chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of pain in a female patient who received SHINGRIX (batch number ZY3X4, expiry date 25th April 2020) for prophylaxis. On 12th April 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 pain. On an unknown date, the outcome of the pain was unknown. It was unknown if the reporter considered the pain to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient experienced normal soreness. This case has been linked with case US2018GSK180113 (reported by the same reporter for the same patient with different dose).
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 adult female patient who received SHINGRIX for prophylaxis. On 18th September 2018, the patient received SHINGRIX. On 18th September 2018, several hours after receiving SHINGRIX, the patient experienced pain in arm. On 19th September 2018, the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced soreness in the left arm in which the SHINGRIX dose was administered. The onset of the event was after a few hours. The patient had denied permission to contact their physician.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Biopsy skin, Chills, Influenza like illness, Middle insomnia, Pruritus
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 60-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included bug bite. On 7th June 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In June 2018, less than a day after receiving SHINGRIX, the patient experienced influenza-like symptoms, fever and chills. On 27th June 2018, the patient experienced rash, pruritus and hives. In June 2018, the outcome of the influenza-like symptoms, fever and chills were recovered/resolved. On an unknown date, the outcome of the rash was not recovered/not resolved and the outcome of the pruritus and hives were unknown. It was unknown if the reporter considered the influenza-like symptoms, fever, chills, rash, pruritus and hives to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX vaccine in the left arm and woke up in the middle of the night after receiving the vaccine with fever and chills and flu-like symptoms. The reaction lasted 12 hours and resolved. Twenty days after vaccination, the patient started to have itching and hives off and on ever since. The patient described the rash as hives or big mosquito bites on the trunk of her body. She claimed that the rash appeared where she gathered sweat and where there was friction. The rash had also presented on the top of her legs where the crease in her legs reach her buttocks and up to the shoulder on her back. The patient had a biopsy done by her dermatologist and it came back as an inconclusive bug or drug reaction. The patient was not certain if the rash was related to a bug bite. The patient had provided contact details of her physician.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Rash, Urticaria
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 60-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included bug bite. On 7th June 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In June 2018, less than a day after receiving SHINGRIX, the patient experienced influenza-like symptoms, fever and chills. On 27th June 2018, the patient experienced rash, pruritus and hives. In June 2018, the outcome of the influenza-like symptoms, fever and chills were recovered/resolved. On an unknown date, the outcome of the rash was not recovered/not resolved and the outcome of the pruritus and hives were unknown. It was unknown if the reporter considered the influenza-like symptoms, fever, chills, rash, pruritus and hives to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX vaccine in the left arm and woke up in the middle of the night after receiving the vaccine with fever and chills and flu-like symptoms. The reaction lasted 12 hours and resolved. Twenty days after vaccination, the patient started to have itching and hives off and on ever since. The patient described the rash as hives or big mosquito bites on the trunk of her body. She claimed that the rash appeared where she gathered sweat and where there was friction. The rash had also presented on the top of her legs where the crease in her legs reach her buttocks and up to the shoulder on her back. The patient had a biopsy done by her dermatologist and it came back as an inconclusive bug or drug reaction. The patient was not certain if the rash was related to a bug bite. The patient had provided contact details of her physician.
Age: 87.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Dry skin, Headache, Injection site erythema, Peripheral coldness
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of generalized pruritus in a 87-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included ZOSTAVAX (the patient has not had shingles since she had the vaccine). Concurrent medical conditions included shingles (the patient had shingles three times), heart disorder, cancer and allergic reaction to antibiotics. On 13th July 2018, the patient received the 1st dose of SHINGRIX. On 14th July 2018, 1 days after receiving SHINGRIX, the patient experienced generalized pruritus, scratch, burning leg, headache, cold feet and injection site erythema. In July 2018, the patient experienced rash. On an unknown date, the patient experienced skin discoloration. On an unknown date, the outcome of the generalized pruritus, scratch, burning leg, rash, headache, cold feet and injection site erythema were recovered/resolved and the outcome of the skin discoloration was not recovered/not resolved. It was unknown if the reporter considered the generalized pruritus, scratch, burning leg, skin discoloration, rash, headache, cold feet and injection site erythema to be related to SHINGRIX. Additional details were provided as follows: First shingles happened when she was 19 years old. Second time it was not known. The patient received SHINGRIX vaccine up on her shoulder. The next day the patient was feeling itchy and she was scratching all over her body. The night after having the injection the patient felt her feet ice cold. The patient's legs were burning. In addition, the patient did experience redness at the injection site with SHINGRIX, but the redness went all the way down to her elbow. The patient also had a headache. Less than a month after receiving vaccination, the patient visited her physician about two weeks later and her physician told her that she had a rash all over her arm where she received the injection. It was unknown when the patient started experiencing a rash on her arm. Less than a year after receiving vaccination, one of her leg had a darker spot about an inch and a half. The spot was rough and the quality of the skin in that spot was different. She does not believe she had that spot prior to the SHINGRIX injection.
Age: 87.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus generalised, Rash, Scratch, Skin discolouration
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of generalized pruritus in a 87-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included ZOSTAVAX (the patient has not had shingles since she had the vaccine). Concurrent medical conditions included shingles (the patient had shingles three times), heart disorder, cancer and allergic reaction to antibiotics. On 13th July 2018, the patient received the 1st dose of SHINGRIX. On 14th July 2018, 1 days after receiving SHINGRIX, the patient experienced generalized pruritus, scratch, burning leg, headache, cold feet and injection site erythema. In July 2018, the patient experienced rash. On an unknown date, the patient experienced skin discoloration. On an unknown date, the outcome of the generalized pruritus, scratch, burning leg, rash, headache, cold feet and injection site erythema were recovered/resolved and the outcome of the skin discoloration was not recovered/not resolved. It was unknown if the reporter considered the generalized pruritus, scratch, burning leg, skin discoloration, rash, headache, cold feet and injection site erythema to be related to SHINGRIX. Additional details were provided as follows: First shingles happened when she was 19 years old. Second time it was not known. The patient received SHINGRIX vaccine up on her shoulder. The next day the patient was feeling itchy and she was scratching all over her body. The night after having the injection the patient felt her feet ice cold. The patient's legs were burning. In addition, the patient did experience redness at the injection site with SHINGRIX, but the redness went all the way down to her elbow. The patient also had a headache. Less than a month after receiving vaccination, the patient visited her physician about two weeks later and her physician told her that she had a rash all over her arm where she received the injection. It was unknown when the patient started experiencing a rash on her arm. Less than a year after receiving vaccination, one of her leg had a darker spot about an inch and a half. The spot was rough and the quality of the skin in that spot was different. She does not believe she had that spot prior to the SHINGRIX injection.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash generalised, Rash macular
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of red blotches in a 66-year-old female patient who received SHINGRIX (batch number ZG47A, expiry date 12th February 2021) for prophylaxis. On 22nd August 2018, the patient received the 1st dose of SHINGRIX .5 ml. In August 2018, 7 days after receiving SHINGRIX, the patient experienced red blotches, raised rash and generalized rash. On an unknown date, the outcome of the red blotches, raised rash and generalized rash were unknown. It was unknown if the reporter considered the red blotches, raised rash and generalized rash to be related to SHINGRIX. Additional details were provided as follows: The caller was a pharmacist reported that about one week receiving SHINGRIX, the patient experienced red blotches on her hands and feet that eventually spread to all over her body. The caller stated that the red blotches were raised and per the patient they wax and wane, more noticeable after she gets out of the shower.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Pain
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of pain in a 76-year-old male patient who received SHINGRIX (batch number 4FS5N, expiry date 8th March 2021) for prophylaxis. On 20th September 2018, the patient received SHINGRIX (intramuscular) .5 ml. On 21st September 2018, 1 days after receiving SHINGRIX, the patient experienced pain and erythema. On an unknown date, the outcome of the pain and erythema were recovering/resolving. It was unknown if the reporter considered the pain and erythema to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the Certified pharmacy technician (Cpht). The patient received SHINGRIX in right arm. The patient was extremely upset with the pharmacy and said that the vaccine was hurting him really bad on Friday. The symptoms got worse on Saturday and Sunday and it was somewhat better on Monday (date of reporting), but the patient said that it was still hurting him. The reporter said that the patient hung up on them and could not confirm the symptoms. The patient mentioned redness and being painful, but reporter did not know exactly where the events were located.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, 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 76-year-old male patient who received SHINGRIX (batch number 3NY5G, expiry date March 2021) for prophylaxis. On 17th September 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 18th September 2018, 1 days after receiving SHINGRIX, the patient experienced injection site erythema, injection site warmth and injection site itching. On an unknown date, the outcome of the injection site erythema, injection site warmth and injection site itching were not recovered/not resolved. It was unknown if the reporter considered the injection site erythema, injection site warmth and injection site itching to be related to SHINGRIX. Additional details were reported as follows: The reporter stated that the patient received a dose of SHINGRIX and developed a red, itchy and warm to touch at injection site on the next day of vaccination. The patient reported that the events continued and was not improved at the time of reporting.
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Peripheral swelling, Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of fever in a adult female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, 1 day after receiving SHINGRIX, the patient experienced fever, burning sensation and swelling arm. On an unknown date, the outcome of the fever, burning sensation and swelling arm were recovered/resolved. It was unknown if the reporter considered the fever, burning sensation and swelling arm to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced fever, swollen arm, and felt like her arm was on fire the night after receiving the SHINGRIX vaccine. The reporter did not have vaccine information, patient date of birth, initials or if the adverse events were resolved.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash macular
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of diffuse macular rash in a 65-year-old female patient who received SHINGRIX for prophylaxis. On 23rd August 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced diffuse macular rash. On an unknown date, the outcome of the diffuse macular rash was recovered/resolved. It was unknown if the reporter considered the diffuse macular rash to be related to SHINGRIX. Additional details were provided as follows: The healthcare professional reported that the patient experienced a diffuse macular rash after receiving the first SHINGRIX dose. The healthcare professional did not had vaccine information.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Nausea
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of headache 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 headache, nausea and tiredness. On an unknown date, the outcome of the headache, nausea and tiredness were recovered/resolved. It was unknown if the reporter considered the headache, nausea and tiredness to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX in left arm. The patient experienced a slight headache, nausea and was tired for 3 days. This case has been linked to the US2018GSK180391, reported by the same reporter.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Fasciitis, Local reaction, Pain in extremity, Peripheral swelling
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of erythema of extremities in a 73-year-old female patient who received SHINGRIX (batch number CH2X7, expiry date unknown) for prophylaxis. On 25th May 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, pain in arm, swelling arm and fasciitis. On an unknown date, the outcome of the erythema of extremities, pain in arm, swelling arm and fasciitis were unknown. It was unknown if the reporter considered the erythema of extremities, pain in arm, swelling arm and fasciitis to be related to SHINGRIX. Additional details were provided as follows: This case was reported via online chat. The patient received SHINGRIX and had a severe localized reaction that made her entire upper arm red, swollen and painful above the elbow. The doctor who saw her thought it was fasciitis. The doctor asked whether this had been reported before and if there was any concern about the patient getting the second SHINGRIX shot in 6 months.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Impaired work ability, Influenza like illness, Nausea, Pain
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of influenza-like symptoms in a 60-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, less than a year after receiving SHINGRIX, the patient experienced influenza-like symptoms, general body pain, fatigue and nausea. On an unknown date, the outcome of the influenza-like symptoms, general body pain, fatigue and nausea were recovered/resolved. It was unknown if the reporter considered the influenza-like symptoms, general body pain, fatigue and nausea to be related to SHINGRIX. Additional details were provided as follows: This case was reported by a physician assistant (PA). The patient received a dose of SHINGRIX at a pharmacy. The patient experienced flu like symptoms and body ache. She missed 3 days of work. The reporter was unsure when the symptoms were started or resolved. The suspect vaccine lot number, expiry date and the patient's date of birth were unavailable. This case is 1 of the 3 cases, reported by the same reporter.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Influenza like illness
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 51-year-old female patient who received SHINGRIX for prophylaxis. In July 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced influenza-like symptoms, chills and upset stomach. On an unknown date, the outcome of the influenza-like symptoms, chills and upset stomach were unknown. It was unknown if the reporter considered the influenza-like symptoms, chills and upset stomach to be related to SHINGRIX. Additional information received as follows: The patient experienced flu like symptoms which included chilling and stomach upset.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Aphthous ulcer
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of aphthous stomatitis in a 75-year-old male patient who received SHINGRIX (batch number B334Y, expiry date unknown) for prophylaxis. On 2nd June 2018, the patient received the 1st dose of SHINGRIX. On 2nd June 2018, the 1st dose was an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced aphthous stomatitis. On an unknown date, the outcome of the aphthous stomatitis was recovered/resolved. It was unknown if the reporter considered the aphthous stomatitis to be related to SHINGRIX. Additional details were provided as follows: The patient received the vaccine in left deltoid. The patient reported to the pharmacist that he developed canker sores on his mouth after a dose of SHINGRIX. This case has been linked with case US2018GSK179518 (for 2nd dose), reported by same reporter for same patient.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of shingles an unspecified number adult patients who received SHINGRIX for prophylaxis. On an unknown date, the patients received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patients experienced shingles and general body pain. On an unknown date, the outcome of the shingles and general body pain were unknown. It was unknown if the reporter considered the shingles and general body pain to be related to SHINGRIX. Additional details were provided as follows: The case was reported by the retired nurse. The age at vaccination was not applicable. The age group adult was not reported but was captured as adult as per vaccine indication. During a discussion about dosing of SHINGRIX, the reporter stated that, some of her friends have come down with shingles after receiving 1st dose of SHINGRIX. The reporter also stated that, some patients experienced body aches. The reporter did not provide any specifics about each patient.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Impaired work ability, Nausea, Pain
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of fever in a 60-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, 12 hrs after receiving SHINGRIX, the patient experienced fever, general body pain, fatigue, rigors and nausea. On an unknown date, the outcome of the fever, general body pain, fatigue, rigors and nausea were recovered/resolved. It was unknown if the reporter considered the fever, general body pain, fatigue, rigors and nausea to be related to SHINGRIX. Additional details were provided as follows: This case was reported by a physician assistant (PA). The patient received a dose of SHINGRIX at the healthcare professional's (HCP) clinic and experienced fever (body temperature: 102.4 degree F) and body ache 12 to 18 hours later. The symptoms had resolved but the HCP was unaware of the timing for resolution. The patient missed one day of work. The suspect vaccine lot number, expiry date and the patient's date of birth were unavailable. This case is 1 of the 3 cases, reported by the same reporter. Lab Comments: On an unknown date, the body temperature was 102.4 degree F.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of fever in a 60-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, 12 hrs after receiving SHINGRIX, the patient experienced fever, general body pain, fatigue, rigors and nausea. On an unknown date, the outcome of the fever, general body pain, fatigue, rigors and nausea were recovered/resolved. It was unknown if the reporter considered the fever, general body pain, fatigue, rigors and nausea to be related to SHINGRIX. Additional details were provided as follows: This case was reported by a physician assistant (PA). The patient received a dose of SHINGRIX at the healthcare professional's (HCP) clinic and experienced fever (body temperature: 102.4 degree F) and body ache 12 to 18 hours later. The symptoms had resolved but the HCP was unaware of the timing for resolution. The patient missed one day of work. The suspect vaccine lot number, expiry date and the patient's date of birth were unavailable. This case is 1 of the 3 cases, reported by the same reporter. Lab Comments: On an unknown date, the body temperature was 102.4 degree F.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of injection site pain in a 54-year-old female patient who received SHINGRIX for prophylaxis. In September 2018, the patient received the 1st dose of SHINGRIX. In September 2018, less than a month after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were provided as follows: This case was reported by a physician assistant (PA). The patient received a dose of SHINGRIX about 3 weeks before the date of reporting and experienced a sore arm (site reaction) for 2 days. The healthcare professional was unaware of when it began but it had resolved. The suspect vaccine lot number, expiry date and the patient's date of birth were unavailable. This case is 1 of the 3 cases, reported by the same reporter.
Age: 69.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Erythema, Immediate post-injection reaction, Injected limb mobility decreased, Injection site pain, Injection site reaction
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 69-year-old female patient who received Flu Seasonal QIV Dresden for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. Previously administered products included ZOSTAVAX (dose received in 2009, no any adverse events). On 19th September 2018, the patient received Influenza vaccine Quadrivalent 2018-2019 season (intramuscular) and the 1st dose of SHINGRIX (intramuscular). On 19th September 2018, not applicable after receiving Influenza vaccine Quadrivalent 2018-2019 season and immediately after receiving SHINGRIX, the patient experienced injection site pain and injection site movement impairment. On 20th September 2018, the patient experienced red blotches, erythema and skin warm. On an unknown date, the outcome of the injection site pain and injection site movement impairment were recovered/resolved and the outcome of the red blotches, erythema and skin warm were recovering/resolving. It was unknown if the reporter considered the red blotches, erythema and skin warm to be related to Influenza vaccine Quadrivalent 2018-2019 season and SHINGRIX. It was unknown if the reporter considered the injection site pain and injection site movement impairment to be related to SHINGRIX. Additional information received as follows: The patient received Influenza vaccine on the left arm. Around 1:30 pm, the patient received SHINGRIX on the right deltoid and she immediately felt pain at the injection site and the area was stiff. The pain started to resolve the next day, however, she reported that she experienced a bright red blotch that appeared below the injection site that was about 2 inches wide and it spread in an odd pattern on the side of her arm above the elbow. The area was bright red and hot for a couple of days. By one day before reporting date, she could move her arm without pain and the red area was mildly warm and mostly resolved. She only had a light stain on her arm at the time of reporting.
Age: 69.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Rash macular, Skin warm
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 69-year-old female patient who received Flu Seasonal QIV Dresden for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. Previously administered products included ZOSTAVAX (dose received in 2009, no any adverse events). On 19th September 2018, the patient received Influenza vaccine Quadrivalent 2018-2019 season (intramuscular) and the 1st dose of SHINGRIX (intramuscular). On 19th September 2018, not applicable after receiving Influenza vaccine Quadrivalent 2018-2019 season and immediately after receiving SHINGRIX, the patient experienced injection site pain and injection site movement impairment. On 20th September 2018, the patient experienced red blotches, erythema and skin warm. On an unknown date, the outcome of the injection site pain and injection site movement impairment were recovered/resolved and the outcome of the red blotches, erythema and skin warm were recovering/resolving. It was unknown if the reporter considered the red blotches, erythema and skin warm to be related to Influenza vaccine Quadrivalent 2018-2019 season and SHINGRIX. It was unknown if the reporter considered the injection site pain and injection site movement impairment to be related to SHINGRIX. Additional information received as follows: The patient received Influenza vaccine on the left arm. Around 1:30 pm, the patient received SHINGRIX on the right deltoid and she immediately felt pain at the injection site and the area was stiff. The pain started to resolve the next day, however, she reported that she experienced a bright red blotch that appeared below the injection site that was about 2 inches wide and it spread in an odd pattern on the side of her arm above the elbow. The area was bright red and hot for a couple of days. By one day before reporting date, she could move her arm without pain and the red area was mildly warm and mostly resolved. She only had a light stain on her arm at the time of reporting.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of chills in a 61-year-old female patient who received SHINGRIX for prophylaxis. On 25th September 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On 25th September 2018, 10 hrs 30 min after receiving SHINGRIX, the patient experienced chills. On 26th September 2018, the patient experienced fever. On 26th September 2018, the outcome of the chills was recovered/resolved. On an unknown date, the outcome of the fever was unknown. It was unknown if the reporter considered the chills and fever to be related to SHINGRIX. Additional details were provided as follows: On 25th September 2018 at 10:30 am, the patient received SHINGRIX on left deltoid. On the day of vaccination in evening at 9 pm, the patient developed chills. The next morning, the chills had resolved, but her temperature was 101 degrees F. The reporter gave permission for her physician to be contacted.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site vesicles
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site pain in a 63-year-old female patient who received SHINGRIX (batch number 3AF9E, expiry date 2nd February 2021) for prophylaxis. On 11th July 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 12th July 2018, 1 days after receiving SHINGRIX, the patient experienced injection site vesicles. In July 2018, the patient experienced injection site pain and injection site erythema. On an unknown date, the outcome of the injection site pain, injection site erythema and injection site vesicles were recovered/resolved. It was unknown if the reporter considered the injection site pain, injection site erythema and injection site vesicles to be related to SHINGRIX. Additional details were provided as follows: The reporter had a patient that received the SHINGRIX vaccine on right deltoid. Within 24 hours of vaccination, the patient reported having pain and redness at the injection site. The day after this the patient noted vesicles at the injection site. All symptoms were resolved with 48 hours of the vaccination.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site joint pain, Pain in extremity
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site joint pain in a 65-year-old female patient who received SHINGRIX (batch number 524S7, expiry date 28th February 2021) for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, immediately after receiving SHINGRIX, the patient experienced injection site joint pain and pain in arm. On an unknown date, the outcome of the injection site joint pain and pain in arm were recovering/resolving. It was unknown if the reporter considered the injection site joint pain and pain in arm to be related to SHINGRIX. Additional details were reported as follows: In 2018, at approximately 9:38 AM, the patient received SHINGRIX on left deltoid. The licensed practical nurse reported that, after vaccination the patient experienced left arm and shoulder pain at the injection site. The reported lot number (52457) for SHINGRIX did not exist and was updated to 524S7, according to sales datasheet.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a adult female patient who received SHINGRIX (batch number PK9BY, expiry date 19th March 2021) for prophylaxis. On 25th September 2018, the patient received the 1st dose of SHINGRIX. On 27th September 2018, 2 days after receiving SHINGRIX, the patient experienced injection site erythema. On an unknown date, the outcome of the injection site erythema was unknown. It was unknown if the reporter considered the injection site erythema to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The reported lot number (PKNBY) for SHINGRIX did not exist and was updated to PK9BY, according to sales datasheet.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site pain, Injection site urticaria, Pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site wheal in a adult 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 wheal, pain, chills and injection site burning. On an unknown date, the outcome of the injection site wheal, pain, chills and injection site burning were recovered/resolved. It was unknown if the reporter considered the injection site wheal, pain, chills and injection site burning to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The events lasted for two weeks, then resolved.
Sex: F
Vaccine: 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 adult female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fever and pain. On an unknown date, the outcome of the fever and pain were unknown. It was unknown if the reporter considered the fever and pain to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The health care professional reported that the patient experienced fever and aches after the 1st dose of SHINGRIX. No further details were provided.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia
Clinical narrative: This case was reported by a consumer and described the occurrence of joint pain in a 62-year-old female patient who received SHINGRIX (batch number JC92P, expiry date 22nd November 2020) for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of cough (For the tolerability of 1st dose, refer case US2018GSK167643 reported for same patient). On 15th August 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On 15th August 2018, less than a day after receiving SHINGRIX, the patient experienced joint pain. On an unknown date, the outcome of the joint pain was recovering/resolving. The reporter considered the joint pain to be related to SHINGRIX. Additional details were provided as follows: The patient experienced joint pain. It was unclear that if the patient experienced cough, fever, general body pain, muscle pain, headache, lethargy, cold sores lip and palpitation after 2nd dose of SHINGRIX as well hence only 1st dose of SHINGRIX is considered as an suspect for this events.
Sex: U
Vaccine: VARZOS
Symptoms: Pain, Product supply issue
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in a patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. In June 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, the patient received the 2nd dose of SHINGRIX. In June 2018, less than a year after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced pain. On an unknown date, the patient experienced product supply issue. On an unknown date, the outcome of the pain and product supply issue were unknown. It was unknown if the reporter considered the pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX in early June. As bad as the first shot hurt it was not like the patient was looking forward to the second one but he/she did want to complete the series before the 2-6 months was up. The patient was getting concerned because the 2nd shot had not been available at pharmacists. Which meant it probably was not available anywhere near the patient for the second shot.  Besides that, the patient did not know how excited another pharmacy would be about giving the second shot if I did not get the first one at their place of business.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Ophthalmic herpes zoster
Clinical narrative: This case was reported by a consumer and described the occurrence of ophthalmic herpes zoster in a female patient who received SHINGRIX for prophylaxis. On 7th June 2018, the patient received the 1st dose of SHINGRIX. On 1st September 2018, 86 days after receiving SHINGRIX, the patient experienced ophthalmic herpes zoster (serious criteria GSK medically significant). On an unknown date, the outcome of the ophthalmic herpes zoster was unknown. It was unknown if the reporter considered the ophthalmic herpes zoster to be related to SHINGRIX. Additional information was reported as follows: The age at vaccination was not reported. On 7th June 2018, prior to leaving on a 2 month long vacation,  the patient was vaccinated with the 1st dose of SHINGRIX. When the patient returned back from the vacation, his local pharmacies were unable to provide him the 2nd dose of SHINGRIX and the patient experienced shingles in his eyes. The patient inquired how soon after experiencing shingles it was safe to get vaccinated with the second dose of SHINGRIX as the patient did not wanted to get shingles again.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site pain, Injection site rash, Lacrimation increased, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site rash in a 4-year-old male patient who received KINRIX (batch number 4R7NR, expiry date unknown) for prophylaxis. Previously administered products included FLULAVAL (received one year ago and experienced fever, injection site rash (please refer case US2018171870)). On 12th September 2018, the patient received KINRIX. In September 2018, less than 2 weeks after receiving KINRIX, the patient experienced injection site rash, watering eyes, fever and injection site pain. In September 2018, the outcome of the injection site rash, watering eyes, fever and injection site pain were recovered/resolved. It was unknown if the reporter considered the injection site rash, watering eyes, fever and injection site pain to be related to KINRIX. Additional details were reported as follows: This case was reported by the patient's mother. This case was already reported to physician. The patient experienced fever with 102 degree F, watery eyes, and had a reaction on his arm at the injection site. The reporter called it as rash `and said it was all around the injection site which was big and painful and worse and bigger than the last one after flu vaccine.
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Feeling abnormal, Headache, Pyrexia
Clinical narrative: This case was reported by a consumer and described the occurrence of fever in a male patient who received SHINGRIX for prophylaxis. On 26th September 2018, the patient received the 1st dose of SHINGRIX. On 27th September 2018, 1 days after receiving SHINGRIX, the patient experienced fever, joint pain, headache and feels awful. On an unknown date, the outcome of the fever, joint pain, headache and feels awful were unknown. It was unknown if the reporter considered the fever, joint pain, headache and feels awful to be related to SHINGRIX. Additional details were provided as follows: The patient received the 1st injection on the evening of 26th September 2018 and then the patient felt horrible on 27th September 2018. The patient wished his physician would have informed him of the side effects, and most likely would have declined. The patient had a fever, joint pain, headache and it was not fun, and was thinking of not following through with second injection. The patient went to VAERS site to share information, but the website was cumbersome.
Sex: M
Vaccine: VARZOS
Symptoms: Cellulitis, Erythema, Pain, Swelling
Clinical narrative: This case was reported by a pharmacist via sales rep and described the occurrence of cellulitis in a 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 cellulitis (serious criteria GSK medically significant), pain, erythema and swelling. On an unknown date, the outcome of the cellulitis, pain, erythema and swelling were unknown. It was unknown if the reporter considered the cellulitis, pain, erythema and swelling to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced significant pain, redness and swelling. The reporter had to go but agreed to email the sales representative more information when she had a chance.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This case was reported by a pharmacist via out of hour services and described the occurrence of injection site erythema in a adult patient who received SHINGRIX (batch number A2JL7, expiry date 22nd March 2021) for prophylaxis. Concomitant products included SHINGRIX. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving Shingrix, the patient experienced injection site erythema and injection site swelling. On an unknown date, the outcome of the injection site erythema and injection site swelling were unknown. It was unknown if the reporter considered the injection site erythema and injection site swelling to be related to SHINGRIX. Additional details were provided as follows: The case was reported by the registered pharmacist (Rph). The age at vaccination was not reported. The age group was not reported, but was selected adult as per vaccine indication. There was no redness or swelling for the patient after dose 1. The call was an AHVM (After Hours Voice Message) left by pharmacist on Sunday, 23rd September 2018 at 3:15 PM. On her message, she noted that GSK might contact the other pharmacist, who would be on duty the next day, 24th September 2018. A call back to the mentioned pharmacist was made, but there was no further information about the individual patients. This is 1 of the 5 cases, reported by the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site mass, Pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site lump in a female patient who received SHINGRIX for prophylaxis. On 21st September 2018, the patient received the 2nd dose of SHINGRIX. In September 2018, less than a day after receiving SHINGRIX, the patient experienced pain. On 23rd September 2018, the patient experienced injection site lump and injection site erythema. On an unknown date, the outcome of the injection site lump was not recovered/not resolved and the outcome of the pain and injection site erythema were unknown. It was unknown if the reporter considered the injection site lump, pain and injection site erythema to be related to SHINGRIX. Additional details were reported as follows: The patient experienced soreness but then two days later a lump appeared on the injection site and it grown until it was a golf ball size and also red. It was appeared to be getting bigger. The pharmacist did not want to provide the date of birth for the patient. The pharmacist transferred to MI for additional assistance. This case linked with case US2018173608, reported by the same reporter for the same patient (for 1st dose of SHINGRIX).
Sex: M
Vaccine: VARZOS
Symptoms: Vitreous detachment
Clinical narrative: This case was reported by a pharmacist via sales rep and described the occurrence of posterior vitreous detachment in a male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of headache (refer case US2018GSK032011 for 1st dose). On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced posterior vitreous detachment (serious criteria GSK medically significant). On an unknown date, the outcome of the posterior vitreous detachment was unknown. It was unknown if the reporter considered the posterior vitreous detachment to be related to SHINGRIX. Additional information was reported as follows: The age at vaccination was not reported. In 2018, after vaccination with the 2nd dose of SHINGRIX, the patient faced another problem and was diagnosed with a posterior vitreous detachment.