chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Blindness, Cerebrovascular accident, Facial paralysis, Myalgia, Nervous system injury
Clinical narrative: stroke; vision loss; Bell's Palsy; paralysis; severe nerve and muscle pain; severe nerve and muscle pain; neurological injury; Information has been received from a lawyer regarding a case in litigation referring to a female patient of unknown age. Information about medical history, concurrent condition and concomitant medication was not reported. On 24-AUG-2017, the patient was inoculated with Zoster Vaccine Live (ZOSTAVAX) at a pharmacy for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving Zoster Vaccine Live (ZOSTAVAX), in December 2017, the patient suffered debilitating injuries including severe nerve and muscle pain and paralysis, neurological injuries, Bell's Palsy, stroke and vision loss. These injuries were caused by Zoster Vaccine Live (ZOSTAVAX) and resulted in hospitalization and medical treatment. These symptoms lasted for months and greatly diminished the patient's quality of life and ability to function. 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) and caused by the Zoster Vaccine Live (ZOSTAVAX). The patient also experiences mental and emotional distress due to resulting 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 debilitating personal injuries. Further, as a tragic consequence of Zoster Vaccine Live (ZOSTAVAX), the patient suffered serious, progressive, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result 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 severe nerve and muscle pain and paralysis, neurological injuries, Bell's Palsy, stroke and vision loss was not recovered and the lawyer considered all the events to be related to Zoster Vaccine Live (ZOSTAVAX).   Upon internal review, the events paralysis, Bell's Palsy, stroke and vision loss were determined to be medically significant events.
Sex: F
Vaccine: VARZOS
Symptoms: Neuralgia, Paralysis
Clinical narrative: stroke; vision loss; Bell's Palsy; paralysis; severe nerve and muscle pain; severe nerve and muscle pain; neurological injury; Information has been received from a lawyer regarding a case in litigation referring to a female patient of unknown age. Information about medical history, concurrent condition and concomitant medication was not reported. On 24-AUG-2017, the patient was inoculated with Zoster Vaccine Live (ZOSTAVAX) at a pharmacy for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving Zoster Vaccine Live (ZOSTAVAX), in December 2017, the patient suffered debilitating injuries including severe nerve and muscle pain and paralysis, neurological injuries, Bell's Palsy, stroke and vision loss. These injuries were caused by Zoster Vaccine Live (ZOSTAVAX) and resulted in hospitalization and medical treatment. These symptoms lasted for months and greatly diminished the patient's quality of life and ability to function. 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) and caused by the Zoster Vaccine Live (ZOSTAVAX). The patient also experiences mental and emotional distress due to resulting 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 debilitating personal injuries. Further, as a tragic consequence of Zoster Vaccine Live (ZOSTAVAX), the patient suffered serious, progressive, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result 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 severe nerve and muscle pain and paralysis, neurological injuries, Bell's Palsy, stroke and vision loss was not recovered and the lawyer considered all the events to be related to Zoster Vaccine Live (ZOSTAVAX).   Upon internal review, the events paralysis, Bell's Palsy, stroke and vision loss were determined to be medically significant events.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received from a lawyer regarding a case in litigation referring to a female patient of unknown age. Information about medical history, concurrent condition and concomitant medication was not reported. On or around 24-JUL-2013, the patient was inoculated 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 a bad case of the shingles. 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 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 event shingles was not recovered. Causality was assessed as related.   The lawyer considered the event shingles to be disability.
Sex: F
Vaccine: VARZOS
Symptoms: Depressed level of consciousness, Dizziness, Headache
Clinical narrative: feelings of decreased levels of consciousness; bouts of dizziness; headaches; Information has been received from lawyers and a consumer referring to a female patient of unknown age. The patient's medical history, concurrent condition and concomitant therapy were not reported.  On an unknown date, the patient was vaccinated with Zoster Vaccine Live (ZOSTAVAX) (strength, dose, frequency, route, lot# and expiration date were unknown) for routine health maintenance and the prevention of shingles (herpes zoster).  On an unknown date, the patient experienced bouts of dizziness, headaches and feelings of decreased levels of consciousness. As a result of these symptoms, the patient was seen and treated under medical provider. The patient did not recover from the events. As per the reporter, 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. The events were disabling.   The reporter considered the events was related to Zoster Vaccine Live (ZOSTAVAX).  Upon internal review, the event of feelings of decreased levels of consciousness was determined to be medically significant.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; patient received improperly stored dose of vaccine; This spontaneous report was received from a nurse referring to a 4 years old patient of unknown gender. Information about concurrent condition, concomitant medication or medical history was not provided.   On 23-SEP-2019, the patient was vaccinated with improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # S009756, expiration date 27-SEP-2020; vaccine dosage detail  and route were not reported) for prophylaxis, which was reconstituted with properly stored sterile diluent product storage error). Current temperature excursion was -14 Celsius degrees to -10 Celsius degrees (-13 Celsius degrees) for 3 days. There was no previous temperature excursion. No adverse effects were reported. Data logger was involved.
Age: 30.0
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: patient, who is pregnant received a dose of gardasil 9; no adverse effects; This spontaneous prospective pregnancy report was received from a medical assistant referring to a 30-year-old female patient. Her concurrent conditions, medical history, concomitant medications and drug reactions/allergies were not reported.  On 14-OCT-2019, 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 # R011630 and expiration date: 12-DEC-2020) for prophylaxis (strength, route and anatomical location were not reported) (exposure during pregnancy). The last menstrual period (LMP) and estimated date of conception was estimated to be 02-FEB-2019 and 16-FEB-2019. The gestational age was reported to be 36 weeks and 4 days. The estimated date of delivery was reported to be 09-NOV-2019. No adverse effects were reported. The pregnancy outcome was outcome pending. The outcome of exposure during pregnancy was unknown. No product quality complaint (PQC) was involved.
Age: 18.0
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: no adverse effect reported; second dose of GARDASIL 9 about a week ago after was administered first dose of GARDASIL 9 about a year ago; This spontaneous report was received from a pharmacist via company representative refers to a 19 year old male patient. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies or concomitant medications were not reported.   Approximately on an unknown date in October 2018 (reported as "about a year ago"), the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9), first dose (strength, dose, route of administration, lot/batch # and expiration date were not reported) for prophylaxis.   Approximately on 09-OCT-2019 (reported as "about a week ago"), the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9), second dose (strength, dose, route of administration, lot/batch # and expiration date were not reported) for prophylaxis (inappropriate schedule of product administration). The patient experienced no adverse event. No product quality complaint (PQC) was reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; the patient received an improperly stored dose of VARIVAX; This spontaneous report was received from a registered nurse concerning a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug reactions and allergies were not reported. The concomitant medications included sterile diluent.  On 10-OCT-2019, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) lot # S005078, expiration date 19-FEB-2021, administered subcutaneously as prophylaxis (dose, frequency and site of administration were not reported).   It was reported that the vaccine was improperly storage, because it stayed from -14 degree centigrade (°C) to '10°C for 45 minutes and from '9°C to 8 °C (-5°C) for an hour and 15 minutes (product storage error). No adverse effects were reported
Age: 18.0
Sex: M
Vaccine: HPV9
Symptoms: Urticaria
Clinical narrative: hives all over his body; This spontaneous report as received from a consumer refers to a 18 year old male patient.    On 03-OCT-2019 the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) dose 2 in the right arm for prophylaxis.       On 03-OCT-2019, 1 day after onset of therapy the patient experienced urticaria.    The outcome of urticaria was reported as not recovered/not resolved.
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Arm Pain; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   In May 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient herself. The age at vaccination was not reported. The patient received 1st dose in left arm and her arm hurt. The reporter did not consent to follow-up. For tolerance of 2nd dose, refer case This case had been linked to the case US2019187014 and --, reported by the same reporter.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Injection site pain; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd August 2019, the patient received the 1st dose of Shingrix. On an unknown date, several days after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient's husband. The patient dose of Shingrix in the left arm. The reporter stated that, after vaccination, the patient exerienced injection site pain which resolved in few days. The reporter consented to follow up. For the tolerence of 2nd dose refer case US2019AMR188461. This case has been linked with case US2019187932 reported by same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Feeling abnormal, Product use in unapproved indication
Clinical narrative: Feel terrible; Post herpetic neuralgia; This case was reported by a consumer and described the occurrence of feels awful in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included post herpetic neuralgia.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced feels awful and drug use for unapproved indication. On an unknown date, the outcome of the feels awful and drug use for unapproved indication were unknown.   It was unknown if the reporter considered the feels awful to be related to Shingrix.  Additional information received were as follows: The age at vaccination was not reported. The patient had active post herpetic neuralgia and received the shingrix vaccination.  The patient asked would it still work and the patient felt terrible and asked was that normal.
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue, Pain in extremity, Vertigo
Clinical narrative: Vertigo; Was super tired; Arm hurts; This case was reported by a consumer and described the occurrence of vertigo in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14th October 2019, the patient received the 2nd dose of Shingrix. On 15th October 2019, 1 days after receiving Shingrix, the patient experienced tiredness and pain in arm. On 16th October 2019, the patient experienced vertigo. On an unknown date, the outcome of the vertigo, tiredness and pain in arm were unknown.   It was unknown if the reporter considered the vertigo, tiredness and pain in arm to be related to Shingrix.  Additional information received were as follows: The age at vaccination was not reported. On monday, the patient received second shot of Shingrix. On the reporting date, 2 days after receiving Shingrix, the patient experienced vertigo. The patient asked whether that was a normal side effect. The day before reporting date, the patient was super tired and arm was hurt and went to bed at night. This was new on the reporting date.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Suspected shingles; This case was reported by a other health professional via sales rep and described the occurrence of shingles in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 8th October 2019, the patient received the 1st dose of Shingrix. On 15th October 2019, 7 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional information received were as follows: The age at vaccination was not reported. On the reporting date, the patient presented with suspected shingles. The patient was sent for cultures for diagnosis.  The clinic would follow up with Glaxosmithkline with outcome.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Injection site erythema, Injection site pain, Injection site pruritus, Nausea
Clinical narrative: Injection site erythema; Itching; Injection site pain/ tenderness, pain to touch at injection site; Fatigue; Nausea; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 78-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site pain (received 1st dose on 2nd August 2019 and experienced fatigue, refer case US2019187932).   On 14th October 2019, the patient received the 2nd dose of Shingrix. On 14th October 2019, less than a day after receiving Shingrix, the patient experienced injection site pain, fatigue and nausea. On 16th October 2019, the patient experienced injection site erythema and injection site itching. Rechallenge with Shingrix was positive. On 16th October 2019, the outcome of the injection site pain, fatigue and nausea were recovered/resolved. On an unknown date, the outcome of the injection site erythema and injection site itching were unknown.   It was unknown if the reporter considered the injection site pain, fatigue, nausea, injection site erythema and injection site itching to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in left arm. On the same day, after receiving Shingrix, the patient experienced injection site pain with nausea and fatigue.  The nausea and fatigue resolved in 48 hours. On the date of reporting, the patient noticed redness about 1 inch from the injection site with diameter of about 3-4 inches which included tenderness, pain to touch and itching. The reporter consented to follow up.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Vaccine positive rechallenge
Clinical narrative: Injection site erythema; Itching; Injection site pain/ tenderness, pain to touch at injection site; Fatigue; Nausea; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 78-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site pain (received 1st dose on 2nd August 2019 and experienced fatigue, refer case US2019187932).   On 14th October 2019, the patient received the 2nd dose of Shingrix. On 14th October 2019, less than a day after receiving Shingrix, the patient experienced injection site pain, fatigue and nausea. On 16th October 2019, the patient experienced injection site erythema and injection site itching. Rechallenge with Shingrix was positive. On 16th October 2019, the outcome of the injection site pain, fatigue and nausea were recovered/resolved. On an unknown date, the outcome of the injection site erythema and injection site itching were unknown.   It was unknown if the reporter considered the injection site pain, fatigue, nausea, injection site erythema and injection site itching to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in left arm. On the same day, after receiving Shingrix, the patient experienced injection site pain with nausea and fatigue.  The nausea and fatigue resolved in 48 hours. On the date of reporting, the patient noticed redness about 1 inch from the injection site with diameter of about 3-4 inches which included tenderness, pain to touch and itching. The reporter consented to follow up.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Lip swelling, Pyrexia, Swelling face
Clinical narrative: Facial swelling; Facial swelling; Fever; Stomach issues; Shivering; This case was reported by a consumer via call center representative and described the occurrence of fever in a 67-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 6th July 2019, refer case US2019187014). Concomitant products included lisinopril.   On 8th October 2019, the patient received the 2nd dose of Shingrix .5 ml. On 14th October 2019, 6 days after receiving Shingrix, the patient experienced facial swelling and lip swelling. In October 2019, the patient experienced fever, stomach discomfort and shivering. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the fever, stomach discomfort, shivering, facial swelling and lip swelling were recovered/resolved.   It was unknown if the reporter considered the fever, stomach discomfort, shivering, facial swelling and lip swelling to be related to Shingrix.  Additional details were provided as follows: The patient received 1st dose in left arm on Thursday of 8th October 2019. After some days over the weekend, the patient developed a fever of 101.5, stomach issues and shivering. On 14th October 2019 morning, the caller reported her husband woke up with facial and lip swelling. He went to the doctor on 15th October 2019 and they were unsure if facial swelling was a reaction from Shingrix, from the Tylenol he took over the weekend to help with fever, or if it was from his lisinopril which he had reportedly taken for years. Caller reports this reaction was not similar at all to 1st dose where only his arm had hurt. The reporter did not consent to follow-up. This case had been linked to the case US2019187018 and US2019AMR188516, reported by the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Vaccine positive rechallenge
Clinical narrative: Arm Pain; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in May 2019, refer case US2019187018).   In July 2019, the patient received the 2nd dose of Shingrix (intramuscular). On an unknown date, less than 4 months after receiving Shingrix, the patient experienced pain in arm. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient herself. The age at vaccination was not reported. The patient received 1st dose in left arm and her arm hurt. The reporter did not consent to follow-up. This case had been linked to the case US2019187014 and US2019AMR188510, reported by the same reporter.
Sex: F
Vaccine: FLU4
Symptoms: Chills, Dysuria, Guillain-Barre syndrome, Haematuria, Pyrexia
Clinical narrative: Concerned that she was developing Guillain-Barré syndrome; Urinary incontinence with burning; Hematuria; Fever; chills; Urinary incontinence with burning; This case was reported by a nurse via call center representative and described the occurrence of guillain barre syndrome in a female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2019-2020 season) (batch number K72SN, expiry date 30th June 2020) for prophylaxis.   On 8th October 2019, the patient received Fluarix Quadrivalent 2019-2020 season. On 8th October 2019, less than a day after receiving Fluarix Quadrivalent 2019-2020 season, the patient experienced guillain barre syndrome (serious criteria GSK medically significant), urinary incontinence, hematuria, fever, chills and micturition burning. The patient was treated with ciprofloxacin. On an unknown date, the outcome of the guillain barre syndrome was unknown and the outcome of the urinary incontinence, hematuria, fever, chills and micturition burning were recovering/resolving.   It was unknown if the reporter considered the guillain barre syndrome, urinary incontinence, hematuria, fever, chills and micturition burning to be related to Fluarix Quadrivalent 2019-2020 season.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Fluarix Quadrivalent 2019-2020 season and developed urinary incontinence with burning, hematuria, fever and chills within 4 to 5 hours. The patient had not seen her PCP but self-treated at home with Ciprofloxacin. The patient was concerned that she was developing Guillain-Barre syndrome. The patient had not sought treatment from a provider. The symptoms had not fully resolved at the time of the call. The reporter consented to follow up.
Sex: F
Vaccine: FLU4
Symptoms: Urinary incontinence
Clinical narrative: Concerned that she was developing Guillain-Barré syndrome; Urinary incontinence with burning; Hematuria; Fever; chills; Urinary incontinence with burning; This case was reported by a nurse via call center representative and described the occurrence of guillain barre syndrome in a female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2019-2020 season) (batch number K72SN, expiry date 30th June 2020) for prophylaxis.   On 8th October 2019, the patient received Fluarix Quadrivalent 2019-2020 season. On 8th October 2019, less than a day after receiving Fluarix Quadrivalent 2019-2020 season, the patient experienced guillain barre syndrome (serious criteria GSK medically significant), urinary incontinence, hematuria, fever, chills and micturition burning. The patient was treated with ciprofloxacin. On an unknown date, the outcome of the guillain barre syndrome was unknown and the outcome of the urinary incontinence, hematuria, fever, chills and micturition burning were recovering/resolving.   It was unknown if the reporter considered the guillain barre syndrome, urinary incontinence, hematuria, fever, chills and micturition burning to be related to Fluarix Quadrivalent 2019-2020 season.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Fluarix Quadrivalent 2019-2020 season and developed urinary incontinence with burning, hematuria, fever and chills within 4 to 5 hours. The patient had not seen her PCP but self-treated at home with Ciprofloxacin. The patient was concerned that she was developing Guillain-Barre syndrome. The patient had not sought treatment from a provider. The symptoms had not fully resolved at the time of the call. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Extensive swelling of vaccinated limb, Injected limb mobility decreased
Clinical narrative: Arm swelling; Severe arm redness; Unable to use arm; This case was reported by a nurse via call center representative and described the occurrence of extensive swelling of vaccinated limb in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced extensive swelling of vaccinated limb, erythema of extremities and injected limb mobility decreased. On an unknown date, the outcome of the extensive swelling of vaccinated limb and erythema of extremities were unknown and the outcome of the injected limb mobility decreased was recovered/resolved.   It was unknown if the reporter considered the extensive swelling of vaccinated limb, erythema of extremities and injected limb mobility decreased to be related to Shingrix.  Additional information received were as follows: The age at vaccination was not reported. The patient experienced severe arm redness and extensive swelling of vaccinated limb following the first injection of Shingrix. The reporter's collaborative doctor and reporter did not know if this patient could receive the second injection safely. The reporter asked what do they thought. The patient's whole arm had reddnes swelling and she was not able to use her arm for one month. The reporter consented to follow up. The visitor stated that she was busy seeing patients and did not provide patient demographics.
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Bedridden, Fatigue, Rash pruritic
Clinical narrative: No energy / Lack of energy; Hasn't been able to get out of bed; Spots on back near butt.  Like a rash and has itching associated with it; Tired; This case was reported by a consumer via call center representative and described the occurrence of loss of energy in a 71-year-old male patient who received Herpes zoster (Shingrix) (batch number M9P52, expiry date 18th December 2021) for prophylaxis.   On 7th October 2019, the patient received the 1st dose of Shingrix. In October 2019, less than a week after receiving Shingrix, the patient experienced loss of energy, bedridden, itchy rash and fatigue. On an unknown date, the outcome of the loss of energy, bedridden, itchy rash and fatigue were unknown.   It was unknown if the reporter considered the loss of energy, bedridden, itchy rash and fatigue to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient's wife. The age at vaccination was not reported but could be between 70 or 71 years. The reporter stated that patient had no energy, but on the day of reporting has been the worst thus far.  The patient was not been able to get out of bed. had an appointment that he cancelled on the day of reporting. The reporter stated that had spots on his back near his butt like a rash and has itching associated with it. The patient was seen at his physician last Friday for an appointment that was already planned. The patient also felt tired but the spots were not evaluated as they were not present. The reporter stated that there were plans to test for viruses that may be causing the lack of energy, but they are waiting for paperwork of where to go for the testing. The reporter was encouraged to have patient discuss the rash with his doctor and the continued lack of energy and itching. The reporter did not consent to follow up.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Decreased appetite, Fatigue, Influenza like illness, Injected limb mobility decreased
Clinical narrative: Flu like symptoms; fever; fatigue; Gave the injection too far up in the arm / Thinks it was in the deltoid, but not in the biggest part of the deltoid; Stomach issues; loss of appetite; pain left the arm; Red spot below the injection site; Hard and firm spot below the injection site; Spot is sore; Left shoulder is sore and hurts to move it; Left shoulder is sore and hurts to move it; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th October 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 10th October 2019, unknown after receiving Shingrix, the patient experienced vaccine administered at inappropriate site. On 11th October 2019, the patient experienced influenza-like symptoms, fever and fatigue. In October 2019, the patient experienced stomach discomfort, appetite lost, injection site pain, red rash, skin induration, painful rash, shoulder pain and injected limb mobility decreased. On an unknown date, the outcome of the influenza-like symptoms, fever and fatigue were recovered/resolved and the outcome of the stomach discomfort, appetite lost, injection site pain, red rash and skin induration were not recovered/not resolved and the outcome of the painful rash, shoulder pain, injected limb mobility decreased and vaccine administered at inappropriate site were unknown.   It was unknown if the reporter considered the influenza-like symptoms, fever, fatigue, stomach discomfort, appetite lost, injection site pain, red rash, skin induration, painful rash, shoulder pain and injected limb mobility decreased to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient herself. The patient thought that the pharmacist gave the injection too far up in the left arm. It was in the deltoid, but not in the biggest part of the deltoid. It was given about 1 finger breadth down from the acromion process. One day after receiving the vaccine, the patient developed flu like symptoms, including fever and fatigue. Also the patient developed stomach issues, loss of appetite and pain in the left arm after 1 day of vaccination. A couple of days after receiving the vaccine, patient developed a hard and firm, red spot approximately 4 inches below the injection site and this spot was sore. Less than a week after receiving the vaccine, the entire left shoulder was sore and it hurt to move it. The reporter did not consent to follow-up.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Musculoskeletal pain, Pain
Clinical narrative: Flu like symptoms; fever; fatigue; Gave the injection too far up in the arm / Thinks it was in the deltoid, but not in the biggest part of the deltoid; Stomach issues; loss of appetite; pain left the arm; Red spot below the injection site; Hard and firm spot below the injection site; Spot is sore; Left shoulder is sore and hurts to move it; Left shoulder is sore and hurts to move it; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th October 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 10th October 2019, unknown after receiving Shingrix, the patient experienced vaccine administered at inappropriate site. On 11th October 2019, the patient experienced influenza-like symptoms, fever and fatigue. In October 2019, the patient experienced stomach discomfort, appetite lost, injection site pain, red rash, skin induration, painful rash, shoulder pain and injected limb mobility decreased. On an unknown date, the outcome of the influenza-like symptoms, fever and fatigue were recovered/resolved and the outcome of the stomach discomfort, appetite lost, injection site pain, red rash and skin induration were not recovered/not resolved and the outcome of the painful rash, shoulder pain, injected limb mobility decreased and vaccine administered at inappropriate site were unknown.   It was unknown if the reporter considered the influenza-like symptoms, fever, fatigue, stomach discomfort, appetite lost, injection site pain, red rash, skin induration, painful rash, shoulder pain and injected limb mobility decreased to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient herself. The patient thought that the pharmacist gave the injection too far up in the left arm. It was in the deltoid, but not in the biggest part of the deltoid. It was given about 1 finger breadth down from the acromion process. One day after receiving the vaccine, the patient developed flu like symptoms, including fever and fatigue. Also the patient developed stomach issues, loss of appetite and pain in the left arm after 1 day of vaccination. A couple of days after receiving the vaccine, patient developed a hard and firm, red spot approximately 4 inches below the injection site and this spot was sore. Less than a week after receiving the vaccine, the entire left shoulder was sore and it hurt to move it. The reporter did not consent to follow-up.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Product administered at inappropriate site, Pyrexia, Rash, Rash erythematous, Skin induration
Clinical narrative: Flu like symptoms; fever; fatigue; Gave the injection too far up in the arm / Thinks it was in the deltoid, but not in the biggest part of the deltoid; Stomach issues; loss of appetite; pain left the arm; Red spot below the injection site; Hard and firm spot below the injection site; Spot is sore; Left shoulder is sore and hurts to move it; Left shoulder is sore and hurts to move it; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th October 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 10th October 2019, unknown after receiving Shingrix, the patient experienced vaccine administered at inappropriate site. On 11th October 2019, the patient experienced influenza-like symptoms, fever and fatigue. In October 2019, the patient experienced stomach discomfort, appetite lost, injection site pain, red rash, skin induration, painful rash, shoulder pain and injected limb mobility decreased. On an unknown date, the outcome of the influenza-like symptoms, fever and fatigue were recovered/resolved and the outcome of the stomach discomfort, appetite lost, injection site pain, red rash and skin induration were not recovered/not resolved and the outcome of the painful rash, shoulder pain, injected limb mobility decreased and vaccine administered at inappropriate site were unknown.   It was unknown if the reporter considered the influenza-like symptoms, fever, fatigue, stomach discomfort, appetite lost, injection site pain, red rash, skin induration, painful rash, shoulder pain and injected limb mobility decreased to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient herself. The patient thought that the pharmacist gave the injection too far up in the left arm. It was in the deltoid, but not in the biggest part of the deltoid. It was given about 1 finger breadth down from the acromion process. One day after receiving the vaccine, the patient developed flu like symptoms, including fever and fatigue. Also the patient developed stomach issues, loss of appetite and pain in the left arm after 1 day of vaccination. A couple of days after receiving the vaccine, patient developed a hard and firm, red spot approximately 4 inches below the injection site and this spot was sore. Less than a week after receiving the vaccine, the entire left shoulder was sore and it hurt to move it. The reporter did not consent to follow-up.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Lip swelling, Swelling face
Clinical narrative: SWELLING CHEEKS; SWELLING LIPS; This case was reported by a physician via call center representative and described the occurrence of cheek swelling in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 8th October 2019, the patient received Shingrix. On 14th October 2019, 6 days after receiving Shingrix, the patient experienced cheek swelling and lip swelling. On an unknown date, the outcome of the cheek swelling and lip swelling were unknown.   It was unknown if the reporter considered the cheek swelling and lip swelling to be related to Shingrix.  Additional details were provided as follows: The reporter stated that the patient experienced cheek swelling and lip swelling after vaccination. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Feeling hot, Injection site erythema, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: redness at injection site; swelling at injection site; felt feverish; injection site warm; This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11th October 2019, the patient received the 1st dose of Shingrix. On 12th October 2019, 1 days after receiving Shingrix, the patient experienced injection site erythema, injection site swelling, feeling hot and injection site warmth. On an unknown date, the outcome of the injection site erythema, injection site swelling, feeling hot and injection site warmth were not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema, injection site swelling, feeling hot and injection site warmth to be related to Shingrix.  Additional information received were as follows: The age at vaccination was not reported. The patient experienced redness and swelling at the injection site. The patient also noted that the injection site felt warm and that she felt feverish. At time of report, the events had not resolved. The reporter consented to follow up.  The pharmacist was busy and did not had time for a full report.
Sex: U
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: flu like symptoms; This case was reported by a physician via call center representative and described the occurrence of influenza-like symptoms in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was unknown.   It was unknown if the reporter considered the influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable for this report. No additional details were provided regarding product or patient(s) at time of initial report. Most of the patients experienced flu like symptoms after receiving Shingrix. The reporter did not consent to follow up.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Arm Pain; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included lisinopril.   On 6th July 2019, the patient received the 1st dose of Shingrix .5 ml. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The patient received 1st dose in left arm and his arm hurt. The reporter did not consent to follow-up. For tolerance of 2nd dose, refer case US2019AMR188510. This case had been linked to the case US2019187018 and US2019AMR188516, reported by the same reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus, Urticaria
Clinical narrative: Hives on both sides all over body; Extremely itchy; This case was reported by a pharmacist via call center representative and described the occurrence of hives in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th October 2019, the patient received the 1st dose of Shingrix. In October 2019, less than a week after receiving Shingrix, the patient experienced hives and pruritus. On an unknown date, the outcome of the hives and pruritus were unknown.   It was unknown if the reporter considered the hives and pruritus to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter called on how to proceed with 2nd dose of Shingrix after 1st dose reaction. The patient broke out with hives. It was reported that, 8 out of 10 on both sides all over the body and extremely itchy. The health care professional (HCP) was unable to provide full details. The reporter did not consent to follow-up.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus
Clinical narrative: itching all over body; This case was reported by a pharmacist via call center representative and described the occurrence of generalized pruritus in a 79-year-old female patient who received Herpes zoster (Shingrix) (batch number E523B, expiry date 5th November 2021) for prophylaxis.   On 8th August 2019, the patient received the 1st dose of Shingrix (intramuscular). On 9th August 2019, 1 days after receiving Shingrix, the patient experienced generalized pruritus. In August 2019, the outcome of the generalized pruritus was recovered/resolved.   It was unknown if the reporter considered the generalized pruritus to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix on left arm. The next morning after receiving Shingrix, the patient experienced itching all over her body which lasted for one week. The reporter consented to follow up.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Injection site pain
Clinical narrative: Injection site pain; Fatigue; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 78-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd August 2019, the patient received the 1st dose of Shingrix. On 2nd August 2019, less than a day after receiving Shingrix, the patient experienced injection site pain and fatigue. On an unknown date, the outcome of the injection site pain and fatigue were recovered/resolved.   It was unknown if the reporter considered the injection site pain and fatigue to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix in the left arm. The reporter stated that, the injection site pain and fatigue experienced for 3 days and then resolved. For the tolerence of 2nd dose refer case US2019AMR188461. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Headache
Clinical narrative: Severe headache; This case was reported by a nurse via call center representative and described the occurrence of headache in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd August 2019, the patient received Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced headache. On an unknown date, the outcome of the headache was not recovered/not resolved.   It was unknown if the reporter considered the headache to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix vaccination and experienced a severe headache that has not resolved at time of report.  The patient did not have a history of headaches, nor was he prone to getting headaches. The headache is somewhat relieved by exercise but can last up to 9 hours. The reporter consented to follow up.