chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling
Clinical narrative: had bad site reaction on her arm, "physician's" arm was badly swollen; This spontaneous report was received from a pharmacist (conflicting information also reported as a "physician"), who was also the 65-year-old female patient reporting from herself via a company representative. Patient did not know her pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications.    Five to ten years ago, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (strength, dose, route of administration, anatomical location, lot # and expiration date were unknown).  About 5-10 years ago, patient had a bad site reaction on her arm, it was badly swollen (injection site swelling) and she sought medical attention. It was unknown if patient received any treatment for the adverse experience but she recovered on an unknown date. Patient was, at reporting time, scheduled to get pneumococcal 13v conj vaccine (CRM197) (PREVNAR13) vaccine and was wanting to know if she should expect the same reaction.  The causality assessment was not reported.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: Rash to the side of injection site; This case was reported by a consumer via interactive digital media and described the occurrence of rash in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   In September 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced rash. The patient was treated with topical steroid nos (Steroid Cream) and cetirizine hydrochloride (Zyrtec). On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. Age group was selected as adult as per vaccine indication The patient received 1st injection of Shingrix the early part of September.  After the injection the patient had a rash to the side of the injection site.  The patient went to the doctor and they prescribed a steroid cream and said to take Zyrtec.
Sex: M
Vaccine: FLUX
Symptoms: Influenza like illness, Vaccination failure
Clinical narrative: suspected vaccination failure; flu like symptoms; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a elderly male patient who received Flu unspecified (Influenza vaccine) for prophylaxis.   On an unknown date, the patient received Influenza vaccine. On an unknown date, unknown after receiving Influenza vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and influenza-like symptoms. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the influenza-like symptoms was recovered/resolved.   It was unknown if the reporter considered the vaccination failure and influenza-like symptoms to be related to Influenza vaccine.  Additional case details were reported as follows: The reporter was patient's wife. The age at vaccination was not reported. The patient who was over 65, got the regular one flu vaccine and had a slight reaction, flu like symptoms for a couple days but was fine now. This case was considered as suspected vaccination failure as details regarding laboratory test confirmation and time to onset for the event was unknown at the time of reporting. The follow up was not required.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Adverse event, Injection site pain, Pain in extremity
Clinical narrative: Injected arm was hurting / her arm was still hurting; Just pain at the injection site; This case was reported by a other health professional via sales rep and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in March 2020, batch number 7PG2M, expiry date unknown).   On 6th October 2020, the patient received the 2nd dose of Shingrix. In October 2020, less than a week after receiving Shingrix, the patient experienced pain in arm and injection site pain. On an unknown date, the outcome of the pain in arm and injection site pain were unknown.   The reporter considered the pain in arm and injection site pain to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and had no complaints day of immunization.  Within week the injected arm was hurting.  The Doctor told patient to wait a few weeks and massage area.  The patient called and said that arm was still hurting.  No redness, no itching, no swelling, just pain at the injection site. The reporter thinks adverse event was related to Shingrix.  No other vaccine given to patient on 6th October 2020.
Sex: U
Vaccine: VARZOS
Symptoms: Dysphagia, Oropharyngeal pain
Clinical narrative: throat pain; Swallowing issue; This case was reported by a consumer via interactive digital media and described the occurrence of throat pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   In October 2020, the patient received the 2nd dose of Shingrix. In October 2020, several hours after receiving Shingrix, the patient experienced throat pain and swallowing difficult. On an unknown date, the outcome of the throat pain and swallowing difficult were unknown.   It was unknown if the reporter considered the throat pain and swallowing difficult to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not applicable to this report. The age group was not reported but it was selected as an adult as per vaccine indication. The patient had a very unusual painful throat and swallowing issue which started a few hours after 2nd dose of Shingrix. The patient inquired that was this an adverse response. No other information was available.
Sex: U
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: second was brutal; This case was reported by a consumer via interactive digital media and described the occurrence of malaise in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on unknown date, refer case US2020AMR215952).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced malaise. On an unknown date, the outcome of the malaise was unknown.   It was unknown if the reporter considered the malaise to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received Shingrix and was brutal.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR215952:same reporter
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fall, Feeling cold, Head injury, Loss of consciousness
Clinical narrative: passed out; being cold; shivering; fell and hit her head; fell and hit her head; stiffness; extreme muscular pain not sure If that is AE or from the fall; This case was reported by a other health professional via sales rep and described the occurrence of passed out in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28th October 2020, the patient received Shingrix. On 28th October 2020, less than a day after receiving Shingrix, the patient experienced passed out (serious criteria GSK medically significant), feeling cold, shivering, fall, head injury, stiffness and muscle pain. On an unknown date, the outcome of the passed out, feeling cold, shivering, fall, head injury, stiffness and muscle pain were unknown.   It was unknown if the reporter considered the passed out, feeling cold, shivering, fall, head injury, stiffness and muscle pain to be related to Shingrix.  Additional case details were reported as follows: Several hours later patient complained of being cold and shivering. During the night, she went downstairs and passed out. She felt and hit her head. She was now experiencing stiffness and extreme muscular pain, reporter not sure If that was adverse event or from the fall. The patient taking rest and being monitored. She would proceed to the hospital if conditions worsen. The reporter consented to follow up.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Musculoskeletal stiffness, Myalgia
Clinical narrative: passed out; being cold; shivering; fell and hit her head; fell and hit her head; stiffness; extreme muscular pain not sure If that is AE or from the fall; This case was reported by a other health professional via sales rep and described the occurrence of passed out in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28th October 2020, the patient received Shingrix. On 28th October 2020, less than a day after receiving Shingrix, the patient experienced passed out (serious criteria GSK medically significant), feeling cold, shivering, fall, head injury, stiffness and muscle pain. On an unknown date, the outcome of the passed out, feeling cold, shivering, fall, head injury, stiffness and muscle pain were unknown.   It was unknown if the reporter considered the passed out, feeling cold, shivering, fall, head injury, stiffness and muscle pain to be related to Shingrix.  Additional case details were reported as follows: Several hours later patient complained of being cold and shivering. During the night, she went downstairs and passed out. She felt and hit her head. She was now experiencing stiffness and extreme muscular pain, reporter not sure If that was adverse event or from the fall. The patient taking rest and being monitored. She would proceed to the hospital if conditions worsen. The reporter consented to follow up.
Sex: F
Vaccine: RAB
Symptoms: Headache, Malaise, Pain
Clinical narrative: Illness; Head ache; Body aches; This case was reported by a other health professional via call center representative and described the occurrence of feeling unwell in a female patient who received Rabies NVS (RabAvert) for prophylaxis.   On an unknown date, the patient received RabAvert. On an unknown date, unknown after receiving RabAvert, the patient experienced feeling unwell, headache and general body pain. On an unknown date, the outcome of the feeling unwell, headache and general body pain were unknown.   It was unknown if the reporter considered the feeling unwell, headache and general body pain to be related to RabAvert.  Additional details were provided as follows: It was unknown if exposure was pre or post exposure. The age at vaccination was not reported. The HCP stated that the patient had headaches, body aches and illness. The case had been linked with US2020206868 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020206868:same reporter
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Injection site erythema, Pruritus, Rash macular
Clinical narrative: blisters on the inside of her fingers on both hand; red blotches all over her body; redness at the site of injection; Itching; This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 84-year-old female patient who received Herpes zoster (Shingrix) (batch number 99SE3, expiry date 30th September 2022) for prophylaxis.   On 19th October 2020, the patient received the 1st dose of Shingrix (injection). On 19th October 2020, less than a day after receiving Shingrix, the patient experienced injection site erythema and pruritus. On 20th October 2020, the patient experienced blister and red blotches. On an unknown date, the outcome of the injection site erythema and pruritus were recovered/resolved and the outcome of the blister and red blotches were not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema, pruritus, blister and red blotches to be related to Shingrix.  Additional details were reported as follows: This case was reported by the health care professional. The patient received the 1st dose of Shingrix injection and complained of red blotches all over body, itching, blister on the inside of fingers on both hands and redness at the site of injection. The health care professional wanted to know if the blotches and blisters on the fingers were normal occurrences. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Movement disorder, Pain in extremity
Clinical narrative: Local soreness; Difficulty raising arm; This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   In October 2020, the patient received Shingrix. On an unknown date, 3 weeks after receiving Shingrix, the patient experienced pain in arm and movement disorder. On an unknown date, the outcome of the pain in arm and movement disorder were unknown.   It was unknown if the reporter considered the pain in arm and movement disorder to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication.  After receiving dose of Shingrix, the patient experienced local soreness and difficulty raising arm. The reporter consent to follow up.
Age: 54.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Dehydration, Diarrhoea, Dizziness, Dyspnoea, Headache
Clinical narrative: dehydrated; Dizziness; Headache; Sweaty; Stiff joints; Body aches; Diarrhea; Shortness of breath; This case was reported by a consumer via call center representative and described the occurrence of dehydration in a 54-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2020-2021 season) for prophylaxis.   On 23rd October 2020, the patient received Shingrix and Influenza vaccine Quadrivalent 2020-2021 season. On 23rd October 2020, less than a day after receiving Shingrix and Influenza vaccine Quadrivalent 2020-2021 season, the patient experienced dehydration, dizziness, headache, sweating, stiff joint, general body pain, diarrhea and shortness of breath. On an unknown date, the outcome of the dehydration, dizziness, headache, sweating, stiff joint, general body pain, diarrhea and shortness of breath were not recovered/not resolved.   It was unknown if the reporter considered the dehydration, dizziness, headache, sweating, stiff joint, general body pain, diarrhea and shortness of breath to be related to Shingrix and Influenza vaccine Quadrivalent 2020-2021 season.  Additional details were provided as follows: The age at vaccination was not reported. Caller was the husband of the patient and reported his wife received the Shingrix vaccine and flu vaccine in the left arm.  Caller reported that same night after receiving the vaccine his wife had shortness of breath, diarrhea, body aches, stiff joints, was sweaty, headache, dizziness, and dehydration and these are all still ongoing currently. The reporter did not consent to follow-up. The case had been linked with US2020212943 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020212943:same reporter
Age: 54.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Hyperhidrosis, Joint stiffness, Pain
Clinical narrative: dehydrated; Dizziness; Headache; Sweaty; Stiff joints; Body aches; Diarrhea; Shortness of breath; This case was reported by a consumer via call center representative and described the occurrence of dehydration in a 54-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2020-2021 season) for prophylaxis.   On 23rd October 2020, the patient received Shingrix and Influenza vaccine Quadrivalent 2020-2021 season. On 23rd October 2020, less than a day after receiving Shingrix and Influenza vaccine Quadrivalent 2020-2021 season, the patient experienced dehydration, dizziness, headache, sweating, stiff joint, general body pain, diarrhea and shortness of breath. On an unknown date, the outcome of the dehydration, dizziness, headache, sweating, stiff joint, general body pain, diarrhea and shortness of breath were not recovered/not resolved.   It was unknown if the reporter considered the dehydration, dizziness, headache, sweating, stiff joint, general body pain, diarrhea and shortness of breath to be related to Shingrix and Influenza vaccine Quadrivalent 2020-2021 season.  Additional details were provided as follows: The age at vaccination was not reported. Caller was the husband of the patient and reported his wife received the Shingrix vaccine and flu vaccine in the left arm.  Caller reported that same night after receiving the vaccine his wife had shortness of breath, diarrhea, body aches, stiff joints, was sweaty, headache, dizziness, and dehydration and these are all still ongoing currently. The reporter did not consent to follow-up. The case had been linked with US2020212943 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020212943:same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Herpes zoster, Pain
Clinical narrative: shingles after first dose of shingrix/herpes zoster outbreak.; soreness/still with a lot of pain; redness; This case was reported by a consumer via call center representative and described the occurrence of shingles in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 16th October 2020, the patient received the 1st dose of Shingrix. On 17th October 2020, 1 days after receiving Shingrix and an unknown time after starting acyclovir, the patient experienced shingles, pain and erythema. The patient was treated with acyclovir. On an unknown date, the outcome of the shingles, pain and erythema were not recovered/not resolved.   It was unknown if the reporter considered the shingles, pain and erythema to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and experienced soreness, redness and an outbreak of Shingles the following day.  The patient took acyclovir twice a week during the herpes zoster outbreak. The patient reports a second outbreak that started on 24th October 2020 and still with a lot of pain. Th reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: completed the dosing over a year ago and most recent flare up was undergoing at the day of call; shingles episodes/flare up; This case was reported by a pharmacist via call center representative and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On 26th October 2020, the outcome of the shingles was not recovered/not resolved. On an unknown date, the outcome of the vaccination failure was unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.  Additional details were provided as follows: Age at vaccination was not reported. It was reported that the patient had completed the dosing for Shingirx but still had shingles episodes.  The patient completed the dosing over a year ago and most recent flare up was undergoing at the time of reporting (on 26th October 2020). The case was considered as suspected vaccination failure since the details regarding laboratory confirmation were not provided. The reporter consented to follow up.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness, Feeling abnormal, Heart rate increased, Myalgia, Nausea
Clinical narrative: Feeling horrible; High fever (not confirmed using a thermometer); Shakes; Dizziness; Feeling of vomiting; The worst muscle aches ever had; Increased heart rate of 20 beats higher than normal; This case was reported by a consumer via call center representative and described the occurrence of feels awful in a 61-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included atrial fibrillation and coronary stent placement.   On 26th October 2020, the patient received the 2nd dose of Shingrix (intramuscular). In October 2020, less than a week after receiving Shingrix, the patient experienced feels awful, fever, tremor, dizziness, nausea, muscle pain and heart rate increased. On an unknown date, the outcome of the feels awful, fever, tremor, dizziness, nausea, muscle pain and heart rate increased were not recovered/not resolved.   It was unknown if the reporter considered the feels awful, fever, tremor, dizziness, nausea, muscle pain and heart rate increased to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix on upper left arm and feeling horrible, and experiencing a high fever not confirmed using a thermometer, shakes, dizziness, feeling of vomiting, the worst muscle aches ever had and an increased heart rate of 20 beats higher than normal. The patient stated had A.fib with a heart stent. The reporter did not consent to follow up. Not all information was available and did not want to provide further adverse event details and other information because they were not feeling well.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia, Tremor
Clinical narrative: Feeling horrible; High fever (not confirmed using a thermometer); Shakes; Dizziness; Feeling of vomiting; The worst muscle aches ever had; Increased heart rate of 20 beats higher than normal; This case was reported by a consumer via call center representative and described the occurrence of feels awful in a 61-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included atrial fibrillation and coronary stent placement.   On 26th October 2020, the patient received the 2nd dose of Shingrix (intramuscular). In October 2020, less than a week after receiving Shingrix, the patient experienced feels awful, fever, tremor, dizziness, nausea, muscle pain and heart rate increased. On an unknown date, the outcome of the feels awful, fever, tremor, dizziness, nausea, muscle pain and heart rate increased were not recovered/not resolved.   It was unknown if the reporter considered the feels awful, fever, tremor, dizziness, nausea, muscle pain and heart rate increased to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix on upper left arm and feeling horrible, and experiencing a high fever not confirmed using a thermometer, shakes, dizziness, feeling of vomiting, the worst muscle aches ever had and an increased heart rate of 20 beats higher than normal. The patient stated had A.fib with a heart stent. The reporter did not consent to follow up. Not all information was available and did not want to provide further adverse event details and other information because they were not feeling well.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Myalgia, Pain
Clinical narrative: His body has been achy / generalized aching throughout his whole body; Myalgia; This case was reported by a consumer via call center representative and described the occurrence of general body pain in a 62-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26th October 2020, the patient received the 1st dose of Shingrix (intramuscular). In October 2020, less than a week after receiving Shingrix, the patient experienced general body pain and myalgia. On an unknown date, the outcome of the general body pain was not recovered/not resolved and the outcome of the myalgia was unknown.   It was unknown if the reporter considered the general body pain and myalgia to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in left arm and body had been achy, myalgia.  The reporter said no pain at the injection site, just generalized aching throughout his whole body and did not wish to provide HCP information. The reporter did not consent to follow up.
Age: 55.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Incomplete course of vaccination, Injection site reaction
Clinical narrative: Did not return within recommended time frame  to receive the second dose; Injection site reaction; This case was reported by a pharmacist via call center representative and described the occurrence of injection site reaction in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 9th September 2019, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On 9th September 2019, less than a day after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced injection site reaction. On an unknown date, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the injection site reaction was recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the injection site reaction to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and experienced injection site reaction, which resolved on its own however did not return within the recommended time frame to receive the second dose, which led to incomplete course of vaccination. The reporter did not consent to follow up.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: rash on arm/hands/chest; This case was reported by a consumer via call center representative and described the occurrence of rash in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29th July 2020, the patient received Shingrix. On 31st July 2020, 2 days after receiving Shingrix, the patient experienced rash. On 2nd August 2020, the outcome of the rash was recovered/resolved.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and had rash on her chest, arm and hands which resolved in 2 days. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Loss of personal independence in daily activities, Pain, Skin warm
Clinical narrative: Swelling at the injection site and upper arm; Body aches / could not get out of the bed; Swelling at the injection site and upper arm, red and warm to touch; Swelling at the injection site and upper arm, red; could not get out of the bed; This case was reported by a other health professional via call center representative and described the occurrence of injection site swelling in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced injection site swelling, general body pain, skin warm, injection site erythema and activities of daily living impaired. On an unknown date, the outcome of the injection site swelling, general body pain, skin warm, injection site erythema and activities of daily living impaired were recovered/resolved.   It was unknown if the reporter considered the injection site swelling, general body pain, skin warm, injection site erythema and activities of daily living impaired to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix 1 year ago and experienced body aches, could not get out of the bed for days.  The patient experienced swelling at the injection site and upper arm, red and warm to touch 2 to 3 days.  The swelling proceeded longer, unsure when the HCP did not feel comfortable to provide any additional information and said patient was in her 60's. The reporter did not consent to follow up.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Limb mass, Mass, Neck mass, Rash
Clinical narrative: lump on his neck, arm and legs; lump on his arm and legs; Rash on his neck, arm and legs; This case was reported by a nurse via call center representative and described the occurrence of neck mass in a elderly female patient who received Herpes zoster (Shingrix) (batch number 2B3P2, expiry date 10th May 2022) for prophylaxis.   On 5th October 2020, the patient received the 1st dose of Shingrix. In October 2020, less than 3 weeks after receiving Shingrix, the patient experienced neck mass, mass and rash. On an unknown date, the outcome of the neck mass and rash were not recovered/not resolved and the outcome of the mass was unknown.   It was unknown if the reporter considered the neck mass, mass and rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. A registered nurse called on behalf of the doctor and reported that a patient received the 1st dose of Shingrix and developed rash and lump on his neck, arm and legs.  The patient was still having all symptoms. The reporter consented to follow up.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Migraine, Pain, Pyrexia
Clinical narrative: lox grade fever; migraine; pain all over body; This case was reported by a dentist via call center representative and described the occurrence of low grade fever in a 50-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix (1st dose received on unknown date).   On 23rd October 2020, the patient received the 2nd dose of Shingrix. On 23rd October 2020, less than a day after receiving Shingrix, the patient experienced low grade fever, migraine and general body pain. On 23rd October 2020, the outcome of the low grade fever, migraine and general body pain were recovered/resolved.   It was unknown if the reporter considered the low grade fever, migraine and general body pain to be related to Shingrix.  Additional details were provided as follows: The patient was vaccinated with 2nd dose of Shingrix. The patient experienced pain all over body, migraine and low grade fever, all lasting for 1 hour after receiving the Shingrix. The reporter consent to follow up.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Angioedema, Lip swelling, Pharyngeal swelling, Pyrexia, Swelling face
Clinical narrative: angiodema; face / became swollen; lips became swollen; tongue started swelling; throat / started swelling; Fever; This case was reported by a consumer via call center representative and described the occurrence of angioedema in a 57-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29th September 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 29th September 2020, less than a day after receiving Shingrix, the patient experienced fever. On 13th October 2020, the patient experienced swollen tongue and throat swelling. On 26th October 2020, the patient experienced facial swelling and lip swelling. On 28th October 2020, the patient experienced angioedema (serious criteria GSK medically significant). The patient was treated with prednisone. On 28th October 2020, the outcome of the swollen tongue and throat swelling were recovered/resolved. On an unknown date, the outcome of the angioedema, facial swelling and lip swelling were not recovered/not resolved and the outcome of the fever was recovered/resolved.   It was unknown if the reporter considered the angioedema, swollen tongue, throat swelling, facial swelling, lip swelling and fever to be related to Shingrix.  Additional case details were reported as follows: The patient reported case for himself. The patient experiencing angioedema.  The patient stated his throat and tongue started swelling up about a week after the injection. After about 4 weeks, his face and lips became swollen. The patient went to the emergency room on day before reporting and received prednisone.  The patient's health care professional would have him follow up with an allergist.  The patient still experiencing some swelling of his face and lips. The reporter consented to follow up.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Swollen tongue
Clinical narrative: angiodema; face / became swollen; lips became swollen; tongue started swelling; throat / started swelling; Fever; This case was reported by a consumer via call center representative and described the occurrence of angioedema in a 57-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29th September 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 29th September 2020, less than a day after receiving Shingrix, the patient experienced fever. On 13th October 2020, the patient experienced swollen tongue and throat swelling. On 26th October 2020, the patient experienced facial swelling and lip swelling. On 28th October 2020, the patient experienced angioedema (serious criteria GSK medically significant). The patient was treated with prednisone. On 28th October 2020, the outcome of the swollen tongue and throat swelling were recovered/resolved. On an unknown date, the outcome of the angioedema, facial swelling and lip swelling were not recovered/not resolved and the outcome of the fever was recovered/resolved.   It was unknown if the reporter considered the angioedema, swollen tongue, throat swelling, facial swelling, lip swelling and fever to be related to Shingrix.  Additional case details were reported as follows: The patient reported case for himself. The patient experiencing angioedema.  The patient stated his throat and tongue started swelling up about a week after the injection. After about 4 weeks, his face and lips became swollen. The patient went to the emergency room on day before reporting and received prednisone.  The patient's health care professional would have him follow up with an allergist.  The patient still experiencing some swelling of his face and lips. The reporter consented to follow up.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site erythema, Injection site pain, Malaise
Clinical narrative: redness / at the injection site / redness / reappeared; soreness at the injection site / soreness reappeared; felt tired; not feeling well; This case was reported by a other health professional via call center representative and described the occurrence of injection site erythema in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix (1st dose received on unknown date).   On 20th October 2020, the patient received the 2nd dose of Shingrix. In October 2020, less than 2 weeks after receiving Shingrix, the patient experienced injection site erythema, injection site pain, tiredness and feeling unwell. On an unknown date, the outcome of the injection site erythema and injection site pain were not recovered/not resolved and the outcome of the tiredness and feeling unwell were recovered/resolved.   It was unknown if the reporter considered the injection site erythema, injection site pain, tiredness and feeling unwell to be related to Shingrix.  Additional deatils were provided as follows: The patient was vaccinated with 2nd dose of Shingrix and experienced redness, soreness at the injection site and felt tired. The symptoms were  resolved in a few days but then the redness and soreness reappeared. They did not know the exact days that the symptoms were resolved and then reappeared. The reporter consent to follow up.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Shingles along the left jawline; mild rash; This case was reported by a nurse via call center representative and described the occurrence of shingles in a 68-year-old female patient who received Herpes zoster (Shingrix) (batch number 7SK92, expiry date 19th October 2022) for prophylaxis.   On 1st September 2020, the patient received the 1st dose of Shingrix (intramuscular). On 25th October 2020, 54 days after receiving Shingrix, the patient experienced shingles and rash. On an unknown date, the outcome of the shingles and rash were unknown.   It was unknown if the reporter considered the shingles and rash to be related to Shingrix.  Additional case details were reported as follows: The patient developed mild rash developed. The patient also developed shingles along the left jawline after receiving the 1st dose of Shingrix. The reporter consented to follow up.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Heart rate increased, Malaise, Palpitations
Clinical narrative: heart was racing / heart palpitations; felt off; This case was reported by a consumer via call center representative and described the occurrence of palpitations in a 59-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2020-2021 season) (batch number N549A, expiry date unknown) for prophylaxis.   Previously administered products included flu vaccine (had in past and did not had these reactions). Concurrent medical conditions included atrial fibrillation. Concomitant products included lisinopril and metoprolol.   On 21st October 2020, the patient received Fluarix Quadrivalent 2020-2021 season (intramuscular). On 21st October 2020, less than an hour after receiving Fluarix Quadrivalent 2020-2021 season, the patient experienced palpitations and feeling unwell. On an unknown date, the outcome of the palpitations and feeling unwell were recovered/resolved.   It was unknown if the reporter considered the palpitations and feeling unwell to be related to Fluarix Quadrivalent 2020-2021 season.  Additional details were provided as follows: The patient received Fluarix vaccine and 1 to 2 minutes after receiving the vaccine she felt off, heart was racing, and had heart palpitations. The patient reported these events lasted about 3 minutes and resolved completely within an hour. The reporter did not consent to follow up. The reporter did not have expiration date information for the vaccine given and did not have HCP information to provide for follow up.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Back pain, Herpes zoster, Rash vesicular, Skin reaction
Clinical narrative: eruption looks like Herpes Zoster; pain around his back; skin reaction; This case was reported by a physician via call center representative and described the occurrence of vesicular rash in a 53-year-old male patient who received Herpes zoster (Shingrix) (batch number 3454N, expiry date 23rd August 2022) for prophylaxis.   On 16th October 2020, the patient received the 1st dose of Shingrix. On 21st October 2020, 5 days after receiving Shingrix, the patient experienced vesicular rash, back pain and skin reaction. On an unknown date, the outcome of the vesicular rash, back pain and skin reaction were not recovered/not resolved.   It was unknown if the reporter considered the vesicular rash, back pain and skin reaction to be related to Shingrix.  Additional information was provided as follows: The patient experienced skin reaction, the eruption that looked like herpes zoster and pain around his back after receiving the 1st dose of Shingrix. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Dizziness, Vertigo
Clinical narrative: diarrhea; vertigo; dizziness; This case was reported by a pharmacist via call center representative and described the occurrence of dizziness 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, unknown after receiving Shingrix, the patient experienced dizziness, diarrhea and vertigo. On an unknown date, the outcome of the dizziness and vertigo were recovered/resolved and the outcome of the diarrhea was unknown.   It was unknown if the reporter considered the dizziness, diarrhea and vertigo to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix vaccine unknown date and experienced dizziness and vertigo for two days and had diarrhea.  The reporter was due for the second dose. There was no additional information reported. The reporter consented to follow up.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site pain
Clinical narrative: left arm really hurts today at the injection site; shivering; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 54-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included migraine.   On 28th October 2020, the patient received the 1st dose of Shingrix (intramuscular). In October 2020, less than a week after receiving Shingrix, the patient experienced shivering. On 29th October 2020, the patient experienced injection site pain. The patient was treated with paracetamol (Acetaminophen). On an unknown date, the outcome of the injection site pain and shivering were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain and shivering to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and her left arm really hurts at the injection site.  The patient also reported some shivering which she said could be related to the cold weather. The patient had been taking acetaminophen for her symptoms. The reporter consented to follow up and could follow up with the patient directly.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Pityriasis rosea, Pruritus, Rash
Clinical narrative: rash was diagnosed by her husband's doctor as pityriasis rosea; itching on his back; rash and itching on his back; This case was reported by a consumer via call center representative and described the occurrence of pityriasis rosea in a 77-year-old male patient who received Herpes zoster (Shingrix) (batch number T7S73, expiry date 30th June 2021) for prophylaxis.   On 2nd September 2020, the patient received the 1st dose of Shingrix (intramuscular). In September 2020, 2 weeks after receiving Shingrix, the patient experienced pityriasis rosea, pruritus and rash. On an unknown date, the outcome of the pityriasis rosea, pruritus and rash were not recovered/not resolved.   It was unknown if the reporter considered the pityriasis rosea, pruritus and rash to be related to Shingrix.  Additional details were provided as follows: The case was reported by the wife of the patient. The patient received Shingrix and about 2 weeks later developed a rash and itching on his back and these had not resolved.  The reporter reported the rash was diagnosed by doctor as pityriasis rosea and was in the shape of a Christmas tree.  The reported stated the rash was fading and doctor said it could take months to resolve completely. The reporter consented to follow up.
Sex: U
Vaccine: FLUX
Symptoms: Malaise, Pneumonia
Clinical narrative: pneumonia; got very sick; Initial information received on 18-Oct-2020 regarding an unsolicited valid serious social media case received from a consumer or non-healthcare professional.  This case was linked to cases 2020SA294125, 2020SA294135, 2020SA294140, 2020SA294160, 2020SA294161, 2020SA294162, 2020SA294163, 2020SA294142, 2020SA294143, 2020SA294164, 2020SA294165, 2020SA294144, 2020SA294145, 2020SA294166, 2020SA294167, 2020SA294167, 2020SA294174, 2020SA294175, 2020SA294146, 2020SA294147, 2020SA294148, 2020SA294168, 2020SA294169, 2020SA294173, 2020SA294172, 2020SA294151, 2020SA294171, 2020SA294170, 2020SA294149, 2020SA294150, 2020SA294152, 2020SA294153, 2020SA294154, 2020SA294155, 2020SA294156, 2020SA294136, 2020SA294137, 2020SA294158, 2020SA294138, 2020SA294139, 2020SA294159 and 2020SA294231 (same reporter).  This case involves a patient (with unknown demographics) who got very sick (malaise) and pneumonia, when received INFLUENZA VACCINE.  The patient's medical history, past 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 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 very sick (malaise) and pneumonia (unknown latency) following the administration of INFLUENZA VACCINE. These events were assessed as medically significant.  Other relevant tests not reported.  It was not reported if the patient received a corrective treatment.  At the time of reporting, outcome for events was unknown.  There will be no information available on the batch number for this case.; Sender's Comments: This poorly documented social media case concerns a patient (with unknown demographics) who experienced pneumonia and malaise after vaccination with INFLUENZA VACCINE (unknown manufacturer). The time to onset was unknown. Also, patient's medical condition at the time of vaccination and lab tests ruling out alternate etiologies were not reported. Based upon the reported information, the role of the vaccine cannot be assessed.
Sex: M
Vaccine: FLUX
Symptoms: Myocardial infarction, Pneumonia
Clinical narrative: heart attack; double pneumonia; Initial information received on 21-Oct-2020 regarding an unsolicited valid serious social media case from a consumer and additional information received on 25-Oct-2020.  This case is linked to case 2020SA300788 (same reporter).  This case involves male patient (age unknown) who had heart attack (myocardial infarction) and double pneumonia (pneumonia), while he received INFLUENZA VACCINE.  Medical history, concomitant therapy, medical treatment(s), 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 (batch number and expiry date were unknown) via an unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient had serious heart attack (myocardial infarction) and double pneumonia (pneumonia) right after the administration of INFLUENZA VACCINE. These events were assessed as medically significant.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  Outcome was unknown for both the events at the time of reporting.  There will be no information available on the batch number for this case.; Sender's Comments: This case concerns a male patient (age unknown) who had myocardial infarction and pneumonia just after vaccination with INFLUENZA VACCINE. The time to onset is unknown. However, medical condition at the time of vaccination, laboratory data and other ruling out etiologies were not reported. Based upon the reported information the role of the suspect vaccine cannot be assessed.