chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nipple disorder, Nipple pain, Pain, Peripheral swelling, Pyrexia
Clinical narrative: So tired; I had menstrual problems; depressed/my depression has plummeted since; Breast pain; I feel I have no voice to speak; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), in 2021 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "depression" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: BREAST PAIN (non-serious) with onset 2021, outcome "unknown"; MUTISM (non-serious) with onset 2021, outcome "unknown", described as "I feel I have no voice to speak"; MENSTRUAL DISORDER (medically significant) with onset 2021, outcome "unknown", described as "I had menstrual problems"; DEPRESSION (non-serious) with onset 2021, outcome "unknown", described as "depressed/my depression has plummeted since"; FATIGUE (non-serious), outcome "unknown", described as "So tired". Therapeutic measures were taken as a result of menstrual disorder.  Additional information: In 2021, the patient got Pfizer version of the COVID vaccine, and her depression had plummeted since. The patient had menstrual problems that led to a D and C and breast pain, and the patient felt the patient had no voice to speak. And no one acknowledged the pain or cared - if she had known what would result, she wouldn't have taken the vaccine - and she could only assume it was the cause because nothing was found wrong with her reproductive system, and she had no other recent medical changes. The patient was so tired and so depressed and so tired of being depressed.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Breast pain, Depression, Fatigue, Menstrual disorder, Mutism
Clinical narrative: So tired; I had menstrual problems; depressed/my depression has plummeted since; Breast pain; I feel I have no voice to speak; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), in 2021 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "depression" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: BREAST PAIN (non-serious) with onset 2021, outcome "unknown"; MUTISM (non-serious) with onset 2021, outcome "unknown", described as "I feel I have no voice to speak"; MENSTRUAL DISORDER (medically significant) with onset 2021, outcome "unknown", described as "I had menstrual problems"; DEPRESSION (non-serious) with onset 2021, outcome "unknown", described as "depressed/my depression has plummeted since"; FATIGUE (non-serious), outcome "unknown", described as "So tired". Therapeutic measures were taken as a result of menstrual disorder.  Additional information: In 2021, the patient got Pfizer version of the COVID vaccine, and her depression had plummeted since. The patient had menstrual problems that led to a D and C and breast pain, and the patient felt the patient had no voice to speak. And no one acknowledged the pain or cared - if she had known what would result, she wouldn't have taken the vaccine - and she could only assume it was the cause because nothing was found wrong with her reproductive system, and she had no other recent medical changes. The patient was so tired and so depressed and so tired of being depressed.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Blood glucose fluctuation, COVID-19, Nausea, SARS-CoV-2 test positive, Vomiting
Clinical narrative: 09/09/22 presents to EC ED with "altered mental status". PMHx of "HTN, DM, CAD and CHF"
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, Mental status changes, SARS-CoV-2 test positive
Clinical narrative: 09/09/22 presents to EC ED with "altered mental status". PMHx of "HTN, DM, CAD and CHF"
Sex: F
Vaccine: FLUX, UNK
Symptoms: Asthenia, Dizziness, Dyspnoea, Heart rate increased
Clinical narrative: Fast heartbeat; Difficulty breathing; Dizziness; Weakness; This spontaneous case was retrieved on 26-Oct-2022 from Vaccine Adverse Event Reporting System (VAERS) (reference number: 2474479-1), reported by other non-healthcare professional (consumer), and concerned a female patient of an unreported age.  The patient's medical history was not reported. The patient's concomitant medications included unspecified Covid-19 vaccine used for immunisation.  It was reported that on 12-Sep-2022, the patient was vaccinated with influenza vaccine (brand not specified; dose, anatomical location, and route of administration: not reported) for immunization. The batch number reported was 312832 and expiry date was 11-May-2022. The reported batch number was identified by Seqirus to be linked to suspect product with Fluad Quadrivalent (influenza vaccine inact sag 4v) instead of reported suspect product influenza vaccine. Based on the reported batch number, the suspect product was changed to Fluad Quadrivalent.  On an unspecified date, an unknown amount of time after receiving Fluad Quadrivalent and non-company co-suspect COVID-19 vaccine, the patient had fast heartbeat, experienced weakness, difficulty breathing and dizziness. The patient denied facial swelling.  On an unspecified date, the patient went to hospital and was admitted for ten days. Patient also ended up on on a rehabilitation unit for 43 days.  At the time of initial reporting, the patient had not recovered from all events.  The reporter did not provide a causality assessment.The patient had a bad experience after receiving the Seqirus flu shot.   All events were considered as serious due to the seriousness criterion of hospitalization.  Company comment: A patient of unreported age experienced increased heart rate, dyspnoea, dizziness, and asthenia an unknown amount of time after receiving the suspect product Fluad Quadrivalent and non-company co-suspect COVID-19 vaccine. More information regarding patient's medical history and diagnostic findings is needed. Due to lack of information and unclear temporal relationship, causality for the reported events is unassessable.; Sender's Comments: A patient of unreported age experienced increased heart rate, dyspnoea, dizziness, and asthenia an unknown amount of time after receiving the suspect product Fluad Quadrivalent and non-company co-suspect COVID-19 vaccine. More information regarding patient's medical history and diagnostic findings is needed. Due to lack of information and unclear temporal relationship, causality for the reported events is unassessable.
Sex: U
Vaccine: PPV, PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: no additional AE reported; expired dose of PNEUMOVAX 23 was administered to the patient on 21OCT2022; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies details were not reported.  On 21-OCT-2022, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, 0.5 ml, lot #U003306, expiration date: 15-OCT-2022, administered for prophylaxis (strength, and route of administration were not provided) (Expired product administered). It was reported that the vaccine did not experience a temperature excursion. No additional information provided. No additional adverse event was reported. No product quality complaint was reported.
Age: 65.0
Sex: F
Vaccine: FLUA4, FLUA4, FLUA4
Symptoms: Musculoskeletal pain, Pain, Pain in extremity
Clinical narrative: Patient called to report that she has had pain in her right shoulder blade and it hurts when she moves her arm above her head since receiving the vaccine last Wednesday.  Also states that at one point last week after receiving vaccine pain was going down right arm and into hand. She has not seen anyone about the pain.
Age: 65.0
Sex: F
Vaccine: FLUA4, FLUA4, FLUA4
Symptoms: Immediate post-injection reaction, Injection site pain, Screaming, Ultrasound scan, X-ray
Clinical narrative: Patient called to report that she has had pain in her right shoulder blade and it hurts when she moves her arm above her head since receiving the vaccine last Wednesday.  Also states that at one point last week after receiving vaccine pain was going down right arm and into hand. She has not seen anyone about the pain.
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: Body temperature, COVID-19, SARS-CoV-2 test
Clinical narrative: muscle weakness in the arm; ranging from a slight fever (99.8); some body aches; This spontaneous case was reported by a patient and describes the occurrence of MUSCULAR WEAKNESS (muscle weakness in the arm), PYREXIA (ranging from a slight fever (99.8)) and MYALGIA (some body aches) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Concomitant products included CALCIUM for an unknown indication.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MUSCULAR WEAKNESS (muscle weakness in the arm), PYREXIA (ranging from a slight fever (99.8)) and MYALGIA (some body aches). At the time of the report, MUSCULAR WEAKNESS (muscle weakness in the arm), PYREXIA (ranging from a slight fever (99.8)) and MYALGIA (some body aches) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99.8 (Slight).         Patient do not had a compromised immune system, and  not taking any medications other than calcium and vitamins. No treatment information was provided   This case was linked to MOD-2022-662883, MOD-2022-662837 (Patient Link).
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: muscle weakness in the arm; ranging from a slight fever (99.8); some body aches; This spontaneous case was reported by a patient and describes the occurrence of MUSCULAR WEAKNESS (muscle weakness in the arm), PYREXIA (ranging from a slight fever (99.8)) and MYALGIA (some body aches) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Concomitant products included CALCIUM for an unknown indication.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MUSCULAR WEAKNESS (muscle weakness in the arm), PYREXIA (ranging from a slight fever (99.8)) and MYALGIA (some body aches). At the time of the report, MUSCULAR WEAKNESS (muscle weakness in the arm), PYREXIA (ranging from a slight fever (99.8)) and MYALGIA (some body aches) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99.8 (Slight).         Patient do not had a compromised immune system, and  not taking any medications other than calcium and vitamins. No treatment information was provided   This case was linked to MOD-2022-662883, MOD-2022-662837 (Patient Link).
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: Body temperature, Muscular weakness, Myalgia, Pyrexia
Clinical narrative: muscle weakness in the arm; ranging from a slight fever (99.8); some body aches; This spontaneous case was reported by a patient and describes the occurrence of MUSCULAR WEAKNESS (muscle weakness in the arm), PYREXIA (ranging from a slight fever (99.8)) and MYALGIA (some body aches) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Concomitant products included CALCIUM for an unknown indication.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MUSCULAR WEAKNESS (muscle weakness in the arm), PYREXIA (ranging from a slight fever (99.8)) and MYALGIA (some body aches). At the time of the report, MUSCULAR WEAKNESS (muscle weakness in the arm), PYREXIA (ranging from a slight fever (99.8)) and MYALGIA (some body aches) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99.8 (Slight).         Patient do not had a compromised immune system, and  not taking any medications other than calcium and vitamins. No treatment information was provided   This case was linked to MOD-2022-662883, MOD-2022-662837 (Patient Link).
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Acoustic stimulation tests, Tinnitus
Clinical narrative: Nasal Swab Positive; Nasal Swab Positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 61-year-old male patient received BNT162b2 (BNT162B2), on 18Mar2021 at 13:00 as dose 1, single (Lot number: EN6208), in right arm, on 09Sep2021 at 13:00 as dose 2, single (Lot number: ER8732), in right arm and on 06Dec2021 at 16:00 as dose 3 (booster), single (Lot number: 33030BD) at the age of 61 years, in right arm for covid-19 immunization. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 12Jul2022, outcome "unknown" and all described as "Nasal Swab Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (12Jul2022) Positive.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201269702 same patient/drug, different dose/event;US-PFIZER INC-202201269523 same patient/drug, different dose/event;
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Tinnitus
Clinical narrative: Nasal Swab Positive; Nasal Swab Positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 61-year-old male patient received BNT162b2 (BNT162B2), on 18Mar2021 at 13:00 as dose 1, single (Lot number: EN6208), in right arm, on 09Sep2021 at 13:00 as dose 2, single (Lot number: ER8732), in right arm and on 06Dec2021 at 16:00 as dose 3 (booster), single (Lot number: 33030BD) at the age of 61 years, in right arm for covid-19 immunization. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 12Jul2022, outcome "unknown" and all described as "Nasal Swab Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (12Jul2022) Positive.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201269702 same patient/drug, different dose/event;US-PFIZER INC-202201269523 same patient/drug, different dose/event;
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Nasal Swab Positive; Nasal Swab Positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 61-year-old male patient received BNT162b2 (BNT162B2), on 18Mar2021 at 13:00 as dose 1, single (Lot number: EN6208), in right arm, on 09Sep2021 at 13:00 as dose 2, single (Lot number: ER8732), in right arm and on 06Dec2021 at 16:00 as dose 3 (booster), single (Lot number: 33030BD) at the age of 61 years, in right arm for covid-19 immunization. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 12Jul2022, outcome "unknown" and all described as "Nasal Swab Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (12Jul2022) Positive.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201269702 same patient/drug, different dose/event;US-PFIZER INC-202201269523 same patient/drug, different dose/event;
Age: 52.0
Sex: F
Vaccine: COVID19-2
Symptoms: Dyspnoea, Immediate post-injection reaction, Pharyngeal swelling
Clinical narrative: PT FELT DIFFICULT  BREATHING AFTER ABOUT 5-10 MINUTES AFTER GOT THE SHOT.  PATIENT FELT LIKE THROAT CLOSE UP AND SO GAVE ONE SHOT OF EPIPEN, PATIENT THEN FELT BETTER AFTER THAT.  THEN MEDICS SHOW UP, CHECKED VITAL SIGNS AND EVERY LOOKED GOOD.
Age: 67.0
Sex: M
Vaccine: COVID19-2
Symptoms: Conjunctival hyperaemia, Enophthalmos, Eye pain, Eyelid ptosis, Swelling of eyelid
Clinical narrative: Swollen left eyelid, left ptosis, conjunctival injection. left eyeball pain, left enophthalmos
Age: 36.0
Sex: F
Vaccine: COVID19-2
Symptoms: Angiogram, Atrial fibrillation, Cardiac monitoring abnormal, Chest discomfort, Chest pain
Clinical narrative: Chest pain, palpitations
Age: 36.0
Sex: F
Vaccine: COVID19-2
Symptoms: Echocardiogram, Fibrin D dimer, Full blood count, Lipase, Metabolic function test
Clinical narrative: Chest pain, palpitations
Age: 36.0
Sex: F
Vaccine: COVID19-2
Symptoms: Neck pain, Pain, Palpitations, Troponin
Clinical narrative: Chest pain, palpitations
Age: 4.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Injection site vesicles
Clinical narrative: Swelling, redness of the admin the morning by 11/3/22 in the morning large blisters formed at the site Mupirocin and reflex initially given in the morning then discountinued and started on prednisone that same night
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Diarrhoea, Facial paralysis, Heart rate increased, Hypertension
Clinical narrative: facial paralysis, lower leg swelling, coughing, rappid heartrate, muscle aches, body trembes, high bp, nausea, diahrrea
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Peripheral swelling, Tremor
Clinical narrative: facial paralysis, lower leg swelling, coughing, rappid heartrate, muscle aches, body trembes, high bp, nausea, diahrrea
Age: 61.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient reports she did not experience any side effects from the vaccine; Patient reports that she was administered two doses of the GARDASIL 9 vaccine at 61 years old; Patient reports that she was administered two doses of the GARDASIL 9 vaccine at 61 years old; This spontaneous report was received from a currently 62 years old female patient with liver injury. Patient reported that she needed a liver transplant but she had not received the liver transplant yet, but her health status had improved. There was no information about the patient's allergies, drug reactions, concomitant therapies or medical history provided. Patient reported that she was administered two doses of the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) vaccine at 61 years old (product administered to patient of inappropriate age). Patient also reported that her HCP recommended she receive the vaccine because their was evidence to support the administration with liver damage.  On 11-NOV-2021, the patient was vaccinated with first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9)  (exact dose, lot #, expiration date, route of administration and anatomical location were not reported). On 12-JAN-2022, the patient was vaccinated with second dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast)(GARDASIL 9) (lot#T039466, expiration date: 20-MAY-2023)(exact dose, route of administration and anatomical location were not reported). Vaccines were administered for prophylaxis. She reported that she was due for her third dose of the vaccine but did not receive the third dose. The patient reported she did not experience any side effects from the vaccine.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; VARIVAX that had undergone temperature excursion was administered to a patient; This spontaneous report was received from a registered nurse and refers to a 12-month-old patient. Information regarding the patient's concomitant therapies, concurrent conditions, medical history and historical drugs was not provided.  On 29-OCT-2022, the patient was vaccinated with improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX) (dosage regimen not provided), lot # W002601 and expiration date 24-JAN-2024 administered as prophylaxis.  The improperly stored dose of the suspect vaccine experienced a temperature excursion for 1 hour and 45 minutes on an unknown date; previous temperature excursions were reported.  No adverse symptoms were reported.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; HCP reported GARDASIL 9 was administered after a temperature excursion to a patient; This spontaneous report was received from a medical assistant referring to a unknown age and gender patient. No information regarding the patient's medical history, concurrent conditions, previous drug reactions or allergies and concomitant medications was provided.  On 25-SEP-2022, the medical assistant reported that dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot number 1780878, expiration date 02-DEC-2023 who had been verified to be a valid number, once) (dose and strength were not provided) was administered after temperature excursion to a patient. The excursion occurred with a temperature and time frame of 1.4 degrees centigrade (°C) for 0 hours 56 minutes; 1.2°C for 4 hours; 0.7°C for 17 hours 30 minutes; 0.9°C for 18 hours 47 minutes; 0.9°C for 13 hours 32 minutes. No additional adverse event was provided.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs; HBP called in and reported that the improperly stored vaccine was administered.; This spontaneous report was received from an office manager and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 13-OCT-2022, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, lot #W011622, expiration date: 06-APR-2024, administered for prophylaxis (dose, anatomical location, and route of administration were not provided). Administrated varicella virus vaccine live (oka/merck) (VARIVAX) was stored at -14 Celsius degrees up to -10 Celsius degrees (-11.9 Celsius degrees) for 42 minutes, no previous temperature excursion were reported (product storage error).  There were no adverse events reported (no adverse event).  This is one of four reports received from the same reporter.; Sender's Comments:  US-009507513-2210USA005958: US-009507513-2210USA005648: US-009507513-2210USA005741:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs; HBP called in and reported that teh improperly stored vaccine was administrated.; This spontaneous report was received from an office manager and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 13-OCT-2022, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, lot #W011622, expiration date: 06-APR-2024, administered for prophylaxis (dose, anatomical location, and route of administration were not provided). Administrated varicella virus vaccine live (oka/merck) (VARIVAX) was stored at -14 Celsius degrees up to -10 Celsius degrees (-11.9 Celsius degrees) for 42 minutes, no previous temperature excursion were reported (product storage error).  There were no adverse events reported (no adverse event).  This is one of four reports received from the same reporter.; Sender's Comments:  US-009507513-2210USA005958: US-009507513-2210USA005639: US-009507513-2210USA005648:
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; HCP reporting an improperly stored vaccine was administered to a patient; This spontaneous report has been received from a medical assistant referring a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported.   On 30-AUG-2022, the patient was vaccinated with an improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, at a dose of 0.5 milliliters (lot number: W007371, which has been verified to be a valid lot number with an expiration date: 13-JUL-2023; strength, vaccination scheme, route of administration and anatomical site of application were not provided) administered for prophylaxis (product storage error).  The administered vaccine experienced a temperature excursion at 34.5 fahrenheit (F) for 1 hour 7 minutes 0 seconds. Also, was reported a previous temperature excursion of 66.7 fahrenheit (F) for 13 hours 52 minutes 0 seconds. No additional adverse event reported.  This is one of several reports received from the same reporter.  ; Sender's Comments:  US-009507513-2210USA005917: US-009507513-2210USA005916: US-009507513-2210USA005929: US-009507513-2210USA005624: US-009507513-2210USA005942: US-009507513-2210USA005994: US-009507513-2210USA005979: US-009507513-2210USA005937: US-009507513-2210USA006007: US-009507513-2210USA005936:
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE information provided; MMR II was administered to three patients after the product's expiration date; This spontaneous report was received from an office manager concerning a patient of unknown age and gender. Their concurrent conditions, medical history, drug reactions/allergies, and concomitant medications were not provided.   On 23-SEP-2022, the patient was vaccinated with an expired dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live recombinant Human albumin (rHA) (M-M-R II) 0.5 mL administered as prophylaxis, lot number T029549 with reported expiration date of 01-SEP-2022, however, upon internal review was determined to be 10-SEP-2022 (route of administration was not provided) (Expired product administered). The product it was stored appropriately prior to administration and had no temperature excursions according to the reporter. No additional adverse event information was provided (No adverse event).   This was one of three cases from the same reporter.; Sender's Comments:  US-009507513-2210USA010243:AE report #: 02276199 US-009507513-2210USA010314:
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: No symptomatic side effects reported. No additional AE; Patient was administered Rotateq after it's expiration date / Inadvertently administered expired vaccine; This spontaneous report has been received from a registered nurse, concerning a patient of unknown age and gender.  The patient's medical history, concurrent conditions, historical drugs, and concomitant therapies were not reported.  On 24-OCT-2022, the patient was inadvertently vaccinated with expired dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, 2 milligram (lot number 1742415 has been verified to be valid for rotavirus vaccine, live, oral, pentavalent (ROTATEQ), expiration date reported and validated as 12-OCT-2022), administered orally as prophylaxis (strength was not provided) (Expired product administered).  No symptomatic side effects reported. No additional adverse event (AE) details.
Age: 0.25
Sex: M
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional AE reported.; Caller reported that a patient received the dose of RECOMBIVAX HB twice. Patient received the scheduled dose at 8 weeks on 8/31/2022 and received an additional dose at 17 weeks on 10/31/2022.; This spontaneous report has been received from a nurse referring to a 3-month-old male patient. The patient's medical history, previous drug reactions or allergies, and concomitant therapies were not reported.  On 31-AUG-2022, the patient was vaccinated with an scheduled dose at 8 weeks of hepatitis b vaccine (recombinant) (thimerosal free) (RECOMBIVAX HB) intramuscular injection, and it was reported that he received an additional dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) at 17 weeks on 31-OCT-2022, both administrations at a dose of 0.5 milliliter (ml) (strength, vaccination scheme frequency, route of administration, and anatomical site of application were not provided; lot number W022795 that was verified to be valid, expiration date not reported, but upon internal validation established as 19-MAY-2025) as prophylaxis (inappropriate schedule of product administration).  There was no additional adverse event (AE) reported (no adverse event).
Sex: U
Vaccine: FLUN4
Symptoms: Oropharyngeal pain, Rhinorrhoea, Sneezing
Clinical narrative: RUNNY NOSE; Runny nose, sneeze, sore throat; SNEEZE; Runny nose, sneeze, sore throat; SORE THROAT; Runny nose, sneeze, sore throat; A spontaneous report has been received from a consumer. The report concerns a patient of unknown gender (age not provided) of Unknown ethnic origin.    No medical history was reported. The following demography was reported for the patient's parent:   Sex: ASKU    No concomitant products were reported.    The patient received Flumist Quadrivalent (influenza vaccine live reassort 4v) (batch number Unknown), via nasal route, on an unknown date.     No malfunction has been reported for FLUMIST QUADRIVALENT.    On an unknown date, the patient experienced runny nose (preferred term: Rhinorrhoea). On an unknown date, the patient experienced sneeze (preferred term: Sneezing). On an unknown date, the patient experienced sore throat (preferred term: Oropharyngeal pain).     It is unknown if any action was taken with Flumist Quadrivalent (influenza vaccine live reassort 4v).     At the time of reporting, the event of runny nose, sneeze and sore throat was improving.     The events were considered non-serious.     The reporter considered that there was a reasonable possibility of a causal relationship between Flumist Quadrivalent (influenza vaccine live reassort 4v) and the following event(s): runny nose, sore throat and sneeze.     Device Information:     Combination Product Report: Yes    Product As Reported: FLUMIST QUADRIVALENT  Common Device Name: Nasal Spray  Procode: CCQ  Product Role: Suspect
Age: 17.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Seizure, Syncope
Clinical narrative: seizure; fainted (syncope); This case was reported by a other health professional via other manufacturer and described the occurrence of seizure in a 17-year-old male patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis and MENQUADFI (batch number U7924AAC, expiry date unknown) for prophylaxis.   On 15th August 2022, the patient received Bexsero, Bexsero Pre-Filled Syringe Device and MENQUADFI (intramuscular). On 15th August 2022, less than a day after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced seizure (serious criteria GSK medically significant and other: serious as per reporter) and syncope (serious criteria GSK medically significant and other: serious as per reporter). On 15th August 2022, the outcome of the seizure and syncope were recovered/resolved.   It was unknown if the reporter considered the seizure and syncope to be related to Bexsero and Bexsero Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 27-OCT-2022 Reporter's comment: Less than a day after receiving Bexsero and Menquadfi vaccine, the patient had developed a serious event of seizure and fainted (syncope). It was not reported if the patient received a corrective treatment for the events. The reporter considered the seriousness criteria as medically significant for both events.  The case listedness was reported as unlisted. The reporter had consented to follow up. It was unknown if the reporter considered the seizure and syncope to be related to Menquadfi.
Sex: U
Vaccine: VARZOS
Symptoms: Guillain-Barre syndrome
Clinical narrative: Guillain-Barre Syndrome; This case was reported by a consumer via interactive digital media and described the occurrence of guillain barre syndrome in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced guillain barre syndrome (serious criteria GSK medically significant). On an unknown date, the outcome of the guillain barre syndrome was unknown.   The reporter considered the guillain barre syndrome to be possibly related to Shingrix.     Additional Information: GSK Receipt Date: 28-OCT-2022 Reporter's Comments: This case was received from consumer via interactive digital media. The reporter stated that the possible side effects of the Shingrix vaccine, Guillain-Barre Syndrome was listed, and reporter want to know one experiences that side effect, was it permanent. Additional Supportive Information: The follow up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Too many complaints about it not working/Suspected vaccination failure; Shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, 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 Shingles vaccine.     Additional Information: GSK Receipt Date: 28-OCT-2022 Reporter's Comment: This case was reported by a consumer via interactive digital media. The patient received a dose of Shingles vaccine and reported it did not work. The reporter reported that too many complaints about it not working. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, laboratory test and time to onset confirming shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available. This case had been linked with US2021AMR178992, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR178992:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Bell's palsy, Dyskinesia, Eyelid function disorder
Clinical narrative: Bell's Palsy; Can't blink or close your eye; mouth wandering all over your face; This case was reported by a consumer via interactive digital media and described the occurrence of bell's palsy in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. In October 2022, less than 2 weeks after receiving Shingles vaccine, the patient experienced bell's palsy (serious criteria GSK medically significant), eyelid function disorder and mouth movement impaired. On an unknown date, the outcome of the bell's palsy, eyelid function disorder and mouth movement impaired were unknown.   It was unknown if the reporter considered the bell's palsy, eyelid function disorder and mouth movement impaired to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 30-OCT-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient received a dose of Shingles vaccine and 2 weeks ago after taking Shingles shot the patient reported that could not blink or close your eye and mouth wandering all over your face. The patient reported that it's time to wake up to the risk of having Bell's palsy if you take the Shingles shot. Additional Supportive Information: Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: had one in 2019, has been over 3 years; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 74-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in August 2019).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Linked case(s) involving the same patient: US2022AMR154368   Additional Information: GSK Receipt Date: 24-OCT-2022 Reporter's comment: The case was self-reported by the patient. The patient believed at that time (1st dose), only one shot was advised. The patient reported that now he/she saw GlaxoSmithKline were advising 2 shots within a 6 months period.  The patient asked what he/she should do about the second shot since it had been more than 3 years. The patient reported that his/her primary care would have to contact GlaxoSmithKline. The patient was on daily suppression acyclovir. The patient asked would someone from GlaxoSmithKline contact him/her. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. For the tolerance of acyclovir refer case US2022AMR154368, reported by same reporter.; Sender's Comments:  US-GSK-US2022AMR154368:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Erythema
Clinical narrative: redness around my neck and face; This case was reported by a consumer via interactive digital media and described the occurrence of erythema in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced erythema. On an unknown date, the outcome of the erythema was unknown.   It was unknown if the reporter considered the erythema to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 24-OCT-2022 Reporter's Comments: This case was reported by patient via interactive digital media. The patient had second shingles shot and had redness around my neck and part on my face. Additional Supportive Information: The follow up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Visual impairment
Clinical narrative: vision changes; This case was reported by a consumer via interactive digital media and described the occurrence of visual disturbance in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced visual disturbance. On an unknown date, the outcome of the visual disturbance was unknown.   It was unknown if the reporter considered the visual disturbance to be related to Shingrix.  Additional Information: GSK Receipt Date: 24-OCT-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The reporter wanted to know how common vision changes were after receiving Shingrix. Additional Supportive Information: The follow up would not possible as no contact details were available.
Sex: F
Vaccine: MENB, MNQ
Symptoms: Pain in extremity
Clinical narrative: her arms were extremely sore / terrible soreness, on a scale was an 8/arm pain; This case was reported by a consumer and described the occurrence of pain in arm in a 18-year-old female patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis and Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received the 1st dose of Bexsero, Bexsero Pre-Filled Syringe Device and the 1st dose of Menveo. On an unknown date, 1 day after receiving Bexsero, Bexsero Pre-Filled Syringe Device and Menveo, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Bexsero, Bexsero Pre-Filled Syringe Device and Menveo. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Linked case(s) involving the same patient: US2022AMR155112   Additional Information: GSK Receipt Date: 25-OCT-2022 and 30-OCT-2022 Reporter's comment: The case was reported by parent of the patient. The reporter reported that the patient received first dose of Bexsero and Menveo into unknown arm on the same day and then returned 3 weeks later for a second dose of Bexsero. The patient's arms were extremely sore the following day and she was recovered now. The reporter would think arm pain was not unusual, however she said on a scale of 1 to 10 her arms hurt at about an 8 for 2 to 5 days after the first shots given on the same day.  The patient said her soreness was really terrible if she tried to lift her arms higher than shoulder height, like while driving. Additional Supportive Information: This case had been linked with US2022AMR155112, reported by same reporter.; Sender's Comments:  US-GSK-US2022AMR155112:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: arm feel like someone shot me!; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included back surgery (Family History) (the patient mother had 2 back surgeries), fractured hip (Family History) (the patient's mother had broken hip), renal failure (Family History) (the patient's mother had kidney failure) and pain (Family History) (the patient's mother had shingles that was most pain). Previously administered products included Shingrix (first dose received on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 27-Oct-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient received the first dose of Shingrix that was uneventful.  The patient received second shot and caused arm to feel like someone had shot me. The patient was thinking if the pain was from shingles, then the patient would take 2 more shots to prevent it. The event was over in a day and all was well.  The patient's mother had 4 children naturally, 2 back surgeries, a broken hip, and kidney failure. The mother said shingles was the most pain.  The patient was very thankful that we have a vaccine for it. Additional Supportive Information: The follow up would not possible, as no contact, details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Arm has been painful; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Additional patient notes included the relevant medical history or any additional safety information was unknown.   On 26th October 2022, the patient received Shingles vaccine. On 27th October 2022, 1 days after receiving Shingles vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 27-Oct-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient received the Shingles vaccine before the day of reporting and stated it was not painful but had pain in arm, but it was very tolerable. The patient stated did not think twice.  Additional Supportive Information: The follow up would not possible as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Soreness in arms after each dose; This case was reported by a consumer and described the occurrence of pain in arm in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix (intramuscular). On an unknown date, less than a year after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Linked case(s) involving the same patient: US2022AMR156695   Additional Information: GSK Receipt Date: 27-OCT-2022 Reporter's Comment: The case was reported by the patient. The patient shared that, she received her Shingrix vaccine back in the summer of 2020 and she did not remember the exact month. The patient experienced soreness in her arm after injection in 2020. Additional Supportive Information: For tolerance of 2nd dose, refer case US2022AMR156695; Sender's Comments:  US-GSK-US2022AMR156695:Same reporter