chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Injury associated with device
Clinical narrative: This case was reported by a pharmacist via sales rep and described the occurrence of needle stick/puncture in a adult patient who intended to administer SHINGRIX to the patient for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, immediately after receiving SHINGRIX, the patient experienced needle stick/puncture. On an unknown date, the outcome of the needle stick/puncture was unknown. It was unknown if the reporter considered the needle stick/puncture to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not applicable for this report. One of the pharmacists suffered a needle stick while preparing or administering a dose of SHINGRIX.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Neuropathy peripheral, Pain in extremity
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of neuropathy in a 59-year-old male patient who received SHINGRIX (batch number Y24KE, expiry date 11th October 2020) for prophylaxis. On 21st July 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In July 2018, less than a week after receiving SHINGRIX, the patient experienced neuropathy (serious criteria GSK medically significant) and pain in arm. On an unknown date, the outcome of the neuropathy and pain in arm were unchanged. It was unknown if the reporter considered the neuropathy and pain in arm to be related to SHINGRIX. Additional details were provided as follows: The reporting pharmacist stated that the patient came in complaining that his arm was sore, and he was experiencing neuropathy on the long front of his left leg from knee to upper thigh. Even having clothes on was painful. No further details were provided by the pharmacist.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site indentation, Injection site necrosis
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of injection site necrosis in a 57-year-old female patient who received SHINGRIX for prophylaxis. On 4th June 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site necrosis (serious criteria GSK medically significant) and injection site indentation. On an unknown date, the outcome of the injection site necrosis and injection site indentation were not recovered/not resolved. It was unknown if the reporter considered the injection site necrosis and injection site indentation to be related to SHINGRIX. Additional information was reported as follows: At the time of reporting, the patient was 57 years old. The age at vaccination could be 56 or 57 years. The physician reported to the sales representative that the patient experienced permanent damage from the indentation and necrosis.
Age: 17.0
Sex: M
Vaccine: HEPA, HPV9, MENB, MNQ, VARCEL
Symptoms: Chills, Fatigue, Muscular weakness, Pyrexia
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of fever in a 17-year-old male patient who received BEXSERO for prophylaxis. Co-suspect products included HAVRIX for prophylaxis, MENVEO for prophylaxis, Varicella vaccine for prophylaxis and GARDASIL 9 for prophylaxis. On 25th July 2018, the patient received BEXSERO, HAVRIX, MENVEO, Varicella vaccine and GARDASIL 9 at an unknown dose and frequency. On 25th July 2018, less than a day after receiving BEXSERO, HAVRIX, MENVEO and Varicella vaccine, the patient experienced fever, fatigue, lower extremities weakness of and chills. The patient was treated with ibuprofen. On an unknown date, the outcome of the fever and chills were recovered/resolved and the outcome of the fatigue and lower extremities weakness of were recovering/resolving. It was unknown if the reporter considered the fever, fatigue, lower extremities weakness of and chills to be related to BEXSERO, HAVRIX, MENVEO and Varicella vaccine. Additional information was reported as follows: The healthcare professional reported that the patient was vaccinated with 5 vaccines, each vaccinated separately but on the same day. The patient called later on the same day of vaccination and experienced low grade fever of 99.6 degree F, along with chills, fatigue and leg weakness. The patient was instructed to take Ibuprofen as directed by the healthcare professional and take rest. On the next day of the vaccination, the healthcare professional called the patient and spoke to the patient's father and he stated that the patient was feeling much better after rest. Where Ibuprofen and fluids helped and the patient's symptoms were resolving.
Sex: U
Vaccine: MENB
Symptoms: Psychotic disorder
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of psychotic episode in a patient who received BEXSERO for prophylaxis. Concurrent medical conditions included celiac disease. On an unknown date, the patient received BEXSERO. On an unknown date, unknown after receiving BEXSERO, the patient experienced psychotic episode. On an unknown date, the outcome of the psychotic episode was unknown. It was unknown if the reporter considered the psychotic episode to be related to BEXSERO. Additional information was reported as follows: The age at vaccination was not reported. The nurse notified the reporter, that the patient after vaccination with BEXSERO experienced psychotic events. No further patient or event details were reported. This was 1 of the 2 cases reported by the same reporter, for the patient belonging to the same family.
Sex: M
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site haemorrhage
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site hemorrhage 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, immediately after receiving SHINGRIX, the patient experienced injection site hemorrhage and intramuscular formulation administered by other route. On an unknown date, the outcome of the injection site hemorrhage and intramuscular formulation administered by other route were unknown. It was unknown if the reporter considered the injection site hemorrhage to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The healthcare professional (HCP) administered SHINGRIX to heavy a patient with a 1 mm syringe and noticed a small drop of blood after administering the vaccine at the injection site. The HCP was not sure if the injection got into muscle, which led to possible incorrect route of vaccine administration. The HCP did not wish to provide any further details including product, event or patient.
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of hives in a female patient who received SHINGRIX for prophylaxis. On 18th July 2018, the patient received the 1st dose of SHINGRIX. On 20th July 2018, 2 days after receiving SHINGRIX, the patient experienced hives. The patient was treated with prednisone. On an unknown date, the outcome of the hives was Not Recovered/Not Resolved. It was unknown if the reporter considered the hives to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX in right arm. On 20th July 2018, Friday, the patient noticed hives on her right underarm. On Saturday morning (21st July 2018), the patient had hives under her left arm, in the afternoon, she had hives under both breasts and in the bikini line and in the evening the patient had hives on both upper arms and the front of both thighs. By Sunday afternoon (22nd July 2018), most hives had cleared up. On Monday night (23rd July 2018), and Tuesday morning (24th July 2018), the patient had huge hives on both inner thighs, both arms, and both arm pits. The patient saw the doctor Tuesday morning (24th July 2018) and got prednisone. The patient wanted to know, if she was allergic to so she need to know what the ingredients are.
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Eye swelling, Rash
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of rash in a adult female patient who received BEXSERO for prophylaxis. The patient's past medical history included eczema. On 26th June 2018, the patient received BEXSERO. On 28th June 2018, 2 days after receiving BEXSERO, the patient experienced rash and eye swelling. The patient was treated with ZYRTEC and BENADRYL. On an unknown date, the outcome of the rash and eye swelling were recovered/resolved. The reporter considered the rash and eye swelling to be related to BEXSERO. Additional details were provided as follows: The patient's initials and date of birth were unknown. The patient was 19 years old at the time of vaccination. The patient's mother reported rash, shoulder and arm, as well as one eye swelling 2 days after BEXSERO was administered in an unknown deltoid. The provider assumed it was related to the vaccine. The patient started on BENADRYL and ZYRTEC and symptoms mostly resolved within 4 days. The provider indicated patient's symptoms most likely had fully resolved by the time this event was reported to GlaxoSmithKline field medical and sales. All other information regarding vaccination details were unknown. The reporter agreed to follow up from GSK.
Sex: U
Vaccine: MENB, MNQ
Symptoms: Meningitis, Pain, Product quality issue, Pyrexia
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of meningitis in a patient who received BEXSERO (batch number 16G201, expiry date unknown) for prophylaxis. This case was associated with a product complaint. Co-suspect products included MENACTRA for prophylaxis. On an unknown date, the patient received BEXSERO and MENACTRA at an unknown dose. On an unknown date, less than a day after receiving BEXSERO and unknown after receiving MENACTRA, the patient experienced meningitis (serious criteria GSK medically significant), general body pain, fever and pharmaceutical product complaint. On an unknown date, the outcome of the meningitis, general body pain, fever and pharmaceutical product complaint were unknown. It was unknown if the reporter considered the meningitis, general body pain and fever to be related to BEXSERO. Additional details were provided as follows: The licensed practical nurse (LPN) reported this case. The age at vaccination was not reported. The reporter states that they noticed a trend of administering BEXSERO and patients returning within the same day complaining of adverse events (3 adverse events in 1 week). The patient experienced symptoms of meningitis and body ache. The patient had to be transported to the emergency department (ED) via ambulance. The reporter believed the co-administration issue with MENACTRA and BEXSERO. The reporter stated since administering BEXSERO only and no other vaccines at the visit, they had not seen any other additional incidents. Once they stopped co-administering BEXSERO with MCV4, the adverse event trend stopped. This case has been linked to US2018GSK13439, reporter by same reporter for unspecified number of patients.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of fever in a 63-year-old male patient who received SHINGRIX for prophylaxis. On 20th July 2018, the patient received SHINGRIX. On 21st July 2018, 1 days after receiving SHINGRIX, the patient experienced fever. On 22nd July 2018, the outcome of the fever was recovered/resolved. It was unknown if the reporter considered the fever to be related to SHINGRIX. Additional information was reported as follows: The physician stated that, one of their patients was vaccinated with a shot of SHINGRIX from the office on the past Friday, before the date of reporting. On Saturday, the patient experienced fever (body temperature: 103 degree F) for a day. The patient did not call or came in, so they did not see him. The reporter did not agree to be followed up.
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Myalgia, Nausea
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fatigue in a adult patient who received SHINGRIX for prophylaxis. The patient's past medical history included viral meningitis and headache. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fatigue, nausea, muscle pain and headache. On an unknown date, the outcome of the fatigue, nausea and muscle pain were unknown and the outcome of the headache was recovered/resolved. It was unknown if the reporter considered the fatigue, nausea, muscle pain and headache to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced fatigue, nausea and muscle pain and went to bed and slept for 12 hours. The patient experienced 48 hour long headache, the intensity of which compared to the one the patient had with viral meningitis. The patient began to wonder if getting shingles would had been the better option.
Sex: F
Vaccine: VARZOS
Symptoms: Loss of personal independence in daily activities, Pain in extremity
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of pain in arm in a female patient who received SHINGRIX for prophylaxis. In May 2018, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain in arm and activities of daily living impaired. On an unknown date, the outcome of the pain in arm and activities of daily living impaired were unknown. It was unknown if the reporter considered the pain in arm and activities of daily living impaired to be related to SHINGRIX. Additional details reported as follows: The patient was approximately 55 years at the time of reporting. The age at vaccination was not reported. However, it could be 54 or 55 years. The patient received SHINGRIX in mid of May 2018. The patient experienced very sore arm that impeded daily activities. The reporter did not agree to be followed up.
Sex: U
Vaccine: MENB, MNQ
Symptoms: Meningitis, Pain, Product quality issue, Pyrexia
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of meningitis in an unspecified number of patients who received BEXSERO (batch number 16G201, expiry date unknown) for prophylaxis. This case was associated with a product complaint. Co-suspect products included MENACTRA for prophylaxis. On an unknown date, the patient received BEXSERO and MENACTRA at an unknown dose. On an unknown date, less than a day after receiving BEXSERO and unknown after receiving MENACTRA, the patient experienced meningitis (serious criteria GSK medically significant), general body pain, fever and pharmaceutical product complaint. On an unknown date, the outcome of the meningitis, general body pain, fever and pharmaceutical product complaint were unknown. It was unknown if the reporter considered the meningitis, general body pain and fever to be related to BEXSERO. Additional details were provided as follows: The licensed practical nurse (LPN) reported this case. The age at vaccination was not applicable for this report. The reporter stated that they noticed a trend of administering BEXSERO and patients returning within the same day complaining of adverse events (3 adverse events in 1 week). The patients experienced symptoms of meningitis, body ache and fever. The reporter believed the co-administration issue with MENACTRA and BEXSERO. The reporter stated that since administering BEXSERO only and no other vaccines at the visit; they had not seen any other additional incidents. Once they stopped co-administering BEXSERO with MCV4, the adverse event trend stopped. QA department reported lot number was valid and the product was not returned. This case has been linked to US2018GSK133021, reported by the same reporter.
Sex: U
Vaccine: MENB, MNQ
Symptoms: Headache
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of headache in a patient who received BEXSERO for prophylaxis. Co-suspect products included MENACTRA for prophylaxis. On an unknown date, the patient received BEXSERO at an unknown dose and MENACTRA at an unknown dose. On an unknown date, unknown after receiving BEXSERO, the patient experienced headache. On an unknown date, the outcome of the headache was recovered/resolved. It was unknown if the reporter considered the headache to be related to BEXSERO. Additional details were provided as follows: The age at vaccination was not reported. The physician stated that she administered a dose of BEXSERO, at the same visit as MENACTRA and the patient experienced headache for a week.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Syncope
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of fainting in a 18-year-old female patient who received BEXSERO (batch number 16G201, expiry date May 2019) for prophylaxis. On 26th July 2018, the patient received BEXSERO. On 26th July 2018, less than a day after receiving BEXSERO, the patient experienced fainting. On an unknown date, the outcome of the fainting was unknown. It was unknown if the reporter considered the fainting to be related to BEXSERO. Additional details were reported as follows: The patient received BEXSERO in left deltoid. After receiving BEXSERO the patient felt ok. At the checkout desk the patient fainted. The patient did not have anything to eat yet. This was at 10 AM. The patient was basically rolled out of bed and came to office for the vaccine.
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Chromaturia, Injection site rash, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site rash in a male patient who received SHINGRIX for prophylaxis. On 18th July 2018, the patient received the 1st dose of SHINGRIX. In July 2018, less than a week after receiving SHINGRIX, the patient experienced injection site rash, general body pain, joint pain, fever, chills and urine coloring orange. In July 2018, the outcome of the injection site rash, general body pain, joint pain, fever and chills were recovered/resolved. On an unknown date, the outcome of the urine coloring orange was unknown. It was unknown if the reporter considered the injection site rash, general body pain, joint pain, fever, chills and urine coloring orange to be related to SHINGRIX. Additional information was received as follows: The reporter was the patient's friend. The age at vaccination was not reported. The reporter was scheduled for 1st SHINGRIX vaccine but then asked a question for a friend (patient). The patient experienced rash at site, body or joint aches, fever, chills for 4 days. The patient's urine was sometimes a bright yellow and orange. The reporter asked, whether that was a side effect of SHINGRIX.
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site rash in a male patient who received SHINGRIX for prophylaxis. On 18th July 2018, the patient received the 1st dose of SHINGRIX. In July 2018, less than a week after receiving SHINGRIX, the patient experienced injection site rash, general body pain, joint pain, fever, chills and urine coloring orange. In July 2018, the outcome of the injection site rash, general body pain, joint pain, fever and chills were recovered/resolved. On an unknown date, the outcome of the urine coloring orange was unknown. It was unknown if the reporter considered the injection site rash, general body pain, joint pain, fever, chills and urine coloring orange to be related to SHINGRIX. Additional information was received as follows: The reporter was the patient's friend. The age at vaccination was not reported. The reporter was scheduled for 1st SHINGRIX vaccine but then asked a question for a friend (patient). The patient experienced rash at site, body or joint aches, fever, chills for 4 days. The patient's urine was sometimes a bright yellow and orange. The reporter asked, whether that was a side effect of SHINGRIX.
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of dizziness in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced dizziness. On an unknown date, the outcome of the dizziness was unknown. It was unknown if the reporter considered the dizziness to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced dizziness about a month ago from the time of reporting. The dizziness resolved after a day. The healthcare professional did not have any other information and didn't have additional time to talk. The healthcare professional was opened to follow up on this adverse event. The patient complained of unusual dizziness next morning.
Sex: M
Vaccine: FLU4
Symptoms: Influenza like illness
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a male patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis. On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved. It was unknown if the reporter considered the influenza-like symptoms to be related to Influenza vaccine Quadrivalent unspecified season. Additional details were provided as follows: The age at vaccination was not reported. The patient stated that over the past 2 decades he had experienced flu-like symptoms after receiving the flu vaccine (unknown manufacturer). The patient did not provide any additional details. The patient did not wish to provide any contact information and ended the call before any additional details could be obtained. For tolerability after receiving SHINGRIX vaccine, refer case US2018133471.
Age: 73.0
Sex: M
Vaccine: HEP
Symptoms: Asthenia, Chromaturia, Dizziness, Fatigue, Feeling abnormal
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of weakness in a 73-year-old male patient who received Engerix B adult for prophylaxis. The patient's past medical history included non-Hodgkin's lymphoma (in chest, and he had chemo and radiation that). The patient had a Family History of drug hypersensitivity (patient's mother and sister very sensitive to medications). Previously administered products included Engerix B adult with an associated reaction of asthenia (1st dose received on 26th June 2018, refer case US2018133497), Diovan with an associated reaction of rhabdomyolysis (rhabdomyolysis also caused by statins) and Hepatitis B vaccine with an associated reaction of therapeutic response decreased (received in 2008, antibody titers were low, refer case US2018GSK135695). Concurrent medical conditions included heart disease, unspecified (from radiation treatment), cardiac pacemaker insertion, tachycardia and drug hypersensitivity (very sensitive to medications). On 24th July 2018, the patient received the 2nd dose of Engerix B adult. On 24th July 2018, less than a day after receiving Engerix B adult, the patient experienced weakness, urine discoloration, dizziness, fatigue and feeling abnormal. Rechallenge with Engerix B adult was positive. On an unknown date, the outcome of the weakness, dizziness, fatigue and feeling abnormal were not recovered/not resolved and the outcome of the urine discoloration was recovered/resolved. It was unknown if the reporter considered the weakness, urine discoloration, dizziness, fatigue and feeling abnormal to be related to Engerix B adult. Additional details were provided as follows: Within 3 hours after vaccination, the patient experienced weakness, fatigue, dizziness, and lightheadedness. The patient did not drink much water and had very dark urine. The patient said he was trying to work on his boat and had been drinking a lot of water. When the patient went to the restroom, he noticed that his urine was very dark. The patient was not sure where that came from. As he drank two and a half bottles of water during the day, the urine got lighter and lighter when going to the restroom. On the day of reporting, the patient said he still felt as on the day of vaccination. Other than the discolored urine, the other effects had not resolved for him. The patient said that he felt like someone who had been beaten, no energy to do anything. The patient stated that he had heart problems, which could have some of the same symptoms. The patient did not think the vaccine might have been the cause of the issues.
Age: 73.0
Sex: M
Vaccine: HEP
Symptoms: Vaccine positive rechallenge
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of weakness in a 73-year-old male patient who received Engerix B adult for prophylaxis. The patient's past medical history included non-Hodgkin's lymphoma (in chest, and he had chemo and radiation that). The patient had a Family History of drug hypersensitivity (patient's mother and sister very sensitive to medications). Previously administered products included Engerix B adult with an associated reaction of asthenia (1st dose received on 26th June 2018, refer case US2018133497), Diovan with an associated reaction of rhabdomyolysis (rhabdomyolysis also caused by statins) and Hepatitis B vaccine with an associated reaction of therapeutic response decreased (received in 2008, antibody titers were low, refer case US2018GSK135695). Concurrent medical conditions included heart disease, unspecified (from radiation treatment), cardiac pacemaker insertion, tachycardia and drug hypersensitivity (very sensitive to medications). On 24th July 2018, the patient received the 2nd dose of Engerix B adult. On 24th July 2018, less than a day after receiving Engerix B adult, the patient experienced weakness, urine discoloration, dizziness, fatigue and feeling abnormal. Rechallenge with Engerix B adult was positive. On an unknown date, the outcome of the weakness, dizziness, fatigue and feeling abnormal were not recovered/not resolved and the outcome of the urine discoloration was recovered/resolved. It was unknown if the reporter considered the weakness, urine discoloration, dizziness, fatigue and feeling abnormal to be related to Engerix B adult. Additional details were provided as follows: Within 3 hours after vaccination, the patient experienced weakness, fatigue, dizziness, and lightheadedness. The patient did not drink much water and had very dark urine. The patient said he was trying to work on his boat and had been drinking a lot of water. When the patient went to the restroom, he noticed that his urine was very dark. The patient was not sure where that came from. As he drank two and a half bottles of water during the day, the urine got lighter and lighter when going to the restroom. On the day of reporting, the patient said he still felt as on the day of vaccination. Other than the discolored urine, the other effects had not resolved for him. The patient said that he felt like someone who had been beaten, no energy to do anything. The patient stated that he had heart problems, which could have some of the same symptoms. The patient did not think the vaccine might have been the cause of the issues.
Sex: F
Vaccine: VARZOS
Symptoms: Headache
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of headache in a female patient who received SHINGRIX for prophylaxis. On 23rd July 2018, the patient received the 1st dose of SHINGRIX. On 23rd July 2018, less than a day after receiving SHINGRIX, the patient experienced headache. The patient was treated with ADVIL and tramadol. On 24th July 2018, the outcome of the headache was recovered/resolved. It was unknown if the reporter considered the headache to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the office manager. In evening, the patient woke up with painful headache unlike anything she has had before. The healthcare professional (HCP) told her to take ADVIL and Tramadol. It lasted one day. The patient had not contacted HCP office for anything further that office manager knew about. The reporter agreed to be followed up.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of pain in arm in a female patient who received SHINGRIX for prophylaxis. In November 2017, the patient received SHINGRIX. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: The caller reported that she received the vaccine and the first week was sore and achy pain in her arm where she received the shot. Then the pain was getting worse and could not even put her clothes on. The caller stated that, she went to the physician in January and May but at the reporting time, she was still in pain. The caller had already reported the adverse events (AE), but the safety department was unable to locate the AE on their end. This call had been transferred to Medical information for further assistance.
Sex: M
Vaccine: TDAP
Symptoms: Hypersensitivity, Laboratory test, Muscle rigidity, Pyrexia, Serology test
Clinical narrative: This case was reported by a consumer and described the occurrence of rigidity in a male patient who received BOOSTRIX for prophylaxis. On an unknown date, the patient received BOOSTRIX at an unknown dose. On an unknown date, unknown after receiving BOOSTRIX, the patient experienced rigidity (serious criteria hospitalization), high temperature and allergy. BOOSTRIX was discontinued. On an unknown date, the outcome of the rigidity, high temperature and allergy were unknown. It was unknown if the reporter considered the rigidity, high temperature and allergy to be related to BOOSTRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient's mother reported that the patient was deathly allergic to the pertussis vaccine. She was asking did this was taken into account for people like patient. The patient wound up in the hospital with an extremely high temperature and rigidity. The patient tested for meningitis but the test results was showed to be negative. The reporter said, the patient would never have the shot for pertussis ever again, not even the booster shot. Lab Comments: On a unknown date, the patient did laboratory test.
Sex: U
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site erythema, injection site pain and injected limb mobility decreased. On an unknown date, the outcome of the injection site erythema, injection site pain and injected limb mobility decreased were unknown. It was unknown if the reporter considered the injection site erythema, injection site pain and injected limb mobility decreased to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. This was an unsolicited report of injection site reaction received via GSK employee. The reporter noted a 10 centimeter erythema at the injection site along with pain and difficulty raising the arm above the shoulder. The reporter was unsure of how long the symptoms lasted. This was the only information provided and the reporter did not wish to be contacted again about this event. The reporter wished to remain anonymous and would not provide any initials, date of birth, age or contact information.
Sex: F
Vaccine: FLU4
Symptoms: 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 adult female patient who received Influenza vaccine Quadrivalent. Previously administered products included Flu vaccine with an associated reaction of injection site pain (patient had gotten the flu vaccine every year for the past nine years). On an unknown date, the patient received Influenza vaccine Quadrivalent 2015-2016 season. On an unknown date, less than a year after receiving Influenza vaccine Quadrivalent 2015-2016 season, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved. It was unknown if the reporter considered the injection site pain to be related to Influenza vaccine Quadrivalent 2015-2016 season. Additional details were provided as follows: The age at the vaccination was not reported. The patient reported that she has gotten the flu vaccine every year for the past nine years and it usually hurts a little at the injection site, but resolved after a couple days. This was fourth of the 9 cases reported by the same reporter for the same patient.
Sex: F
Vaccine: FLU3
Symptoms: 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 adult female patient who received Flu Seasonal TIV Dresden (Influenza vaccine unspecified 2009-10 season) for prophylaxis. On an unknown date, the patient received Influenza vaccine unspecified 2009-10 season. On an unknown date, less than a year after receiving Influenza vaccine unspecified 2009-10 season, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved. It was unknown if the reporter considered the injection site pain to be related to Influenza vaccine unspecified 2009-10 season. Additional details were provided as follows: The age at the vaccination was not reported. The patient reported that she has gotten the flu vaccine every year for the past nine years and it usually hurts a little at the injection site, but resolved after a couple days. This was 9 of the 9 cases reported by the same reporter for the same patient.
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Injection site pain, Vaccine positive rechallenge
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a adult female patient who received Influenza vaccine for prophylaxis. Previously administered products included Influenza vaccine with an associated reaction of injection site pain (patient had gotten the flu vaccine for the past nine year). On an unknown date, the patient received Influenza vaccine. On an unknown date, less than a year after receiving Influenza vaccine, the patient experienced injection site pain. Rechallenge with Influenza vaccine was positive. On an unknown date, the outcome of the injection site pain was recovered/resolved. It was unknown if the reporter considered the injection site pain to be related to Influenza vaccine. Additional details were provided as follows: The age at the vaccination was not reported. The patient reported that she has gotten the flu vaccine every year for the past nine years and it usually hurts a little at the injection site, but resolved after a couple days. This was 8 of the 9 cases reported by the same reporter for the same patient.
Sex: F
Vaccine: FLU4
Symptoms: 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 adult female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2014-2015 season) for prophylaxis. Previously administered products included Flu vaccine with an associated reaction of injection site pain (patient had gotten the flu vaccine every year for the past nine years). On an unknown date, the patient received Influenza vaccine Quadrivalent 2014-2015 season. On an unknown date, less than a year after receiving Influenza vaccine Quadrivalent 2014-2015 season, the patient experienced injection site pain. Rechallenge with Influenza vaccine Quadrivalent 2014-2015 season was positive. On an unknown date, the outcome of the injection site pain was recovered/resolved. It was unknown if the reporter considered the injection site pain to be related to Influenza vaccine Quadrivalent 2014-2015 season. Additional details were provided as follows: The age at the vaccination was not reported. The patient reported that she has gotten the flu vaccine every year for the past nine years and it usually hurts a little at the injection site, but resolved after a couple days. This was third of the 9 cases reported by the same reporter for the same patient.
Sex: F
Vaccine: FLU4
Symptoms: 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 adult female patient who received Flu Seasonal QIV Dresden. Previously administered products included Flu vaccine with an associated reaction of injection site pain (patient had gotten the flu vaccine every year for the past nine years). On an unknown date, the patient received Influenza quadrivalent vaccine unspecified 2013-2014 season. On an unknown date, less than a year after receiving Influenza quadrivalent vaccine unspecified 2013-2014 season, the patient experienced injection site pain. Rechallenge with Influenza quadrivalent vaccine unspecified 2013-2014 season was positive. On an unknown date, the outcome of the injection site pain was recovered/resolved. It was unknown if the reporter considered the injection site pain to be related to Influenza quadrivalent vaccine unspecified 2013-2014 season. Additional details were provided as follows: The age at the vaccination was not reported. The patient reported that she has gotten the flu vaccine every year for the past nine years and it usually hurts a little at the injection site, but resolved after a couple days. This was 5 of the 9 cases reported by the same reporter for the same patient.
Sex: F
Vaccine: FLU3
Symptoms: 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 adult female patient who received Flu Seasonal TIV Dresden (Influenza vaccine unspecified 2012-13 season) for prophylaxis. Previously administered products included Flu vaccine with an associated reaction of injection site pain (patient had gotten the flu vaccine every year for the past nine years). On an unknown date, the patient received Influenza vaccine unspecified 2012-13 season. On an unknown date, less than a year after receiving Influenza vaccine unspecified 2012-13 season, the patient experienced injection site pain. Rechallenge with Influenza vaccine unspecified 2012-13 season was positive. On an unknown date, the outcome of the injection site pain was recovered/resolved. It was unknown if the reporter considered the injection site pain to be related to Influenza vaccine unspecified 2012-13 season. Additional details were provided as follows: The age at the vaccination was not reported. The patient reported that she has gotten the flu vaccine every year for the past nine years and it usually hurts a little at the injection site, but resolved after a couple days. This was 6 of the 9 cases reported by the same reporter for the same patient.
Sex: F
Vaccine: FLU3
Symptoms: 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 adult female patient who received Flu Seasonal TIV Dresden (Influenza vaccine unspecified 2011-12 season) for prophylaxis. Previously administered products included Flu vaccine with an associated reaction of injection site pain (patient had gotten the flu vaccine every year for the past nine years). On an unknown date, the patient received Influenza vaccine unspecified 2011-12 season. On an unknown date, less than a year after receiving Influenza vaccine unspecified 2011-12 season, the patient experienced injection site pain. Rechallenge with Influenza vaccine unspecified 2011-12 season was positive. On an unknown date, the outcome of the injection site pain was recovered/resolved. It was unknown if the reporter considered the injection site pain to be related to Influenza vaccine unspecified 2011-12 season. Additional details were provided as follows: The age at the vaccination was not reported. The patient reported that she has gotten the flu vaccine every year for the past nine years and it usually hurts a little at the injection site, but resolved after a couple days. This was 7 of the 9 cases reported by the same reporter for the same patient.
Sex: F
Vaccine: FLU4
Symptoms: 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 adult female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2016-2017 season) for prophylaxis. Previously administered products included Flu vaccine with an associated reaction of injection site pain (patient had gotten the flu vaccine every year for the past nine years). On an unknown date, the patient received Influenza vaccine Quadrivalent 2016-2017 season (intramuscular). On an unknown date, less than a year after receiving Influenza vaccine Quadrivalent 2016-2017 season, the patient experienced injection site pain. Rechallenge with Influenza vaccine Quadrivalent 2016-2017 season was positive. On an unknown date, the outcome of the injection site pain was recovered/resolved. It was unknown if the reporter considered the injection site pain to be related to Influenza vaccine Quadrivalent 2016-2017 season. Additional details were provided as follows: The age at the vaccination was not reported. The patient reported that she has gotten the flu vaccine every year for the past nine years and it usually hurts a little at the injection site, but resolved after a couple days. This was second of the 9 cases reported by the same reporter for the same patient.
Sex: M
Vaccine: VARZOS
Symptoms: Blood creatine phosphokinase increased, Fatigue, Full blood count abnormal, Hypochloraemia, Hyponatraemia
Clinical narrative: This case was reported by a other health professional and described the occurrence of lymphopenia in a male patient who received SHINGRIX for prophylaxis. On 19th July 2018, the patient received the 1st dose of SHINGRIX. In July 2018, less than a week after receiving SHINGRIX, the patient experienced lymphopenia, fever, general body pain, general malaise, fatigue, leukocytosis, erythrocyte sedimentation rate increased, creatine kinase increased, hyponatremia and hypochloremia. On an unknown date, the outcome of the lymphopenia, fever, general body pain, general malaise, fatigue, leukocytosis, erythrocyte sedimentation rate increased, creatine kinase increased, hyponatremia and hypochloremia were unknown. It was unknown if the reporter considered the lymphopenia, fever, general body pain, general malaise, fatigue, leukocytosis, erythrocyte sedimentation rate increased, creatine kinase increased, hyponatremia and hypochloremia to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX in reporter's office. Few hours after receiving SHINGRIX, the patient experienced fever, though unmeasured, with body aches, general malaise and fatigue. On 24th July 2018, the patient was seen by doctor in his office with the above stated chief complaints. Subsequently, CBC (Complete blood count), BMP (Basic metabolic panel), CK (Creatine kinase) and ESR (Erythrocyte sedimentation rate) laboratory tests were ordered. The patient's laboratory tests showed leukocytosis and lymphocytopenia with elevated ESR (66) and CK (1153) and hyponatremia and hypochloremia. Lab Comments: On an unknown date the CBC, BMP, CK and ESR laboratory tests were performed which showed leukocytosis and lymphocytopenia with elevated ESR (66) and CK (1153) and hyponatremia and hypochloremia.
Sex: M
Vaccine: VARZOS
Symptoms: Leukocytosis, Lymphopenia, Malaise, Metabolic function test abnormal, Pain
Clinical narrative: This case was reported by a other health professional and described the occurrence of lymphopenia in a male patient who received SHINGRIX for prophylaxis. On 19th July 2018, the patient received the 1st dose of SHINGRIX. In July 2018, less than a week after receiving SHINGRIX, the patient experienced lymphopenia, fever, general body pain, general malaise, fatigue, leukocytosis, erythrocyte sedimentation rate increased, creatine kinase increased, hyponatremia and hypochloremia. On an unknown date, the outcome of the lymphopenia, fever, general body pain, general malaise, fatigue, leukocytosis, erythrocyte sedimentation rate increased, creatine kinase increased, hyponatremia and hypochloremia were unknown. It was unknown if the reporter considered the lymphopenia, fever, general body pain, general malaise, fatigue, leukocytosis, erythrocyte sedimentation rate increased, creatine kinase increased, hyponatremia and hypochloremia to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX in reporter's office. Few hours after receiving SHINGRIX, the patient experienced fever, though unmeasured, with body aches, general malaise and fatigue. On 24th July 2018, the patient was seen by doctor in his office with the above stated chief complaints. Subsequently, CBC (Complete blood count), BMP (Basic metabolic panel), CK (Creatine kinase) and ESR (Erythrocyte sedimentation rate) laboratory tests were ordered. The patient's laboratory tests showed leukocytosis and lymphocytopenia with elevated ESR (66) and CK (1153) and hyponatremia and hypochloremia. Lab Comments: On an unknown date the CBC, BMP, CK and ESR laboratory tests were performed which showed leukocytosis and lymphocytopenia with elevated ESR (66) and CK (1153) and hyponatremia and hypochloremia.