chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain, Pain in extremity, Pain in jaw, Peripheral swelling, Toothache
Clinical narrative: Swelling of knuckles; Code Knuckles Pain/ Hip is hurting; Jaw hurt / Felt like she had a toothache; Fingers and knuckles became inflamed; Fingers and knuckles became swollen; Pain; Neck became sore; Knuckles again became red; This case was reported by a consumer via call center representative and described the occurrence of inflammation localized in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included unilateral renal agenesis, celiac disease and hypothyroidism.   On 28th August 2019, the patient received the 1st dose of Shingrix. On 6th September 2019, 9 days after receiving Shingrix, the patient experienced inflammation localized and swelling of fingers. On 14th September 2019, the patient experienced toothache. In September 2019, the patient experienced pain, neck pain and red hands. On 17th September 2019, the patient experienced pain in hip. On an unknown date, the patient experienced swollen joints. The patient was treated with naproxen (Aleve). On an unknown date, the outcome of the inflammation localized, toothache, pain in hip and swollen joints were unknown and the outcome of the swelling of fingers, pain, neck pain and red hands were not recovered/not resolved.   It was unknown if the reporter considered the inflammation localized, swelling of fingers, pain, neck pain, red hands, toothache, pain in hip and swollen joints to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and her fingers and knuckles became inflamed and swollen.  She took Alleve for 4 days and the pain got a little better but then then her neck became sore and her knuckles again became swollen, red, and painful. she said it almost felt like she had a toothache and her hip was hurting. The reporter consented to follow up. The reporter gave permission for her physician to be contacted. Unable to obtain additional details the reporter was difficult to follow she reported adverse events seen with her husband.   This case linked with US2019170058, reported by same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Miliaria, Rash, Skin warm
Clinical narrative: golf ball sized rash / very hard borders; hot to touch; skin warm; This case was reported by a pharmacist via call center representative and described the occurrence of rash in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced rash, heat rash and skin warm. On an unknown date, the outcome of the rash, heat rash and skin warm were unknown.   It was unknown if the reporter considered the rash, heat rash and skin warm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group of the patient was not reported, but selected as an adult as per vaccine indication. The reporter stated that, after vaccination with Shingrix, the patient experienced golf ball sized rash hot to touch and very hard borders.
Sex: U
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site reaction, Pain, Pruritus, Pyrexia
Clinical narrative: fever; body aches; injection site reaction; injection site itching; flu-like symptoms; This case was reported by a consumer via call center representative and described the occurrence of fever in a adult 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 fever, general body pain, injection site reaction, pruritus and influenza-like symptoms. On an unknown date, the outcome of the fever, general body pain, injection site reaction, pruritus and influenza-like symptoms were unknown.   It was unknown if the reporter considered the fever, general body pain, injection site reaction, pruritus and influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group of the patient was not reported, but selected as an adult as per vaccine indication. The patient reported that, after vacccination with dose of Shingrix, the patient experienced fever, general body pain, injection site reaction, itching and influenza-like symptoms. The patient asked if should get 2nd dose of Shingrix.
Age: 70.0
Sex: U
Vaccine: FLUX, VARZOS
Symptoms: Chills, Erythema, Fatigue, Gastrointestinal disorder, Headache
Clinical narrative: arm swollen; arm red; painful arm; felt sick; Fatigue; Headache; Shivering; Gastrointestinal symptoms; Myalgia; This case was reported by a consumer via call center representative and described the occurrence of swelling arm in a 70-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu unspecified (Flu vaccine) for prophylaxis.   On 13th September 2019, the patient received the 1st dose of Shingrix and Flu vaccine. In September 2019, less than a week after receiving Shingrix and Flu vaccine, the patient experienced swelling arm, erythema of extremities, pain in arm, feeling unwell, fatigue, headache, shivering, gastrointestinal symptom nos and myalgia. On an unknown date, the outcome of the swelling arm, erythema of extremities, pain in arm, feeling unwell, fatigue, headache, shivering, gastrointestinal symptom nos and myalgia were unknown.   It was unknown if the reporter considered the swelling arm, erythema of extremities, pain in arm, feeling unwell, fatigue, headache, shivering, gastrointestinal symptom nos and myalgia to be related to Shingrix and Flu vaccine.  Additional case details were reported as follows: The patient received vaccines in unknown arm. The patient received the first shot of Shingrix on Friday, before day of reporting and felt sick a weekend and arm was still swollen, red and painful. The patient had flu shot in other arm on the same day. The patient did not have idea that the new Shingrix had possibility of more side effects. The patient enquired whether his/her arm feels better over a few days. Less than a week after vaccination, the patient had fatigue, headache, shivering and gastrointestinal symptoms, except fever and myalgia. The patient would not look forward to the 2nd dose. The reporter consented to follow up.
Age: 70.0
Sex: U
Vaccine: FLUX, VARZOS
Symptoms: Malaise, Myalgia, Pain in extremity, Peripheral swelling
Clinical narrative: arm swollen; arm red; painful arm; felt sick; Fatigue; Headache; Shivering; Gastrointestinal symptoms; Myalgia; This case was reported by a consumer via call center representative and described the occurrence of swelling arm in a 70-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu unspecified (Flu vaccine) for prophylaxis.   On 13th September 2019, the patient received the 1st dose of Shingrix and Flu vaccine. In September 2019, less than a week after receiving Shingrix and Flu vaccine, the patient experienced swelling arm, erythema of extremities, pain in arm, feeling unwell, fatigue, headache, shivering, gastrointestinal symptom nos and myalgia. On an unknown date, the outcome of the swelling arm, erythema of extremities, pain in arm, feeling unwell, fatigue, headache, shivering, gastrointestinal symptom nos and myalgia were unknown.   It was unknown if the reporter considered the swelling arm, erythema of extremities, pain in arm, feeling unwell, fatigue, headache, shivering, gastrointestinal symptom nos and myalgia to be related to Shingrix and Flu vaccine.  Additional case details were reported as follows: The patient received vaccines in unknown arm. The patient received the first shot of Shingrix on Friday, before day of reporting and felt sick a weekend and arm was still swollen, red and painful. The patient had flu shot in other arm on the same day. The patient did not have idea that the new Shingrix had possibility of more side effects. The patient enquired whether his/her arm feels better over a few days. Less than a week after vaccination, the patient had fatigue, headache, shivering and gastrointestinal symptoms, except fever and myalgia. The patient would not look forward to the 2nd dose. The reporter consented to follow up.
Sex: U
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 an unspecified number of adult 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 pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm 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 selected as per the vaccine indication. The reporter stated that several patient's experienced arm pain following Shingrix vaccination. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pyrexia, Rash
Clinical narrative: rash suspected shingles; rash suspected shingles; high fever (107F); This case was reported by a consumer via call center representative and described the occurrence of shingles in a adult 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 shingles, rash and fever. On an unknown date, the outcome of the shingles, rash and fever were unknown.   It was unknown if the reporter considered the shingles, rash and fever 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 selected as per the vaccine indication. The patient had the 1st dose vaccine and developed high fever and rash suspected shingles. The reporter asked does patient need to take the 2nd dose of Shingrix.      Lab Comments: On an unknown date body temperature was recorded
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: pain of shot; This case was reported by a consumer via call center representative and described the occurrence of pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced pain. The patient was treated with non-drug therapy (Cold Compress). On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient asked help for pain of shot. The patient heard that, the pain was typical but wondered if anything would help like cold compress.
Age: 56.0
Sex: U
Vaccine: VARZOS
Symptoms: Malaise, Pain in extremity
Clinical narrative: arm pain; sick; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 56-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   In September 2019, the patient received Shingrix. In September 2019, less than a week after receiving Shingrix, the patient experienced pain in arm and sickness. On an unknown date, the outcome of the pain in arm and sickness were unknown.   It was unknown if the reporter considered the pain in arm and sickness to be related to Shingrix.  Additional details were reported as follows: About 45 hours before the reporting date, the patient received Shingrix.  The patient asked, the duration that the side effects start after getting the vaccine. The patient had only arm pain and was wondering if this adverse event was over or could get the patient sick.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: arm pain; swelling; This case was reported by a consumer via sales rep and described the occurrence of pain in arm in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, 3 days after receiving Shingrix, the patient experienced pain in arm and swelling. On an unknown date, the outcome of the pain in arm and swelling were unknown.   It was unknown if the reporter considered the pain in arm and swelling to be related to Shingrix.  Additional details were reported as follows: The reporter was patient's spouse. The age at vaccination was not reported. The patient experienced significant arm pain and swelling after receipt of shingrix dose. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Injection site erythema, Injection site pain, Pain
Clinical narrative: Injection site soreness; Redness; Body aches; Fatigue; This case was reported by a other health professional via sales rep and described the occurrence of injection site pain in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced injection site pain, injection site erythema, general body pain and fatigue. On an unknown date, the outcome of the injection site pain, injection site erythema, general body pain and fatigue were unknown.   It was unknown if the reporter considered the injection site pain, injection site erythema, general body pain and fatigue to be related to Shingrix.  Additional details were provided as follows: The patient date of birth was reported as 26th December. The age at vaccination was not reported. The reporter stated that, after vaccination with dose of Shingrix experienced injection site soreness, redness, body pain and fatigue. The reporter consented to follows up.
Sex: M
Vaccine: VARZOS
Symptoms: Blood test, Feeling abnormal, Influenza like illness, Mobility decreased, Myalgia
Clinical narrative: Polymyalgia; Felt like truck hit me; Slight fever; Aches in shoulders, neck, hands and hip area; Could not get out of chair without assistance or reach above my head; Flu like feeling; This case was reported by a consumer via call center representative and described the occurrence of polymyalgia in a 73-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th July 2019, the patient received the 1st dose of Shingrix. On 18th July 2019, 1 days after receiving Shingrix, the patient experienced polymyalgia, feeling abnormal, fever, general body pain, mobility decreased and influenza like illness. The patient was treated with steroids nos (Steroids). On an unknown date, the outcome of the polymyalgia, feeling abnormal, general body pain, mobility decreased and influenza like illness were not recovered/not resolved and the outcome of the fever was recovered/resolved.   It was unknown if the reporter considered the polymyalgia, feeling abnormal, fever, general body pain, mobility decreased and influenza like illness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported but could be between 72 to 73 years. The patient felt like truck hit, slight fever and aches in pains in shoulders, neck, hands and hip area. The patient could not get out of chair without assistance or reach above my head. The patient was having flu like feeling also. The patient had numerous x rays and blood work from family doctor and also Rheumatoid Specialist. The patient was diagnosed with Polymyalgia and had been on heavy steroids. The patient stated that will not be getting the booster dose of Shingrix. The patient was upset for getting the vaccine. The patient suggested to do more testing on People with arthritis and autoimmune diseases as they may not want to get it.      Lab Comments: on an unknown date numerous x rays and blood work were done
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Pyrexia, X-ray
Clinical narrative: Polymyalgia; Felt like truck hit me; Slight fever; Aches in shoulders, neck, hands and hip area; Could not get out of chair without assistance or reach above my head; Flu like feeling; This case was reported by a consumer via call center representative and described the occurrence of polymyalgia in a 73-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th July 2019, the patient received the 1st dose of Shingrix. On 18th July 2019, 1 days after receiving Shingrix, the patient experienced polymyalgia, feeling abnormal, fever, general body pain, mobility decreased and influenza like illness. The patient was treated with steroids nos (Steroids). On an unknown date, the outcome of the polymyalgia, feeling abnormal, general body pain, mobility decreased and influenza like illness were not recovered/not resolved and the outcome of the fever was recovered/resolved.   It was unknown if the reporter considered the polymyalgia, feeling abnormal, fever, general body pain, mobility decreased and influenza like illness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported but could be between 72 to 73 years. The patient felt like truck hit, slight fever and aches in pains in shoulders, neck, hands and hip area. The patient could not get out of chair without assistance or reach above my head. The patient was having flu like feeling also. The patient had numerous x rays and blood work from family doctor and also Rheumatoid Specialist. The patient was diagnosed with Polymyalgia and had been on heavy steroids. The patient stated that will not be getting the booster dose of Shingrix. The patient was upset for getting the vaccine. The patient suggested to do more testing on People with arthritis and autoimmune diseases as they may not want to get it.      Lab Comments: on an unknown date numerous x rays and blood work were done
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: Rash; Minor swelling at site of vaccine injection; Itching; This case was reported by a consumer via sales rep and described the occurrence of injection site rash in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included ophthalmic herpes zoster (had shingles in the eye 15 years ago from the time of reporting) and post herpetic neuralgia (had severe post herpetic for many years).   On 9th September 2019, the patient received the 1st dose of Shingrix. In September 2019, less than 2 weeks after receiving Shingrix, the patient experienced injection site rash, injection site swelling and injection site itching. On an unknown date, the outcome of the injection site rash, injection site swelling and injection site itching were unknown.   It was unknown if the reporter considered the injection site rash, injection site swelling and injection site itching 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 selected as per the vaccine indication. The patient stated that had the rash and minor swelling and itching. The patient asked about how long may the rash and minor swelling at the site of vaccine injection last and is treatment needed. The patient preferred to have anonymous. The patient was advised to speak with healthcare provider for the next steps. The patient had vaccination at local pharmacy and there were no warnings on information sheet or from pharmacist that history of shingles a concern.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles/symptoms of shingles; This case was reported by a nurse via sales rep and described the occurrence of shingles in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than 2 weeks after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient reported showing symptoms of shingles within 2 weeks of getting shingrix. The reporter did not consent to follow up.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Allergy test negative, Differential white blood cell count normal, Eosinophil count increased, Full blood count, Rash
Clinical narrative: hives of bilateral upper and lower extremties; rash; Cbc w/ diff elevated eosinophils; This case was reported by a other health professional via sales rep and described the occurrence of hives in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 31st August 2019, the patient received the 1st dose of Shingrix. On 1st September 2019, 1 days after receiving Shingrix, the patient experienced hives, rash and eosinophil count increased. The patient was treated with steroids nos, steroids nos, steroids nos, steroids nos (Steroid (Not Specified)), benadryl (nos) (Benadryl), antihistamine, antihistamine, antihistamine, antihistamine (Antihistamine) and prednisone. On an unknown date, the outcome of the hives, rash and eosinophil count increased were unknown.   It was unknown if the reporter considered the hives, rash and eosinophil count increased to be related to Shingrix.  Additional details were provided as follows: It was reported that the patient experienced hives of bilateral upper and lower extremities started day after injection. It was reported that the rash improved with steroid injection and benedryl, stopped antihistamine, then rash reoccurred 10 days later. Benedryl was ineffective. The physician gave another steroid shot and prescribed allegation and prednisone 20mg for 10 days. The patient underwent allergy panel for eggs, nut, wheat, milk, seseme and soy results were negative. The patient's CBC w/ diff elevated eosinophils. All other counts within normal limits.      Lab Comments: The patient underwent allergy panel for eggs, nut, wheat, milk, sesemeand soy showed all negative
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: hives of bilateral upper and lower extremties; rash; Cbc w/ diff elevated eosinophils; This case was reported by a other health professional via sales rep and described the occurrence of hives in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 31st August 2019, the patient received the 1st dose of Shingrix. On 1st September 2019, 1 days after receiving Shingrix, the patient experienced hives, rash and eosinophil count increased. The patient was treated with steroids nos, steroids nos, steroids nos, steroids nos (Steroid (Not Specified)), benadryl (nos) (Benadryl), antihistamine, antihistamine, antihistamine, antihistamine (Antihistamine) and prednisone. On an unknown date, the outcome of the hives, rash and eosinophil count increased were unknown.   It was unknown if the reporter considered the hives, rash and eosinophil count increased to be related to Shingrix.  Additional details were provided as follows: It was reported that the patient experienced hives of bilateral upper and lower extremities started day after injection. It was reported that the rash improved with steroid injection and benedryl, stopped antihistamine, then rash reoccurred 10 days later. Benedryl was ineffective. The physician gave another steroid shot and prescribed allegation and prednisone 20mg for 10 days. The patient underwent allergy panel for eggs, nut, wheat, milk, seseme and soy results were negative. The patient's CBC w/ diff elevated eosinophils. All other counts within normal limits.      Lab Comments: The patient underwent allergy panel for eggs, nut, wheat, milk, sesemeand soy showed all negative
Age: 72.0
Sex: M
Vaccine: UNK, VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Classic rash on left side of abdomen only; Shingles; This case was reported by a physician via sales rep and described the occurrence of rash in a 72-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included apremilast (Otezla) for an unknown indication.   On 13th September 2019, the patient received the 1st dose of Shingrix. On an unknown date, the patient started Otezla at an unknown dose and frequency. On 17th September 2019, 4 days after receiving Shingrix, the patient experienced rash and shingles. The action taken with Otezla was unknown. On an unknown date, the outcome of the rash and shingles were unknown.   It was unknown if the reporter considered the rash and shingles to be related to Shingrix.  Additional case details were reported as follows: The patient seen at office week of 16th September 2019, showing classic rash on left side of abdomen only, patient began experienced symptoms week of September 2019, approximately 4 days after receiving Shingrix vaccine. The patient also using Otezla prescribed by rheumatologist.  The reporter did not think incidence of shingles related to use of Shingrix. The reporter consented to follow up.
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Redness at injection site; Pain at injection site; This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 79-year-old male patient who received Herpes zoster (Shingrix) (batch number TB2PK, expiry date 5th October 2021) for prophylaxis.   On 13th September 2019, the patient received Shingrix. On 17th September 2019, 4 days after receiving Shingrix, the patient experienced injection site erythema and injection site pain. On an unknown date, the outcome of the injection site erythema and injection site pain were unknown.   It was unknown if the reporter considered the injection site erythema and injection site pain to be related to Shingrix.  Additional details were provided as follows: The pharmacist reported that the patient had redness and pain at injection site following Shingrix vaccination. The reporter did not consent to follow up.
Age: 94.0
Sex: M
Vaccine: VARZOS
Symptoms: Burning sensation, Erythema, Pruritus, Pruritus genital, Scratch
Clinical narrative: Itching all over his body/itching presented on his feet and toes; Feels a burning on his face that comes and goes; His face gets red in color; His head, back and legs are scratched; itching on his testicles; This case was reported by a consumer via call center representative and described the occurrence of generalized pruritus in a 94-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included cancer. Concomitant products included antineoplastic agents (nos) (Anticancer Agent (Nos)).   In 2019, the patient received the 2nd dose of Shingrix. On 17th September 2019, less than 9 months after receiving Shingrix, the patient experienced genital itching male. On an unknown date, the patient experienced generalized pruritus, burning sensation, red face and scratch. On an unknown date, the outcome of the generalized pruritus and red face were not recovered/not resolved and the outcome of the burning sensation, scratch and genital itching male were unknown.   It was unknown if the reporter considered the generalized pruritus, burning sensation, red face, scratch and genital itching male to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix in either March or April and following that dose he has developed itching all over his body. His head, back and legs are scratched from him scratching them.The itching presented on his feet and toes just recently and before the date of reporting he complained of itching on his testicles. He feels a burning on his face that comes and goes.When it presents, his face gets red in color. There was no rash present with this itching. The reporter consented to follow up.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Headache, Influenza like illness, Pain, Pain in extremity
Clinical narrative: Rash on her face, neck and chest/spot on her neck and chest are again red; Itchy/spot on her neck and chest are again itchy; raised red, hot area about 4x2 inches on the arm; hot area on the arm; Flu like symptoms; Sore arm; Headache; Body aches; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th September 2019, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 12th September 2019, less than a day after receiving Shingrix, the patient experienced influenza-like symptoms, pain in arm, headache and general body pain. On 13th September 2019, the patient experienced erythema of extremities and skin warm. On 14th September 2019, the patient experienced red rash and itchy rash. On 14th September 2019, the outcome of the skin warm, red rash and itchy rash were not recovered/not resolved and the outcome of the pain in arm, headache and general body pain were recovered/resolved. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved and the outcome of the erythema of extremities was not recovered/not resolved.   It was unknown if the reporter considered the influenza-like symptoms, erythema of extremities, skin warm, red rash, pain in arm, headache, general body pain and itchy rash to be related to Shingrix.  Additional details were provided as follows: The patient received the 2nd dose of Shingrix and developed flu like symptoms including headache and body aches. These symptoms were resolved. The patient had sore arms but that resolved. 24 hours after the vaccination the patient experienced a raised red, hot area about 4x2 inches on the arm in which she got the vaccine but closer to her body than the injection site. She started getting a rash on her face, neck and chest.  This continued and then the rash on the face was pretty much gone.  It had settled down to redness and wasn't itchy or hot. After work out the patient noticed the spot on her neck and chest are again red and itchy and feels like the symptoms are returning. The reporter consented to follow up. This case linked with US2019169081, reported by same reporter.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash erythematous, Rash pruritic, Skin warm
Clinical narrative: Rash on her face, neck and chest/spot on her neck and chest are again red; Itchy/spot on her neck and chest are again itchy; raised red, hot area about 4x2 inches on the arm; hot area on the arm; Flu like symptoms; Sore arm; Headache; Body aches; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th September 2019, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 12th September 2019, less than a day after receiving Shingrix, the patient experienced influenza-like symptoms, pain in arm, headache and general body pain. On 13th September 2019, the patient experienced erythema of extremities and skin warm. On 14th September 2019, the patient experienced red rash and itchy rash. On 14th September 2019, the outcome of the skin warm, red rash and itchy rash were not recovered/not resolved and the outcome of the pain in arm, headache and general body pain were recovered/resolved. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved and the outcome of the erythema of extremities was not recovered/not resolved.   It was unknown if the reporter considered the influenza-like symptoms, erythema of extremities, skin warm, red rash, pain in arm, headache, general body pain and itchy rash to be related to Shingrix.  Additional details were provided as follows: The patient received the 2nd dose of Shingrix and developed flu like symptoms including headache and body aches. These symptoms were resolved. The patient had sore arms but that resolved. 24 hours after the vaccination the patient experienced a raised red, hot area about 4x2 inches on the arm in which she got the vaccine but closer to her body than the injection site. She started getting a rash on her face, neck and chest.  This continued and then the rash on the face was pretty much gone.  It had settled down to redness and wasn't itchy or hot. After work out the patient noticed the spot on her neck and chest are again red and itchy and feels like the symptoms are returning. The reporter consented to follow up. This case linked with US2019169081, reported by same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Skin exfoliation
Clinical narrative: All of her skin peeling off; This case was reported by a pharmacist via call center representative and described the occurrence of skin peeling in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced skin peeling. On an unknown date, the outcome of the skin peeling was unknown.   It was unknown if the reporter considered the skin peeling to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The batch number was not reported. The pharmacist reported that the patient experienced all her skin peeling off following a dose of Shingrix. The health care professional reported no additional details about the event.
Age: 65.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Chest discomfort, Hypersensitivity
Clinical narrative: Allergic reaction; Tightness in chest; This case was reported by a pharmacist via call center representative and described the occurrence of allergic reaction in a 65-year-old female patient who received Herpes zoster (Shingrix) (batch number 9AB33, expiry date 6th December 2021) for prophylaxis.   Co-suspect products included INFLUENZA VIRUS VACCINE INACTIVATED (FLUZONE HIGH DOSE) for prophylaxis.   Concurrent medical conditions included shellfish allergy (reaction to allergies for shellfish and peanuts) and peanut allergy.   On 16th September 2019, the patient received Shingrix (intramuscular) and FLUZONE HIGH DOSE. In September 2019, less than a week after receiving Shingrix, the patient experienced allergic reaction and chest tightness. On an unknown date, the outcome of the allergic reaction and chest tightness were recovered/resolved.   It was unknown if the reporter considered the allergic reaction and chest tightness to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix along with Fluzone High Dose flu shot. The patient described she as an allergic reaction that included tightness in her chest like her reaction to allergies for shellfish and peanuts.   The Caller reports patient went to the hospital and issue has resolved. The emergency room visit was required.
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia
Clinical narrative: In the middle of the night he woke up to a very painful knee; This case was reported by a pharmacist via call center representative and described the occurrence of knee pain in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th September 2019, the patient received the 1st dose of Shingrix. In September 2019, less than a day after receiving Shingrix, the patient experienced knee pain. On an unknown date, the outcome of the knee pain was unknown.   It was unknown if the reporter considered the knee pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The batch number was not reported. The patient received Shingrix and in the middle of the night he woke up to a very painful knee.  The reporter consented to follow up. The caller stated it was unknown if it was related and was asking about potential side effects.  The reporter did not have further information to provide at reporting time.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Abdominal pain upper, Axillary pain, Bedridden, Dizziness
Clinical narrative: Not feeling good (malaise); Fever; Headache; Nausea; Feeling lightheaded over the weekend; Remaining in bed; Soreness under armpit; Stomach started to bother a little / and it feels dull; Stomach hurts a little; Soreness at the injection site/Pain in arm; Arm felt heavy lifting up; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 13th September 2019 06:30, the patient received the 1st dose of Shingrix (intramuscular). On 13th September 2019, immediately after receiving Shingrix, the patient experienced injection site pain and heaviness in arm. On 14th September 2019, the patient experienced malaise, fever, headache, nausea, light headedness, bedridden, axillary pain, upset stomach and stomach pain. The patient was treated with paracetamol (Tylenol) and non-drug therapy, non-drug therapy (Ice Pack (No Medication)). On 15th September 2019, the outcome of the headache was recovered/resolved. On an unknown date, the outcome of the injection site pain, heaviness in arm, malaise, fever, bedridden, axillary pain, upset stomach and stomach pain were unknown and the outcome of the nausea was not recovered/not resolved and the outcome of the light headedness was recovered/resolved.   It was unknown if the reporter considered the injection site pain, heaviness in arm, malaise, fever, headache, nausea, light headedness, bedridden, axillary pain, upset stomach and stomach pain to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and approximately 6:30 pm in her left arm and immediately had soreness at the injection site.  The caller reports her arm felt heavy lifting up. The following day the patient waking up in morning and soreness in her arm, not feeling good (malaise), having a fever of 100 F, onset of headache that was relieved Sunday, nausea that lasted throughout the day, remaining in bed throughout the weekend, feeling lightheaded over the weekend, and soreness under armpit.  The caller at the time of reporting soreness now extending down her arm and approximately half an hour prior to contacting GSK she began to feel nauseous again.  The caller reported when this nausea came her stomach started to bother her a little.  The caller reported her stomach hurts a little and it feels dull but not a feeling of needing to go to bathroom. The reporter consented to follow up.  This case linked with US2019AMR169698, reported by same reporter.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Immediate post-injection reaction, Injection site pain, Limb discomfort, Malaise
Clinical narrative: Not feeling good (malaise); Fever; Headache; Nausea; Feeling lightheaded over the weekend; Remaining in bed; Soreness under armpit; Stomach started to bother a little / and it feels dull; Stomach hurts a little; Soreness at the injection site/Pain in arm; Arm felt heavy lifting up; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 13th September 2019 06:30, the patient received the 1st dose of Shingrix (intramuscular). On 13th September 2019, immediately after receiving Shingrix, the patient experienced injection site pain and heaviness in arm. On 14th September 2019, the patient experienced malaise, fever, headache, nausea, light headedness, bedridden, axillary pain, upset stomach and stomach pain. The patient was treated with paracetamol (Tylenol) and non-drug therapy, non-drug therapy (Ice Pack (No Medication)). On 15th September 2019, the outcome of the headache was recovered/resolved. On an unknown date, the outcome of the injection site pain, heaviness in arm, malaise, fever, bedridden, axillary pain, upset stomach and stomach pain were unknown and the outcome of the nausea was not recovered/not resolved and the outcome of the light headedness was recovered/resolved.   It was unknown if the reporter considered the injection site pain, heaviness in arm, malaise, fever, headache, nausea, light headedness, bedridden, axillary pain, upset stomach and stomach pain to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and approximately 6:30 pm in her left arm and immediately had soreness at the injection site.  The caller reports her arm felt heavy lifting up. The following day the patient waking up in morning and soreness in her arm, not feeling good (malaise), having a fever of 100 F, onset of headache that was relieved Sunday, nausea that lasted throughout the day, remaining in bed throughout the weekend, feeling lightheaded over the weekend, and soreness under armpit.  The caller at the time of reporting soreness now extending down her arm and approximately half an hour prior to contacting GSK she began to feel nauseous again.  The caller reported when this nausea came her stomach started to bother her a little.  The caller reported her stomach hurts a little and it feels dull but not a feeling of needing to go to bathroom. The reporter consented to follow up.  This case linked with US2019AMR169698, reported by same reporter.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pyrexia
Clinical narrative: Not feeling good (malaise); Fever; Headache; Nausea; Feeling lightheaded over the weekend; Remaining in bed; Soreness under armpit; Stomach started to bother a little / and it feels dull; Stomach hurts a little; Soreness at the injection site/Pain in arm; Arm felt heavy lifting up; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 13th September 2019 06:30, the patient received the 1st dose of Shingrix (intramuscular). On 13th September 2019, immediately after receiving Shingrix, the patient experienced injection site pain and heaviness in arm. On 14th September 2019, the patient experienced malaise, fever, headache, nausea, light headedness, bedridden, axillary pain, upset stomach and stomach pain. The patient was treated with paracetamol (Tylenol) and non-drug therapy, non-drug therapy (Ice Pack (No Medication)). On 15th September 2019, the outcome of the headache was recovered/resolved. On an unknown date, the outcome of the injection site pain, heaviness in arm, malaise, fever, bedridden, axillary pain, upset stomach and stomach pain were unknown and the outcome of the nausea was not recovered/not resolved and the outcome of the light headedness was recovered/resolved.   It was unknown if the reporter considered the injection site pain, heaviness in arm, malaise, fever, headache, nausea, light headedness, bedridden, axillary pain, upset stomach and stomach pain to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and approximately 6:30 pm in her left arm and immediately had soreness at the injection site.  The caller reports her arm felt heavy lifting up. The following day the patient waking up in morning and soreness in her arm, not feeling good (malaise), having a fever of 100 F, onset of headache that was relieved Sunday, nausea that lasted throughout the day, remaining in bed throughout the weekend, feeling lightheaded over the weekend, and soreness under armpit.  The caller at the time of reporting soreness now extending down her arm and approximately half an hour prior to contacting GSK she began to feel nauseous again.  The caller reported when this nausea came her stomach started to bother her a little.  The caller reported her stomach hurts a little and it feels dull but not a feeling of needing to go to bathroom. The reporter consented to follow up.  This case linked with US2019AMR169698, reported by same reporter.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Muscle spasms
Clinical narrative: leg cramping; This case was reported by a pharmacist via call center representative and described the occurrence of leg cramps in a 67-year-old male patient who received Herpes zoster (Shingrix) (batch number E2A23, expiry date 13th September 2021) for prophylaxis.   On 9th September 2019, the patient received the 1st dose of Shingrix (intramuscular). In September 2019, less than 2 weeks after receiving Shingrix, the patient experienced leg cramps. On an unknown date, the outcome of the leg cramps was not recovered/not resolved.   It was unknown if the reporter considered the leg cramps to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix on right arm and experienced leg cramping that has not resolved unclear which leg involved.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Burning sensation, Middle insomnia
Clinical narrative: Burning sensation all over body / Palms of hands and bottoms of feed were burning; Felt like they had blistered; This case was reported by a nurse via call center representative and described the occurrence of burning sensation in a 66-year-old male patient who received Herpes zoster (Shingrix) (batch number 9277N, expiry date 27th June 2021) for prophylaxis.   Concurrent medical conditions included parkinsonism.   On 16th September 2019, the patient received Shingrix (intramuscular). On 16th September 2019, less than a day after receiving Shingrix, the patient experienced burning sensation and blister. On an unknown date, the outcome of the burning sensation and blister were recovered/resolved.   It was unknown if the reporter considered the burning sensation and blister to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and in the middle of the night he woke up with a burning sensation all over his body.  The palms of his hands and bottoms of his feed were burning so badly it felt like they had blistered.  The symptoms resolved after about 4 hours.
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Pain; This case was reported by a nurse via sales rep and described the occurrence of pain in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14th 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. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported but it could be 67 or 68 years. The field representative reported the adverse event by a nurse. The patient experienced pain with the first dose of Shingrix.  No further details were provided. The case was linked with the case US2019169171, reported by same reporter for same patient.