chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported.; A nurse reported V ARlV AX was improperly stored and administered.; This spontaneous report was received from a licensed practical nurse, referring to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history, concurrent conditions, previous drug reactions, allergies, or concomitant medications were not reported.   On unspecified dates, the patients were vaccinated with an improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX) injection (lot number T017686 which has been verified to be valid, expiration date reported and validated as 21-MAY-2022) (lot number T017682 which has been verified to be valid, expiration date reported and validated as 21-MAY-2022) (doses and frequencies were unknown by the reporter; vaccination schemes, routes of administration, and anatomical site of injection were not reported) as prophylaxis. The administered doses of the vaccine were stored on 19-JAN-2021, at a temperature of 9.1 degrees Fahrenheit (F), during a time frame of 2 hours, as recorded by a digital data logger. There were previous temperature excursions reported on 02-DEC-2020, 6 F to 14 F (11 F) during a time frame of 1 hour, and 14 F to 46 F (36F) during a time frame of 3 hours. On 14-DEC-2020, 6 F to 14 F (13.8 F) during a time frame of 6 hours, and 14 F to 46 F (15.8) during a time frame of 42 minutes. On 21-DEC-2020, 6 F to 14 F (8.8 F) during a time frame of 1 hour and 30 minutes. On 07-JAN-2021, 6 F to 14 F (9.5 F) during a time frame of 10 hours. On 18-JAN-2021, 14 F to 46 F (32.4 F) during a time frame of 5 hours 0 minutes and 0 seconds. No additional adverse events were reported in the patients.  This is a non-valid case due to the lack of patient identifiers.  Follow up information was received from the  licensed practical nurse on 28-JAN-2021 regarding a 1 year old female patient. with 2 siblings, birth weight of 4.7 lb. Her concomitant therapies included measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II), hepatitis a virus vaccine inactivated(HAVRIX) and pneumococcal 4 6b 9v 14 18c 19f 23f conj vaccine (crm197)(PREVNAR). The patient's concurrent conditions and medical history were not provided.   Since 02-DEC-2020, the varicella virus vaccine live (oka/merck)(VARIVAX) experienced temperature excursions with a total of 29.5h.    On 14-JAN-2021, the patient was vaccinated with her first dose of this improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) lot# T017686, expiration date 21-MAY-2022, subcutaneously in the left thigh, for prophylaxis, on a private doctor's office/hospital with public funds.  This is one of several reports from the same reporter (US-009507513-2102USA002533,US-009507513-2102USA002536,US-009507513-2102USA002535,US-009507513-2102USA002534 and US-009507513-2102USA002537).; Sender's Comments:  US-009507513-2102USA002533: US-009507513-2102USA002536: US-009507513-2102USA002535: US-009507513-2102USA002534: US-009507513-2102USA002537:
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration
Clinical narrative: a GARDASIL 9 alternate dosing interval; This spontaneous report was received from a pharmacist referring to a 18 years old male patient. The patient's concomitant mediation, pertinent medical history and drug allergies or reactions were not reported.  On an unknown date in November 2019, the patient was vaccinated with first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, dose, route, lot # and expiration date were unknown) for prophylaxis. According to the prescribing information, instead of receiving the second dose 2 months later in January 2020, the patient missed the January 2020 dose and received the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, dose, route, lot # and expiration date were unknown) for prophylaxis on an unknown date in November 2020 (inappropriate schedule of product administration).
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional adverse event reported; Dose of V AQT A that was inadvertently administered after its labeled expiry date; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, drug reactions or allergies pertinent medical history and concomitant therapies were not reported.   On 18-JAN-2021, the patient was inadvertently vaccinated with a expired dose of hepatitis a vaccine, inactivated (VAQTA) 25U/0.5 ml, lot # S032359, expiration date 11-JAN-2021, 1 dosage form (route was not reported) for prophylaxis. There were no known temperature excursions on vaccine. Nurse inquired about need for revaccination. No additional adverse event reported, and no further information provided. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: S032359; expirationdate: 11-JAN-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: M
Vaccine: RV5
Symptoms: Antiviral prophylaxis, Expired product administered, No adverse event
Clinical narrative: No additional adverse effects to report; his son was administered an expired ROTATEQ vaccine; This spontaneous report was received from the father's son, a patient of unknown age. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.      On 26-JAN-2021, the patient was vaccinated with an expired dose of rotavirus vaccine, live, oral, pentavalent(ROTATEQ), 1 dosage form, oral (lot number and expiration date were not reported) for prophylaxis. No additional adverse effects were reported.
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: an expired GARDASIL 9 was given to a patient; No additional AE/PQCs reported; This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. No information was provided about the patient's pertinent medical history, concomitant medication, drug allergies/reaction.  On 27-JAN-2021, the patient was vaccinated with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) 0.5 ml (strength, route of administration, dose number, lot number was not reported with expiration date of 11-SEP-2020) for prophylaxis (expired product administered). No additional adverse event/product quality complaints (PQCs) was reported.
Sex: U
Vaccine: RV5
Symptoms: Antiviral prophylaxis, No adverse event, Product storage error
Clinical narrative: no adverse event; an improperly stored vaccine was administered; This spontaneous report was received from a nurse refers to a patient of unknown age and gender. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.       On 25-JAN-2021, the patient was vaccinated with improperly stored dose of rotavirus vaccine, live, oral, pentavalent(ROTATEQ) lot number 1688504, expiration date reported as 18-NOV-2021, but upon internal validation was determined as 19-NOV-2021, 1 dosage form, oral for prophylaxis. No other adverse event was reported.  The vaccines underwent a temperature excursion above 9 degrees Celsius (°C) (13.4°C) for 2 hours and 9 minutes. There were not previous temperature excursion. The call was due to digital data logger.; Sender's Comments:  US-009507513-2101USA013457:
Sex: U
Vaccine: HEPA, MMR
Symptoms: Product storage error
Clinical narrative: Caller is reporting that an improperly stored vaccine was administered on 25JAN202 l.; Information has been received from a nurse, referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 25-JAN-2021, the patient was vaccinated with an improperly stored dose of hepatitis a vaccine, inactivated(VAQTA) lot # T013205, expiration date reported on 02-DEC-2021, but upon internal validation established as 03-DEC-2021 (anatomical location and administration route were not reported) and with an improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) lot # S004119 expiration date reported on 10-FEB-2021, but upon internal validation established as 11-FEB-2021 (anatomical location and administration route were not reported) both vaccines as prophylaxis. The vaccines had a temperature excursion of above 9 Celsius (°C) (13.4 °C), during 2 hours and 9 minutes. It was confirm that a digital data logger was involved.     combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck. devicelotnumber: T013205; expirationdate: 03-DEC-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
Sex: M
Vaccine: HPV9
Symptoms: Skin papilloma
Clinical narrative: patient had warts on hands that "went away" after GARDASIL 9 vaccination series; This spontaneous report as received from a pharmacist refers to a 21 year old male patient.    On an unknown date the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) for prophylaxis.  The patient had warts on hands that "went away" after hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) vaccination series. Also reported that these warts had been treated with "other medications" before and "nothing worked".
Sex: U
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: Caller is reporting that an improperly stored vaccine was administered on 25JAN2021; This spontaneous report was received from a Register Nurse referring to a patient of unknown age and gender. The patient's medical history, concomitant medications, drug allergies, or reactions were not reported.   On 25-JAN-2021, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 1 injection, (lot #1688504 has been verified to be a valid lot number for Rotavirus Vaccine, Live, Oral, Pentavalent, expiration date reported as 18-NOV-2021, but upon internal validation established as 19-NOV-2021) l for prophylaxis (strength and administration route were not provided) (product storage error).  The vaccine was exposed to a temperature above 9 Celsius degrees (C) (13.4 C) for a time frame of 2 hours and 9 minutes recorded by a digital data logger; the vaccine did not experience previous temperature excursions.
Sex: U
Vaccine: MMRV
Symptoms: Antiviral prophylaxis, Product storage error
Clinical narrative: temperature excursion involving PROQUAD; This spontaneous report was received from a nurse referring to a patient of unknown age or gender. The patient's medical conditions, alletgies or concomitant therapies were not reported.  On 27-JAN-2021, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) 0.5 ml, lot # T025510, expiration date 23-JAN-2022, for prophylaxis (route of administration, and anatomical site of injection were not reported), with a temperature excursion or 8.3F and 8.1F, time frame 5 minutes and 5 minutes respectively, there was no previous temperature excursion and recorded by a digital data logger.   This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-2101USA013383:
Sex: U
Vaccine: MMRV
Symptoms: Product storage error, Product temperature excursion issue
Clinical narrative: Nurse calling to report a temperature excursion involving PROQUAD; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions or allergies were not reported.   On 27-JAN-2021, the patient was vaccinated with  improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (strength and route were not reported, lot # T025510, expiration date 23-JAN-2022) (therapy type: recombinant Human albumin (rHA)) at a dose of 0.5 milliliter for prophylaxis (product storage error).        It was reported that the suspect vaccine was exposed to a temperature of minus 8.3 Fahrenheit (F) for a time frame of 5 minutes and 8.1 F for a time frame of 5 minutes, as recorded by the digital data logger. There were no previous temperature excursions.   This is one of the several reports reported by the same reporter.; Sender's Comments:  US-009507513-2101USA013383: US-009507513-2101USA013552: US-009507513-2101USA013563:
Sex: F
Vaccine: HEPA
Symptoms: Antiviral prophylaxis, Expired product administered, No adverse event
Clinical narrative: no additional AE; Patient was inadvertently administered expired dose; This spontaneous report was received from a medical assistant referring to a 60 years old female patient. The patient's concurrent condition, medical history and concomitant therapy were not reported.       On 28-JAN-2021, the patient was inadvertently vaccinated with a expired dose of hepatitis a vaccine, inactivated (VAQTA) lot # S036494 with expiration date 09-JAN-2021, 1 ml (route was not reported) for prophylaxis (expired vaccine used). The product has not been involved in any temperature excursions. No additional adverse event. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S036494; expirationdate: 09-JAN-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error, Product temperature excursion issue
Clinical narrative: Improper storage of product in use; This spontaneous report was received from a licensed nurse practitioner concerning a patient of unknown gender and age. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 28-JAN-2021, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) (lot # T024281, dose:0 .5 milliliter, expiration date: 15-JUL-2022, dose number and route unspecified)  for prophylaxis. The administered dose of the vaccine experienced a temperature excursion 7.1 degrees Fahrenheit for 50 hours/ 45minutes. It was reported that the vaccine was no exposed a previous excursion and it was not recorded by data logger. No product quality complaint was involved.
Age: 46.0
Sex: F
Vaccine: PPV
Symptoms: Antibiotic prophylaxis, Viral titre decreased
Clinical narrative: Her pneumonia titers were low; This spontaneous report was received from a physician who was also the patient, reporting on herself. She was approximately 46 years old and her ethnicity was reported as other. Her concurrent conditions included autoimmune antibodies to thyroid with normal thyroid values, and unspecified food and environmental allergies. Her medical history and concomitant medications were not provided.  On approximately 06-DEC-2020 (reported as "a full month prior, 30 days prior"), the patient was vaccinated with Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) for prophylaxis (dose, route of administration, anatomical location, lot number and expiration date were not reported).   On an unspecified date, the patient's pneumonia titers were low.   The outcome of the event and the causal relationship between the event and the suspect vaccine were not reported.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error, Product temperature excursion issue
Clinical narrative: VARIVAX administered after a temperature excursion; This spontaneous report was received from a Licensed Practical Nurse referring to a patient of unknown gender and age. The patient's medical history, concurrent conditions, previous drug reactions or allergies and concomitant therapies were unknown.  On 28-JAN-2021, the patient was vaccinated with improperly stored varicella virus vaccine live (Oka/Merck)(VARIVAX) (0.5 ml, once, strength and route were not reported, lot # T024281 has been verified as valid, expiration date 15-JUL-2022) for prophylaxis.  The vaccine administered experienced a temperature excursion of 7.1 degrees Fahrenheit, for a time frame of 59 hours 45 minutes. There were no previous temperature excursions. No digital data logger was involved.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Antiviral prophylaxis, No adverse event, Product storage error
Clinical narrative: Proquad was stored in the refrigerator instead of freezer; No further AE; This spontaneous report as received from a other health professional refers to a patient of unknown age and gender.      The patient's concurrent conditions, medical history and concomitant medications were not provided.  On 28-JAN-2021, the patient was vaccinated with an incorrect storage vaccine of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # T025221 with expiration date of 19-JAN-2022), 0.5 ml, for prophylaxis (route of administration was not provided); and with varicella virus vaccine live (oka/merck) (VARIVAX) 0.5 ml, for prophylaxis (route of administration, lot# and expiration date were not provided). The vaccine measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) was stored in the refrigerator instead of the freezer since 01-DEC-2020 with a temperature of 44F during 1506 hours and had since then been administered to patients. There was not previous temperature excursion and this was not call because of a data logger. There was not adverse event involved.
Age: 13.0
Sex: U
Vaccine: HPV9
Symptoms: Incomplete course of vaccination, No adverse event
Clinical narrative: a patient got 1st dose of GARDASIL 9 in October 2017. Patient missed the 2nd dose.; No additional AE reported; This spontaneous report was received from a physician, referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.  In October 2017, 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) (dose, route, lot# and expiration date were not reported) for prophylaxis.  On an unknown date, the patient missed the second dose. No additional AE reported.
Sex: F
Vaccine: PPV
Symptoms: Adverse drug reaction, Antibiotic prophylaxis, Epistaxis, Hypersensitivity, Nasal congestion
Clinical narrative: Nasal congestion; hemorrhage from her nose; This spontaneous report was received from a 63 year old female patient who was reporting on herself. The patient's medical history included sinus infections. The patient's concomitant therapies included unspecified thyroid medicine and metformin hydrochloride(GLUCOPHAGE XR). the patient had drug reactions/allergies to scopolamine and prednisone.  On 06-JUL-2016 (also reported as "about 5 years ago") the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23), 0.5 milliliter for prophylaxis (frequency, route of administration, anatomical location, lot number and expiration date were not provided). On the same date (also reported as "in the days following the pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) vaccine"), the patient had nasal congestion for about two years followed by a hemorrhage from her nose (epistaxis). The patient did not seek medical attention and no lab diagnostics/studies were performed. The outcome of nasal congestion was resolved on approximately 06-JUL-2018 and epistaxis was reported as resolved on an unknown date. The causality assessment was not provided.
Age: 1.67
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: An expired dose of the vaccine was given on 1/29/2021; This spontaneous report was received from a physician concerning a 20 month old patient of an unknown gender. There was no information regarding the patient's medical history, concurrent conditions, concomitant medications or drug reactions/allergies.  On 29-JAN-2021, the patient was vaccinated with a dose of  hepatitis a vaccine, inactivated(VAQTA) 0.5ml  lot # T008149 with expiration date of 06-JAN-2021 for prophylaxis (frequency, route of administration, anatomical location, lot number and expiration date were not provided).
Sex: U
Vaccine: MMR
Symptoms: Antiviral prophylaxis, Expired product administered, No adverse event
Clinical narrative: No additional AE/PQC involved; Nurse called to report expired dose of MMR II given to patient; This spontaneous report as received from a nurse refers to a patient of unknown age. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided.      On 03-FEB-2021, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) for prophylaxis (strength, dose, route of administration, anatomical location, lot # and expiration date were not reported). No additional Adverse Event (AE)/Product Quality Complaint (PQC) was involved.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Product storage error, Product temperature excursion issue
Clinical narrative: No additional AE reported.; A nurse reported V ARlV AX was improperly stored and administered.; This spontaneous report was received from a licensed practical nurse regarding a 1 year old male patient with 1 siblings, birth weight of 8.3 lb. Her concomitant therapies included measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II), hepatitis a virus vaccine inactivated(HAVRIX) and influenza virus split virion 4v vaccine inactivated (FLULAVAL). The patient's concurrent conditions and medical history were not provided.   Since 12-FEB-2020, the varicella virus vaccine live (oka/merck)(VARIVAX) experienced temperature excursions with a total of 29.5h.    On 08-DEC-2020, the patient was vaccinated with her first dose of this improperly stored varicella virus vaccine live (oka/merck)(VARIVAX), lot# T017686, expiration date 20-NOV-2021  subcutaneously in the left thigh, for prophylaxis, on a private doctor's office/hospital with public funds.  This is one of several reports from the same reporter (US-009507513-2101USA011364).; Sender's Comments:  US-009507513-2101USA011364:Original Case : 2101USA011364
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Antiviral prophylaxis, Poor quality product administered, Product storage error
Clinical narrative: No additional AE reported.; A nurse reported V ARlV AX was improperly stored and administered.; This spontaneous report was received from a licensed practical nurse regarding a 4 year old female patient with 1 sibling, birth weight of 8.7 lb. Her concomitant therapies included measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II).  Since 02-DEC-2020, the varicella virus vaccine live (oka/merck)(VARIVAX) experienced temperature excursions with a total of 29.5h.    On 12-JAN-2021, the patient was vaccinated with her first dose of this improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) lot# T017686, expiration date 21-MAY-2022, subcutaneously in the Right Arm, for prophylaxis, on a private doctor's office/hospital with public funds.  This is one of several reports from the same reporter (US-009507513-2101USA011364).; Sender's Comments:  US-009507513-2101USA011364:Original Case : 2101USA011364
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: No additional AE reported.; A nurse reported V ARlV AX was improperly stored and administered.; This spontaneous report was received from a licensed practical nurse regarding a 4 year old female patient with 2 siblings, birth weight of 6.5 lb. Her concomitant therapies included measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II).   Since 02-DEC-2020, the varicella virus vaccine live (oka/merck)(VARIVAX) experienced temperature excursions with a total of 29.5h.    On 13-JAN-2021, the patient was vaccinated with her first dose of this improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) Lot# T017682,  expiration date 21-MAY-2022, subcutaneously in the left arm, for prophylaxis, on a private doctor's office/hospital with private funds.  This is one of several reports from the same reporter (US-009507513-2101USA011364).; Sender's Comments:  US-009507513-2101USA011364:Original Case : 2101USA011364
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Antiviral prophylaxis, Product storage error
Clinical narrative: No additional AE reported.; A nurse reported V ARlV AX was improperly stored and administered.; This spontaneous report was received from the  licensed practical nurseregarding a 4 year old male patient. Her concomitant therapies included measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II). The patient's concurrent conditions and medical history were not provided.   Since 02-DEC-2020, the varicella virus vaccine live (oka/merck)(VARIVAX) experienced temperature excursions with a total of 29.5h.    On 04-JAN-2021, the patient was vaccinated with her first dose of this improperly stored varicella virus vaccine live (oka/merck)(VARIVAX)  lot# T017686, expiration date 21-MAY-2022, subcutaneously in the left arm, for prophylaxis, on a private doctor's office/hospital with public funds.  This is one of several reports from the same reporter (US-009507513-2101USA011364).; Sender's Comments:  US-009507513-2101USA011364:Original Case : 2101USA011364
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: No additional AE reported.; A nurse reported V ARlV AX was improperly stored and administered.; This spontaneous report was received from a licensed practical nurse regarding a 4 year old female patient with birth weight of 8 lb. Her concomitant therapies included measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II).  Since 02-DEC-2020, the varicella virus vaccine live (oka/merck)(VARIVAX) experienced temperature excursions with a total of 29.5h.    On 08-JAN-2021, the patient was vaccinated with her first dose of this improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) lot # T017682, expiration date 21-MAY-2022, subcutaneous in the left arm, for prophylaxis, on a private doctor's office/hospital with private funds.  This is one of several reports from the same reporter (US-009507513-2101USA011364).; Sender's Comments:  US-009507513-2101USA011364:Original Case : 2101USA011364
Sex: U
Vaccine: VARZOS
Symptoms: Illness
Clinical narrative: Some have been sick with them; This case was reported by a pharmacist and described the occurrence of sickness in unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown.   It was unknown if the reporter considered the sickness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable for this report.   Pharmacist reported that some patients received the dose of Shingrix and got sick. The reporter consented to follow up. This case is 1 of the 5 cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR257399:same reporter_individual pt US-GLAXOSMITHKLINE-US2020AMR257416:same reporter_some patients (sick, 2nd dose) US-GLAXOSMITHKLINE-US2020256890:same reporter_individual pt US-GLAXOSMITHKLINE-US2020256891:same reporter_some patients (late)
Sex: U
Vaccine: VARZOS
Symptoms: Illness
Clinical narrative: Some have been sick with them; This case was reported by a pharmacist and described the occurrence of sickness in unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown.   It was unknown if the reporter considered the sickness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable for this report.   Pharmacist reported that some patients received the dose of Shingrix and got sick. The reporter consented to follow up. This is 1 of the 5 cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR257400:same reporter_some patients (sick, 1st dose) US-GLAXOSMITHKLINE-US2020AMR257399:same reporter_individual pt US-GLAXOSMITHKLINE-US2020256890:same reporter_individual pt US-GLAXOSMITHKLINE-US2020256891:same reporter_some patients (late) US-GLAXOSMITHKLINE-US2020AMR257399:
Sex: U
Vaccine: VARZOS
Symptoms: Deafness
Clinical narrative: permanent hearing loss; This case was reported by a consumer via call center representative and described the occurrence of hearing loss in a adult 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 hearing loss (serious criteria GSK medically significant). On an unknown date, the outcome of the hearing loss was unknown.   It was unknown if the reporter considered the hearing loss to be related to Shingrix.  Additional details were provided as follows:  The age at vaccination was not reported.  The age group was not reported but was captured as adult as per vaccine indication.  After receiving dose of Shingrix, the patient experienced the incidence of permanent hearing loss. The reporter did not consent to follow up.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Herpes zoster, Nausea, Pain
Clinical narrative: didn't sleep; headache; nausea; body ache; chills; rash came back raised up and got a little itchy; raised rash; rash may be a mild case of shingles; This case was reported by a consumer and described the occurrence of shingles in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of rash pruritic (also experienced tingling after receiving 1st dose on 30th August 2020, refer case US2020AMR245204).   On 3rd December 2020, the patient received the 2nd dose of Shingrix. On 3rd December 2020, less than a day after receiving Shingrix, the patient experienced insomnia, headache, nausea, general body pain and chills. In December 2020, the patient experienced shingles, itchy rash and raised rash. The patient was treated with valaciclovir hydrochloride (Valtrex). Rechallenge with Shingrix was positive. On 4th December 2020, the outcome of the insomnia was recovered/resolved. On 6th December 2020, the outcome of the headache, nausea, general body pain and chills were recovered/resolved. On an unknown date, the outcome of the shingles, itchy rash and raised rash were unknown.   It was unknown if the reporter considered the shingles, insomnia, headache, nausea, general body pain, chills, itchy rash and raised rash to be related to Shingrix.  Additional details were reported as follows: The patient did not sleep, headache, nausea, body ache chills lasted till 6th December 2020.  In December 2020, less than a week after receiving Shingrix, her rash came back raised up and got a little itchy.  The rash had never been oozy or blistery and Valtrex makes it decrease in intensity.  In December 2020, less than a week after receiving Shingrix, her general practitioner said the rash might be a mild case of shingles, but she would scheduled for a lyme test next week from day of reporting she may see a dermatologist this friday.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR245204:same reporter
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Paraesthesia, Pruritus, Rash papular, Rash pruritic, Sleep disorder
Clinical narrative: didn't sleep; headache; nausea; body ache; chills; rash came back raised up and got a little itchy; raised rash; rash may be a mild case of shingles; This case was reported by a consumer and described the occurrence of shingles in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of rash pruritic (also experienced tingling after receiving 1st dose on 30th August 2020, refer case US2020AMR245204).   On 3rd December 2020, the patient received the 2nd dose of Shingrix. On 3rd December 2020, less than a day after receiving Shingrix, the patient experienced insomnia, headache, nausea, general body pain and chills. In December 2020, the patient experienced shingles, itchy rash and raised rash. The patient was treated with valaciclovir hydrochloride (Valtrex). Rechallenge with Shingrix was positive. On 4th December 2020, the outcome of the insomnia was recovered/resolved. On 6th December 2020, the outcome of the headache, nausea, general body pain and chills were recovered/resolved. On an unknown date, the outcome of the shingles, itchy rash and raised rash were unknown.   It was unknown if the reporter considered the shingles, insomnia, headache, nausea, general body pain, chills, itchy rash and raised rash to be related to Shingrix.  Additional details were reported as follows: The patient did not sleep, headache, nausea, body ache chills lasted till 6th December 2020.  In December 2020, less than a week after receiving Shingrix, her rash came back raised up and got a little itchy.  The rash had never been oozy or blistery and Valtrex makes it decrease in intensity.  In December 2020, less than a week after receiving Shingrix, her general practitioner said the rash might be a mild case of shingles, but she would scheduled for a lyme test next week from day of reporting she may see a dermatologist this friday.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR245204:same reporter
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Vaccine positive rechallenge
Clinical narrative: didn't sleep; headache; nausea; body ache; chills; rash came back raised up and got a little itchy; raised rash; rash may be a mild case of shingles; This case was reported by a consumer and described the occurrence of shingles in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of rash pruritic (also experienced tingling after receiving 1st dose on 30th August 2020, refer case US2020AMR245204).   On 3rd December 2020, the patient received the 2nd dose of Shingrix. On 3rd December 2020, less than a day after receiving Shingrix, the patient experienced insomnia, headache, nausea, general body pain and chills. In December 2020, the patient experienced shingles, itchy rash and raised rash. The patient was treated with valaciclovir hydrochloride (Valtrex). Rechallenge with Shingrix was positive. On 4th December 2020, the outcome of the insomnia was recovered/resolved. On 6th December 2020, the outcome of the headache, nausea, general body pain and chills were recovered/resolved. On an unknown date, the outcome of the shingles, itchy rash and raised rash were unknown.   It was unknown if the reporter considered the shingles, insomnia, headache, nausea, general body pain, chills, itchy rash and raised rash to be related to Shingrix.  Additional details were reported as follows: The patient did not sleep, headache, nausea, body ache chills lasted till 6th December 2020.  In December 2020, less than a week after receiving Shingrix, her rash came back raised up and got a little itchy.  The rash had never been oozy or blistery and Valtrex makes it decrease in intensity.  In December 2020, less than a week after receiving Shingrix, her general practitioner said the rash might be a mild case of shingles, but she would scheduled for a lyme test next week from day of reporting she may see a dermatologist this friday.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR245204:same reporter
Sex: M
Vaccine: VARZOS
Symptoms: Body temperature increased, Palpitations
Clinical narrative: racing heart beat of 100 per minute.; experiencing a fever of 101; This case was reported by a consumer and described the occurrence of heart rate increased in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd January 2021, the patient received the 2nd dose of Shingrix. On 4th January 2021, 1 days after receiving Shingrix, the patient experienced heart rate increased and fever. On an unknown date, the outcome of the heart rate increased and fever were not recovered/not resolved.   It was unknown if the reporter considered the heart rate increased and fever to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not provided. The reporter was patient's wife. The patient received 2nd dose of Shingrix, and experienced increased heart rate of 100 beats per minute and  fever of about 101 degree Celsius. The reporter did not consent to follow up.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration, Myalgia
Clinical narrative: received her two doses / 28 days apart, 08Dec2020 and 05Jan2021; myalgia 3 days after the 2nd dose.; This case was reported by a pharmacist and described the occurrence of myalgia in a 83-year-old female patient who received Herpes zoster (Shingrix) (batch number 3PD3E, expiry date 8th October 2022) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 5th January 2021, the patient received the 2nd dose of Shingrix. On 5th January 2021, unknown after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too short. In January 2021, the patient experienced myalgia. On an unknown date, the outcome of the myalgia was not recovered/not resolved and the outcome of the drug dose administration interval too short was unknown.   It was unknown if the reporter considered the myalgia to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. 3 days after receiving 2nd dose of Shingrix, patient experienced myalgia. The patient received 2nd dose of Shingrix, less than the recommended interval , which led to shortening of vaccination schedule. The reporter did not consent to follow up.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Sore Arm; This case was reported by a consumer and described the occurrence of pain in arm in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th January 2021, the patient received the 1st dose of Shingrix (intramuscular). On 17th January 2021, several hours after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional information are as follows: The patient reported for herself. The patient received dose of shingrix  and experienced after few hours as she began to experience a sore arm. The reporter did not had  lot number or expiration date. The patient was still experiencing some soreness in her arm (unresolved). The reporter did not consented to follow up. No further information was available
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Computerised tomogram normal, Erythema, Injection site cellulitis, Injection site erythema, Injection site swelling
Clinical narrative: It was diagnosed as cellulitis; area gradually became swollen and red; area gradually became swollen and red; right buttock area; This case was reported by a consumer and described the occurrence of injection site cellulitis in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th October 2020, the patient received the 1st dose of Shingrix. On 9th October 2020, several hours after receiving Shingrix, the patient experienced injection site swelling, injection site erythema and vaccine administered at inappropriate site. On an unknown date, the patient experienced injection site cellulitis. The patient was treated with antibiotics nos. On an unknown date, the outcome of the injection site cellulitis and vaccine administered at inappropriate site were unknown and the outcome of the injection site swelling and injection site erythema were recovered/resolved.   It was unknown if the reporter considered the injection site cellulitis, injection site swelling and injection site erythema to be related to Shingrix.  Additional details were provided as follows: The patient received the 1st dose of Shingrix on her right buttock area which led to vaccine administered at inappropriate site. Few hours later, the patient experienced area gradually became swollen and red and the swelling was the size of a softball. The patient was diagnosed with cellulitis and treated with antibiotics in emergency room visit. A CT scan was performed and an abscess was ruled out. The patient recoverd after week and half . The patient felt it was important to note that she is a natural red head and it has been proven that red heads can react strangely to medications. The reporter consented to follow up. No further information was available.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Musculoskeletal pain
Clinical narrative: It was diagnosed as cellulitis; area gradually became swollen and red; area gradually became swollen and red; right buttock area; This case was reported by a consumer and described the occurrence of injection site cellulitis in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th October 2020, the patient received the 1st dose of Shingrix. On 9th October 2020, several hours after receiving Shingrix, the patient experienced injection site swelling, injection site erythema and vaccine administered at inappropriate site. On an unknown date, the patient experienced injection site cellulitis. The patient was treated with antibiotics nos. On an unknown date, the outcome of the injection site cellulitis and vaccine administered at inappropriate site were unknown and the outcome of the injection site swelling and injection site erythema were recovered/resolved.   It was unknown if the reporter considered the injection site cellulitis, injection site swelling and injection site erythema to be related to Shingrix.  Additional details were provided as follows: The patient received the 1st dose of Shingrix on her right buttock area which led to vaccine administered at inappropriate site. Few hours later, the patient experienced area gradually became swollen and red and the swelling was the size of a softball. The patient was diagnosed with cellulitis and treated with antibiotics in emergency room visit. A CT scan was performed and an abscess was ruled out. The patient recoverd after week and half . The patient felt it was important to note that she is a natural red head and it has been proven that red heads can react strangely to medications. The reporter consented to follow up. No further information was available.
Sex: U
Vaccine: COVID19
Symptoms: Guillain-Barre syndrome
Clinical narrative: Potential Guillain-Barre; A spontaneous report was received from a pharmacist concerning an unknown patient who received Moderna's COVID-19 vaccine and potentially developed Guillain-Barre Syndrome.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On an unknown date, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   On 19 Jan 2021, the patient is in the hospital for potential Guillain-Barre Syndrome.  No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the event, potential Guillain-Barre Syndrome, was unknown/ not reported.; Reporter's Comments: This case concerns a patient of unknown age and gender, who experienced a serious unexpected event of potential Guillain-Barre Syndrome which required hospitalization. The event occurred on an unspecified date after first dose of mRNA-1273, lot # unknown. Treatment details were not provided. Very limited information regarding this event has been provided at this time. Based on the current available information and temporal association between the use of the product and onset of the event a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Arrhythmia, Cardiac disorder
Clinical narrative: Arrhythmias; A spontaneous report was received from a consumer concerning a female patient who received Moderna's COVID-19 Vaccine (mRNA-1273), and who experienced arrhythmias.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  Prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   Patient had adverse heart reaction after receiving the vaccination. Patient has some arrhythmias and ended up in the ER two days later. Treatment information was not provided.   Action taken with mRNA-1273 in response to the event was not provided.   The outcome of the events, adverse heart reaction and arrhythmias were not reported.; Reporter's Comments: This case concerns a female patient of unknown age with unknown medical history subject, who experienced a serious unexpected event of arrhythmia. The event occurred on unspecified time after the first dose of mRNA-1273 vaccine (but not later than 2 days after vaccination). Treatment information was reported; however, patient was sent to emergency room.  Outcome of reported arrhythmia is unknown. The event was assessed as possibly related, however additional information has been requested.