chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Influenza like illness, Injection site pain, Pain, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 55-year-old female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included multiple sclerosis (diagnosed in 1999, takes AVONEX injections for the same). Concomitant products included AVONEX. On 1st August 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 1st August 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain, general body pain, chills, fever and influenza-like symptoms. The patient was treated with ibuprofen. On an unknown date, the outcome of the injection site pain was not recovered/not resolved and the outcome of the general body pain, chills, fever and influenza-like symptoms were recovered/resolved. It was unknown if the reporter considered the injection site pain, general body pain, chills, fever and influenza-like symptoms to be related to SHINGRIX. Additional information was reported as follows: In 1999, the patient was diagnosed with Multiple sclerosis and took AVONEX injections for the same. The patient had only one AVONEX injection in her arm ever, which was several years ago, the patient had a similar reaction as after vaccination with SHINGRIX, since then the patient had always had AVONEX at alternate sites and never had reaction to the same again. The patient stated that after vaccination with the first dose of SHINGRIX, the patient had severe pain in her arm where was vaccinated. There was no redness or swelling experienced by the patient. The patient also developed bad flu-like symptoms. The patient had fever, body aches like someone was beating her up with a sledgehammer and bad chill. The patient was taking ibuprofen at the time of reporting and it was only taking the edge off a little. It took a full week for the events to resolve. This case was linked with case US2018GSK188899 (2nd dose), reported by the same reporter for the same patient.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Mobility decreased, Nausea, Pain
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of nausea in a 64-year-old female patient who received SHINGRIX (batch number AS9CM, expiry date unknown) for prophylaxis. On 14th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 14th May 2018, less than a day after receiving SHINGRIX, the patient experienced nausea, pain, headache and mobility decreased. On an unknown date, the outcome of the nausea and headache were unknown and the outcome of the pain and mobility decreased were recovered/resolved. It was unknown if the reporter considered the nausea, pain, headache and mobility decreased to be related to SHINGRIX. Additional details were provided as follows: The healthcare professional (HCP) reported that the patient developed nausea, headache, and severe soreness (where she could not lift anything) within 4 hours after receiving a dose of the SHINGRIX. The HCP did not have expiration date of vaccine. The soreness lasted for 5 weeks and resolved.
Age: 62.0
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of vaccination failure in a 62-year-old male patient who received SHINGRIX (batch number Z9RR4, expiry date 15th November 2020) for prophylaxis. Co-suspect products included SHINGRIX (batch number DD43M, expiry date 7th March 2021) for prophylaxis and FLUZONE (INACTIVATED INFLUENZA VACCINE)) (batch number U1986AB, expiry date 30th June 2019) for prophylaxis. On 28th June 2018, the patient received the 1st dose of SHINGRIX. On 28th August 2018, the patient received the 2nd dose of SHINGRIX and the 1st dose of FLUZONE (INACTIVATED INFLUENZA VACCINE) (intramuscular). On 9th October 2018, 103 days after receiving SHINGRIX and 42 days after receiving SHINGRIX, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to SHINGRIX and SHINGRIX. Additional details were provided as follows: The patient received 2nd dose of SHINGRIX on an unknown arm. The patient received FLUZONE shot on the other arm. On 9th October2018, the patient was diagnosed with shingles. This case was considered as suspected vaccination as confirmatory laboratory test for shingle was not provided. It was unknown if the reporter considered the shingles to be related to FLUZONE.
Age: 9.0
Sex: F
Vaccine: FLU4
Symptoms: Allergy test, Eye swelling, Full blood count, Headache, Injection site reaction
Clinical narrative: Was seen in office again on 10/4/18. Initial reaction was local at site and extended down to elbow by the next days, then began having sore throat, headache eye swollen. BENADRYL being given, lab done. 10/5 called rash under arms, around neck, down back worse. Prednisone given 10/7/18. Taken to hospital and admitted. Is currently still in hosp.
Age: 9.0
Sex: F
Vaccine: FLU4
Symptoms: Local reaction, Oropharyngeal pain, Rash
Clinical narrative: Was seen in office again on 10/4/18. Initial reaction was local at site and extended down to elbow by the next days, then began having sore throat, headache eye swollen. BENADRYL being given, lab done. 10/5 called rash under arms, around neck, down back worse. Prednisone given 10/7/18. Taken to hospital and admitted. Is currently still in hosp.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site hypersensitivity, Injection site pain, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site warmth in a 57-year-old female patient who received SHINGRIX for prophylaxis. On 8th October 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 9th October 2018, 1 days after receiving SHINGRIX, the patient experienced injection site warmth, injection site pain, general body pain, injection site rash, itchy rash and injection site swelling. On an unknown date, the outcome of the injection site warmth, injection site rash and itchy rash were not recovered/not resolved and the outcome of the injection site pain and general body pain were recovered/resolved and the outcome of the injection site swelling was unknown. It was unknown if the reporter considered the injection site warmth, injection site pain, general body pain, injection site rash, itchy rash and injection site swelling to be related to SHINGRIX. Additional information was reported as follows: On Monday night, the patient was vaccinated with SHINGRIX in left arm. The patient never got sick and she had an allergic reaction to SHINGRIX at the injection site. The patient claimed that she experienced hotness, swelling and a rash that had spread into her inner biceps at the time of reporting. The rash was also itchy and it hurt. The patient experienced the adverse events on the following day after vaccination. The patient also reported soreness around the injection site. The patient had denied permission to contact her physician.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Rash, Rash pruritic
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site warmth in a 57-year-old female patient who received SHINGRIX for prophylaxis. On 8th October 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 9th October 2018, 1 days after receiving SHINGRIX, the patient experienced injection site warmth, injection site pain, general body pain, injection site rash, itchy rash and injection site swelling. On an unknown date, the outcome of the injection site warmth, injection site rash and itchy rash were not recovered/not resolved and the outcome of the injection site pain and general body pain were recovered/resolved and the outcome of the injection site swelling was unknown. It was unknown if the reporter considered the injection site warmth, injection site pain, general body pain, injection site rash, itchy rash and injection site swelling to be related to SHINGRIX. Additional information was reported as follows: On Monday night, the patient was vaccinated with SHINGRIX in left arm. The patient never got sick and she had an allergic reaction to SHINGRIX at the injection site. The patient claimed that she experienced hotness, swelling and a rash that had spread into her inner biceps at the time of reporting. The rash was also itchy and it hurt. The patient experienced the adverse events on the following day after vaccination. The patient also reported soreness around the injection site. The patient had denied permission to contact her physician.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Axillary pain, Chills, Ear pain, Injection site pain, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of chills in a 56-year-old female patient who received SHINGRIX for prophylaxis. On 10th October 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 10th October 2018, less than a day after receiving SHINGRIX, the patient experienced chills, ear pain, pain, injection site pain and axillary pain. On 11th October 2018, the patient experienced rash. On an unknown date, the outcome of the chills, ear pain, pain and axillary pain were recovered/resolved and the outcome of the rash was not recovered/not resolved and the outcome of the injection site pain was unknown. It was unknown if the reporter considered the chills, ear pain, rash, pain, injection site pain and axillary pain to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX on left arm. The patient reported soreness up to her ear and under her left arm. The patient was a little sore the day before reporting, at the injection site and she had chills and was achy last night. The patient also had a rash start the day of reporting on her trunk. The patient claims that she only gets a rash when she had a virus.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of chills in a 56-year-old female patient who received SHINGRIX for prophylaxis. On 10th October 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 10th October 2018, less than a day after receiving SHINGRIX, the patient experienced chills, ear pain, pain, injection site pain and axillary pain. On 11th October 2018, the patient experienced rash. On an unknown date, the outcome of the chills, ear pain, pain and axillary pain were recovered/resolved and the outcome of the rash was not recovered/not resolved and the outcome of the injection site pain was unknown. It was unknown if the reporter considered the chills, ear pain, rash, pain, injection site pain and axillary pain to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX on left arm. The patient reported soreness up to her ear and under her left arm. The patient was a little sore the day before reporting, at the injection site and she had chills and was achy last night. The patient also had a rash start the day of reporting on her trunk. The patient claims that she only gets a rash when she had a virus.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Product supply issue
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of chills in a 71-year-old female patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. On 28th March 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, the patient received the 2nd dose of SHINGRIX. On 28th March 2018, 14 hrs after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced chills. On an unknown date, the patient experienced product supply issue. On 29th March 2018, the outcome of the chills was recovered/resolved. On an unknown date, the outcome of the product supply issue was unknown. It was unknown if the reporter considered the chills to be related to SHINGRIX. Additional details were provided as follows: At the time of reporting, the patient was beyond the 6 month window for dose 2 of SHINGRIX and she could not find a pharmacy or doctor who carries SHINGRIX. The patient had denied permission to contact their physician.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 57-year-old male patient who received SHINGRIX (batch number 95LX9, expiry date 22nd February 2021) for prophylaxis. On 31st July 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced shingles and rash. The patient was treated with VALTREX. On an unknown date, the outcome of the shingles was recovered/resolved and the outcome of the rash was not recovered/not resolved. It was unknown if the reporter considered the shingles and rash to be related to SHINGRIX. Additional details were provided as follows: Some time after receiving the 1st dose of SHINGRIX on left deltoid, the patient developed shingles and rash. The patient was prescribed Valtrex and the shingles resolved. For tolerance to 2nd dose refer linked case US2018GSK188479.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site pain in a adult patient who received 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 pain. On an unknown date, the outcome of the injection site pain was unknown. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional information was received as follows: The age at vaccination was not applicable. The age group was not provided, but was captured adult as per vaccine indication. The reporting Licensed Practical Nurse stated that she had seen multiple patients with arm soreness at the injection site after SHINGRIX and she did not had additional information.
Sex: M
Vaccine: HEP
Symptoms: Ankylosing spondylitis, Autoimmune disorder, Gastritis, Pernicious anaemia, Vitamin B12 deficiency
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of ankylosing spondylitis in a male patient who received ENGERIX B for prophylaxis. On an unknown date, the patient received ENGERIX B adult. On an unknown date, unknown after receiving ENGERIX B adult, the patient experienced ankylosing spondylitis (serious criteria GSK medically significant), pernicious anemia, gastritis, vitamin d deficiency and vitamin b12 deficiency. On an unknown date, the outcome of the ankylosing spondylitis, pernicious anemia, gastritis, vitamin d deficiency and vitamin b12 deficiency were unknown. It was unknown if the reporter considered the ankylosing spondylitis, pernicious anemia, gastritis, vitamin d deficiency and vitamin b12 deficiency to be related to ENGERIX B adult. Additional information received as follows: The patient reported that in 2013, after receiving ENGERIX B adult, he experienced pernicious anemia, ankylosing spondylitis, Vitamin B12 deficiency, Vitamin D deficiency and autoimmune gastritis. No any any further information was provided. The patient had denied permission to contact their physician.
Sex: M
Vaccine: HEP
Symptoms: Vitamin D deficiency
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of ankylosing spondylitis in a male patient who received ENGERIX B for prophylaxis. On an unknown date, the patient received ENGERIX B adult. On an unknown date, unknown after receiving ENGERIX B adult, the patient experienced ankylosing spondylitis (serious criteria GSK medically significant), pernicious anemia, gastritis, vitamin d deficiency and vitamin b12 deficiency. On an unknown date, the outcome of the ankylosing spondylitis, pernicious anemia, gastritis, vitamin d deficiency and vitamin b12 deficiency were unknown. It was unknown if the reporter considered the ankylosing spondylitis, pernicious anemia, gastritis, vitamin d deficiency and vitamin b12 deficiency to be related to ENGERIX B adult. Additional information received as follows: The patient reported that in 2013, after receiving ENGERIX B adult, he experienced pernicious anemia, ankylosing spondylitis, Vitamin B12 deficiency, Vitamin D deficiency and autoimmune gastritis. No any any further information was provided. The patient had denied permission to contact their physician.
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Gait inability, Laboratory test, Malaise, Memory impairment, Mobility decreased
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of myelitis transverse in a 85-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included trigeminal neuralgia. On 3rd July 2018, the patient received SHINGRIX (intramuscular) .5 mcg/mg. In July 2018, less than a month after receiving SHINGRIX, the patient experienced myelitis transverse (serious criteria hospitalization and GSK medically significant), unable to walk (serious criteria hospitalization), memory deficit (serious criteria hospitalization), urinary incontinence (serious criteria hospitalization), balance difficulty (serious criteria hospitalization), urinary frequency (serious criteria hospitalization), constipation (serious criteria hospitalization), mobility decreased (serious criteria hospitalization) and bladder dysfunction. On 16th July 2018, the patient experienced appetite lost (serious criteria hospitalization), general body pain (serious criteria hospitalization) and feeling unwell. On an unknown date, the outcome of the myelitis transverse, appetite lost, unable to walk and bladder dysfunction were recovering/resolving and the outcome of the memory deficit, urinary incontinence, balance difficulty and urinary frequency were not recovered/not resolved and the outcome of the general body pain and constipation were recovered/resolved and the outcome of the mobility decreased and feeling unwell were unknown. It was unknown if the reporter considered the myelitis transverse, appetite lost, unable to walk, memory deficit, urinary incontinence, balance difficulty, urinary frequency, general body pain, constipation, mobility decreased, feeling unwell and bladder dysfunction to be related to SHINGRIX. Additional information was reported as follows: The patient had a history of trigeminal neuralgia and it was related to her trigeminal neuralgia.  On 16th July 2018, the patient started feeling very unwell and experienced loss of appetite. The patient stated that something was wrong all over. On 16th July 2018, the patient went to the hospital, she was in great pain, the pain was all over. The patient could not move down from her waist, she was only able to move her toes. The patient was catharized in the hospital. The patient stated that she was not completely recovered. The patient had also lost control on her bladder function, which had left her with incontinency and urinary frequency. The patients' memory function was poor. The patient had to think longer for answers. The patient was diagnosed with transverse myelitis while she was hospitalised. The hospital performed tests and was admitted for a period of 2 and a half weeks as she could not walk and then was a taken to a rehab for a period of 2 and a half weeks again. The patient was suggested with treatment and she had blood removed and plasma exchanged 5 times with 1 day in between each treatment. At the time of reporting, the patient walks with a walker due to loss of balance.
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Myelitis transverse, Pain, Plasmapheresis, Pollakiuria, Transfusion
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of myelitis transverse in a 85-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included trigeminal neuralgia. On 3rd July 2018, the patient received SHINGRIX (intramuscular) .5 mcg/mg. In July 2018, less than a month after receiving SHINGRIX, the patient experienced myelitis transverse (serious criteria hospitalization and GSK medically significant), unable to walk (serious criteria hospitalization), memory deficit (serious criteria hospitalization), urinary incontinence (serious criteria hospitalization), balance difficulty (serious criteria hospitalization), urinary frequency (serious criteria hospitalization), constipation (serious criteria hospitalization), mobility decreased (serious criteria hospitalization) and bladder dysfunction. On 16th July 2018, the patient experienced appetite lost (serious criteria hospitalization), general body pain (serious criteria hospitalization) and feeling unwell. On an unknown date, the outcome of the myelitis transverse, appetite lost, unable to walk and bladder dysfunction were recovering/resolving and the outcome of the memory deficit, urinary incontinence, balance difficulty and urinary frequency were not recovered/not resolved and the outcome of the general body pain and constipation were recovered/resolved and the outcome of the mobility decreased and feeling unwell were unknown. It was unknown if the reporter considered the myelitis transverse, appetite lost, unable to walk, memory deficit, urinary incontinence, balance difficulty, urinary frequency, general body pain, constipation, mobility decreased, feeling unwell and bladder dysfunction to be related to SHINGRIX. Additional information was reported as follows: The patient had a history of trigeminal neuralgia and it was related to her trigeminal neuralgia.  On 16th July 2018, the patient started feeling very unwell and experienced loss of appetite. The patient stated that something was wrong all over. On 16th July 2018, the patient went to the hospital, she was in great pain, the pain was all over. The patient could not move down from her waist, she was only able to move her toes. The patient was catharized in the hospital. The patient stated that she was not completely recovered. The patient had also lost control on her bladder function, which had left her with incontinency and urinary frequency. The patients' memory function was poor. The patient had to think longer for answers. The patient was diagnosed with transverse myelitis while she was hospitalised. The hospital performed tests and was admitted for a period of 2 and a half weeks as she could not walk and then was a taken to a rehab for a period of 2 and a half weeks again. The patient was suggested with treatment and she had blood removed and plasma exchanged 5 times with 1 day in between each treatment. At the time of reporting, the patient walks with a walker due to loss of balance.
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Urinary incontinence, Walking aid user
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of myelitis transverse in a 85-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included trigeminal neuralgia. On 3rd July 2018, the patient received SHINGRIX (intramuscular) .5 mcg/mg. In July 2018, less than a month after receiving SHINGRIX, the patient experienced myelitis transverse (serious criteria hospitalization and GSK medically significant), unable to walk (serious criteria hospitalization), memory deficit (serious criteria hospitalization), urinary incontinence (serious criteria hospitalization), balance difficulty (serious criteria hospitalization), urinary frequency (serious criteria hospitalization), constipation (serious criteria hospitalization), mobility decreased (serious criteria hospitalization) and bladder dysfunction. On 16th July 2018, the patient experienced appetite lost (serious criteria hospitalization), general body pain (serious criteria hospitalization) and feeling unwell. On an unknown date, the outcome of the myelitis transverse, appetite lost, unable to walk and bladder dysfunction were recovering/resolving and the outcome of the memory deficit, urinary incontinence, balance difficulty and urinary frequency were not recovered/not resolved and the outcome of the general body pain and constipation were recovered/resolved and the outcome of the mobility decreased and feeling unwell were unknown. It was unknown if the reporter considered the myelitis transverse, appetite lost, unable to walk, memory deficit, urinary incontinence, balance difficulty, urinary frequency, general body pain, constipation, mobility decreased, feeling unwell and bladder dysfunction to be related to SHINGRIX. Additional information was reported as follows: The patient had a history of trigeminal neuralgia and it was related to her trigeminal neuralgia.  On 16th July 2018, the patient started feeling very unwell and experienced loss of appetite. The patient stated that something was wrong all over. On 16th July 2018, the patient went to the hospital, she was in great pain, the pain was all over. The patient could not move down from her waist, she was only able to move her toes. The patient was catharized in the hospital. The patient stated that she was not completely recovered. The patient had also lost control on her bladder function, which had left her with incontinency and urinary frequency. The patients' memory function was poor. The patient had to think longer for answers. The patient was diagnosed with transverse myelitis while she was hospitalised. The hospital performed tests and was admitted for a period of 2 and a half weeks as she could not walk and then was a taken to a rehab for a period of 2 and a half weeks again. The patient was suggested with treatment and she had blood removed and plasma exchanged 5 times with 1 day in between each treatment. At the time of reporting, the patient walks with a walker due to loss of balance.
Sex: F
Vaccine: VARZOS
Symptoms: Blindness, Laboratory test normal, Vaccination complication
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of blindness in a 70-year-old female patient who received 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 blindness (serious criteria GSK medically significant). On an unknown date, the outcome of the blindness was unknown. It was unknown if the reporter considered the blindness to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient's friend who wished to remain anonymous. The age at vaccination was not reported. The patient received SHINGRIX and shortly after developed complications that led to blindness. The patient's tests for stroke were negative and finally the doctor determined that the patient had a reaction to SHINGRIX. The reporter thought the event might have already been reported to GlaxoSmithKline (no duplicate case found). The reporter could not provide any other details. The patient had denied permission to contact their physician. Lab Comments: On an unknwon date, the patient's tests for stroke were negative.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of suspected vaccination failure in a 77-year-old male patient who received SHINGRIX. Co-suspect products included SHINGRIX (batch number L9CS4, expiry date 31st July 2021) for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On 31st July 2018, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX and SHINGRIX, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to SHINGRIX and SHINGRIX. Additional details were provided as follows: The patient had received both doses of SHINGRIX however had experienced recurrent bouts of shingles after receiving the vaccines. This case was considered to be a suspected vaccination failure case, as the details regarding laboratory confirmation for shingles and exact time to onset were unknown. No further details were provided.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 71-year-old female patient who received SHINGRIX for prophylaxis. On 2nd May 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain in arm and injection site erythema. On an unknown date, the outcome of the pain in arm and injection site erythema were recovered/resolved. It was unknown if the reporter considered the pain in arm and injection site erythema to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the right deltoid. The patient stated that, she had very little effects from the 1st dose of SHINGRIX, mostly a very sore arm, which took about a week to resolve. There was a large red circle on the patient's arm at the injection site which gradually disappeared. The patient read various reports about the adverse affects of SHINGRIX and wanted to know if there had been cases of optical neuropathy, as she was due for the 2nd shot very soon.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Balance disorder, Dry mouth, Ear pain, Glycosylated haemoglobin increased
Clinical narrative: This case was reported by a pharmacist via sales rep and described the occurrence of ear pain in a 81-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (1st dose received on 25th May 2018). On 11th September 2018, the patient received the 2nd dose of SHINGRIX. In September 2018, less than a week after receiving SHINGRIX, the patient experienced ear pain, dry mouth and balance difficulty. On an unknown date, the outcome of the ear pain, dry mouth and balance difficulty were unknown. It was unknown if the reporter considered the ear pain, dry mouth and balance difficulty to be related to SHINGRIX. Additional details were reported as follows: On 22nd May 2017, the patient's Glycosylated hemoglobin (A1C) was 7.1. On 30th January 2018, the patient's A1C was 6.9. In 2018, the patient A1C was elevated to 13.7. On 17th September 2018, the patient reported to primary care physician (PCP) with ear pain, dry mouth and poor balance. Nothing else was new in the patient's medical chart between previous A1C and elevated A1C except SHINGRIX. The reporter was agree to follow up from GlaxoSmithKline.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Aphthous ulcer, Hyperaesthesia, Hypersensitivity, Lip swelling, Pruritus
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of aphthous stomatitis in a adult male patient who received SHINGRIX for prophylaxis. In June 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced aphthous stomatitis, allergic reaction, fever, lip swelling, skin peeling, touch sensitivity increased, sores mouth, generalized rash and pruritus. On an unknown date, the outcome of the aphthous stomatitis was recovered/resolved and the outcome of the allergic reaction, fever, lip swelling, skin peeling, touch sensitivity increased, sores mouth, generalized rash and pruritus were unknown. It was unknown if the reporter considered the aphthous stomatitis, allergic reaction, fever, lip swelling, skin peeling, touch sensitivity increased, sores mouth, generalized rash and pruritus to be related to SHINGRIX. Additional details were reported as follows: The patient had a severe allergic reaction to the SHINGRIX shot. The patient experienced fever, swallowed lip, canker sores in the mouth, bumps internal and external on several parts of the body, skin peeling and send ivory to touch and some itching. The patient saw 3 doctors to assist in diagnosing the problem. The patient stated to contact at GSK's earliest convenience. The patient was not planning on a 2nd shot but need GSK's input. All symptoms were resolved within 10 days to 2 weeks.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia, Rash generalised, Skin exfoliation, Stomatitis
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of aphthous stomatitis in a adult male patient who received SHINGRIX for prophylaxis. In June 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced aphthous stomatitis, allergic reaction, fever, lip swelling, skin peeling, touch sensitivity increased, sores mouth, generalized rash and pruritus. On an unknown date, the outcome of the aphthous stomatitis was recovered/resolved and the outcome of the allergic reaction, fever, lip swelling, skin peeling, touch sensitivity increased, sores mouth, generalized rash and pruritus were unknown. It was unknown if the reporter considered the aphthous stomatitis, allergic reaction, fever, lip swelling, skin peeling, touch sensitivity increased, sores mouth, generalized rash and pruritus to be related to SHINGRIX. Additional details were reported as follows: The patient had a severe allergic reaction to the SHINGRIX shot. The patient experienced fever, swallowed lip, canker sores in the mouth, bumps internal and external on several parts of the body, skin peeling and send ivory to touch and some itching. The patient saw 3 doctors to assist in diagnosing the problem. The patient stated to contact at GSK's earliest convenience. The patient was not planning on a 2nd shot but need GSK's input. All symptoms were resolved within 10 days to 2 weeks.
Sex: M
Vaccine: FLUX, VARZOS
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: This case was reported by a pharmacist via sales rep and described the occurrence of fever in a elderly male patient who received SHINGRIX for prophylaxis. Co-suspect products included INFLUENZA VACCINE for an unknown indication. On 7th October 2018, the patient received the 2nd dose of SHINGRIX and INFLUENZA VACCINE. On 7th October 2018, less than a day after receiving SHINGRIX and 1 day after receiving SHINGRIX and INFLUENZA VACCINE, the patient experienced fever, pain and chills. On an unknown date, the outcome of the fever, pain and chills were unknown. It was unknown if the reporter considered the fever, pain and chills to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported, but he was above 65 year old The patient got SHINGRIX concomitantly with high dose of Flu shot.  Both shots were given in the same arm. The patient experienced pain, fever, chills until the next day. The reporter said thought it was due to the high dose flu. The reporter did not agree to follow up from GlaxoSmithKline.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Injection site reaction, Rash vesicular, Skin reaction
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of injection site rash in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site rash and vesicular rash. On an unknown date, the outcome of the injection site rash and vesicular rash were recovered/resolved. It was unknown if the reporter considered the injection site rash and vesicular rash to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. After receiving SHINGRIX, the patient had a skin reaction at injection site. There was a bubbly rash that lasted a week.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia, Product supply issue
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of shingles in a male patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. Previously administered products included ZOSTAVAX. On an unknown date, the patient received the 1st dose of SHINGRIX and the 2nd dose of SHINGRIX. On an unknown date, 213 days after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced shingles, post herpetic neuralgia and product supply issue. On an unknown date, the outcome of the shingles and post herpetic neuralgia were not reported and the outcome of the product supply issue was unknown. It was unknown if the reporter considered the shingles and post herpetic neuralgia to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient was a retired physician who spoke to sales representative at the GSK booth at the event. The patient stated that he had received his 1st dose of SHINGRIX 7 months before the date of reporting. The patient had not been able to get the second dose because of supply issue. The patient was at the time of reporting experiencing a case of shingles. The patient had pain in one dermatome near his abdomen but no rash.
Sex: F
Vaccine: TDAP
Symptoms: Immediate post-injection reaction, Injection site pain, Wrong technique in product usage process
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 65-year-old female patient who received dTpa vaccine for prophylaxis. On an unknown date, the patient received dTpa vaccine. On an unknown date, immediately after receiving dTpa vaccine, the patient experienced injection site pain and wrong injection technique. On an unknown date, the outcome of the injection site pain was recovered/resolved and the outcome of the wrong injection technique was unknown. It was unknown if the reporter considered the injection site pain to be related to dTpa vaccine. Additional details were reported as follows: The age at vaccination was not reported. The patient was 65 years old at the time of reporting. Approximately 20 to 25 years before the date of reporting, the patient had a Tdap injection (unknown manufacturer) and she experienced tremendous pain during the injection and afterwards at the injection site. The patient believed that the pain was caused by the way it was administered, which led to wrong injection techniques. The pain in her arm was eventually resolved. The patient did not have many details regarding this event involving the Tdap vaccine. The patient denied permission to contact their physician. This case has been linked to the US2018179152, reported by the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Pain
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of muscle pain in a 65-year-old female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, 2 days after receiving SHINGRIX, the patient experienced muscle pain and general body pain. On an unknown date, the outcome of the muscle pain and general body pain were recovered/resolved. It was unknown if the reporter considered the muscle pain and general body pain to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient received a dose of SHINGRIX 6 months prior to October 2018. After vaccination, the patient experienced body/muscle aches and the first symptoms began 2 days after vaccination. The event was continued for 6 months. The reporter agreed to be follow up from GlaxoSmithKline.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of hives in a 53-year-old female patient who received SHINGRIX for prophylaxis. On 8th October 2018, the patient received the 1st dose of SHINGRIX. In October 2018, less than a week after receiving SHINGRIX, the patient experienced hives. On an unknown date, the outcome of the hives was unknown. It was unknown if the reporter considered the hives to be related to SHINGRIX. Additional details were provided as follows: A lot number of SHINGRIX was unknown. On 10th October 2018, the patient came back with hives around neck and chest area. The provider explained that the patient was not short of breathe or experiencing difficulty breathing, however just broke out in hives around the neck and chest area.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Immediate post-injection reaction, Injected limb mobility decreased, Injection site pain
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site pain in a 61-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included spinal laminectomy (level 3, carried out one month ago with cadaver grafting). Previously administered products included Acetaminophen. On 9th October 2018, the patient received the 1st dose of SHINGRIX. On 9th October 2018, immediately after receiving SHINGRIX, the patient experienced injection site pain. In October 2018, the patient experienced fever, chills, headache, nausea and injected limb mobility decreased. On an unknown date, the outcome of the injection site pain, fever, chills, headache, nausea and injected limb mobility decreased were unknown. It was unknown if the reporter considered the injection site pain, fever, chills, headache, nausea and injected limb mobility decreased to be related to SHINGRIX. Additional information was reported as follows: The patient was a family nurse practitioner. The patient stated that she was a vaccine champion at her clinic. One day before the date of reporting, the patient was vaccinated with SHINGRIX. She explained it was ridiculously painful and it hurt while vaccination and became worse the next day following it. The patient stated that she did not mind for the events fever, chills, headache and nausea but could barely move her arm and it throbbed constantly. One month before the date of reporting, the patient had level 3 cervical laminectomy with cadaver grafting, she required no pain medications other than Acetaminophen a few times post operation. The patient was dreading to get her second dose of SHINGRIX and wondered how she should possibly recommend the vaccine to her 92-year-old mother and her elderly patients. The patient stated that she knew that she was not the first to report this but had to say something, as the pain was unacceptably painful. The patient stated that her co-workers found it to be the same experience about SHINGRIX as that of the patient.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pain, Pyrexia
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site pain in a 61-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included spinal laminectomy (level 3, carried out one month ago with cadaver grafting). Previously administered products included Acetaminophen. On 9th October 2018, the patient received the 1st dose of SHINGRIX. On 9th October 2018, immediately after receiving SHINGRIX, the patient experienced injection site pain. In October 2018, the patient experienced fever, chills, headache, nausea and injected limb mobility decreased. On an unknown date, the outcome of the injection site pain, fever, chills, headache, nausea and injected limb mobility decreased were unknown. It was unknown if the reporter considered the injection site pain, fever, chills, headache, nausea and injected limb mobility decreased to be related to SHINGRIX. Additional information was reported as follows: The patient was a family nurse practitioner. The patient stated that she was a vaccine champion at her clinic. One day before the date of reporting, the patient was vaccinated with SHINGRIX. She explained it was ridiculously painful and it hurt while vaccination and became worse the next day following it. The patient stated that she did not mind for the events fever, chills, headache and nausea but could barely move her arm and it throbbed constantly. One month before the date of reporting, the patient had level 3 cervical laminectomy with cadaver grafting, she required no pain medications other than Acetaminophen a few times post operation. The patient was dreading to get her second dose of SHINGRIX and wondered how she should possibly recommend the vaccine to her 92-year-old mother and her elderly patients. The patient stated that she knew that she was not the first to report this but had to say something, as the pain was unacceptably painful. The patient stated that her co-workers found it to be the same experience about SHINGRIX as that of the patient.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 65-year-old male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, 3 days after receiving SHINGRIX, the patient experienced fatigue and injection site pain. On an unknown date, the outcome of the fatigue and injection site pain were recovered/resolved. It was unknown if the reporter considered the fatigue and injection site pain to be related to SHINGRIX. Additional details were reported as follows: The patient had soreness at the injection site less than a year after receiving SHINGRIX vaccine. The fatigue peaked about 3 days after the vaccination. The both events were for several days. This case was linked with case US2018182833, reported by same reporter and having same patient.
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: This case was reported by a consumer and described the occurrence of pain in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year 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 information was received as follows: The age at vaccination was not reported. After receiving the SHINGRIX the patient experienced sore and it was okay to apply aloe or ICYHOT to the area.