chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: Peripheral swelling, Pruritus, Rash, Swelling, Urticaria
Clinical narrative: Allergic reaction; This spontaneous report was received from a physician and a vaccine provider referring to a 17 years old female patient. The patient's medical history included lump removed from neck. The patient had no concomitant medication, no illness at time of vaccination or pre-existing physician-diagnosed allergies, birth defects, medical conditions (specify). The patient's drug reactions/ allergies was unknown.  On 02-AUG-2020 (it was also reported as 02-AUG-2018), 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) (lot # R002344 with expiration date 16-NOV-2020; dose was not reported) intramuscularly in the left arm for prophylaxis.    The patient had no immediate problems on the first day or the second day after the vaccine was administered. On 04-AUG-2020 late in the evening after eating and showering, the patient developed itching to the lower abdomen. The patient applied some sort of gel to the area but did not know the name of the gel. The patient had no further problems that night and went to bed. On 05-AUG-2020, the patient developed swelling and rash to the neck, lower back and thighs (It was also reported on 05-AUG-2018, 3 days after the vaccination, the patient developed hives, the patient might have had snack prior to developing hives heat was passed due date). On 06-AUG-2020, the patient awoke with a worsening rash and was now on both arms as well. The patient contacted his physician and was treated with hydroxyzine (25 mg, q6h, po). On 07-AUG-2020, the patient went in to see his physician who felt like it episode was caused by hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). It was reported that the rash was widely spread, erythematous, purely macular with irregular edges to the extremities, face and trunk. On 09-AUG-2020 (reported as by day 8), the patient was improved. It was reported that the physician wanted to know if additional doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) should be given after the patient had experienced an allergic reaction. The outcome of the event was recovered on an unknown date in 2020. The causality between the event and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was unknown. 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: R002344; expirationdate: 16-NOV-2020; deviceage and unit: 0 ; operatorofdevice: Health Care Professional; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash pruritic
Clinical narrative: she believes the rash to be a shingles infection; the patient developed an itchy, painful rash; the patient developed an itchy, painful rash; This spontaneous report was received from a female adult patient of unknown age. Information regarding the patient's pertinent medical history, current condition, drug reactions/allergies and concomitant medication were unknown.        On an unknown date in 2012 (also reported as approximately 8 years ago), the patient was vaccinated with zoster vaccine live (ZOSTAVAX) injectable (dose, strength, frequency, lot# and expiration date were unknown) for prophylaxis.         On unknown date, the patient developed an itchy, painful rash. she believed the rash to be a shingles infection. The outcome of the events was unknown. The causality assessment between the event and zoster vaccine live (ZOSTAVAX) was not provided.
Age: 1.0
Sex: U
Vaccine: MMR, MMRV
Symptoms: Pyrexia
Clinical narrative: HCP reports this patient had a fever of 100.0 degrees after inadvertently being administered PROQUAD and MMRll.; a dose of PROQUAD and a dose ofMMR II were given concomitantly to a patient today; This spontaneous report as received from a medical assistant referring to a 1-year-old patient. Information regarding the patient's pertinent medical history, historical drugs, concurrent conditions and previous drug reactions or allergies was not reported.      On 20-NOV-2020, the patient was inadvertently administered concomitantly a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # T019420, expiration date 02-DEC-2021, 0.5 milliliter and a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) lot # S013683, expiration date 05-MAY-2021, 0.5 milliliter for prophylaxis (vaccination scheme frequency, route of administration and anatomical site of vaccination were not reported). Concomitant therapies included sterile diluent.     On an unknown date, the patient experienced a fever of 100 degrees (pyrexia) after the vaccinations. The outcome of pyrexia was unknown.     The causal relationship between pyrexia and Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) and Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) was unknown.
Sex: U
Vaccine: VARZOS
Symptoms: Balance disorder, Cardiovascular disorder, Visual impairment
Clinical narrative: cardiovascular event; vision issues; balance problems; This spontaneous report has been received from a lawyer regarding a case in litigation, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (strength, lot expiration date, dosage, anatomical location and route of administration were not provided), for routine health maintenance and its intended purpose: the prevention of shingles (herpes zoster). Shortly after vaccination, the patient suffered a cardiovascular event (cardiovascular disorder), vision issues (visual impairment) and balance problems (balance disorder). As a result of those symptoms, the patient was seen and treated by medical providers was still under their care. As a direct and proximate result, the patient's symptoms had resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). The patient also experienced 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, 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, the patient had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages.  The cardiovascular disorder, visual impairment and balance disorder were considered disabling events.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: No additional AE was reported; PROQUAD was administered to a patient that had undergone temperature excursion; This spontaneous report was received from a nurse referring to a 4 year old female patient. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.       On 30-NOV-2020, the patient was vaccinated with dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD), 1 dosage form (route of administration, lot number and expiration date were not provided) for prophylaxis, that underwent a temperature excursion.  The temperature excursion was of 72.1 Farhrenheit degrees (°F) for 3 hours and 15 minutes. The vaccine had no experienced previous temperature excursions. The call was due to digital data logger.
Sex: F
Vaccine: MMR
Symptoms: Erythema annulare
Clinical narrative: a rash that was found to be erythema annulare centrifugum; This spontaneous report was received from a medical assistant referring to a female patient of unknown age. Information regarding the patient's concurrent conditions, medical history, historical drugs and concomitant therapies was not provided.       On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II)  for prophylaxis (dose, vaccination scheme frequency, route of administration, anatomical site of vaccination, lot number and expiration date were not reported).         On an unknown date, the patient experienced a rash that was found to be erythema annulare centrifugum. At the time of reporting, the patient had not recovered from erythema annulare.        The causal relationship between measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) and erythema annulare was unknown.
Sex: U
Vaccine: VARZOS
Symptoms: Facial paralysis
Clinical narrative: Bell's Palsy; This initial spontaneous report was received on from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medication were not provided.   21-JAN-2013, the patient was vaccinated with a dose zoster vaccine live (ZOSTAVAX) (dosage regimen was not reported) for the long-term prevention of shingles and zoster-related conditions.  On an unspecified date, subsequent to the patient vaccination, the patient presented bell's palsy. As a direct and proximate result, the patient had and would be continued suffer ongoing injuries, including but not limited: 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 cost included care for hospitalization, physician care, monitoring, treatment, medication, and supplies. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of patient's conditions.  As a direct and proximate result, the patient suffered severe and permanent physical injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury.   The reporter considered the event of bell's palsy to be related to zoster vaccine live (ZOSTAVAX).  Upon internal review the event of bell's palsy was considered to be medically significant.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Underdose
Clinical narrative: NO ADVERSE EVENT; 2 month old baby spit out ROTATEQ; This spontaneous report was received from an other health professional and refers to a 2-month-old patient. The patient's concurrent condition, medical history, concomitant medications, drugs reactions or allergies were not provided.  On an unknown date, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent(ROTATEQ), orally for prophylaxis (dose, lot # and expiration date were not provided). The reporter stated that a 2 month old baby spit out rotavirus vaccine, live, oral, pentavalent(ROTATEQ). There was no adverse event reported. The outcome of underdose was unknown.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This spontaneous report was received from a lawyer regarding a case in litigation referring to a patient (pt) of unknown age and gender. Information regarding current condition, historical condition or concomitant medication was not provided. In 2014, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, strength, route, batch/lot# and expiration date were unknown) by a pharmacist at a pharmacy for the long-term prevention of shingles and zoster-related conditions. On an unknown date, subsequent the pt's zoster vaccine live (ZOSTAVAX) inoculation, the pt was treated by a health care provider for shingles. As a direct and proximate result of the pt's use of the zoster vaccine live (ZOSTAVAX) vaccine, the pt had and would continue to 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 including 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 would continue to suffer such losses, and damages in the future. The outcome of shingles was unknown. The reporter considered shingles to be related to zoster vaccine live (ZOSTAVAX).
Sex: U
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: No additional adverse event; Incorrect storage of drug; administered post temperature excursion; This spontaneous report was received from a registered nurse concerning a patient of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical history provided. On 30-NOV-2020 , the patient was vaccinated with an unspecified dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9), prefilled syringe, dose:0.5 milliliter,  lot # T007024, expiration date: 23-APR-2022 for prophylaxis (dose number, and route of administration were not reported) post temperature excursion, but it was reported The vaccine administered experienced a temperature excursion of 9.2 degrees Celsius (C), for a time frame of 9 minutes. There was no previous temperature excursion reported and no data logger was involved. No additional adverse events were reported.  This is one of several reports received from the same reporter. 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: T007024; expirationdate: 23-APR-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2012USA000834: US-009507513-2012USA000976: US-009507513-2012USA000997: US-009507513-2012USA000913:
Sex: F
Vaccine: VARZOS
Symptoms: Balance disorder, Dysarthria, Facial paralysis, Facial paresis, Rash
Clinical narrative: Bell's Palsy; painful rash on her side; balance issues; vision problems; slurred speech; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or around January 2014, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (lot number, dosage and route of administration not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX) vaccine, the patient suffered a painful rash on her side, balance issues, facial weakness and paralysis, vision problems, and slurred speech. The patient was diagnosed with Bell's Palsy. The aforementioned injuries, which resulted in hospitalization, were caused by zoster vaccine live (ZOSTAVAX). 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 zoster vaccine live (ZOSTAVAX). The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of her condition. As 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 was considered not recovered/not resolved. The events were considered related to zoster vaccine live (ZOSTAVAX).  Upon internal review, Bell's Palsy were determined to be medically significant. The reporter considered all the events to be disability.
Sex: F
Vaccine: VARZOS
Symptoms: Visual impairment
Clinical narrative: Bell's Palsy; painful rash on her side; balance issues; vision problems; slurred speech; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or around January 2014, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (lot number, dosage and route of administration not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX) vaccine, the patient suffered a painful rash on her side, balance issues, facial weakness and paralysis, vision problems, and slurred speech. The patient was diagnosed with Bell's Palsy. The aforementioned injuries, which resulted in hospitalization, were caused by zoster vaccine live (ZOSTAVAX). 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 zoster vaccine live (ZOSTAVAX). The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of her condition. As 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 was considered not recovered/not resolved. The events were considered related to zoster vaccine live (ZOSTAVAX).  Upon internal review, Bell's Palsy were determined to be medically significant. The reporter considered all the events to be disability.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered
Clinical narrative: no adverse effects reported; patient was indavertently adminsitered a dose of Pneumovax 23 which had expired on 7/31/2020; This spontaneous report was received from a pharmacy technician, referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions/allergies, and concomitant therapies were not reported.  On 25-NOV-2020, the patient was inadvertently vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) as prophylaxis (strength and route of administration were not provided, frequency and lot number were unknown; expiration date was reported as 31-JUL-2020) (expired product administered). No adverse effects were reported. The outcome of expired product administered was unknown.
Sex: U
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: improperly stored vaccine; No additional AE; This spontaneous report has been received from an allied health, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided.  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) dose 1, lot # T007035 with expiration date 01-MAY-2022 ((strength, frequency, route and anatomical location were not provided) for prophylaxis.    The vaccine was stored at a temperature of 60 and 34 Fahrenheit degrees, time frame of 85 hours and 18 hours with no previous temperature excursion. Digital Data logger was involved. 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: T007035; expirationdate: 01-MAY-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration
Clinical narrative: This is the last dose of a 2-dose regimen; No additional AEs; This spontaneous report was received from a registered nurse referring to a female patient younger than 15 years old.   No information was provided regarding the patient's medical history, concurrent conditions, past drug history or concomitant medications.   On 26-JUN-2020 and on 02-DEC-2020, the patient was vaccinated with doses 1 and 2 of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) respectively, for prophylaxis  (dose, route and site of administration, lot number and expiration date were not reported).  The nurse stated that this was the last dose of a 2-dose regimen (inappropriate schedule of product administration).  Nurse originally called in to inquire of an alternate dosing schedule for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). No additional adverse events or product quality complains were reported.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: got a sh gles shot and by chance got the shingles/suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were received as follows: The age at vaccination was not reported. The patient got the shingles vaccine and experienced shingles. The reporter wanted to look at the ingredients first, aluminum, mercury and formaldehyde. This case was considered as suspected vaccination failure as time to onset, number of doses and laboratoty confirmatory test were unknown at the time of reporting.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Abdominal pain, Arthralgia, Dizziness, Hyperhidrosis
Clinical narrative: It was itchy; A one pus filled pimple at the site of injection; A one pus filled pimple at the site of injection / It was red\Red around the injection site; Still tender at the site of injection; Feeling of passing out; Arm was sore; Had sweating; Joint ache; Nausea / sick to stomach / a rolling feeling inside her stomach; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th October 2020, the patient received the 1st dose of Shingrix. On 20th October 2020, less than a day after receiving Shingrix, the patient experienced pain in arm, sweating, joint pain and nausea. On 21st October 2020, the patient experienced feels awful. On 10th November 2020, the patient experienced injection site eruption and injection site erythema. On 14th November 2020, the patient experienced injection site itching. In November 2020, the patient experienced injection site tenderness. On an unknown date, the outcome of the pain in arm, sweating, joint pain, nausea and feels awful were recovered/resolved and the outcome of the injection site eruption, injection site erythema, injection site itching and injection site tenderness were unknown.   It was unknown if the reporter considered the pain in arm, sweating, joint pain, nausea, feels awful, injection site eruption, injection site erythema, injection site itching and injection site tenderness to be related to Shingrix.  Additional details were received as follows: The patient had first dose of the Shingrix vaccine in her left arm and that night her arm was sore, and had sweating, joint ache, and nausea and the next day, she had the feeling of passing out, she was sick to her stomach with a rolling feeling inside her stomach, which all resolved. Three weeks later she had a one pus filled pimple at the site of injection and it was red and 4 days later it was itchy, and red around the injection site. At the time of reporting, the injection site was tender. The reporter consented to follow up.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site rash, Malaise
Clinical narrative: It was itchy; A one pus filled pimple at the site of injection; A one pus filled pimple at the site of injection / It was red\Red around the injection site; Still tender at the site of injection; Feeling of passing out; Arm was sore; Had sweating; Joint ache; Nausea / sick to stomach / a rolling feeling inside her stomach; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th October 2020, the patient received the 1st dose of Shingrix. On 20th October 2020, less than a day after receiving Shingrix, the patient experienced pain in arm, sweating, joint pain and nausea. On 21st October 2020, the patient experienced feels awful. On 10th November 2020, the patient experienced injection site eruption and injection site erythema. On 14th November 2020, the patient experienced injection site itching. In November 2020, the patient experienced injection site tenderness. On an unknown date, the outcome of the pain in arm, sweating, joint pain, nausea and feels awful were recovered/resolved and the outcome of the injection site eruption, injection site erythema, injection site itching and injection site tenderness were unknown.   It was unknown if the reporter considered the pain in arm, sweating, joint pain, nausea, feels awful, injection site eruption, injection site erythema, injection site itching and injection site tenderness to be related to Shingrix.  Additional details were received as follows: The patient had first dose of the Shingrix vaccine in her left arm and that night her arm was sore, and had sweating, joint ache, and nausea and the next day, she had the feeling of passing out, she was sick to her stomach with a rolling feeling inside her stomach, which all resolved. Three weeks later she had a one pus filled pimple at the site of injection and it was red and 4 days later it was itchy, and red around the injection site. At the time of reporting, the injection site was tender. The reporter consented to follow up.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea
Clinical narrative: It was itchy; A one pus filled pimple at the site of injection; A one pus filled pimple at the site of injection / It was red\Red around the injection site; Still tender at the site of injection; Feeling of passing out; Arm was sore; Had sweating; Joint ache; Nausea / sick to stomach / a rolling feeling inside her stomach; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th October 2020, the patient received the 1st dose of Shingrix. On 20th October 2020, less than a day after receiving Shingrix, the patient experienced pain in arm, sweating, joint pain and nausea. On 21st October 2020, the patient experienced feels awful. On 10th November 2020, the patient experienced injection site eruption and injection site erythema. On 14th November 2020, the patient experienced injection site itching. In November 2020, the patient experienced injection site tenderness. On an unknown date, the outcome of the pain in arm, sweating, joint pain, nausea and feels awful were recovered/resolved and the outcome of the injection site eruption, injection site erythema, injection site itching and injection site tenderness were unknown.   It was unknown if the reporter considered the pain in arm, sweating, joint pain, nausea, feels awful, injection site eruption, injection site erythema, injection site itching and injection site tenderness to be related to Shingrix.  Additional details were received as follows: The patient had first dose of the Shingrix vaccine in her left arm and that night her arm was sore, and had sweating, joint ache, and nausea and the next day, she had the feeling of passing out, she was sick to her stomach with a rolling feeling inside her stomach, which all resolved. Three weeks later she had a one pus filled pimple at the site of injection and it was red and 4 days later it was itchy, and red around the injection site. At the time of reporting, the injection site was tender. The reporter consented to follow up.
Age: 58.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Back pain, Blister, Herpes zoster, Pain in extremity, Vaccination failure
Clinical narrative: noticed two blisters, one below her neck and one on the right side of her back; Suspected vaccination failure; shingles; right sided back pain; right arm pain; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a 58-year-old female patient who received Herpes zoster (Shingrix) (batch number ER5ZB, expiry date 9th June 2021) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) (batch number K2ZY4, expiry date 13th April 2021) for prophylaxis.   On 12th March 2019, the patient received the 2nd dose of Shingrix. On 27th November 2018, the patient received the 1st dose of Shingrix. On 28th November 2020, 627 days after receiving Shingrix and 732 days after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, back pain and pain in arm. On 29th November 2020, the patient experienced blister. The patient was treated with valaciclovir (Valacyclovir). On an unknown date, the outcome of the vaccination failure, shingles, back pain, pain in arm and blister were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, back pain, pain in arm and blister to be related to Shingrix and Shingrix.  Additional details were provided as follows: The patient had reported the events for herself. The patient started to experience severe right sided back pain and right arm pain and on sunday 29th November 2020, she noticed two blisters, one below her neck and one on the right side of her back and she was diagnosed with shingles. The patient was started on valcyclovir. This case was considered to be a suspected vaccination failure case, as the details regarding laboratory confirmation for shingles was unknown. The reporter consented to follow-up.
Sex: U
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: sick; Initial information was received on 12-Oct-2020 regarding an unsolicited valid non-serious social media case from a consumer via Social media.  This case involves a patient (unknown demography) who was sick for 2 to 3 days (illness), while the patient received INFLUENZA VACCINE.  Medical history, medical treatments, concomitant medications, vaccinations and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient was sick for 2 to 3 days (illness, non-serious event) (unknown latency) following the administration of INFLUENZA VACCINE.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of report, the outcome was unknown for the event.  There will be no information available on the lot number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: got sick; Initial information was received on 12-Oct-2020 regarding an unsolicited valid non-serious case received from a patient (consumer or non-health care professional0 via Social media.  This case is linked to case 2020SA289370. (same reporter)  This case involves patient with unknown demographics who experienced got sick (illness), while patient received INFLUENZA VACCINE.  It was reported that, patient every year vaccinated with  INFLUENZA VACCINE (Flu shot) and every year got sick for 2-3 days.  Past medical treatment, family history and concomitant medication/therapy were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [lot number and expiry date not reported] via an unknown route at unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious got sick (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, the event outcome reported as unknown for illness.   There will be no information available on the batch number for this case.
Sex: M
Vaccine: FLUX
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Injection area just a small tender bump; Injection area just a small tender bump; Initial information was received on 10-Oct-2020 regarding an unsolicited valid non-serious social media case from the non-health care professional (patient's wife).  This case is linked to case 2020SA289784 (same reporter).  This case involves a 76 years old male patient who had a small tender bump at injection area (vaccination site pain and vaccination site mass), after he received INFLUENZA VACCINE.  The patient had received flu vaccines in the past for prophylactic vaccination.  The patient's medical history, past medical treatment, family history and concomitant medication were not reported.   On an unknown date, the patient received a high dose of suspect senior INFLUENZA VACCINE produced by unknown manufacturer (batch number and other dosing details were not reported) for prophylactic vaccination.  On an unknown date, the patient developed non-serious a small tender bump at injection area (vaccination site pain and vaccination site mass), (unknown latency) following the administration of INFLUENZA VACCINE. Otherwise the patient was perfectly fine.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, the outcome of the events was not reported.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: flu; Initial information received on 13-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer/non- healthcare professional via social media.  This case is linked to case 2020SA290167(same reporter).  This case involves patient (age and gender unspecified) who experienced flu (influenza), while he/she received vaccine INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (batch number and expiration date unknown) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient experienced flu (influenza), (unknown latency, non-serious event).  No laboratory data was provided.   It was not reported if the patient received a corrective treatment.  At the time of report, the outcome of event was unknown.  There will be no information available on the batch number for this case.
Sex: F
Vaccine: FLUX
Symptoms: Hot flush
Clinical narrative: slight hot flash reaction; Initial information was received on 13-Oct-2020 regarding an unsolicited valid non-serious case from a consumer/non-health care professional (patient).   This case involves female patient (age unspecified) who had a slight hot flash reaction (hot flush), while she received INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On an unknown date, the patient received a mega dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious slight hot flash reaction (hot flush) 1 day following the administration of INFLUENZA VACCINE for 45 minutes.  No laboratory data was provided.  It was not reported if the patient received a corrective treatment.  On an unknown date, the patient recovered from the event.  There will be no information available on the batch number for this case.
Sex: F
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: home sick with the flu; Initial information received on 14-Oct-2020 regarding an unsolicited valid non-serious case from a consumer/non-healthcare professional.  This case is linked to case 2020SA291094 (same reporter).  This case involves a female patient of unknown age who was home sick with the flu (influenza), while she received vaccine influenza vaccine.  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.   Concomitant medication was not reported.  On an unknown date, the patient received a dose of suspect influenza vaccine (lot number and expiration date not reported) via unknown route in unknown administration site for prophylaxis vaccination.   On an unknown date, 2 days after initiation of suspect vaccine therapy, the patient was home sick with the flu (influenza).   No laboratory data was provided.   It was not reported if the patient received a corrective treatment.  At the time of report, the outcome of event was unknown.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: patient was home sick with the flu; Initial information received on 14-Oct-2020 regarding an unsolicited valid non-serious case received from a non-health care professional via digital media through social media.  This case is linked to cases 2020SA291094 (same reporter).  This case involves a patient (age and gender unknown) who had home sick with the flu (influenza), while the patient received vaccine Influenza vaccine.  The patient's medical history, past medical treatment(s), concomitant therapy, vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect Influenza Vaccine produced by unknown manufacturer (lot number and expiry date not reported) via unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, (latency: unknown) after starting the suspect vaccine therapy, within 2 days ,  the patient had home sick with the flu (influenza) .  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, outcome of the event was unknown.   There will be no information available on batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Influenza, Vaccine positive rechallenge
Clinical narrative: Flu; Initial information was received on 14-Oct-2020 regarding an unsolicited valid non-serious case from a consumer/non-healthcare professional.  This case is linked to cases 2020SA291983, 2020SA291967, 2020SA291968, 2020SA291969, 2020SA291970, 2020SA291971, 2020SA291972, 2020SA291980, 2020SA291973, 2020SA291974, 2020SA291975, 2020SA291976, 2020SA291977, 2020SA291978, 2020SA291979, 2020SA291981, 2020SA291982, 2020SA291966 and 2020SA291965.  This case involves a patient (age and gender unspecified) who had flu (influenza) after received INFLUENZA VACCINE.  Medical history, medical treatment(s), past vaccination(s), concomitant medications and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE. Consumer have had the flu shot twice in life, and both time got the flu. The only two times consumer have ever had it.  No laboratory data was provided.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome of events were unknown.  There will be no information available on the batch number for this case..
Sex: M
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: Sick; Initial information was received on 14-Oct-2020 regarding an unsolicited valid non-serious case from a consumer or non-health care professional.   This case involves a male patient (age unspecified) who got sick (illness), while patient received INFLUENZA VACCINE [flu shot].  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [lot number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient got sick (illness) for 5 days (unknown latency) following the administration of INFLUENZA VACCINE.  Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, the event outcome reported as unknown for event.  There will be no information available on the lot number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: Friend got the flu shot last week & has the flu this week vaccines are trash; Initial information received on 15-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional. This case is linked to case 2020SA292385 (original case).  This case involves patient (unspecified gender and age) reported friend got the flu shot last week and had the flu this week vaccines were trash (influenza), while he/she received vaccine INFLUENZA VACCINE .  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (batch number and expiration date unknown) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient reported that friend got the flu shot last week and had the flu this week vaccines were trash (influenza), (unknown latency, non-serious event).  No laboratory data was provided.  It was not reported if the patient received a corrective treatment.  At the time of report, the outcome of event was unknown.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Malaise, Mobility decreased, Pyrexia, Vomiting
Clinical narrative: puking, feverish and laid up in bed; Initial information received on 15-Oct-2020 regarding an unsolicited valid non-serious case from a consumer (patient). This case involves an adult patient with an unknown demographics who experienced puking, feverish and laid up in bed (pyrexia), while he/she received vaccine Influenza Vaccine.  The patient's medical history, past medical treatment(s), concomitant therapy, vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect Influenza Vaccine produced by unknown manufacturer (lot number and expiry date not reported) via unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, patient stated that he/she had been getting them since he/she was 21 and for 26 years not a problem. He/she gotten sick but not dragging it out for days, puking, feverish and laid up in bed (pyrexia) (Unknown latency) following the administration of Influenza Vaccine.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, outcome of the event was unknown.   There will be no information available on batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: felt terrible for about 36 hours; was sick for about 24 hours years ago; Initial information received on 15-Oct-2020 regarding an unsolicited valid non-serious case from a consumer (patient).   This case is linked to case ID: 2020SA292420, 2020SA292419, 2020SA292422, 2020SA292423, 2020SA292424, 2020SA292425, 2020SA292426, 2020SA292410, 2020SA292411, 2020SA292412, 2020SA292413, 2020SA292414, 2020SA292385, 2020SA292416, 2020SA292417, 2020SA292418, 2020SA292421.  This case involves a patient of unknown demographics who was sick for about 24 hours years ago (illness) and felt terrible for about 36 hours (feeling abnormal), after receiving INFLUENZA VACCINE.  The patient's medical history, past medical treatments, vaccinations, concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiration date not reported) via an unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient was sick for about 24 hours years ago (illness) and felt terrible for about 36 hours (feeling abnormal), (non-serious event) (unknown latency) following the administration of INFLUENZA VACCINE.  No laboratory data reported.  It was not reported if the patient received a corrective treatment.  At the time of report, the outcome was unknown for the events.  There will be no information on the batch number for this case.