chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: MMR
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: No adverse effects reported; patient was administered M-M-R II intramuscularly instead of subcutaneously; This spontaneous report was received from a licensed practical nurse and refers to a 66-year-old female patient. The patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications were not reported.  On 25-SEP-2019, the patient was vaccinated with properly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant Human Albumin (rHA))(M-M-R II) injection, lot number S010706, expiration date 08-APR-2021 (dose and site of administration were not reported) for prophylaxis. The patient was administered measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant Human Albumin (rHA))(M-M-R II) intramuscularly instead of subcutaneously, which was considered to be a medication error. The vaccine was reconstituted with properly stored sterile diluent (STERILE WATER), lot number S015086, expiration date reported as 06-FEB-2022. The patient was receiving measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant Human Albumin (rHA))(M-M-R II) as she worked with college students and it was a job recommended vaccine. No adverse events were reported.
Sex: F
Vaccine: HEP, MMR, UNK, VARCEL
Symptoms: Hepatitis B antibody negative
Clinical narrative: The patient has a "negative titer for Hepatitis B".; This spontaneous report has been received from an employee concerning a 20 year old non-pregnant female patient. The patient's concurrent conditions were not provided. She had no concomitant medications or pertinent medical history.  On unspecified dates, the patient was vaccinated with doses of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), varicella virus vaccine live (oka/merck) (VARIVAX) and hepatitis b vaccine (recombinant) (RECOMBIVAX HB) (routes of administration, anatomical locations, lot numbers and expiration dates were not provided), as routine vaccination for the prevention of measles, mumps, rubella, varicella and hepatitis B. Other suspect therapies included sterile diluent (MERCK STERILE DILUENT) (route of administration, lot number and expiration date were not provided).  On an unknown date in September 2019, the patient had a measles, mumps, and rubella; varicella virus and hepatitis B titer, and the results showed that the patient had immunity to measles, mumps, rubella and varicella. The results also showed a negative titer for Hepatitis B (hepatitis B antibody negative). It was reported that the patient did not seek medical attention and no treatment was given for the event.  The outcome of hepatitis B antibody negative was assessed as not recovered.   The causal relationship between the suspect therapies and the event was unknown.
Age: 19.0
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: consumer reports no adverse effects; she received a dose of GARDASIL9 during pregnancy.; This spontaneous prospective pregnancy report was received from a 19 year old female patient, reporting on herself. The patient had no pertinent medical history, concomitant medications, concurrent conditions or drug allergies or reactions.      On 26-AUG-2019,  the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), by injection, for prophylaxis (dose number, route of administration, anatomical location, lot number and expiration date were not reported).       On 07-SEP-2019, the patient underwent urinary and clinic pregnancy test, and she discovered that she was pregnant. The gestation period by the time of reporting was approximately 2 months; therefore, the patient's last menstrual period (LMP) was on approximately 01-AUG-2019 and exposure to hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) occurred at about 3 weeks of pregnancy. Her estimated date of delivery (EDD) was 07-MAY-2020. The pregnancy outcome was pending. Aside from being pregnant, the patient reported no adverse events.
Age: 14.0
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse effects reported; the one 14-year-old patient was inadvertently administered one adult dose of VAQTA; This spontaneous report was received from a pharmacy technician and refers to a 14-year-old patient of unknown gender. No information regarding the patient's concurrent conditions, medical history or concomitant medications was provided. On 24-SEP-2019, the patient was inadvertently administered one adult dose of hepatitis a vaccine, inactivated (VAQTA) 1 dosage form, expiration date: 06-MAR-2020 (exact dose, frequency, route of administration and lot# were not reported). No adverse effects were reported.
Age: 48.0
Sex: M
Vaccine: PPV
Symptoms: Injection site rash, Injection site swelling
Clinical narrative: a rash and swelling at the injection site; a rash and swelling at the injection site; This spontaneous report was received from an office manager and refers to a 48-year-old male patient. There was no information about the patient's concurrent condition, concomitant medication and medically history provided.  On 25-SEP-2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, lot number S013490, expiration date 06-MAR-2019, for vaccination (dose and route of administration was not provided).  On 27-SEP-2019, the patient experienced rash and swelling at the injection site. The patient sought medical attention and he called medical practice.  The outcome of the event was unknown. The causality assessment was not provided.  The office manager is requesting a lot check.; Sender's Comments:  US-009507513-1910USA003395: US-009507513-1910USA003334:
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain
Clinical narrative: The college student reported she experienced" a lot of pain" at the injection site; This spontaneous report was received from a pharmacist, via a company representative, referring to a female patient of unknown age, who was a "college student". Information regarding medical history, concurrent conditions or concomitant medication was not provided.  On an unknown date (reported a many years ago), the patient received a dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) for prophylaxis (route of vaccination, dosage information, lot number and expiration date unknown by the reporter)   On an unknown date (also reported a many years ago), she experienced" a lot of pain" at the injection site. It was unknown if treatment was given for the adverse event, if laboratory diagnostics or studies were performed, or if the patient sought medical attention.  The outcome of injection site pain was unknown. The causality assessment was not provided.
Sex: M
Vaccine: VARZOS
Symptoms: Facial asymmetry, Facial paralysis, Headache
Clinical narrative: Bell's Palsy/developed sudden left-sided facial paralysis with notable facial droop and headache; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unspecified age. Information about the patient's concurrent condition, concomitant medication or medical history was not provided. On or around 08-DEC-2011 the patient was vaccinated with zoster vaccine live(ZOSTAVAX) (strength, dose, route, lot # and expiration date were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unspecified date (reported as shortly after the vaccination, unsure it's in December 2011 or 2012), the patient developed sudden left-sided facial paralysis with notable facial droop and headache. He presented to the emergency room, was diagnosed with Bell's Palsy and prescribed valacyclovir (VALTREX) with a prednisone taper. The patient continued to seek treatment and follow up care with a neurologist for ongoing facial asymmetry symptom's as a result of the Bell's Palsy. As the result of vaccine live(ZOSTAVAX), the patient suffered severe, 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. He also suffered medical expenses, the loss of accumulations and other economic and non-economic damages. The outcome of Bell's Palsy was not recovered. The reporter considered the event to be disable and related to Zoster Vaccine Live(ZOSTAVAX). Upon internal review, Bell's Palsy was determined to be medically significant.
Sex: M
Vaccine: MMR
Symptoms: Antibody test negative, Measles antibody negative, Mumps antibody test negative, Rubella antibody positive
Clinical narrative: Falls in the equivocal range for measles and mumps; This spontaneous report was received from a consumer refers to a 15 year old male patient. The patient's medical history, concurrent condition and concomitant history were unknown. On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (strength, dose, frequency, route of administration, lot # and expiry date unspecified) for prophylaxis. On an unknown date in 2019 (also reported as "recently"), the patient's measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II)-titer showed the patient was immune to Rubella, but falls in the equivocal range for Measles & Mumps (antibody test negative). The reporter also stated that he would love to give to the patient only the vaccines he needs, and vaccines that do not contain RA273, WI-38, or MRC-5. The outcome of antibody test negative was unknown. Causality assessment was not provided by the reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received from a lawyer regarding a case in litigation concerning a male patient(pt) of unknown age. The pt's medical history, concurrent conditions and concomitant medications were not provided. In 2018, the pt was inoculated with zoster vaccine live(ZOSTAVAX)(dose, route of administration, anatomical location, lot#, expiration date were unknown) at a pharmacy for the long-term prevention of shingles and/or zoster-related conditions. Subsequent to zoster vaccine live(ZOSTAVAX) inoculation, the pt was treated by a healthcare provider for shingles. As a direct and proximate result of zoster vaccine live(ZOSTAVAX), the pt had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: treated by a healthcare provider for shingles; Information has been received from a lawyer and the patient regarding a case in litigation concerning a male patient of unknown age. No information was provided regarding the patient's past medical history, concurrent conditions, or concomitant medication. In 2013, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (lot number, dosage and route of administration not provided) by a health care provider for the long term prevention of shingles and zoster related conditions. Subsequent to the patient's vaccination, he was treated by a healthcare provider for shingles. As a direct and proximate result of patient's vaccination, he would continue suffer ongoing injuries including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future.    The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX). The outcome of shingles was unknown.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: patient was treated by a healthcare provider for shingles; Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was provided regarding the patient's past medical history, concurrent conditions, or concomitant medication.  On or about 19-FEB-2009, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (lot number, dosage and route of administration not provided) at a pharmacy for for the long-term prevention of shingles and zoster-related conditions.  Subsequent to the patient's vaccination, the patient was treated by a healthcare provider for shingles. As a direct and proximate result of patient's vaccination, she had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The reporter considered shingles to be related to zoster vaccine live (ZOSTAVAX).  The outcome of shingles was unknown.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: received improperly stored vaccine; This spontaneous report was received from a physician referring to a patient of unknown age and gender. The patient's pertinent concurrent condition, medical history, drug reactions/allergies and concomitant therapy were not reported. On an unknown date, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (strength, frequency, anatomical location and route were not reported) (1 dosage form and lot # S007075 with expiration date of 06-SEP-2020) for prophylaxis (product storage error). The outcome of product storage error was unknown. It was reported that the vaccine was exposed to a temperature of 32.5 degree Fahrenheit for a time frame of 8 hours. There was no previous temperature excursion reported. No product quality complaint (PQC) was associated with this report.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event.; a patient was administered improperly stored PROQUAD; This spontaneous report was received from a medical assistant refers to a 13-month-old patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 23-SEP-2019, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) lot # S012040, expiration date 17-APR-2021 (exact dose, route of administration,  lot # and expiration date were not reported)  for prophylaxis. The sterile diluent was used to reconstitute the  varicella virus vaccine live (oka/merck)(VARIVAX) The outcome of product storage error and no adverse event was unknown. Administered dose of vaccine experienced the temperature excursion of 5 to 46 degrees Fahrenheit for 6 hours and 15 minutes. Data logger was not involved. There were no previous excursions reported
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Pain, Pemphigoid, Rash, Retinal detachment
Clinical narrative: mucous membrane pemphigoid; retinal detachment of the left eye; retinal tear in the right eye; widespread, plaque-like rash; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unspecified age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or around 08-OCT-2014, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (route of administration, anatomical location, lot# and expiration date were not provided) vaccine for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster).  Shortly after receiving zoster vaccine live (ZOSTAVAX) vaccine, the patient suffered a widespread, plaque-like rash. The patient then suffered blistering lesions causing pain and bleeding which was diagnosed as mucous membrane pemphigoid. In addition, the patient suffered and ultimately was diagnosed with retinal detachment of the left eye and retinal tear in the right eye. As a direct and proximate result of Company's defective zoster vaccine live (ZOSTAVAX), the patient's symptoms resulted in physical limitations not present prior to using Company's product. The patient also experiences 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 patient sustained severe and permanent personal injuries. Further, as a tragic consequence of Company's wrongful conduct, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of Company's conduct, the patient suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was not recovered. The reporter considered all events to be related to zoster vaccine live (ZOSTAVAX).  Upon internal review, the events of pemphigoid, retinal tear and retinal detachment were considered to be medially significant. All events were additionally considered to be disabling.
Sex: M
Vaccine: VARZOS
Symptoms: Retinal tear, Skin haemorrhage, Skin lesion, Skin plaque
Clinical narrative: mucous membrane pemphigoid; retinal detachment of the left eye; retinal tear in the right eye; widespread, plaque-like rash; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unspecified age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or around 08-OCT-2014, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (route of administration, anatomical location, lot# and expiration date were not provided) vaccine for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster).  Shortly after receiving zoster vaccine live (ZOSTAVAX) vaccine, the patient suffered a widespread, plaque-like rash. The patient then suffered blistering lesions causing pain and bleeding which was diagnosed as mucous membrane pemphigoid. In addition, the patient suffered and ultimately was diagnosed with retinal detachment of the left eye and retinal tear in the right eye. As a direct and proximate result of Company's defective zoster vaccine live (ZOSTAVAX), the patient's symptoms resulted in physical limitations not present prior to using Company's product. The patient also experiences 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 patient sustained severe and permanent personal injuries. Further, as a tragic consequence of Company's wrongful conduct, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of Company's conduct, the patient suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was not recovered. The reporter considered all events to be related to zoster vaccine live (ZOSTAVAX).  Upon internal review, the events of pemphigoid, retinal tear and retinal detachment were considered to be medially significant. All events were additionally considered to be disabling.
Sex: M
Vaccine: HPV9
Symptoms: No adverse event, Wrong technique in product usage process
Clinical narrative: The patient received a dose of GARDASIL 9 where a healthcare worker did not shake the vaccine vial prior to administration; No adverse symptoms reported; This spontaneous report was received from a male consumer, referring to himself, the patient's age was not provided. The patient's pertinent medical history, concomitant therapies, as well as drug reactions or allergies were unknown.     On unspecified date, the patient  received a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) for prophylaxis (strength, dose, route of administration, anatomical location, lot number and expiration date were not reported), the healthcare worker did not shook the vaccine vial prior to administration (wrong technique in product usage process), no adverse symptoms reported.
Sex: M
Vaccine: VARZOS
Symptoms: Burning sensation, Herpes zoster, Pain, Post herpetic neuralgia, Skin ulcer
Clinical narrative: postherpetic neuralgia; shingles; Information has been received from a lawyer referring to a male patient of unknown age. The patient's medical history, concurrent condition and concomitant therapy were not reported.  On or about 28-NOV-2016, the patient was vaccinated with Zoster Vaccine Live (ZOSTAVAX) (strength, dose, frequency, route, lot# and expiration date were unknown) for the prevention of shingles (herpes zoster) and routine health maintenance.   On an unknown date, the patient experienced painful cluster of sores on his right lateral buttock that burned and was diagnosed with shingles. The patient continued to suffer recurrent shingles outbreaks and has been diagnosed with postherpetic neuralgia. The patient did not recover from the events. As per the reporter, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The event was disabling.   The reporter considered the events was related to Zoster Vaccine Live (ZOSTAVAX).
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received from a lawyer referring to a female patient of unknown age. The patient's medical history, concurrent condition and concomitant therapy were not reported.  In 2010, the patient was vaccinated with Zoster Vaccine Live (ZOSTAVAX) (strength, dose, frequency, route, lot# and expiration date were unknown) for long-term prevention of shingles and/or zoster-related conditions.   On an unknown date, the patient experienced shingles. The patient did not recover from the events. The patient received the treatment. As per the reporter, the patient has and will continue suffer significant medical and related expenses as result of the injury which costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies. The patient was hospitalized due to the event on an unknown date.  The reporter considered the event was related to Zoster Vaccine Live (ZOSTAVAX).
Age: 0.17
Sex: M
Vaccine: RV5
Symptoms: Blood test, Diarrhoea
Clinical narrative: Diarrhoea; This spontaneous report was received from a registered nurse (RN) refers to a 11-week-old male patient.  The patient did not have any pertinent medical history, past drugs and allergies. The concomitant medications included multivitamin and fluconazole.  On 27-SEP-2019, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ), via oral route (lot number R029818 and expiration date: 09-JUL-2020) for prevention of rota-virus (prophylaxis). On 02-OCT-2019, the patient experienced diarrhoea. On 03-OCT-2019, the patient was taken to the emergency room. The nurse reported that the patient was unable to submit a stool sample to be analyzed. Treatment was not given for the event. The patient underwent unspecified blood work. It was also reported that the patient's brother experienced same event. At the time of report, the event of diarrhoea was recovering. The causality assessment was not reported.  This is one of two reports received from same reporter.; Sender's Comments:  US-009507513-1910USA007401:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect reported; on patient received improperly stored VARIVAX; This spontaneous report as received from a nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 22-AUG-2019, the patient was vaccinated with an improperly stored  dose of varicella virus vaccine live (oka/merck)(VARIVAX)  lot # S005078 expiration date 19-FEB-2021 or lot # R019237 expiration date 04-JUL-2020 (strength, dose, frequency and anatomical location were not provided) for prophylaxis. The reporter had not clear which lot # was given to the patient, since both lot # had temperature excursion. The varicella virus vaccine live (oka/merck)(VARIVAX) was reconstituted with properly stored sterile diluent. The administered doses of the vaccines were stored with the temperature  between -14 degrees centigrades to -10 degrees centigrades (mainly at -9.74 degrees centigrades), the time frame was unknown by reporter. There was a digital data logger involved, but there was no previous temperature excursion. No adverse effect reported.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: a patient received a dose of MMR vaccine following a temperature excursion; no adverse effects were reported; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not provided.  On 09-OCT-2019, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) lot # R031680, expiration date on 01-NOV-2020, for prophylaxis (strength, dosage, frequency and route were not provided), following a temperature excursion (product storage error). No adverse effects were reported.  It was explained that measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II), was in a temperature excursion of 47°F/9°C (72.4°F) for 8 hours and 50 minutes and highest temperature was above 47°F/9°C (70.2 °F) for 9 hours and 39 minutes. There was a previous temperature excursion and the total time and highest temperature was above 47°F/9°C (54.7F) for 1 hour and 50 minutes. There was not data logger.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect; Patient was administered with an improperly stored VARIVAX; This spontaneous case was received from other healthcare professional (nurse) referring to a patient of unknown age and gender. The patient's concomitant medication included sterile diluent. The patient's current condition, pertinent medical history, drug reactions/allergies were not reported. On 21-JUN-2019, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) lot number S002874, expiration date 29-JAN-2021(strength, dose, frequency, route of administration were not reported) for prophylaxis which was improperly stored (product storage error). The sterile diluent used to reconstitute varicella virus vaccine live (Oka/Merck) (VARIVAX) was properly stored. No adverse effects were reported. Varicella virus vaccine live (Oka/Merck) (VARIVAX) underwent temperature excursion of 7.64 Fahrenheit in time frame of 20 minutes. There was no previous temperature excursion. The call was placed because of a data logger. There was no product quality complaint (PQC) present.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: NO ADVERSE EVENT; improperly stored vaccine administered; This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. The patient's concomitant therapies included sterile diluent.       On 13-AUG-2019, the patient was vaccinated with a dose of improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) (Lot # S005078, Expiry date : 19-FEB-2021 or lot # R019237, Expiry date : 04-JUL-2020, the reporting nurse was unable to confirm which lot was administered to the patient) for prophylaxis. It was reported that the vaccine experienced a temperature excursion of -14 degrees Celsius to -10 degrees Celsius (-9.74 Celsius) for an unknown time frame (product storage error). There was no previous temperature excursion. There were no adverse effects reported. There was no product quality complaint involved. It was reported that this call was reported due to a digital data logger.
Sex: F
Vaccine: VARZOS
Symptoms: Blindness, Herpes zoster
Clinical narrative: shingles; vision loss; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unspecified age. Information about the patient's concurrent condition, concomitant medication or medical history was not provided. In or around September 2017 the patient was vaccinated with zoster vaccine live(ZOSTAVAX) (strength, dose, route, lot # and expiration date were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unspecified date in 2017 (reported as shortly after the vaccination), the patient suffered shingles and vision loss. As the result of vaccine live(ZOSTAVAX), the patient suffered severe, 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. She also suffered medical expenses, the loss of accumulations and other economic and non-economic damages. The outcome of shingles and vision loss was not recovered. The reporter considered the events to be disable and related to Zoster Vaccine Live(ZOSTAVAX).  Upon internal review, vision loss was determined to be medically significant.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received from a lawyer regarding a case in litigation concerning a female patient(pt) of unknown age.The pt's medical history, concurrent conditions and concomitant medications were not provided. In or around September 2014, the pt was inoculated with zoster vaccine live(ZOSTAVAX)(dose, route of administration, anatomical location, lot#, expiration date were unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). In 2014 (reported as "shortly after receiving zoster vaccine live(ZOSTAVAX)"), the pt suffered shingles. As a direct and proximate result of zoster vaccine live(ZOSTAVAX), the pt experienced mental and emotional distress due to resulting physical limitations and seriousness of pt's condition. As a result of the zoster vaccine live(ZOSTAVAX), the pt  sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live(ZOSTAVAX), 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 of zoster vaccine live(ZOSTAVAX), the pt had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages.  Shingles was considered to be disability by the reporter.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects were reported.; The nurse reported the patient was administered an improperly stored dose of V ARIV AX (S002874 1/29/2021) on 10/7/2019; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported.  On 07-OCT-2019, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot # S002874 and expiry date 29-JAN-2021; route of administration, injection site and exact dose were not provided) for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent (lot # N030413 and expiry date 05-JUL-2020). The vaccine was exposed to the temperature of 7.64 degrees Fahrenheit (F) for 20 minutes. There was previous temperature excursion, when the vaccine was exposed to 19.34 F for 34 minutes. The digital data logger was involved. No adverse effects were reported.
Age: 0.83
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse effect; 10 month old patient received a third dose of ROTATEQ today; This spontaneous report was received from a nurse prescriber regarding a 10 month old patient.   The patient's medical history, concomitant medication, and drug reactions/allergies were not reported. On 09-OCT-2019, the patient was vaccinated with 3rd dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ)  (lot/batch#, expiration date unknown) inappropriate schedule of vaccine administered. No adverse effects were reported.
Sex: F
Vaccine: MMR
Symptoms: Injection site erythema, Injection site nodule, Injection site swelling, Pain in extremity
Clinical narrative: The patient experienced swelling, redness and nodule at the injection site; The patient experienced swelling, redness and nodule at the injection site; The patient experienced swelling, redness and nodule at the injection site; hand pain; This spontaneous report was received from a pharmacist and refers to a 53 year old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not provided.  On 21-AUG-2019, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) subcutaneous for prophylaxis,  lot # S005248, expiration date on 20-FEB-2021, (strength, dosage and frequency were not provided).  In September 2019 (reported as "two to three weeks after adminstration"), the patient experienced swelling, redness, and a nodule at the injection site was well hand pain. The patient did not seek medical attention and there was not treatment given for the adverse events.  The patient had recovered from injection site swelling, pain in extremity, injection site nodule and injection site erythema on an unspecified date in 2019.  The reporter did not provide causality assessment between the events and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II).
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect reported; on 8/29/2019, on patient received improperly stored VARlVAX (Lot S005078 & expiration date 2/19/2021 or lot R019237 & expiration date 7/4/2020); This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported.  On 29-AUG-2019, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot # R019237 and expiry date 04-JUL-2020 or lot # S005078 and expiry date 19-FEB-2021 (the nurse was not sure which lot # was given to the patient); route of administration, injection site and exact dose were not provided) for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent. The vaccine was exposed to the temperature between -14 degrees Celsius (C) to -10 C (-9,74 C) during unknown time period. There was no previous temperature excursion. The digital data logger was involved. No adverse effects were reported.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: improperly stored vaccine; This spontaneous report was received from a physician referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, drug reactions and allergies were unknown. On an unknown date, the patient was vaccinated with improperly stored (product storage error) measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) with lot # S007075, expiration date 06-SEP-2020 (dose, anatomical location and route of administration were not reported) for prophylaxis. Doses of suspect vaccine experienced the temperature excursion 32.5-degree Fahrenheit (F) for 8 hours. It was reported that previous temperature excursion was not done. Data logger was involved. No product quality complaint (PQC) involved.
Age: 57.0
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: Asthenia, Influenza like illness, Nausea, Pain, Pyrexia
Clinical narrative: Flu-like Symptoms; feverish; nausea; achy; low energy; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 57-year-old male patient who received Flu Seasonal QIV Dresden (Fluarix Tetra 2019-2020 season) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 27th September 2019, the patient received the 2nd dose of Fluarix Tetra 2019-2020 season and the 2nd dose of Shingrix. On 27th September 2019, 5 hrs after receiving Fluarix Tetra 2019-2020 season and Shingrix, the patient experienced influenza-like symptoms, fever, nausea, pain and energy decreased. On 30th September 2019, the outcome of the influenza-like symptoms was resolved with sequelae. On an unknown date, the outcome of the fever, nausea, pain and energy decreased were resolved with sequelae.   It was unknown if the reporter considered the influenza-like symptoms, fever, nausea, pain and energy decreased to be related to Fluarix Tetra 2019-2020 season and Shingrix.  Additional information received were as follows: The patient received 2nd dose Shingrix in his right arm and Fluarix Quadrivalent in his left arm and he experienced flu-like symptoms approximately 5-6 hours following vaccination that consisted of severe nausea, feverish, achy, and low energy.  The caller reports flu-like symptoms lasted approximately 2 days and was resolved. The reporter consented to follow up. The caller was a GlaxoSmithKline employee who did not work for the field.  The caller was the wife of the patient in this report. This report is 2 of 2, reported by same reporter.
Sex: U
Vaccine: FLU4
Symptoms: Herpes zoster, Rash
Clinical narrative: Shingles; Rash to R Flank; This case was reported by a nurse and described the occurrence of shingles in a patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2019-2020 season) for prophylaxis.   Concurrent medical conditions included pruritus and burning sensation.   On 24th September 2019, the patient received FluLaval Tetra 2019-2020 season. On 26th September 2019, 2 days after receiving FluLaval Tetra 2019-2020 season, the patient experienced shingles and rash. The patient was treated with acyclovir. On an unknown date, the outcome of the shingles and rash were unknown.   It was unknown if the reporter considered the shingles and rash to be related to FluLaval Tetra 2019-2020 season.  Additional details were provided as follows: The age at vaccination was not reported. The patient reported having itching and burning symptoms the week prior to diagnosis of shingles. The patient received gave an employee a FluLaval Tetra 2019-2020 season in left deltoid and was found to have a rash to right flank and diagnosed with shingles. The patient was started on Acyclovir. The reporter asked if the Flulaval vaccination interfere with her current treatment with antiviral medications for shingles.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site rash
Clinical narrative: Bruising at or below the injection site; Rash rash at or belowinjection site; This case was reported by a pharmacist and described the occurrence of injection site bruising in an unspecified number of adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced injection site bruising and injection site rash. On an unknown date, the outcome of the injection site bruising and injection site rash were unknown.   It was unknown if the reporter considered the injection site bruising and injection site rash to be related to Shingrix.  Additional information received were as follows: The age at vaccination was not applicable for this report. The age group was not reported but it was selected as adult as per the vaccine indication. The batch number was not reported. The patient experiencing bruising and rash at or below injection site after receiving Shingrix.  The reporter would try to go back and look at patient vaccine history and call back if she needed to. The reporter was agreeable to follow up. This case linked with US2019179984, US2019179981 and US2019179979, reported by same reporter.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Headache, Injection site pain, Nausea, Skin discolouration
Clinical narrative: Headache; Naseua; Pain at shot location; Was very white no color at all; Feel bad; This case was reported by a consumer and described the occurrence of headache in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd October 2019, the patient received the 2nd dose of Shingrix. In October 2019, less than a week after receiving Shingrix, the patient experienced headache, nausea, injection site pain, skin discoloration and feeling bad. On an unknown date, the outcome of the headache, nausea, injection site pain, skin discoloration and feeling bad were not recovered/not resolved.   It was unknown if the reporter considered the headache, nausea, injection site pain, skin discoloration and feeling bad to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix in the upper left deltoid. The reporter stated that, the day before reporting, the patient received dose of Shingrix and experienced headache, naseua a lot of pain at shot location. The reporter stated that, the patient was going back to the bed and was tough, so he would see how the patient rebounds, In no improvement, he would take the patient to the primary care. The reporter stated that, when the patient came out of the bedroom, was very white no color at all. The reporter stated that, the patient received 1st and 2nd dose at pharmacy. The reporter consented to follow up with physician.
Sex: U
Vaccine: FLU4
Symptoms: Erythema, Feeling drunk, Injection site urticaria, Product complaint, Vomiting
Clinical narrative: Product Complaint; Large golf ball sized whelp at site; Erythema streak across chest and up neck; Vomiting; Feeling "drunk, like a weird state of awareness."; This case was reported by a pharmacist via call center representative and described the occurrence of injection site urticaria in a adult patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2019-2020 season) (batch number T9N35, expiry date 30th June 2020) for prophylaxis. This case was associated with a product complaint.   On 3rd October 2019, the patient received Fluarix Quadrivalent 2019-2020 season. On 3rd October 2019, less than an hour after receiving Fluarix Quadrivalent 2019-2020 season, the patient experienced injection site urticaria, erythema, vomiting and feeling drunk. On an unknown date, the patient experienced pharmaceutical product complaint. On an unknown date, the outcome of the injection site urticaria, erythema, vomiting, feeling drunk and pharmaceutical product complaint were unknown.   It was unknown if the reporter considered the injection site urticaria, erythema, vomiting and feeling drunk to be related to Fluarix Quadrivalent 2019-2020 season.  Additional details were provided as follows: The patient demographic details were not provided. The age at vaccination was not reported. The age group selected as an adult as the patient was employee. The pharmacy manager stated that, within minutes after vaccination, the patient experienced large golf ball sized whelp at site, erythema streak across chest and up neck, vomitting and felt drunk like a weird state of awareness. The reporter stated that all 9 employees received dose from same batch number and was warm transferred to the response center for documentation of potential product complaint. The pharmacy manager did not have any patient-specific details available at the time of this call, but stated safety could follow up. The reporter consented to follow up. This case was 2 of 9 linked cases reported by same reporter.
Sex: U
Vaccine: FLU4
Symptoms: Erythema, Feeling drunk, Injection site urticaria, Product complaint
Clinical narrative: Product Complaint; Large golf ball sized whelp at site; Erythema streak across chest and up neck; Feeling "drunk, like a weird state of awareness."; This case was reported by a pharmacist via call center representative and described the occurrence of injection site urticaria in a adult patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2019-2020 season) (batch number T9N35, expiry date 30th June 2020) for prophylaxis. This case was associated with a product complaint.   On 3rd October 2019, the patient received Fluarix Quadrivalent 2019-2020 season. On 3rd October 2019, less than an hour after receiving Fluarix Quadrivalent 2019-2020 season, the patient experienced injection site urticaria, erythema and feeling drunk. On an unknown date, the patient experienced pharmaceutical product complaint. On an unknown date, the outcome of the injection site urticaria, erythema, feeling drunk and pharmaceutical product complaint were unknown.   It was unknown if the reporter considered the injection site urticaria, erythema and feeling drunk to be related to Fluarix Quadrivalent 2019-2020 season.  Additional details were provided as follows: The patient demographic details were not provided. The age at vaccination was not reported. The pharmacy manager stated that, within minutes after vaccination, the patient experienced large golf ball sized whelp at site, erythema streak across chest and up neck and felt drunk like a weird state of awareness. The reporter stated that all 9 employees received dose from same batch number and was warm transferred to the Glaxosmithkline response center for documentation of potential product complaint. The pharmacy manager did not have any patient-specific details available at the time of this call, but stated safety could follow up. The reporter consented to follow up. This case was 4 of 9 linked cases reported by same reporter.