chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Drainage, Injection site pain, Nasal congestion, Oropharyngeal pain, Respiratory symptom
Clinical narrative: less than 24 hours after getting shot #1 i felt as if i was coming down with a cold, very congested, stuffy nose, slight sore throat probably from drainage. injection site pain which is normal, but i just felt under the weather. it cleared up within 48 hours of time of injection.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Respiratory tract congestion
Clinical narrative: less than 24 hours after getting shot #1 i felt as if i was coming down with a cold, very congested, stuffy nose, slight sore throat probably from drainage. injection site pain which is normal, but i just felt under the weather. it cleared up within 48 hours of time of injection.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Headache, Nausea, Pain
Clinical narrative: Cold legs, Fever, bodyache including fingers ache, chills, nausea,  body weakness,  headache.  From Saturday to Tuesday.   Tylenol
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia, Sensory disturbance
Clinical narrative: Cold legs, Fever, bodyache including fingers ache, chills, nausea,  body weakness,  headache.  From Saturday to Tuesday.   Tylenol
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: 1 dose of V ARIV AX administered 10/08/2020 after the vaccine experienced a temp excursion; No additional AE details; 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 provided.   On 08-OCT-2020, the patient was vaccinated with a dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot # T000344 and expiration date 05-JAN-2022, frequency and route were not reported) for prophylaxis. It was reported that the suspect vaccine was exposed to a temperature minus 13.5 degree Celsius for a time frame of 8 hours and 55 minutes, the temperature excursions were detected by a data logger. There was no previous temperature excursion. No additional adverse event (AE) information provided.
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event
Clinical narrative: I think it was given IM instead of SQ; This spontaneous report was received from a consumer referring to herself of unknown age. The patient's concomitant medication, pertinent medical history and drug reactions or allergies were not provided.     On 08-DEC-2020, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) (strength and dose were not reported, lot# was reported as T00370, expiration date was not provided) for prophylaxis. The reporter thought the suspect vaccine was given Intramuscular (IV) instead of subcutaneous (SQ). She wanted to know if it was ok if it was given IM.  This agent referenced the varicella virus vaccine live (oka/merck) (VARIVAX)  prescribing information (PI) regarding route of administration and method of administration. This agent referred the reporter to her healthcare provider. The reporter verbalized understanding and said if it was given IM instead of SQ she would call back.
Age: 55.0
Sex: U
Vaccine: PPV, UNK
Symptoms: Product storage error
Clinical narrative: No additional information was provided regarding if the consumer experienced any side effects; PNEUMOVAX 23 was administered on 23 NOV 2020 after the excursion occurred; This spontaneous report was received from a registered nurse and refers to a 55-year-old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 23-NOV-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection in prefilled syringe, lot # T022294, expiration date: 26-MAR-2022, 1 time dose (injection site and route of administration were not provided) for prophylaxis.  The administered vaccine had experienced a temperature excursion of above 9 degrees Celsius (C) (13.5 C) for 3 hours. The digital data logger was involved in recording the temperature excursion details. No previous temperature excursion had occurred. No adverse effects were reported. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T022294; expirationdate: 26-MAR-2022; 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: VARZOS
Symptoms: Rash pruritic
Clinical narrative: Rash pruritic; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of an unknown age and gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 28-AUG-2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot #, expiration date, dose, dose # and route not specified) for the long-term prevention of singles and zoster-related conditions. Subsequently on an unknown date, the patient was treated for painful itching rash (rash pruritic). The outcome of the event was unknown. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).  Additional information was received on 22-DEC-2020 from a Licensed Practical Nurse via medical records concerning a patient of unknown age and gender who had risk factor for hepatitis C. On 28-AUG-2015, the pt. was vaccinated with zoster vaccine live (ZOSTAVAX) 0.65 ml subcutaneously in left arm (lot # L015416 with expiration date of 01-AUG-2016 with sterile diluent with expiration date of 15-MAY-2016.
Age: 1.5
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: A pediatric patient was administered VAQTA (pediatric dose vial ) that was past expiration date.; This spontaneous report was received from a Nurse Practitioner referring to an 18 month old patient. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported.     On 03-DEC-2020, the pediatric patient was vaccinated with hepatitis a vaccine, inactivated(VAQTA)(strength, route, dose, frequency, and  anatomical location were unknown) pediatric dose vial that was past expiration date, with lot # S034636 and expiration date 14-NOV-2020, for prophylaxis.
Sex: U
Vaccine: MMR
Symptoms: Product storage error
Clinical narrative: temperature excursion for MMR II; No additional AEs; This spontaneous report was received from a medical assistant referring to patients of unknown age and gender. Information regarding the patients' pertinent medical history, concurrent condition, drug reactions/allergies and concomitant medication were not provided.  On unknown dates, these patients received improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (formulation, strength, route, vaccination scheme and anatomical sites of vaccination were not reported, lot # S015284, expiration date 19-MAY-2021) for prophylaxis. The vaccine administered experienced a temperature excursion of 52.3 degrees Fahrenheit, for a time frame of 1 hour and 45 minutes. There were no previous temperature excursions. The call was not due to digital data logger. Due to Coronavirus (COVID-19), no one could monitor the data logger information. No additional adverse events reported.  This case has been considered non-valid due to the lack of patients' identifiers.
Age: 4.0
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered
Clinical narrative: Caller is reporting a 4 year old given PROQUAD AND VARIVAX at the same time.; Caller reports no other AE with this event.; This spontaneous report was received from a caller and refers to a 4-year-old patient of an unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On an unknown date, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) 0.5 milliliter (route of administration, anatomical location, lot # and expiration date were not reported) and varicella virus vaccine live (Oka/Merck) (VARIVAX) 0.5 milliliter (route of administration, anatomical location, lot # and expiration date were not reported) at the same time (inappropriate schedule of product administration). Both vaccines were administered for prophylaxis. There was no other adverse event reported.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: temperature excursion involving PROQUAD; 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 07-DEC-2020, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD) 0.5 milliliter, lot number T011302 (conflicting information as it was also reported as T021302), expiration date 19-FEB-2021 (route of administration not provided) for prophylaxis.  The vaccine had a temperature excursion of -5 degrees Celsius for 20 hours. There were no previous temperature excursions. The call was due to digital data logger.  This is one of several cases reported by the same reporter.; Sender's Comments:  US-009507513-2012USA010555: US-009507513-2012USA010579: US-009507513-2012USA010585: US-009507513-2012USA010590: US-009507513-2012USA010592: US-009507513-2012USA010629: US-009507513-2012USA010652: US-009507513-2012USA010667: US-009507513-2012USA010678: US-009507513-2012USA010683: US-009507513-2012USA010686: US-009507513-2012USA010698: US-009507513-2012USA010722: US-009507513-2012USA010725: US-009507513-2012USA011227:
Age: 65.0
Sex: F
Vaccine: PPV, UNK
Symptoms: Injection site swelling, Muscle spasms, Pyrexia, Vomiting
Clinical narrative: bad reaction; leg cramps; swelling at the injection site; vomiting; fever; This spontaneous report has been received from a 65 years old (currently was 67 years old) female patient. Concomitant therapies included levothyroxine sodium (SYNTHROID). The patient was allergic to sulfa. Information about medical history and concurrent conditions was not provided.     On 13-JUL-2018, the patient was vaccinated with 1 dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (lot #, expiration date and dose details were not provided) intramuscularly for prevention of pneumococcal disease. On an unknown date, the patient started therapy with generic formulation of atorvastatin calcium (LIPITOR) (lot #, expiration date, strength, route and dose details were not provided) for unknown indication.   On 13-JUL-2018, 6 hours after administration of the vaccine, the patient experienced swelling at the injection site, fever and vomiting. On an unknown date, the patient had a bad reaction after vaccination of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23). On an unknown date, the patient experienced leg cramps from the generic formulation of atorvastatin calcium (LIPITOR). The patient was seen by her doctor on 14-JUL-2018 (reported as the next day) and did not recall if any treatment was provided for her symptoms or when she recovered from these symptoms.      At the time of this report, the outcome of the events was unknown. The causality assessment between the events and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was not provided.
Age: 1.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered, Product administered to patient of inappropriate age
Clinical narrative: No adverse event; a baby was administered a adult dose of VAQTA; the vaccine was expired; This spontaneous report was received from a medical assistant (also reported as nurse) referring to a 1-year-old female patient. The patient's concomitant medication, drug reactions, allergies and medical history were unknown.     On 23-DEC-2020, the patient was vaccinated with an adult dose of hepatitis a vaccine, inactivated (VAQTA) 1ml, once, lot # S030588 with expiration date 20-OCT-2020 (route of administration was not reported) for prophylaxis (incorrect dosage administered, no adverse event and expired product administered). No additional adverse event (AE) was reported.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: no additional AE/PQC reported; administration of improperly stored PROQUAD; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medications were not reported.   On 23-SEP-2020, the patient was vaccinated with improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (albumin status: recombinant Human albumin (rHA) (PROQUAD) lot # T015598, expiration date 02-NOV-2021 for prophylaxis (exact dose, strength, dose #, route of administration and anatomical location were not provided).   The temperature excursion was as follows: 20.5 degrees Fahrenheit (F) for 1 hour and 54 minutes. There was following previous excursion: from 6 degrees Fahrenheit to 14 degrees Fahrenheit (12.3 F) for 23 hours. The digital data logger was involved. No additional adverse events were reported.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: No additional AE; administration of improperly stored VARlVAX; This spontaneous report was received from a caller (unspecified) informing agent of the administration and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 15-SEP-2020, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # T002842, expiration date 23-JAN-2022 (dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of -8 to -14 degrees Celsius from 05-SEP-2020 to 15-SEP-2020. Data logger was involved. There were no previous excursions reported.
Age: 1.0
Sex: U
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: No additional AE; the MMRII expired on 12/9/2020 and was inadvertently administered to the patient on 12/23/2020; This spontaneous report has been received from a licensed practical nurse concerning a 1 year old of unknown gender. The patient's concurrent conditions, historical drugs, medical history and concomitant therapies were not reported.    On 23-DEC-2020, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA)(M-M-R II) 0.5 ml,  Lot # R035700, expiration date 09-DEC-2020 for prophylaxis (dosage regimen was not reported).   It was reported that no additional adverse events were reported (AE) and that the measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live did not experience any temperature excursion.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: administration of improperly stored PROQUAD; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. Information regarding the patient's  medical history, concurrent conditions and concomitant medications was not provided. On 29-SEP-2020, the patient was vaccinated with improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) lot # T015598 with expiration date of 02-NOV-2021, for prophylaxis.  The administered vaccine experimented temperature of excursión of 20.5 degrees Fahrenheit for 1 hour 54 minutes 0 seconds; previous temperature excursion? 6 degrees Fahrenheit  to 14 degrees Fahrenheit  (12.3F) for 23 hours 0 minutes  0seconds. Digital data logger was involved.
Age: 7.0
Sex: M
Vaccine: MMR
Symptoms: Anaphylactic reaction
Clinical narrative: anaphylactic reaction; This spontaneous report has been received from an approximately 57 years old male patient, referring to himself via Pfizer. The patient's concurrent conditions included an allergy to eggs. Medical history and concomitant medications were not provided.   On an unknown date in 1970 (reported at the age of 7 years old), the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (dose, frequency, route, lot number and expiration date were not provided) for prophylaxis.      In approximately 1970, the patient experienced an anaphylactic reaction and required treatment with epinephrine. The patient worked in a long term care assisted living facility and was unable to obtain the mRNA, lipids ((4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate), 2 [(polyethylene glycol)-2000]-N,N-ditetradecylacetamide, 1,2-Distearoyl-sn-glycero-3-phosphocholine, and cholesterol), potassium chloride, monobasic potassium phosphate, sodium chloride, dibasic sodium phosphate dihydrate, and sucrose (COVID-19) vaccine (Pfizer-Biontech) due to the facility refused to vaccinate him after the patient divulged that he had the previously reaction with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) vaccine.   The outcome of anaphylactic reaction was unknown.   The reporter considered anaphylactic reaction to be related to Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live(M-M-R II).  Upon internal review, anaphylactic reaction was determined to be medically significant.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Syncope
Clinical narrative: Syncope; This spontaneous report as received from a pharmacist, and refers to a 66 year old female patient with asthma. The patient is allergic to sulfa, novocaine and lidocaine. Information regarding the patient's medical history was not reported.     On 27-DEC-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) lot # T022294 and expiration date on 26-MAR-2022, intramuscular in the left deltoid for pneumococcal prophylaxis. On the same day, she had a syncope. The patient did not seek for medical attention and any treatment was given.   At the reporting time, reported as "this morning", the syncope was improving but ongoing.   The reporter considered syncope to be related to Pneumococcal Vaccine, Polyvalent (23-valent)(PNEUMOVAX23).  Upon internal review, the event of syncope was considered to be medically significant. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T022294; expirationdate: 26-MAR-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
Sex: F
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: No additional AE; multiple temperature excursions/multiple doses of ROTATEQ were administered to multiple patients; This spontaneous report was received from an office administrator referring to an infant female patient of unknown age. Information regarding the patient's pertinent medical history, historical drugs, concurrent conditions, concomitant therapies, and previous drug reactions or allergies was not reported.      On 08-NOV-2020, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # 1661000, expiration date 13-MAY-2021, at a dose of 2 milliliter once, orally for prophylaxis. There were multiple temperature excursions (temperature values and time frames were not reported) recorded by a data logger.  No addtional adverse event reported.  This is one of several reports received from the same reporter.
Sex: M
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: No additional AE; multiple temperature excursions/multiple doses of ROTATEQ were administered to multiple patients; This spontaneous report was received from an office administrator referring to an infant male patient of unknown age. Information regarding the patient's pertinent medical history, historical drugs, concurrent conditions, concomitant therapies, and previous drug reactions or allergies was not reported.      On 08-NOV-2020, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # 1661000, expiration date 13-MAY-2021, at a dose of 2 milliliter once, orally for prophylaxis. There were multiple temperature excursions (temperature values and time frames were not reported) recorded by a data logger. No addtional adverse event reported.   This is one of several reports received from the same reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Cerebrovascular accident, Confusional state, Dementia, Encephalitis, Gait disturbance
Clinical narrative: cerebrovascular accident/right leg weakness, numbness, trouble ambulating and confusion/concomitant weakness related to his cerebrovascular accident; meningoencephalitis; dementia; Information has been received from a lawyer, regarding a case in litigation, and refers to a male patient (pt) of unknown age. No information about the pt's medical history, concurrent conditions and concomitant medications was provided. On or around 29-DEC-2017, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On unknown dates, shortly after receiving zoster vaccine live (ZOSTAVAX), the pt suffered right leg weakness, numbness, trouble ambulating and confusion. The pt was diagnosed with having a cerebrovascular accident, meningoencephalitis and dementia with concomitant weakness related to his cerebrovascular accident. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt's symptoms had resulted in physical limitations not present prior to using the suspect vaccine. The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence, the pt 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 and injury. As a direct and proximate result, the pt had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was considered to be not recovered/not resolved. The reporter considered the events of cerebrovascular accident, encephalitis, and dementia to be related to zoster vaccine live (ZOSTAVAX).  The reporter considered the events of cerebrovascular accident, encephalitis, and dementia to be disabling.
Sex: M
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Muscular weakness
Clinical narrative: cerebrovascular accident/right leg weakness, numbness, trouble ambulating and confusion/concomitant weakness related to his cerebrovascular accident; meningoencephalitis; dementia; Information has been received from a lawyer, regarding a case in litigation, and refers to a male patient (pt) of unknown age. No information about the pt's medical history, concurrent conditions and concomitant medications was provided. On or around 29-DEC-2017, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On unknown dates, shortly after receiving zoster vaccine live (ZOSTAVAX), the pt suffered right leg weakness, numbness, trouble ambulating and confusion. The pt was diagnosed with having a cerebrovascular accident, meningoencephalitis and dementia with concomitant weakness related to his cerebrovascular accident. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt's symptoms had resulted in physical limitations not present prior to using the suspect vaccine. The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence, the pt 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 and injury. As a direct and proximate result, the pt had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was considered to be not recovered/not resolved. The reporter considered the events of cerebrovascular accident, encephalitis, and dementia to be related to zoster vaccine live (ZOSTAVAX).  The reporter considered the events of cerebrovascular accident, encephalitis, and dementia to be disabling.
Sex: F
Vaccine: VARZOS
Symptoms: Cardiac failure congestive, Lung disorder, Renal failure
Clinical narrative: congestive heart failure; renal failure; lung problems; Information has been received regarding a case in litigation from an attorney concerning a female patient of unknown age. The patient's pertinent medical history, concurrent conditions or concomitant medications were not provided. On unspecified date, the patient received a dose of Zoster Vaccine Live (ZOSTAVAX) (lot #, expiration date, route of administration, dosage, and anatomical location were not provided) for prevention of shingles. After receiving the dose of Zoster Vaccine Live (ZOSTAVAX), the patient suffered congestive heart failure, lung problems and renal failure. As a result of these symptoms, the patient was seen and treated by the medical provider and was still under their care. As a direct and proximate result of vaccination, the patient's symptoms have resulted in physical limitations not present prior the use of this vaccine, and the patient sustained severe and permanent personal and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. At the time of the report, the reporter considered the events to be related to Zoster Vaccine Live (ZOSTAVAX). The patient had not recovered from the events, and the author considered the events to be disabling.  Upon internal review cardiac failure congestive and renal failure were considered medically significant.
Age: 1.0
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: No other AE; Caller reports AE related to administration of expired PROQUAD.; Excursion occurred 11/17/2020; This spontaneous report was received from an office manager, referring to a 12-months-old male patient. The patient's pertinent medical history, current conditions, previous drug reactions or allergies and concomitant medications were not reported.   On 17-NOV-2020, a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) (lot number T016991, which has been verified to be valid, expiration date reported and validated as 11-NOV-2021) experienced temperature excursion (product storage error).  On 07-DEC-2020, the patient received the mentioned vaccine, which was expired (expired product administered ) at a dose of 0.5 milliliter, as prophylaxis (formulation, strength, vaccination scheme, anatomical site of vaccination and route of administration were not provided). No additional adverse events were reported.  This is one of several reports received from the same reporter.
Sex: U
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: temperature excursion; This spontaneous report was received from a registered nurse and refers to currently 11-year-old patient of unknown gender.   There was no information about patient's concomitant medications, concurrent conditions or pertinent medical history.  On an unknown date, the patient was vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot number 1637641 with expiration date 16-FEB-2022 (dose, route, and anatomical location were not reported) which where stored at temperature excursion. The hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) was exposed to temperatures between 0.3 and 11 degrees Celsius during 4 hours 45 minutes and 1 hour, 30 minutes respectively. There was previous temperature excursion of 17 degrees Celsius during 2 hours and 42 minutes. Data digital logger was filled.  This is one of several reports from the same source. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1637641; expirationdate: 16-FEB-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
Age: 14.0
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration
Clinical narrative: a patient received the GARDASIL 9 vaccine on 19-JUL-2019. They have not received their second dose yet; No additional AE was reported; This spontaneous report was received from an administrator and refers to a 14-year-old patient of unknown gender. There was no information about patient's concomitant medications, concurrent conditions or pertinent medical history.  On 19-JUL-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) (dose, route, anatomical location, lot number and expiration date were not reported) for prophylaxis. At the time of the report, the patient had not received the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9). No additional adverse event was reported.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: she denies any further AE/PQC; patient has received the vaccine prior temperature excursion; This spontaneous report was received from a medical assistant, referring to a patient of unknown age and gender. The patient's pertinent medical history, current conditions, previous drug reactions or allergies and concomitant medications were not reported.   On 28-DEC-2020, the patient received an improperly stored (product storage error) dose of varicella virus vaccine live (oka/merck) (VARIVAX), at a dose of 0.5 milliliter (ml), as prophylaxis (formulation, strength, vaccination scheme, route of administration and anatomical site of vaccination were not reported; lot number T021828, which has been verified to be valid, expiration date reported and validated as 25-JUN-2022). The vaccine administered experienced a temperature excursion of -6.7 degrees Celsius, for a time frame of 22 hours, as recorded by a data logger. There was no previous temperature excursion reported. No additional adverse event were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2012USA013452:
Sex: F
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: patient received an improperly stored vaccine; This spontaneous report as received from a medical assistant refers to a currently 5 year old female patient. On an unknown date, the patient was vaccinated with a 0.5 mL dose of improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # T025221 exp date 19-JAN-2022) (route not reported) first identified on 28-DEC-2020. There was a data logger issue reported. The temperature of excursion was -6.7 °C for a time frame of 22 hours. There was no previous temperature of excursion.
Sex: U
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: improperly stored ROTATEQ was administered; This spontaneous report as received from a nurse refers to a 2 month old patient. On 28-DEC-2020, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot # 1660991 exp date 27-APR-2021) orally. Data logger issue was reported. The temperature of excursion was 9°C (8.5 °C) for a time frame of 2 hours and above 9 °C (8.5 °C) for a time frame of 2 hours. There was no previous temperature excursion.
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Inappropriate schedule of product administration
Clinical narrative: No adverse event; Pneumococcal received on 31-JUL-2014 and 14-SEP-2016; This spontaneous report was received from a 65-year-old female patient, concerning to herself. The patient's medical history, previous drug reactions or allergies and concomitant medications were not reported.      On 31-JUL-2014, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (reported as "pneumococcal") for prophylaxis. (strength, dose, route of administration, anatomical location, lot # and expiration date were not provided). On 14-SEP-2016, it was reported that another doses of pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (reported as pneumococcal") was administered (inappropriate schedule of product administration). No adverse event involved with vaccine reported.  This is one of two reports received from the same patient.; Sender's Comments:  US-009507513-2004USA006765:
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Peripheral swelling
Clinical narrative: severe swelling in the arm, so bad it looked like cellulitis/ severe reaction; severe swelling in the arm, so bad it looked like cellulitis/ severe reaction; This spontaneous report was received from a female patient of unknown age who was reporting on herself. There was no information about the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant therapies provided.  On 25-SEP-2018, she was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (dose, route of administration, anatomical location, strength, lot number and expiration date were not provided) for prophylaxis. The patient requested ingredients contained in pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) because on an unknown date in September 2018 she experienced severe swelling in the arm. The swelling looked so bad, like cellulitis. She sought for medical attention and informed her physician about this event, but also refused to inform if ant treatment was provided. The outcome of arm swelling looking like cellulitis was unknown.  The reporter did not provide a causal assessment between the mentioned events and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23). Upon internal review, cellulitis was determined to be medically significant.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect dose administered
Clinical narrative: No other AE; The patient did not receive the full dose of GARDASIL 9; The patient did not receive the full dose of GARDASIL 9; This spontaneous report as received from a nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant therapies provided.  On 26-OCT-2020 and on 28-DEC-2020, the patient was vaccinated respectively first and second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) prefilled syringe (dose, route of administration, anatomical location, strength, lot number and expiration date were not provided) for prophylaxis.  28-DEC-2020, during the second vaccination, the needle broke (product administration interrupted) and therefore patient did not receive the full dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (underdose). There was no product quality complain (PQC) because the needle was made by other manufacturer. No other adverse event (AE) was reported. Due to that the patient did not received full dose of vaccine the dose was determined to be invalid. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; 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: HEPA, UNK
Symptoms: Expired product administered
Clinical narrative: patient was given expired VAQTA; This spontaneous report as received from a medical assistant and refers to a 39-year-old male patient of unknown gender. There was no information about the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant therapies provided.  On 28-DEC-2020, the patient was vaccinated with expired dose of hepatitis a vaccine, inactivated (VAQTA) 0.5 milliliter, intramuscular injection (anatomical location and strength were not provided) lot # S025258, expiration date 05-NOV-2020, for prophylaxis. At the reporting time the patient seems to be fine and have not sought for medical attention. No product quality complain was present. The patient did not die and the event of administration of expired vaccine was not life threatening. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S025258; expirationdate: 05-NOV-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
Age: 0.33
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: Caller reported temperature excursion; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 24-FEB-2020, the patient was vaccinated with an improperly stored of varicella virus vaccine live (oka/merck)(VARIVAX) 0.5 milliliter, for prophylaxis (lot # T017688 has been verified to be a valid lot number varicella virus vaccine live (oka/merck), expiration date reported and establish as 21-MAY-2022) (strength, route of administration and anatomical location were not provided).  The temperature of storage and time frame of the excursion were -13.3° Celsius (C) for 4 hours and 15 minutes respectively.  A digital data logger was involved, and there was not previous temperature excursion.
Age: 0.5
Sex: U
Vaccine: RV5
Symptoms: Incorrect dose administered
Clinical narrative: No additional AE reported; ROTATEQ improperly stored and administered; This spontaneous report was received from a medical assistance, referring to a 6 months patient of unknown gender. The patient's historical drugs, medical history, concomitant therapies, drugs allergies and concurrent conditions were not reported.   On 28-DEC-2020, the patient was vaccinated with improperly stored dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) orally, lot # 1684157, expiration date 26-JUN-2021, for prophylaxis (strength, dose and frequency were not reported).   The temperature excursion was of 32.1 Fahrenheit degrees (°F) for an hour. A previous temperature excursion was not reported. A digital data logger was involved. No adverse effects were reported.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Menstruation irregular
Clinical narrative: another 1-2 days later, the patient got another full cycle period again; This spontaneous report as received from a physician concerning a 12-year-old female patient.There was no information about the patient's medical history or concomitant medication. The patient had completed her normal menstrual cycle and 1-2 days later got the shot, date unspecified. 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) for prophylaxis  (dose, route of administration, lot number and expiration date were not reported).  After receiving the shot, another 1-2 days later (on an unknown date), the patient got another full cycle period again(menstruation irregular). The patient's parent was concerned and thought maybe it had to do with the of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9)  injection and the parent was now hesitant for the patient to receive the second dose. The physician is now requesting information on of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) and menstrual cycles. No additional information. No PQC reported. The outcome of menstruation irregular was unknown.The physician did not asses de causal relationship between the HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast)(GARDASIL 9) and the event. The  patient's parent  was concerned and thought maybe it had to do with the vaccine.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Abdominal pain upper, Blindness transient, Chills, Dizziness, Feeling cold
Clinical narrative: she passed out; she couldn't see; sick; stomach started to hurt; had chills; her arms hurt; she was freezing; her arm had swollen like a balloon; her arm had swollen like a balloon and became hard as a rock; hit her head; dizzy; she couldn't walk around her house; Her heart was "loudly" palpating; extremely low blood pressure/Her heart was "loudly" palpating; This spontaneous report as received from a consumer concerning herself a 67  year old patient. Pertinent medical history, drug reactions and allergies, and concomitant medications were reported as none.  Early in June 2017, the patient was vaccinated with a second dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) in the left arm for prophylaxis (route of administration, lot number and expiration date were not reported).   In June 2017, reported as later that same date after received the vaccine, she started to feel sick. She reported that her stomach started to hurt, had chills, and her arms hurt. As the day progressed, her sickness continually "got worse and worse". She reported that she was freezing despite tons of clothing and layers on. The next day her arm had swollen like a balloon and became hard as a rock. At one point she passed out and hit her head on her dresser. When she woke up, she couldn't see, and eventually her sight came back in blobs/spots (blindness transient). Over the next week, approximately in June 2017, it progressively became worse and she reported being so dizzy that she couldn't walk (blindness transient) around her house without grabbing onto a wall (Gait inability). Her heart was "loudly" palpating (Heart rate decreased) and she had an extremely low blood pressure. One doctor told her that her "heart is just not operating as it should", however a different doctor said her heart was fine. After completing a detox, changing her diet, and taking vitamin supplements she slowly started feeling better (also reported as not recovered by the same reporter). She reported that she "hasn't been the same" since she received that re-vaccination. She still currently experienced dizziness from time to time and was afraid to take the COVlD-19 vaccine due to her adverse experience with the pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) vaccine. None laboratory test was performed  The outcome of illness, hypotension, heart rate decreased, gait inability, dizziness, head injury, induration, peripheral swelling, feeling cold, pain in extremity, chills and abdominal pain upper was reported as not recovered. The outcome of loss of consciousness and blindness transient was reported as recovered, on an unspecified date in 2017 (conflicting information also reported as not recovered).        The causal relationship between the events and therapy with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) was  assessed as related  by reporter.  Upon internal review the events of passed out and she couldn't see (Blindness transient )was considered to be medically significant.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Gait disturbance, Head injury, Heart rate decreased, Hypotension, Induration
Clinical narrative: she passed out; she couldn't see; sick; stomach started to hurt; had chills; her arms hurt; she was freezing; her arm had swollen like a balloon; her arm had swollen like a balloon and became hard as a rock; hit her head; dizzy; she couldn't walk around her house; Her heart was "loudly" palpating; extremely low blood pressure/Her heart was "loudly" palpating; This spontaneous report as received from a consumer concerning herself a 67  year old patient. Pertinent medical history, drug reactions and allergies, and concomitant medications were reported as none.  Early in June 2017, the patient was vaccinated with a second dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) in the left arm for prophylaxis (route of administration, lot number and expiration date were not reported).   In June 2017, reported as later that same date after received the vaccine, she started to feel sick. She reported that her stomach started to hurt, had chills, and her arms hurt. As the day progressed, her sickness continually "got worse and worse". She reported that she was freezing despite tons of clothing and layers on. The next day her arm had swollen like a balloon and became hard as a rock. At one point she passed out and hit her head on her dresser. When she woke up, she couldn't see, and eventually her sight came back in blobs/spots (blindness transient). Over the next week, approximately in June 2017, it progressively became worse and she reported being so dizzy that she couldn't walk (blindness transient) around her house without grabbing onto a wall (Gait inability). Her heart was "loudly" palpating (Heart rate decreased) and she had an extremely low blood pressure. One doctor told her that her "heart is just not operating as it should", however a different doctor said her heart was fine. After completing a detox, changing her diet, and taking vitamin supplements she slowly started feeling better (also reported as not recovered by the same reporter). She reported that she "hasn't been the same" since she received that re-vaccination. She still currently experienced dizziness from time to time and was afraid to take the COVlD-19 vaccine due to her adverse experience with the pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) vaccine. None laboratory test was performed  The outcome of illness, hypotension, heart rate decreased, gait inability, dizziness, head injury, induration, peripheral swelling, feeling cold, pain in extremity, chills and abdominal pain upper was reported as not recovered. The outcome of loss of consciousness and blindness transient was reported as recovered, on an unspecified date in 2017 (conflicting information also reported as not recovered).        The causal relationship between the events and therapy with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) was  assessed as related  by reporter.  Upon internal review the events of passed out and she couldn't see (Blindness transient )was considered to be medically significant.