was reported by patient herself. The patient reported that she received a dose of Shingrix at her doctor's office and after the injection she was extremely fatigue, had no appetite and slept yesterday 20 hours.  The patient reported soreness in her arm and muscles. The reporter consented to followup. Lot and expiry date was unknown.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Malaise
Clinical narrative: didn't feel good; Injection site pain; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 05-MAY-2023, the patient received the 1st dose of Shingrix (intramuscular, unknown deltoid). On 05-MAY-2023, less than a day after receiving Shingrix, the patient experienced injection site pain (Verbatim: Injection site pain). On an unknown date, the patient experienced feeling unwell (Verbatim: didn't feel good). The outcome of the injection site pain and feeling unwell were resolved.   It was unknown if the reporter considered the injection site pain and feeling unwell to be related to Shingrix.   It was unknown if the company considered the injection site pain and feeling unwell to be related to Shingrix.   Additional Information: GSK Receipt Date: 09-MAY-2023 The reporter was the patient.  She mentioned that she received Shingrix and had injection site pain and did not feel good overall. Nothing else was reported. The reporter did not consent to follow-up.
Age: 0.42
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: patient was administered a dose of Kinrix on 1/Nov/2022, On that date, the patient's age was 5 months.; 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 5-month-old female patient who received DTPa-IPV (Kinrix) (batch number H99J7, expiry date 26-MAY-2023) for prophylaxis.   On 01-NOV-2022, the patient received Kinrix. On 01-NOV-2022, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: patient was administered a dose of Kinrix on 1/Nov/2022, On that date, the patient's age was 5 months.). The outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 09-MAY-2023 The vaccine administration facility was the same as primary reporter The reporter consented to follow up. The patient received Kinrix at 5 months of age, which led to inappropriate age at vaccine administration.
Age: 0.92
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Inappropriate age./an 11-month-old patient was administered a dose of Kinrix; 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 11-month-old female patient who received DTPa-IPV (Kinrix) (batch number 7P5J5, expiry date 30-SEP-2022) for prophylaxis.   On an unknown date, the patient received Kinrix. On an unknown date, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Inappropriate age./an 11-month-old patient was administered a dose of Kinrix). The outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 09-MAY-2023 The vaccine administration facility was the same as primary reporter The reporter did not specify administration date. The reporter consented to follow up. The patient received Kinrix at 11-month-old, which led to inappropriate age at vaccine administration.
Sex: U
Vaccine: DTAPHEPBIP, DTAPHEPBIP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: had pediarix 2/13/2015, 3/13/2015, and 5/5/2015.; had pediarix 2/13/2015, 3/13/2015, and 5/5/2015.; This non-serious 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 DTPa-HBV-IPV (Pediarix) for prophylaxis.   Co-suspect products included DTPa-HBV-IPV (Pediarix) for prophylaxis.   Concomitant products included PEDIARIX.   On 05-MAY-2015, the patient received the 3rd dose of Pediarix. On 13-MAR-2015, the patient received the 2nd dose of Pediarix. On 13-MAR-2015, not applicable after receiving Pediarix, an unknown time after receiving Pediarix and an unknown time after receiving PEDIARIX, the patient experienced drug dose administration interval too short (Verbatim: had pediarix 2/13/2015, 3/13/2015, and 5/5/2015.). On 05-MAY-2015, the patient experienced drug dose administration interval too short (Verbatim: had pediarix 2/13/2015, 3/13/2015, and 5/5/2015.). The outcome of the drug dose administration interval too short and drug dose administration interval too short were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 10-MAY-2023 The registered nurse (RN) reported that patient she did not had birth dose of hepatitis B. The reporter stated that it was not counting 3rd dose of hepatitis B on 5th May 2015, tried to figure out why as it says 6 to 8 weeks intervals between shots as this was 7.5 weeks from 2nd to 3rd dose. The patient received 3rd and 2nd dose of Pediarix earlier than recommended interval, which led to shortening of vaccination schedule.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Accidentally received the liquid portion of Menveo/ diluent only; Accidentally received the liquid portion of Menveo/ diluent only; This non-serious case was reported by a consumer via sales rep and described the occurrence of inappropriate dose of vaccine administered in a 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 dose of vaccine administered (Verbatim: Accidentally received the liquid portion of Menveo/ diluent only) and inappropriate preparation of medication (Verbatim: Accidentally received the liquid portion of Menveo/ diluent only). The outcome of the inappropriate dose of vaccine administered and inappropriate preparation of medication were unknown.   Additional Information: GSK Receipt Date: 10-MAY-2023 The sales representative reported that a patient had accidentally received the liquid portion of Menveo.  After the agent was told that a healthcare professional had to reach out, they stated they would instruct the healthcare professional and ended the call.  The agent gave no information about them, the healthcare professional, the vaccine, patient or vaccination other than the fact that the liquid portion had been accidentally administered. The patient received the liquid portion of Menveo, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Sex: F
Vaccine: VARZOS
Symptoms: Loss of consciousness
Clinical narrative: Passed out; This serious case was reported by a other health professional via call center representative and described the occurrence of passed out in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 30 min after receiving Shingrix, the patient experienced passed out (Verbatim: Passed out) (serious criteria GSK medically significant). The outcome of the passed out was unknown.   It was unknown if the reporter considered the passed out to be related to Shingrix.     It was unknown if the company considered the passed out to be related to Shingrix.   Additional Information: GSK Receipt Date: 11-MAY-2023 The reporter reported that the patient received Shingrix vaccine and experienced passed out. The reporter wanted to know it appropriate to administer the second dose of Shingrix vaccine. The reporter did consent to follow up.
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Product storage error
Clinical narrative: Menveo vaccines on 04May2023 that lasted 45 minutes and reached a low temperature of -0.8C; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a 12-year-old female patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On 05-MAY-2023, the patient received Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced incorrect storage of drug (Verbatim: Menveo vaccines on 04May2023 that lasted 45 minutes and reached a low temperature of -0.8C). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK receipt date: 11-May-2023 The pharmacist reported that a clinic experienced a temperature excursion with Menveo vaccines one day prior to the reporting date that lasted 45 minutes and reached a low temperature of minus 0.8 Celsius. The reporter did not know which lot number was administered. At the time of reporting, the dose had not been repeated. The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up. The patient received a dose of Menveo after temperature excursion, which led to incorrect storage of drug.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Product storage error
Clinical narrative: clinic experienced a temperature excursion with Menveo vaccines on 04May2023 that lasted 45 minutes and reached a low temperature of -0.8C. On 05May2023 a dose of Menveo was administered to a 16 year old female patient; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a 16-year-old female patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On 05-MAY-2023, the patient received Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced incorrect storage of drug (Verbatim: clinic experienced a temperature excursion with Menveo vaccines on 04May2023 that lasted 45 minutes and reached a low temperature of -0.8C. On 05May2023 a dose of Menveo was administered to a 16 year old female patient). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK receipt date: 11-May-2023 The pharmacist reported that a clinic experienced a temperature excursion with Menveo vaccines one day prior to the reporting date that lasted 45 minutes and reached a low temperature of minus 0.8 Celsius. The reporter did not know which lot number was administered. At the time of reporting, the dose had not been repeated. The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up. The patient received a dose of Menveo after temperature excursion, which led to incorrect storage of drug.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, FLU4
Symptoms: Product storage error
Clinical narrative: Product Storage Error; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a 6-month-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number 25L52, expiry date 28-MAR-2025) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2022-2023 season) (batch number 7X574, expiry date 30-JUN-2023) for prophylaxis.   On 05-MAY-2023, the patient received Pediarix and FluLaval Quadrivalent 2022-2023 season. On an unknown date, an unknown time after receiving Pediarix and FluLaval Quadrivalent 2022-2023 season, the patient experienced incorrect storage of drug (Verbatim: Product Storage Error). The outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 11-May-2023 The pharmacist reported that a clinic experienced a temperature excursion with  Pediarix and FluLaval QIV vaccines one day prior to the reporting date that lasted 45 minutes and reached a low temperature of minus 0.8 Celsius. At the time of reporting, the dose had not been repeated. The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up. The patient received a dose of  Pediarix and FluLaval QIV vaccines after temperature excursion, which led to incorrect storage of drug.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, FLU4
Symptoms: Product storage error
Clinical narrative: clinic experienced a temperature excursion with Pediarix and FluLaval QIV vaccines on 04May2023 that lasted 45 minutes and reached a low temperature of -0.8C.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a 6-month-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number 25L52, expiry date 28-MAR-2025) for prophylaxis.   Co-suspect products included Flu Seasonal QIV (FluLaval Quadrivalent 2022-2023 season) (batch number 7X574, expiry date 30-JUN-2023) for prophylaxis.   On 05-MAY-2023, the patient received Pediarix and FluLaval Quadrivalent 2022-2023 season. On an unknown date, an unknown time after receiving Pediarix and FluLaval Quadrivalent 2022-2023 season, the patient experienced incorrect storage of drug (Verbatim: clinic experienced a temperature excursion with Pediarix and FluLaval QIV vaccines on 04May2023 that lasted 45 minutes and reached a low temperature of -0.8C.). The outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 11-May-2023 The pharmacist reported that a clinic experienced a temperature excursion with Pediarix and FluLaval QIV vaccines one day prior to the reporting date that lasted 45 minutes and reached a low temperature of minus 0.8 Celsius. At the time of reporting, the dose had not been repeated. The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up. The patient received a dose of Pediarix and FluLaval QIV vaccines after temperature excursion, which led to incorrect storage of drug.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Product storage error
Clinical narrative: temperature excursion with Pediarix vaccines on 04May2023 that lasted 45 minutes and reached a low temperature of -0.8C; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a 6-month-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number 25L52, expiry date 28-MAR-2025) for prophylaxis.   On 05-MAY-2023, the patient received Pediarix. On an unknown date, an unknown time after receiving Pediarix, the patient experienced incorrect storage of drug (Verbatim: temperature excursion with Pediarix vaccines on 04May2023 that lasted 45 minutes and reached a low temperature of -0.8C). The outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 11-May-2023 The pharmacist reported that a clinic experienced a temperature excursion with Pediarix vaccines one day prior to the reporting date that lasted 45 minutes and reached a low temperature of minus 0.8 Celsius. At the time of reporting, the dose had not been repeated. The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up. The patient received a dose of Pediarix after temperature excursion, which led to incorrect storage of drug.
Age: 20.0
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Expired dose of Havrix was administered to patient; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 20-year-old male patient who received HAV (Havrix 1440) (batch number KM72C, expiry date 18-JUN-2022) for prophylaxis.   On 11-MAY-2023, the patient received Havrix 1440. On 11-MAY-2023, an unknown time after receiving Havrix 1440, the patient experienced expired vaccine used (Verbatim: Expired dose of Havrix was administered to patient ). 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: 11-MAY-2023 The expired dose of Havrix was administered to patient today, which led to expired vaccine used.  Address and email address were both shared for follow up Havrix formulation was confirmed by batch look up. The reporter consented to follow up.