chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
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 73 year old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   On or about 29-JUL-2016, 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.   On an unspecified date, the patient was treated by a healthcare provider for herpes zoster. The outcome of the event herpes zoster was not reported. The reporter considered the event herpes zoster to be related to zoster vaccine live (ZOSTAVAX).  Additional information has been requested.
Sex: M
Vaccine: HPV9
Symptoms: Injection site pain
Clinical narrative: it "did hurt for 45 seconds" when he was "stabbed by the needle"; This spontaneous report was received from a male consumer of unknown age referring to himself. The patient's current condition included sinus issues such as a "deviated septum" and "drainage not wide enough". The patient had sinus surgery scheduled to realign the deviated septum but had not had it yet. No information regarding the patient's drug reactions or allergies and concomitant therapies was provided. On approximately 07-JUN-2019 (reported as "3 or 4 days ago"), the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) first dose (strength, dose, route of administration, indication, lot # and expiration date were not reported) for prophylaxis. It was reported that when the patient was "stabbed by the needle" it "did hurt for 45 seconds". The outcome of the event was reported as recovered on the same date. The patient did not seek medical attention. The relatedness between the event and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not reported.
Sex: F
Vaccine: MMR
Symptoms: Rash
Clinical narrative: rash that looked like "pin point freckles on chest stomach and arms" that is "not itchy"; This spontaneous report was received from a pharmacist referring to a female patient of unknown age. The patient had no concurrent condition, concomitant medication or medical history. Drug reactions / allergies  were unknown.     On 28-MAY-2019 the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (dose, frequency, lot# and expiration date were unknown) via subcutaneous for prophylaxis. On an unknown date, the patient experienced a rash that looked like pin point freckles on chest stomach and arms that was not itchy. On 13-JUN-2019, the patient came to pharmacist presenting the event. Treatment was given for the event. The outcome of the event was reported as not recovered/not resolved. The reporter considered the event to be related to Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live(M-M-R II). Medical attention was sought.
Sex: M
Vaccine: HEPA, HIBV, PNC13
Symptoms: Flushing, Lip erythema, Lip swelling, Rash, Swollen tongue
Clinical narrative: red and puffy lips; facial flushing; red and puffy lips; swollen tongue; rash; hives around mouth and back; Information has been received from a medical assistant, referring to a 3 years old male patient. The patient had no drug reaction or allergies. Information of concurrent condition and concomitant therapy was unknown by reporter.    On an unknown date, the patient was vaccinated with haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (dose, strength, route, lot# and expiration date were unknown) for prophylaxis.  On the same day, the patient was also administered an unspecified hepatitis a virus vaccine (manufacturer GlaxoSmithKline) and pneumococcal 13v conj vaccine (crm197)(PREVNAR 13) (manufacturer Pfizer) (indication, dose, frequency, strength, route, lot# and expiration date were unknown).   In March 2017 (reported as around March 2017, after administration of with haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB)), the patient developed red and puffy lips, swollen tongue, facial flushing, rash, and hives around mouth and back. All the events were not cancer. The outcome of all events was recovered. The relationship between haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) and all of the events was not reported.
Sex: M
Vaccine: HEPA, HIBV, PNC13
Symptoms: Urticaria
Clinical narrative: red and puffy lips; facial flushing; red and puffy lips; swollen tongue; rash; hives around mouth and back; Information has been received from a medical assistant, referring to a 3 years old male patient. The patient had no drug reaction or allergies. Information of concurrent condition and concomitant therapy was unknown by reporter.    On an unknown date, the patient was vaccinated with haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (dose, strength, route, lot# and expiration date were unknown) for prophylaxis.  On the same day, the patient was also administered an unspecified hepatitis a virus vaccine (manufacturer GlaxoSmithKline) and pneumococcal 13v conj vaccine (crm197)(PREVNAR 13) (manufacturer Pfizer) (indication, dose, frequency, strength, route, lot# and expiration date were unknown).   In March 2017 (reported as around March 2017, after administration of with haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB)), the patient developed red and puffy lips, swollen tongue, facial flushing, rash, and hives around mouth and back. All the events were not cancer. The outcome of all events was recovered. The relationship between haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) and all of the events was not reported.
Age: 66.0
Sex: F
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 68 year old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   In March 2017, 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. On an unspecified date, the patient was treated by healthcare provider for herpes zoster. The outcome of the event herpes zoster was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).   Additional information has been requested.
Age: 60.0
Sex: F
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 70 year old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   On or about 09-SEP-2009, 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. On an unspecified date, the patient was treated by a physician for herpes zoster. The outcome of the event herpes zoster was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).   Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 62 year old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 13-JUL-2017, 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 shingles. On an unspecified date, the patient was treated by a healthcare provider for shingles. The outcome of the event shingles was not reported. The reporter considered the event shingles to be related to zoster vaccine live (ZOSTAVAX).  Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: herpers zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 78 year old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 08-AUG-2016, 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. On an unspecified date, the patient was treated by a physician for herpes zoster. The outcome of the event herpes zoster was not reported. The reporter considered the event herpes zoster to be related to zoster vaccine live (ZOSTAVAX).  Additional information has been requested.
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: was administered the first dose of GARDASIL 9 when she was 13 years old/was then administered a second dose of GARDASIL 9 when the patient is now 19 years old; No adverse effects were reported; Information has been received from a nurse, referring to a 19 years old female patient. Information of concurrent condition, medical history and concomitant therapy was not provided.   On 15-AUG-2013 (reported as when she was 13 years old), the patient was administered the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (dose, strength, lot# and expiration date were unknown) intramuscularly for prophylaxis. On 19-JUN-2019, the patient was administered the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (dose and strength were unknown; lot# was reported as 1614897 and expiration date 20-SEP-2021) intramuscularly for prophylaxis (inappropriate schedule of product administration).  No adverse effects were reported.
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, Product availability issue
Clinical narrative: patient received his first GARDASIL 9 (lot N004798 & 10/31/19) on 6/29/2017 and the second GARDASIL 9 (lot 1602283 & 8/16/21) on 6/17/2019; No adverse effect reported; The office did not have any GARDASIL 9 in stock; This spontaneous report was received from a nurse referring to a 14 years old male patient. Information about concurrent condition, concomitant medication and medical history was not provided.   On 29-JUN-2017 the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (lot # N004798, expiration date 31-OCT-2019; strength, dose and route were not reported) for prophylaxis. On 17-JUN-2019, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (lot # 1602283 expiration date reported as 16-AUG-2021, but upon internal validation established as 18-AUG-2021; strength, dose and route were not reported) for prophylaxis (inappropriate schedule of product administration). In 2018 when the patient was at the age of 14, the office did not have any hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) in stock.  The outcome of product availability issue was unknown. The causality assessment was not provided.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects were reported; 13 unspecified patients were administered a dose of ROTATEQ / The shipment took 4 days to arrive (on a refrigerated vaccine that is only guaranteed with a one day delivery); shipment of ROTATEQ was supposed to be delivered on 10-MAY-2019, however, wasnot received until 13-MAY-2019; This spontaneous report was received from an office manager and an specified reporter from the Customer Resolution Team referring to 13 patients of unknown age and gender. The patients' concurrent conditions, past medical history, concomitant medications, and drug reactions or allergies were not reported.  On 10-MAY-2019, a shipment of vaccine, live, oral, pentavalent (ROTATEQ) was supposed to be delivered, however, it was not received until 13-MAY-2019 (Product distribution issue). Shipment was received late; it took 4 days to arrive (on a refrigerated vaccine that is only guaranteed with a one day delivery). On unspecified dates in 2019 since that day, the patients received improperly stored doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot # R035367 and expiration date of 07-OCT-2020) (dose not reported), orally for prophylaxis. It was advised to not use the doses but by this time, 13 doses of the 25 pack were already administered. No data was available for the temperature or the time frame during the time the shipment was delayed. There were no previous temperature excursions and a data logger was not involved. No adverse effects were reported..  The outcome of product distribution issue and was resolved on 13-MAY-2019. The causality  was not provided..  This is a non-valid case due to lack of patients' identifiers.
Age: 24.0
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse effects; patient was administered one dose of GARDASIL 9 on 8/14/2014, and one dose of GARDASIL 9 on 6/24/2016; This spontaneous report was received from a medical assistant and refers to a 24-year-old female patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 14-AUG-2014, the patient was vaccinated with one dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (exact dose, site and route of administration, lot # and expiration date were not reported) for prophylaxis and on 24-JUN-2016, she was vaccinated with another dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (exact dose, site and route of administration, lot # and expiration date were not reported) for prophylaxis. No adverse effects were reported.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product administered at inappropriate site
Clinical narrative: The patient is very petite/ thin and prefers injections in her buttock.; No adverse effect reported; This spontaneous report has been received from a medical assistant regarding to a currently 26-year-old female patient. The patient's concurrent conditions, medical history, concomitant therapies, drug reaction and allergies were not reported.   On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, lot #, expiration date and route of administration were not reported) in her buttock (laterally unspecified) for prophylaxis. The patient had received 2 doses of the vaccine and stated that since she was very petite/thin, she preferred the injection in her buttock. It was reported that the vaccine therapy was continued.No adverse effects reported.
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy, No adverse event, Pregnancy test positive
Clinical narrative: a patient received her second dose of GARDASIL-9 on 6/24/2019/ The patient took a home pregnancy test (which was positive) on 6/26/2019; No adverse effects were reported in the patient; Information has been received from a medical assistant concerning a female patient of unknown age. The patient's medical history, concurrent condition and concomitant therapy were not reported.  On 24-JUN-2019, the patient received her second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot# R009614, expiration date 30-NOV-2020; strength and dose were unknown) intramuscularly for prophylaxis.       On 26-JUN-2019, the patient took a home pregnancy test, which was positive. No adverse effects were reported in the patient. The last menstrual period (LMP) and the estimated date of delivery (EDD) was not provided (Vaccine exposure during pregnancy). The outcome of pregnant was pending.
Sex: F
Vaccine: HPV9
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: a bump appeared at the injection site that is tender to the touch; Information has been received from a female pharmacist (who is also the patient) of unknown age via a company representative referring to herself. Information about concurrent condition, concomitant medication and drug reactions/allergies was not provided.  On 17-JUN-2019, the patient was vaccinated with the 1st dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, dose, lot# and expiration date were not reported) for prophylaxis.   The reporter reported that on an unknown date in June 2019, an unspecified amount of time after receiving the first dose of the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), a bump appeared at the injection site that is tender to the touch (Injection site mass). She also stated this has happened before with other vaccines. No treatment was given. Information about lab diagnostics/studies and medical attention was unknown by the reporter.  The outcome of the event was reported as recovering. The causality between the event and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not reported.
Age: 21.0
Sex: U
Vaccine: MMR, UNK
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse effect; MMR II vaccine was reconstituted with expired diluent; MMR II vaccine was reconstituted with expired diluent; This spontaneous report was received from a nurse referring to a 21 years old patient of unknown gender. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapies were not reported.  On 22-JUN-2019 the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (dose, frequency, lot# and expiration date were not reported), subcutaneous for prophylaxis. The vaccine was reconstituted with expired sterile diluent (lot# was M041089, expiration date was 10-JUN-2019) (expired product administered and product preparation error). The nurse could confirm that the sterile diluent was expired on the date of administration and the measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) was not expired. No adverse events were reported.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: Was inadvertently administered a dose of GARDASIL 9 on an unspecified date, that had been improperly stored; No adverse effect reported; This spontaneous report was received from a licensed practical nurse referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions, known allergies and concomitant medications was not provided.      On an unknown date, the patient was inadvertently vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) with lot # 1586751 and expiration date of 16-FEB-2021 (strength, dose and anatomical route of vaccination were not provided) for prophylaxis, that had been improperly stored. No adverse effects were reported.   Hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), was exposed to a temperature excursion of 65.3 °F for a 4 hours time frame. The vaccines was no involved in any previous temperature excursion. Call was made due to a data logger.
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: rash; Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication.   On 01-FEB-2015, the patient was inoculated the zoster vaccine live (ZOSTAVAX)(lot number, dosage and route of administration not provided) for its intended purpose: the prevention of shingles (herpes zoster). Shortly thereafter (approximately in February 2015), patient suffered a severe rash. On 10-JUL-2015, patient had a severe rash and was placed on valacyclovir hydrochloride(VALTREX). As a direct and proximate result of zoster vaccine live (ZOSTAVAX), patient's symptoms had resulted in physical limitations not present prior to using this product. Patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the zoster vaccine live (ZOSTAVAX), patient sustained severe and permanent personal injuries. Further, as a tragic consequence of this wrongful conduct, 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.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; multiple patients were vaccinated with an improperly stored vaccine; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported.  On 22-MAY-2019, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), 2 ml, orally, lot # R034700, expiry date 16-JUN-2020 for prophylaxis. The vaccine was exposed to a temperature of 34.2 Fahrenheit degrees for 4 hours and 54 minutes. Digital data logger was involved. There were no previous temperature excursions. No adverse effects were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA011674: US-009507513-1907USA000883: US-009507513-1907USA000884: US-009507513-1907USA000885: US-009507513-1907USA000926: US-009507513-1907USA000886: US-009507513-1907USA000887: US-009507513-1907USA000888: US-009507513-1907USA000927: US-009507513-1907USA000930: US-009507513-1907USA000931: US-009507513-1907USA000932: US-009507513-1907USA000889: US-009507513-1907USA000890: US-009507513-1907USA000891: US-009507513-1907USA000892: US-009507513-1907USA000928: US-009507513-1907USA000933: US-009507513-1907USA000934: US-009507513-1907USA000935: US-009507513-1907USA000893: US-009507513-1907USA000894: US-009507513-1907USA000895: US-009507513-1907USA000929: US-009507513-1907USA000936: US-009507513-1907USA000937: US-009507513-1907USA000938: US-009507513-1907USA000896: US-009507513-1907USA000897: US-009507513-1907USA000898: US-009507513-1907USA000899: US-009507513-1907USA000900: US-009507513-1907USA000901: US-009507513-1907USA000902: US-009507513-1907USA000903: US-009507513-1907USA000904: US-009507513-1907USA000905: US-009507513-1907USA000906: US-009507513-1907USA000907: US-009507513-1907USA000908: US-009507513-1907USA000909: US-009507513-1907USA000910: US-009507513-1907USA000862: US-009507513-1907USA000912: US-009507513-1907USA000913: US-009507513-1907USA000914: US-009507513-1907USA000915: US-009507513-1907USA000916: US-009507513-1907USA000917: US-009507513-1907USA000918: US-009507513-1907USA000919: US-009507513-1907USA000920: US-009507513-1907USA000921: US-009507513-1907USA000922: US-009507513-1907USA000882: US-009507513-1907USA000923: US-009507513-1907USA000924: US-009507513-1907USA000925:
Sex: U
Vaccine: MMR
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: No adverse effects reported; Incorrect route of product administration; This spontaneous report was received from a registered nurse concerning a patient of unknown age, gender and race. The patient's pertinent medical history, concurrent conditions, drug allergies or reactions, historical and concomitant drugs were not reported.  On 28-JUN-2019, the patient was vaccinated with one dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) recombinant human albumin (rHA) (lot number R031636 with expiration date on 01-NOV-2020) intramuscular (incorrect route of product administration) rather than subcutaneous for prophylaxis (strength and frequency were not reported). No adverse effects reported
Sex: F
Vaccine: HPV9
Symptoms: Limb discomfort, Myalgia, Pain, Pain in extremity
Clinical narrative: Pain in arm for 6 weeks; Heaviness; Discomfort with movement; Muscle soreness; This spontaneous report as received from a pharmacist and a nurse refers to a currently 40 year old female patient. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant medications were unknown. On an unknown date, 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) (Strength, dose, route of administration, anatomical location, lot number and expiry date were unknown) for prophylaxis. On an unknown date, the patient experienced pain in the arm for 6 weeks post administration with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). On unknown dates, the patient also experienced heaviness, discomfort with movement and muscle soreness after getting vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). On an unknown date, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). However, no adverse experiences were reported with the second dose of  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). No product quality complaint (PQC) was associated with the report. The outcome of the event of pain in extremity was considered to be recovering (Also reported as "starting to go away now "). The outcome of the events of discomfort, movement disorder and myalgia was considered to be unknown. The reporter did not provide the causality assessment for the reported events with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9).
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse effects reported; patient received concomitant administration of PROQUAD (lot and expiration unspecified)  and VARIVAX; Information has been received from an administrator concerning a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported.  On 28-JUN-2019, the received concomitant administration of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot and expiration date unspecified) and varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot# N021315, expiration date 07-AUG-2019) for prophylaxis (inappropriate dose of vaccine administered). No adverse effects was reported.
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 14-MAY-2019, the patient was vaccinated with an improperly stored dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) orally for prophylaxis (lot number R029815 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-009507513-1907USA001848: US-009507513-1907USA001849: US-009507513-1906USA011434: 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: US-009507513-1907USA001804: US-009507513-1907USA001805: US-009507513-1907USA001806: US-009507513-1907USA001807: US-009507513-1907USA001808: US-009507513-1907USA001809: US-009507513-1907USA001810: US-009507513-1907USA001811: US-009507513-1907USA001812: US-009507513-1907USA001813: US-009507513-1907USA001814: US-009507513-1907USA001815: US-009507513-1907USA001816: US-009507513-1907USA001817: US-009507513-1907USA001818: US-009507513-1907USA001819: US-009507513-1907USA001820: US-009507513-1907USA001821: US-009507513-1907USA001822: US-009507513-1907USA001823: US-009507513-1907USA001824: US-009507513-1907USA001825: US-009507513-1907USA001826: US-009507513-1907USA001827: US-009507513-1907USA001828: US-009507513-1907USA001829: US-009507513-1907USA001830: US-009507513-1907USA001831: US-009507513-1907USA001832: US-009507513-1907USA001833: US-009507513-1907USA001834: US-009507513-1907USA001835: US-009507513-1907USA001836: US-009507513-1907USA001837: US-009507513-1907USA001838: US-009507513-1907USA001839: US-009507513-1907USA001840: US-009507513-1907USA001841: US-009507513-1907USA001843: US-009507513-1907USA001844: US-009507513-1907USA001845: US-009507513-1907USA001846: US-009507513-1907USA001847: US-009507513-1907USA000952: US-009507513-1907USA000989: US-009507513-1907USA000962: US-009507513-1907USA000988: US-009507513-1907USA000963: US-009507513-1907USA000953: US-009507513-1907USA000959: US-009507513-1907USA000968: US-009507513-1907USA000967: US-009507513-1907USA000964: US-009507513-1907USA000966: US-009507513-1907USA000954: US-009507513-1907USA000969: US-009507513-1907USA000970: US-009507513-1907USA000965:
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 20-MAY-2019, the patient was vaccinated with an improperly stored dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) orally for prophylaxis (lot number R029815 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-009507513-1907USA001848: US-009507513-1907USA001849: US-009507513-1906USA011434: 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: US-009507513-1907USA001804: US-009507513-1907USA001805: US-009507513-1907USA001806: US-009507513-1907USA001807: US-009507513-1907USA001808: US-009507513-1907USA001809: US-009507513-1907USA001810: US-009507513-1907USA001811: US-009507513-1907USA001812: US-009507513-1907USA001813: US-009507513-1907USA001814: US-009507513-1907USA001815: US-009507513-1907USA001816: US-009507513-1907USA001817: US-009507513-1907USA001818: US-009507513-1907USA001819: US-009507513-1907USA001820: US-009507513-1907USA001821: US-009507513-1907USA001822: US-009507513-1907USA001823: US-009507513-1907USA001824: US-009507513-1907USA001825: US-009507513-1907USA001826: US-009507513-1907USA001827: US-009507513-1907USA001828: US-009507513-1907USA001829: US-009507513-1907USA001830: US-009507513-1907USA001831: US-009507513-1907USA001832: US-009507513-1907USA001833: US-009507513-1907USA001834: US-009507513-1907USA001835: US-009507513-1907USA001836: US-009507513-1907USA001837: US-009507513-1907USA001838: US-009507513-1907USA001839: US-009507513-1907USA001840: US-009507513-1907USA001841: US-009507513-1907USA001842: US-009507513-1907USA001844: US-009507513-1907USA001845: US-009507513-1907USA001846: US-009507513-1907USA001847: US-009507513-1907USA000952: US-009507513-1907USA000989: US-009507513-1907USA000962: US-009507513-1907USA000988: US-009507513-1907USA000963: US-009507513-1907USA000953: US-009507513-1907USA000959: US-009507513-1907USA000968: US-009507513-1907USA000967: US-009507513-1907USA000964: US-009507513-1907USA000966: US-009507513-1907USA000954: US-009507513-1907USA000969: US-009507513-1907USA000970: US-009507513-1907USA000965:
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 22-MAY-2019, the patient was vaccinated with an improperly stored dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) orally for prophylaxis (lot number R029815 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-009507513-1907USA001848: US-009507513-1907USA001849: US-009507513-1906USA011434: 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: US-009507513-1907USA001804: US-009507513-1907USA001805: US-009507513-1907USA001806: US-009507513-1907USA001807: US-009507513-1907USA001808: US-009507513-1907USA001809: US-009507513-1907USA001810: US-009507513-1907USA001811: US-009507513-1907USA001812: US-009507513-1907USA001813: US-009507513-1907USA001814: US-009507513-1907USA001815: US-009507513-1907USA001816: US-009507513-1907USA001817: US-009507513-1907USA001818: US-009507513-1907USA001819: US-009507513-1907USA001820: US-009507513-1907USA001821: US-009507513-1907USA001822: US-009507513-1907USA001823: US-009507513-1907USA001824: US-009507513-1907USA001825: US-009507513-1907USA001826: US-009507513-1907USA001827: US-009507513-1907USA001828: US-009507513-1907USA001829: US-009507513-1907USA001830: US-009507513-1907USA001831: US-009507513-1907USA001832: US-009507513-1907USA001833: US-009507513-1907USA001834: US-009507513-1907USA001835: US-009507513-1907USA001836: US-009507513-1907USA001837: US-009507513-1907USA001838: US-009507513-1907USA001839: US-009507513-1907USA001840: US-009507513-1907USA001841: US-009507513-1907USA001842: US-009507513-1907USA000965: US-009507513-1907USA001843: US-009507513-1907USA001845: US-009507513-1907USA001846: US-009507513-1907USA001847: US-009507513-1907USA000952: US-009507513-1907USA000989: US-009507513-1907USA000962: US-009507513-1907USA000988: US-009507513-1907USA000963: US-009507513-1907USA000953: US-009507513-1907USA000959: US-009507513-1907USA000968: US-009507513-1907USA000967: US-009507513-1907USA000964: US-009507513-1907USA000966: US-009507513-1907USA000954: US-009507513-1907USA000969: US-009507513-1907USA000970:
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 29-MAY-2019, the patient was vaccinated with an improperly stored dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) orally for prophylaxis (lot number R029815 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-009507513-1907USA001848: US-009507513-1907USA001849: US-009507513-1907USA001847: US-009507513-1907USA001846: US-009507513-1906USA011434: 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: US-009507513-1907USA001804: US-009507513-1907USA001805: US-009507513-1907USA001806: US-009507513-1907USA001807: US-009507513-1907USA001808: US-009507513-1907USA001809: US-009507513-1907USA001810: US-009507513-1907USA001811: US-009507513-1907USA001812: US-009507513-1907USA001813: US-009507513-1907USA001814: US-009507513-1907USA001815: US-009507513-1907USA001816: US-009507513-1907USA001817: US-009507513-1907USA001818: US-009507513-1907USA001819: US-009507513-1907USA001820: US-009507513-1907USA001821: US-009507513-1907USA001822: US-009507513-1907USA001823: US-009507513-1907USA001824: US-009507513-1907USA001825: US-009507513-1907USA001826: US-009507513-1907USA001827: US-009507513-1907USA001828: US-009507513-1907USA001829: US-009507513-1907USA001830: US-009507513-1907USA001831: US-009507513-1907USA001832: US-009507513-1907USA001833: US-009507513-1907USA001834: US-009507513-1907USA001835: US-009507513-1907USA001836: US-009507513-1907USA001837: US-009507513-1907USA001838: US-009507513-1907USA001839: US-009507513-1907USA001840: US-009507513-1907USA001841: US-009507513-1907USA001842: US-009507513-1907USA001843: US-009507513-1907USA001844: US-009507513-1907USA000952: US-009507513-1907USA000989: US-009507513-1907USA000962: US-009507513-1907USA000988: US-009507513-1907USA000963: US-009507513-1907USA000953: US-009507513-1907USA000959: US-009507513-1907USA000968: US-009507513-1907USA000967: US-009507513-1907USA000964: US-009507513-1907USA000966: US-009507513-1907USA000954: US-009507513-1907USA000969: US-009507513-1907USA000970: US-009507513-1907USA000965:
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 29-MAY-2019, the patient was vaccinated with an improperly stored dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) orally for prophylaxis (lot number R029815 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-009507513-1907USA001848: US-009507513-1907USA001849: US-009507513-1906USA011434: 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: US-009507513-1907USA001804: US-009507513-1907USA001805: US-009507513-1907USA001806: US-009507513-1907USA001807: US-009507513-1907USA001808: US-009507513-1907USA001809: US-009507513-1907USA001810: US-009507513-1907USA001811: US-009507513-1907USA001812: US-009507513-1907USA001813: US-009507513-1907USA001814: US-009507513-1907USA001815: US-009507513-1907USA001816: US-009507513-1907USA001817: US-009507513-1907USA001818: US-009507513-1907USA001819: US-009507513-1907USA001820: US-009507513-1907USA001821: US-009507513-1907USA001822: US-009507513-1907USA001823: US-009507513-1907USA001824: US-009507513-1907USA001825: US-009507513-1907USA001826: US-009507513-1907USA001827: US-009507513-1907USA001828: US-009507513-1907USA001829: US-009507513-1907USA001830: US-009507513-1907USA001831: US-009507513-1907USA001832: US-009507513-1907USA001833: US-009507513-1907USA001834: US-009507513-1907USA001835: US-009507513-1907USA001836: US-009507513-1907USA001837: US-009507513-1907USA001838: US-009507513-1907USA001839: US-009507513-1907USA001840: US-009507513-1907USA001841: US-009507513-1907USA001842: US-009507513-1907USA001843: US-009507513-1907USA001844: US-009507513-1907USA001845: US-009507513-1907USA000965: US-009507513-1907USA001847: US-009507513-1907USA000952: US-009507513-1907USA000989: US-009507513-1907USA000962: US-009507513-1907USA000988: US-009507513-1907USA000963: US-009507513-1907USA000953: US-009507513-1907USA000959: US-009507513-1907USA000968: US-009507513-1907USA000967: US-009507513-1907USA000964: US-009507513-1907USA000966: US-009507513-1907USA000954: US-009507513-1907USA000969: US-009507513-1907USA000965:
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 12-JUN-2019, the patient was vaccinated with an improperly stored dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) orally for prophylaxis (lot number R029815 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-009507513-1907USA001848: US-009507513-1907USA001849: US-009507513-1906USA011434: 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: US-009507513-1907USA001804: US-009507513-1907USA001805: US-009507513-1907USA001806: US-009507513-1907USA001807: US-009507513-1907USA001808: US-009507513-1907USA001809: US-009507513-1907USA001810: US-009507513-1907USA001811: US-009507513-1907USA001812: US-009507513-1907USA001813: US-009507513-1907USA001814: US-009507513-1907USA001815: US-009507513-1907USA001816: US-009507513-1907USA001817: US-009507513-1907USA001818: US-009507513-1907USA001819: US-009507513-1907USA001820: US-009507513-1907USA001821: US-009507513-1907USA001822: US-009507513-1907USA001823: US-009507513-1907USA001824: US-009507513-1907USA001825: US-009507513-1907USA001826: US-009507513-1907USA001827: US-009507513-1907USA001828: US-009507513-1907USA001829: US-009507513-1907USA001830: US-009507513-1907USA001831: US-009507513-1907USA001832: US-009507513-1907USA001833: US-009507513-1907USA001834: US-009507513-1907USA001835: US-009507513-1907USA001836: US-009507513-1907USA001837: US-009507513-1907USA001838: US-009507513-1907USA001839: US-009507513-1907USA001840: US-009507513-1907USA001841: US-009507513-1907USA001842: US-009507513-1907USA001843: US-009507513-1907USA001844: US-009507513-1907USA001845: US-009507513-1907USA001846: US-009507513-1907USA000952: US-009507513-1907USA000989: US-009507513-1907USA000962: US-009507513-1907USA000988: US-009507513-1907USA000963: US-009507513-1907USA000953: US-009507513-1907USA000959: US-009507513-1907USA000968: US-009507513-1907USA000967: US-009507513-1907USA000964: US-009507513-1907USA000966: US-009507513-1907USA000954: US-009507513-1907USA000969: US-009507513-1907USA000970: US-009507513-1907USA000965:
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 17-JUN-2019, the patient was vaccinated with an improperly stored dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) orally for prophylaxis (lot number R029815 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-009507513-1907USA001849: US-009507513-1906USA011434: 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: US-009507513-1907USA001804: US-009507513-1907USA001805: US-009507513-1907USA001806: US-009507513-1907USA001807: US-009507513-1907USA001808: US-009507513-1907USA001809: US-009507513-1907USA001810: US-009507513-1907USA001811: US-009507513-1907USA001812: US-009507513-1907USA001813: US-009507513-1907USA001814: US-009507513-1907USA001815: US-009507513-1907USA001816: US-009507513-1907USA001817: US-009507513-1907USA001818: US-009507513-1907USA001819: US-009507513-1907USA001820: US-009507513-1907USA001821: US-009507513-1907USA001822: US-009507513-1907USA001823: US-009507513-1907USA001824: US-009507513-1907USA001825: US-009507513-1907USA001826: US-009507513-1907USA001827: US-009507513-1907USA001828: US-009507513-1907USA001829: US-009507513-1907USA001830: US-009507513-1907USA001831: US-009507513-1907USA001832: US-009507513-1907USA001833: US-009507513-1907USA001834: US-009507513-1907USA001835: US-009507513-1907USA001836: US-009507513-1907USA001837: US-009507513-1907USA001838: US-009507513-1907USA001839: US-009507513-1907USA001840: US-009507513-1907USA001841: US-009507513-1907USA001842: US-009507513-1907USA001843: US-009507513-1907USA001844: US-009507513-1907USA001845: US-009507513-1907USA001846: US-009507513-1907USA001847: US-009507513-1907USA000952: US-009507513-1907USA000989: US-009507513-1907USA000962: US-009507513-1907USA000988: US-009507513-1907USA000963: US-009507513-1907USA000959: US-009507513-1907USA000968: US-009507513-1907USA000967: US-009507513-1907USA000964: US-009507513-1907USA000966: US-009507513-1907USA000954: US-009507513-1907USA000969: US-009507513-1907USA000970: US-009507513-1907USA000965: