chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Muscular weakness, Pain in extremity, Sleep disorder
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 70-year-old female patient who received SHINGRIX (batch number L9CS4, expiry date 22nd February 2021) for prophylaxis. On 25th August 2018, the patient received the 1st dose of SHINGRIX .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain in arm and weakness of arms. On an unknown date, the outcome of the pain in arm was not recovered/not resolved and the outcome of the weakness of arms was unknown. It was unknown if the reporter considered the pain in arm and weakness of arms to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left arm. The pain had not resolved and her arm was weaker than normal and when rolling over onto in the night it woke her up due to the pain. This case has been linked with case US2018172577, reported by same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Myalgia
Clinical narrative: This case was reported by a consumer via out of hour services and described the occurrence of muscle pain in a female patient who received SHINGRIX for prophylaxis. In September 2018, the patient received SHINGRIX. In September 2018, less than a week after receiving Shingrix, the patient experienced muscle pain and erythema. The patient was treated with MOTRIN. On an unknown date, the outcome of the muscle pain and erythema were not recovered/not resolved. It was unknown if the reporter considered the muscle pain and erythema to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient had the vaccination last week and ever since, she had bad muscle pain and her arm was still red. It seems to be getting worse. She was taking MOTRIN every few hours. The information was left on a voice mail so no additional information or explanation was available.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Positron emission tomogram, Thymus enlargement
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of thymus enlargement in a 76-year-old male patient who received SHINGRIX for prophylaxis. The patient's past medical history included lymphoma (with treatment, most of it resolved except for a spot on thymus). On 4th June 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced thymus enlargement. On an unknown date, the outcome of the thymus enlargement was not recovered/not resolved. It was unknown if the reporter considered the thymus enlargement to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient for himself. The patient received SHINGRIX in the left arm. After receiving SHINGRIX, his next PET scan showed that the thymus was increasing in size. The healthcare professional was not sure if it was caused from SHINGRIX. He did not have vaccine information since he got it done at the pharmacy.
Sex: U
Vaccine: FLU3
Symptoms: Guillain-Barre syndrome
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of Guillain-Barre syndrome in a patient who received Flu trivalent vaccine for prophylaxis. On an unknown date, the patient received Flu trivalent vaccine at an unknown dose. On an unknown date, unknown after receiving Flu trivalent vaccine, the patient experienced Guillain-Barre syndrome (serious criteria GSK medically significant). On an unknown date, the outcome of the Guillain-Barre syndrome was unknown. It was unknown if the reporter considered the Guillain-Barre syndrome to be related to Flu trivalent vaccine. Additional details were provided as follows: The age at vaccination was not reported. The healthcare professional reported that the patient had a history of Guillain-Barre syndrome after receiving an unknown flu vaccine. No additional information could be obtained.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Brain neoplasm, Chemotherapy, Influenza like illness, Injection site pain, Nausea
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of brain neoplasm in a 68-year-old female patient who received SHINGRIX for prophylaxis. On 13th May 2018, the patient received the 1st dose of SHINGRIX. On 26th June 2018, 44 days after receiving SHINGRIX, the patient experienced brain neoplasm (serious criteria GSK medically significant). On an unknown date, the patient experienced influenza-like symptoms, nausea and injection site pain. The patient was treated with non-drug therapy (Radiation) and chemotherapy, nos (Chemotherapy). On an unknown date, the outcome of the brain neoplasm was unknown and the outcome of the influenza-like symptoms, nausea and injection site pain were recovered/resolved. It was unknown if the reporter considered the brain neoplasm, influenza-like symptoms, nausea and injection site pain to be related to SHINGRIX. Additional information received as follows: The case was reported by the patient's husband. The patient was diagnosed with a brain tumor. As treatment, the patient had a resection of the brain tumor. The patient had flu-like symptoms, nausea and some pain at the injection site. The symptoms were lasted about 3 days. The reporter stated he did not believe the tumor was related to SHINGRIX. As per initial report the patient received the vaccine on 12th may 2018 however during follow up the vaccination date was reported as 13th May 2018.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Radiotherapy
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of brain neoplasm in a 68-year-old female patient who received SHINGRIX for prophylaxis. On 13th May 2018, the patient received the 1st dose of SHINGRIX. On 26th June 2018, 44 days after receiving SHINGRIX, the patient experienced brain neoplasm (serious criteria GSK medically significant). On an unknown date, the patient experienced influenza-like symptoms, nausea and injection site pain. The patient was treated with non-drug therapy (Radiation) and chemotherapy, nos (Chemotherapy). On an unknown date, the outcome of the brain neoplasm was unknown and the outcome of the influenza-like symptoms, nausea and injection site pain were recovered/resolved. It was unknown if the reporter considered the brain neoplasm, influenza-like symptoms, nausea and injection site pain to be related to SHINGRIX. Additional information received as follows: The case was reported by the patient's husband. The patient was diagnosed with a brain tumor. As treatment, the patient had a resection of the brain tumor. The patient had flu-like symptoms, nausea and some pain at the injection site. The symptoms were lasted about 3 days. The reporter stated he did not believe the tumor was related to SHINGRIX. As per initial report the patient received the vaccine on 12th may 2018 however during follow up the vaccination date was reported as 13th May 2018.
Sex: U
Vaccine: VARZOS
Symptoms: Kidney transplant rejection
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of kidney transplant rejection in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced kidney transplant rejection (serious criteria GSK medically significant). On an unknown date, the outcome of the kidney transplant rejection was unknown. It was unknown if the reporter considered the kidney transplant rejection to be related to SHINGRIX. Additional information received as follows: The age at vaccination was not reported. The age group was not reported but was selected adult as per vaccine indication. The healthcare professional was a retail pharmacist. The healthcare professional stated receiving a call regarding the administration of SHINGRIX to the patient who had an organ transplant. The healthcare professional stated that a staff member at a physician's office stated that the patient there recently lost their kidney transplant due to receiving a shingles vaccine but that the patient also had multiple other issues that likely led to the loss of the kidney transplant. The healthcare professional did not have access to this patient, did not know this patient. Retail pharmacy did not administer this vaccine. The healthcare professional did not have any additional information to document for this adverse event. No vaccine or patient information available, only information was received by the healthcare professional in passing conversation over the phone while discussing the different patient.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Hypersomnia, Loss of personal independence in daily activities, Myalgia
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of headache in a 63-year-old female patient who received SHINGRIX for prophylaxis. In August 2018, the patient received SHINGRIX. In August 2018, less than a day after receiving SHINGRIX, the patient experienced headache, fatigue, myalgia, sleep excessive and activities of daily living impaired. On an unknown date, the outcome of the headache, fatigue, sleep excessive and activities of daily living impaired were recovered/resolved and the outcome of the myalgia was unknown. It was unknown if the reporter considered the headache, fatigue, myalgia, sleep excessive and activities of daily living impaired to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX on left arm. Within 2 hours after the vaccination, the patient experienced headache. The patient normally did not have headache. The patient slept most of that afternoon and fatigue to the point of not being able to do anything. The patient also experienced myalgia and slept 12 hours the next day. The all symptoms resolved within 3 days. The reporter agreed to be follow up from GlaxoSmithKline.
Sex: U
Vaccine: VARZOS
Symptoms: Discomfort, Dizziness, Fatigue, Flushing, Headache
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of generalized muscle aches in a patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of rash (received 1st dose 3 months ago and experienced similar reaction as that with 2nd dose refer case US2018GSK176765). On 18th September 2018, the patient received the 2nd dose of SHINGRIX. On 18th September 2018, less than a day after receiving SHINGRIX, the patient experienced discomfort and pain. On 19th September 2018, the patient experienced generalized muscle aches, injection site pain, headache, flushing, pruritus facial, dizziness, tiredness and influenza. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the generalized muscle aches, discomfort, injection site pain, headache, flushing, pruritus facial, dizziness, tiredness, influenza and pain were unknown. It was unknown if the reporter considered the generalized muscle aches, discomfort, injection site pain, headache, flushing, pruritus facial, dizziness, tiredness, influenza and pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was captured adult as per vaccine indication. The patient got a dose of SHINGRIX vaccination a day prior to reporting date in afternoon. There was not much pain or discomfort at all until the reporting date. This morning the patient woke up with moderate or greater muscle pain in my whole body-especially my lower back, pain at the injection site, headache, flushing, itchiness in various areas-mostly the face, head and back, some dizziness and some tiredness. The patient stated that If the patient did not know any different the patient would thought to came down with the flu, except for the itchiness part. The patient stated that, that the side effects were downplayed quite a bit in your disclosures (1 in 10 experienced side effects). The patient had a very similar reaction adding a rash as well with the first injection 3 months ago. This case has been linked to the US2018GSK176765, reported by the same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Influenza, Injection site pain, Myalgia, Pain, Pruritus
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of generalized muscle aches in a patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of rash (received 1st dose 3 months ago and experienced similar reaction as that with 2nd dose refer case US2018GSK176765). On 18th September 2018, the patient received the 2nd dose of SHINGRIX. On 18th September 2018, less than a day after receiving SHINGRIX, the patient experienced discomfort and pain. On 19th September 2018, the patient experienced generalized muscle aches, injection site pain, headache, flushing, pruritus facial, dizziness, tiredness and influenza. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the generalized muscle aches, discomfort, injection site pain, headache, flushing, pruritus facial, dizziness, tiredness, influenza and pain were unknown. It was unknown if the reporter considered the generalized muscle aches, discomfort, injection site pain, headache, flushing, pruritus facial, dizziness, tiredness, influenza and pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was captured adult as per vaccine indication. The patient got a dose of SHINGRIX vaccination a day prior to reporting date in afternoon. There was not much pain or discomfort at all until the reporting date. This morning the patient woke up with moderate or greater muscle pain in my whole body-especially my lower back, pain at the injection site, headache, flushing, itchiness in various areas-mostly the face, head and back, some dizziness and some tiredness. The patient stated that If the patient did not know any different the patient would thought to came down with the flu, except for the itchiness part. The patient stated that, that the side effects were downplayed quite a bit in your disclosures (1 in 10 experienced side effects). The patient had a very similar reaction adding a rash as well with the first injection 3 months ago. This case has been linked to the US2018GSK176765, reported by the same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Vaccine positive rechallenge
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of generalized muscle aches in a patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of rash (received 1st dose 3 months ago and experienced similar reaction as that with 2nd dose refer case US2018GSK176765). On 18th September 2018, the patient received the 2nd dose of SHINGRIX. On 18th September 2018, less than a day after receiving SHINGRIX, the patient experienced discomfort and pain. On 19th September 2018, the patient experienced generalized muscle aches, injection site pain, headache, flushing, pruritus facial, dizziness, tiredness and influenza. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the generalized muscle aches, discomfort, injection site pain, headache, flushing, pruritus facial, dizziness, tiredness, influenza and pain were unknown. It was unknown if the reporter considered the generalized muscle aches, discomfort, injection site pain, headache, flushing, pruritus facial, dizziness, tiredness, influenza and pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was captured adult as per vaccine indication. The patient got a dose of SHINGRIX vaccination a day prior to reporting date in afternoon. There was not much pain or discomfort at all until the reporting date. This morning the patient woke up with moderate or greater muscle pain in my whole body-especially my lower back, pain at the injection site, headache, flushing, itchiness in various areas-mostly the face, head and back, some dizziness and some tiredness. The patient stated that If the patient did not know any different the patient would thought to came down with the flu, except for the itchiness part. The patient stated that, that the side effects were downplayed quite a bit in your disclosures (1 in 10 experienced side effects). The patient had a very similar reaction adding a rash as well with the first injection 3 months ago. This case has been linked to the US2018GSK176765, reported by the same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect route of product administration, Vaccination site rash
Clinical narrative: This case was reported by a pharmacist via sales rep and described the occurrence of injection site rash in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX (subcutaneous) .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site rash and intramuscular formulation administered by other route. On an unknown date, the outcome of the injection site rash and intramuscular formulation administered by other route were unknown. It was unknown if the reporter considered the injection site rash to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The patient received dose of SHINGRIX via the subcutaneous route, which led to incorrect route of vaccine administration. The patient developed a rash at the injection site. It was entered an MSL task regarding whether to be readministered or not. The reporter agreed to be followed up.
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness, Fall, Head injury
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of head injury in a male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX. On an unknown date, less than a day after receiving SHINGRIX, the patient experienced head injury, light headedness and fall. On an unknown date, the outcome of the head injury, lightheadedness and fall were unknown. It was unknown if the reporter considered the head injury, lightheadedness and fall to be related to SHINGRIX. Additional details were provided as follows: The age of vaccination was not reported. The patient got lightheaded and dizzy, fell down at home and cracked head open on same day of injection. The reporter did not agree to follow up from GlaxoSmithKline.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Influenza like illness, Myalgia, Pyrexia
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of influenza-like symptoms in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced influenza-like symptoms, muscle pain, fever and chills. On an unknown date, the outcome of the influenza-like symptoms, fever and chills were recovered/resolved and the outcome of the muscle pain was unknown. It was unknown if the reporter considered the influenza-like symptoms, muscle pain, fever and chills to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not provided. The patient experienced substantial flu like symptoms for 24 hours, muscle aches, fever and chills. The reporter agreed to be followed up. This case is linked with US2018GSK173206, reported by the same reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Influenza like illness, Myalgia, Pyrexia
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of influenza-like symptoms in a male 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 influenza-like symptoms, muscle pain, fever and chills. On an unknown date, the outcome of the influenza-like symptoms, muscle pain, fever and chills were recovered/resolved. It was unknown if the reporter considered the influenza-like symptoms, muscle pain, fever and chills to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not provided. The patient experienced substantial flu like symptoms for 24 hours, muscle aches, fever and chills. The reporter agreed to be followed up. This case is linked with US2018GSK173205, reported by the same reporter.
Age: 4.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of injection site erythema in a 4-year-old female patient who received FLULAVAL TETRA 2018-2019 season (batch number 4DY9K, expiry date 7th June 2019) for prophylaxis. On an unknown date, the patient received FLULAVAL TETRA 2018-2019 season. On an unknown date, less than 2 months after receiving FLULAVAL TETRA 2018-2019 season, the patient experienced injection site erythema, injection site swelling and injection site itching. On an unknown date, the outcome of the injection site erythema, injection site swelling and injection site itching were unknown. It was unknown if the reporter considered the injection site erythema, injection site swelling and injection site itching to be related to FLULAVAL TETRA 2018-2019 season. Additional information was reported as follows: On 18th September 2018, the patient's mother called and stated that the patient experienced redness and swelling at the injection site and the patient in care of, also experienced itchiness to the injection site area. On 19th and 20th September a call was attempted in order to contact the patient's mother but haven't heard here back till the time of reporting.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: This case was reported by a consumer and described the occurrence of local swelling in a female patient who received SHINGRIX for prophylaxis. On 18th September 2018, the patient received SHINGRIX. In September 2018, less than a week after receiving SHINGRIX, the patient experienced local swelling, localized erythema, skin warm and skin induration. On an unknown date, the outcome of the local swelling, localized erythema, skin warm and skin induration were unknown. It was unknown if the reporter considered the local swelling, localized erythema, skin warm and skin induration to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient for herself. The age at vaccination was not reported. On Tuesday afternoon the patient received SHINGRIX and experienced a lot of redness, warmth, and swelling below the injection. It was kind of hard also. About the size of a pancake. The patient has been putting ice on it but it has not gone down. The patient asked that how long can she expect the swelling and warmth to last. It has been almost 3 days.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness, Nausea, Pollakiuria, Pyrexia, Tinnitus
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of nausea in a 64-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of pain (1st dose received on 29th March 2018, for tolerance see case US2018171939). On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a day after receiving SHINGRIX, the patient experienced nausea, fever, urinary frequency, ringing in ears and dizziness. On an unknown date, the outcome of the nausea, fever, urinary frequency, ringing in ears and dizziness were recovered/resolved. It was unknown if the reporter considered the nausea, fever, urinary frequency, ringing in ears and dizziness to be related to SHINGRIX. Additional details were provided as follows: In 2018, the patient received the vaccine within 3 weeks before the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Influenza like illness, Malaise, Pain in extremity, Tremor
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in an unspecified number of adult 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 pain in arm, tremor, shivers, influenza-like symptoms and sickness. On an unknown date, the outcome of the pain in arm, tremor, shivers, influenza-like symptoms and sickness were unknown. It was unknown if the reporter considered the pain in arm, tremor, shivers, influenza-like symptoms and sickness to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not applicable. The age group was not reported, but was captured as adult as per the vaccine indication. The reporter stated that that he had many friends with similar experiences (pain in arm, tremor, shivers, influenza-like symptoms and sickness) like the reporter. The patient had denied permission to contact their physician. This case has been linked with case US2018171908, reported by the same reporter (for himself).
Sex: U
Vaccine: VARZOS
Symptoms: Discomfort, Dizziness, Fatigue, Flushing, Headache
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of generalized muscle aches in a 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 generalized muscle aches, discomfort, injection site pain, headache, flushing, pruritus facial, dizziness, tiredness, influenza, pain and rash. On an unknown date, the outcome of the generalized muscle aches, discomfort, injection site pain, headache, flushing, pruritus facial, dizziness, tiredness, influenza, pain and rash were unknown. It was unknown if the reporter considered the generalized muscle aches, discomfort, injection site pain, headache, flushing, pruritus facial, dizziness, tiredness, influenza, pain and rash to be related to SHINGRIX. Additional details were provided as follows: Three months ago, from the reporting date, the patient experienced pain, discomfort, moderate or greater muscle pain in the patient's whole body-especially my lower back, pain at the injection site, headache, flushing, itchiness in various areas-mostly the face, head and back, some dizziness, some tiredness, flu and rash. This case has been linked to the US2018GSK176765, reported by the same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Influenza, Injection site pain, Myalgia, Pain, Pruritus
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of generalized muscle aches in a 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 generalized muscle aches, discomfort, injection site pain, headache, flushing, pruritus facial, dizziness, tiredness, influenza, pain and rash. On an unknown date, the outcome of the generalized muscle aches, discomfort, injection site pain, headache, flushing, pruritus facial, dizziness, tiredness, influenza, pain and rash were unknown. It was unknown if the reporter considered the generalized muscle aches, discomfort, injection site pain, headache, flushing, pruritus facial, dizziness, tiredness, influenza, pain and rash to be related to SHINGRIX. Additional details were provided as follows: Three months ago, from the reporting date, the patient experienced pain, discomfort, moderate or greater muscle pain in the patient's whole body-especially my lower back, pain at the injection site, headache, flushing, itchiness in various areas-mostly the face, head and back, some dizziness, some tiredness, flu and rash. This case has been linked to the US2018GSK176765, reported by the same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of generalized muscle aches in a 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 generalized muscle aches, discomfort, injection site pain, headache, flushing, pruritus facial, dizziness, tiredness, influenza, pain and rash. On an unknown date, the outcome of the generalized muscle aches, discomfort, injection site pain, headache, flushing, pruritus facial, dizziness, tiredness, influenza, pain and rash were unknown. It was unknown if the reporter considered the generalized muscle aches, discomfort, injection site pain, headache, flushing, pruritus facial, dizziness, tiredness, influenza, pain and rash to be related to SHINGRIX. Additional details were provided as follows: Three months ago, from the reporting date, the patient experienced pain, discomfort, moderate or greater muscle pain in the patient's whole body-especially my lower back, pain at the injection site, headache, flushing, itchiness in various areas-mostly the face, head and back, some dizziness, some tiredness, flu and rash. This case has been linked to the US2018GSK176765, reported by the same reporter.
Age: 1.25
Sex: M
Vaccine: DTAPIPVHIB, FLU4, UNK, VARCEL
Symptoms: Extensive swelling of vaccinated limb, Injection site erythema, Injection site oedema, Injection site streaking, Injection site swelling
Clinical narrative: Patient was given 4 vaccines on 9/28/18 around 1:30pm. Varicella was given subcutaneous in Right Thigh. Pentacel & Fluzone were given intramuscular in Left Thigh. Around 5pm on 9/29/18, Patient was taken to ED for extensive swelling of left thigh with what mom describes as "red streaks" from injection site towards knee. All previous vaccinations were tolerated with minimal site redness and warmth, and low grade fever.
Age: 1.25
Sex: M
Vaccine: DTAPIPVHIB, FLU4, UNK, VARCEL
Symptoms: Ultrasound scan abnormal
Clinical narrative: Patient was given 4 vaccines on 9/28/18 around 1:30pm. Varicella was given subcutaneous in Right Thigh. Pentacel & Fluzone were given intramuscular in Left Thigh. Around 5pm on 9/29/18, Patient was taken to ED for extensive swelling of left thigh with what mom describes as "red streaks" from injection site towards knee. All previous vaccinations were tolerated with minimal site redness and warmth, and low grade fever.
Age: 0.5
Sex: F
Vaccine: MMR
Symptoms: Rash
Clinical narrative: Rash on torso arms and legs.
Age: 92.0
Sex: M
Vaccine: PNC13
Symptoms: Blood creatinine increased, Dehydration, Dizziness, Fall, Haematoma
Clinical narrative: Pt developed low grade fever followed by dizziness which led to a fall and hematoma on left forearm.
Age: 92.0
Sex: M
Vaccine: PNC13
Symptoms: Leukocytosis, Pyrexia, White blood cell count increased
Clinical narrative: Pt developed low grade fever followed by dizziness which led to a fall and hematoma on left forearm.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Patient had a warm, red area surrounding the injection site that was tender to touch. It was in the area that the KINRIX was placed.
Age: 1.58
Sex: M
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse and refers to a 19-month old male patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant medications was provided. On 26-JUL-2018, the patient was vaccinated with improperly stored VAQTA lot # of R007388 with expiration date on 27-MAY-2019 (dose, route and site of administration were not reported) for prophylaxis. It was unknown if the sterile diluent used for reconstitution was properly stored. Administered dose of vaccine experienced the temperature excursion of 47 to 77 degrees Fahrenheit for 72 hours and range above 32 up to 35 degrees Fahrenheit for 72 hours. There were no previous temperature excursions reported. No adverse effect was reported. Additional information is not expected. Sender's Comments: US-009507513-1810USA000253.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Diarrhoea, Feeling of body temperature change, Headache, Immediate post-injection reaction
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of general body pain in a 60-year-old male patient who received SHINGRIX for prophylaxis. On 19th September 2018, the patient received the 1st dose of SHINGRIX. On 19th September 2018, immediately after receiving SHINGRIX, the patient experienced general body pain, pain in arm, sleeplessness, chills, headache, diarrhea, fever, feeling hot and feeling cold. The patient was treated with ibuprofen. On an unknown date, the outcome of the general body pain, pain in arm, sleeplessness, chills, fever, feeling hot and feeling cold were unknown and the outcome of the headache and diarrhea were not recovered/not resolved. It was unknown if the reporter considered the general body pain, pain in arm, sleeplessness, chills, headache, diarrhea, fever, feeling hot and feeling cold to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX on right arm. The wife of the patient called to report that after her husband had the injection, he started to experience the side effects throughout the day. The body ache began right away in his arm and then spread throughout the body. Within eight hours, he started having diarrhea. Twelve hours after receiving the vaccine, he started having a fever, chills and a headache. She stated that he would go back and forth with being hot and cold. He took some ibuprofen for the body aches and headaches. He still had diarrhea and the headache, but both were not as bad as they were yesterday. He was unable to sleep last night because of the side effects. The wife called his physician this morning for advice on what to do about the side effects.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Insomnia, Pain, Pain in extremity, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of general body pain in a 60-year-old male patient who received SHINGRIX for prophylaxis. On 19th September 2018, the patient received the 1st dose of SHINGRIX. On 19th September 2018, immediately after receiving SHINGRIX, the patient experienced general body pain, pain in arm, sleeplessness, chills, headache, diarrhea, fever, feeling hot and feeling cold. The patient was treated with ibuprofen. On an unknown date, the outcome of the general body pain, pain in arm, sleeplessness, chills, fever, feeling hot and feeling cold were unknown and the outcome of the headache and diarrhea were not recovered/not resolved. It was unknown if the reporter considered the general body pain, pain in arm, sleeplessness, chills, headache, diarrhea, fever, feeling hot and feeling cold to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX on right arm. The wife of the patient called to report that after her husband had the injection, he started to experience the side effects throughout the day. The body ache began right away in his arm and then spread throughout the body. Within eight hours, he started having diarrhea. Twelve hours after receiving the vaccine, he started having a fever, chills and a headache. She stated that he would go back and forth with being hot and cold. He took some ibuprofen for the body aches and headaches. He still had diarrhea and the headache, but both were not as bad as they were yesterday. He was unable to sleep last night because of the side effects. The wife called his physician this morning for advice on what to do about the side effects.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Lip blister, Peripheral swelling, Pyrexia, Rash
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of lip blister in a 53-year-old female patient who received SHINGRIX (batch number 9NJ59, expiry date 8th February 2021) for prophylaxis. On 13th July 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 13th July 2018, less than a day after receiving SHINGRIX, the patient experienced lip blister, swelling arm, rash, fever and chills. On an unknown date, the outcome of the lip blister, swelling arm, rash, fever and chills were recovered/resolved.  It was unknown if the reporter considered the lip blister, swelling arm, rash, fever and chills to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the right deltoid. The patient experienced swelling in the right upper arm. Fever and chills were resolved in 24 hours. The patient called the office, however, was did not come in to be seen by the doctor. The contact details of the physician was provided.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Headache, Musculoskeletal pain, Myalgia, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in a 71-year-old female patient who received SHINGRIX for prophylaxis. On 20th September 2018, the patient received the 2nd dose of SHINGRIX. On 20th September 2018, less than a day after receiving SHINGRIX, the patient experienced pain, muscle pain, back pain, shoulder pain and headache. On an unknown date, the outcome of the pain, muscle pain and back pain were not recovered/not resolved and the outcome of the shoulder pain and headache were unknown. It was unknown if the reporter considered the pain, muscle pain, back pain, shoulder pain and headache to be related to SHINGRIX. Additional details were provided as follows:  The age at vaccination was not reported. On the same day of vaccination, the patient started experiencing achy, muscle ache in her back, shoulder and head.
Sex: U
Vaccine: FLUA3, VARZOS
Symptoms: Abdominal discomfort, Chills, Fatigue, Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of shivering in a adult patient who received SHINGRIX for prophylaxis. Co-suspect products included FLUAD for prophylaxis. On an unknown date, the patient received SHINGRIX and FLUAD. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced shivering, fever, fatigue and gastrointestinal upset. On an unknown date, the outcome of the shivering, fever, fatigue and gastrointestinal upset were recovered/resolved. It was unknown if the reporter considered the shivering, fever, fatigue and gastrointestinal upset to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIS and FLUAD into arm. The pharmacist reported that she had given SHINGRIX to many people and followed up with each recipient. Additionally, she had given 2 patients FLUAD at the same visit as SHINGRIX (in opposite arms). The pharmacist stated that, most of the patient's reported shivering, gastrointestinal (GI) upset, fatigue or low-grade fever which was mild and resolve within 24 hours. The pharmacist stated that these 2 people did not report any different or more severe side effects compared to those who did not receive FLUAD and got SHINGRIX alone. The pharmacist said that, she did not feel like these adverse events were worthwhile to report, as they were all mild and self limiting. The patients that received FLUAD on the same day did not experience worse symptoms. This case has been linked to the US2018GSK177718 (unspecified number of patients who received only SHINGRIX) and US2018GSK177719 (the 2nd patient who received SHINGRIX and FLUAD both), reported by the same reporter.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Bone pain, Chills, Decreased appetite, Fatigue
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a 68-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included Influenza vaccine and PREVNAR. On 18th September 2018 14:00, the patient received the 1st dose of SHINGRIX (intramuscular). On 18th September 2018 22:30, 8 hrs 30 min after receiving SHINGRIX, the patient experienced fever, chills, bone pain, muscle pain, tiredness, nausea, vomiting, headache, appetite lost, influenza-like symptoms and joint pain. The patient was treated with TYLENOL. On an unknown date, the outcome of the fever, chills, bone pain, muscle pain, vomiting, headache, influenza-like symptoms and joint pain were recovered/resolved and the outcome of the tiredness, nausea and appetite lost were unchanged. It was unknown if the reporter considered the fever, chills, bone pain, muscle pain, tiredness, nausea, vomiting, headache, appetite lost, influenza-like symptoms and joint pain to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX on the left deltoid. On the day of vaccination, at around 10:30 PM the patient experienced events. She took TYLENOL as soon as she got home after vaccination, and she took two TYLENOL 500mg tablets the night before the date of reporting. The patient recovered from everything except she still experienced nausea, tiredness and loss of appetite. The patient had denied permission to contact their physician. No further details were provided.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Influenza like illness, Myalgia, Nausea, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a 68-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included Influenza vaccine and PREVNAR. On 18th September 2018 14:00, the patient received the 1st dose of SHINGRIX (intramuscular). On 18th September 2018 22:30, 8 hrs 30 min after receiving SHINGRIX, the patient experienced fever, chills, bone pain, muscle pain, tiredness, nausea, vomiting, headache, appetite lost, influenza-like symptoms and joint pain. The patient was treated with TYLENOL. On an unknown date, the outcome of the fever, chills, bone pain, muscle pain, vomiting, headache, influenza-like symptoms and joint pain were recovered/resolved and the outcome of the tiredness, nausea and appetite lost were unchanged. It was unknown if the reporter considered the fever, chills, bone pain, muscle pain, tiredness, nausea, vomiting, headache, appetite lost, influenza-like symptoms and joint pain to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX on the left deltoid. On the day of vaccination, at around 10:30 PM the patient experienced events. She took TYLENOL as soon as she got home after vaccination, and she took two TYLENOL 500mg tablets the night before the date of reporting. The patient recovered from everything except she still experienced nausea, tiredness and loss of appetite. The patient had denied permission to contact their physician. No further details were provided.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a 68-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included Influenza vaccine and PREVNAR. On 18th September 2018 14:00, the patient received the 1st dose of SHINGRIX (intramuscular). On 18th September 2018 22:30, 8 hrs 30 min after receiving SHINGRIX, the patient experienced fever, chills, bone pain, muscle pain, tiredness, nausea, vomiting, headache, appetite lost, influenza-like symptoms and joint pain. The patient was treated with TYLENOL. On an unknown date, the outcome of the fever, chills, bone pain, muscle pain, vomiting, headache, influenza-like symptoms and joint pain were recovered/resolved and the outcome of the tiredness, nausea and appetite lost were unchanged. It was unknown if the reporter considered the fever, chills, bone pain, muscle pain, tiredness, nausea, vomiting, headache, appetite lost, influenza-like symptoms and joint pain to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX on the left deltoid. On the day of vaccination, at around 10:30 PM the patient experienced events. She took TYLENOL as soon as she got home after vaccination, and she took two TYLENOL 500mg tablets the night before the date of reporting. The patient recovered from everything except she still experienced nausea, tiredness and loss of appetite. The patient had denied permission to contact their physician. No further details were provided.
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Peripheral swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of swelling arm in a female patient who received SHINGRIX for prophylaxis. On 17th September 2018, the patient received the 2nd dose of SHINGRIX. In September 2018, less than a week after receiving SHINGRIX, the patient experienced swelling arm and general body pain. On an unknown date, the outcome of the swelling arm and general body pain were unknown. It was unknown if the reporter considered the swelling arm and general body pain to be related to SHINGRIX. Additional details were provided as follows: The caller reported adverse event for herself and her husband. The age at vaccination was not reported. The patient wanted to know if her reaction was common with SHINGRIX, and how long should she wait before getting the flu shot. The patient experienced swollen arm and body pain. The caller was driving, therefore very limited data was provided. This case has been linked with US2018172540, reported by the same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain 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, immediately after receiving SHINGRIX, the patients experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional 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, he noticed when a patient received a shot from the box with 10 vials, the patient does not complain about the pain during injection, but when he used an injection from the single box, every patient had complained about the injection hurting.