chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram ST segment, Pericarditis
Clinical narrative: Pericarditis, diagnosed by history EKG changes- Diffuse ST segment elevation; within 24 hrs of symptoms; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 47 year-old female patient (patient was not pregnant at the time of vaccination) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 14Jan2022 (Lot number: BD33030) at the age of 47 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Generalized anxiety disorder" (unspecified if ongoing); "Endometriosis" (unspecified if ongoing); "Osteoporosis" (unspecified if ongoing). Concomitant medication(s) the patient received within 2 weeks of vaccination included: BUSPIRONE; CLONAZEPAM; NORTREL [LEVONORGESTREL]. Past drug history included: Avelox, reaction(s): "Known Allergies: Avelox"; Ranitidine, reaction(s): "Known Allergies: Ranitidine". Vaccination history included: Bnt162b2 (Dose 1, Lot number: Ek5730, Location of injection: Arm left, Route of administration: Intramuscular), administration date: 18Dec2020, when the patient was 46 years old, for COVID-19 immunization; Bnt162b2 (Dose 2, Lot number: EK4176, Location of injection: Arm left, Route of administration: Intramuscular), administration date: 08Jan2021, when the patient was 46 years old, for COVID-19 immunization. The following information was reported: PERICARDITIS (medically significant) with onset 20Jan2022 18:00, outcome "not recovered", described as "Pericarditis, diagnosed by history EKG changes- Diffuse ST segment elevation; within 24 hrs of symptoms". The event "pericarditis, diagnosed by history ekg changes- diffuse st segment elevation; within 24 hrs of symptoms" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: electrocardiogram st segment: diffuse st segment elevation. Therapeutic measures were taken as a result of pericarditis which included Indomethacin, colchicine. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The device date was reported as 21Jan2022.; Sender's Comments: Based on the information provide and plausible temporal association, the causality between BNT162B2 and PERICARDITIS cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Cystogram, Foetal disorder, Renal scan, Ultrasound foetal abnormal
Clinical narrative: Baby born with left kidney hydronephrosis with blocked drainage or  kinked ureter requiring surgical repair. Problem was detected in utero.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered, No adverse event
Clinical narrative: A booster clinic was set up with Pharmacy and Facility to ensure that residents were receiving the boosters. All paperwork had been done and consents signed. This resident was given a booster even though staff told pharmacist there was no consent. Family was notified of the adverse event. They had declined to let her have the booster even though she had had the initial vaccines.
Sex: F
Vaccine: VARZOS
Symptoms: Axillary pain, Breast pain, Diarrhoea, Erythema, Injection site pain
Clinical narrative: from metformin she developed diarrhea; intercostal neuralgia; pain from the injection; redness; itches a great deal; pain; This spontaneous report was received from a 52 year old female patient consumer reporting on herself, diabetic with allergy to acetaminophen, hydrocodone bitartrate (VICODIN) and a history of hysterectomy.      On 19-OCT-2012, the patient was vaccinated with vaccine live zoster (ZOSTAVAX), right arm (lot # H012578; exp date: 23-SEP-2013) (route and dose not provided) for prevention of shingles. No other co-suspects were reported. Concomitant medications included sitagliptin phosphate (JANUVIA), metformin hydrochloride (GLUMETZA) and glipizide.     On 30-OCT-2012 (11 days after vaccination), the patient suffered pain from the injection. The pain started in her armpit under her right arm. The patient visually saw redness under her arm that was the size of her hand. The patient stated that there were no lumps or swelling. The patient could not see any signs of shingles under her arm but it itched a great deal. The patient also mentioned that the pain had developed in her right breast first and from the breast exam and mammogram tests (results not provided) the pain then occurred in the left breast as well. She has been in pain for 3 months. Treatment was not given. The patient sought medical attention, she went to the doctors office.   On unknown date, the patient had developed diarrhea from the metformin. At the time of the report, she was taking metformin hydrochloride (GLUMETZA) which cleared the diarrhea up for her.   The outcome of pain from the injection, pain, itches a great deal and redness was unknown.    Follow-up information has been received from a consumer reporting on herself. The consumer reported that her physician confirmed that she developed intercostal neuralgia on both sides of her body.  The outcome of intercostal neuralgia is unknown.  Follow-up information received confirmed that Hysterectomy was the patients medical history.  Follow-up information has been received from a layer on 24-JAN-2022 regarding a case in litigation. In or around October 2012, the patient received a dose of Zoster Vaccine Live (ZOSTAVAX) for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving the dose, the patient suffered from neuralgia. The patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment. At the time of the report, the outcome of neuralgia was not recovered. The reporter considered the event of neuralgia to be related to Zoster Vaccine Live (ZOSTAVAX).  The event of neuralgia was considered disabling.
Sex: F
Vaccine: VARZOS
Symptoms: Intercostal neuralgia, Mammogram, Pain, Pruritus
Clinical narrative: from metformin she developed diarrhea; intercostal neuralgia; pain from the injection; redness; itches a great deal; pain; This spontaneous report was received from a 52 year old female patient consumer reporting on herself, diabetic with allergy to acetaminophen, hydrocodone bitartrate (VICODIN) and a history of hysterectomy.      On 19-OCT-2012, the patient was vaccinated with vaccine live zoster (ZOSTAVAX), right arm (lot # H012578; exp date: 23-SEP-2013) (route and dose not provided) for prevention of shingles. No other co-suspects were reported. Concomitant medications included sitagliptin phosphate (JANUVIA), metformin hydrochloride (GLUMETZA) and glipizide.     On 30-OCT-2012 (11 days after vaccination), the patient suffered pain from the injection. The pain started in her armpit under her right arm. The patient visually saw redness under her arm that was the size of her hand. The patient stated that there were no lumps or swelling. The patient could not see any signs of shingles under her arm but it itched a great deal. The patient also mentioned that the pain had developed in her right breast first and from the breast exam and mammogram tests (results not provided) the pain then occurred in the left breast as well. She has been in pain for 3 months. Treatment was not given. The patient sought medical attention, she went to the doctors office.   On unknown date, the patient had developed diarrhea from the metformin. At the time of the report, she was taking metformin hydrochloride (GLUMETZA) which cleared the diarrhea up for her.   The outcome of pain from the injection, pain, itches a great deal and redness was unknown.    Follow-up information has been received from a consumer reporting on herself. The consumer reported that her physician confirmed that she developed intercostal neuralgia on both sides of her body.  The outcome of intercostal neuralgia is unknown.  Follow-up information received confirmed that Hysterectomy was the patients medical history.  Follow-up information has been received from a layer on 24-JAN-2022 regarding a case in litigation. In or around October 2012, the patient received a dose of Zoster Vaccine Live (ZOSTAVAX) for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving the dose, the patient suffered from neuralgia. The patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment. At the time of the report, the outcome of neuralgia was not recovered. The reporter considered the event of neuralgia to be related to Zoster Vaccine Live (ZOSTAVAX).  The event of neuralgia was considered disabling.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: Varivax exposed to a temperature excursion was administered; This spontaneous report was received from a physician concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.     On 21-DEC-2021 the patient was vaccinated with a dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot # U020238 with expiration date: 28-JUN-2023, (dose, route of administration not reported) as prophylaxis, that had experienced a temperature excursion at 8.2 Fahrenheit degrees for 1 hour and 30 minutes. There were no previous temperature excursions.
Sex: F
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional AE reported; HCP reported that 3rd dose of RECOMBIVAX HB was given too soon to an adult patient; This spontaneous report was received from a nurse and refers to a 24-year-old female patient. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant therapies were not provided.  On 19-NOV-2021, the patient received the first dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) Vial. Then, on 17-DEC-2021, the second dose was given and on 05-JAN-2022, the third dose was given too soon (Inappropriate schedule of product administration). All doses were administered as an intramuscular injection, 1 milliliter, with a lot #T025374, expiration date: 25-JAN-2023, for prophylaxis (strength, and route of administration were not provided).  No additional Adverse Event (AE) was reported.
Age: 21.0
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Vaccine administration schedule is outside of the recommended schedule located in the prescribing information; This spontaneous report was received from a pharmacist referring to a 21 years old female patient. The patient's concomitant medications, concurrent conditions, medical history and drug reactions/allergies were not reported.  On 07-SEP-2021, the patient was vaccinated with the first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) for prophylaxis (dose, route, lot # and expiration date were not reported).  On 06-JAN-2022, the patient came for her second dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) for prophylaxis (dose, route, lot # and expiration date were unknown). The vaccine administration schedule was outside of the recommended schedule located in the prescribing information (inappropriate schedule of product administration).
Sex: F
Vaccine: HEP
Symptoms: Accidental exposure to product, Exposure via blood, Haemorrhage, Skin laceration, Syringe issue
Clinical narrative: she took the syringe out of the tray and noted the flange was broken; the broken syringe cut ther finger and she had blood; the broken syringe cut ther finger and she had blood; the broken syringe cut ther finger and she had blood; This spontaneous report was received from a health professional via a company representative and refers to a female patient of unknown age. No information regarding patient's medical history, concurrent conditions or concomitant therapies was provided.  On an unknown date, the patient worked with a box of hepatitis b vaccine (recombinant) thimerosal free (RECOMBIVAX HB) where one of the syringes was broken (Syringe issue). The patient reached to grab it when she cut her finger on the syringe (Skin laceration and Accidental exposure to product). It was reported in regard to the incident that "She took the syringe out of the tray and noted the flange was broken. The broken syringe cut her finger and she had blood." and also in regard to the question whether the product was administered or exposed to patient's bodily fluids "not administered but caller did get a cut on her finger from broken flange that drew blood" (Exposure via blood). The reported lot# was U032668 and the expiration date was confirmed to be 24-APR-2023. The outcome of these event was unknown.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Urticaria
Clinical narrative: daughter received GARDASIL 9 roughly around June 2019 and began experiencing hives within a few weeks; This spontaneous report was received from patient's mother reporting on her daughter, a female patient of approximately 12-year-old. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant therapies were not reported.  Roughly around June 2019, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered for Human Papillomavirus (HPV) prevention(strength, lot #, expiry date, and route of administration were not provided).   Since receiving the first dose of vaccine, within a few weeks, in 2019, the patient had been experiencing hives (urticaria). She received all recommended doses, sought medical attention and had been going to an allergist and multiple allergy tests were performed with no results indicating a food or substance allergy. The patient began allergy shots as treatment around 6 months ago and at reporting time, she was receiving a shot every 4-6 weeks. The patient's mother stated she spoke with the doctor and after piecing the dates together, they believe it was possible that hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) caused this experience.  At reporting time, the patient had not recovered from urticaria.
Sex: U
Vaccine: HPV9
Symptoms: Extra dose administered
Clinical narrative: no additional AE reported; HCP reported patient received a fourth dose of Gardasil 9. HCP stated dose number three was received twice; This spontaneous report has been received from a nurse, regarding a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concomitant medications, concurrent conditions and previous drug reactions or allergies were unknown.  On 20-OCT-2021, the patient was vaccinated with the fourth (4th) dose of hpv rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) at a dose of 0.5 milliliters (mL) as prophylaxis (lot number U007477 verified as valid, expiration date reported and stablished as 14-APR-2023) (route of administration and anatomical location of vaccination); the nurse reported that the patient received the third dose twice (extra dose administered). No additional adverse event (AE).
Sex: U
Vaccine: HPV4, HPV9, HPV9, HPV9
Symptoms: Extra dose administered, Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional AEs reported; patient received 4 doses of GARDASIL or GARDASIL 9; 1st dose was administered on 12/2014, 2nd dose 12/15/2020, 3rd dose 2/26/2021; This spontaneous report was received from a physician and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant therapies were not provided.  In December 2014, the patient was vaccinated with the first dose of either hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided) or quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) intramuscular injection, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided) (unidentified Merck hpv vaccine administered (name and lot number not provided)).   Then, on 15-DEC-2020, the patient received the second dose with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (inappropriate schedule of product administration).   On 26-FEB-2021, the third dose with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was given.   On 22-JAN-2022, a fourth dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was administered (extra dose administered) (0.5 ml, by intramuscular route, Lot #U007652, expiration date on 14-APR-2023).  No additional Adverse Experiences (AEs) were reported.
Age: 5.0
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered
Clinical narrative: no additional information provided; an expired dose of PROQUAD was given to the patient; This spontaneous report has been received from a registered nurse referring to a 5 years old patient of an unknown gender. The patient's concurrent conditions, pertinent medical history, drug reactions/allergies and concomitant therapies were not reported.  On 21-DEC-2021, the patient was vaccinated with an expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (strength, dose, frequency and route of administration were not reported; lot # was unknown, but the expiration date was reported as 19-DEC-2021) for prophylaxis (expired product administered). The reporter stated no previous temperature excursion. No additional information was provided. No product quality complaint was reported.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No AE; A dose of MMR-II expired on 12-JAN-2022 and was administered on 18-JAN-2022; This spontaneous report was received from a pharmacist referring to a patient of unreported age and gender. The patient's relevant medical history, previous drug reactions or allergies and concomitant medications were not provided.    On 18-JAN-2022, the patient was vaccinated with expired measles, mumps, and rubella (wistar RA 27-3) virus vaccine, live recombinant human albumin (rHA) (M-M-R II) (expired product administered) (lot number T001213, expiration date 12-JAN-2022; dose, dose number, vaccination scheme, route of administration, and anatomical location of vaccination were not reported) for prophylaxis. The measles, mumps, and rubella (wistar RA 27-3) virus vaccine, live (rHA) (M-M-R II), had no previous temperature excursion.   No product quality complaint (PQC) and no additional adverse event (AEs) was reported.
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AEs; Patient was given an expired ROTATEQ; This spontaneous report was received from a licensed practical nurse referring to a patient of unreported age and gender. The patient's pertinent medical history, previous drug reactions or allergies and concomitant medications were not provided.    On 21-JAN-2022, the patient was vaccinated with first dose of expired rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (expired product administered) (lot number U007860, expiration date 14-JAN-2022; dose, vaccination scheme, route of administration, and anatomical location of vaccination were not reported) for prophylaxis.         No product quality complaint (PQC) and no additional adverse event (AEs) was reported.
Sex: U
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: Patient had no known side effects; Temperature excursion for ROTATEQ which was supported. 1 dose of ROTATEQ was administered to a patient; This spontaneous report was received from a vaccine coordinator regarding a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, concomitant therapies, drug reactions, and allergies were not provided.   On 04-JAN-2022, patient was vaccinated with a temperature excursion for Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) which was supported, one dose, lot number 174228, was confirmed to be non-valid to Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ), expiration date: 09-JAN-2022 (product storage error). The caller reported that one dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) was administered to the patient. The patient had no known side effects.
Sex: F
Vaccine: HPV9
Symptoms: Inability to afford medication, Inappropriate schedule of product administration, Product dose omission issue
Clinical narrative: injection which she states is way over due; missed dose; Inability to afford medication; This spontaneous report was received from a female patient of unknown age, reporting on herself. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant therapies, and previous drug reactions or allergies was not provided.  On an unknown date, the patient was vaccinated with a first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (formulation, exact dose, route of administration, vaccination scheme frequency, anatomical location, lot number and expiration date were not reported).  At the reporting time, the patient was seeking assistance for her second hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) injection which she stated was over due because she can not afford it (inappropriate schedule of product administration, inability to afford medication and product dose omission issue).
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient has had no known side effects; a patient was administered an expired vaccine; This spontaneous report was received from the patient's husband who was also a physician referring to a patient of unknown age and gender. Information regarding the patient's concurrent conditions or concomitant medications was not provided.  On 21-DEC-2021, the patient was vaccinated with an expired rotavirus vaccine, live, oral, pentavalent (ROTATEQ) at a dose of 2 milliliters orally (vaccination scheme frequency were not reported; valid lot number 1694410 with expiration date 19-DEC-2021) for prophylaxis (expired product administered).  No adverse event was reported.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: No additional AE; Caller stated the vaccine was administered after a temperature excursion; This spontaneous report has been from a nurse concerning to a patient of unknown age and gender. No information was provided regarding the patients' medical history, concurrent conditions, drug or allergy history. No concomitant therapies were reported.  On 20-JAN-2022, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, 0.5 milliliter,(lot #U022321 and expiration date since it makes match with the autopopulated expiration date 15-JUL-2023), (strength, route of administration, and indication were not provided), which where stored at temperature excursion. The temperature excursion was - 14 degree Celsius for a time frame of 12 minutes. There was not previous temperature excursion.
Age: 65.0
Sex: U
Vaccine: PPV
Symptoms: Dyspnoea, Malaise, Oropharyngeal pain, Pyrexia
Clinical narrative: sore throat; Difficulty breathing; Fever; feeling sooo sick; This spontaneous report has been received from a 65-year-old patient of unknown gender reporting on him/herself.   The patient's concurrent conditions included asthma and allergies. The patient's medical history and concomitant medications were not reported.   On 20-JAN-2022,  the patient was vaccinated with Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) (dose, frequency, lot #, and route of administration were not provided) for an unknown indication.  On the same date (reported as since the vaccine), the patient have been so sick, with fever, sore throat, and difficulty breathing.  The outcome for the events was unknown.   Causal relationship with the suspect vaccine and the events was unknown.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional Adverse event; Caller stated the vaccine was admnistered after a temperature excursion; This spontaneous report has been from a nurse concerning to a patient of unknown age and gender. No information was provided regarding the patients' medical history, concurrent conditions, drug or allergy history. No concomitant therapies were reported.  On 21-JAN-2022, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, 0.5 milliliter,(lot #U020239 and expiration date since it makes match with the autopopulated expiration date 28-JUN-2023), (strength, route of administration, and indication were not provided), which where stored at temperature excursion. The temperature excursion was - 14 degree Celsius for a time frame of 12 minutes. There was not previous temperature excursion. No additional adverse event was reported.  This is one of several case reported for the same reporter.; Sender's Comments:  US-009507513-2201USA007199:
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: No additional AE; Caller stated the vaccine was administered after a temperature excursion; This spontaneous report has been from a nurse concerning to a patient of unknown age and gender. No information was provided regarding the patients' medical history, concurrent conditions, drug or allergy history. No concomitant therapies were reported.  On 25-JAN-2022, the patient was vaccinated with varicella measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (rHA) subcutaneous injection, 0.5 milliliter, (lot #U016975 and expiration date since it makes match with the autopopulated expiration date 14-NOV-2022) (strength, route of administration, and indication were not provided), which where stored at temperature excursion. The temperature excursion was - 14 degree Celsius for a time frame of 12 minutes. There was not previous temperature excursion.  This is a one of several cases send for the same reporter.; Sender's Comments:  US-009507513-2201USA007199: US-009507513-2201USA007340:
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: No additional AE.; Caller stated the vaccine was administered after a temperature excursion.; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding patient's concurrent conditions, medical history, drug reactions, allergies and concomitant medications.  On 21-JAN-2022, the patient was vaccinated with a improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX), 0.5 ml, lot # U020239, expiration date 28-JUN-2023, (route of administration and anatomical location were not reported) for prophylaxis (product storage error). No additional adverse events were reported (no adverse event). There was no product quality complaint involved.  For varicella virus vaccine live (oka/merck) (VARIVAX), temperature excursion was reported as -14.1 Celsius (C) degree for 12 minutes. There was no previous temperature excursion reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; the vaccine was administered after a temperature excursion; This spontaneous report as received from a nurse refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions, allergies and concomitant therapies was provided.  On 14-JAN-2022, after a temperature excursion, the patient was vaccinated with a varicella virus vaccine live (oka/merck) (VARIVAX), lot # U022321, expiry date 15-JUL-2023, 0.5 milliliter (route and site of administration were not reported) for prophylaxis. The administered dose of vaccine experienced the temperature excursion of -14.1 degrees Celsius for 12 minutes. There was no previous temperature excursion reported. No additional adverse event was reported.
Sex: U
Vaccine: HEP, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE or PQC reported.; aller stated RECOMBIV AX HB and ROT ATEQ were administered after a temperature excursion.; This spontaneous report was received from a office manager and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, medical history, allergies and concomitant therapies provided.  On 30-DEC-2021, the patient was vaccinated with incorrectly stored hepatitis b vaccine (recombinant) (RECOMBIVAX HB), thiomersal free, 0.5 milliliter, lot # T007984 and expiration date 01-NOV-2022, (route of administration, site of administration were not provided) for prophylaxis and rotavirus vaccine, live, oral, pentavalent (ROTATEQ), 2 milliliter, lot # T034512 and expiration date 25-MAR-2022, orally, (strength was not provided) for prophylaxis (product storage error). Reporter was unable to provided complete data to evaluate the stability of the product. The temperature and the time frame for the excursion was unknown. It was unknown if there was a previous excursion. No additional adverse event was reported (no adverse event).
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; the vaccine was administered after a temperature excursion; This spontaneous report as received from a nurse refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions, allergies and concomitant therapies was provided.  On 18-JAN-2022, after a temperature excursion, the patient was vaccinated with a varicella virus vaccine live (oka/merck) (VARIVAX), lot # U022321, expiry date 15-JUL-2023, 0.5 milliliter (route and site of administration were not reported) for prophylaxis. The administered dose of vaccine experienced the temperature excursion of -14.1 degrees Celsius for 12 minutes. There was no previous temperature excursion reported. No additional adverse event was reported.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; Patient was inadvertently administered PROQUAD after the labeled expiration date; This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant therapies, and drug reactions or allergies was not reported.      On 27-JAN-2022, the patient was inadvertently vaccinated after the labeled expiration date Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) 0.5 ml (lot# T025510 and expiration date 23-JAN-2022) (Expired product administered) (route of administration and anatomical site of vaccination were not reported), as prophylaxis. It was reported that, Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) did not experience any temperature excursion.   No additional adverse event (AE) (No adverse event). No PQC reported.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: No additional AEreported; Dose of ROQUAD was administered Intramuscular; This spontaneous report as received from a medical assistant referring to a patient of unknown age and gender. Patient's concurrent conditions, medical history and concomitant medications were not provided.  On 17-JAN-2022, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # U009262 and expiration date reported as 19-SEP-2022), 0.5 milliliter, intramuscular for prophylaxis (incorrect route of product administration). No additional AEs or PQC reported.
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: No other AE occurred; Expired vaccine used; This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, historical drug and concomitant therapies were not reported.  On 27-JAN-2022, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent(ROTATEQ), lot # 1707415, expiration date : 18-JAN-2022 (dose, route of administration and anatomical location) for prophylaxis. (expired product administered). No other adverse event occurred.
Age: 33.0
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional AE; Patient did not wait and received V ARlV AX on Jan 27, 2022, which was four days earlier than it was suppose to be.; This spontaneous report was received from pharmacist and refers to a 33-year-old patent (gender not reported). No information was provided regarding the patient's medical history, concurrent conditions, previous drug reactions, allergies and concomitant medications.  On 03-JAN-2022, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (strength, dose, route of administration, anatomical location, lot number and expiration date were not reported) for prophylaxis, then on 27-JAN-2022, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) Once (strength, dose, route of administration, anatomical location, lot number and expiration date were not reported). The patient did not wait and received varicella virus vaccine live (oka/merck) (VARIVAX) four days earlier than it was suppose to (Inappropriate schedule of product administration). No additional adverse events.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: a patient received a expired dose of VAQTA; This spontaneous report has been received from an administrator referring to a patient of unknown age and gender. The patient's pertinent medical history, drugs reactions or allergies and concomitant medications were not reported.  On 27-JAN-2022, the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA) as prophylaxis (strength, dose, frequency, route of administration, and anatomical injection site were unknown by the reporter; lot number T017179 has been verified to be a valid lot number for hepatitis a vaccine, inactivated, with an expiration date on 26-OCT-2021) (expired product administered).
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; expired dose of MMR II was administered; This spontaneous report was received from a physician referring to a patient of unknown age and gender. The patient's pertinent medical history, previous drug reactions or allergies and concomitant medications were not provided.  On 28-JAN-2022, the patient was vaccinated with expired dose of measles, mumps, and rubella (wistar RA 27-3) virus vaccine, live (rHA) (M-M-R II) (expired product administered) 0.5 milliliter (lot number T001213, expiration date 12-JAN-2022; dose number, vaccination scheme, route of administration, and anatomical location of vaccination were not reported) for prophylaxis.        There was no previous temperature excursion. No product quality complaint (PQC) and no additional adverse event (AEs) was reported.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Overdose, Wrong product administered
Clinical narrative: No additional ae reported; Concomitant administration of VARIVAX and PROQUAD was administered to a patient instead of MMR II and VARIVAX; Concomitant administration of VARIVAX and PROQUAD was administered to a patient instead of MMR II and VARIVAX; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug allergies or reactions, and concomitant medications were not reported.    On 28-JAN-2022, the patient was vaccinated concomitantly with varicella virus vaccine live (oka/merck)(VARIVAX) and measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) for prophylaxis (strength, dose, anatomical location, route of administration, lot #, and expiration date were not reported) instead of Measles, Mumps, and Rubella Virus Vaccine Live (MMR II) and (Varicella Virus Vaccine Live (VARIVAX) (overdose and wrong product administered).   The nurse was requesting medical information regarding the side effects so she can inform the patient's parents.  No additional adverse events were reported.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional adverse event; Administration of expired MMR II; This spontaneous report has been received from a consumer referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant therapies, and drug reactions or allergies was not reported.      On 26-Jan-2022, the patient was vaccinated with expired measles, mumps, and rubella (wistar RA 27-3) virus vaccine, live (M-M-R II) (Expired product administered) (lot# T001214 and expiration date: 12-JAN-2022) (exact dose, vaccination scheme, route of administration and anatomical site of vaccination were not reported), as prophylaxis. Reporter inquired viability of administered dose.  No additional adverse event (AE) reported. No PQC reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse event reported; The patient was vaccinated with improperly stored PROQUAD; This spontaneous report was received from a nurse practitioner referring to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, concomitant medications, drug reactions or allergies were no reported.   On an unspecified date, the patient was vaccinated with improperly stored Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) rHA(Lot# U010746 and expiration date 03-OCT-2022) (exact dose and frequency were not reported) as prophylaxis. (product storage error). On 09-DEC-2021, the vaccine underwent a temperature excursion of minus 14 degree Celsius to minus 10 degree Celsius for 0 hours 10 minutes and 0 seconds and minus 10 degree Celsius to 8 degree Celsius (7.4 Celsius) for 8 hours 20 minutes and 0 seconds. There was no previous temperature excursion. No additional adverse event reported, no further information provided.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse event reported; Incorrect product storage; This spontaneous report was received from a nurse practitioner referring to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, concomitant medications, drug reactions or allergies were no reported.   On an unspecified date, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) (Lot# U015682 and expiration date 18-MAY-2023) (exact dose and frequency were not reported) as prophylaxis. (product storage error). The vaccine underwent a temperature excursion of minus 14 degree Celsius to minus 10 degree Celsius for 0 hours 10 minutes and 0 seconds and minus 10 degree Celsius to minus 8 degree Celsius (7.4 Celsius) for 8 hours 20 minutes and 0 seconds. There was no previous temperature excursion. No additional adverse event reported, no further information provided.
Sex: U
Vaccine: VARZOS
Symptoms: Headache, Illness, Nausea, Pyrexia
Clinical narrative: Felt sick; Nausea; Headache; Fever; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced sickness, nausea, headache and fever. On an unknown date, the outcome of the sickness, nausea, headache and fever were recovered/resolved.   It was unknown if the reporter considered the sickness, nausea, headache and fever to be related to Shingles vaccine.     Linked case(s) involving the same patient:  US2022AMR013107  Additional details were provided as follows: The patient self-reported this report. The age at vaccination was not reported. The patient heard how awful the shingles was.  The patient got a dose of Shingles vaccine and felt sick for a week after each shot (nausea, headache, fever), but patient guessed it was better than getting shingles. The follow-up could not be possible as no contact details were available. For tolerance of 2nd dose refer case US2022AMR013107.
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue
Clinical narrative: Fatigued; This case was reported by a consumer via interactive digital media and described the occurrence of fatigue in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Concomitant products included SHINGLES VACCINE INJECTION (ZOSTER VACCINE RECOMBINANT, ADJUVANTED, NON-LIVE).   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced fatigue. On an unknown date, the outcome of the fatigue was recovered/resolved.   It was unknown if the reporter considered the fatigue to be related to Shingles vaccine.  Additional details were reported as follows: Age at vaccination was not reported. The patient received a dose of Shingles vaccine and 2 months later received a booster dose. The patient reported fatigue for a day and that was all. Consent to follow up was not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Feeling abnormal, Pyrexia
Clinical narrative: ran fever; felt bad; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced fever and feeling bad. On an unknown date, the outcome of the fever and feeling bad were unknown.   It was unknown if the reporter considered the fever and feeling bad to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient. The age at vaccination was not reported. The patient had fever and felt bad after his/her shot, this helped encourage patient to get the second one.  The patient was better to feel poorly 2 days than chance shingles. The case has been linked to US2022AMR014001, responded to same comment.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR014001:Response to same comment
Sex: U
Vaccine: VARZOS
Symptoms: Feeling hot, Pain of skin, Skin lesion
Clinical narrative: skin hot; skin sore to touch; inward pain where there was lesion; This case was reported by a consumer via interactive digital media and described the occurrence of feeling hot 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 feeling hot, skin pain and skin lesion. On an unknown date, the outcome of the feeling hot, skin pain and skin lesion were not recovered/not resolved.   It was unknown if the reporter considered the feeling hot, skin pain and skin lesion to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received Shingle vaccine years ago and reported that going on six weeks with skin hot and sore to touch and inward pain every where there was a lesion. The patient reported that surely vaccine did not helped. The follow-up would not possible as no contact details were available
Sex: U
Vaccine: VARZOS
Symptoms: Skin odour abnormal
Clinical narrative: body odor; This case was reported by a consumer via interactive digital media and described the occurrence of body odor 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 body odor. On an unknown date, the outcome of the body odor was unknown.   It was unknown if the reporter considered the body odor to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by patient. The age at vaccination was not reported. The patient asked about Shingles vaccine , could it cause body odor.  GSK note - product name is Shingrix but the patient mentioned name of vaccine as shingles vaccine, it is coded as reported.
Sex: U
Vaccine: VARZOS
Symptoms: Hypersensitivity
Clinical narrative: allergy/ allergic reaction to hair dye; This case was reported by a consumer via interactive digital media and described the occurrence of allergic reaction 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 allergic reaction. On an unknown date, the outcome of the allergic reaction was unknown.   It was unknown if the reporter considered the allergic reaction to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case The age at vaccination was not reported. The patient got Shingrix vaccine and enquired could the vaccine cause allergic reaction to hair dye. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Arthralgia, Pain in extremity, Pyrexia
Clinical narrative: Fever; arm was sore from shoulder to elbow; arm was sore from shoulder to elbow; This case was reported by a consumer via interactive digital media and described the occurrence of fever 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 fever, pain in arm and shoulder pain. On an unknown date, the outcome of the fever, pain in arm and shoulder pain were unknown.   It was unknown if the reporter considered the fever, pain in arm and shoulder pain to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient. The age at vaccination was not reported. The patient received shingles vaccine and had a fever, sore arm from shoulder to elbow. The patient could deal with this pain as he/she did not want shingles. The case has been linked to US2022AMR013188, reported for other patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR013188:Response to same comment