chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 4.0
Sex: F
Vaccine: IPV
Symptoms: Product storage error
Clinical narrative: Initial information received on 10-Sep-2018 regarding an unsolicited valid non-serious case received from other health professional. This case is linked to case 2018SA256250 (Same reporter). This case involves a 4 years old female patient who was vaccinated with 0.5 ml dose of IPOL (Batch number: NIK931M and expiry date: 19-Nov-2010) (dose in series, route and site of administration were not reported) on 30-Aug-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications were not reported. It was a case of actual medication error due to incorrect product storage because the vaccine had been out of range for over 30 minutes and should of been discarded. It was unknown if any adverse event occurred or not. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by the sender: None.
Sex: F
Vaccine: FLUR4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 10-Sep-2018 regarding an unsolicited valid non-serious case received from a Pharmacist. This case is linked to case 2018SA256372 (same reporter). This case involves a four years old female patient who was vaccinated with FLUBLOK QIV (lot number QFAA1814) via unknown route in the left thigh on 10 Sep 2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No Concomitants therapies received. It was an actual medication error due to drug administered to patient of inappropriate age. It was not reported whether the patient had any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, FLUR4, MMR
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 10-Sep-2018 regarding an unsolicited valid non-serious case received from a Pharmacist. This case is linked to case 2018SA256369 (same reporter). This case involves a five years old male patient who was vaccinated with FLUBLOK QIV (lot number QFAA1814, expiry date: 30-Jun-2019) via unknown route in the left thigh on 10-Sep-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included QUADRACEL; and MMRVAXPRO. It was an actual medication error due to inappropriate age at vaccine administration. No Reported symptoms. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 63.0
Sex: F
Vaccine: FLUR4
Symptoms: Injection site haemorrhage, Injection site swelling
Clinical narrative: Initial information received on 11-Sep-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 63 years old female patient who experienced injection site reaction- a small bulge formed at site and grew in size, bulge grew to about the diameter of a nickel and was raised to a height of about 3 stacked nickels and injection today into right deltoid and it bled more than usual, while she received vaccine FLUBLOK QIV. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 11-Sep-2018, the patient received a 0.5 mL dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE, lot QFAA1812 via unknown route in the right deltoid (frequency-once). On 11-Sep-2018, on same day of post-vaccination, patient developed a non-serious injection site reaction- a small bulge formed at site and grew in size, bulge grew to about the diameter of a nickel and was raised to a height of about 3 stacked nickels (injection site mass) and injection today into right deltoid and it bled more than usual (Injection site bleeding). Relevant tests were not reported. Final diagnosis was injection site reaction- a small bulge formed at site and grew in size, bulge grew to about the diameter of a nickel and was raised to a height of about 3 stacked nickels and injection today into right deltoid and it bled more than usual. It was not reported if the patient received a corrective treatment. The outcome of the event was reported as unknown. Documents held by sender: none.
Age: 55.0
Sex: F
Vaccine: HEPA
Symptoms: Pruritus, Urticaria
Clinical narrative: Pt. states noticed face started itching early evening then noticed started to have hives - on face and neck. Called pharmacy and spoke to pharmacist - took BENADRYL.
Age: 6.0
Sex: F
Vaccine: IPV
Symptoms: Urticaria
Clinical narrative: Hives all over body and legs sudden and lasting 48 hours. BENADRYL did not have an effect. Hives moved all over body and would come and go in the same location. Pt was prescribed oral steroids and  BENADRYL 0n 8/29/18. Neither had an effect. After 48 hours, the hives subsided on its own. No new occurrences or products were used at home when she broke out in sudden hives. Pt saw the nurse practitioner at the office. Dr is the pt's regular doctor and was updated on her hives by pt's mother during the office visit. Pt's hive were extreme and prolonged all over her body, legs, and face. They would reoccur in the same spots.
Age: 77.0
Sex: F
Vaccine: HEPA, PPV
Symptoms: Arthritis, Blood urine present, Mobility decreased, Pain in extremity, Pallor
Clinical narrative: Right arm started hurting about 5 hours after the PPSV23 shot. Felt as if she couldn't move her arm. Called local ER and was advised to take OTC pain meds overnight and follow up with call to clinic in the morning. Called the clinic in the morning as she felt the arm was not improved. Came into the clinic for an injection of ketorolac 30mg to see if that would help her pain. She also felt as if her kidneys on the right side hurt. She awoke the next morning and said that she had blood in her urine. Went into the clinic for a visit and had a urine sample run witch was negative for infection and gross hematuria. She reports that the next morning the blood in urine was gone. A few days later she said that she took off her fingernail polish and noticed that her nail beds were "more white" than usual and feels this is related to the shot. She also reports that she had a "flair of her arthritis in her thumb joints on both sides" after the shot. States that currently her arm is "better, but still bothers her." Says that she has been going to the chiropractor to help with the side effects.
Age: 77.0
Sex: F
Vaccine: HEPA, PPV
Symptoms: Renal pain, Urine analysis normal
Clinical narrative: Right arm started hurting about 5 hours after the PPSV23 shot. Felt as if she couldn't move her arm. Called local ER and was advised to take OTC pain meds overnight and follow up with call to clinic in the morning. Called the clinic in the morning as she felt the arm was not improved. Came into the clinic for an injection of ketorolac 30mg to see if that would help her pain. She also felt as if her kidneys on the right side hurt. She awoke the next morning and said that she had blood in her urine. Went into the clinic for a visit and had a urine sample run witch was negative for infection and gross hematuria. She reports that the next morning the blood in urine was gone. A few days later she said that she took off her fingernail polish and noticed that her nail beds were "more white" than usual and feels this is related to the shot. She also reports that she had a "flair of her arthritis in her thumb joints on both sides" after the shot. States that currently her arm is "better, but still bothers her." Says that she has been going to the chiropractor to help with the side effects.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Redness, swelling and pain around injection site appearing around a day after vaccination. Proceeded to get better over the next  day or so. Appearance when she came in (3 days post vaccination) was slightly hot and swollen.
Age: 89.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Blood test normal, Chills, Fatigue, Pain in extremity
Clinical narrative: 9/10/18: ache/pain all the way down arm into wrist. 9/11/18: tired and increased pain, took TYLENOL, fever/chills started, stayed in bed all day. 9/12/18: fever went up to 102F, continued with TYLENOL, went to Dr. did blood work and xray which were normal eventually recovered on own.
Age: 89.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia, X-ray normal
Clinical narrative: 9/10/18: ache/pain all the way down arm into wrist. 9/11/18: tired and increased pain, took TYLENOL, fever/chills started, stayed in bed all day. 9/12/18: fever went up to 102F, continued with TYLENOL, went to Dr. did blood work and xray which were normal eventually recovered on own.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Nausea, Night sweats, Pain, Peripheral swelling
Clinical narrative: Arm swelling, pain, night sweats, chills, nausea; lasted 3 days.
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site nodule, Injection site pain, Injection site swelling
Clinical narrative: Patient states that the next morning she at the injection was redness and swelling and it was tender. There wasn't a change the next day but come Saturday at the swelling worsened and was easily visible and tender. Patient states that most of the symptoms have subsided as of this morning and it is no longer tender to touch and but it feels like a small ball at the injection with no pain.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Blood test, Injection site induration
Clinical narrative: This spontaneous report as received from a nurse prescriber refers to a 66-year-old female patient. The patient did not have any pertinent medical history and she did not use any concomitant medications. The patient was allergic to penicillin. On 22-AUG-2018, she was vaccinated with a dose of PNEUMOVAX 23 in the right upper arm, lot # R009162, expiration date: 06-JAN-2020 (exact dose and route of administration were not reported) for prophylaxis. On the same day, after PNEUMOVAX 23 was administered to the patient, she experienced induration in the area of right shoulder to antecubital region of the right arm. On 24-AUG-2018, the patient sought medical attention and was seen by the nurse prescriber. Blood work was performed (results not provided) and unspecified treatment was given for the adverse event. The patient appeared doing well but she did not recover. The relatedness between the event and PNEUMOVAX 23 was not provided.
Age: 15.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Registered nurse regarding a 15 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 20-JUN-2017, the patient was vaccinated with improperly stored dose of GARDASIL 9 (lot# N004798 with expiration date: 31-OCT-2019) (dosing details and route of administration was not reported) for prophylaxis (product storage error). No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports from the same reporter. Sender's Comments: US-009507513-1804USA005153.
Age: 17.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Registered nurse regarding a 17 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 20-JUN-2017, the patient was vaccinated with improperly stored dose of GARDASIL 9 (lot# N004798 with expiration date: 31-OCT-2019) (dosing details and route of administration was not reported) for prophylaxis (product storage error). No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports from the same reporter. Sender's Comments: US-009507513-1804USA005153.
Age: 13.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Registered nurse regarding a 13 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 26-APR-2018, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot# N004798 with expiration date: 31-OCT-2019 (dosing details and route of administration was not reported) for prophylaxis (product storage error). No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1804USA005153.
Age: 12.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Registered nurse regarding a 12 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 11-JUN-2018, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot# N004798 with expiration date: 31-OCT-2019 (dosing details and route of administration was not reported) for prophylaxis (product storage error). No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports received from the same reporter. ; Sender's Comments: US-009507513-1804USA005153:
Age: 18.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Registered nurse regarding an 18 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 11-JUL-2018, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot# N004798 with expiration date: 31-OCT-2019 (dosing details and route of administration was not reported) for prophylaxis. No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1804USA005153.
Age: 14.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Registered nurse regarding 14 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 19-JUN-2017, the patient was vaccinated with improperly stored dose of GARDASIL 9 (lot# N004798 with expiration date: 31-OCT-2019) (dosing details and route of administration was not reported) for prophylaxis (product storage error). No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports from the same reporter. Sender's Comments: US-009507513-1804USA005153.
Age: 15.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Registered nurse regarding a 15 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 01-AUG-2018, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot# N004798 with expiration date: 31-OCT-2019 (dosing details and route of administration was not reported) for prophylaxis (product storage error). No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1804USA005153.
Age: 14.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Registered nurse regarding a 14 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 28-MAR-2018, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot# N004798 with expiration date: 31-OCT-2019 (dosing details and route of administration was not reported) for prophylaxis. No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1804USA005153.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Burning sensation, Feeling cold, Headache, Hyperaesthesia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of burning sensation in a 67-year-old female patient who received SHINGRIX for prophylaxis. On 29th August 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, less than a week after receiving SHINGRIX, the patient experienced burning sensation, weakness, sickness, headache, increased skin sensitivity, feeling cold and fever. On an unknown date, the outcome of the burning sensation, weakness, headache, increased skin sensitivity, feeling cold and fever were unknown and the outcome of the sickness was recovered/resolved. It was unknown if the reporter considered the burning sensation, weakness, sickness, headache, increased skin sensitivity, feeling cold and fever to be related to SHINGRIX. Additional details were provided as follows: The patient developed a fever and headache initially. The patient at the time of reporting described that she got a burning sensation in her hands that comes and goes. She had cold sensations and nerve sensations in her legs. She felt weak and she no longer had the harmonious hum in her brain that she had prior to the vaccination. The patient said that she had been sick for six days. The patient had denied permission to contact their physician. The reporter was unable to obtain additional information.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of burning sensation in a 67-year-old female patient who received SHINGRIX for prophylaxis. On 29th August 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, less than a week after receiving SHINGRIX, the patient experienced burning sensation, weakness, sickness, headache, increased skin sensitivity, feeling cold and fever. On an unknown date, the outcome of the burning sensation, weakness, headache, increased skin sensitivity, feeling cold and fever were unknown and the outcome of the sickness was recovered/resolved. It was unknown if the reporter considered the burning sensation, weakness, sickness, headache, increased skin sensitivity, feeling cold and fever to be related to SHINGRIX. Additional details were provided as follows: The patient developed a fever and headache initially. The patient at the time of reporting described that she got a burning sensation in her hands that comes and goes. She had cold sensations and nerve sensations in her legs. She felt weak and she no longer had the harmonious hum in her brain that she had prior to the vaccination. The patient said that she had been sick for six days. The patient had denied permission to contact their physician. The reporter was unable to obtain additional information.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 58-year-old male patient who received SHINGRIX for prophylaxis. On 5th September 2018, the patient received the 2nd dose of SHINGRIX. On 5th September 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain. In September 2018, the patient experienced headache and fatigue. On 6th September 2018, the outcome of the injection site pain was recovered/resolved. On an unknown date, the outcome of the headache and fatigue were unknown. It was unknown if the reporter considered the injection site pain, headache and fatigue to be related to SHINGRIX. Additional details were provided as follows: On 5th September 2018 08:30, the patient received SHINGRIX on the left arm. The reporter received the SHINGRIX vaccine and was experienced soreness and pain at the injection site that lasted the whole day. On 6th September 2018 13:00, 1 day 4hr 30min after receiving SHINGRIX, the patient experienced headache and fatigue. On the day of reporting the patient's soreness and pain was almost fully resolved. The reporter gave permission for his physician to be contacted. Unable to obtain additional information.
Sex: M
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 male patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included solitary kidney. On 4th August 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional information was received as follows: The age at vaccination was not reported. No further information was reported. This case was linked to the case US2018GSK167259, reported by the same reporter for the same patient.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 73-year-old female patient who received SHINGRIX for prophylaxis.  On 29th August 2018, the patient received the 1st dose of SHINGRIX. On 29th August 2018, several hours after receiving SHINGRIX, the patient experienced injection site erythema. On an unknown date, the outcome of the injection site erythema was recovering/resolving. It was unknown if the reporter considered the injection site erythema to be related to SHINGRIX. Additional details were reported as follows: At 16:00 O' clock, the patient received SHINGRIX vaccine in right arm. The patient experienced redness at the injection site either the night of or the next day following vaccination with SHINGRIX vaccine. The patient could not recall the exact onset time. The events was resolving after a few days but then a larger red spot appeared before the reporting day. It was red above, below and on the sides of the injection site. The patient had denied permission to contact their physician.   This case was linked with cases US2018GSK165658 and US2018162299 (husband's case), reported by the same reporter.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of localized erythema in a 77-year-old female patient who received SHINGRIX (batch number 2J4P2 ?, expiry date 7th March 2021) for prophylaxis. On 4th September 2018, the patient received SHINGRIX. On 6th September 2018, 2 days after receiving SHINGRIX, the patient experienced localized erythema, skin warm and local swelling. On an unknown date, the outcome of the localized erythema, skin warm and local swelling were unchanged. It was unknown if the reporter considered the localized erythema, skin warm and local swelling to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX and developed redness, swelling, and warmth 3 to 4 inches below the injection site.
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of pain in arm 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 pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The reporter is the dentist, he stated that his friend's wife (the patient) experienced sore arm for several days and then she recovered. This case has been linked with case US2018163110, US2018163111 and US2018163104 reported by the same reporter.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Feeling abnormal, Malaise
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of feeling unwell in a 71-year-old male patient who received SHINGRIX for prophylaxis. In May 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In May 2018, 12 hrs after receiving SHINGRIX, the patient experienced feeling unwell and feeling bad. On an unknown date, the outcome of the feeling unwell and feeling bad were recovered/resolved. It was unknown if the reporter considered the feeling unwell and feeling bad to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX vaccine on right arm. The patient felt sick, described as feeling lousy about 12 hours after the injection. The event resolved after one day. The patient had denied permission to contact their physician.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Back pain, Emotional distress, Fatigue, Gait disturbance, Injection site erythema
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 69-year-old female patient who received SHINGRIX for prophylaxis. On 2nd September 2018, the patient received the 1st dose of SHINGRIX. On 2nd September 2018, less than a day after receiving SHINGRIX, the patient experienced fatigue, injection site erythema, walking difficulty, back pain and spasms. On an unknown date, the outcome of the fatigue, injection site erythema, walking difficulty, back pain and spasms were not recovered/not resolved. It was unknown if the reporter considered the fatigue, injection site erythema, walking difficulty, back pain and spasms to be related to SHINGRIX. Additional details were provided as follows: The patient had no history of back pain. The patient received SHINGRIX on the left arm. The patient was upset because she had severe reactions to the SHINGRIX. On the same evening of vaccination, the patient started to develop the symptoms which included fatigue, back pain and spasms in the back. The patient clarified that, the back pain and spasms in the back are on the same side of the body where she received the SHINGRIX.  The patient said that she had difficulty walking due to SHINGRIX. The patient experienced a huge red circle at the injection site and still had it. The patient was upset because, she had been seeing an acupuncture specialist and physical therapist to handle the side effects with SHINGRIX. The patient mentioned a comment that she believed GlaxoSmithKline should pay for all her treatment expenses.  This is 1 of 4 cases, reported by the same reporter.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Muscle spasms
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 69-year-old female patient who received SHINGRIX for prophylaxis. On 2nd September 2018, the patient received the 1st dose of SHINGRIX. On 2nd September 2018, less than a day after receiving SHINGRIX, the patient experienced fatigue, injection site erythema, walking difficulty, back pain and spasms. On an unknown date, the outcome of the fatigue, injection site erythema, walking difficulty, back pain and spasms were not recovered/not resolved. It was unknown if the reporter considered the fatigue, injection site erythema, walking difficulty, back pain and spasms to be related to SHINGRIX. Additional details were provided as follows: The patient had no history of back pain. The patient received SHINGRIX on the left arm. The patient was upset because she had severe reactions to the SHINGRIX. On the same evening of vaccination, the patient started to develop the symptoms which included fatigue, back pain and spasms in the back. The patient clarified that, the back pain and spasms in the back are on the same side of the body where she received the SHINGRIX.  The patient said that she had difficulty walking due to SHINGRIX. The patient experienced a huge red circle at the injection site and still had it. The patient was upset because, she had been seeing an acupuncture specialist and physical therapist to handle the side effects with SHINGRIX. The patient mentioned a comment that she believed GlaxoSmithKline should pay for all her treatment expenses.  This is 1 of 4 cases, reported by the same reporter.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Back pain, Erythema, Feeling hot, Malaise, Muscle spasms
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 69-year-old female patient who received SHINGRIX for prophylaxis. On 2nd September 2018, the patient received the 1st dose of SHINGRIX. On 2nd September 2018, less than a day after receiving SHINGRIX, the patient experienced fatigue, injection site erythema, walking difficulty, back pain and spasms. On an unknown date, the outcome of the fatigue, injection site erythema, walking difficulty, back pain and spasms were not recovered/not resolved. It was unknown if the reporter considered the fatigue, injection site erythema, walking difficulty, back pain and spasms to be related to SHINGRIX. Additional details were provided as follows: The patient had no history of back pain. The patient received SHINGRIX on the left arm. The patient was upset because she had severe reactions to the SHINGRIX. On the same evening of vaccination, the patient started to develop the symptoms which included fatigue, back pain and spasms in the back. The patient clarified that, the back pain and spasms in the back are on the same side of the body where she received the SHINGRIX.  The patient said that she had difficulty walking due to SHINGRIX. The patient experienced a huge red circle at the injection site and still had it. The patient was upset because, she had been seeing an acupuncture specialist and physical therapist to handle the side effects with SHINGRIX. The patient mentioned a comment that she believed GlaxoSmithKline should pay for all her treatment expenses.  This is 1 of 4 cases, reported by the same reporter.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 69-year-old female patient who received SHINGRIX for prophylaxis. On 2nd September 2018, the patient received the 1st dose of SHINGRIX. On 2nd September 2018, less than a day after receiving SHINGRIX, the patient experienced fatigue, injection site erythema, walking difficulty, back pain and spasms. On an unknown date, the outcome of the fatigue, injection site erythema, walking difficulty, back pain and spasms were not recovered/not resolved. It was unknown if the reporter considered the fatigue, injection site erythema, walking difficulty, back pain and spasms to be related to SHINGRIX. Additional details were provided as follows: The patient had no history of back pain. The patient received SHINGRIX on the left arm. The patient was upset because she had severe reactions to the SHINGRIX. On the same evening of vaccination, the patient started to develop the symptoms which included fatigue, back pain and spasms in the back. The patient clarified that, the back pain and spasms in the back are on the same side of the body where she received the SHINGRIX.  The patient said that she had difficulty walking due to SHINGRIX. The patient experienced a huge red circle at the injection site and still had it. The patient was upset because, she had been seeing an acupuncture specialist and physical therapist to handle the side effects with SHINGRIX. The patient mentioned a comment that she believed GlaxoSmithKline should pay for all her treatment expenses.  This is 1 of 4 cases, reported by the same reporter.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in an elderly female patient who received SHINGRIX for prophylaxis. In August 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In August 2018, immediately after receiving SHINGRIX, the patient experienced injection site pain, injection site itching and injection site erythema. On an unknown date, the outcome of the injection site pain, injection site itching and injection site erythema were recovered/resolved. It was unknown if the reporter considered the injection site pain, injection site itching and injection site erythema to be related to SHINGRIX. Additional information was reported as follows: The age at vaccination was not reported, but it could be 77 or 78 years old. The patient was vaccinated with the dose of SHINGRIX, about 3 weeks before the date of vaccination. When she first received the shot, she stated that her arm "hurt a little bit," but she moved it around and it stopped hurting. Within two days after the patient experienced redness at the injection site that it was the size of baseballs and itching at the injection site. The redness was about 6 inches long and about 3 to 4 inches wide. All the events experienced by the patient lasted for a period of about 10 days. The patient's doctor informed her not to get vaccinated with the 2nd dose. The patient had denied permission to contact their physician. The reporter declined to leave address.
Age: 72.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Back pain, Chills, Fatigue, Gait disturbance, Gait inability
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 72-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (1st dose received on an unknown date, more than 2 months before the 2nd dose). On 2nd September 2018, the patient received the 2nd dose of SHINGRIX. On 2nd September 2018, less than a day after receiving SHINGRIX, the patient experienced fatigue, spasms, walking difficulty, injection site erythema, chills, sleeplessness and back pain. On 3rd September 2018, the patient experienced unable to walk. On an unknown date, the outcome of the fatigue, spasms, walking difficulty, sleeplessness and back pain were not recovered/not resolved and the outcome of the injection site erythema and chills were recovered/resolved and the outcome of the unable to walk was recovering/resolving. It was unknown if the reporter considered the fatigue, spasms, walking difficulty, injection site erythema, chills, sleeplessness, back pain and unable to walk to be related to SHINGRIX. Additional details were provided as follows: This adverse event report was collected directly from the patient. The patient had no history of having back pain. The patient received SHINGRIX on the left arm. On the same day of vaccination, the patient started to develop the symptoms. The patient experienced fatigue, back pain, spasms in the back. The patient clarified that the back pain and spasms in the back are on the same side of the body where he received the SHINGRIX. The patient had difficulty walking due to the SHINGRIX. The patient's side effects were worse than what his wife experienced. The back pain was so severe that he was unable to walk on Monday or Tuesday. He could barely walk with the assistance of a walker on date of reporting. The patient could not walk a long distance either, he immediately had back pain. The patient could not sleep because of the muscle spasms in the back. He had severe cramping in his hip and last night he had leg cramps (4 days after vaccination). The patient stated that, all the symptoms happened on the left side where he got the vaccine. He also had a huge red circle at the injection site. The patient also experienced chills. He recovered from these two symptoms on an unknown date. The patient was upset because he had been seeing an acupuncture specialist and physical therapist to handle the side effects with SHINGRIX. The patient had been prescribed a muscle relaxer and that did not help at all. This is 1 of 4 cases, reported by the same reporter.
Age: 72.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Insomnia, Muscle spasms, Walking aid user
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 72-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (1st dose received on an unknown date, more than 2 months before the 2nd dose). On 2nd September 2018, the patient received the 2nd dose of SHINGRIX. On 2nd September 2018, less than a day after receiving SHINGRIX, the patient experienced fatigue, spasms, walking difficulty, injection site erythema, chills, sleeplessness and back pain. On 3rd September 2018, the patient experienced unable to walk. On an unknown date, the outcome of the fatigue, spasms, walking difficulty, sleeplessness and back pain were not recovered/not resolved and the outcome of the injection site erythema and chills were recovered/resolved and the outcome of the unable to walk was recovering/resolving. It was unknown if the reporter considered the fatigue, spasms, walking difficulty, injection site erythema, chills, sleeplessness, back pain and unable to walk to be related to SHINGRIX. Additional details were provided as follows: This adverse event report was collected directly from the patient. The patient had no history of having back pain. The patient received SHINGRIX on the left arm. On the same day of vaccination, the patient started to develop the symptoms. The patient experienced fatigue, back pain, spasms in the back. The patient clarified that the back pain and spasms in the back are on the same side of the body where he received the SHINGRIX. The patient had difficulty walking due to the SHINGRIX. The patient's side effects were worse than what his wife experienced. The back pain was so severe that he was unable to walk on Monday or Tuesday. He could barely walk with the assistance of a walker on date of reporting. The patient could not walk a long distance either, he immediately had back pain. The patient could not sleep because of the muscle spasms in the back. He had severe cramping in his hip and last night he had leg cramps (4 days after vaccination). The patient stated that, all the symptoms happened on the left side where he got the vaccine. He also had a huge red circle at the injection site. The patient also experienced chills. He recovered from these two symptoms on an unknown date. The patient was upset because he had been seeing an acupuncture specialist and physical therapist to handle the side effects with SHINGRIX. The patient had been prescribed a muscle relaxer and that did not help at all. This is 1 of 4 cases, reported by the same reporter.
Age: 72.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Back pain, Gait inability, Influenza like illness, Loss of personal independence in daily activities, Musculoskeletal discomfort
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 72-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (1st dose received on an unknown date, more than 2 months before the 2nd dose). On 2nd September 2018, the patient received the 2nd dose of SHINGRIX. On 2nd September 2018, less than a day after receiving SHINGRIX, the patient experienced fatigue, spasms, walking difficulty, injection site erythema, chills, sleeplessness and back pain. On 3rd September 2018, the patient experienced unable to walk. On an unknown date, the outcome of the fatigue, spasms, walking difficulty, sleeplessness and back pain were not recovered/not resolved and the outcome of the injection site erythema and chills were recovered/resolved and the outcome of the unable to walk was recovering/resolving. It was unknown if the reporter considered the fatigue, spasms, walking difficulty, injection site erythema, chills, sleeplessness, back pain and unable to walk to be related to SHINGRIX. Additional details were provided as follows: This adverse event report was collected directly from the patient. The patient had no history of having back pain. The patient received SHINGRIX on the left arm. On the same day of vaccination, the patient started to develop the symptoms. The patient experienced fatigue, back pain, spasms in the back. The patient clarified that the back pain and spasms in the back are on the same side of the body where he received the SHINGRIX. The patient had difficulty walking due to the SHINGRIX. The patient's side effects were worse than what his wife experienced. The back pain was so severe that he was unable to walk on Monday or Tuesday. He could barely walk with the assistance of a walker on date of reporting. The patient could not walk a long distance either, he immediately had back pain. The patient could not sleep because of the muscle spasms in the back. He had severe cramping in his hip and last night he had leg cramps (4 days after vaccination). The patient stated that, all the symptoms happened on the left side where he got the vaccine. He also had a huge red circle at the injection site. The patient also experienced chills. He recovered from these two symptoms on an unknown date. The patient was upset because he had been seeing an acupuncture specialist and physical therapist to handle the side effects with SHINGRIX. The patient had been prescribed a muscle relaxer and that did not help at all. This is 1 of 4 cases, reported by the same reporter.
Age: 72.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 72-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (1st dose received on an unknown date, more than 2 months before the 2nd dose). On 2nd September 2018, the patient received the 2nd dose of SHINGRIX. On 2nd September 2018, less than a day after receiving SHINGRIX, the patient experienced fatigue, spasms, walking difficulty, injection site erythema, chills, sleeplessness and back pain. On 3rd September 2018, the patient experienced unable to walk. On an unknown date, the outcome of the fatigue, spasms, walking difficulty, sleeplessness and back pain were not recovered/not resolved and the outcome of the injection site erythema and chills were recovered/resolved and the outcome of the unable to walk was recovering/resolving. It was unknown if the reporter considered the fatigue, spasms, walking difficulty, injection site erythema, chills, sleeplessness, back pain and unable to walk to be related to SHINGRIX. Additional details were provided as follows: This adverse event report was collected directly from the patient. The patient had no history of having back pain. The patient received SHINGRIX on the left arm. On the same day of vaccination, the patient started to develop the symptoms. The patient experienced fatigue, back pain, spasms in the back. The patient clarified that the back pain and spasms in the back are on the same side of the body where he received the SHINGRIX. The patient had difficulty walking due to the SHINGRIX. The patient's side effects were worse than what his wife experienced. The back pain was so severe that he was unable to walk on Monday or Tuesday. He could barely walk with the assistance of a walker on date of reporting. The patient could not walk a long distance either, he immediately had back pain. The patient could not sleep because of the muscle spasms in the back. He had severe cramping in his hip and last night he had leg cramps (4 days after vaccination). The patient stated that, all the symptoms happened on the left side where he got the vaccine. He also had a huge red circle at the injection site. The patient also experienced chills. He recovered from these two symptoms on an unknown date. The patient was upset because he had been seeing an acupuncture specialist and physical therapist to handle the side effects with SHINGRIX. The patient had been prescribed a muscle relaxer and that did not help at all. This is 1 of 4 cases, reported by the same reporter.