chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Antibody test negative, Measles antibody negative
Clinical narrative: unspecified "titre test" was drawn on an patient which showed "negative titres for measles and varicella"; unspecified "titre test" was drawn on an patient which showed "negative titres for measles and varicella"; This spontaneous report was received from a nurse practitioner referring to a 29 years old female patient. The patient's drug reactions/allergies included penicillin, levofloxacin(LEVAQUIN) and hydrogen peroxide(PEROXYL). The patient's concomitant therapy included unspecified birth control pills.  On an unknown date at the age of 1 year and 3 weeks and at 4 years of age, the patient was vaccinated with the 1st and 2nd dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (strength, dose detail, route, lot # and expiration date were not reported) for prophylaxis.  On an unspecified date in  May 2001 and February 2007, the patient was vaccinated with the 1st and 2nd dose of varicella virus vaccine live (oka/merck)(VARIVAX) (strength, dose detail, route, lot # and expiration date were not reported) for prophylaxis.    On 06-JUN-2019, an unspecified titre test was drawn on an the patient which showed negative titres for measles and varicella.   The patient sought medical attention but was not given treatment. It was unknown if the patient performed lab diagnostics/studies. The outcome of measles the events was reported as not recovered. The causality of the events was not provided.
Age: 0.5
Sex: F
Vaccine: MMRV, UNK
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: 6 month old female was given (...) Proquad instead of M-M-R II; 6 month old female was given (...) Proquad instead of M-M-R II; 6 month old female was given (...) Proquad instead of M-M-R II; no adverse event; This spontaneous report was received from a nurse and refers to a 6 months old female patient. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided. On an unknown date, the patient was vaccinated with a properly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) albumin status rHA, injection, lot # S002496, expiration date 23-JUL-2020 (dose and route of administration were not reported) for prophylaxis instead of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (dose, route of administration, lot # and expiration date were not reported). The patient was getting measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) due to a family travel to a high risk area. Measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) was reconstituted with properly stored sterile diluent (STERILE DILUENT) (formulation, strength, dose, frequency, route of administration, indication, lot # expiration date were not reported). No adverse effect was reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: the patient was vaccinated with improperly stored PROQUAD; No adverse symptoms reported; Information has been received from a licensed practical nurse referring to a patient of an unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, concomitant medications or drug reactions/allergies.   On an unknown date, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) with lot number S003326 and expiration date on 02-AUG-2020, for prophylaxis (dose, dose number, anatomical injection site and route of administration were not reported) (product storage error).  It was reported that on an unknown date, the vaccine was exposed to a temperature of (-0.3 Celsius degrees) for 50 minutes. There was no previous temperature excursion reported. The call was placed because of a Digital Data logger report. No adverse effects were reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect; Improperly stored dose of VARIVAX administered; This spontaneous report was received from a nurse regarding a patient of unknown age and gender. The patient's concurrent conditions, medical history and drug reactions/allergies were not reported. Concomitant medication included sterile diluent. On 24-JUN-2019, the patient was vaccinated with a dose of improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX), lot # S000133 and expiry date: 02-JAN-2021 (product storage error) subcutaneously for prophylaxis (strength, dose, unit and anatomical location were not reported). The diluent was stored appropriately. No adverse effects were reported. The administered dose of vaccine experienced temperature excursion from 6ºF to 14ºF for a time frame of 2 hours and 40 minutes and 15ºF to 46ºF for a time frame of 7 hours and 40 minutes. There were no previous temperature excursions. The call was due to digital data logger. The outcome of the events was unknown. No product quality complaint (PQC) was involved.  This is one of the five reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA009882:1250974 US-009507513-1906USA010076:1251186 US-009507513-1906USA009880:1251149 US-009507513-1906USA009914:1251178
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect; improperly stored doses of ROTATEQ were administered; Route of Administration: intramuscular; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies, drug reactions, allergies or medical history provided.  On 24-JUN-2019, the patient was vaccinated with improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # R033255, expiration date 26-JUN-2020, intramuscular (dose, frequency and anatomical location were not reported). The vaccine was stored in temperature above 47 Fahrenheit degrees for 2 hours. The temperature was measured by "data logger". There was no previous temperature excursion. No adverse effect was reported.  This is one of six reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA009902: US-009507513-1906USA009882: US-009507513-1906USA009880: US-009507513-1906USA009914: US-009507513-1907USA002467:
Age: 0.5
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects were reported.; 6 month old infant was administered one dose of improperly stored ROTATEQ; This spontaneous report was received from a nurse and refers to a 6 month old patient of unknown gender. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided. On 25-JUN-2019, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # R034878, expiration date 11-SEP-2020 (dose and route of administration were not reported) for prophylaxis. The reported vaccine was exposed to the temperature above 47 (53 F) degrees Fahrenheit for 2 hours and 15 minutes. The vaccine underwent previous temperature excursion of above than 47 (50 F) degrees Fahrenheit for 1 hour. A digital data logger was involved. No adverse event was reported.
Sex: F
Vaccine: MMR
Symptoms: Hypersensitivity, Injection site erythema, Injection site rash, Injection site swelling, Oropharyngeal pain
Clinical narrative: sore throat; The rash has spread to her stomach, arms and face; She "thought she might be having an allergic reaction"; She has "redness and swelling at the injection site, along with several bumps around the area"; She has "redness and swelling at the injection site, along with several bumps around the area"; along with several bumps around the area"; This spontaneous report has been received from a registered nurse referring to a 49 year old female patient. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not provided.   On 10-JUN-2019, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) lot # R031628 with expiration date of 01-NOV-2020, 1 dosage form, subcutaneously (strength, frequency, dose, and anatomical location were not provided). for measles, mumps, rubella protection.         On 24-JUN-2019, the patient thought she might be having an allergic reaction (hypersensitivity), she presented redness and swelling at the injection site (infusion site swelling and injection site erythema), along with several bumps around the area (skin disorder). The patient received "anthistamine and ibuprofen" to relieve the symptoms.  On 26-JUN-2019, the patient's symptoms were worsening, since she experienced sore throat (oropharyngeal pain) and the rash had spread to her stomach, arms and face (rash generalised). The patient sought medical attention. At the reporting time, the outcome of hypersensitivity, rash generalised, oropharyngeal pain, skin disorder, infusion site swelling and injection site erythema was reported as not resolved. The causality assessment was not provided.  This is one of two cases from the same reporter.; Sender's Comments:  US-009507513-1906USA011145:
Sex: F
Vaccine: MMR
Symptoms: Rash
Clinical narrative: sore throat; The rash has spread to her stomach, arms and face; She "thought she might be having an allergic reaction"; She has "redness and swelling at the injection site, along with several bumps around the area"; She has "redness and swelling at the injection site, along with several bumps around the area"; along with several bumps around the area"; This spontaneous report has been received from a registered nurse referring to a 49 year old female patient. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not provided.   On 10-JUN-2019, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) lot # R031628 with expiration date of 01-NOV-2020, 1 dosage form, subcutaneously (strength, frequency, dose, and anatomical location were not provided). for measles, mumps, rubella protection.         On 24-JUN-2019, the patient thought she might be having an allergic reaction (hypersensitivity), she presented redness and swelling at the injection site (infusion site swelling and injection site erythema), along with several bumps around the area (skin disorder). The patient received "anthistamine and ibuprofen" to relieve the symptoms.  On 26-JUN-2019, the patient's symptoms were worsening, since she experienced sore throat (oropharyngeal pain) and the rash had spread to her stomach, arms and face (rash generalised). The patient sought medical attention. At the reporting time, the outcome of hypersensitivity, rash generalised, oropharyngeal pain, skin disorder, infusion site swelling and injection site erythema was reported as not resolved. The causality assessment was not provided.  This is one of two cases from the same reporter.; Sender's Comments:  US-009507513-1906USA011145:
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Neuralgia, Post herpetic neuralgia, Rash, Sensory loss
Clinical narrative: post herpetic neuralgia; Herpes Zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unspecified age. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   On an unknown date, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, lot # and expiration date were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster).   On an unknown date, after receiving zoster vaccine live (ZOSTAVAX), the patient suffered painful rash, nerve pain not accompanied by a rash and loss of sensation in her left breast. As a result of these symptoms patient presented to a medical provider and was diagnosed with herpes zoster and postherpetic neuralgia. Thereafter, patient has continued to suffer the effects of herpes zoster and postherpetic neuralgia. As a result, patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms have resulted in physical limitations not present prior to using the product. As a result of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of the Company's wrongful conduct, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The events were considered related to zoster vaccine live (ZOSTAVAX).  Herpes zoster and post herpetic neuralgia were considered to be disabling.
Sex: M
Vaccine: MMRV
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: No adverse effect; Patient was inadvertently administered Proquad via intramuscular rather than subcutaneous route; This spontaneous report was received from a medical assistant refers to an 12 month old male patient. Patient's medical history, drug allergies/reactions and concurrent conditions were not reported. Concomitant therapies included sterile diluent (DILUENT MERCK Injection) (lot# S000130, expiry date of 23-AUG-2021). On 26-JUN-2019, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, (lot # S002494, expiration date of 23-JUL-2020) via intramuscularly route (incorrect route of product administration) for prophylaxis. The reporter informed that vaccine administered inadvertently via intramuscular route instead of subcutaneous. The vaccine was properly stored and it reconstituted with properly stored sterile diluent. Patient did not experience any adverse effects (no adverse event).  No product quality complaint involved.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effect; multiple patients were vaccinated with improperly stored VAQTA on multiple dates; This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 22-OCT-2019, the patient was vaccinated with improperly stored hepatitis a vaccine, inactivated(VAQTA) lot # R002086, expiry date 22-APR-2019 for prophylaxis.  No adverse event was reported. Previous temperature excursion was reported. Data logger was involved.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1907USA000067:
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effect; multiple patients were vaccinated with improperly stored VAQTA on multiple dates; This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 09-MAY-2019, the patient was vaccinated with improperly stored hepatitis a vaccine, inactivated(VAQTA) lot # R027431, expiry date 08-SEP-2019 for prophylaxis.  No adverse event was reported. Previous temperature excursion was reported. Data logger was involved.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effect; multiple patients were vaccinated with improperly stored VAQTA on multiple dates; This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 30-APR-2019, the patient was vaccinated with improperly stored hepatitis a vaccine, inactivated(VAQTA) lot # R027431, expiry date 08-SEP-2019 for prophylaxis.  No adverse event was reported. Previous temperature excursion was reported. Data logger was involved.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effect; multiple patients were vaccinated with improperly stored VAQTA on multiple dates; This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 02-MAY-2019, the patient was vaccinated with improperly stored hepatitis a vaccine, inactivated(VAQTA) lot # R027431, expiry date 08-SEP-2019 for prophylaxis.  No adverse event was reported. Previous temperature excursion was reported. Data logger was involved.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effect; multiple patients were vaccinated with improperly stored VAQTA on multiple dates; This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 08-MAY-2019, the patient was vaccinated with improperly stored hepatitis a vaccine, inactivated(VAQTA) lot # R027431, expiry date 08-SEP-2019 for prophylaxis.  No adverse event was reported. Previous temperature excursion was reported. Data logger was involved.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effect; multiple patients were vaccinated with improperly stored VAQTA on multiple dates; This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 29-APR-2019, the patient was vaccinated with improperly stored hepatitis a vaccine, inactivated(VAQTA) lot # R027431, expiry date 08-SEP-2019 for prophylaxis.  No adverse event was reported. Previous temperature excursion was reported. Data logger was involved.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effect; multiple patients were vaccinated with improperly stored VAQTA on multiple dates; This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 12-DEC-2018 , the patient was vaccinated with improperly stored hepatitis a vaccine, inactivated(VAQTA) lot # R002086, expiry date 22-APR-2019 for prophylaxis.  No adverse event was reported. Previous temperature excursion was reported. Data logger was involved.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1907USA000067:
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effect; multiple patients were vaccinated with improperly stored VAQTA on multiple dates; This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 14-DEC-2018, the patient was vaccinated with improperly stored hepatitis a vaccine, inactivated(VAQTA) lot # R002086, expiry date 22-APR-2019 for prophylaxis.  No adverse event was reported. Previous temperature excursion was reported. Data logger was involved.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1907USA000067:
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effect; multiple patients were vaccinated with improperly stored VAQTA on multiple dates; This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 26-DEC-2018, the patient was vaccinated with improperly stored hepatitis a vaccine, inactivated(VAQTA) lot # R002086, expiry date 22-APR-2019 for prophylaxis.  No adverse event was reported. Previous temperature excursion was reported. Data logger was involved.; Sender's Comments:  US-009507513-1907USA000067:
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effect; multiple patients were vaccinated with improperly stored VAQTA on multiple dates; This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 27-DEC-2018 , the patient was vaccinated with improperly stored hepatitis a vaccine, inactivated(VAQTA) lot # R002086, expiry date 22-APR-2019 for prophylaxis.  No adverse event was reported. Previous temperature excursion was reported. Data logger was involved.; Sender's Comments:  US-009507513-1907USA000067:
Sex: M
Vaccine: HPV4, MEN, UNK
Symptoms: Gynaecomastia
Clinical narrative: gynecomastia; This spontaneous report as received from a receptionist via a company representative refers to a currently 16-year-old male patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On unknown dates in 2015, the patient was vaccinated with three doses of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (dose, route of administration, lot # and expiration date were not reported) for prophylaxis. On unknown dates in 2015, reported as at the same time, the patient was administered with diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (manufacturer unknown) and meningococcal vaccine (unspecified) (manufacturer unknown) (doses, route of administration, lot # and expiration date were not reported) for prophylaxis.  On an unknown date, about 6 months after the series of vaccine administration, the patient experienced gynecomastia. No treatment was given for the event.   The outcome of the event was reported as recovering/resolving, as he was getting older. The relatedness between the event and suspect vaccines was not reported.
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 17-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-009507513-1907USA000862: US-009507513-1906USA011674: US-009507513-1907USA000883: US-009507513-1907USA000884: US-009507513-1907USA000885: US-009507513-1907USA000926: US-009507513-1907USA000927: US-009507513-1907USA000886: US-009507513-1907USA000887: US-009507513-1907USA000888: US-009507513-1907USA000928: US-009507513-1907USA000930: US-009507513-1907USA000931: US-009507513-1907USA000932: US-009507513-1907USA000889: US-009507513-1907USA000890: US-009507513-1907USA000891: US-009507513-1907USA000892: 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-009507513-1907USA000904: US-009507513-1907USA000905: US-009507513-1907USA000906: US-009507513-1907USA000907: US-009507513-1907USA000908: US-009507513-1907USA000909: US-009507513-1907USA000910: US-009507513-1907USA000911: 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: 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 20-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-009507513-1907USA000927: US-009507513-1907USA000886: US-009507513-1907USA000887: US-009507513-1907USA000888: US-009507513-1907USA000928: US-009507513-1907USA000930: US-009507513-1907USA000931: US-009507513-1907USA000932: US-009507513-1907USA000889: US-009507513-1907USA000890: US-009507513-1907USA000891: US-009507513-1907USA000892: 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-009507513-1907USA000862: US-009507513-1907USA000905: US-009507513-1907USA000906: US-009507513-1907USA000907: US-009507513-1907USA000908: US-009507513-1907USA000909: US-009507513-1907USA000910: US-009507513-1907USA000911: 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: 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 20-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-009507513-1907USA000927: US-009507513-1907USA000886: US-009507513-1907USA000887: US-009507513-1907USA000888: US-009507513-1907USA000928: US-009507513-1907USA000930: US-009507513-1907USA000931: US-009507513-1907USA000932: US-009507513-1907USA000889: US-009507513-1907USA000890: US-009507513-1907USA000891: US-009507513-1907USA000892: 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-009507513-1907USA000862: US-009507513-1907USA000906: US-009507513-1907USA000907: US-009507513-1907USA000908: US-009507513-1907USA000909: US-009507513-1907USA000910: US-009507513-1907USA000911: 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: 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 21-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:  1907USA000925:Original Case : 1907USA000862 US-009507513-1906USA011674: US-009507513-1907USA000883: US-009507513-1907USA000884: US-009507513-1907USA000885: US-009507513-1907USA000926: US-009507513-1907USA000927: US-009507513-1907USA000886: US-009507513-1907USA000887: US-009507513-1907USA000888: US-009507513-1907USA000928: US-009507513-1907USA000930: US-009507513-1907USA000931: US-009507513-1907USA000932: US-009507513-1907USA000889: US-009507513-1907USA000890: US-009507513-1907USA000891: US-009507513-1907USA000892: 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-009507513-1907USA000862: US-009507513-1907USA000907: US-009507513-1907USA000908: US-009507513-1907USA000909: US-009507513-1907USA000910: US-009507513-1907USA000911: 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: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; one separate dose of an improperly stored vaccine, PEDVAXHIB was administered to one separate patient.; Information has been received from a medical assistant, referring to a patient of unknown age and gender. Information of concomitant therapy, pertinent medical history and drug reactions/allergies was not reported.    On 18-JUN-2019, the patient was vaccinated with improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) 0.5 milliliter (one dose, lot# R021077, expiration date: 11-JUN-2021, frequency was unknown) intramuscularly for prophylaxis (incorrect product storage). No adverse effect was reported.  The vaccines were exposed to temperature of 34.2 Fahrenheit (F) for 4 hour 54 minutes. The temperature excursion was detected by a data logger. No previous excursions were reported.  This is one of several reports from the same reporter. ; Sender's Comments:  US-009507513-1906USA011674:
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; one separate dose of an improperly stored vaccine, PEDVAXHIB was administered to one separate patient.; Information has been received from a medical assistant, referring to a patient of unknown age and gender. Information of concomitant therapy, pertinent medical history and drug reactions/allergies was not reported.    On 18-JUN-2019, the patient was vaccinated with improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) 0.5 milliliter (one dose, lot# R021077, expiration date: 11-JUN-2021, frequency was unknown) intramuscularly for prophylaxis (incorrect product storage). No adverse effect was reported.  The vaccines were exposed to temperature of 34.2 Fahrenheit (F) for 4 hour 54 minutes. The temperature excursion was detected by a data logger. No previous excursions were reported.  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-1906USA011674:
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; one separate dose of an improperly stored vaccine, PEDVAXHIB was administered to one separate patient.; Information has been received from a medical assistant, referring to a patient of unknown age and gender. Information of concomitant therapy, pertinent medical history and drug reactions/allergies was not reported.    On 20-JUN-2019, the patient was vaccinated with improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) 0.5 milliliter (one dose, lot# R021077, expiration date: 11-JUN-2021, frequency was unknown) intramuscularly for prophylaxis (incorrect product storage). No adverse effect was reported.  The vaccines were exposed to temperature of 34.2 Fahrenheit (F) for 4 hour 54 minutes. The temperature excursion was detected by a data logger. No previous excursions were reported.  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-1906USA011674:
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; one separate dose of an improperly stored vaccine, PEDVAXHIB was administered to one separate patient.; Information has been received from a medical assistant, referring to a patient of unknown age and gender. Information of concomitant therapy, pertinent medical history and drug reactions/allergies was not reported.    On 24-JUN-2019, the patient was vaccinated with improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) 0.5 milliliter (one dose, lot# R021077, expiration date: 11-JUN-2021, frequency was unknown) intramuscularly for prophylaxis (incorrect product storage). No adverse effect was reported.  The vaccines were exposed to temperature of 34.2 Fahrenheit (F) for 4 hour 54 minutes. The temperature excursion was detected by a data logger. No previous excursions were reported.  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-1906USA011674:
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; one separate dose of an improperly stored vaccine, PEDVAXHIB was administered to one separate patient.; Information has been received from a medical assistant, referring to a patient of unknown age and gender. Information of concomitant therapy, pertinent medical history and drug reactions/allergies was not reported.    On 25-JUN-2019, the patient was vaccinated with improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) 0.5 milliliter (one dose, lot# R021077, expiration date: 11-JUN-2021, frequency was unknown) intramuscularly for prophylaxis (incorrect product storage). No adverse effect was reported.  The vaccines were exposed to temperature of 34.2 Fahrenheit (F) for 4 hour 54 minutes. The temperature excursion was detected by a data logger. No previous excursions were reported.  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-1906USA011674:
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; one separate dose of an improperly stored vaccine, PEDVAXHIB was administered to one separate patient.; Information has been received from a medical assistant, referring to a patient of unknown age and gender. Information of concomitant therapy, pertinent medical history and drug reactions/allergies was not reported.    On 26-JUN-2019, the patient was vaccinated with improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) 0.5 milliliter (one dose, lot# R021077, expiration date: 11-JUN-2021, frequency was unknown) intramuscularly for prophylaxis (incorrect product storage). No adverse effect was reported.  The vaccines were exposed to temperature of 34.2 Fahrenheit (F) for 4 hour 54 minutes. The temperature excursion was detected by a data logger. No previous excursions were reported.  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-1906USA011674:
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; one separate dose of an improperly stored vaccine, PEDVAXHIB was administered to one separate patient.; Information has been received from a medical assistant, referring to a patient of unknown age and gender. Information of concomitant therapy, pertinent medical history and drug reactions/allergies was not reported.    On 27-JUN-2019, the patient was vaccinated with improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) 0.5 milliliter (one dose, lot# R021077, expiration date: 11-JUN-2021, frequency was unknown) intramuscularly for prophylaxis (incorrect product storage). No adverse effect was reported.  The vaccines were exposed to temperature of 34.2 Fahrenheit (F) for 4 hour 54 minutes. The temperature excursion was detected by a data logger. No previous excursions were reported.  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-1906USA011674:
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: NO adverse effect; inadvertently administered one dose of expired rotateq; This spontaneous report was received from a Registered Nurse referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not provided. On 27-JUN-2019, the patient was inadvertently administered one dose of expired rotavirus vaccine, live, oral, Pentavalent (ROTATEQ) (lot # N030995 and expiration date: 17-JUN-2019) (dose number, frequency, strength were unspecified) via oral route for prophylaxis. No adverse events reported. No product quality complaint (PQC) involved.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: light case of shingles; This spontaneous report was received from a 84-year-old female consumer referring to herself. Her concurrent conditions, medical history and concomitant medications was not reported.     On an unknown date in 2009 (also reported as ten years ago), the patient was vaccinated with a single shot of zoster vaccine live (ZOSTAVAX) via unknown route (route also reported as injection) for prophylaxis (strength, dose, unit, anatomical location, lot # and expiration date was not reported). On an unknown date in February 2017 (also reported as two year ago), the patient experienced a "light case" of shingles (herpes zoster). The outcome of herpes zoster was reported as recovered/resolved. Causality assessment of the event was not provided.
Age: 12.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Fall, Syncope, Tooth avulsion, Tooth repair
Clinical narrative: Almost inmediately after administration of GARDASIL9, the patient had a syncope episode; Patient fell foward; Patient knockedout a front tooth; This spontaneous case was received from a nurse, concerning a 12 years old male patient. The patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications were unknown by reporter.  On 26-JUN-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), 1 dosage form, per intramuscular route, (strength,  lot number and expiration date were unknown by reporter) for prevent human papilloma virus (HPV). On the same date, the patient also was vaccinated with a dose of meningococcal ACYW conj vaccine (CRM197) (MENVEO) (, (strength, dose, frequency, route of administration, lot number, expiration date and indication were not reported).   On the same date,  almost immediately after the administration of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9), the patient experienced syncope episode, fell forward (fall) and knocked out a front tooth (tooth avulsion).It was reported that the patient sought medical attention; but it was unknown by reporter if any laboratory diagnostic or studies were performed or if the patient received any treatment for the events.  In approximately June 2019, the patient's tooth was recovered, and the patient visited an unspecified dentist and the tooth was placed back in the mouth.  At the reporting time the outcome of the syncope episode and fall, , and the causality assessment between HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) administration and all the events occurrence were not provided.
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Antibody test negative, Rash vesicular, Wrong technique in product usage process
Clinical narrative: titers were drawn for varicella, the titers were found to be negative.; The patient developed a rash with several vesicles an unknown period of time after receiving the vaccine combination.; The patient developed a rash with several vesicles an unknown period of time after receiving the vaccine combination.; "home brewed combination vaccine that combined"; This spontaneous report was received from a nurse practitioner (also reported as a physician assistant) via a field representative referring to a currently 12 years old female patient. Information about pertinent medical history, drug reactions/allergies and concomitant medication was unknown.  On an unknown date in the past, the patient was vaccinated with a home brewed combination vaccine that combined varicella virus vaccine live (oka/merck) (VARIVAX) and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneously (dose detail, lot # and expiration date were not reported for both) for prophylaxis (reported as vaccination) (Wrong technique in product usage process).  On an unknown date, after received the combination vaccine of varicella virus vaccine live (oka/merck) (VARIVAX) and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), the patient developed a rash with several vesicles for an unknown period. On an unknown date, in recently, the patient was seen at the physician's office, where titers were drawn for varicella. The titers were found to be negative. On an unknown date (also reported as in a recent date), the patient was given a dose of varicella virus vaccine live (oka/merck) (VARIVAX) via subcutaneously (dose detail, lot # and expiration date were not reported) for prophylaxis as a result.   It was unknown if treatment was given for the events. The outcome of rash, several vesicles and titers was negative was reported as recovered. The causality assessment between ash, several vesicles, titers negative and suspect vaccines were not reported.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: adult dose administered to a 17 yeras old patient; no adverse effects; This spontaneous report was received from a nurse regarding to a 17-year-old adolescent patient of unknown gender. Information on patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) (dose, strength, frequency were not reported, lot # S001832 with expiration date 12-MAY-2020) via unknown route for prophylaxis. On an unknown date the 17-year-old patient was administered an adult dose of hepatitis a vaccine, inactivated (VAQTA) (product administered to patient of inappropriate age). No adverse effects were reported (no adverse event). There was not involvement of product quality complaint (PQC).
Age: 6.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effect; The Nurse reports that on 6/13/2019. 1 specified patient received improperlv stored PROQUAD (lot S002924 & expiration 7/28/2020).; This spontaneous report was received from a nurse refers to a 6-year-old patient of unknown gender. The patient's concurrent condition and medical history were unknown. The patient's concomitant therapy included sterile diluent (STERILE DILUENT). On 13-JUN-2019, the patient received improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) of lot # S002924 with expiry date 28-JUL-2020, therapy type: rha (strength, dose, frequency, route of administration unknown) for prophylaxis (product storage error). The measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) was reconstituted with properly stored diluent. On an unknown date, the vaccine was exposed to temperature of 6 °Fahrenheit (°F) to 14 °F (10.4 F) for 1 hour and 30 minutes. Previous temperature excursion was on temperature of 6 °F to 14 °F (10.4 F) for 1 hour and 56 minutes and 15 °F to 46 °F (29 F) for 5 hours. The data logger was involved. No adverse effects reported. The outcomes of the events were unknown. No product quality complaint involved.
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Injection site warmth, Pain in extremity
Clinical narrative: arm  was extremely sore; swelled; hot and swollen; This spontaneous report as received from a consumer refers to a female patient of unknown age.    On JUN-2019 the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) for prophylaxis.       On 07-JUN-2019 the patient experienced pain in extremity, injection site warmth and swelling.    The outcome of pain in extremity and injection site warmth is unknown. The outcome of swelling was reported as recovering/resolving.