chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HEP, RV5, HEP, RV5
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 03-JUL-2018, the patient was vaccinated with doses of improperly stored ROTATEQ taken orally, lot # reported as R003149 with expiration date 19-FEB-2019 (dose, strength, frequency and anatomical location were not reported). Other suspect therapy included RECOMBIVAX HB lot #N011851 with expiration date 19-DEC-2019 (dose, strength, frequency, route, and anatomical location were not reported) both for prophylaxis. The doses of the vaccines were exposed to a temperature below 9.3 Celsius degrees (°C) with a time frame of 8 hours and 46 minutes. There was no previous temperature excursion. A digital data logger was involved. Furthermore, no product quality complaint (PQC) was involved.
Sex: U
Vaccine: HEP, RV5, HEP, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 03-JUL-2018, the patient was vaccinated with doses of improperly stored ROTATEQ taken orally, lot # reported as R003149 with expiration date 19-FEB-2019 (dose, strength, frequency and anatomical location were not reported). Other suspect therapy included RECOMBIVAX HB lot #N011851 with expiration date 19-DEC-2019 (dose, strength, frequency, route, and anatomical location were not reported) both for prophylaxis. The doses of the vaccines were exposed to a temperature below 9.3 Celsius degrees (°C) with a time frame of 8 hours and 46 minutes. There was no previous temperature excursion. A digital data logger was involved. Furthermore, no product quality complaint (PQC) was involved.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pruritus, Rash, Rash erythematous, Trigeminal neuralgia
Clinical narrative: This spontaneous report was received from an approximately 73 year old female patient, reporting on herself. The patient's concurrent conditions included polymyalgia rheumatica diagnosed in 2015, and allergy to REGLAN and sulfa. The patient's concomitant medications included prednisone (manufacturer unknown). On an unknown date in June 2008, the patient received an unspecified dose of ZOSTAVAX for prevention of shingles (dose, route of administration, anatomical location, lot number and expiration date were not reported). On an unspecified date in 2011, the patient was diagnosed with shingles by a dermatologist and was treated with an unspecified dose of valganciclovir. On an unspecified date in January 2015, the patient was again diagnosed with shingles at an Urgent Clinic and treated with an unspecified dose of valganciclovir. On 22-JUN-2018 (reported as "2 weeks ago"), the patient was diagnosed with shingles for the third time at an Urgent Clinic, with symptoms that included severe itching, trigeminal nerve pain and red rash on left side of neck. The patient was treated with valganciclovir, gabapentin, and carbamazepine. No lab diagnostics or studies were performed. By the time of the reporting, the patient was not recovered from shingles. The reporter did not assess the causal relationship between ZOSTAVAX and the event.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Information has been received on 09-JUL-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. The patient brings this action for personal injuries and damages suffered as a result of being inoculated with the ZOSTAVAX. The patient was inoculated with the ZOSTAVAX for the long-term prevention of shingles. The patient was diagnosed with shingles after being inoculated with the ZOSTAVAX and suffered serious physical, emotional, and economic damages as a result of his shingles and associated injuries. In 2015, the patient was inoculated with the ZOSTAVAX at a pharmacy, for routine adult health maintenance and the intended purpose for the prevention of shingles. The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster, the very virus the ZOSTAVAX is intended to prevent. Later in 2015, the patient was treated by a physician, for a vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date in 2013, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, for routine adult health maintenance and the intended purpose for the long-term prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster and severe complications. The patient was diagnosed with shingles after being inoculated with the ZOSTAVAX and suffered serious physical, emotional, and economic damages as a result of her shingles and associated injuries. On or about 23-DEC-2013, the patient was treated for a vesicular outbreak, which was diagnosed as shingles. The patient was prescribed FAMVIR and prednisone for management of her painful symptoms and chronic pain. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date in 2015, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) by a physician, for routine adult health maintenance and the intended purpose for the long-term prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. The patient was diagnosed with shingles after being inoculated with the ZOSTAVAX and suffered serious physical, emotional, and economic damages as a result of his shingles and associated injuries. On an unknown date in 2015, the patient was treated by the physician for a vesicular outbreak, which was diagnosed as herpes zoster or shingles. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date in 2012, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, for routine adult health maintenance and the intended purpose for the long-term prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. The patient was diagnosed with shingles after being inoculated with the ZOSTAVAX and suffered serious physical, emotional, and economic damages as a result of her shingles and associated injuries. On an unknown date in 2016, the patient was treated by the physician for a vesicular outbreak, which was diagnosed as herpes zoster or shingles. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: M
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant referring to an unspecified number of male patients of unknown age. The patients' pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were inadvertently vaccinated with improperly stored doses of PEDVAXHIB lot # N034410 with expiration date 01-FEB-2020, and lot # N007749 with expiration date 29-NOV-2019 (also reported as "29-NOV-2018"), for prophylaxis (route of administration was not reported). No adverse effect was reported. It was stated that the vaccine was exposed to a temperature between 47 to 77 Fahrenheit degrees for 2 hours and 30 minutes. No previous temperature excursion was reported. A digital data logger was involved.
Sex: U
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: This spontaneous report has been received from a other health professional refers to a patient of unknown age and gender. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of VAQTA lot # N023953 with expiration date of 05-NOV-2018, (strength, dose, frequency, route, and anatomical location were not provided) intramuscular for prophylaxis. The vaccine was exposed to a temperature range of 9°C to 25°C (14.8 C), during a time frame of 2 hours and 47 minutes which was called by a data logger. No previous temperature excursions were reported.
Age: 87.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site haemorrhage, Injection site swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site swelling in a 87-year-old female patient who received SHINGRIX (batch number 32GR4, expiry date 4th July 2020) for prophylaxis. Concurrent medical conditions included hemorrhagic disorder (patient bleeds easily). On 2nd July 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 2nd July 2018, immediately after receiving SHINGRIX, the patient experienced injection site swelling and injection site hemorrhage. On an unknown date, the outcome of the injection site swelling was not recovered/not resolved and the outcome of the injection site hemorrhage was recovered/resolved. It was unknown if the reporter considered the injection site swelling and injection site hemorrhage to be related to SHINGRIX. Additional details were provided as follows: The caller was the pharmacist calling on behalf of the patient. The caller stated that immediately after she administered the SHINGRIX vaccine to the patient, there was bleeding and swelling at the injection site. The caller described the swelling was about 2 cm with raised circle.
Age: 87.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Immediate post-injection reaction, Injection site haemorrhage, Injection site swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site swelling in a 87-year-old female patient who received SHINGRIX (batch number 32GR4, expiry date 4th July 2020) for prophylaxis. Concurrent medical conditions included hemorrhagic disorder (patient bleeds easily). On 2nd July 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 2nd July 2018, immediately after receiving SHINGRIX, the patient experienced injection site swelling and injection site hemorrhage. On an unknown date, the outcome of the injection site swelling was not recovered/not resolved and the outcome of the injection site hemorrhage was recovered/resolved. It was unknown if the reporter considered the injection site swelling and injection site hemorrhage to be related to SHINGRIX. Additional details were provided as follows: The caller was the pharmacist calling on behalf of the patient. The caller stated that immediately after she administered the SHINGRIX vaccine to the patient, there was bleeding and swelling at the injection site. The caller described the swelling was about 2 cm with raised circle.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Headache, Myalgia, Nausea, Pyrexia
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of headache in a 17-year-old female patient who received BEXSERO (batch number 166901A, expiry date 30th November 2018) for prophylaxis. On 18th June 2018, the patient received the 1st dose of BEXSERO. On 18th June 2018, several hours after receiving BEXSERO, the patient experienced headache, nausea, fever and myalgia. The patient was treated with ibuprofen. On 19th June 2018, the outcome of the headache, nausea, fever and myalgia were recovered/resolved. The reporter considered the headache, nausea, fever and myalgia to be almost certainly related to BEXSERO. Additional details were provided as follows: The age at vaccination was not reported. The patient was seen in the healthcare professional's office and advised to take ibuprofen and go to bed. When the patient woke up the following morning, her symptoms had resolved. The reporter stated that a report had been filed by healthcare professional with VAERS.
Sex: M
Vaccine: VARZOS
Symptoms: Adverse event
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of adverse event in a male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced adverse event. On an unknown date, the outcome of the adverse event was unknown. It was unknown if the reporter considered the adverse event to be related to SHINGRIX. Additional details were provided as follow: The age at vaccination was not reported. The patient indicated that he was having an adverse event (not further specified) to SHINGRIX. No other information was provided.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site swelling
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of injection site swelling in a 75-year-old female patient who received SHINGRIX (batch number 3AF9E, expiry date 2nd February 2021) for prophylaxis. On 25th June 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, 1 day after receiving SHINGRIX, the patient experienced injection site swelling and injection site itching. On an unknown date, the outcome of the injection site swelling and injection site itching were recovering/resolving. The reporter considered the injection site swelling and injection site itching to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on left deltoid. The patient experienced swelling and itching at the injection site the next day after receiving the SHINGRIX vaccination.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Feeling cold, Irritability, Laboratory test normal
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of chills in a 65-year-old male patient who received SHINGRIX (batch number HG4P3, expiry date 30th April 2019) for prophylaxis. On 18th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In June 2018, 3 days after receiving SHINGRIX, the patient experienced chills. On an unknown date, the patient experienced cold and feeling irritated. On an unknown date, the outcome of the chills and cold were unchanged and the outcome of the feeling irritated was unknown. The reporter considered the chills and cold to be related to SHINGRIX. It was unknown if the reporter considered the feeling irritated to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX on left deltoid. The patient experienced chills and shivering approximately three days after receiving the vaccine. On 6th June 2018, the physician conducted lab work to determine the cause of these symptoms and the results were all negative. The patient was still experiencing these symptoms and had started recently to feel cold (latency was less than a year) even though it was hot outside. The consumer was annoyed and irritated (latency was less than a year) that he was still having these symptoms. The information was transferred to MI.
Age: 77.0
Sex: F
Vaccine: TDAP
Symptoms: Injected limb mobility decreased
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injected limb mobility decreased in a 77-year-old female patient who received BOOSTRIX (batch number 54B74, expiry date 14th September 2020) for prophylaxis. On 26th June 2018, the patient received BOOSTRIX (intramuscular) .5 ml. On an unknown date, less than a week after receiving BOOSTRIX, the patient experienced injected limb mobility decreased. On an unknown date, the outcome of the injected limb mobility decreased was not recovered/not resolved. It was unknown if the reporter considered the injected limb mobility decreased to be related to BOOSTRIX. Additional details were provided as follows: The patient received the vaccine in the left deltoid. The patient called the pharmacist on the day of reporting and said she could not raise the arm in which she received the vaccination. The reporter's call was transferred to Medical Information (MI) for additional assistance. The reported batch number 58B74 for BOOSTRIX did not exist and was updated to 54B74 as per the sales database.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site erythema and injection site warmth. On an unknown date, the outcome of the injection site erythema and injection site warmth were recovered/resolved. It was unknown if the reporter considered the injection site erythema and injection site warmth to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The healthcare professional (HCP) reported that the patient had redness and warmth at the injection site that last about 1 day and then resolved.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Feeling hot, Pain in extremity, Tenderness
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 63-year-old male patient who received SHINGRIX for prophylaxis. On 2nd July 2018 12:00, the patient received the 1st dose of SHINGRIX (intramuscular). On 2nd July 2018, less than a day after receiving SHINGRIX, the patient experienced pain in arm and extremities hot feeling of. On an unknown date, the outcome of the pain in arm and extremities hot feeling of were unchanged. It was unknown if the reporter considered the pain in arm and extremities hot feeling of to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient's girlfriend. The patient received SHINGRIX vaccine on the left arm. The patient experienced sore arm, pain and heat radiating down the arm. On the day of reporting, his arm was also tender. His symptoms had gotten worse from the vaccination day (a day before reporting). The patient was in the same room in the background while the reporter reported this event, and he had denied permission to contact their physician. No further details were provided.
Age: 20.0
Sex: F
Vaccine: HEPAB
Symptoms: Anal incontinence, Rash, Rash erythematous, Seizure
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of seizure in a 20-year-old female patient who received TWINRIX (batch number 3HG77, expiry date 3rd July 2020) for prophylaxis. On 29th June 2018, the patient received the 2nd dose of TWINRIX adult. On 29th June 2018, 45 sec after receiving TWINRIX adult, the patient experienced seizure (serious criteria GSK medically significant), fecal incontinence and erythematous rash. On an unknown date, the outcome of the seizure and fecal incontinence were recovered/resolved and the outcome of the erythematous rash was recovering/resolving. It was unknown if the reporter considered the seizure, fecal incontinence and erythematous rash to be related to TWINRIX adult. Additional details were provided as follows: The case was received from Office manager. The patient has no history of seizures. About 45 seconds after the TWINRIX vaccination was given, the patient went into a seizure. A bright red rash developed on bilateral, arms, face and chest. The rash dissipated as the patient came out of the seizure. When the ambulance arrived at 12:05pm to take her to the emergency room, her vitals were stable. The reporter read the notes to her but did not know what b by l stands for. She also did not know what time the vaccination was given.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of suspected vaccination failure in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The physician stated that she was recommending SHINGRIX to the patient, and that patient stated he knew someone who developed shingles after getting SHINGRIX. No other information was provided. This case was considered as suspected vaccination failure because the time to onset and schedule completion of SHINGRIX was unknown at the time of reporting.
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Pain, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of gastrointestinal upset in a male patient who received SHINGRIX for prophylaxis. 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 gastrointestinal upset, fever and general body pain. On an unknown date, the outcome of the gastrointestinal upset, fever and general body pain were unknown.  It was unknown if the reporter considered the gastrointestinal upset, fever and general body pain to be related to SHINGRIX. Additional details were received as follows: The patient experienced gastrointestinal (GI) upset, fever and aches all over. The patient asked would the 2nd dose of SHINGRIX knock him down like above mentioned events.
Sex: F
Vaccine: HEPAB
Symptoms: Asthenia, Tinnitus
Clinical narrative: This case was reported by a consumer via interactive digital media and described the occurrence of tinnitus in a female patient who received HAB TWINRIX for prophylaxis. On an unknown date, the patient received TWINRIX at an unknown dose. On an unknown date, unknown after receiving TWINRIX, the patient experienced tinnitus and debility. On an unknown date, the outcome of the tinnitus and debility were not reported. The reporter considered the tinnitus and debility to be possibly related to TWINRIX. Additional details were provided as follows: This case was reported via email was shared with GSK Corporate Media team via the Corporate Media Enquiries function on GSK.com. The age at vaccination was not reported. As the patient was traveling in August 2018, the patient was administered with a TWINRIX vaccine. Sadly the patient became a victim of strong tinnitus with all signs pointing to this vaccine as the culprit. This was debilitating for the patient and she needed a solution as this was not mentioned as side effect. The patient wanted to know if there was any way to do anything to reverse the effects of this vaccine. As the patient did not work in the medical field, she did not understand why she was advised to even asked to had a Hepatitis B vaccine in her system. The patient was praying this would not turning into nerve damage and she needed immediate support.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: This case was reported by a consumer via patient support programs and described the occurrence of chills in a 68-year-old female patient who received SHINGRIX (batch number ZN22Z, expiry date unknown) for prophylaxis. Previously administered products included SHINGRIX (For tolerance after 1st dose of SHINGRIX, refer case US2018GSK121493). On 25th June 2018, the patient received the 2nd dose of SHINGRIX 50 µg. On 25th June 2018, less than a day after receiving SHINGRIX, the patient experienced chills, fever and general body pain. On 25th June 2018, the outcome of the chills, fever and general body pain were recovered/resolved. The reporter considered the chills, fever and general body pain to be probably related to SHINGRIX. Additional details were reported as follows: The patient experienced body ache. The patient did not have any seriousness criteria (hospitalized, life threatening, disability, death, surgical or medical intervention or congenital anomaly). For tolerance after 1st dose of SHINGRIX, refer case US2018GSK12149.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Pain, Pyrexia
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of fever in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fever, chills, pain and fatigue. On an unknown date, the outcome of the fever, chills, pain and fatigue were recovered/resolved. It was unknown if the reporter considered the fever, chills, pain and fatigue to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient experienced fever, chills, soreness and fatigue which lasted for 24 hours. The reporter agreed to be followed up.
Sex: F
Vaccine: MEN
Symptoms: Anxiety, Headache, Malaise, Obsessive-compulsive disorder, Panic attack
Clinical narrative: This case was reported by a consumer via interactive digital media and described the occurrence of obsessive-compulsive disorder in a female patient who received Men B NVS (Meningococcal B vaccine) for prophylaxis. On an unknown date, the patient received Meningococcal B vaccine at an unknown dose. On an unknown date, unknown after receiving Meningococcal B vaccine, the patient experienced obsessive-compulsive disorder, fever, panic attack, anxiety, sickness and headache. On an unknown date, the outcome of the obsessive-compulsive disorder, fever, panic attack, anxiety, sickness and headache were unknown. It was unknown if the reporter considered the obsessive-compulsive disorder, fever, panic attack, anxiety, sickness and headache to be related to Meningococcal B vaccine. Additional details were reported as follows: The age at vaccination was not reported. The patient stated funny she was and she got really sick from the immunization including headaches, fever, severe anxiety, panic attacks and obsessive-compulsive disorder. The reporter said do not do it.
Sex: F
Vaccine: MEN
Symptoms: Pyrexia
Clinical narrative: This case was reported by a consumer via interactive digital media and described the occurrence of obsessive-compulsive disorder in a female patient who received Men B NVS (Meningococcal B vaccine) for prophylaxis. On an unknown date, the patient received Meningococcal B vaccine at an unknown dose. On an unknown date, unknown after receiving Meningococcal B vaccine, the patient experienced obsessive-compulsive disorder, fever, panic attack, anxiety, sickness and headache. On an unknown date, the outcome of the obsessive-compulsive disorder, fever, panic attack, anxiety, sickness and headache were unknown. It was unknown if the reporter considered the obsessive-compulsive disorder, fever, panic attack, anxiety, sickness and headache to be related to Meningococcal B vaccine. Additional details were reported as follows: The age at vaccination was not reported. The patient stated funny she was and she got really sick from the immunization including headaches, fever, severe anxiety, panic attacks and obsessive-compulsive disorder. The reporter said do not do it.
Sex: M
Vaccine: MEN
Symptoms: Abdominal pain upper, Cholecystectomy, Diarrhoea, Gastrointestinal disorder, Irritable bowel syndrome
Clinical narrative: This case was reported by a consumer via facebook interactive digital media and described the occurrence of irritable bowel syndrome in a 18-year-old male patient who received Men B NVS (Meningococcal B vaccine) for prophylaxis. Previously administered products included Meningococcal B vaccine with an associated reaction of general physical health deterioration (1st dose, refer case US2018GSK122233). On an unknown date, the patient received Meningococcal B vaccine at an unknown dose. On an unknown date, unknown after receiving Meningococcal B vaccine, the patient experienced irritable bowel syndrome, gastrointestinal disorder, chronic diarrhea, stomach pain and liver disorder. On an unknown date, the outcome of the irritable bowel syndrome, gastrointestinal disorder, chronic diarrhea, stomach pain and liver disorder were unknown. It was unknown if the reporter considered the irritable bowel syndrome, gastrointestinal disorder, chronic diarrhea, stomach pain and liver disorder to be related to Meningococcal B vaccine. Additional details were provided as follows: The age at vaccination was not reported. The patient had suffered many health problems since first dose. Then the booster dose just made it worse.  No one would give the reporter a straight answer if it was a possibility. The patient had gastrointestinal issues that came out of no where. The patient had his gallbladder out. The patient had chronic diarrhea and stomach pain, liver issues. The physician said it as irritable bowel syndrome. The case was linked with the case US2018GSK122233, reported by the same reporter for the same patient.
Sex: M
Vaccine: MEN
Symptoms: Liver disorder
Clinical narrative: This case was reported by a consumer via facebook interactive digital media and described the occurrence of irritable bowel syndrome in a 18-year-old male patient who received Men B NVS (Meningococcal B vaccine) for prophylaxis. Previously administered products included Meningococcal B vaccine with an associated reaction of general physical health deterioration (1st dose, refer case US2018GSK122233). On an unknown date, the patient received Meningococcal B vaccine at an unknown dose. On an unknown date, unknown after receiving Meningococcal B vaccine, the patient experienced irritable bowel syndrome, gastrointestinal disorder, chronic diarrhea, stomach pain and liver disorder. On an unknown date, the outcome of the irritable bowel syndrome, gastrointestinal disorder, chronic diarrhea, stomach pain and liver disorder were unknown. It was unknown if the reporter considered the irritable bowel syndrome, gastrointestinal disorder, chronic diarrhea, stomach pain and liver disorder to be related to Meningococcal B vaccine. Additional details were provided as follows: The age at vaccination was not reported. The patient had suffered many health problems since first dose. Then the booster dose just made it worse.  No one would give the reporter a straight answer if it was a possibility. The patient had gastrointestinal issues that came out of no where. The patient had his gallbladder out. The patient had chronic diarrhea and stomach pain, liver issues. The physician said it as irritable bowel syndrome. The case was linked with the case US2018GSK122233, reported by the same reporter for the same patient.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: This case was reported by a consumer via patient support programs and described the occurrence of chills in a 68-year-old female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced chills, fever and general body pain. On an unknown date, the outcome of the chills, fever and general body pain were recovered/resolved. It was unknown if the reporter considered the chills, fever and general body pain to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. But it could be 67 or 68 years old. The patient experienced body ache. The patient did not have any seriousness criteria (hospitalized, life threatening, disability, death, surgical or medical intervention or congenital anomaly). For tolerance after 2nd dose of SHINGRIX, refer case US2018GSK119861.
Sex: M
Vaccine: MEN
Symptoms: Adverse event
Clinical narrative: This case was reported by a consumer via interactive digital media and described the occurrence of adverse event in a male patient who received Men B NVS (Meningococcal B vaccine) for prophylaxis.  On an unknown date, the patient received the 1st dose of Meningococcal B vaccine. On an unknown date, unknown after receiving Meningococcal B vaccine, the patient experienced adverse event. On an unknown date, the outcome of the adverse event was unknown. It was unknown if the reporter considered the adverse event to be related to Meningococcal B vaccine. Additional details were provided as follows: The age at vaccination was not reported. The patient had suffered many health problems since first dose. The case was linked with the case US2018GSK120696, reported by the same reporter for the same patient.
Age: 28.0
Sex: M
Vaccine: PPV
Symptoms: Activated partial thromboplastin time normal, Blood creatinine increased, Blood culture, Blood lactic acid, Culture
Clinical narrative: Per telephone report from CNP of ER, pt presented to ER today with fever 104 degrees f. Patient was given 650mg Tylenol 7/11/18 at 8:37am. Out come unknown at this time.
Age: 28.0
Sex: M
Vaccine: PPV
Symptoms: Differential white blood cell count normal, Full blood count normal, International normalised ratio normal, Metabolic function test normal, Prothrombin time prolonged
Clinical narrative: Per telephone report from CNP of ER, pt presented to ER today with fever 104 degrees f. Patient was given 650mg Tylenol 7/11/18 at 8:37am. Out come unknown at this time.
Age: 28.0
Sex: M
Vaccine: PPV
Symptoms: Pyrexia, Streptococcus test negative, White blood cell count increased
Clinical narrative: Per telephone report from CNP of ER, pt presented to ER today with fever 104 degrees f. Patient was given 650mg Tylenol 7/11/18 at 8:37am. Out come unknown at this time.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Discomfort, Rash erythematous, Swelling
Clinical narrative: Extreme discomfort, swelling, raised red rash appeared the next evening(7/10/2018).
Sex: F
Vaccine: PPV
Symptoms: Antibody test negative, Immunoglobulin therapy, Infection
Clinical narrative: This literature marketed report has been received from the authors of the published article, and refers to a 15-year-old female patient with genetically diagnosed Pitt Hopkins syndrome. The patient's concurrent conditions included humoral immunodeficiency, persistent hypogammaglobulinemia (immunoglobulin G (IgG): 398 mg/dL, immunoglobulin A (IgA): 21 mg/dL, immunoglobulin M (IgM): 40 mg/dL), and recurrent sinopulmonary infections. The patient was placed on chronic antibiotics for approximately two years prior to presentation. On an unknown date, the patient was administered PNEUMOVAX 23 as a booster vaccination (dose, route of administration, lot # and expiration date were not reported). On an unknown date, the patient had non-protective titers to streptococcus IgG antibody (6/23 titers protective greater than 1.3 mcg/mL) despite vaccination with PNEUMOVAX 23. She also had borderline tetanus (0.18 IU/mL) and diphtheria titers (0.11 IU/mL). Given this laboratory evaluation and her recurrent illness, immunoglobulin replacement therapy (IGRT) was started. She continued to have infections despite therapeutic IGRT. Chronic antibiotic treatment was initially tapered, however needed to be reintroduced as intravenous immunoglobulin treatment alone was not stopping her infections, despite a IgG level over 1000 mg/dL. At the reporting time, the patient remained healthy with the combination of IGRT and prophylactic antibiotics. The outcome of the event "non-protective titers to streptococcus IgG antibody" was not reported. The reporter considered the event to be related to PNEUMOVAX 23.
Sex: F
Vaccine: MENB
Symptoms: Laceration, Syringe issue
Clinical narrative: This is a spontaneous report from a contactable consumer via a Pfizer sales representative. A female patient (nurse) of an unspecified age accidentally exposed to TRUMENBA (lot number and expiration date not reported), via an unspecified route of administration on 05Jul2018 at a single dose for immunization. The patient's medical history and concomitant medications were not reported. On 05Jul2018, it was reported that as a result of the tip of the syringe breaking off when the nurse (patient) attempted to screw the needle on, her hand was nicked with the glass. Outcome of the event was unknown. Information on lot number, batch number and expiration date has been requested.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Pallor
Clinical narrative: This is a spontaneous report from a contactable Nurse via Pfizer sales representative. A 16-year-old female patient received TRUMENBA, via an unspecified route of administration on an unspecified date for immunization. The patient medical history and concomitant medications were not reported. Patient was seated on exam room table after receiving a dose of TRUMENBA, her face turned white so they laid her down. She recovered in approximately 5 minutes and was able to leave office on her own accord. The outcome of the event was recovered.
Sex: U
Vaccine: DTAP, HIBV, IPV, PNC13, RVX
Symptoms: Rash generalised
Clinical narrative: Initial information received on 26-Jun-2018 regarding an unsolicited valid non-serious case received from an Office Manager of pediatric practice. This case was linked with case 2018SA177896 (same reporter). This case involves a four months old patient (gender not reported) who experienced generalized rash all over without other adverse effect, while he/she received vaccines ACT-HIB and IPOL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient's concomitant medications included DTAP (Manufacturer: GSK); PREVENAR and ROTAVIRUS VACCINE. On 12-Jun-2018, the patient received a dose of suspect IPV (VERO) (Lot number: N1G51, expiry date: 02-Aug-2019, dose in series was not known) via intramuscular route in the right thigh. On 12-Jun-2018, the patient received a dose of suspect HIB (PRP/T) VACCINE (Lot number: UI917A, expiry date: 09-Oct-2019, dose in series was not known) via intramuscular route in the right thigh. On an unknown date, the patient developed a non-serious generalized rash all over without other adverse effect (rash generalized following the administration of IPV (VERO) and HIB (PRP/T) VACCINE. (Other relevant tests included No lab test reported). Final diagnosis was generalized rash all over without other adverse effect. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for generalized rash all over without other adverse effect. List of documents held by sender: none.
Sex: M
Vaccine: RAB
Symptoms: Drug dose omission
Clinical narrative: Initial information received on 02-Jul-2018 regarding an unsolicited valid non-serious case received from Nurse. This case involves a male patient who received first dose of IMOVAX in the emergency room on the day of exposure on 26th or the 27th of June 2018 and scheduled for his second dose of IMOVAX on day 5. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was not reported. It was a case of actual medication error due to missed dose as patient arrived at the health department on the 30th of June for day 3 injection on the schedule but the health department was closed. It was unknown whether 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 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.
Sex: U
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: Initial information received on 03-Jul-2018 regarding an unsolicited valid non-serious case received from pharmacist professional. This case involves patient (age and gender not reported) who was vaccinated with an expired dose of ADACEL (batch number, route and site of administration were not reported, Expiry date: 27-May-2018) on 04-Jul-2018. The patient's medical history and concomitant medications were not reported. It was an actual medication error due to expired vaccine used. It was not known whether 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 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 sender: none.
Sex: F
Vaccine: RAB
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Initial information received on 29-Jun-2018 regarding an unsolicited valid non-serious case received from physician. This case involves a 27 years old female patient who received first vaccine IMOVAX on day 12 after the bite on 18 June 2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was not reported. On 18-Jun-2018, the patient received a 0.5 ml single dose of suspect RABIES (HDC) VACCINE lot 96650. It was case of actual medication error due to inappropriate schedule of vaccine administered as patient had received 1st vaccine on day 12 after the bite and it was 23 days after the bite and 11 days since she received injection. It was unknown whether patient had any adverse reaction. 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.
Sex: F
Vaccine: FLU4
Symptoms: Expired product administered, No adverse event
Clinical narrative: Initial information received on 03-Jul-2018 regarding an unsolicited valid non-serious case received from a non-other healthcare professional. This case involves 76-year-old female patient who was vaccinated with an expired dose of FLUZONE QUADRIVALENT expiry date: 30-Jun-2018 (batch number, route and site of administration were not reported) on an unspecified date. The patient's medical history and concomitant medications were not reported. It was an actual medication error due to expired vaccine used. No reportable side effects. 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 sender: none.