chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Intensive care, Renal failure, Sepsis
Clinical narrative: sepsis; renal failure; This case was reported by a consumer and described the occurrence of sepsis in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th July 2019, the patient received Shingrix. On 18th July 2019, 3 days after receiving Shingrix, the patient experienced sepsis (serious criteria hospitalization and GSK medically significant) and renal failure (serious criteria hospitalization and GSK medically significant). On an unknown date, the outcome of the sepsis and renal failure were unknown.   It was unknown if the reporter considered the sepsis and renal failure to be related to Shingrix.  Additional details were received as follows: This case was reported by a patient via a pharmacy claims management company. The age at vaccination was not reported. The patient stated that, he had bad reaction from Shingrix and was admitted to the hospital on 18th July 2019 due to sepsis, renal failure and other ailments. The patient had to stay in ICU (intensive care unit). The patient requested to settle his claims for the injuries/ damages sustained resulting from Shingrix vaccine.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site mass, Injection site pain, Injection site swelling, Pyrexia, Rash pruritic
Clinical narrative: Pain at injection site; Lump at injection site; Fever; Red itchy rash under breast; Redness under breast; Swelling at injection site; localized pain; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 61-year-old female patient who received Herpes zoster (Shingrix) (batch number TT9BR, expiry date 13th September 2021) for prophylaxis.   On 30th May 2019, the patient received the 1st dose of Shingrix. On 30th May 2019, less than a day after receiving Shingrix, the patient experienced injection site pain, injection site lump, fever, itchy rash, erythema, injection site swelling and pain localized. On an unknown date, the outcome of the injection site pain, injection site lump, fever, itchy rash, erythema, injection site swelling and pain localized were recovered/resolved.   It was unknown if the reporter considered the injection site pain, injection site lump, fever, itchy rash, erythema, injection site swelling and pain localized to be related to Shingrix.  Additional information received were as follows: The pharmacist reported that they had a paitent who received 1st dose of Shingrix and experienced an adverse reaction like pain and lump at injections site, fever, and raised red itchy rash under breasts that lasted 3 to 4 days, localized pain and swelling at injection site, fever but main issue was the rash that broke out under breasts, which was very itchy and lasted 3-4 days. The patient confirmed with healthcare professional that the rash was under both breasts and she was unable to verify which arm was affected as the vaccine was not administered at her facility. The reporter consented to follow up.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash pustular
Clinical narrative: Pain at injection site; Lump at injection site; Fever; Red itchy rash under breast; Redness under breast; Swelling at injection site; localized pain; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 61-year-old female patient who received Herpes zoster (Shingrix) (batch number TT9BR, expiry date 13th September 2021) for prophylaxis.   On 30th May 2019, the patient received the 1st dose of Shingrix. On 30th May 2019, less than a day after receiving Shingrix, the patient experienced injection site pain, injection site lump, fever, itchy rash, erythema, injection site swelling and pain localized. On an unknown date, the outcome of the injection site pain, injection site lump, fever, itchy rash, erythema, injection site swelling and pain localized were recovered/resolved.   It was unknown if the reporter considered the injection site pain, injection site lump, fever, itchy rash, erythema, injection site swelling and pain localized to be related to Shingrix.  Additional information received were as follows: The pharmacist reported that they had a paitent who received 1st dose of Shingrix and experienced an adverse reaction like pain and lump at injections site, fever, and raised red itchy rash under breasts that lasted 3 to 4 days, localized pain and swelling at injection site, fever but main issue was the rash that broke out under breasts, which was very itchy and lasted 3-4 days. The patient confirmed with healthcare professional that the rash was under both breasts and she was unable to verify which arm was affected as the vaccine was not administered at her facility. The reporter consented to follow up.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Injection site mass, Injection site pain, Injection site swelling, Pain
Clinical narrative: Pain at injection site; Lump at injection site; Fever; Red itchy rash under breast; Redness under breast; Swelling at injection site; localized pain; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 61-year-old female patient who received Herpes zoster (Shingrix) (batch number TT9BR, expiry date 13th September 2021) for prophylaxis.   On 30th May 2019, the patient received the 1st dose of Shingrix. On 30th May 2019, less than a day after receiving Shingrix, the patient experienced injection site pain, injection site lump, fever, itchy rash, erythema, injection site swelling and pain localized. On an unknown date, the outcome of the injection site pain, injection site lump, fever, itchy rash, erythema, injection site swelling and pain localized were recovered/resolved.   It was unknown if the reporter considered the injection site pain, injection site lump, fever, itchy rash, erythema, injection site swelling and pain localized to be related to Shingrix.  Additional information received were as follows: The pharmacist reported that they had a paitent who received 1st dose of Shingrix and experienced an adverse reaction like pain and lump at injections site, fever, and raised red itchy rash under breasts that lasted 3 to 4 days, localized pain and swelling at injection site, fever but main issue was the rash that broke out under breasts, which was very itchy and lasted 3-4 days. The patient confirmed with healthcare professional that the rash was under both breasts and she was unable to verify which arm was affected as the vaccine was not administered at her facility. The reporter consented to follow up.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pyrexia, Rash erythematous, Rash pruritic
Clinical narrative: Pain at injection site; Lump at injection site; Fever; Red itchy rash under breast; Redness under breast; Swelling at injection site; localized pain; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 61-year-old female patient who received Herpes zoster (Shingrix) (batch number TT9BR, expiry date 13th September 2021) for prophylaxis.   On 30th May 2019, the patient received the 1st dose of Shingrix. On 30th May 2019, less than a day after receiving Shingrix, the patient experienced injection site pain, injection site lump, fever, itchy rash, erythema, injection site swelling and pain localized. On an unknown date, the outcome of the injection site pain, injection site lump, fever, itchy rash, erythema, injection site swelling and pain localized were recovered/resolved.   It was unknown if the reporter considered the injection site pain, injection site lump, fever, itchy rash, erythema, injection site swelling and pain localized to be related to Shingrix.  Additional information received were as follows: The pharmacist reported that they had a paitent who received 1st dose of Shingrix and experienced an adverse reaction like pain and lump at injections site, fever, and raised red itchy rash under breasts that lasted 3 to 4 days, localized pain and swelling at injection site, fever but main issue was the rash that broke out under breasts, which was very itchy and lasted 3-4 days. The patient confirmed with healthcare professional that the rash was under both breasts and she was unable to verify which arm was affected as the vaccine was not administered at her facility. The reporter consented to follow up.
Sex: F
Vaccine: UNK, VARCEL
Symptoms: Product preparation error
Clinical narrative: vaccinated a female patient wit Varivax diluet with Lidocaine instead of Sterile Diluent; This spontaneous report has been received from a pharmacist, concerning a 5-year-old female patient.  The patient's medical history, concurrent conditions and concomitant medications were not provided.  On 08-JUL-2019, the patient was vaccinated with the second dose of varicella virus vaccine live (oka/merck)(VARIVAX) (dose, frequency, route, lot number and expiration date were not provided) for prophylaxis which was diluted with lidocaine(LIDOCAINE) (dose, frequency, route, lot number, expiration date and indication were not provided) instead of sterile diluent (wrong technique in product usage process).
Sex: F
Vaccine: HPV9
Symptoms: Device connection issue, No adverse event
Clinical narrative: No adverse effects reported; during the administration, the needle disengaged from the needle hub of the plastic syringe and a large amount of the vaccine ended up on the tablet; during the administration, the needle disengaged from the needle hub of the plastic syringe and a large amount of the vaccine ended up on the tablet; This spontaneous report was received from a medical assistant referring to a female patient of unknown age. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided.    On 19-JUL-2019, the patient would had been vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # S008151 (verified to be a valid lot number), expiration date reported and established as 20-NOV-2021, for prophylaxis; however, during the administration, the needle disengaged from the needle hub of the plastic syringe (needle issue) and a large amount of the vaccine was lost ending up on the table and the vaccine was not administered to the patient. The medical assistant had already shut down her computer and no adverse effects were reported.  At the reporting time, the outcome of needle issue was unknown. The causality assessment was not provided.
Sex: U
Vaccine: HPV2, HPV4, HPV9
Symptoms: Inappropriate schedule of product administration, Interchange of vaccine products, No adverse event
Clinical narrative: altered dosing schedule: "in 2011" the patient received the first dose in the HPV vaccination series with CERVARIX, on 09-JUL-2013 the patient received the second dose in the HPV vaccination series with GARDASIL and on 30-JUL-2019, the patient receiv; altered dosing schedule: "in 2011" the patient received the first dose in the HPV vaccination series with CERVARIX, on 09-JUL-2013 the patient received the second dose in the HPV vaccination series with GARDASIL and on 30-JUL-2019, the patient receiv; No adverse effects reported; This spontaneous report was received from a physician regarding a currently 23-year-old patient of unknown gender. There was no information reported about the patient's concomitant medications, pertinent medical history and drug reactions or allergies.   On an unspecified date in 2011, the patient received the first dose of the HPV vaccination series, with the dose and frequency reported as: 0.5mL "0,2,6 months", with HPV rL1 16 18 VLP vaccine (baculovirus) (CERVARIX) (dose, route, lot number and expiration date were not provided); then, on 09-JUL-2013, the patient received the second dose with Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) (dose, route, lot number and expiration date were not provided); and then, on 30-JUL-2019, the third dose with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (lot number and expiration date have been verified as valid: R003557, 20-NOV-2020) for prophylaxis (Interchange of vaccine products, Inappropriate schedule of product administration). No adverse effects reported.  This case one of two cases from the same reporter (MARRS# 1907USA016808).; Sender's Comments:  US-009507513-1907USA016808:
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Plaintiff was treated by a healthcare provider for shingles; Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications.  On an unknown date in 2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, strength, route, lot# and expiration date were unknown) for the long-term prevention of shingles and/or zoster-related conditions (prophylaxis).         On an unknown date, the patient was treated by a healthcare provider for shingles. The event caused patient's hospitalized. The outcome of the event was unknown. The relationship between zoster vaccine live (ZOSTAVAX) and the event was considered as related by the reporter.   As a direct and proximate result of patient's use of the zoster vaccine live (ZOSTAVAX) vaccine, Patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; incorrect product storage; This spontaneous report wsa received from a registered nurse, concerning a patient of unknown age and gender. The patient's pertinent medican history, concurrent conditions, drug reactions, allergies and concomitant medications were not reported.   On 23-JUL-2019, the patient was vaccinated with an improperly stored hepatitis b vaccine (recombinant) (RECOMBIVAX HB) for prophylaxis, lot #R001529 and expiration date 07-NOV-2020 (strength, dose, frequency and route of administration were not reported). No adverse event was reported.   The temperature excursion was reported as above 47°F/9°C (9.9°C) during a time frame of 1 hour and 50 minutes. No previous temperature excursion was reported.   No digital data logger was involved.  This is one of several reports received from the same reporter; Sender's Comments:  US-009507513-1908USA004312:
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia, Rash, Rash vesicular
Clinical narrative: post herpetic neuralgia; The pt was diagnosed with herpes zoster; Herpes Zoster; painful blistering rash on her arms, back and stomach; painful blistering rash on her arms, back and stomach; Information has been received from a lawyer regarding a case in litigation concerning a female patient (pt) of unknown age. No information was received regarding the pt's past medical history, concurrent conditions, or concomitant medication. On an unknown date, a healthcare provider administered the zoster vaccine live (ZOSTAVAX) to the patient (dosage regimen, route of administration, lot number and expiration date were not reported) for routine health maintenance and for the prevention of shingles. After receiving the vaccination, pt suffered a painful blistering rash on her arms, back and stomach. As a result of these symptoms, pt presented to her medical provider and she was diagnosed with herpes zoster and postherpetic neuralgia. Thereafter, the pt had continued to suffer the effects of herpes zoster and postherpetic neuralgia and she would continue to suffer significant medical expenses, pain and suffering, and other damages. The outcome of the events was considered to be not recovered. Causality assessment between zoster vaccine live (ZOSTAVAX) and the events was considered to be related.  Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Facial pain, Herpes zoster, Neuropathy peripheral, Pain in extremity, Paraesthesia
Clinical narrative: Leg pain / Diagnosed with polyneuropathy; Paresthesia in the feet likely due to peripheral neuropathy; Pain the right side of her face and sores developed on the right side of her mouth / Herpes zoster; Information has been received regarding a case in litigation, referring to female patient of unknown age. Information regarding the patient's pertinent medical history, concurrent conditions, known allergies and concomitant medications was not provided. On or about 17-JUN-2016, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, frequency, lot # and expiration date were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles. Shortly after receiving zoster vaccine live (ZOSTAVAX), the patient suffered pain on the right side of her face and sores developed on the right side of her mouth. The patient was diagnosed with herpes zoster and then continued to suffer from leg pain. As a result of leg pain, she was additionally diagnosed with polyneuropathy and paresthesia in the feet likely due to peripheral neuropathy. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms had resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). The patient also experience mental and emotional distress due to resulting physical limitations and seriousness of the patient's condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of  zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of Merck's wrongful conduct, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of defendants' conduct, the patient had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. At the time of the report, the outcome of polyneuropathy, herpes zoster and neuropathy peripheral was reported as not recovered. The reporter considered polyneuropathy, neuropathy peripheral and herpes zoster to be related to Zoster Vaccine Live(ZOSTAVAX).     Upon internal review, polyneuropathy and neuropathy peripheral were determined to be medically significant.
Sex: F
Vaccine: VARZOS
Symptoms: Polyneuropathy, Stomatitis
Clinical narrative: Leg pain / Diagnosed with polyneuropathy; Paresthesia in the feet likely due to peripheral neuropathy; Pain the right side of her face and sores developed on the right side of her mouth / Herpes zoster; Information has been received regarding a case in litigation, referring to female patient of unknown age. Information regarding the patient's pertinent medical history, concurrent conditions, known allergies and concomitant medications was not provided. On or about 17-JUN-2016, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, frequency, lot # and expiration date were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles. Shortly after receiving zoster vaccine live (ZOSTAVAX), the patient suffered pain on the right side of her face and sores developed on the right side of her mouth. The patient was diagnosed with herpes zoster and then continued to suffer from leg pain. As a result of leg pain, she was additionally diagnosed with polyneuropathy and paresthesia in the feet likely due to peripheral neuropathy. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms had resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). The patient also experience mental and emotional distress due to resulting physical limitations and seriousness of the patient's condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of  zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of Merck's wrongful conduct, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of defendants' conduct, the patient had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. At the time of the report, the outcome of polyneuropathy, herpes zoster and neuropathy peripheral was reported as not recovered. The reporter considered polyneuropathy, neuropathy peripheral and herpes zoster to be related to Zoster Vaccine Live(ZOSTAVAX).     Upon internal review, polyneuropathy and neuropathy peripheral were determined to be medically significant.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effects reported; Administration of 3 separate doses of an improperly stored vaccine of MMR II; This spontaneous report was received from a nurse concerning 3 patients of unknown age and gender. The patient's concurrent conditions and medical history, as well as concomitant medications, were not reported.  On 01-JUL-2019, the patients were vaccinated with improperly stored doses of 0.5 milliliter of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) lot# R029516, expiration date 14-OCT-2020, which had a temperature excursion of -8.37 C for 2 hours and 30 minutes, and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) of an unknown lot# and expiration date, which had an unknown temperature excursion for an unspecified time; both vaccines were administered once for prophylaxis (strength were unknown) and were reconstitute with properly stored sterile diluent. The reporter stated that the temperature excursions were detected by a data logger. The vaccines had no other temperature excursions and no adverse effects were reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effects reported; patient was vaccinated with one dose of improperly stored PROQUAD; This spontaneous report was received from an other health professional (Nurse) refers to a 6 year old patient. The patient's medical history and concurrent conditions were unknown. On 02-AUG-2019, the patient was vaccinated with improperly stored (product storage error) measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (lot # r030803, expiration date: 22-APR-2020) of digital data logger therapy type (Strength and anatomical location were unknown) of 1 dosage form for prophylaxis which was reconstituted with properly stored sterile diluent(STERILE DILUENT). Concomitant therapies included sterile diluent(STERILE DILUENT) (lot and expiration date were unknown). No adverse events was reported. The vaccine was stored at a temperature of 6 degree fahrenheit to 14 degree fahrenheit for 24 hours. No product quality issue was reported.
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, Injection site pain, Poor quality sleep
Clinical narrative: is not sleeping well due to the pain; injection site was very painful; first dose given in 21Jul2017 and third dose given in 27Jul2019; This spontaneous report was received from a consumer (patient's father) referring to a 17 year old male patient. The patient's pertinent medical history, concurrent condition, drugs reactions/allergies and concomitant medication were unknown. On 21-JUL-2017, the patient was vaccinated with first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose and lot number with expiration date was not reported) to prevent HPV (human papilloma virus) as a part of normal immunization regimen (prophylaxis). On an unknown date, the patient was vaccinated with second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose and lot number with expiration date was not reported) and on 27-JUL-2019, the patient was vaccinated with third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) intramuscularly on high on shoulders (dose and lot number with expiration date were not reported) (inappropriate schedule of vaccine administered). On 27-JUL-2019, after vaccination, the patient experienced injection site pain as he stated that the injection site was very painful. In August 2019 (stated as 2 weeks later), the patient was in severe pain at the injection site and was not sleeping well due to pain (poor quality sleep). The reporter reported that the shot was given high on the shoulders and the patient said it felt as though it went through his rotator cuff. The patient sought medical attention and went back to the physician for treatment and was told that the injection was given normally who didn't think that it went through the rotator cuff. The physician asked the patient to come back in one more week if the pain did not subside by then. The patient was recommended to take ibuprofen for the pain which the patient took and it relieved some of the pain for one evening but the pain came back afterwards. The patient was not currently taking ibuprofen. The reporter did not give permission to contact the physician. No product quality complaint was reported. The patient did not recover from the events of injection site pain and poor quality sleep. Causality assessment for the events was not provided by the reporter.   The reporter considered the events of injection site pain and poor quality sleep as serious (disability).
Sex: F
Vaccine: HPV9
Symptoms: Pain, Syncope
Clinical narrative: Fainted shortly after receiving one dose of GARDASIL-9; Pain from the injection; This spontaneous report was received from a pharmacist via company representative concerning to a female patient of unknown age. Information regarding the patient's pertinent medical history, drug reactions / allergies and concomitant medications were unknown by reporter.     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), intramuscular, as prophylaxis (reported as "vaccination") (strength, dose, and formulation were not provided; lot # and expiration date were unknown by reporter).         On an unknown date, the patient fainted (syncope) shortly after receiving one dose of  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) due to pain from injection (pain). It was unknown by reporter if the patient sought medical attention, if any laboratory diagnostic or studies were performed or if the patient received any treatment for the events.     The outcome of the events was unknown,  and the causality between hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) and the events was not provided.  Upon internal review the event syncope was determined to be a medically significant.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-1908USA003485:
Sex: M
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse effects were reported; The nurse reported a 48 year old male patient was administered his first dose of GARDASIL 9.; This spontaneous report has been received from a nurse regarding to a 48-year-old male patient. The patient's concurrent conditions, medical history, concomitant medications, drug allergies or reactions were not provided.   On 06-JUN-2019, the patient was vaccinated with the first dose hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, route of administration and anatomical location of vaccine were not provided) lot # R027577, because he was at a high risk of contracting and sexual transmitted disease (STD). No adverse effects were reported.
Age: 17.0
Sex: U
Vaccine: HEPA
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: No adverse effects were reported; a 17 year old patient was inadvertently administered an adult dose of VAQTA; This spontaneous report was received from a medical assistant referring to a 17 year old patient of an unknown gender. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant therapies were not provided.     On 06-AUG-2019, the patient was inadvertently vaccinated with an adult dose of hepatitis a vaccine, inactivated (VAQTA) lot # S012250 (verified to be a valid lot number), expiration date reported and established as 07-JUL-2020, for prophylaxis. No adverse effects were reported.
Sex: F
Vaccine: VARZOS
Symptoms: Balance disorder, Dizziness, Fatigue, Headache, Herpes zoster
Clinical narrative: neurological episodes causing headaches, dizziness and balance problems; neurological episodes causing headaches, dizziness and balance problems; neurological episodes causing headaches, dizziness and balance problems; neurological episodes causing headaches, dizziness and balance problems; an outbreak of a painful rash resulting in chronic, sensitive skin on her spine and back and across her shoulder blade and underneath her harm, as well as severe fatigue/ diagnosed with shingles (herpes zoster); Information has been received from a lawyer regarding a case in litigation concerning a female patient(pt) of unknown age. The pt's medical history, concurrent conditions and concomitant medications were not provided. On 02-AUG-2017, the pt was inoculated with zoster vaccine live(ZOSTAVAX) at a pharmacy for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). After approximately then days of receiving zoster vaccine live(ZOSTAVAX), the pt suffered debilitating injuries including an outbreak of a painful rash resulting in chronic, sensitive skin on her spine and back and across her shoulder blade and underneath her harm, as well as severe fatigue. On 22-AUG-2017, the pt was diagnosed with shingles (herpes zoster) which had resulted in subsequent outbreaks since the initial diagnosis, all as a result of zoster vaccine live(ZOSTAVAX). Since these initial injuries manifested, the pt experienced frequent neurological episodes causing headaches, dizziness and balance problems. As a direct and proximate result of zoster vaccine live(ZOSTAVAX), the pt's symptoms had resulted in physical limitations not present prior to using zoster vaccine live(ZOSTAVAX) and caused by the zoster vaccine live(ZOSTAVAX). As a result of zoster vaccine live(ZOSTAVAX), the pt sustained severe and disfiguring personal injuries. Further, as a tragic consequence, the pt suffered serious, progressive, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, the pt had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages.
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: neurological episodes causing headaches, dizziness and balance problems; neurological episodes causing headaches, dizziness and balance problems; neurological episodes causing headaches, dizziness and balance problems; neurological episodes causing headaches, dizziness and balance problems; an outbreak of a painful rash resulting in chronic, sensitive skin on her spine and back and across her shoulder blade and underneath her harm, as well as severe fatigue/ diagnosed with shingles (herpes zoster); Information has been received from a lawyer regarding a case in litigation concerning a female patient(pt) of unknown age. The pt's medical history, concurrent conditions and concomitant medications were not provided. On 02-AUG-2017, the pt was inoculated with zoster vaccine live(ZOSTAVAX) at a pharmacy for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). After approximately then days of receiving zoster vaccine live(ZOSTAVAX), the pt suffered debilitating injuries including an outbreak of a painful rash resulting in chronic, sensitive skin on her spine and back and across her shoulder blade and underneath her harm, as well as severe fatigue. On 22-AUG-2017, the pt was diagnosed with shingles (herpes zoster) which had resulted in subsequent outbreaks since the initial diagnosis, all as a result of zoster vaccine live(ZOSTAVAX). Since these initial injuries manifested, the pt experienced frequent neurological episodes causing headaches, dizziness and balance problems. As a direct and proximate result of zoster vaccine live(ZOSTAVAX), the pt's symptoms had resulted in physical limitations not present prior to using zoster vaccine live(ZOSTAVAX) and caused by the zoster vaccine live(ZOSTAVAX). As a result of zoster vaccine live(ZOSTAVAX), the pt sustained severe and disfiguring personal injuries. Further, as a tragic consequence, the pt suffered serious, progressive, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, the pt had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages.
Sex: F
Vaccine: HPV9
Symptoms: Injection site pain
Clinical narrative: she complained of injection site pain; This spontaneous report was received from a pharmacist, via company representative, referring to an adolescent female patient, whose age was reported as " 16 or 17 years old". The patient's pertinent medical history, concomitant medications, concurrent conditions and drug allergies or reactions were not reported.      On an unknown date, the patient was vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) for prophylaxis (strength, dose number, frequency, route of administration, anatomical location of injection, lot # and expiration date were unknown by the reporter).        Afterwards, on an unspecified date in February 2019, the patient experienced injection site pain.      At the time of this report, the outcome of injection site pain, and the causality assessment between hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) and the event's occurrence, were both unknown.
Sex: F
Vaccine: HPV9
Symptoms: Acne cystic
Clinical narrative: She has experienced acne for the last 6 weeks/Nurse Prescriber noted that the patient had "cystic acne"; This spontaneous report was received from a nurse prescriber and refers to a 24 year old female patient. The patient did not have any concurrent condition, medical history, drug allergies/reactions or concomitant medications.  On 27-JUN-2019, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 1 dose (anatomical site of vaccination was not reported; route of administration, lot number and expiration date were unknown by the reporter) as Human Papillomavirus (HPV) vaccination.  On 27-JUN-2019 (also reported as the last 6 weeks, ever since a couple days after the injection), the patient experienced acne, then the nurse prescriber noted that the patient had acne cystic on the office visit, but no treatment was provided.  At the time of this report, the patient had not recovered from acne cystic.  The reporter stated that she did not believe that acne cystic  was related to HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast)(GARDASIL 9), but the patient had no other changes since receiving the shot.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered
Clinical narrative: No adverse effects reported; An expired dose of PROQUAD was administered to the patient; This spontaneous report was received from a nurse concerning a patient of unknown age and gender. There was no information regarding the patient's medical history, concurrent conditions or concomitant medications.    On 29-JUL-2019, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live rha(PROQUAD) lot # N034561 with expiration date of 03-JUN-2019, for prophylaxis (dose, frequency, route of administration and anatomical location were not provided).
Sex: F
Vaccine: HEPA
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: patient was inadvertently administered one dose of tbe adult V AQT A vaccine; No adverse effects were reported; This spontaneous report was received from a nurse concerning to a 16 year old female patient. The patient's historical conditions, previous drug reactions, allergies, concurrent condition and concomitant medications were not provided.     On an unknown date, the patient was inadvertently vaccinated with one dose of the adult hepatitis a vaccine, inactivated (VAQTA) 50/1.0 U/ml  (Inappropriate age at vaccine administration) (route of administration, lot number and expiration date were not reported). No adverse effects were reported.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; incorrect product storage; This spontaneous report wsa received from a registered nurse, concerning a patient of unknown age and gender. The patient's pertinent medican history, concurrent conditions, drug reactions, allergies and concomitant medications were not reported.   On 29-JUL-2019, the patient was vaccinated with an improperly stored hepatitis b vaccine (recombinant) (RECOMBIVAX HB) for prophylaxis, lot #R001529 and expiration date 07-NOV-2020 (strength, dose, frequency and route of administration were not reported). No adverse event was reported.   The temperature excursion was reported as above 47°F/9°C (9.9°C) during a time frame of 1 hour and 50 minutes. No previous temperature excursion was reported.   No digital data logger was involved.  This is one of several reports received from the same reporter; Sender's Comments:  US-009507513-1908USA001033:
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash pruritic
Clinical narrative: itchy; rash on her stomach; This case was reported by a consumer via call center representative and described the occurrence of itchy rash in a 63-year-old female patient who received Herpes zoster (Shingrix) (batch number CA374, expiry date unknown) for prophylaxis.   The patient's past medical history included leukemia, shingles (healing, outbreak with PHN) and post herpetic neuralgia (pre-vaccination). Concurrent medical conditions included immunocompromised. Concomitant products included allergy medication {nos} (Allergy Pill) and silver (Silver Solution).   On 22nd April 2019, the patient received the 1st dose of Shingrix. On 23rd April 2019, 1 days after receiving Shingrix, the patient experienced itchy rash. On 3rd May 2019, the patient experienced rash. On an unknown date, the outcome of the itchy rash and rash were unknown.   It was unknown if the reporter considered the itchy rash and rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. On next day of receiving Shingrix, the patient developed an intermittently itchy rash on her entire left arm. At the time of call, the patient reported that she had a rash on her stomach of unknown cause. At the time of the call, the symptoms were not reported to be resolved. The reporter given the permission for physician contact.   Follow up information received from physician on 31st July 2019: The patient's demographic details were updated. The patient was not pregnant. The batch number of the suspect vaccine was updated. The patient's concomitant medication included Gabapentin, Losartan, Levothyroxine and Oxcarbazepine. The patient had chronic lymphoid leukemia since August 2009, post herpetic neuralgia (pre-vaccination), which were continuing, shingles since 16th March 2019, which was not continued. On 24th April 2019, the patient received 1st dose of 0.5 ml Shingrix intramuscularly. On 25th April 2019, the patient experienced itchy rash. The patient experienced rash on her stomach, which resolved on an unknown date. No diagnostic tests were performed. The events were managed with Aveeno, hydrocortisone, cetirizine/ loratadine. On 4th May 2019, the event itchy rash resolved. The VAERS details were updated. The reporter considered the itchy rash and rash to be related to Shingrix. This case had been linked with case US2019AMR142803, reported by the same reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This case was reported by a physician via call center representative and described the occurrence of shingles in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 23rd July 2019 03:30, the patient received Shingrix. In July 2019, less than a week after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were received as follows: The case was reported by patient's wife. The age vaccination was not reported. The age group was not reported but was selected as per the vaccine indication. On 23rd July 2019 03:30 pm the patient had a vaccine and within 48 hours developed shingles which was confirmed by a visit to Urgent Care.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Achiness all over; This case was reported by a consumer via call center representative and described the occurrence of general body pain in a elderly 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, less than 3 months after receiving Shingrix, the patient experienced general body pain. On an unknown date, the outcome of the general body pain was unknown.   It was unknown if the reporter considered the general body pain to be related to Shingrix.  Additional case details were reported as follows: The patient received vaccine about 2 to 3 months before the date of reporting and experienced an achiness all over. For tolerability of 2nd dose of Shingrix, refer case US2019140566. The reporter did not give permission to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: flu like symptoms; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In April 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was unknown.   It was unknown if the reporter considered the influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: The patient could not remember exactly when she had received the 1st dose of Shingrix, but there were three months gap in between both the doses. The patient experienced flu like symptoms, that were worse than having the flu. For the tolerance of 2nd dose of Shingrix refer case US2019141366.
Sex: U
Vaccine: VARZOS
Symptoms: Asthenia, Disability, Somnolence
Clinical narrative: incapacitated; Complete lack of energy; slept for 24 hrs almost straight; This case was reported by a consumer via interactive digital media and described the occurrence of disability in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced disability (serious criteria GSK medically significant), feeling of total lack of energy and sleepiness. On an unknown date, the outcome of the disability and feeling of total lack of energy were unknown and the outcome of the sleepiness was recovered/resolved.   It was unknown if the reporter considered the disability, feeling of total lack of energy and sleepiness to be related to Shingrix.  Additional details were received as follows: The patient's age at vaccination was not reported. Previously, the patient had received vaccine but was not effective as Shingrix.  After receiving 1st dose of Shingrix, the patient was incapacitated for 3 days, had complete lack of energy and was slept for 24 hours almost straight. The patient had prescription of Shingrix but vaccine was received late because patient's physician warned that Shingrix could cause flu like symptoms for 4 days. The patient considered that, Shingles was way worse than a mild case of flu and received vaccines. The patient complained to GlaxoSmithKline that they were misleading the patient's as the side effects listed were massive and debilitating. It is one of two cases, reported by the same reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: myalgia; This case was reported by a consumer via sales rep and described the occurrence of myalgia in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced myalgia. On an unknown date, the outcome of the myalgia was recovered/resolved.   It was unknown if the reporter considered the myalgia to be related to Shingrix.  Additional details were provided as follows: The reporter reported this case for the someone she knew. The age at vaccination was not reported. The patient had myalgia for 2 or 3 days after 2nd dose of Shingrix. The reporter refused to follow up as the myalgia was a known side effect of the Shingrix.
Sex: U
Vaccine: VARZOS
Symptoms: Adverse reaction
Clinical narrative: general reaction; This case was reported by a other health professional via call center representative and described the occurrence of adverse reaction in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown.   It was unknown if the reporter considered the adverse reaction to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. Medical assistant reported that the patient experienced a general reaction after Shingrix rather than a local one. Additional information was not known, including the nature of the general reaction. The reporter did not give consent to follow up. No additional information was available.