chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a Medical Certified Assistance referring to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On an unknown date in 2017, the patient was vaccinated with an expired dose of VAQTA lot # L048460, expiration date on 14-JAN-2017 (strength, dose number, route and anatomical location were not provided) for prophylaxis. No adverse event reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Registered Nurse concerning an unspecified number of patients of unknown age and gender. The patients' concurrent conditions, medical history and historical drugs were not reported. On 02-MAY-2017, the patients were vaccinated with improperly stored doses of VARIVAX lot number M035142, expiration date 03-AUG-2018 (dose and route were not reported) for prophylaxis. The concomitant medication included sterile diluent. The temperature involved was between -9°C to 8°C, with time frame of 2 hours, 30 minutes. There was no previous temperature excursion, and a data logger was not involved. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from an office manager concerning an unknown number of patients of unknown ages and genders. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with doses of VAQTA, (lot # M003011, expiration date: 15-NOV-2017) (lot # M021124, expiration date: 02-FEB-2018) for prophylaxis (dose number, route and anatomical location of administration were not reported). The doses were stored between 32 to 35 Fahrenheit degrees for 120 hours, and 31 Fahrenheit degrees for 216 hours. There was no previous temperature excursion nor data logger involved. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1705USA004193: US-009507513-1705USA004190: US-009507513-1705USA004191: US-009507513-1705USA004192: US-009507513-1705USA004194.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from an office manager concerning an unknown number of patients of unknown ages and genders. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with doses of RECOMBIVAX HB, for prophylaxis (dose number, route and anatomical location of administration, lot number and expiration date were not reported). The doses were stored between 32 to 35 Fahrenheit degrees for 120 hours, and 31 Fahrenheit degrees for 216 hours. There was no previous temperature excursion nor data logger involved. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1705USA004094: US-009507513-1705USA004191: US-009507513-1705USA004192: US-009507513-1705USA004193: US-009507513-1705USA004194.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from an office manager concerning an unknown number of patients of unknown ages and genders. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with doses of PEDVAXHIB, for prophylaxis (dose number, route and anatomical location of administration, lot number and expiration date were not reported). The doses were stored between 32 to 35 Fahrenheit degrees for 120 hours, and 31 Fahrenheit degrees for 216 hours. There was no previous temperature excursion nor data logger involved. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1705USA004190: US-009507513-1705USA004094: US-009507513-1705USA004192: US-009507513-1705USA004193: US-009507513-1705USA004194.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from an office manager concerning an unknown number of patients of unknown ages and genders. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with doses of GARDASIL 9, (lot # L038503, expiration date: 18-DEC-2017) (lot # M026306, expiration date: 30-APR-2018) (lot # L026602, expiration date 19-OCT-2017) for prophylaxis (dose number, route and anatomical location of administration were not reported). The doses were stored between 32 to 35 Fahrenheit degrees for 120 hours, and 31 Fahrenheit degrees for 216 hours. There was no previous temperature excursion nor data logger involved. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1705USA004190: US-009507513-1705USA004191: US-009507513-1705USA004094: US-009507513-1705USA004193: US-009507513-1705USA004194.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from an office manager concerning an unknown number of patients of unknown ages and genders. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with doses of PNEUMOVAX 23, for prophylaxis (dose number, route and anatomical location of administration, lot number and expiration date were not reported). The doses were stored between 32 to 35 Fahrenheit degrees for 120 hours, and 31 Fahrenheit degrees for 216 hours. There was no previous temperature excursion nor data logger involved. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1705USA004190: US-009507513-1705USA004191: US-009507513-1705USA004192: US-009507513-1705USA004094: US-009507513-1705USA004194.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from an office manager concerning an unknown number of patients of unknown ages and genders. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with doses of ROTATEQ, (lot # M005733, expiration date: 01-OCT-2017) (lot # M004726, expiration date: 19-OCT-2017) (lot # M034799, expiration date: 01-FEB-2018) (lot # L033545, expiration date: 30-MAY-2017) orally for prophylaxis (dose number were not reported). The doses were stored between 32 to 35 Fahrenheit degrees for 120 hours, and 31 Fahrenheit degrees for 216 hours. There was no previous temperature excursion nor data logger involved. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1705USA004193: US-009507513-1705USA004190: US-009507513-1705USA004191: US-009507513-1705USA004192: US-009507513-1705USA004094.
Age: 0.08
Sex: U
Vaccine: RV5
Symptoms: Gastroenteritis rotavirus, Rotavirus infection, Rotavirus test positive
Clinical narrative: This spontaneous report has been received from a physician referring to two to three patients of unknown age or gender. The patients had not medical history, concurrent conditions, drug reactions/allergies or concomitant medications. On unknown dates, the patients were vaccinated with the first, the second and the third doses of ROTATEQ (strength, dose, route, lot # and expiration date were not reported) by oral route as rotavirus vaccination. Approximately in 2017 (reported as over last couple of months), the patients were diagnosed with rotavirus, after the patients had completed the 3 dose series of ROTATEQ. Stool samples were sent on an unspecified date to an unspecified laboratory, for confirmation of rotavirus and the results from the laboratory were positive for rotavirus. The patients were treated and subsequently, on unknown dates in 2017, they recovered from the event. No additional information was provided. The causal relationship between the event and the suspect therapy was not provided. Upon internal review the gastroenteritis rotavirus was considered as a medically significant event. Follow up information has been received from the same physician on 04-MAY-2017, regarding a 3 year old patient of unknown gender. On 06-AUG-2015, the patient was vaccinated with third dose of ROTATEQ (lot number # L008034, expiry date not reported). On 09-APR-2015 and 08-JUN-2015, the patient received the first (lot# K016311) and second (lot# K023157) vaccine doses. This is one of the three reports received from the same reporter. Additional information is not expected. Patient's age, age at vaccination, start date of the suspect therapy and narrative were updated.; Sender's Comments: US-009507513-1704USA008747: US-009507513-1705USA004199:
Age: 0.33
Sex: U
Vaccine: RV5
Symptoms: Gastroenteritis rotavirus, Rotavirus infection, Rotavirus test positive
Clinical narrative: This spontaneous report has been received from a physician referring to two to three patients of unknown age or gender. The patients had not medical history, concurrent conditions, drug reactions/allergies or concomitant medications. On unknown dates, the patients were vaccinated with the first, the second and the third doses of ROTATEQ (strength, dose, route, lot # and expiration date were not reported) by oral route as rotavirus vaccination. Approximately in 2017 (reported as over last couple of months), the patients were diagnosed with rotavirus, after the patients had completed the 3 dose series of ROTATEQ. Stool samples were sent on an unspecified date to an unspecified laboratory, for confirmation of rotavirus and the results from the laboratory were positive for rotavirus. The patients were treated and subsequently, on unknown dates in 2017, they recovered from the event. No additional information was provided. The causal relationship between the event and the suspect therapy was not provided. Upon internal review the gastroenteritis rotavirus was considered as a medically significant event. Follow up information has been received from the same physician on 04-MAY-2017, regarding a 7 year old patient of unknown gender. On 02-AUG-2010, the patient was vaccinated with third dose of ROTATEQ (lot number # and expiry date not reported). On 28-MAR-2010 and 27-MAY-2010, patient received the first and second  vaccine doses, respectively. This is one of the three reports received from the same reporter. Additional information is not expected. Patient's age, age at vaccination, start date of the suspect therapy and narrative were updated.; Sender's Comments: US-009507513-1704USA008747: US-009507513-1705USA004198:
Age: 1.08
Sex: F
Vaccine: MMR
Symptoms: Balance disorder, Clumsiness, Crying, Decreased appetite, Diarrhoea
Clinical narrative: Symptoms 4/19 diarrhea; 4/22-4/23 fever 99.5-101.3; 4/24 Morning temperature, rash appeared red dots on belly, back, neck; 4/24/17 doctors visit. Lack of appetite. Irritability. Clumsiness, loss of balance. As of 4/26 clumsiness, irritability. Cry bursts at night. Child seems to back to normal after 2 weeks.
Age: 1.08
Sex: F
Vaccine: MMR
Symptoms: Irritability, Pyrexia, Rash erythematous
Clinical narrative: Symptoms 4/19 diarrhea; 4/22-4/23 fever 99.5-101.3; 4/24 Morning temperature, rash appeared red dots on belly, back, neck; 4/24/17 doctors visit. Lack of appetite. Irritability. Clumsiness, loss of balance. As of 4/26 clumsiness, irritability. Cry bursts at night. Child seems to back to normal after 2 weeks.
Sex: M
Vaccine: FLUX, MMR
Symptoms: Amylase increased, Blood culture negative, Blood sodium decreased, Computerised tomogram head abnormal, Cough
Clinical narrative: This literature case, initially received on 26-Apr-2017 was reported by other health professional concerns an 82 years old elderly male patient. The patient's medical history includes paroxysmal atrial fibrillation, hypertension, severe aortic valve stenosis, heart valve replacement (replacement with a tissue valve). On an unspecified date, the patient received INN Flu Vaccine Seasonal and MMR (dose, route of administration, anatomical site, batch number, expiration date: not reported). Indication not reported. On an unspecified date the patient received MMR and Influenza vaccine for that season and was presented to primary care with 3 days of cough, myalgias and sore throat. He received azithromycin empirically. The next day he had left cheek swelling. On physical examination, he was febrile at 39 degree Celsius with a heart rate of 102 (not tachypnea). He appeared volume replete and well nourished. Head examination revealed an enlarged gland without palpable fluctuance. Stensen's duct was hyperemic but without purulent discharge. Laboratory tests were within normal limits except for depressed sodium level - 131 mmol/L- and elevated amylase - 615 mmol/L. There was no leucocytosis. CT scan of his head/neck revealed an enlarged enhancing left parotid gland consistent with parotitis with inflammatory changes in surrounding soft tissues without cervical lymphadenopathy, focal fluid collections, masses or obstructing lesion or sialolith in the parotid duct. Nasopharyngeal swab was positive for influenza A, other viral tests (influenza B, respiratory syncytial virus) and blood cultures were negative. The patient was discharged on amoxicillin/clavulanic acid. Action taken with the drug was not reported. The parotitis resolved in 5 days without sequelae. Reporter's Assessment: The reporter did not provide the causality between the events and the suspect influenza vaccine. This case report was serious (medically significant, hospitalization).
Sex: M
Vaccine: FLUX, MMR
Symptoms: Hyperaemia, Influenza A virus test positive, Influenza B virus test, Influenza virus test negative, Lymphadenopathy
Clinical narrative: This literature case, initially received on 26-Apr-2017 was reported by other health professional concerns an 82 years old elderly male patient. The patient's medical history includes paroxysmal atrial fibrillation, hypertension, severe aortic valve stenosis, heart valve replacement (replacement with a tissue valve). On an unspecified date, the patient received INN Flu Vaccine Seasonal and MMR (dose, route of administration, anatomical site, batch number, expiration date: not reported). Indication not reported. On an unspecified date the patient received MMR and Influenza vaccine for that season and was presented to primary care with 3 days of cough, myalgias and sore throat. He received azithromycin empirically. The next day he had left cheek swelling. On physical examination, he was febrile at 39 degree Celsius with a heart rate of 102 (not tachypnea). He appeared volume replete and well nourished. Head examination revealed an enlarged gland without palpable fluctuance. Stensen's duct was hyperemic but without purulent discharge. Laboratory tests were within normal limits except for depressed sodium level - 131 mmol/L- and elevated amylase - 615 mmol/L. There was no leucocytosis. CT scan of his head/neck revealed an enlarged enhancing left parotid gland consistent with parotitis with inflammatory changes in surrounding soft tissues without cervical lymphadenopathy, focal fluid collections, masses or obstructing lesion or sialolith in the parotid duct. Nasopharyngeal swab was positive for influenza A, other viral tests (influenza B, respiratory syncytial virus) and blood cultures were negative. The patient was discharged on amoxicillin/clavulanic acid. Action taken with the drug was not reported. The parotitis resolved in 5 days without sequelae. Reporter's Assessment: The reporter did not provide the causality between the events and the suspect influenza vaccine. This case report was serious (medically significant, hospitalization).
Sex: M
Vaccine: FLUX, MMR
Symptoms: Myalgia, Oropharyngeal pain, Parotid gland enlargement, Parotitis, Pyrexia
Clinical narrative: This literature case, initially received on 26-Apr-2017 was reported by other health professional concerns an 82 years old elderly male patient. The patient's medical history includes paroxysmal atrial fibrillation, hypertension, severe aortic valve stenosis, heart valve replacement (replacement with a tissue valve). On an unspecified date, the patient received INN Flu Vaccine Seasonal and MMR (dose, route of administration, anatomical site, batch number, expiration date: not reported). Indication not reported. On an unspecified date the patient received MMR and Influenza vaccine for that season and was presented to primary care with 3 days of cough, myalgias and sore throat. He received azithromycin empirically. The next day he had left cheek swelling. On physical examination, he was febrile at 39 degree Celsius with a heart rate of 102 (not tachypnea). He appeared volume replete and well nourished. Head examination revealed an enlarged gland without palpable fluctuance. Stensen's duct was hyperemic but without purulent discharge. Laboratory tests were within normal limits except for depressed sodium level - 131 mmol/L- and elevated amylase - 615 mmol/L. There was no leucocytosis. CT scan of his head/neck revealed an enlarged enhancing left parotid gland consistent with parotitis with inflammatory changes in surrounding soft tissues without cervical lymphadenopathy, focal fluid collections, masses or obstructing lesion or sialolith in the parotid duct. Nasopharyngeal swab was positive for influenza A, other viral tests (influenza B, respiratory syncytial virus) and blood cultures were negative. The patient was discharged on amoxicillin/clavulanic acid. Action taken with the drug was not reported. The parotitis resolved in 5 days without sequelae. Reporter's Assessment: The reporter did not provide the causality between the events and the suspect influenza vaccine. This case report was serious (medically significant, hospitalization).
Sex: M
Vaccine: FLUX, MMR
Symptoms: Respiratory syncytial virus test negative, Swelling face
Clinical narrative: This literature case, initially received on 26-Apr-2017 was reported by other health professional concerns an 82 years old elderly male patient. The patient's medical history includes paroxysmal atrial fibrillation, hypertension, severe aortic valve stenosis, heart valve replacement (replacement with a tissue valve). On an unspecified date, the patient received INN Flu Vaccine Seasonal and MMR (dose, route of administration, anatomical site, batch number, expiration date: not reported). Indication not reported. On an unspecified date the patient received MMR and Influenza vaccine for that season and was presented to primary care with 3 days of cough, myalgias and sore throat. He received azithromycin empirically. The next day he had left cheek swelling. On physical examination, he was febrile at 39 degree Celsius with a heart rate of 102 (not tachypnea). He appeared volume replete and well nourished. Head examination revealed an enlarged gland without palpable fluctuance. Stensen's duct was hyperemic but without purulent discharge. Laboratory tests were within normal limits except for depressed sodium level - 131 mmol/L- and elevated amylase - 615 mmol/L. There was no leucocytosis. CT scan of his head/neck revealed an enlarged enhancing left parotid gland consistent with parotitis with inflammatory changes in surrounding soft tissues without cervical lymphadenopathy, focal fluid collections, masses or obstructing lesion or sialolith in the parotid duct. Nasopharyngeal swab was positive for influenza A, other viral tests (influenza B, respiratory syncytial virus) and blood cultures were negative. The patient was discharged on amoxicillin/clavulanic acid. Action taken with the drug was not reported. The parotitis resolved in 5 days without sequelae. Reporter's Assessment: The reporter did not provide the causality between the events and the suspect influenza vaccine. This case report was serious (medically significant, hospitalization).
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Erythema, Peripheral swelling, Pruritus, Skin warm
Clinical narrative: Caused swelling in whole upper arm. Very red and hot. Itchy. Lasted 3 days.
Age: 58.0
Sex: M
Vaccine: TDAP
Symptoms: Pain in extremity, Rash, Tenderness
Clinical narrative: Explain experiences rash, tender and painful on arm. 5/7/2017, patient went to urgent care and was given prednisone and clindamycin for 14 days.
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Headache, Influenza like illness, Insomnia, Musculoskeletal pain
Clinical narrative: Approximately 4 hours after receiving the vaccine I started having some flu like symptoms. Headache, lightheaded, feverish. Took TYLENOL went to rest still wasn't better when I woke up. I struggled to sleep through the night woke up in the morning with severe pain all over. My entire body is aching head, neck, shoulders, arms and legs feel worse than anywhere else. Took TYLENOL again and reached out to the office where the shot was administered. A Physician contacted me we discussed my symptoms and I was told that the vaccine would not cause me to feel this way and it could be a possible virus. It's just a coincidence, so contact my primary care Dr.
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Neck pain, Pain, Pain in extremity, Pyrexia
Clinical narrative: Approximately 4 hours after receiving the vaccine I started having some flu like symptoms. Headache, lightheaded, feverish. Took TYLENOL went to rest still wasn't better when I woke up. I struggled to sleep through the night woke up in the morning with severe pain all over. My entire body is aching head, neck, shoulders, arms and legs feel worse than anywhere else. Took TYLENOL again and reached out to the office where the shot was administered. A Physician contacted me we discussed my symptoms and I was told that the vaccine would not cause me to feel this way and it could be a possible virus. It's just a coincidence, so contact my primary care Dr.
Sex: F
Vaccine: MMR
Symptoms: Joint swelling, Pain in extremity
Clinical narrative: On 14-OCT-2016, the patient received M-M-RVAXPRO (rHA (recombinant human albumin)) (lot# reported as A69FE139A)). Reaction started 10 days after receiving vaccination (on 24-OCT-2016), the patient developed swollen wrists, ankles, knees and nerve pain down right arm (site of vaccination into right arm). General practitioner, who saw her prescribed naproxen and amitriptyline.  The symptoms subsided after one month. Stated was not taking any other medication at time of vaccination. As a result of reaction, second measles mumps and rubella vaccine not given.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Emotional disorder
Clinical narrative: This spontaneous report was received from a physician via company representative and refers to a 12 year old female patient. There was no information regarding patient's medical history, concomitant medications, drug reactions or allergies provided. On approximately 04-APR-2017, (reported as 2 weeks ago), the patient was vaccinated with unidentified Merck HPV vaccine administered (name and lot number not provided) (reporter was unable to determine which vaccine was used) (exact dose, route of administration, lot number and expiration date were not provided) in immunization series for prophylaxis. On an unknown date in April 2017, after receiving vaccine, the patient experienced emotional outbreaks. Due to the event, the physician was contacted by the patient's parents. The physician advised not to treat the event as related to the vaccine. The patient was fine at the time of the report and that there was no call back from parents of the patient, that the emotional outbreaks continued. There was no product quality complaint involved in this case. Additional information has been requested.
Sex: M
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a practice administrator refers to a 10-year-old male patient. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions, or allergies was provided. On 17-APR-2017, the 10-year-old patient was vaccinated with properly- stored expired dose of M-M-R II lot # L010488, expiration date: 26-MAR-2017 (rHA; dose, and route of administration were not provided). No adverse effect was reported. Additional information is not expected, as there was no consent to contact the physician.
Age: 0.75
Sex: U
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker via a company representative refers to a 9 month old patient of an unknown gender. The patient's medical history, concurrent conditions, concomitant medications and drug reactions or allergies were not reported. On 20-APR-2017, the patient was vaccinated with an expired dose of RECOMBIVAX HB lot # L014418, expiration date 13-APR-2017 (dose, route of administration and anatomical location were not reported) for prophylaxis. No adverse effects were reported. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 70 year old female patient with high blood pressure. The patient's past medical history was unknown (other relevant medical history was also reported as "none"). On 26-APR-2016, the patient was subcutaneously vaccinated with a 0.65 ml dose of ZOSTAVAX (lot# M040145, expiry date 26-DEC-2017). On 22-APR-2017, the patient was vaccinated subcutaneously with another 0.65 ml dose of ZOSTAVAX (lot# M040145, expiry date 26-DEC-2017). On the same day, she received PNEUMOVAX 23 (dose, route of administration, lot# and expiry date were not reported). The patient's concomitant medications included  hydrochlorothiazide and levothyroxine sodium (manufacturer unknown). The patient did not experience any adverse effect and no laboratory tests were performed. The patient planned to follow up with her physician. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered pharmacist and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. From 02-DEC-2016 to 17-APR-2017, the patients were vaccinated with improperly stored doses of ZOSTAVAX lot # M039452, expiration date 19-DEC-2017 (dose and route of administration were not reported). The vaccines were reconstituted with correctly stored sterile diluent. There was no adverse effect reported. Product quality complaint was not involved. Administered doses of vaccines experienced the temperature excursion between 15 and 46 degrees Fahrenheit for 4 hours and 30 minutes. A Digital Data Logger was involved. There were no previous excursions reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 25-APR-2017, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 lot # M022086, expiration date 09-OCT-2017 (dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion between 47 and 77 degrees Fahrenheit (51F) for 30 minutes. A Digital Data Logger was involved. There were no previous temperature excursions reported. Product quality complaint was not involved. Additional information has been requested.
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a physician's assistant concerning a female patient of unknown age. No information was provided regarding the patient's past medical history, concurrent conditions, or concomitant medication. It was reported that the patient received her first dose of GARDASIL 9 on an unknown date in 2016 from an unknown doctor's office (lot number, expiration date, and route of administration not provided). The patient received her second dose of GARDASIL 9 on 28-MAR-2017 (lot number, expiration date, and route of administration not provided). No adverse effects reported. No additional information was provided. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain
Clinical narrative: Information was received from a pharmacist concerning a 61 year old female with no pertinent medical history, no known allergies, and no concomitant medications. On 12-JAN-2016, the patient received ZOSTAVAX for vaccination (lot number, expiration date, dosage, and route of administration not provided) which was reconstituted with diluent (lot number not provided). On 28-APR-2017, the patient reported that she has been experiencing unspecified pain for the last year since the ZOSTAVAX vaccination. It was also reported that "she now has shingles."  The outcome of the events was reported as not recovered. No further information reported. Additional information has been requested.
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information was received from a registered nurse refers to a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The nurse reported that the patient received her first dose of GARDASIL 9 intramuscularly on an unknown date in 2014 (lot number and expiration date not provided). The patient presented on 01-MAY-2017 to receive her second dose of GARDASIL 9 intramuscularly. No adverse effect reported. No additional information provided. Additional information has been requested.
Age: 62.0
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a medical assistant refers to an 62 year old male patient. The patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications were not reported. On 28-MAR-2017, the patient was inadvertently vaccinated with a dose of PROQUAD (exact dose, route of administration, lot# and expiration date were not provided) for prophylaxis instead of M-M-R II. The medical assistant confirmed that the event was not related to product confusion. No adverse events were reported. No additional information was provided. Additional information has been requested.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Diarrhoea, Diarrhoea haemorrhagic
Clinical narrative: This spontaneous report was received from a patient's mother, who was a nurse, and refers to her 9-week-old daughter. The patient's concomitant medications, pertinent medical history and drug reactions or allergies were not reported. On 18-APR-2017, the patient was vaccinated with a dose of ROTATEQ, lot # M040270, orally (exact dose and expiry date were not reported), RECOMBIVAX HB intramuscular injection, lot # reported as M045653 (exact dose and expiry date were not reported), PREVNAR, intramuscularly (exact dose was not reported) and PENTACEL intramuscular injection (exact dose was not reported) as a routine vaccination. Subsequently, on 21-APR-2017, the patient developed bloody mucous diarrhea, which continued for two days and then off and on until 29-APR-2017. No medical attention was sought. The patient did not have any lab diagnostics studies performed and no treatment was given for the event. Causality between the event and suspect therapies was not provided. Product quality complaint was not involved. Upon internal review, the event of bloody mucous diarrhea was considered to be medically significant. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: YF
Symptoms: Injection site reaction, Skin lesion
Clinical narrative: Ringworm like skin lesion around injection site for about one month. Pt has a history of uppper arm swelling after DTaP dose number 5 vaccine.
Age: 0.25
Sex: M
Vaccine: HIBV
Symptoms: Feeling jittery, Nervousness
Clinical narrative: Very jittery. Like his nerves were fried.
Age: 21.0
Sex: F
Vaccine: TDAP
Symptoms: Fall, Nausea, Syncope, Wound
Clinical narrative: Immediately following vaccination, patient stated they felt fine. Looked fine. At register paying for services patient stated felt nauseous. RPH offered to help her to the private room. Patient was walking to room and fainted, crashing into displays. RPH helped catch and ease patient to the floor. EMS was called, but no treatment aside from ice from wound from fall.
Age: 26.0
Sex: M
Vaccine: MMR
Symptoms: Peripheral swelling, Pruritus, Rash
Clinical narrative: Rash on arms, abdomen and legs. Itching and hand swelling. Took oral BENADRYL and used cortisone cream.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Patient reported itching, some swelling, and localized pain around injection site and extending to surrounding tissue. Patient reported improvements in symptoms since injection date on 5/9/17 but still experiencing some pain.
Age: 78.0
Sex: M
Vaccine: PNC13
Symptoms: Cerebrovascular accident
Clinical narrative: Patient had a stroke within 24 hours of leaving facility.
Age: 23.0
Sex: M
Vaccine: HPV9
Symptoms: Dizziness, Road traffic accident, Syncope
Clinical narrative: Pt waited 15 minutes after receiving the HPV GARDASIL vaccine and then was released. Pt went to car and left the facility then started to feel dizzy and had a syncope episode and then drove car off the road. Pt was transported to the ER after due to MVA and syncope.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unknown patients of unknown age and gender. On an unknown date, the patients were vaccinated with improperly stored doses of M-M-R II (dose and route of administration were not reported, lot # M029919 with expiration date: 13-JUN-2018). No adverse effects were reported. Data logger was involved. There was a previous temperature excursion. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1705USA004592: US-009507513-1705USA004591: US-009507513-1705USA004590: US-009507513-1705USA004589.
Sex: U
Vaccine: HPV4
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report was received from a physician via a company representative and refers to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history and concomitant therapies was reported. On unknown dates, the patient received first and second dose of GARDASIL 9 (dose, route of administration, lot# and expiration date were not provided). On an unknown date, the patient received an interchanged dose of GARDASIL (dose, route of administration, lot# and expiration date were not provided) instead of GARDASIL 9 as a third dose of the human papilloma virus (HPV) vaccination schedule. There was no symptoms reported. There was no product quality complaints (PQC) involved. Additional information has been requested.
Age: 35.0
Sex: F
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report has been received from a Medical Assistant, concerning to a 35 year old patient of unknown gender. The patient's medical history, concurrent condition and concomitant medication were not provided. On 21-MAR-2017,  the patient was vaccinated with an expired dose of M-M-R II lot # L009213 and expiration date of 17-MAR-2017, albumin status rHA (dose, frequency, route of administration were not provided) for prophylaxis.  No adverse effect were reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 06-MAR-2017, the patient was vaccinated with improperly stored ZOSTAVAX lot # M040623 with an expiration date 31-DEC-2017 (dose, route of administration and anatomical location were not reported).  Other suspect therapies included sterile diluent (dose, route of administration, frequency, lot# and expiration date were not reported) used to reconstitute ZOSTAVAX. No adverse reactions were reported. Administered doses of ZOSTAVAX experienced temperature excursions from 15 to 46 degrees Fahrenheit for 720 hours. There was no previous temperature excursions. A digital data logger was not involved. According to the reporter sterile diluent did not have any temperature excursions. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1705USA004598.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report has been received from a medical assistant and refers to an unspecified number of patients of unknown age and gender. The patients' medical histories, concurrent conditions, drug allergies/reactions, and concomitant therapies were not reported. The medical assistant reported that on unspecified dates, the unspecified number of patients were vaccinated with improperly stored doses of RECOMBIVAX HB (lot # M035487, expiration date 23-FEB-2019; doses, routes of administration, and frequencies were not reported) for prophylaxis. The vaccine data logger measured a temperature range from 0°C to 1°C for a total time frame of 36 minutes. Previous temperature excursions ranges were reported from 0°C to 1°C for 22 minutes, 0°C to 1°C for 39 minutes, 0°C to 1°C for 29 minutes and 0°C to 1°C for 18 minutes. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1703USA011300: US-009507513-1704USA001657: US-009507513-1703USA011300.
Sex: F
Vaccine: HPV9
Symptoms: Burning sensation, Oral mucosal eruption
Clinical narrative: This spontaneous report was received from a certified medical assistant, concerning a 16 years-old non-pregnant female patient. The patient did not have pertinent medical history, concomitant medications, drug reactions or allergies. On 15-FEB-2017, the patient was vaccinated with the first dose of GARDASIL 9 with lot # M016193 and expiration date on 24-APR-2018 (strength, dose and anatomical location were not reported), administered intramuscularly for HPV prophylaxis; but after that, she had a burning rash around her mouth, that did not completely resolved but its status was improving. The patient did not seek medical attention, no treatment was given for the events and no laboratory diagnostics studies were performed. The relatedness between the oral discomfort and oral mucosal eruption with the vaccine was not reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Age: 27.0
Sex: U
Vaccine: MMR
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to a 27-year-old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date (at 1 year of age), the patient was vaccinated with the first dose of M-M-R II (dose, route of administration, lot# and expiration date were not provided). On an unknown date (at 27-years of age), after prolonged interval, the patient received the second dose of M-M-R II (dose, route of administration, lot# and expiration date were not provided). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse, concerning a patient of an unknown age and gender. There were no concurrent conditions, medical history, drug reactions or allergies or concomitant medications reported. On 14-APR-2017 and 21-APR-2017, the patient was orally vaccinated with the first and second dose of ROTATEQ (dose, frequency, strength, lot # and expiration date were not reported), respectively, for prophylaxis; this vaccination schedule was outside the recommendations per ROTATEQ prescribing information. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to a multiple, unknown patients of unknown age and gender. The patients' pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. The medical assistant reported that, on unknown dates, the patients received improperly stored doses of VARIVAX Lot # M039316 with an expiration date on 20-SEP-2018 (dose and route of administration were not reported) for prophylaxis. No adverse effects were reported. The vaccines were stored in a temperature in the range of -9°C to 8°C (-6°C) for a total time of 18 hours. The call was because of a data logger and no previous temperature excursion was registered. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1705USA003934.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received on 20-APR-2017 from a registered nurse which refers to one patient (age and gender unknown) who received an unspecified dose in VARIVAX (Lot number M040137, Expiration date 28-SEP-2018) immunization series that was improperly stored. The patient's pertinent medical history, current conditions and concomitant medications were not reported. The excursion details reported: The vaccine, VARIVAX (Lot number M040137, Expiration date 28-SEP-2018) was exposed to the Temperature (reported in Fahrenheit (F)) between 6F-14F for the time frame of 18.5 hours plus between 15F-46F for the time frame of 49.15 hours plus 47.8F (between 47F to 77F) for the time frame of 26.25 hours. There were no previous temperature excursions. The call was because of a data logger. No adverse effects reported. No additional information was provided. Additional information has been requested. This is one of two reports from the same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a pharmacist regarding a multiple patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant medication were not reported. On an unknown date, the patients received improperly stored ZOSTAVAX (lot # M024700, expiration date: 18-JUL-2017; lot # M037014, expiration date: 22-NOV-2017) dose details and indication was not provided) subcutaneously for prophylaxis. It was reported that the vaccines were exposed to the temperature of 6F to 14F (7F) during a time frame of 38 days. It was verified with pharmacist that ZOSTAVAX was reconstituted with sterile diluent (MERCK) (unknown lot # and expiration date) and was correctly stored (also reported as improperly stored). Previous temperature excursion was reported. The call was because of data logger. No adverse effects were reported. There were no product quality complaints (PQC) involved. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant concerning multiple unspecified patients. The medical assistant reported that multiple doses of improperly stored GARDASIL 9 (lot # M037770, expiration date 01-JUN-2019) were administered to multiple patients on unknown dates and times (route of administration unknown). No adverse effects reported. Temperature: 32°F to 35°F Time frame: 22 hours 22 minutes Previous temperature excursions: No Data logger involved: Yes. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse (also reported as "medical assistant"), concerning unspecified number of patients of unknown age and gender. There were no concurrent conditions, medical history, drug reactions or allergies or concomitant medications reported. On unspecified dates, the patients were subcutaneously vaccinated with improperly stored doses of VARIVAX injection (dose and frequency were not reported) lot # M040139 with expiration date of 24-SEP-2018, for prophylaxis. The sterile diluents (lot # and expiration date were not reported) used to reconstitute the VARIVAX were properly stored. The temperature excursion of the VARIVAX was between 6 °F and 14 °F for a time frame of 2 hours and 45 minutes and between 15 °F and 46 °F for a time frame of 5 hours and 45 minutes. Also, a previous temperature excursion occurred between 6 °F and 14 °F for a time frame of 4 hours and 30 minutes and between 15 °F and 46 °F for a time frame of 6 hours and 25 minutes. No side effects were reported. Data logger was involved. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to a multiple, unknown patients of unknown age and gender. The patients' pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. The medical assistant reported that, on unknown dates, the patients received improperly stored doses of PROQUAD Lot # M022402 with an expiration date on 01-NOV-2017 and Lot # reported as M043307 with an expiration date on 24-APR-2018 (dose and route of administration were not reported) for prophylaxis. No adverse effects were reported. The vaccines were stored in a temperature in the range of -9°C to 8°C (-6°C) for a total time of 18 hours. The call was because of a data logger and no previous temperature excursion was registered. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA013351.
Age: 1.0
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product packaging quantity issue, Product quality issue
Clinical narrative: This spontaneous report was received from a medical assistant via a company representative concerning a 12 month old patient. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported. On 03-MAY-2017, the patient was vaccinated with a dose of VAQTA 0.5 ml vial, 0.4 ml, lot # N003194, expiration date: 28-OCT-2017, as prophylaxis (Route of administration was not reported). It was reported that the patient only received 0.4 ml of VAQTA rather than the full 0.5 ml volume, due to the volume of the vial was less than 0.5 ml. The patient had not demonstrated any adverse effects. A product quality complaint was involved. Additional information has been requested.