chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 70.0
Sex: F
Vaccine: FLU3, PPV, FLU4, PPV
Symptoms: Asthenia, Chills, Computerised tomogram, Infection, Lethargy
Clinical narrative: This spontaneous report as received from a patient's husband, referring to his 70 year old wife. The patient's medical history included surgical removal of meningioma in 1997. As a current condition, it was reported that a calcified partial meningioma remains. The patient's drug allergies included penicillin and sulfa drugs. Concomitant therapies included unspecified vitamins. On 26-SEP-2017, the patient was vaccinated with PNEUMOVAX 23, intramuscular, for prevention of pneumococcal disease (strength, dose, frequency, lot # and expiration date were not reported) and FLUZONE (strength, dose, frequency, route, lot # and expiration date were not reported). Later on the same date in the evening, the patient experienced severe chills and became unresponsive, so the reporter had to call to the emergency number and when the emergency medical technicians arrived "diagnosed her with a stroke as she had no motor reponses". On an unspecified date in September 2017, she was transported to a hospital, where she was seen by multiple unspecified physicians and teams of neurologists. After some tests including magnetic resonance imaging (MRI), computed tomography (CT-scan) and lumbar puncture (reported as hundred of tests), it was found that the patient did not have a stroke but had an infection, however, no cause could be determined regarding the infection. It was reported that the patient was hospitalized for 4 days and then released on therapy with unspecified antibiotics. Additionally, the reporter stated she still felt weak and lethargic. At the time of reporting, the outcome of lethargic, felt weak and infection were not recovered. The outcome of unresponsive to stimuli was unknown (also reported as not recovered; conflicting information). Additionally, the assessment causality between chills, unresponsive to stimuli, infection, felt weak, and lethargic with PNEUMOVAX 23 was not provided. Upon internal review, unresponsive to stimuli was determined to be medically significant. Sender's Comments: US-009507513-1710USA001228.
Age: 70.0
Sex: F
Vaccine: FLU3, PPV, FLU4, PPV
Symptoms: Lumbar puncture, Motor dysfunction, Nuclear magnetic resonance imaging, Unresponsive to stimuli
Clinical narrative: This spontaneous report as received from a patient's husband, referring to his 70 year old wife. The patient's medical history included surgical removal of meningioma in 1997. As a current condition, it was reported that a calcified partial meningioma remains. The patient's drug allergies included penicillin and sulfa drugs. Concomitant therapies included unspecified vitamins. On 26-SEP-2017, the patient was vaccinated with PNEUMOVAX 23, intramuscular, for prevention of pneumococcal disease (strength, dose, frequency, lot # and expiration date were not reported) and FLUZONE (strength, dose, frequency, route, lot # and expiration date were not reported). Later on the same date in the evening, the patient experienced severe chills and became unresponsive, so the reporter had to call to the emergency number and when the emergency medical technicians arrived "diagnosed her with a stroke as she had no motor reponses". On an unspecified date in September 2017, she was transported to a hospital, where she was seen by multiple unspecified physicians and teams of neurologists. After some tests including magnetic resonance imaging (MRI), computed tomography (CT-scan) and lumbar puncture (reported as hundred of tests), it was found that the patient did not have a stroke but had an infection, however, no cause could be determined regarding the infection. It was reported that the patient was hospitalized for 4 days and then released on therapy with unspecified antibiotics. Additionally, the reporter stated she still felt weak and lethargic. At the time of reporting, the outcome of lethargic, felt weak and infection were not recovered. The outcome of unresponsive to stimuli was unknown (also reported as not recovered; conflicting information). Additionally, the assessment causality between chills, unresponsive to stimuli, infection, felt weak, and lethargic with PNEUMOVAX 23 was not provided. Upon internal review, unresponsive to stimuli was determined to be medically significant. Sender's Comments: US-009507513-1710USA001228.
Age: 74.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV, FLU3, PPV
Symptoms: Peripheral swelling
Clinical narrative: Initial unsolicited report received from pharmacist on 05-Oct-2017. This case involves 73-year-old female patient who was vaccinated with 0.5 ml dose (once) of FLUZONE HIGH DOSE (UI848AA) and PNEUMOVAX (Batch number: M043987) (expiration date, dose and site of administration was not reported for both vaccine) in left arm via intramuscular route on 04 Oct 2017. The patient's medical history and concomitant medications were not reported. On 05 Oct 2017, one day following the vaccination, the patient experienced swelling in arm and she was seen by physician and diagnosed with possible cellulitis. Lab data was not reported. The patient received corrective treatment with unspecified antibiotics. The patient had not recovered from the events. Upon internal review, the company decided to consider the event serious due to important medical event cellulitis and swollen arm. List of documents held by sender: none; Sender's Comments: The patient has experienced swelling in arm and she was seen by physician and diagnosed with possible cellulitis after vaccination with FLUZONE HIGH-DOSE. Time to onset is compatible with the role of vaccine. Further information regarding immune status at the time of vaccination, previous vaccination and tolerance, laboratory investigations excluding alternative etiologies would be needed to fully assess this case. Moreover, as two vaccines were administered concomitantly, the role of each component cannot be assessed separately.
Age: 74.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV, FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Initial unsolicited report received from pharmacist on 05-Oct-2017. This case involves 73-year-old female patient who was vaccinated with 0.5 ml dose (once) of FLUZONE HIGH DOSE (UI848AA) and PNEUMOVAX (Batch number: M043987) (expiration date, dose and site of administration was not reported for both vaccine) in left arm via intramuscular route on 04 Oct 2017. The patient's medical history and concomitant medications were not reported. On 05 Oct 2017, one day following the vaccination, the patient experienced swelling in arm and she was seen by physician and diagnosed with possible cellulitis. Lab data was not reported. The patient received corrective treatment with unspecified antibiotics. The patient had not recovered from the events. Upon internal review, the company decided to consider the event serious due to important medical event cellulitis and swollen arm. List of documents held by sender: none; Sender's Comments: The patient has experienced swelling in arm and she was seen by physician and diagnosed with possible cellulitis after vaccination with FLUZONE HIGH-DOSE. Time to onset is compatible with the role of vaccine. Further information regarding immune status at the time of vaccination, previous vaccination and tolerance, laboratory investigations excluding alternative etiologies would be needed to fully assess this case. Moreover, as two vaccines were administered concomitantly, the role of each component cannot be assessed separately.
Age: 27.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Dizziness, Electrocardiogram, Flushing, Full blood count, Hypoaesthesia
Clinical narrative: Patient became tachycardic, dizzy, short of breath, and developed chest pain with near syncope 30mins after receiving the shot.
Age: 27.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Laboratory test, Palpitations, Presyncope
Clinical narrative: Patient became tachycardic, dizzy, short of breath, and developed chest pain with near syncope 30mins after receiving the shot.
Age: 27.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Blood thyroid stimulating hormone, Chest pain, Dizziness, Drug screen, Dyspnoea
Clinical narrative: Patient became tachycardic, dizzy, short of breath, and developed chest pain with near syncope 30mins after receiving the shot.
Age: 27.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Electrocardiogram, Full blood count, Metabolic function test, Presyncope, Tachycardia
Clinical narrative: Patient became tachycardic, dizzy, short of breath, and developed chest pain with near syncope 30mins after receiving the shot.
Age: 27.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Thyroxine
Clinical narrative: Patient became tachycardic, dizzy, short of breath, and developed chest pain with near syncope 30mins after receiving the shot.
Age: 65.0
Sex: F
Vaccine: FLU3, PNC13, FLU3, PNC13
Symptoms: Erythema, Induration, Limb mass, Pain in extremity, Peripheral swelling
Clinical narrative: Patient received PREVNAR-13 in the left arm and FLUZONE HD in the right arm on September 25, 2017. She reported on October 11 that she had an allergic reaction in both arms. The left arm was red and swollen the size of a baseball. The right arm reaction was more severe and lasted longer. She reported that she had a temperature of 99 for a day. She phoned her doctor and began taking BENADRYL by mouth. She also showed it to her daughter's doctor when she was there but was not treated by that doctor.
Age: 65.0
Sex: F
Vaccine: FLU3, PNC13, FLU3, PNC13
Symptoms: Pyrexia
Clinical narrative: Patient received PREVNAR-13 in the left arm and FLUZONE HD in the right arm on September 25, 2017. She reported on October 11 that she had an allergic reaction in both arms. The left arm was red and swollen the size of a baseball. The right arm reaction was more severe and lasted longer. She reported that she had a temperature of 99 for a day. She phoned her doctor and began taking BENADRYL by mouth. She also showed it to her daughter's doctor when she was there but was not treated by that doctor.
Age: 65.0
Sex: F
Vaccine: FLU3, PNC13, FLU3, PNC13
Symptoms: Erythema, Hypersensitivity, Peripheral swelling
Clinical narrative: Patient received PREVNAR-13 in the left arm and FLUZONE HD in the right arm on September 25, 2017. She reported on October 11 that she had an allergic reaction in both arms. The left arm was red and swollen the size of a baseball. The right arm reaction was more severe and lasted longer. She reported that she had a temperature of 99 for a day. She phoned her doctor and began taking BENADRYL by mouth. She also showed it to her daughter's doctor when she was there but was not treated by that doctor.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Pain, Rash erythematous
Clinical narrative: Painful, red raised rash below site of injection and down the arm. Lasted approximately 2 days.  Showed signs of improvement by the third day.
Age: 0.42
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV1
Symptoms: Feeling abnormal, Foaming at mouth, Pallor, Retching, Staring
Clinical narrative: Foaming at the mouth, staring off in to space, very out of it, gagging, throwing up, paleness, started at 5pm, until 8:30 pm. Was given zofran and puked everything out of her system.
Age: 0.42
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV1
Symptoms: Vomiting
Clinical narrative: Foaming at the mouth, staring off in to space, very out of it, gagging, throwing up, paleness, started at 5pm, until 8:30 pm. Was given zofran and puked everything out of her system.
Age: 31.0
Sex: F
Vaccine: PPV
Symptoms: Neck pain, Pain in extremity
Clinical narrative: Sore arm and neck on the side of administration.
Age: 36.0
Sex: F
Vaccine: FLUX
Symptoms: Myalgia
Clinical narrative: Sore deltoid muscle continues 3 weeks after injection.
Sex: M
Vaccine: PPV
Symptoms: Expired product administered
Clinical narrative: Information has been received from a pharmacist via (PDC) referring to a 62 year old male patient. The patient had diabetes and hypertension. Concomitant medications included glimepiride and insulin. On an unknown date, the patient started vaccination with PNEUMOVAX 23 0.5 mL (route, lot # and expiration date unknown) for "an unknown indication based on his age". On 17-SEP-2017, the patient was inadvertently vaccinated with an expired dose of PNEUMOVAX 23 (0.5 mL, lot # L019836, expiration date 24-MAR-2017; route was not provided) (expired vaccine used). Relevant laboratory data was unknown. As of 17-SEP-2017, it was unknown if the patient would receive PNEUMOVAX 23 again and the outcome of the receiving PNEUMOVAX 23 that had expired was unknown. During this report, the patient's other medications also included bupropion hydrochloride (WELLBUTRIN), Lisinopril (manufacturer unknown), metoprolol succinate (TOPROL XL), pantoprazole sodium (PROTONIX) and gabapentin.
Sex: U
Vaccine: HPV9, MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a certified medical assistant referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On an unknown date, the patient was vaccinated with improperly stored doses of doses of GARDASIL 9 lot number N004799 and expiration date of 15-NOV-2019 for prophylaxis (dose and route of administration were not reported) and M-M-R II rHA lot number L040960 with an expiration date of 16-OCT-2017 and lot number M045402 with an expiration date of 14-NOV-2018 for prophylaxis (dose and route of administration were not provided). The vaccine was exposed to a temperature excursion of 47.1°F with a time frame of 30 minutes. There was no previous temperature excursion. A "data logger" was involved. No adverse effects were reported. This is one of the several reports received from the same reporter.; Sender's Comments:  US-009507513-1710USA006358: US-009507513-1710USA006359: US-009507513-1710USA006360: US-009507513-1710USA006361: US-009507513-1710USA006362: US-009507513-1710USA006363: US-009507513-1710USA006364: US-009507513-1710USA006365: US-009507513-1710USA006366: US-009507513-1710USA006367: US-009507513-1710USA006368: US-009507513-1710USA006369: US-009507513-1710USA006370: US-009507513-1710USA006371: US-009507513-1710USA006372: US-009507513-1710USA006373: US-009507513-1710USA006357: US-009507513-1710USA006355: US-009507513-1710USA006356:
Sex: F
Vaccine: PNC13, PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Nervousness
Clinical narrative: Information has been received from a pharmacist referring to a 76 year old female patient. Relevant medical history was unknown. The patient was given 1 dose of PREVNAR 13 last year in 2015 and the patient got a flu shot from this pharmacy in September or October of 2015 and 2016. The pharmacist was not aware of any other previous PNEUMOVAX 23 doses given at any other facility. On 22-SEP-2017, the patient was vaccinated with the PNEUMOVAX 23 (lot # M024673, expiration date 17-NOV-2017; dose and route were not reported) once in her right arm for prophylaxis. On the same date, the patient got the PREVNAR 13 in her left arm. Last night on 22-SEP-2017 after getting the PNEUMOVAX 23, the patient's right arm from her shoulder to her elbow was hot, swollen, red and warm to the touch. The patient did not have hives and she was not having trouble breathing. In the morning of 23-SEP-2017, the patient's symptoms worsened so she was getting nervous and worried about it. No relevant lab tests were done at this time. As of 23-SEP-2017, the patient was no longer getting the PNEUMOVAX 23 and her arm was still hot, swollen, red and warm to the touch and she was worried and nervous about it. The causality between the events and PNEUMOVAX 23 was unknown.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a healthcare worker referring to a 66 year old female patient with Down's syndrome. The patient had no drug reactions or allergies to be reported. On 09-JAN-2013, the patient was vaccinated with ZOSTAVAX, 0.65 ml, subcutaneous, for prophylaxis (lot number and expiration date were not reported). Approximately on 21-SEP-2017 (reported as "about a week" since the report's date), the patient sought medical attention by office visit; the healthcare worker described that the patient "came down with the worst case of shingles the doctor had ever seen" and that "the shingles were all down her right leg, hip, thigh and her groin area" (herpes zoster). The physician prescribed a lidocaine (LIDODERM) patch on for 12 hours and off for 12 hours, diphenhydramine (BENADRYL), acetaminophen (TYLENOL), and famciclovir (FAMVIR) for a week (no details provided). The patient's outcome for herpes zoster was reported as not recovered. The causality assessment between ZOSTAVAX and herpes zoster event was unknown.
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to a female patient of unknown age. The patient's medical history and drug reactions and allergies were not provided. On 28-SEP-2017, the patient was vaccinated with a dose of ZOSTAVAX for prophylaxis before telling the pharmacist that she had received another dose of ZOSTAVAX)in -2016 (reported as 1 year ago), so the patient had an extra dose administered (route, lot number and expiration date were not provided for any of the vaccines). Concomitant therapies included sterile diluent (STERILE DILUENT). No adverse events were reported.
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report was received from a nurse prescriber referring to a 14 year old male patient. The patient's medical history and drug reactions or allergies were not reported. In March 2014 the patient received the first dose of his human papilloma virus (HPV) vaccination series with GARDASIL for prophylaxis (strength, route, dose, units, frequency or lot number were not reported). In July 2017 the patient received the second dose of his HPV vaccination series with GARDASIL 9 for prophylaxis (strength, route, dose, units, frequency or lot number were not reported). No adverse effects were reported.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse concerning a patient of unknown age and gender. There was no information about the patient's concurrent conditions, medical history or concomitant medication. On 25-SEP-2017, the patient was inadvertently vaccinated with an expired dose of  M-M-R II lot # L036853 and expiration date 24-SEP-2017, for prophylaxis (dose and route of administration were not reported) reconstituted with sterile diluent (MERCK STERILE DILUENT) (dose, route of administration, lot number and expiration date were not reported). No adverse effects were reported.
Sex: M
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information was received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's medical history, concurrent conditions or concomitant medications. On or about 11-AUG-2015, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration unknown), as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 06-JUL-2016, the patient was treated at a medical center for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. The patient was prescribed valacyclovir for the management of his symptoms and pain. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information was received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's medical history, concurrent conditions or concomitant medications. On or about 14-SEP-2011, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration unknown), as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 16-OCT-2016, the patient was treated at an Emergency Department for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster, or shingles. The patient was prescribed acyclovir, gabapentin, and oxycodone-acetaminophen for management of her painful condition. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a licensed practical nurse (LPN) and refers to a 12 years old male patient. Information regarding the pertinent medical history, drug reactions or allergies was not provided. The patient's concomitant medication included MENVEO and diphtheria toxoid, pertussis acellular 3-component vaccine, tetanus toxoid. On 04-AUG-2017 in the afternoon, the patient the patient received his second dose of VARIVAX that was improperly stored, Lot # N007930 with expiry date 08-MAR-2019 (dose, route and anatomical location not reported) that was reconstituted with sterile diluent (DILUENT MRK INJ) for prophylaxis. No adverse effects were reported. The administered dose of the vaccine underwent a temperature excursion between -9 ° Celsius (C) and 8 °C for 57 hours and 40 minutes. Previous temperature excursions were between -14 °C and -10 °C for 23 hours and 57 minutes; and between -9 ° C and 8 °C for a time frame of 4 hours and 43 minutes. The call was not placed because of a data logger. This report is one of multiple reports received from the same reporter.; Sender's Comments: US-009507513-1708USA009081: US-009507513-1708USA010551: US-009507513-1709USA012931: US-009507513-1709USA012932: US-009507513-1708USA010551: US-009507513-1710USA006528:
Sex: U
Vaccine: HPV4
Symptoms: Amnesia, Dehydration, Dyspnoea, General symptom, Malaise
Clinical narrative: This spontaneous report was received from a physician via a company representative and social media reported in the article, referring to a 16 year old patient of unknown gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On an unknown date, the patient was vaccinated with a dose of GARDASIL for prophylaxis (route of administration, lot number and expiration date were not reported). On an unknown date, the patient became chronically ill (general symptom) after receiving GARDASIL. Additionally, on unknown dates, the patient experienced episodes of seizure-like activity, difficulty breathing, back spasms, paralysis, dehydration, memory loss, and tremors. At the time of the report the outcome of the events episodes of seizure-like activity, difficulty breathing, back spasms, paralysis, dehydration, memory loss, , general symptom, and tremors was unknown. Additionally, the reporter did not provide a causality assessment between the all aforementioned events and therapy with GARDASIL. The reporter considered seizure-like activity, difficulty breathing, back spasms, paralysis, dehydration, memory loss, and tremors to be regular life threatening events. This is one of several cases received from the same reporter.; Sender's Comments: US-009507513-1710USA005917: US-009507513-1710USA004064: US-009507513-1710USA005919: AU-MERCK-1110USA02522: AU-MERCK-1110USA02731: US-MERCK-0812USA03226: AU-MERCK-0711AUS00143: AU-MERCK-0803USA02516: US-009507513-1311USA011110:
Sex: U
Vaccine: HPV4
Symptoms: Muscle spasms, Paralysis, Seizure like phenomena, Tremor
Clinical narrative: This spontaneous report was received from a physician via a company representative and social media reported in the article, referring to a 16 year old patient of unknown gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On an unknown date, the patient was vaccinated with a dose of GARDASIL for prophylaxis (route of administration, lot number and expiration date were not reported). On an unknown date, the patient became chronically ill (general symptom) after receiving GARDASIL. Additionally, on unknown dates, the patient experienced episodes of seizure-like activity, difficulty breathing, back spasms, paralysis, dehydration, memory loss, and tremors. At the time of the report the outcome of the events episodes of seizure-like activity, difficulty breathing, back spasms, paralysis, dehydration, memory loss, , general symptom, and tremors was unknown. Additionally, the reporter did not provide a causality assessment between the all aforementioned events and therapy with GARDASIL. The reporter considered seizure-like activity, difficulty breathing, back spasms, paralysis, dehydration, memory loss, and tremors to be regular life threatening events. This is one of several cases received from the same reporter.; Sender's Comments: US-009507513-1710USA005917: US-009507513-1710USA004064: US-009507513-1710USA005919: AU-MERCK-1110USA02522: AU-MERCK-1110USA02731: US-MERCK-0812USA03226: AU-MERCK-0711AUS00143: AU-MERCK-0803USA02516: US-009507513-1311USA011110:
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a certified medical assistant referring to a currently 13 months old patient of unknown gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On an unknown date, the patient was vaccinated with an improperly stored dose of VAQTA, lot number N017094 and expiration date of 31-AUG-2018 for prophylaxis (dose and route of administration were not provided). The vaccine was exposed to a temperature excursion of 47.1°F with a time frame of 30 minutes. There was no previous temperature excursion. A "data logger" was involved. No adverse effects were reported. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1710USA006357: US-009507513-1710USA006358: US-009507513-1710USA006359: US-009507513-1710USA006360: US-009507513-1710USA006361: US-009507513-1710USA006362: US-009507513-1710USA006373: US-009507513-1710USA006364: US-009507513-1710USA006365: US-009507513-1710USA006366: US-009507513-1710USA006367: US-009507513-1710USA006368: US-009507513-1710USA006369: US-009507513-1710USA006370: US-009507513-1710USA006371: US-009507513-1710USA006372: US-009507513-1710USA006356: US-009507513-1709USA011980: US-009507513-1710USA006363:
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a certified medical assistant referring to a 19 months old patient of unknown gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On an unknown date, the patient was vaccinated with an improperly stored dose of VAQTA, lot number N017094 and expiration date of 31-AUG-2018 for prophylaxis (dose and route of administration were not provided). The vaccine was exposed to a temperature excursion of 47.1°F with a time frame of 30 minutes. There was no previous temperature excursion. A "data logger" was involved. No adverse effects were reported. This is one of the several reports received from the same reporter.; Sender's Comments:  US-009507513-1710USA006357: US-009507513-1710USA006358: US-009507513-1710USA006359: US-009507513-1710USA006360: US-009507513-1710USA006361: US-009507513-1710USA006362: US-009507513-1710USA006373: US-009507513-1710USA006364: US-009507513-1710USA006365: US-009507513-1710USA006366: US-009507513-1710USA006367: US-009507513-1710USA006368: US-009507513-1710USA006369: US-009507513-1710USA006370: US-009507513-1710USA006371: US-009507513-1710USA006372: US-009507513-1709USA011980: US-009507513-1710USA006355: US-009507513-1710USA006363:
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a certified medical assistant referring to a currently 14 year old patient of unknown gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On an unknown date, the patient was vaccinated with an improperly stored dose of VAQTA, lot number N017094 and expiration date of 31-AUG-2018 for prophylaxis (dose and route of administration were not provided). The vaccine was exposed to a temperature excursion of 47.1°F with a time frame of 30 minutes. There was no previous temperature excursion. A "data logger" was involved. No adverse effects were reported. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1709USA011980: US-009507513-1710USA006358: US-009507513-1710USA006359: US-009507513-1710USA006360: US-009507513-1710USA006361: US-009507513-1710USA006362: US-009507513-1710USA006373: US-009507513-1710USA006364: US-009507513-1710USA006365: US-009507513-1710USA006366: US-009507513-1710USA006367: US-009507513-1710USA006368: US-009507513-1710USA006369: US-009507513-1710USA006370: US-009507513-1710USA006371: US-009507513-1710USA006372: US-009507513-1710USA006356: US-009507513-1710USA006355: US-009507513-1710USA006363:
Sex: U
Vaccine: HPV9, MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a certified medical assistant referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On an unknown date, the patient was vaccinated with improperly stored doses of doses of GARDASIL 9 lot number N004799 and expiration date of 15-NOV-2019 for prophylaxis (dose and route of administration were not reported) and M-M-R II rHA lot number L040960 with an expiration date of 16-OCT-2017 and lot number M045402 with an expiration date of 14-NOV-2018 for prophylaxis (dose and route of administration were not provided). The vaccine was exposed to a temperature excursion of 47.1°F with a time frame of 30 minutes. There was no previous temperature excursion. A "data logger" was involved. No adverse effects were reported. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1710USA006358: US-009507513-1710USA006359: US-009507513-1710USA006360: US-009507513-1710USA006361: US-009507513-1710USA006362: US-009507513-1710USA006363: US-009507513-1710USA006364: US-009507513-1710USA006365: US-009507513-1710USA006366: US-009507513-1710USA006367: US-009507513-1710USA006368: US-009507513-1710USA006369: US-009507513-1710USA006370: US-009507513-1710USA006371: US-009507513-1710USA006372: US-009507513-1710USA006373: US-009507513-1710USA006357: US-009507513-1710USA006355: US-009507513-1710USA006356:
Sex: U
Vaccine: HPV9, MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a certified medical assistant referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On an unknown date, the patient was vaccinated with improperly stored doses of doses of GARDASIL 9 lot number N004799 and expiration date of 15-NOV-2019 for prophylaxis (dose and route of administration were not reported) and M-M-R II rHA lot number L040960 with an expiration date of 16-OCT-2017 and lot number M045402 with an expiration date of 14-NOV-2018 for prophylaxis (dose and route of administration were not provided). The vaccine was exposed to a temperature excursion of 47.1°F with a time frame of 30 minutes. There was no previous temperature excursion. A "data logger" was involved. No adverse effects were reported. This is one of the several reports received from the same reporter.; Sender's Comments:  US-009507513-1710USA006357: US-009507513-1710USA006358: US-009507513-1709USA011980: US-009507513-1710USA006360: US-009507513-1710USA006361: US-009507513-1710USA006362: US-009507513-1710USA006373: US-009507513-1710USA006364: US-009507513-1710USA006365: US-009507513-1710USA006366: US-009507513-1710USA006367: US-009507513-1710USA006368: US-009507513-1710USA006369: US-009507513-1710USA006370: US-009507513-1710USA006371: US-009507513-1710USA006372: US-009507513-1710USA006356: US-009507513-1710USA006355: US-009507513-1710USA006363:
Sex: U
Vaccine: HPV9, MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a certified medical assistant referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On an unknown date, the patient was vaccinated with improperly stored doses of GARDASIL 9 lot number N004799 and expiration date of 15-NOV-2019 for prophylaxis (dose and route of administration were not reported) and M-M-R II rHA lot number L040960 with an expiration date of 16-OCT-2017 and lot number M045402 with an expiration date of 14-NOV-2018 for prophylaxis (dose and route of administration were not provided). The vaccine was exposed to a temperature excursion of 47.1°F with a time frame of 30 minutes. There was no previous temperature excursion. A "data logger" was involved. No adverse effects were reported. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1710USA006357: US-009507513-1710USA006358: US-009507513-1710USA006359: US-009507513-1709USA011980: US-009507513-1710USA006361: US-009507513-1710USA006362: US-009507513-1710USA006373: US-009507513-1710USA006364: US-009507513-1710USA006365: US-009507513-1710USA006366: US-009507513-1710USA006367: US-009507513-1710USA006368: US-009507513-1710USA006369: US-009507513-1710USA006370: US-009507513-1710USA006371: US-009507513-1710USA006372: US-009507513-1710USA006356: US-009507513-1710USA006355: US-009507513-1710USA006363.
Sex: U
Vaccine: HPV9, MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a certified medical assistant referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On an unknown date, the patient was vaccinated with improperly stored doses of GARDASIL 9 lot number N004799 and expiration date of 15-NOV-2019 for prophylaxis (dose and route of administration were not reported) and M-M-R II rHA lot number L040960 with an expiration date of 16-OCT-2017 and lot number M045402 with an expiration date of 14-NOV-2018 for prophylaxis (dose and route of administration were not provided). The vaccine was exposed to a temperature excursion of 47.1°F with a time frame of 30 minutes. There was no previous temperature excursion. A "data logger" was involved. No adverse effects were reported. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1710USA006357: US-009507513-1710USA006358: US-009507513-1710USA006359: US-009507513-1710USA006360: US-009507513-1709USA011980: US-009507513-1710USA006362: US-009507513-1710USA006373: US-009507513-1710USA006364: US-009507513-1710USA006365: US-009507513-1710USA006366: US-009507513-1710USA006367: US-009507513-1710USA006368: US-009507513-1710USA006369: US-009507513-1710USA006370: US-009507513-1710USA006371: US-009507513-1710USA006372: US-009507513-1710USA006356: US-009507513-1710USA006355: US-009507513-1710USA006363.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a certified medical assistant referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On an unknown date, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 lot number M036728 and expiration date of 20-MAY-2018 for prophylaxis (dose and route of administration were not provided). The vaccine was exposed to a temperature excursion of 47.1°F with a time frame of 30 minutes. There was no previous temperature excursion. A "data logger" was involved. No adverse effects were reported. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1710USA006357: US-009507513-1710USA006358: US-009507513-1710USA006359: US-009507513-1710USA006360: US-009507513-1710USA006361: US-009507513-1709USA011980: US-009507513-1710USA006373: US-009507513-1710USA006364: US-009507513-1710USA006365: US-009507513-1710USA006366: US-009507513-1710USA006367: US-009507513-1710USA006368: US-009507513-1710USA006369: US-009507513-1710USA006370: US-009507513-1710USA006371: US-009507513-1710USA006372: US-009507513-1710USA006356: US-009507513-1710USA006355: US-009507513-1710USA006363:
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a certified medical assistant referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On an unknown date, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 lot number M036728 and expiration date of 20-MAY-2018 for prophylaxis (dose and route of administration were not provided). The vaccine was exposed to a temperature excursion of 47.1°F with a time frame of 30 minutes. There was no previous temperature excursion. A "data logger" was involved. No adverse effects were reported. This is one of the several reports received from the same reporter.; Sender's Comments:  US-009507513-1710USA006357: US-009507513-1710USA006358: US-009507513-1710USA006359: US-009507513-1710USA006360: US-009507513-1710USA006361: US-009507513-1710USA006362: US-009507513-1710USA006373: US-009507513-1710USA006364: US-009507513-1710USA006365: US-009507513-1710USA006366: US-009507513-1710USA006367: US-009507513-1710USA006368: US-009507513-1710USA006369: US-009507513-1710USA006370: US-009507513-1710USA006371: US-009507513-1710USA006372: US-009507513-1710USA006356: US-009507513-1710USA006355: US-009507513-1709USA011980:
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a certified medical assistant referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On an unknown date, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 lot number M036728 and expiration date of 20-MAY-2018 for prophylaxis (dose and route of administration were not provided). The vaccine was exposed to a temperature excursion of 47.1°F with a time frame of 30 minutes. There was no previous temperature excursion. A "data logger" was involved. No adverse effects were reported. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1710USA006357: US-009507513-1710USA006358: US-009507513-1710USA006359: US-009507513-1710USA006360: US-009507513-1710USA006361: US-009507513-1710USA006362: US-009507513-1710USA006373: US-009507513-1709USA011980: US-009507513-1710USA006365: US-009507513-1710USA006366: US-009507513-1710USA006367: US-009507513-1710USA006368: US-009507513-1710USA006369: US-009507513-1710USA006370: US-009507513-1710USA006371: US-009507513-1710USA006372: US-009507513-1710USA006356: US-009507513-1710USA006355: US-009507513-1710USA006363:
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a certified medical assistant referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On an unknown date, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 lot number M036728 and expiration date of 20-MAY-2018 for prophylaxis (dose and route of administration were not provided). The vaccine was exposed to a temperature excursion of 47.1°F with a time frame of 30 minutes. There was no previous temperature excursion. A "data logger" was involved. No adverse effects were reported.  This is one of the several reports received from the same reporter.; Sender's Comments:  US-009507513-1710USA006357: US-009507513-1710USA006358: US-009507513-1710USA006359: US-009507513-1710USA006360: US-009507513-1710USA006361: US-009507513-1710USA006362: US-009507513-1710USA006373: US-009507513-1710USA006364: US-009507513-1709USA011980: US-009507513-1710USA006366: US-009507513-1710USA006367: US-009507513-1710USA006368: US-009507513-1710USA006369: US-009507513-1710USA006370: US-009507513-1710USA006371: US-009507513-1710USA006372: US-009507513-1710USA006356: US-009507513-1710USA006355: US-009507513-1710USA006363:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a certified medical assistant referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On an unknown date, the patient was vaccinated with an improperly stored dose of ROTATEQ, lot number M041768 with an expiration date of 25-JUN-2018 and lot number N004946 with an expiration date of 05-OCT-2018 orally for prophylaxis (dose was not provided). The vaccine was exposed to a temperature excursion of 47.1°F with a time frame of 30 minutes. There was no previous temperature excursion. A "data logger" was involved. No adverse effects were reported. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1710USA006357: US-009507513-1710USA006358: US-009507513-1710USA006359: US-009507513-1710USA006360: US-009507513-1710USA006361: US-009507513-1710USA006362: US-009507513-1710USA006373: US-009507513-1710USA006364: US-009507513-1710USA006365: US-009507513-1709USA011980: US-009507513-1710USA006367: US-009507513-1710USA006368: US-009507513-1710USA006369: US-009507513-1710USA006370: US-009507513-1710USA006371: US-009507513-1710USA006372: US-009507513-1710USA006356: US-009507513-1710USA006355: US-009507513-1710USA006363:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a certified medical assistant referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On an unknown date, the patient was vaccinated with an improperly stored dose of ROTATEQ, lot number M041768 with an expiration date of 25-JUN-2018 and lot number N004946 with an expiration date of 05-OCT-2018 orally for prophylaxis (dose was not provided). The vaccine was exposed to a temperature excursion of 47.1°F with a time frame of 30 minutes. There was no previous temperature excursion. A "data logger" was involved. No adverse effects were reported. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1710USA006357:  US-009507513-1710USA006358: US-009507513-1710USA006359: US-009507513-1710USA006360: US-009507513-1710USA006361: US-009507513-1710USA006362: US-009507513-1710USA006373: US-009507513-1710USA006364: US-009507513-1710USA006365: US-009507513-1710USA006366: US-009507513-1709USA011980: US-009507513-1710USA006368: US-009507513-1710USA006369: US-009507513-1710USA006370: US-009507513-1710USA006371: US-009507513-1710USA006372: US-009507513-1710USA006356: US-009507513-1710USA006355: US-009507513-1710USA006363:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a certified medical assistant referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On an unknown date, the patient was vaccinated with an improperly stored dose of ROTATEQ, lot number M041768 with an expiration date of 25-JUN-2018 and lot number N004946 with an expiration date of 05-OCT-2018 orally for prophylaxis (dose was not provided). The vaccine was exposed to a temperature excursion of 47.1°F with a time frame of 30 minutes. There was no previous temperature excursion. A "data logger" was involved. No adverse effects were reported. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1710USA006357: US-009507513-1710USA006358: US-009507513-1710USA006359: US-009507513-1710USA006360: US-009507513-1710USA006361: US-009507513-1710USA006362: US-009507513-1710USA006373: US-009507513-1710USA006364: US-009507513-1710USA006365: US-009507513-1710USA006366: US-009507513-1710USA006367: US-009507513-1709USA011980: US-009507513-1710USA006369: US-009507513-1710USA006370: US-009507513-1710USA006371: US-009507513-1710USA006372: US-009507513-1710USA006356: US-009507513-1710USA006355: US-009507513-1710USA006363:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a certified medical assistant referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On an unknown date, the patient was vaccinated with an improperly stored dose of ROTATEQ, lot number M041768 with an expiration date of 25-JUN-2018 and lot number N004946 with an expiration date of 05-OCT-2018 orally for prophylaxis (dose was not provided). The vaccine was exposed to a temperature excursion of 47.1°F with a time frame of 30 minutes. There was no previous temperature excursion. A "data logger" was involved. No adverse effects were reported. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1710USA006357: US-009507513-1710USA006358: US-009507513-1710USA006359: US-009507513-1710USA006360: US-009507513-1710USA006361: US-009507513-1710USA006362: US-009507513-1710USA006373: US-009507513-1710USA006364: US-009507513-1710USA006365: US-009507513-1710USA006366: US-009507513-1710USA006367: US-009507513-1710USA006368: US-009507513-1709USA011980: US-009507513-1710USA006370: US-009507513-1710USA006371: US-009507513-1710USA006372: US-009507513-1710USA006356: US-009507513-1710USA006355: US-009507513-1710USA006363: