chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; Multiple patients were vaccinated with improperly stored ROTATEQ on multiple dates; Information has been received from a medical assistant concerning a patient of unknown age, gender and race. The patient's medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medications were not reported.  On 26-JUN-2019, the patient was vaccinated with an improperly stored dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) orally for prophylaxis (lot number R0298515 with expiration date in 18-JUN-2020) (strength and anatomical location were not provided).  The Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) was stored at an unknown temperature for an unknown time frame. There was a previous temperature excursion and the call was because of a data logger.  No adverse effects reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1907USA001816: US-009507513-1907USA001815: US-009507513-1907USA001817: US-009507513-1907USA001814: US-009507513-1907USA001813: US-009507513-1907USA001812: US-009507513-1907USA001811: US-009507513-1907USA001810: US-009507513-1907USA001809: US-009507513-1907USA001808: US-009507513-1906USA011434: US-009507513-1907USA001806: US-009507513-1907USA001805: US-009507513-1907USA001835: US-009507513-1907USA001834: US-009507513-1907USA001833: US-009507513-1907USA001807: US-009507513-1907USA001848: US-009507513-1907USA001847: US-009507513-1907USA001846: US-009507513-1907USA001804: US-009507513-1907USA001845: US-009507513-1907USA001844: US-009507513-1907USA001843: US-009507513-1907USA001842: US-009507513-1907USA001841: US-009507513-1907USA001840: US-009507513-1907USA001839: US-009507513-1907USA001838: US-009507513-1907USA001837: US-009507513-1907USA001836: US-009507513-1907USA001832: US-009507513-1907USA001831: US-009507513-1907USA001830: US-009507513-1907USA001829: US-009507513-1907USA001828: US-009507513-1907USA001827: US-009507513-1907USA001826: US-009507513-1907USA001825: US-009507513-1907USA001824: US-009507513-1907USA001823: US-009507513-1907USA001822: US-009507513-1907USA001821: US-009507513-1907USA001820: US-009507513-1907USA001819: US-009507513-1907USA001818: US-009507513-1907USA000965: US-009507513-1907USA000970: US-009507513-1907USA000969: US-009507513-1907USA000954: US-009507513-1907USA000966: US-009507513-1907USA000964: US-009507513-1907USA000967: US-009507513-1907USA000968: US-009507513-1907USA000959: US-009507513-1907USA000962: US-009507513-1907USA000953: US-009507513-1907USA000963: US-009507513-1907USA000988: US-009507513-1907USA000989: US-009507513-1907USA000952: US-009507513-1907USA001793: US-009507513-1907USA001794: US-009507513-1907USA001795: US-009507513-1907USA001796: US-009507513-1907USA001797: US-009507513-1907USA001798: US-009507513-1907USA001799: US-009507513-1907USA001800: US-009507513-1907USA001801: US-009507513-1907USA001802: US-009507513-1907USA001803:
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse effects were reported; A 25 year old female patient received one dose of PROQUAD; This spontaneous report had been received from a physician concerning a 25-year-old female patient. There was no information about the patient's medical history, drug reactions, allergies, concomitant medications or concurrent conditions to be reported.  It was reported that on 02-JUL-2019, this 25-year-old patient was vaccinated with 1 dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (product administered to patient of inappropriate age) (strength, route of administration, lot number and expiration date unknown). No adverse effects were reported.
Age: 34.0
Sex: M
Vaccine: MMR
Symptoms: Pyrexia, Rash generalised, Skin exfoliation, Skin lesion, Stevens-Johnson syndrome
Clinical narrative: Stevens-Johnson syndrome; Stevens-Johnson syndrome/lesions started to reappear; Information was received from a 34 year old male consumer, referring to himself. The patient's pertinent medical history included post-traumatic stress disorder. The patient's concomitant medications included ibuprofen(MOTRIN), sumatriptan, propranolol hydrochloride, venlafaxine hydrochloride(EFFEXOR) and gabapentin. The patient had no drug reactions or allergies.  On 19-JAN-2003, The patient received the measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (lot#, expiration date, concentration and route unknown; 1 shot) vaccine for prophylaxis, and about 5 days following that (24-JAN-2003), patient developed bumps all over the body, including eyes and tongue, with low grade fever. Additionally, the bumps were really pronounced on inner thigh, legs, feet, arms, and back. The patient reported that she developed the Stevens-Johnson syndrome. On 27-JAN-2003, the patient was admitted to a Medical Center and was hospitalized for 2 days. Subsequently, the patient was prescribed an unspecified intravenous steroid. The patient stated that the steroids calmed it down, and a week later, the skin started to peel. The Stevens-Johnson syndrome was recovered on an unknown date. About 2 year ago (in 2017), the patient reported lesions started to reappear. The outcome of reappeared stevens-johnson syndrome was reported as not recovered/resolved. The reporter did not provide the causality between events and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II).  Upon internal review, stevens-johnson syndrome was determined to be medically significant.
Age: 34.0
Sex: M
Vaccine: MMR
Symptoms: Tongue eruption
Clinical narrative: Stevens-Johnson syndrome; Stevens-Johnson syndrome/lesions started to reappear; Information was received from a 34 year old male consumer, referring to himself. The patient's pertinent medical history included post-traumatic stress disorder. The patient's concomitant medications included ibuprofen(MOTRIN), sumatriptan, propranolol hydrochloride, venlafaxine hydrochloride(EFFEXOR) and gabapentin. The patient had no drug reactions or allergies.  On 19-JAN-2003, The patient received the measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (lot#, expiration date, concentration and route unknown; 1 shot) vaccine for prophylaxis, and about 5 days following that (24-JAN-2003), patient developed bumps all over the body, including eyes and tongue, with low grade fever. Additionally, the bumps were really pronounced on inner thigh, legs, feet, arms, and back. The patient reported that she developed the Stevens-Johnson syndrome. On 27-JAN-2003, the patient was admitted to a Medical Center and was hospitalized for 2 days. Subsequently, the patient was prescribed an unspecified intravenous steroid. The patient stated that the steroids calmed it down, and a week later, the skin started to peel. The Stevens-Johnson syndrome was recovered on an unknown date. About 2 year ago (in 2017), the patient reported lesions started to reappear. The outcome of reappeared stevens-johnson syndrome was reported as not recovered/resolved. The reporter did not provide the causality between events and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II).  Upon internal review, stevens-johnson syndrome was determined to be medically significant.
Sex: M
Vaccine: HPV9, MNQ, UNK
Symptoms: Eye swelling
Clinical narrative: bilateral eye swelling / he had slight puffiness around eyes; This spontaneous report was received from a physician concerning to a 11 year old male patient. The patient's historical conditions, previous drug reactions, allergies, concurrent condition and concomitant medications were not provided.     On 01-JUL-2019, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (strength, dose and route of administration were not reported; lot # R004689 and expiration date 29-NOV-2019) , diphtheria toxoid (+) pertussis vaccine (unspecified) (+) tetanus toxoid ( DPT ) (strength, dose, route of administration, lot number and expiration date were not reported), meningococcal ACYW conj vaccine (dip toxoid) (MENACTRA) (strength, dose, route of administration, lot number and expiration date were not reported). All the vaccines were administered because he was 11 years old.  On 01-JUL-2019, the patient experienced bilateral eye swelling 7 hours after administration of vaccines. The physician reported the patient's father "gave the patient diphenhydramine hydrochloride (BENADRYL) (strength, dose, route of administration route, lot number and expiration date were not reported). The physician reported that the patient came back to the office on 02-JUL-2019 for medical attention, and he had slight puffiness around eyes (eye swelling), normal breathing, normal exam.   The outcome and causality assessment between eye swelling and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) was not reported.
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse effects reported; expired vaccine administered/ the patient got one expired dose of GARDASIL 9; This spontaneous report was received from a pharmacist refers to a patient of unspecified demographics. The patient's concurrent conditions, medical history, concomitant medications, past drugs, allergies and reactions were unknown. On 27-JUN-2019, the patient was vaccinated with one expired dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # M043731, expiry date:22-JUN-2019), 1 dosage form via intramuscular route for prophylaxis (Expired product administered).The product was stored properly until administration. No adverse effects were reported. No Product quality complaint (PQC) was involved.
Sex: F
Vaccine: PPV
Symptoms: Abdominal discomfort, Erythema, Fatigue, Headache, Injection site erythema
Clinical narrative: bodyaches; headache; fatigue; redness at the injection site which went down past elbow and a low grade fever, diagnosed with a "skin infection"; upset stomach; This spontaneous report was received from a 62-year-old female patient reporting on herself.   The patient's medical history included ear infections and sinus infections. The patient's concurrent condition included high blood pressure. The patient's concomitant medications included propranolol and hydrochlorothiazide, losartan potassium (HYZAAR). The patient was allergic to cefaclor (CECLOR), clarithromycin (BIAXIN), unspecified generic for azithromycin (ZITHROMAX), unspecified preservatives, thimerosal (MERSOL), and neomycin sulfate (MYCIFRADIN).  On 25-JUN-2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (strength, route, dose and frequency were unknown) (lot # R031812 and expiration date: 26-SEP-2020) for prophylaxis (also reported as " I am prone to ear infection and sinus infections and I am a teacher and my doctor thought it would help my immune system"). On same day, later at night, the patient experienced redness at the injection site which went down past her elbow, a low-grade fever, body aches, headache, upset stomach, and fatigue. As treatment the patient saw her physician on 27-JUN-2019 and was diagnosed with a "skin infection" and was prescribed with cephalexin (KEFLEX) (500mg, four times a day). Treatment also included unspecified blood work which showed "white blood cell count was up a little bit". The patient requested a lot check of the pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23). The patient reported that her symptoms resolved on 30-JUN-2019. The causality assessment for all the events was not provided.
Sex: F
Vaccine: PPV
Symptoms: Pain, Pyrexia, Skin infection, White blood cell count increased
Clinical narrative: bodyaches; headache; fatigue; redness at the injection site which went down past elbow and a low grade fever, diagnosed with a "skin infection"; upset stomach; This spontaneous report was received from a 62-year-old female patient reporting on herself.   The patient's medical history included ear infections and sinus infections. The patient's concurrent condition included high blood pressure. The patient's concomitant medications included propranolol and hydrochlorothiazide, losartan potassium (HYZAAR). The patient was allergic to cefaclor (CECLOR), clarithromycin (BIAXIN), unspecified generic for azithromycin (ZITHROMAX), unspecified preservatives, thimerosal (MERSOL), and neomycin sulfate (MYCIFRADIN).  On 25-JUN-2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (strength, route, dose and frequency were unknown) (lot # R031812 and expiration date: 26-SEP-2020) for prophylaxis (also reported as " I am prone to ear infection and sinus infections and I am a teacher and my doctor thought it would help my immune system"). On same day, later at night, the patient experienced redness at the injection site which went down past her elbow, a low-grade fever, body aches, headache, upset stomach, and fatigue. As treatment the patient saw her physician on 27-JUN-2019 and was diagnosed with a "skin infection" and was prescribed with cephalexin (KEFLEX) (500mg, four times a day). Treatment also included unspecified blood work which showed "white blood cell count was up a little bit". The patient requested a lot check of the pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23). The patient reported that her symptoms resolved on 30-JUN-2019. The causality assessment for all the events was not provided.
Sex: F
Vaccine: MMR
Symptoms: Pneumonia, Respiratory tract infection, Upper respiratory tract infection
Clinical narrative: pneumonia; Upper respiratory infection; This spontaneous report was received from a consumer refers to a 32 year-old-female patient. The patient's current conditions, medical history, drug reactions/allergies, concomitant therapy were none. On an unknown date in1988 when the patient was 15-18 months old, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (1 dosage form (one shot), intramuscular in thigh, strength and lot number with expiration date was not reported) for routine immunisation. On an unknown date in 1988, within few days after receiving vaccine, the patient experienced upper respiratory tract infection. The patient sought medical attention and went back to doctor for respiratory infection. The patient was treated for the same. A week later ,the patient ended up in the emergency room for pneumonia. The patient had the one bout of pneumonia. The patient was treated for the events. It was unknown whether the patient underwent any lab diagnostics/studies. Product quality issue was not involved. The outcome of upper respiratory tract infection and pneumonia was reported as recovered. The reporter's causality assessment was not provided.  Upon internal review, the event of pneumonia was determined as medically significant.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: No adverse event, Underdose
Clinical narrative: No adverse effects reported; received a partial dose of GARDASIL 9 because "she moved when the needle was in her arm."the syringe has about "a quarter of the product leftover."; Information has been received from a medical assistant referring to a 12 year old female patient. The patient's pertinent medical history, drug reactions/allergies, current condition and concomitant medication were not provided.  On 02-JUL-2019,the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (batch/lot number reported as N0268814; expiration date 23-JUN-2021; a partial dose; strength and frequency were not provided) intramuscularly in the left arm for prophylaxis. The patient received a partial dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) because she moved when the needle was in her arm (incorrect dose administered). The syringe had about a quarter of the product leftover.  No adverse effects were reported.
Age: 69.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No known adverse effects; patient received a dose of PROQUAD in error. (This is not a case of product confusion); This spontaneous report was received from a nurse refers to a 69 year old patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 31-JAN-2019, the patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # R021232, expiration date: 21-JAN-2020, therapy type: rha (strength, anatomical location not reported) subcutaneously in error (wrong product administered) and that was not a case of product confusion. The nurse was distracted by someone and grabbed the wrong vaccine by mistake. No adverse effects were reported. No product quality complaints were involved.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: recurrent herpes zoster outbreaks; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient (pt) of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In or around 29-OCT-2015, pt was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route of administration were not specified) for routine health maintenance an for its intended purpose: the prevention of shingles (herpes zoster). On an unspecified date in 2015, shortly after receiving zoster vaccine live (ZOSTAVAX), pt experienced multiple recurrent herpes zoster outbreaks. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, pt's symptoms have resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). Pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), pt sustained severe and permanent personal injuries. Further, as a tragic consequence of Company's wrongful conduct, 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 Company's conduct, pt has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages.The outcome of herpes zoster was reported as not recovered. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX). The event of zoster vaccine live (ZOSTAVAX) was considered to be disabling.
Sex: U
Vaccine: MMR
Symptoms: Product storage error
Clinical narrative: the patient has been administered dose of vaccine which was improperly stored.; This spontaneous report has been received from a vaccine coordinator who was also a medical assistant concerning a patient of unknown age and gender. The patient's medical history, drug allergies, concurrent conditions and concomitant therapies were not reported.  On 11-JUN-2019, the patient was vaccinated with an improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) with lot number R002510 and expiration date on 25-JAN-2020 (dose, dose number, route of administration and anatomical location were not provided), for prophylaxis.   It was reported that on 19-MAY-2019, 20-MAY-2019 and in 2020 (conflicting information), the vaccine was exposed to a temperature above 9 degrees Celsius: 16.4 degrees Celsius for 5 hours and 30 minutes, and below 2 degrees Celsius: 0 degrees Celsius for 9.8 hours. There was no previous temperature excursion. The call was placed because of a Digital Data logger report.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA004562:
Sex: U
Vaccine: MMR
Symptoms: Product storage error
Clinical narrative: the patient has been administered dose of vaccine which was improperly stored.; This spontaneous report has been received from a vaccine coordinator who was also a medical assistant concerning a patient of unknown age and gender. The patient's medical history, drug allergies, concurrent conditions and concomitant therapies were not reported.  On 31-MAY-2019, the patient was vaccinated with an improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) with lot number R002510 and expiration date on 25-JAN-2020 (dose, dose number, route of administration and anatomical location were not provided), for prophylaxis.   It was reported that on 19-MAY-2019, 20-MAY-2019 and in 2020 (conflicting information), the vaccine was exposed to a temperature above 9 degrees Celsius: 16.4 degrees Celsius for 5 hours and 30 minutes, and below 2 degrees Celsius: 0 degrees Celsius for 9.8 hours. There was no previous temperature excursion. The call was placed because of a Digital Data logger report.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA004562:
Sex: U
Vaccine: MMR
Symptoms: Product storage error
Clinical narrative: the patient has been administered dose of vaccine which was improperly stored.; This spontaneous report has been received from a vaccine coordinator who was also a medical assistant concerning a patient of unknown age and gender. The patient's medical history, drug allergies, concurrent conditions and concomitant therapies were not reported.  On 29-MAY-2019, the patient was vaccinated with an improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) with lot number R002510 and expiration date on 25-JAN-2020 (dose, dose number, route of administration and anatomical location were not provided), for prophylaxis.   It was reported that on 19-MAY-2019, 20-MAY-2019 and in 2020 (conflicting information), the vaccine was exposed to a temperature above 9 degrees Celsius: 16.4 degrees Celsius for 5 hours and 30 minutes, and below 2 degrees Celsius: 0 degrees Celsius for 9.8 hours. There was no previous temperature excursion. The call was placed because of a Digital Data logger report.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA004562:
Sex: U
Vaccine: MMR
Symptoms: Product storage error
Clinical narrative: the patient has been administered dose of vaccine which was improperly stored.; This spontaneous report has been received from a vaccine coordinator who was also a medical assistant concerning a patient of unknown age and gender. The patient's medical history, drug allergies, concurrent conditions and concomitant therapies were not reported.  On 25-MAY-2019, the patient was vaccinated with an improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) with lot number R002510 and expiration date on 25-JAN-2020 (dose, dose number, route of administration and anatomical location were not provided), for prophylaxis.   It was reported that on 19-MAY-2019, 20-MAY-2019 and in 2020 (conflicting information), the vaccine was exposed to a temperature above 9 degrees Celsius: 16.4 degrees Celsius for 5 hours and 30 minutes, and below 2 degrees Celsius: 0 degrees Celsius for 9.8 hours. There was no previous temperature excursion. The call was placed because of a Digital Data logger report.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA004562:
Sex: U
Vaccine: MMR
Symptoms: Product storage error
Clinical narrative: the patient has been administered dose of vaccine which was improperly stored.; This spontaneous report has been received from a vaccine coordinator who was also a medical assistant concerning a patient of unknown age and gender. The patient's medical history, drug allergies, concurrent conditions and concomitant therapies were not reported.  On 23-MAY-2019, the patient was vaccinated with an improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) with lot number R002510 and expiration date on 25-JAN-2020 (dose, dose number, route of administration and anatomical location were not provided), for prophylaxis.   It was reported that on 19-MAY-2019, 20-MAY-2019 and in 2020 (conflicting information), the vaccine was exposed to a temperature above 9 degrees Celsius: 16.4 degrees Celsius for 5 hours and 30 minutes, and below 2 degrees Celsius: 0 degrees Celsius for 9.8 hours. There was no previous temperature excursion. The call was placed because of a Digital Data logger report.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA004562:
Sex: U
Vaccine: MMR
Symptoms: Product storage error
Clinical narrative: the patient has been administered dose of vaccine which was improperly stored.; This spontaneous report has been received from a vaccine coordinator who was also a medical assistant concerning a patient of unknown age and gender. The patient's medical history, drug allergies, concurrent conditions and concomitant therapies were not reported.  On 20-MAY-2019, the patient was vaccinated with an improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) with lot number R002510 and expiration date on 25-JAN-2020 (dose, dose number, route of administration and anatomical location were not provided), for prophylaxis.   It was reported that on 19-MAY-2019, 20-MAY-2019 and in 2020 (conflicting information), the vaccine was exposed to a temperature above 9 degrees Celsius: 16.4 degrees Celsius for 5 hours and 30 minutes, and below 2 degrees Celsius: 0 degrees Celsius for 9.8 hours. There was no previous temperature excursion. The call was placed because of a Digital Data logger report.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA004562:
Sex: U
Vaccine: MMR
Symptoms: Product storage error
Clinical narrative: the patient has been administered dose of vaccine which was improperly stored.; This spontaneous report has been received from a vaccine coordinator who was also a medical assistant concerning a patient of unknown age and gender. The patient's medical history, drug allergies, concurrent conditions and concomitant therapies were not reported.  On 28-MAY-2019, the patient was vaccinated with an improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) with lot number R002510 and expiration date on 25-JAN-2020 (dose, dose number, route of administration and anatomical location were not provided), for prophylaxis.   It was reported that on 19-MAY-2019, 20-MAY-2019 and in 2020 (conflicting information), the vaccine was exposed to a temperature above 9 degrees Celsius: 16.4 degrees Celsius for 5 hours and 30 minutes, and below 2 degrees Celsius: 0 degrees Celsius for 9.8 hours. There was no previous temperature excursion. The call was placed because of a Digital Data logger report.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA004562:
Sex: U
Vaccine: MMR
Symptoms: Product storage error
Clinical narrative: the patient has been administered dose of vaccine which was improperly stored.; This spontaneous report has been received from a vaccine coordinator who was also a medical assistant concerning a patient of unknown age and gender. The patient's medical history, drug allergies, concurrent conditions and concomitant therapies were not reported.  On 30-MAY-2019, the patient was vaccinated with an improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) with lot number R002510 and expiration date on 25-JAN-2020 (dose, dose number, route of administration and anatomical location were not provided), for prophylaxis.   It was reported that on 19-MAY-2019, 20-MAY-2019 and in 2020 (conflicting information), the vaccine was exposed to a temperature above 9 degrees Celsius: 16.4 degrees Celsius for 5 hours and 30 minutes, and below 2 degrees Celsius: 0 degrees Celsius for 9.8 hours. There was no previous temperature excursion. The call was placed because of a Digital Data logger report.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA004562:
Sex: U
Vaccine: MMR
Symptoms: Product storage error
Clinical narrative: the patient has been administered dose of vaccine which was improperly stored.; This spontaneous report has been received from a vaccine coordinator who was also a medical assistant concerning a patient of unknown age and gender. The patient's medical history, drug allergies, concurrent conditions and concomitant therapies were not reported.  On 22-MAY-2019, the patient was vaccinated with an improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) with lot number R002510 and expiration date on 25-JAN-2020 (dose, dose number, route of administration and anatomical location were not provided), for prophylaxis.   It was reported that on 19-MAY-2019, 20-MAY-2019 and in 2020 (conflicting information), the vaccine was exposed to a temperature above 9 degrees Celsius: 16.4 degrees Celsius for 5 hours and 30 minutes, and below 2 degrees Celsius: 0 degrees Celsius for 9.8 hours. There was no previous temperature excursion. The call was placed because of a Digital Data logger report.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA004562:
Sex: U
Vaccine: MMR
Symptoms: Product storage error
Clinical narrative: the patient has been administered dose of vaccine which was improperly stored.; This spontaneous report has been received from a vaccine coordinator who was also a medical assistant concerning a patient of unknown age and gender. The patient's medical history, drug allergies, concurrent conditions and concomitant therapies were not reported.  On 08-JUN-2019, the patient was vaccinated with an improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) with lot number R002510 and expiration date on 25-JAN-2020 (dose, dose number, route of administration and anatomical location were not provided), for prophylaxis.   It was reported that on 19-MAY-2019, 20-MAY-2019 and in 2020 (conflicting information), the vaccine was exposed to a temperature above 9 degrees Celsius: 16.4 degrees Celsius for 5 hours and 30 minutes, and below 2 degrees Celsius: 0 degrees Celsius for 9.8 hours. There was no previous temperature excursion. The call was placed because of a Digital Data logger report.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA004562:
Sex: U
Vaccine: MMR
Symptoms: Product storage error
Clinical narrative: the patient has been administered dose of vaccine which was improperly stored.; This spontaneous report has been received from a vaccine coordinator who was also a medical assistant concerning a patient of unknown age and gender. The patient's medical history, drug allergies, concurrent conditions and concomitant therapies were not reported.  On 21-MAY-2019, the patient was vaccinated with an improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) with lot number R002510 and expiration date on 25-JAN-2020 (dose, dose number, route of administration and anatomical location were not provided), for prophylaxis.   It was reported that on 19-MAY-2019, 20-MAY-2019 and in 2020 (conflicting information), the vaccine was exposed to a temperature above 9 degrees Celsius: 16.4 degrees Celsius for 5 hours and 30 minutes, and below 2 degrees Celsius: 0 degrees Celsius for 9.8 hours. There was no previous temperature excursion. The call was placed because of a Digital Data logger report.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA004562:
Sex: U
Vaccine: MMR
Symptoms: Product storage error
Clinical narrative: the patient has been administered dose of vaccine which was improperly stored.; This spontaneous report has been received from a vaccine coordinator who was also a medical assistant concerning a patient of unknown age and gender. The patient's medical history, drug allergies, concurrent conditions and concomitant therapies were not reported.  On 03-JUN-2019, the patient was vaccinated with an improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) with lot number R002510 and expiration date on 25-JAN-2020 (dose, dose number, route of administration and anatomical location were not provided), for prophylaxis.   It was reported that on 19-MAY-2019, 20-MAY-2019 and in 2020 (conflicting information), the vaccine was exposed to a temperature above 9 degrees Celsius: 16.4 degrees Celsius for 5 hours and 30 minutes, and below 2 degrees Celsius: 0 degrees Celsius for 9.8 hours. There was no previous temperature excursion. The call was placed because of a Digital Data logger report.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA004562:
Sex: U
Vaccine: MMR
Symptoms: Product storage error
Clinical narrative: the patient has been administered dose of vaccine which was improperly stored.; This spontaneous report has been received from a vaccine coordinator who was also a medical assistant concerning a patient of unknown age and gender. The patient's medical history, drug allergies, concurrent conditions and concomitant therapies were not reported.  On 04-JUN-2019, the patient was vaccinated with an improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) with lot number R002510 and expiration date on 25-JAN-2020 (dose, dose number, route of administration and anatomical location were not provided), for prophylaxis.   It was reported that on 19-MAY-2019, 20-MAY-2019 and in 2020 (conflicting information), the vaccine was exposed to a temperature above 9 degrees Celsius: 16.4 degrees Celsius for 5 hours and 30 minutes, and below 2 degrees Celsius: 0 degrees Celsius for 9.8 hours. There was no previous temperature excursion. The call was placed because of a Digital Data logger report.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA004562:
Sex: U
Vaccine: MMR
Symptoms: Product storage error
Clinical narrative: the patient has been administered dose of vaccine which was improperly stored.; This spontaneous report has been received from a vaccine coordinator who was also a medical assistant concerning a patient of unknown age and gender. The patient's medical history, drug allergies, concurrent conditions and concomitant therapies were not reported.  On 10-JUN-2019, the patient was vaccinated with an improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) with lot number R002510 and expiration date on 25-JAN-2020 (dose, dose number, route of administration and anatomical location were not provided), for prophylaxis.   It was reported that on 19-MAY-2019, 20-MAY-2019 and in 2020 (conflicting information), the vaccine was exposed to a temperature above 9 degrees Celsius: 16.4 degrees Celsius for 5 hours and 30 minutes, and below 2 degrees Celsius: 0 degrees Celsius for 9.8 hours. There was no previous temperature excursion. The call was placed because of a Digital Data logger report.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA004562:
Age: 41.0
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: 41-year-old patient received her first dose of Gardasil 9 on 01-FEB-2019; No adverse effect reported; This spontaneous report was received from a pharmacist, concerning a 41-years-old female patient. The patient's medical history, concomitant medications, concurrent conditions and drug  allergies were not reported.   On 03-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), one dosage form for prophylaxis (anatomical site of injection, route of administration was not reported) (lot # N020352 has been verified to be a valid lot number for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast), with expiration date on 10-APR-2020) (product use issue).  It was reported that the patient would received the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(G ARDASIL 9) on 03-JUL-2019. No adverse effects reported.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Ophthalmic herpes zoster
Clinical narrative: Herpes Zoster with Occular Involvment; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 58 years old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or around 12-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 shingles and zoster-related conditions. On an unspecified date, the patient experienced herpes zoster with occular involvement. On an unspecified date, the patient was treated by a physician for herpes zoster with ocular involvement. The outcome of the event herpes zoster with ocular involvement was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).   Upon internal review, the event herpes zoster with ocular involvement was determined to be medically significant.  Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Ophthalmic herpes zoster
Clinical narrative: Herpes Zoster with Opthalmic complications; This initial spontaneous report was received from a lawyer regarding a case in litigation and referred to a currently 78 years old male patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On an unknown date in 2013, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot number, expiration date, dose, dose number and route not specified) for prophylaxis. On an unspecified date, the patient experienced Herpes Zoster with Opthalmic complications. On an unspecified date, the patient was treated by a physician for Herpes Zoster with Opthalmic complications. The outcome of the events Herpes Zoster with Opthalmic complications was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).  Upon internal review, the event ophthalmic herpes zoster was determined to be medically significant.  Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 83-year-old male patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On an unspecified date in 2011, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) at a pharmacy (lot#, expiration date, dose, dose# and route of administration not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced herpes zoster and was treated by a physician. The outcome of herpes zoster was unknown. The reporter considered herpes zoster to be related to Zoster Vaccine Live (ZOSTAVAX).
Sex: U
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: Rash; This case was reported by a pharmacist via call center representative and described the occurrence of injection site rash in an unspecified number of adult patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site rash. On an unknown date, the outcome of the injection site rash was unknown.   It was unknown if the reporter considered the injection site rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The age group was not reported but captured as adult as per vaccine indication. The reporter briefly mentioned that, he had seen rash with other patients whom he had vaccinated Shingrix in the past.  No further details were provided. This case has been linked with the case US2019112256, reported by the same reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: soreness; This case was reported by a consumer via call center representative and described the occurrence of pain in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th June 2019, the patient received the 1st dose of Shingrix. In June 2019, less than a week after receiving Shingrix, the patient experienced pain. On an unknown date, the outcome of the pain was recovered/resolved.   It was unknown if the reporter considered the pain to be related to Shingrix.  Additional information was provided as follows: Age at vaccination was not reported. The patient received 1st dose of Shingrix and experienced soreness. This case has been linked with US2019AMR114755, reported by same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Burning sensation, Haematuria
Clinical narrative: Microhematuria; Burning; This case was reported by a physician via call center representative and described the occurrence of microscopic hematuria in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26th June 2019, the patient received the 1st dose of Shingrix. On 28th June 2019, 2 days after receiving Shingrix, the patient experienced microscopic hematuria and burning sensation. On an unknown date, the outcome of the microscopic hematuria and burning sensation were unknown.   It was unknown if the reporter considered the microscopic hematuria and burning sensation to be related to Shingrix.  Additional details were provided as follows:  The age at vaccination was not reported. The age group was not reported but was selected as adult as per the vaccine indication. The patient received the 1st dose of the Shingrix vaccine 2 days ago and on the date of reporting presented to his office with microhematuria and burning. The reporter said, could not obtain any additional information as the caller disconnected the phone line
Sex: U
Vaccine: TDAP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: giving Adacel to patients older than 64; Initial information received on 02-Jul-2019 regarding an unsolicited valid non-serious case received from a nurse.   This case involves 10 patients of over 64 years of age who received vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot number not reported via unknown route.  It was of actual medication error due to  Inappropriate age at vaccine administration.  No adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Sex: M
Vaccine: HIBV, HPVX
Symptoms: Extra dose administered, No adverse event, Wrong product administered
Clinical narrative: a 11 years old male patient received a fifth dose of Act-Hib- instead of an HPV; a 11 years old male patient received a fifth dose of Act-Hib- instead of an HPV; a 11 years old male patient received a fifth dose of Act-Hib- instead of an HPV, 4 th dose being completed in Oct-2009; Initial information received on 02-Jul-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 11 years old male patient who received a 0.5ml fifth dose of HIB (PRP/T) VACCINE [ACT-HIB] lot UI959AA, Expiration Date: 19-Jun-2020 via intramuscular route in the right deltoid on 25-Jun-2019 instead of HPV VACCINE.  The patient's past vaccination(s) included ACTHIB in OCT-2009 with fourth dose.  The patient's past medical history, medical treatment(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, TETANUS VACCINE TOXOID (BOOSTRIX) and MENINGOCOCCAL VACCINE A/C/Y/W CONJ (DIP TOX) (MENACTRA).  It was an actual medication error due to extra dose administered, inappropriate age at vaccine administration and wrong vaccine administered.  Adverse event was not reported.  The outcome of events was reported as unknown.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Age: 86.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pyrexia, Skin exfoliation
Clinical narrative: Shivering, fever, layer of skin on younger peeled off
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Chills, Erythema, Headache, Loss of personal independence in daily activities
Clinical narrative: High fever, chills, headache, body ache, inability to perform normal daily tasks for 3 solid days. Burning & itching rad manifested on 3rd day.  This is still continuing on 5th day after vaccination.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pruritus, Pyrexia
Clinical narrative: High fever, chills, headache, body ache, inability to perform normal daily tasks for 3 solid days. Burning & itching rad manifested on 3rd day.  This is still continuing on 5th day after vaccination.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Fatigue, Gastrointestinal pain, Pain in extremity, Rash
Clinical narrative: Localized arm pain, Intestinal cramping, tired, joint pain the day after the vaccine shot.  Advil and nap provide quick relief. Painful, swollen, warm, rash located two inches away from injection sight on left arm developed two days after vaccine shot.  Exercised as usual plus additional arm movement to relieve arm pain.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin warm, Swelling
Clinical narrative: Localized arm pain, Intestinal cramping, tired, joint pain the day after the vaccine shot.  Advil and nap provide quick relief. Painful, swollen, warm, rash located two inches away from injection sight on left arm developed two days after vaccine shot.  Exercised as usual plus additional arm movement to relieve arm pain.
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Emotional distress, Hyperhidrosis, Pyrexia, Rash morbilliform
Clinical narrative: Fever for 3 days beginning 7/1/19 - Measels rash beginning 7/5 - child inconsolable for days, sweating  a lot, fever broke 7/5-6