chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 77.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Asthenia, Back pain, Erythema, Eye irritation, Feeling hot
Clinical narrative: body aches; fatigue/ tired; rash / spread down her arm from the elbow / around her arm / It was bright red / then lightened up; around her arm / It was bright red / then lightened up; skin turned brown; skin was hard with a texture; skin was hard with a texture; skin feels tight; has allergies / make/ eyes burn / eyes were burning worse than normal after / the vaccine; eyes were burning; were yellow with red streaks; This case was reported by a consumer via call center representative and described the occurrence of general body pain in a 77-year-old female patient who received Herpes zoster (Shingrix) (batch number JP427, expiry date 31st May 2022) for prophylaxis.   The patient's past medical history included brain injury. Concurrent medical conditions included multiple allergies. Concomitant products included macrogol, propylene glycol (Systane Eye Drops).   On 6th October 2020, the patient received the 1st dose of Shingrix. On 6th October 2020, less than a day after receiving Shingrix, the patient experienced general body pain and fatigue. In October 2020, the patient experienced red rash, redness, skin discoloration, skin induration, skin texture abnormal, skin tightness, allergy aggravated, burning in eyes and eye color change. On 28th October 2020, the outcome of the skin discoloration was recovered/resolved. On an unknown date, the outcome of the general body pain, fatigue and eye color change were recovered/resolved and the outcome of the red rash, redness and burning in eyes were recovering/resolving and the outcome of the skin induration, skin texture abnormal, skin tightness and allergy aggravated were unknown.   It was unknown if the reporter considered the general body pain, fatigue, red rash, redness, skin discoloration, skin induration, skin texture abnormal, skin tightness, allergy aggravated, burning in eyes and eye color change to be related to Shingrix.  Additional details were provided as follows: The patient received the 1st dose of Shingrix in left deltoid.  The patient reported body aches and fatigue the evening she received she received the vaccine. The aches and fatigue lasted 2-3 days.  On the 2nd or 3rd day after administration, a rash appeared below the injection site and it spread down her arm from the elbow and also around her arm.   It was 2 inches down and 4 inches around not quite completing a circle. It was bright red at first and then lightened up. The skin turned brown and was hard with a texture.   The discoloration was gone on the day of reporting but the skin felt tight. The patient had allergies that make her eyes burn and she used Systane drops. The patient's eyes were burning worse than normal after receiving the vaccine and they were yellow with red streaks, that lasted a few days. The reporter consented to follow up.
Age: 77.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain in extremity, Skin hypertrophy
Clinical narrative: body aches; fatigue/ tired; rash / spread down her arm from the elbow / around her arm / It was bright red / then lightened up; around her arm / It was bright red / then lightened up; skin turned brown; skin was hard with a texture; skin was hard with a texture; skin feels tight; has allergies / make/ eyes burn / eyes were burning worse than normal after / the vaccine; eyes were burning; were yellow with red streaks; This case was reported by a consumer via call center representative and described the occurrence of general body pain in a 77-year-old female patient who received Herpes zoster (Shingrix) (batch number JP427, expiry date 31st May 2022) for prophylaxis.   The patient's past medical history included brain injury. Concurrent medical conditions included multiple allergies. Concomitant products included macrogol, propylene glycol (Systane Eye Drops).   On 6th October 2020, the patient received the 1st dose of Shingrix. On 6th October 2020, less than a day after receiving Shingrix, the patient experienced general body pain and fatigue. In October 2020, the patient experienced red rash, redness, skin discoloration, skin induration, skin texture abnormal, skin tightness, allergy aggravated, burning in eyes and eye color change. On 28th October 2020, the outcome of the skin discoloration was recovered/resolved. On an unknown date, the outcome of the general body pain, fatigue and eye color change were recovered/resolved and the outcome of the red rash, redness and burning in eyes were recovering/resolving and the outcome of the skin induration, skin texture abnormal, skin tightness and allergy aggravated were unknown.   It was unknown if the reporter considered the general body pain, fatigue, red rash, redness, skin discoloration, skin induration, skin texture abnormal, skin tightness, allergy aggravated, burning in eyes and eye color change to be related to Shingrix.  Additional details were provided as follows: The patient received the 1st dose of Shingrix in left deltoid.  The patient reported body aches and fatigue the evening she received she received the vaccine. The aches and fatigue lasted 2-3 days.  On the 2nd or 3rd day after administration, a rash appeared below the injection site and it spread down her arm from the elbow and also around her arm.   It was 2 inches down and 4 inches around not quite completing a circle. It was bright red at first and then lightened up. The skin turned brown and was hard with a texture.   The discoloration was gone on the day of reporting but the skin felt tight. The patient had allergies that make her eyes burn and she used Systane drops. The patient's eyes were burning worse than normal after receiving the vaccine and they were yellow with red streaks, that lasted a few days. The reporter consented to follow up.
Age: 77.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Eye colour change, Eye irritation, Fatigue, Hypersensitivity
Clinical narrative: body aches; fatigue/ tired; rash / spread down her arm from the elbow / around her arm / It was bright red / then lightened up; around her arm / It was bright red / then lightened up; skin turned brown; skin was hard with a texture; skin was hard with a texture; skin feels tight; has allergies / make/ eyes burn / eyes were burning worse than normal after / the vaccine; eyes were burning; were yellow with red streaks; This case was reported by a consumer via call center representative and described the occurrence of general body pain in a 77-year-old female patient who received Herpes zoster (Shingrix) (batch number JP427, expiry date 31st May 2022) for prophylaxis.   The patient's past medical history included brain injury. Concurrent medical conditions included multiple allergies. Concomitant products included macrogol, propylene glycol (Systane Eye Drops).   On 6th October 2020, the patient received the 1st dose of Shingrix. On 6th October 2020, less than a day after receiving Shingrix, the patient experienced general body pain and fatigue. In October 2020, the patient experienced red rash, redness, skin discoloration, skin induration, skin texture abnormal, skin tightness, allergy aggravated, burning in eyes and eye color change. On 28th October 2020, the outcome of the skin discoloration was recovered/resolved. On an unknown date, the outcome of the general body pain, fatigue and eye color change were recovered/resolved and the outcome of the red rash, redness and burning in eyes were recovering/resolving and the outcome of the skin induration, skin texture abnormal, skin tightness and allergy aggravated were unknown.   It was unknown if the reporter considered the general body pain, fatigue, red rash, redness, skin discoloration, skin induration, skin texture abnormal, skin tightness, allergy aggravated, burning in eyes and eye color change to be related to Shingrix.  Additional details were provided as follows: The patient received the 1st dose of Shingrix in left deltoid.  The patient reported body aches and fatigue the evening she received she received the vaccine. The aches and fatigue lasted 2-3 days.  On the 2nd or 3rd day after administration, a rash appeared below the injection site and it spread down her arm from the elbow and also around her arm.   It was 2 inches down and 4 inches around not quite completing a circle. It was bright red at first and then lightened up. The skin turned brown and was hard with a texture.   The discoloration was gone on the day of reporting but the skin felt tight. The patient had allergies that make her eyes burn and she used Systane drops. The patient's eyes were burning worse than normal after receiving the vaccine and they were yellow with red streaks, that lasted a few days. The reporter consented to follow up.
Age: 77.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site rash, Pain, Rash, Rash erythematous, Skin discolouration
Clinical narrative: body aches; fatigue/ tired; rash / spread down her arm from the elbow / around her arm / It was bright red / then lightened up; around her arm / It was bright red / then lightened up; skin turned brown; skin was hard with a texture; skin was hard with a texture; skin feels tight; has allergies / make/ eyes burn / eyes were burning worse than normal after / the vaccine; eyes were burning; were yellow with red streaks; This case was reported by a consumer via call center representative and described the occurrence of general body pain in a 77-year-old female patient who received Herpes zoster (Shingrix) (batch number JP427, expiry date 31st May 2022) for prophylaxis.   The patient's past medical history included brain injury. Concurrent medical conditions included multiple allergies. Concomitant products included macrogol, propylene glycol (Systane Eye Drops).   On 6th October 2020, the patient received the 1st dose of Shingrix. On 6th October 2020, less than a day after receiving Shingrix, the patient experienced general body pain and fatigue. In October 2020, the patient experienced red rash, redness, skin discoloration, skin induration, skin texture abnormal, skin tightness, allergy aggravated, burning in eyes and eye color change. On 28th October 2020, the outcome of the skin discoloration was recovered/resolved. On an unknown date, the outcome of the general body pain, fatigue and eye color change were recovered/resolved and the outcome of the red rash, redness and burning in eyes were recovering/resolving and the outcome of the skin induration, skin texture abnormal, skin tightness and allergy aggravated were unknown.   It was unknown if the reporter considered the general body pain, fatigue, red rash, redness, skin discoloration, skin induration, skin texture abnormal, skin tightness, allergy aggravated, burning in eyes and eye color change to be related to Shingrix.  Additional details were provided as follows: The patient received the 1st dose of Shingrix in left deltoid.  The patient reported body aches and fatigue the evening she received she received the vaccine. The aches and fatigue lasted 2-3 days.  On the 2nd or 3rd day after administration, a rash appeared below the injection site and it spread down her arm from the elbow and also around her arm.   It was 2 inches down and 4 inches around not quite completing a circle. It was bright red at first and then lightened up. The skin turned brown and was hard with a texture.   The discoloration was gone on the day of reporting but the skin felt tight. The patient had allergies that make her eyes burn and she used Systane drops. The patient's eyes were burning worse than normal after receiving the vaccine and they were yellow with red streaks, that lasted a few days. The reporter consented to follow up.
Age: 77.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Skin induration, Skin texture abnormal, Skin tightness
Clinical narrative: body aches; fatigue/ tired; rash / spread down her arm from the elbow / around her arm / It was bright red / then lightened up; around her arm / It was bright red / then lightened up; skin turned brown; skin was hard with a texture; skin was hard with a texture; skin feels tight; has allergies / make/ eyes burn / eyes were burning worse than normal after / the vaccine; eyes were burning; were yellow with red streaks; This case was reported by a consumer via call center representative and described the occurrence of general body pain in a 77-year-old female patient who received Herpes zoster (Shingrix) (batch number JP427, expiry date 31st May 2022) for prophylaxis.   The patient's past medical history included brain injury. Concurrent medical conditions included multiple allergies. Concomitant products included macrogol, propylene glycol (Systane Eye Drops).   On 6th October 2020, the patient received the 1st dose of Shingrix. On 6th October 2020, less than a day after receiving Shingrix, the patient experienced general body pain and fatigue. In October 2020, the patient experienced red rash, redness, skin discoloration, skin induration, skin texture abnormal, skin tightness, allergy aggravated, burning in eyes and eye color change. On 28th October 2020, the outcome of the skin discoloration was recovered/resolved. On an unknown date, the outcome of the general body pain, fatigue and eye color change were recovered/resolved and the outcome of the red rash, redness and burning in eyes were recovering/resolving and the outcome of the skin induration, skin texture abnormal, skin tightness and allergy aggravated were unknown.   It was unknown if the reporter considered the general body pain, fatigue, red rash, redness, skin discoloration, skin induration, skin texture abnormal, skin tightness, allergy aggravated, burning in eyes and eye color change to be related to Shingrix.  Additional details were provided as follows: The patient received the 1st dose of Shingrix in left deltoid.  The patient reported body aches and fatigue the evening she received she received the vaccine. The aches and fatigue lasted 2-3 days.  On the 2nd or 3rd day after administration, a rash appeared below the injection site and it spread down her arm from the elbow and also around her arm.   It was 2 inches down and 4 inches around not quite completing a circle. It was bright red at first and then lightened up. The skin turned brown and was hard with a texture.   The discoloration was gone on the day of reporting but the skin felt tight. The patient had allergies that make her eyes burn and she used Systane drops. The patient's eyes were burning worse than normal after receiving the vaccine and they were yellow with red streaks, that lasted a few days. The reporter consented to follow up.
Age: 51.0
Sex: M
Vaccine: FLUR4
Symptoms: Pain
Clinical narrative: Pt States he  has had consistent pain after 3 weeks of receiving flu shot.  He presents with a  pain scale of 5 and an 8/9 when he lifts his arm.  Pt states no signs of infection at injection site. We advised him to start OTC NSAID or pain medication and to report to PCP if pain doesn't go away.
Age: 49.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site pain, Pruritus
Clinical narrative: pain in injection area, generalized pruritus. Self treated with one dose of Epi-pen.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: administered expired Menactra vaccine
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain, Asthenia, Hyperhidrosis, Impaired work ability, Myalgia
Clinical narrative: I had nausea, abdominal cramps, overall muscle soreness/body aches, sweating, lack of energy, and arm soreness for 4 days.  I contacted a nurse via on-line chat (in lieu of an office visit due to Covid restrictions).  I received no treatment but I took OTC Peptobismol and stayed home from work and slept.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pain, Pain in extremity
Clinical narrative: I had nausea, abdominal cramps, overall muscle soreness/body aches, sweating, lack of energy, and arm soreness for 4 days.  I contacted a nurse via on-line chat (in lieu of an office visit due to Covid restrictions).  I received no treatment but I took OTC Peptobismol and stayed home from work and slept.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect route of product administration
Clinical narrative: Patient was administered Gardasil 9 the subcutaneous route versus the recommended intramuscular route; This spontaneous report was received from a Licensed Practical Nurse concerning a 11-year-old patient. The patient's pertinent medical history, concurrent conditions and concomitant therapies were unknown by the reporter.     On 20-OCT-2022, the patient was vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # S031287, the expiration date: 08-APR-2022, subcutaneously route versus the recommended intramuscular route (Incorrect route of product administration)    for prophylaxis.    combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S031287; expirationdate: 08-APR-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Age: 76.0
Sex: F
Vaccine: PPV
Symptoms: Herpes zoster, Neuralgia, Pain in extremity
Clinical narrative: arm was a little sore; This spontaneous report was received from a lawyer and the approximately 76-year-old female patient who was also a nurse. The patient was non-smoker. The patient's medical history included chickenpox and seizure disorder. Historical drugs included phenytoin sodium. Concomitant medications could not be determined.  In 2012, the patient was vaccinated with Pneumococcal Vaccine, Polyvalent (23-valent) (manufacturer unknown) (strength, lot #, expiration date, dosage, anatomical location and route of administration were not provided) for prophylaxis.  On an unspecified date, his arm was a little sore (pain in extremity). The patient also experienced herpes zoster, postherpetic neuralgia, vaccination failure and others after vaccination with zoster vaccine live (ZOSTAVAX) (case # 1306USA014036), reported as part of a litigation process.  The outcome of the event was not reported.  The reporter considered pain in extremity to be an adverse reaction or side effect of Pneumococcal Vaccine, Polyvalent (23-valent) (manufacturer unknown).; Sender's Comments:  US-009507513-1306USA014036:
Sex: M
Vaccine: VARZOS
Symptoms: Dyspnoea, Pneumonia
Clinical narrative: right middle lobe pneumonia; Information has been received from a lawyer referring to a male patient of unknown age. Information about concurrent condition, history condition and concomitant medication was not reported. On or around 26-OCT-2017, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot# and expiration date unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX), the patient suffered difficulty breathing and was diagnosed with right middle lobe pneumonia. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms have resulted in physical limitations not present prior to using the vaccine. The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of his 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 zoster vaccine live (ZOSTAVAX), 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 zoster vaccine live (ZOSTAVAX), the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events right middle lobe pneumonia was considered to be not recovered and causal relationship was assessed as related.    The lawyer considered the event right middle lobe pneumonia to be disability.  Upon internal review, the event right middle lobe pneumonia was considered to be medically significant.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: a nurse reporting a temperature excursion, requesting stability data; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/ allergies were not reported.  On 20-OCT-2020, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) (1 dose, lot # S038700, expiration date 01-DEC-2021, strength and route were not provided) for prophylaxis. The vaccine underwent a temperature excursion of -6.6 degree Celsius for 1 hour and 45 minutes; no previous temperature excursion were reported. The call was made due to a digital data logger.   This is one of several cases received from the same reporter.; Sender's Comments:  US-009507513-2010USA010299: US-009507513-2010USA010518: US-009507513-2010USA010508: US-009507513-2010USA010384: US-009507513-2010USA010735: US-009507513-2010USA010348: US-009507513-2010USA010577: US-009507513-2010USA010526: US-009507513-2010USA010709:
Sex: F
Vaccine: FLU3, MMR
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: inappropriate age at vaccine administration; the patient developed a bad rash on her scalp, forearms, and upper thighs; This spontaneous report was received from a pharmacist referring to an adult female patient. Information regarding the patient's concurrent conditions, medical history, historical drugs and concomitant therapies was not provided.   On 27-SEP-2020, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, recombinant human albumin (rha) (M-M-R II) lot # S005251, expiration date 20-FEB-2021 subcutaneously for immunisation (strength and dose were not reported) and with influenza virus split virion 3v vaccine inactivated (FLUARIX) lot # 7J7T3, expiration date 30-JUN-2021, subcutaneously for immunisation  (strength and dose were not reported).   The reporter stated that "the patient developed a bad rash on her scalp, forearms, and upper thighs." She developed this reaction 1-2 days after receiving the injections. Patient denied difficulty breathing. The patient took diphenhydramine (BENADRYL) for the itching/hives. The outcome of rash was reported as resolving.  The reporter was asking if the patient should receive the second dose of the vaccine.   The causal relationship between measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, recombinant human albumin (rha)  (M-M-R II) and influenza virus split virion 3v vaccine inactivated (FLUARIX) and rash was unknown.
Sex: U
Vaccine: VARZOS
Symptoms: Cerebrovascular accident, Diplopia, Dysarthria, Hemiparesis, Nausea
Clinical narrative: acute cerebrovascular accident/ Severe right sided weakness/dysarthria/double vision/Vomiting/nausea; This initial spontaneous report was received from a lawyer regarding a case in litigation, referring to a patient of unknown age and gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In or around 12-NOV-2015, the patient was inoculated with zoster vaccine live (ZOSTAVAX) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster) (strength, dose, route of administration, anatomical location, lot#, and expiration date were not reported). On an unknown date, reported as shortly after received zoster vaccine live (ZOSTAVAX), the patient suffered severe right sided weakness, dysarthria, double vision, nausea and vomiting. The patient was hospitalized and diagnosed with an acute cerebrovascular accident.  As a direct and proximate result of the patient's use of the zoster vaccine live (ZOSTAVAX) vaccine, the patient had resulted in physical limitations not presented prior to used zoster vaccine live (ZOSTAVAX). Also experienced mental and emotional distress due to resulted physical limitations and seriousness of her 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, 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 resulted, the patient had suffered and incurred damages, included medical expenses, the loss of accumulations; and other economic and non-economic damages. The outcome of cerebrovascular accident, nausea, vomiting, diplopia, dysarthria and hemiparesis was not recovered. The reporter considered the aforementioned events to be related to Zoster Vaccine Live (ZOSTAVAX).  Upon internal review, cerebrovascular accident and hemiparesis were determined to be medically significant events.
Sex: U
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: acute cerebrovascular accident/ Severe right sided weakness/dysarthria/double vision/Vomiting/nausea; This initial spontaneous report was received from a lawyer regarding a case in litigation, referring to a patient of unknown age and gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In or around 12-NOV-2015, the patient was inoculated with zoster vaccine live (ZOSTAVAX) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster) (strength, dose, route of administration, anatomical location, lot#, and expiration date were not reported). On an unknown date, reported as shortly after received zoster vaccine live (ZOSTAVAX), the patient suffered severe right sided weakness, dysarthria, double vision, nausea and vomiting. The patient was hospitalized and diagnosed with an acute cerebrovascular accident.  As a direct and proximate result of the patient's use of the zoster vaccine live (ZOSTAVAX) vaccine, the patient had resulted in physical limitations not presented prior to used zoster vaccine live (ZOSTAVAX). Also experienced mental and emotional distress due to resulted physical limitations and seriousness of her 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, 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 resulted, the patient had suffered and incurred damages, included medical expenses, the loss of accumulations; and other economic and non-economic damages. The outcome of cerebrovascular accident, nausea, vomiting, diplopia, dysarthria and hemiparesis was not recovered. The reporter considered the aforementioned events to be related to Zoster Vaccine Live (ZOSTAVAX).  Upon internal review, cerebrovascular accident and hemiparesis were determined to be medically significant events.
Sex: M
Vaccine: HPV4
Symptoms: Amyotrophic lateral sclerosis, Death
Clinical narrative: Our son died of ALS right after he turned 16; This spontaneous information has been received from the patient's mother via company representative, concerning a 16-years-old male patient. The patient's pertinent medical history, concurrent conditions, previously drug reactions, allergies and concomitant medications were not provided.  On an unknown date, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) for prophylaxis (strength, dose, frequency, route of administration, anatomical location, lot number and expiration date were not reported).  On an unknown date, the patient experienced amyotrophic lateral sclerosis (ALS) and died due to this event.  The causal relationship between amyotrophic lateral sclerosis and quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) was not provided.  Upon internal review, amyotrophic lateral sclerosis was determined to be a medically significant event.  This is one of two reports from the same reporter.; Sender's Comments:  US-009507513-2011USA002096:; Reported Cause(s) of Death: ALS
Age: 14.0
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Received their first dose of GARDASIL 9 a year ago, and a pharmacist is inquiring about recommendations for series completion; No additional AE or PQC reported; This spontaneous information has been received from a pharmacist via company representative, concerning a 15-years old patient of unknown age. The patient's pertinent medical history, concurrent conditions, previously drug reactions, allergies and concomitant medications were not provided.  On an unknown date in 2019 (also reported as a year ago), the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) as prophylaxis (strength, dose, route of administration, anatomical location, lot number and expiration date were not reported).   On an unknown date, the pharmacist was inquiring about recommendations for series completion (inappropriate schedule of product administration).   No adverse event was reported.
Sex: U
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: ROTATEQ administered today prior to tbe nurse knowing tbere was a temperature excursion; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.     On 02-NOV-2020, the patient was vaccinated with an improper stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 0.2 milliliter, oral, lot number 1684163, expiration date 26-JUN-2021 for prophylaxis.   The vaccine had a temperature excursion of 12.8 degrees Celsius (C) for 3 hours. There were no previous temperature excursions.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: The customer reported 1 dose of VARlVAX that was stored outside of the recommended storage range was administered to a patient.; No other adverse event reported.; This spontaneous report was received from a registered nurse, referring to a patient of unknown age and gender. The patient's pertinent medical history, current conditions, previous drug reactions or allergies, and concomitant medications were not reported.   On an unknown date, the patient received one dose of varicella virus vaccine live (oka/merck) (VARIVAX), as prophylaxis (formulation, strength, vaccination scheme, route of administration and anatomical site of vaccination were not reported; lot number S038698, which has been verified to be valid, expiration date reported and validated as 01-DEC-2021). The vaccine administered experienced a temperature excursion of -4.9 degrees Celsius (C), for a time frame of 2 hours. There was no previous temperature excursion reported, and there was no data logger involved in the report. No additional adverse events were reported.
Sex: U
Vaccine: VARZOS
Symptoms: Circumstance or information capable of leading to medication error, Product use in unapproved indication
Clinical narrative: Indication: "hsv"; I am one of the fortunate ones. I managed to get it. I will do it.; This spontaneous report was received from a consumer, referring to him/herself as a patient of unknown age and gender. The patient's current condition included herpes simplex virus (reported as "hsv"). The patient's pertinent medical history, previous drug reactions or allergies and concomitant medications were not reported.  The patient stated that, zoster vaccine live (ZOSTAVAX) (formulation, strength, dose, vaccination scheme, route of administration, anatomical site of vaccination, lot number and expiration date were not reported) could be used as treatment for genital and oral HSV (product use in unapproved indication).   At the time of this report, the patient has not received the vaccine yet, he/her was one of the fortunate ones, he/her manage to got it, and he/her has scheduled the administration of zoster vaccine live (ZOSTAVAX) (circumstance or information capable of leading to medication error).  This is one of several reports received from the same reporter.
Age: 0.25
Sex: U
Vaccine: HEP
Symptoms: Product storage error, Recalled product administered
Clinical narrative: Patient had no other issues due to receiving the recalled vaccine; incorrect product storage; Recalled product administered; This spontaneous report was received from a nurse referring to a 3 month old patient. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided.      On 23-OCT-2020, the patient was given a recalled and improperly stored (clarified internally) hepatitis b vaccine (recombinant) (RECOMBIVAX HB) 5 mcg/5 ml, single dose vials, lot # T007984, expiration date on 01-NOV-2022, for prophylaxis (route of administration and anatomical location were unknown). Patient had no other issues due to receiving the recalled and improperly stored vaccine.
Sex: U
Vaccine: PPV
Symptoms: Product storage error, Recalled product administered
Clinical narrative: no other AE information given at this time; incorrect product storage; Recalled product administered; This spontaneous report was received from a certified medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided.      On 08-OCT-2020, the patient was vaccinated with an improperly stored (clarified internally) and recalled pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) 0.5 ml, lot # S036495, expiration date on 13-SEP-2021, for prophylaxis (strength, route of administration and anatomical location were unknown). No other adverse event information was given at the reporting time. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S036495; expirationdate: 13-SEP-2021; deviceage and unit: 0; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: U
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: No Aes; temperature excursion; This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not provided.   On 02-NOV-2020, the patient was vaccinated with an improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) lot # T013546 (strength, indication, dose, route, frequency, anatomical location, lot # and expiration date were not provided) for prophylaxis. The vaccine was exposed to a temperature above 47°F during a time frame of 1 hour. Previous excursions included 50°F for 45 minutes.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error, Recalled product administered
Clinical narrative: Improper storage of product in use; ADMINISTERED RECALLED VACCINE; No other AE information given at this time; This spontaneous report was received from a medical assistant (also reported as certified medical assistant) referring to a patient of unknown age and gender. Information about patient's pertinent concurrent conditions, medical history, concomitant medications and previous drug reactions or allergies were not provided.  On 19-OCT-2020, the patient was vaccinated with incorrectly stored (no details of storing were provided) pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23), which was recalled, a dose was 0.5 milliliter, lot # S036495 was confirmed to be valid, expiration date 13-SEP-2021 (concentration, number of administered dose, route and anatomical location of administration were not reported), for prophylaxis. No adverse events were reported.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S036495; expirationdate: 13-SEP-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2010USA010843: US-009507513-2010USA010890: US-009507513-2010USA010905: US-009507513-2010USA011114: US-009507513-2010USA011126: US-009507513-2010USA011133: US-009507513-2010USA011194: US-009507513-2010USA011201: US-009507513-2010USA011364: US-009507513-2010USA011379: US-009507513-2010USA011790: US-009507513-2010USA012196: US-009507513-2011USA001141: US-009507513-2011USA001174:
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Headache, Injection site pain, Loss of personal independence in daily activities, Nausea
Clinical narrative: injection site very tender; severely incapacitated; headache; Body and headache; chills; nausea; This case was reported by a physician and described the occurrence of injection site tenderness in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site pain (1st dose received on unknown date for further tolerenace refer case US2020AMR215128).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site tenderness, activities of daily living impaired, headache, general body pain, chills and nausea. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site tenderness, activities of daily living impaired, headache, general body pain, chills and nausea were recovered/resolved.   It was unknown if the reporter considered the injection site tenderness, activities of daily living impaired, headache, general body pain, chills and nausea to be related to Shingrix.  Additional details were provided as follows: The age group was not reported, however it was captured as an adult as per vaccine indication. The age at vaccination was not reported. After the 2n dose  of Shingrix, the patient was severely incapacitated with body and headaches, chills, nausea for at least 24 hours. The injection site was also very tender. The patient considered it as an awful experience. For tolerance of 1st dose of Shingrix, refer case US2020AMR215128; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR215128:same patient, 2nd dose
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: injection site very tender; severely incapacitated; headache; Body and headache; chills; nausea; This case was reported by a physician and described the occurrence of injection site tenderness in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site pain (1st dose received on unknown date for further tolerenace refer case US2020AMR215128).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site tenderness, activities of daily living impaired, headache, general body pain, chills and nausea. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site tenderness, activities of daily living impaired, headache, general body pain, chills and nausea were recovered/resolved.   It was unknown if the reporter considered the injection site tenderness, activities of daily living impaired, headache, general body pain, chills and nausea to be related to Shingrix.  Additional details were provided as follows: The age group was not reported, however it was captured as an adult as per vaccine indication. The age at vaccination was not reported. After the 2n dose  of Shingrix, the patient was severely incapacitated with body and headaches, chills, nausea for at least 24 hours. The injection site was also very tender. The patient considered it as an awful experience. For tolerance of 1st dose of Shingrix, refer case US2020AMR215128; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR215128:same patient, 2nd dose
Sex: F
Vaccine: MEN
Symptoms: Death
Clinical narrative: lost another daughter to this damn vaccine; This case was reported by a consumer via interactive digital media and described the occurrence of unknown cause of death in a female patient who received Men B NVS (Meningococcal B vaccine) for prophylaxis.   On an unknown date, the patient received Meningococcal B vaccine. On an unknown date, unknown after receiving Meningococcal B vaccine, the patient experienced unknown cause of death (serious criteria death and GSK medically significant). On an unknown date, the outcome of the unknown cause of death was fatal. The reported cause of death was unknown cause of death.   The reporter considered the unknown cause of death to be related to Meningococcal B vaccine.  Additional details were provided as follows:  The reporter was the patient's parent. After receiving Meningococcal B vaccine, the patient was died due to unknown cause. This case was linked with case US2020AMR218484, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR218484:same reporter; Reported Cause(s) of Death: Unknown cause of death
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Burning sensation, Erythema, Fatigue, Herpes zoster
Clinical narrative: Lesions behind his knee / Form on large scab / multiple lesions on the right side of his temple; multiple lesions on the right side of his temple/lession have combined to form on large scab; Diagnosed with shingles; Painful blister; noticed a painful blister which was red; left knee which was painful; Burning sensation; fatigue; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th October 2020, the patient received the 1st dose of Shingrix. On 19th October 2020, less than a day after receiving Shingrix and an unknown time after starting Valtrex, the patient experienced fatigue. On 24th October 2020, the patient experienced shingles, blister, erythema, pain and burning sensation. On 26th October 2020, the patient experienced scab and skin lesion. The patient was treated with valaciclovir hydrochloride (Valtrex) and sulfamethoxazole + trimethoprim (Bactrim). On an unknown date, the outcome of the shingles, blister, fatigue, erythema, pain, burning sensation, scab and skin lesion were unknown.   It was unknown if the reporter considered the shingles, blister, fatigue, erythema, pain, burning sensation, scab and skin lesion to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in left deltoid and experienced fatigue initially and then five days later noticed a painful blister which was red and burning sensation behind his left knee which was painful and was seen at the urgent care where diagnosed with shingles and given 10 day course of Valtrex and 7 days course of Bactrim 800/160 mg.  They were multiple lesions behind his knee and the lesion had combined to form on large scab.  The patient noticed multiple lesions on the right side of his temple. The reporter consented to follow up.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Scab, Skin lesion
Clinical narrative: Lesions behind his knee / Form on large scab / multiple lesions on the right side of his temple; multiple lesions on the right side of his temple/lession have combined to form on large scab; Diagnosed with shingles; Painful blister; noticed a painful blister which was red; left knee which was painful; Burning sensation; fatigue; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th October 2020, the patient received the 1st dose of Shingrix. On 19th October 2020, less than a day after receiving Shingrix and an unknown time after starting Valtrex, the patient experienced fatigue. On 24th October 2020, the patient experienced shingles, blister, erythema, pain and burning sensation. On 26th October 2020, the patient experienced scab and skin lesion. The patient was treated with valaciclovir hydrochloride (Valtrex) and sulfamethoxazole + trimethoprim (Bactrim). On an unknown date, the outcome of the shingles, blister, fatigue, erythema, pain, burning sensation, scab and skin lesion were unknown.   It was unknown if the reporter considered the shingles, blister, fatigue, erythema, pain, burning sensation, scab and skin lesion to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in left deltoid and experienced fatigue initially and then five days later noticed a painful blister which was red and burning sensation behind his left knee which was painful and was seen at the urgent care where diagnosed with shingles and given 10 day course of Valtrex and 7 days course of Bactrim 800/160 mg.  They were multiple lesions behind his knee and the lesion had combined to form on large scab.  The patient noticed multiple lesions on the right side of his temple. The reporter consented to follow up.