chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shivering in a 61-year-old female patient who received SHINGRIX for prophylaxis. On 22nd August 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In August 2018, less than a week after receiving SHINGRIX, the patient experienced shivering and injection site bruising. On 22nd August 2018, less than a day after receiving SHINGRIX, the patient experienced fatigue, swelling arm, muscle pain and injection site hemorrhage. On an unknown date, the outcome of the shivering, fatigue, swelling arm, injection site bruising, muscle pain and injection site hemorrhage were recovered/resolved. It was unknown if the reporter considered the shivering, fatigue, swelling arm, injection site bruising, muscle pain and injection site hemorrhage to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient for herself. The patient received SHINGRIX in the left deltoid. She stated that the pharmacist must have hit a blood vessel because there was blood on the BAND-AID and noticed a bruise at the injection site about 3 or 4 days later that lasted about a week. Within 12 hours, she experienced muscle pain (resolved over 3 or 4 days), fatigue (resolved after 36 hours) and swelling in the arm. She also had shivering, but it was very short lived. She felt better 48 hours after receiving the vaccine and stated that the side effects were not bad enough to where she would not get the 2nd vaccine.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect route of product administration, Injection site cellulitis, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX (subcutaneous). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site erythema, injection site swelling, fever, injection site warmth, injection site cellulitis and intramuscular formulation administered by other route. On an unknown date, the outcome of the injection site erythema, injection site swelling, fever, injection site warmth, injection site cellulitis and intramuscular formulation administered by other route were unknown. It was unknown if the reporter considered the injection site erythema, injection site swelling, fever, injection site warmth and injection site cellulitis to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced cellulitis, redness, hot, swelling at injection site along with a fever. The healthcare professional would like recommendations for the 2nd dose or not. The patient received SHINGRIX subcutaneously instead of intramuscular route, which led to intramuscular formulation administered by other route. No additional information provided.
Sex: U
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX (subcutaneous). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site erythema, injection site swelling, fever, injection site warmth, injection site cellulitis and intramuscular formulation administered by other route. On an unknown date, the outcome of the injection site erythema, injection site swelling, fever, injection site warmth, injection site cellulitis and intramuscular formulation administered by other route were unknown. It was unknown if the reporter considered the injection site erythema, injection site swelling, fever, injection site warmth and injection site cellulitis to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced cellulitis, redness, hot, swelling at injection site along with a fever. The healthcare professional would like recommendations for the 2nd dose or not. The patient received SHINGRIX subcutaneously instead of intramuscular route, which led to intramuscular formulation administered by other route. No additional information provided.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Chest discomfort, Decreased appetite, Fatigue
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of chest tightness in a 75-year-old female patient who received SHINGRIX for prophylaxis. On 10th September 2018, the patient received the 2nd dose of SHINGRIX. On 11th September 2018, 1 days after receiving SHINGRIX, the patient experienced chest tightness, tiredness and appetite lost. On an unknown date, the outcome of the chest tightness, tiredness and appetite lost were not recovered/not resolved. It was unknown if the reporter considered the chest tightness, tiredness and appetite lost to be related to SHINGRIX. Additional details were provided as follows: The pharmacist called on behalf of a patient. The patient did not get the SHINGRIX vaccine at her pharmacy; however, the patient started having tightness of chest and loss of appetite. The pharmacist said that the patient was also barely getting out of bed, just feeling run down; she then clarified that what she meant by these two events that the patient if feeling tired.
Age: 92.0
Sex: F
Vaccine: VARZOS
Symptoms: Dry skin, Rash, Rash erythematous, Scab
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of erythematous rash in a 92-year-old female patient who received SHINGRIX (batch number 7FY22, expiry date 25th April 2020) for prophylaxis. Co-suspect products included (non-proprietary) Cortisone Shot for an unknown indication. Previously administered products included ZOSTAVAX (received in 2007). On 9th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular) 50 mcg/mg. On an unknown date, the patient started Cortisone Shot at an unknown dose and frequency. In July 2018, between 1 and 3 months after receiving SHINGRIX, the patient experienced erythematous rash. On an unknown date, the patient experienced scab and dry skin. The action taken with Cortisone Shot was unknown (Dechallenge was unknown). Rechallenge with Cortisone Shot was unknown. On an unknown date, the outcome of the erythematous rash and scab were recovering/resolving and the outcome of the dry skin was unknown. It was unknown if the reporter considered the erythematous rash, scab and dry skin to be related to SHINGRIX. Additional details were provided as follows: The caller stated that the patient received SHINGRIX on left arm. Two months ago from the reporting date, the patient experienced rash of red little bumps on the left side of her neck. The caller stated that less than 5 months after receiving SHINGRIX, they were improved in that they were scabs and more dry. The reporter noted that she also had a few under her left breast. The caller also stated that she had a Cortisone shot in her left knee, but cannot recall the timing of that and the rash appearance. The patient stated that the rash never hurt, but wondered if it could be shingles. The caller was referred to her physician for diagnosis and awareness. The caller will receive authorization letter to provide healthcare professional information at a later time. It was unknown if the reporter considered the rash, scab, erythematous rash and shingles to be related to Cortisone shot as well.
Sex: M
Vaccine: HEPAB
Symptoms: Adverse reaction
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of adverse reaction in a male patient who received TWINRIX for prophylaxis. Concurrent medical conditions included allergy (gluten and wheat). On an unknown date, the patient received TWINRIX at an unknown dose. On an unknown date, unknown after receiving TWINRIX, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown. It was unknown if the reporter considered the adverse reaction to be related to TWINRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received TWINRIX vaccine away from home. The patient experienced bad reaction. Due to the patient's reaction, he thought the vaccine might include some gluten or wheat to which he was intolerant. The patient did not wish to provide additional information. The phone number to GSK (GlaxoSmithKline) was provided.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Decreased appetite, Erythema, Fatigue, 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 63-year-old female patient who received SHINGRIX for prophylaxis. On 10th September 2018, the patient received the 1st dose of SHINGRIX. On 11th September 2018, 1 days after receiving SHINGRIX, the patient experienced appetite lost and fatigue. On 12th September 2018, the patient experienced pain in arm, swelling arm, skin warm and erythema of extremities. On an unknown date, the outcome of the pain in arm, swelling arm, appetite lost, skin warm and erythema of extremities were not recovered/not resolved and the outcome of the fatigue was recovering/resolving. It was unknown if the reporter considered the pain in arm, swelling arm, appetite lost, skin warm, fatigue and erythema of extremities to be related to SHINGRIX. Additional information was received as follows: The patient received SHINGRIX on the left arm. The day before the reporting day, she started feeling fatigue and had a loss of appetite. On the reporting day, the redness appeared an inch below the injection site and it was moving down and around the arm. It was also painful and hot to touch. The patient provided contact details of physician.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling, Skin warm
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 63-year-old female patient who received SHINGRIX for prophylaxis. On 10th September 2018, the patient received the 1st dose of SHINGRIX. On 11th September 2018, 1 days after receiving SHINGRIX, the patient experienced appetite lost and fatigue. On 12th September 2018, the patient experienced pain in arm, swelling arm, skin warm and erythema of extremities. On an unknown date, the outcome of the pain in arm, swelling arm, appetite lost, skin warm and erythema of extremities were not recovered/not resolved and the outcome of the fatigue was recovering/resolving. It was unknown if the reporter considered the pain in arm, swelling arm, appetite lost, skin warm, fatigue and erythema of extremities to be related to SHINGRIX. Additional information was received as follows: The patient received SHINGRIX on the left arm. The day before the reporting day, she started feeling fatigue and had a loss of appetite. On the reporting day, the redness appeared an inch below the injection site and it was moving down and around the arm. It was also painful and hot to touch. The patient provided contact details of physician.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Rash, Urticaria
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 71-year-old female patient who received SHINGRIX (batch number 9349T, expiry date 7th March 2021) for prophylaxis. On 30th August 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 31st August 2018, 1 days after receiving SHINGRIX, the patient experienced injection site erythema, rash and welts. The patient was treated with BENADRYL (NOS). On an unknown date, the outcome of the injection site erythema, rash and welts were recovered/resolved. It was unknown if the reporter considered the injection site erythema, rash and welts to be related to SHINGRIX. Additional details were provided as follows: At 13:10 hours, the patient received the SHINGRIX vaccine in the left deltoid.The next day after the vaccination, she experienced redness at the injection site and a rash on her trunk and back.The rash was described as almost resembling whelps. She took BENADRYL and the symptoms were fully resolved quickly. The reporter was unable to provide additional information. The reporter provided the lot number 93492. Explained that this number did not correlate with the SHINGRIX product. She did not know the actual lot number. The reported batch number of SHINGRIX was updated from 93492 to 9349T, as per sales data sheet.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of fever in a 59-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX. On 11th September 2018, the patient received the 2nd dose of SHINGRIX. On 12th September 2018, 1 days after receiving SHINGRIX, the patient experienced fever. On an unknown date, the outcome of the fever was unknown. It was unknown if the reporter considered the fever to be related to SHINGRIX. Additional details were provided as follows: The patient who was also a healthcare professional reported experiencing a fever of 101.2 degrees. This case has been linked to the US2018GSK172085, reported by the same reporter. The reporter was already stated that, healthcare professional experienced fever with first dose and stated that he previously reported the adverse event for the first dose of SHINGRIX, but no case was found, so created case US2018GSK172085.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Erythema, Feeling hot, Injected limb mobility decreased, Pain in extremity
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of low back pain in a 59-year-old female patient who received SHINGRIX (batch number 524S7, expiry date unknown) for prophylaxis. On 31st August 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 31st August 2018, 4 hrs after receiving SHINGRIX, the patient experienced pain in arm and injected limb mobility decreased. On 1st September 2018, the patient experienced erythema of extremities and extremities hot feeling of. On 2nd September 2018, the patient experienced low back pain. The patient was treated with ibuprofen and lidocaine (Lidoderm Patch). On 3rd September 2018, the outcome of the pain in arm, erythema of extremities and extremities hot feeling of were recovered/resolved. On an unknown date, the outcome of the low back pain was not recovered/not resolved and the outcome of the injected limb mobility decreased was unknown. It was unknown if the reporter considered the low back pain, pain in arm, erythema of extremities, extremities hot feeling of and injected limb mobility decreased to be related to SHINGRIX. Additional details were provided as follows: The reporting pharmacist was the patient. The healthcare professional (HCP) got the SHINGRIX vaccine at around 3 to 4 pm at her place of business which was a pharmacy and by 8 pm, her arm hurt and was so sore that, she could not even lift her arm. She also experienced redness of the arm and it felt hot a day after receiving the vaccine. Two days after receiving SHINGRIX, the patient had lower back pain which continued at the time of report. The patient used Ibuprofen and Lidoderm patches which did not relieve the back pain. The reported batch number for SHINGRIX 52457 did not exist and was updated to 524S7 as per sales database. The healthcare professional (HCP) did not have documentation of the expiry date. This case is linked with US2018166458, reported by the same reporter.
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Arthralgia, Back pain, Chills, Chromaturia, Headache
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of fever in a female patient who received SHINGRIX for prophylaxis. Co-suspect products included Influenza vaccine Quadrivalent unspecified season for an unknown indication. Previously administered products included Flu vaccine (receiving the same Flu vaccine for years and never experienced a reaction). On 10th September 2018, the patient received SHINGRIX and Influenza vaccine Quadrivalent unspecified season. On 10th September 2018, less than a day after receiving SHINGRIX and Influenza vaccine Quadrivalent unspecified season, the patient experienced fever, urine discoloration, joint pain, rigors, headache, back pain and generalized aching. The patient was treated with MOTRIN. On 11th September 2018, the outcome of the joint pain, rigors, headache and back pain were recovered/resolved. On an unknown date, the outcome of the fever, urine discoloration and generalized aching were not recovered/not resolved. The reporter considered the fever, urine discoloration, joint pain, rigors, headache, back pain and generalized aching to be related to SHINGRIX and Influenza vaccine Quadrivalent unspecified season. Additional details were provided as follows: This case was reported by the physician for herself. The age at vaccination was not reported. The patient reported that within 4 hours after receiving a dose of SHINGRIX and a Flu vaccine on the same day, he experienced a mild headache, joint pain and back aches. The patient took MOTRIN. At 11 pm the patient experienced a 102 F, body aches, rigors that were uncontrollable and she was almost fell out of the bed and had dark urine. By 11th September 2018, the patient reported that all the symptoms resolved except for fever, soreness all over and dark urine. The patient called Medical information with some questions on how common these reactions were and if GlaxoSmithKline (GSK) had asked recommendations on receiving the 2nd dose of SHINGRIX.
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of fever in a female patient who received SHINGRIX for prophylaxis. Co-suspect products included Influenza vaccine Quadrivalent unspecified season for an unknown indication. Previously administered products included Flu vaccine (receiving the same Flu vaccine for years and never experienced a reaction). On 10th September 2018, the patient received SHINGRIX and Influenza vaccine Quadrivalent unspecified season. On 10th September 2018, less than a day after receiving SHINGRIX and Influenza vaccine Quadrivalent unspecified season, the patient experienced fever, urine discoloration, joint pain, rigors, headache, back pain and generalized aching. The patient was treated with MOTRIN. On 11th September 2018, the outcome of the joint pain, rigors, headache and back pain were recovered/resolved. On an unknown date, the outcome of the fever, urine discoloration and generalized aching were not recovered/not resolved. The reporter considered the fever, urine discoloration, joint pain, rigors, headache, back pain and generalized aching to be related to SHINGRIX and Influenza vaccine Quadrivalent unspecified season. Additional details were provided as follows: This case was reported by the physician for herself. The age at vaccination was not reported. The patient reported that within 4 hours after receiving a dose of SHINGRIX and a Flu vaccine on the same day, he experienced a mild headache, joint pain and back aches. The patient took MOTRIN. At 11 pm the patient experienced a 102 F, body aches, rigors that were uncontrollable and she was almost fell out of the bed and had dark urine. By 11th September 2018, the patient reported that all the symptoms resolved except for fever, soreness all over and dark urine. The patient called Medical information with some questions on how common these reactions were and if GlaxoSmithKline (GSK) had asked recommendations on receiving the 2nd dose of SHINGRIX.
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness, Dyskinesia, Influenza like illness, Lethargy, Malaise
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of influenza-like symptoms in a 70-year-old male patient who received SHINGRIX for prophylaxis. On 31st August 2018, the patient received the 1st dose of SHINGRIX. On 1st September 2018, 1 days after receiving SHINGRIX, the patient experienced sickness. On an unknown date, the patient experienced influenza-like symptoms, pain in arm, lethargy, sleepiness, jerkiness and dizziness. On an unknown date, the outcome of the influenza-like symptoms, pain in arm, lethargy, sleepiness, jerkiness, dizziness and sickness were unknown. It was unknown if the reporter considered the influenza-like symptoms, pain in arm, lethargy, sleepiness, jerkiness, dizziness and sickness to be related to SHINGRIX. Additional details reported as follows: This case was reported by the licensed practical nurse. The age at vaccination was not reported but the patient was around 70 years old. The patient received SHINGRIX on right arm. The reporter, stated to the representative that the patient experienced all the events less than 2 week after vaccination listed but did not have any time frames for onset. She did not give any specific answers as to which flu like symptoms the patient experienced. The patient was sick on Saturday, 1st September 2018 and Sunday, 2nd September 2018 after the injection. The patient slept for two days, but it was not mentioned which days. The patient was better now but his arm was extremely sore. This case has been linked with US2018166446 and US2018166443, reported by same reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity, Somnolence
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of influenza-like symptoms in a 70-year-old male patient who received SHINGRIX for prophylaxis. On 31st August 2018, the patient received the 1st dose of SHINGRIX. On 1st September 2018, 1 days after receiving SHINGRIX, the patient experienced sickness. On an unknown date, the patient experienced influenza-like symptoms, pain in arm, lethargy, sleepiness, jerkiness and dizziness. On an unknown date, the outcome of the influenza-like symptoms, pain in arm, lethargy, sleepiness, jerkiness, dizziness and sickness were unknown. It was unknown if the reporter considered the influenza-like symptoms, pain in arm, lethargy, sleepiness, jerkiness, dizziness and sickness to be related to SHINGRIX. Additional details reported as follows: This case was reported by the licensed practical nurse. The age at vaccination was not reported but the patient was around 70 years old. The patient received SHINGRIX on right arm. The reporter, stated to the representative that the patient experienced all the events less than 2 week after vaccination listed but did not have any time frames for onset. She did not give any specific answers as to which flu like symptoms the patient experienced. The patient was sick on Saturday, 1st September 2018 and Sunday, 2nd September 2018 after the injection. The patient slept for two days, but it was not mentioned which days. The patient was better now but his arm was extremely sore. This case has been linked with US2018166446 and US2018166443, reported by same reporter.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in a 70-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included ZOSTAVAX (dose received on an unknown date). On 26th June 2018 16:00, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, less than 3 months after receiving SHINGRIX, the patient experienced pain and headache. On an unknown date, the outcome of the pain and headache were recovered/resolved. It was unknown if the reporter considered the pain and headache to be related to SHINGRIX. Additional information received as follows: The patient reported that she received SHINGRIX on the left deltoid. The patient experienced feeling achy and having a headache for a couple of days. The contact details of the physician were provided. For tolerance to next dose, refer case US2018GSK171866. This case was linked to the case US2018166447, reported by the same reporter (the reporter's mother case).
Age: 92.0
Sex: F
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 tiredness in a 92-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included ZOSTAVAX. On 26th June 2018 16:00, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, less than 3 months after receiving SHINGRIX, the patient experienced tiredness and injection site pain. On an unknown date, the outcome of the tiredness and injection site pain were recovered/resolved. It was unknown if the reporter considered the tiredness and injection site pain to be related to SHINGRIX. Additional information received as follows: The case was reported by the patient's daughter. The reporter reported that the patient received SHINGRIX on the left deltoid. The contact details of the physician were provided. For tolerance to next dose, refer case US2018GSK171940. This case is linked to the case US2018166441, reported by the same reporter (the daughter's case).
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Immediate post-injection reaction
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of low back pain in a female patient who received SHINGRIX for prophylaxis. On 12th September 2018, the patient received the 2nd dose of SHINGRIX. On 12th September 2018, immediately after receiving SHINGRIX, the patient experienced low back pain. On an unknown date, the outcome of the low back pain was unknown. It was unknown if the reporter considered the low back pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The healthcare professional (HCP) stated that the patient came in on the date of reporting and had just gotten her second dose of SHINGRIX and described back pain. This case is linked with US2018166424, reported by the same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of fever in an unspecified number of adult patients who received SHINGRIX for prophylaxis. On an unknown date, the patients received SHINGRIX at an unknown dose. On an unknown date, 1 day after receiving SHINGRIX, the patients experienced fever and chills. On an unknown date, the outcome of the fever and chills were unknown. It was unknown if the reporter considered the fever and chills to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not applicable for this report. The age group was not reported but was selected as adult as per vaccine indication. The healthcare professional reported that about 25 per cent of patients who received SHINGRIX at their pharmacy experienced fever and chills the next day of vaccination. She states they vaccinated well over 100 patients. No additional information was available.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 62-year-old male patient who received SHINGRIX (batch number B9739, expiry date unknown) for prophylaxis. On 12th June 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 13th June 2018, 1 days after receiving SHINGRIX, the patient experienced fever, general body pain and chills. On 13th June 2018, the outcome of the fever, general body pain and chills were recovered/resolved. It was unknown if the reporter considered the fever, general body pain and chills to be related to SHINGRIX. Additional details were provided as follows: The healthcare professional (HCP) reported that the patient who was a co-worker experienced fever, chills and body aches the day after receiving the SHINGRIX. The symptoms lasted for 4 hours and resolved.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 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 shingles. On an unknown date, the outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional information was reported as follows: The age at vaccination was not reported. The patient experienced shingles, some time after vaccination with the first dose of SHINGRIX. The healthcare professional did not had any additional information and stated that the manager would had to call back for the further information.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: This case was reported by a consumer via out of hour services and described the occurrence of shingles in a male patient who received SHINGRIX for prophylaxis. On 29th August 2018, the patient received SHINGRIX. On 4th September 2018, 6 days after receiving SHINGRIX, the patient experienced shingles and rash. On an unknown date, the outcome of the shingles and rash were unknown. It was unknown if the reporter considered the shingles and rash to be related to SHINGRIX. Additional information was reported as follows: The age at vaccination was not reported. On 4th or 5th September the patient he noticed a rash. On 12th September 2018, the patient went to the doctor where the doctor diagnosed it as shingles. The patient left some patient identifier information, on a voice message after adverse event reporting line hours. This was all the information provided. The reporter stated that, he would attempt a call back and update at time(PCP). The phone number provided by the patient would not go through as the reporter was not able to reach him for any follow-up information.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: 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 73-year-old female patient who received SHINGRIX for prophylaxis. In June 2018, the patient received the 1st dose of SHINGRIX. In June 2018, less than a month after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional information was reported as follows: The patient experienced only a sore arm after vaccination with the 1st dose of SHINGRIX. This case was linked with case US2018GSK171142 (2nd dose), reported by the same reporter for the same patient.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Impaired work ability, Influenza like illness, Paraesthesia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of influenza-like symptoms in a 56-year-old female patient who received SHINGRIX (batch number 37KL2, expiry date 12th February 2021) for prophylaxis. On 12th September 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 13th September 2018, 1 days after receiving SHINGRIX, the patient experienced tingling. In September 2018, the patient experienced influenza-like symptoms and numbness in fingers. On an unknown date, the outcome of the influenza-like symptoms, tingling and numbness in fingers were not recovered/not resolved. It was unknown if the reporter considered the influenza-like symptoms, tingling and numbness in fingers to be related to SHINGRIX. Additional information was reported as follows: The pharmacist reported the case on behalf of the patient. On the date of reporting, the patient reported to the pharmacist that she was experiencing the events flu-like symptoms, numbness in her fingers and her face had started to tingle. The reporter was unsure when the symptoms had started. The patient had to leave the work early on the date of reporting due to the symptoms.
Age: 84.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus, Rash
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of rash in a 84-year-old male patient who received SHINGRIX (batch number H547E, expiry date 22nd February 2021) for prophylaxis. On 11th September 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 12th September 2018, 1 days after receiving SHINGRIX, the patient experienced rash and pruritus. On an unknown date, the outcome of the rash and pruritus were unchanged. It was unknown if the reporter considered the rash and pruritus to be related to SHINGRIX. Additional information was reported as follows: The patient experienced a rash and itching on knees, thighs and behind the arms after vaccination. No further details were provided by the reporter.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Feeling hot, Peripheral coldness, Peripheral swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of erythema of extremities in a 69-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles (in 2010, on the right side of her back), nerve pain (she had hepatic nerve pain that lasted a year) and surgery (Post-herpetic nerve pain that lasted a year). In March 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced erythema of extremities, cold hands and feet, swelling arm and extremities hot feeling of. On an unknown date, the outcome of the erythema of extremities, cold hands & feet, swelling arm and extremities hot feeling of were recovered/resolved. It was unknown if the reporter considered the erythema of extremities, cold hands and feet, swelling arm and extremities hot feeling of to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient received SHINGRIX on left deltoid. She experienced the effects as noted for 48 hours and they resolved. For tolerance after 2nd dose refer case US2018167167.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shingles in a 76-year-old male patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles. Concurrent medical conditions included lymphoblastic lymphoma. On 29th August 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 11th September 2018, 13 days after receiving SHINGRIX, the patient experienced shingles. The patient was treated with antivirals for systemic use. On an unknown date, the outcome of the shingles was not recovered/not resolved. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional information was reported as follows: On 11th September 2018, after vaccination with SHINGRIX, the patient went to the doctor and was diagnosed with an outbreak of shingles. The shingles experienced by the patient was located between his upper back and between both of his shoulder blades. At the time of reporting, the patient was on antiviral medication. However, the patient had not seen any improvement in his symptoms as he had been taking the medication for 2 days only, till the date of reporting. The patient enquired if he should receive the 2nd dose of the vaccine. The reporter provided him with information from the frequently asked questions (FAQ), (what was the immunity percentage after vaccination with only one dose) and referred the patient to his healthcare professional. The reporter also informed the patient that the vaccine was non-live and therefore should not cause disease. The representative provided an information from product information regarding immunosuppressant to the patient and verified that the patient was not on immunosuppressant at the time of reporting. The permission was obtained for contacting the patient's physician.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Feeling hot, Peripheral coldness, Peripheral swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of erythema of extremities in a 70-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles (on the right side of her back), nerve pain (she had hepatic nerve pain that lasted a year) and weight loss (had weight loss surgery and the anesthesia permanently relieved her post herpetic nerve pain). Previously administered products included SHINGRIX with an associated reaction of erythema (1st dose received in March 2018, refer case US2018167159). On 5th September 2018, the patient received the 2nd dose of SHINGRIX. In September 2018, less than 2 weeks after receiving SHINGRIX, the patient experienced erythema of extremities, cold hands & feet, swelling arm and extremities hot feeling of. On an unknown date, the outcome of the erythema of extremities, cold hands and feet, swelling arm and extremities hot feeling of were recovered/resolved. It was unknown if the reporter considered the erythema of extremities, cold hands & feet, swelling arm and extremities hot feeling of to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX on left deltoid. The patient experienced similar effects as she did from the first dose and noted that they lasted for 48 hours and resolved. She kept a cold rag on her arm and it helped to keep the heat down.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Formication, Paraesthesia, Swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of tingling sensation in a 75-year-old female patient who received SHINGRIX for prophylaxis. On 30th March 2018, the patient received the 1st dose of SHINGRIX. In April 2018, 7 days after receiving SHINGRIX, the patient experienced crawling sensation. On an unknown date, the patient experienced tingling sensation, erythema and swelling. On an unknown date, the outcome of the tingling sensation and crawling sensation were recovering/resolving and the outcome of the erythema and swelling were recovered/resolved. It was unknown if the reporter considered the tingling sensation, erythema, crawling sensation and swelling to be related to SHINGRIX. Additional details were reported as follows: The patient reported that she experienced minimal swelling and slight redness after receiving SHINGRIX and 1 week after receiving SHINGRIX, she felt like something was crawling on her from the top of her left shoulder, across her collar bone, to her chin. At the time she felt it all the time but she said it had gotten milder but she still experiences it and sometimes it occurs 2 to 3 times a day. The patient did not have information on the vaccine that was administered to her.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain in extremity
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of shingles in a male patient who received SHINGRIX for prophylaxis. On 7th September 2018, the patient received SHINGRIX. On 8th September 2018, 1 days after receiving SHINGRIX, the patient experienced shingles and pain in arm. On an unknown date, the outcome of the shingles and pain in arm were unknown. It was unknown if the reporter considered the shingles and pain in arm to be related to SHINGRIX. Additional details were reported as follows: This case was reported by Medical Assistant. The age at vaccination was not reported. The sales representative reported the adverse events he heard, by email. The reporter had a patient who reported incidents on 9th September 2018 to the clinic. It was stated that, the day after receiving SHINGRIX, the patient experienced shingles on his shoulder. The patient also said that his arm where he received the vaccine hurt badly. This case was linked with US2018167299, reported by same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Sunburn
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of sunburn in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, couple of days after receiving SHINGRIX, the patient experienced sunburn. On an unknown date, the outcome of the sunburn was unknown. It was unknown if the reporter considered the sunburn to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The healthcare professional reported sunburn on both arms a few days after receiving SHINGRIX. The healthcare professional self-reported this adverse event on healthcare professional chat. The healthcare professional did not provide personal details or vaccine information in this chat.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 73-year-old female patient who received SHINGRIX for prophylaxis. On 20th August 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 21st August 2018, 1 days after receiving SHINGRIX, the patient experienced injection site swelling, injection site itching, injection site pain, injection site erythema and injection site rash. On an unknown date, the outcome of the injection site swelling, injection site itching, injection site pain, injection site erythema and injection site rash were unknown. It was unknown if the reporter considered the injection site swelling, injection site itching, injection site pain, injection site erythema and injection site rash to be related to SHINGRIX. Additional details were reported as follows: The patient experienced red, swollen, sore, itchy rash at the site of injection the next day after receiving the SHINGRIX vaccination on right deltoid. At some unknown time, the redness started to track down her arm but still above the right elbow. She was prescribed an antibiotic and the tracking resolved. At the time of reporting, there was a residual pink rash at the injection site. Reporter's call was transferred to medical information.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Arthritis, Asthenia, Blood test, Chills
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of influenza-like symptoms in a 72-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included arthritis and shingles. On 25th August 2018, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced influenza-like symptoms, wrist pain, shoulder pain, chills, tiredness, weakness, nausea and joint inflammation. On an unknown date, the outcome of the influenza-like symptoms, wrist pain, chills, tiredness, weakness, nausea and joint inflammation were unknown and the outcome of the shoulder pain was recovered/resolved. It was unknown if the reporter considered the influenza-like symptoms, wrist pain, shoulder pain, chills, tiredness, weakness, nausea and joint inflammation to be related to SHINGRIX. Additional details were reported as follows: The caller reported that she experienced flu like symptoms that have persisted. She had been seen by her doctor twice by the reporting date to try and determine what was causing the symptom and she had blood work done. Her WBC was at 11,000 and that neutrophils were elevated as well. The caller also reported that her left wrist joint had been painful and feeling like it was inflamed. The caller reported she had history of arthritis and thought it might be related to that or could be from the vaccine shot since it was on the left side as well. The caller preferred any communication regarding this report go through her since she was a medical professional. The healthcare professional further defined flu like symptoms as chills, felt tired and week, and experienced nausea. She also stated she had shoulder pain but that it resolved. She was not sure if the shoulder pain occurred before or after receiving SHINGRIX.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Influenza like illness, Musculoskeletal pain, Nausea, Neutrophil count increased
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of influenza-like symptoms in a 72-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included arthritis and shingles. On 25th August 2018, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced influenza-like symptoms, wrist pain, shoulder pain, chills, tiredness, weakness, nausea and joint inflammation. On an unknown date, the outcome of the influenza-like symptoms, wrist pain, chills, tiredness, weakness, nausea and joint inflammation were unknown and the outcome of the shoulder pain was recovered/resolved. It was unknown if the reporter considered the influenza-like symptoms, wrist pain, shoulder pain, chills, tiredness, weakness, nausea and joint inflammation to be related to SHINGRIX. Additional details were reported as follows: The caller reported that she experienced flu like symptoms that have persisted. She had been seen by her doctor twice by the reporting date to try and determine what was causing the symptom and she had blood work done. Her WBC was at 11,000 and that neutrophils were elevated as well. The caller also reported that her left wrist joint had been painful and feeling like it was inflamed. The caller reported she had history of arthritis and thought it might be related to that or could be from the vaccine shot since it was on the left side as well. The caller preferred any communication regarding this report go through her since she was a medical professional. The healthcare professional further defined flu like symptoms as chills, felt tired and week, and experienced nausea. She also stated she had shoulder pain but that it resolved. She was not sure if the shoulder pain occurred before or after receiving SHINGRIX.