chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 84.0
Sex: F
Vaccine: FLUX, PNC13, FLUX, PNC13
Symptoms: Injection site nerve damage, Mobility decreased, Monoplegia, Oxygen saturation decreased, Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable consumer (Husband) via Pfizer-sponsored program. A 84-year-old female patient received the first single dose of PREVNAR 13 on 10Oct2016 in the right arm around noon to avoid pneumonia. Concomitant medication included influenza vaccine (FLU) given on 10Oct2016 in the right arm and other unspecified medications. Medical history included atrial fibrillation (AFib) from Oct2016 and ongoing and pneumonitis from 06Oct2016 to 10Oct2016, due to which was hospitalized: she went to emergency room on 06Oct2016 and was discharged from the hospital's ICU on 10Oct2016. She was discharged within a half an hour of getting pneumococcal 13-val conj vaccine and influenza vaccine. Patient has never had the pneumonia shot before. On 10Oct2016 around midday, the patient's right arm was paralyzed, she had zero range of motion and was getting therapy and she also had pain (right arm pain). On 11Oct2016 her oxygen level was really low below 90. The patient who was discharged on 10Oct2016, went back to the hospital on 11Oct2016 due to oxygen level low and stayed until 22Oct2016. Lab tests included right shoulder X-ray on 10Oct2016 that did not show anything, the doctor thought they severed a nerve when they gave her the shot; right shoulder X-ray on 07Dec2016 was negative and was to check rotator cuff. Outcome of oxygen saturation decreased was unknown, while right arm pain and right arm paralyzed not recovered.
Age: 84.0
Sex: F
Vaccine: FLUX, PNC13, FLUX, PNC13
Symptoms: X-ray limb normal
Clinical narrative: This is a spontaneous report from a contactable consumer (Husband) via Pfizer-sponsored program. A 84-year-old female patient received the first single dose of PREVNAR 13 on 10Oct2016 in the right arm around noon to avoid pneumonia. Concomitant medication included influenza vaccine (FLU) given on 10Oct2016 in the right arm and other unspecified medications. Medical history included atrial fibrillation (AFib) from Oct2016 and ongoing and pneumonitis from 06Oct2016 to 10Oct2016, due to which was hospitalized: she went to emergency room on 06Oct2016 and was discharged from the hospital's ICU on 10Oct2016. She was discharged within a half an hour of getting pneumococcal 13-val conj vaccine and influenza vaccine. Patient has never had the pneumonia shot before. On 10Oct2016 around midday, the patient's right arm was paralyzed, she had zero range of motion and was getting therapy and she also had pain (right arm pain). On 11Oct2016 her oxygen level was really low below 90. The patient who was discharged on 10Oct2016, went back to the hospital on 11Oct2016 due to oxygen level low and stayed until 22Oct2016. Lab tests included right shoulder X-ray on 10Oct2016 that did not show anything, the doctor thought they severed a nerve when they gave her the shot; right shoulder X-ray on 07Dec2016 was negative and was to check rotator cuff. Outcome of oxygen saturation decreased was unknown, while right arm pain and right arm paralyzed not recovered.
Age: 21.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a registered nurse referring to a 21 years old female patient. The patient had no concomitant medication, pertinent medical history nor drug reactions/allergies. Since the patient had no vaccination history of varicella for a medical clearance form for her internship, a titer was performed on an unspecified date. Since the results indicated a low titer for varicella, on 30-NOV-2016, the patient was vaccinated with VARIVAX (lot #, expiration date and dose not reported) intramuscularly for prophylaxis. On 02-DEC-2016, the patient contacted the office and reported symptoms of swelling, redness and pain at the injection site, which was considered as possible cellulitis. The patient was treated with sulfamethoxazole (manufacturer unknown) 800 mg/160 mg, 1 tablet twice daily for possible cellulitis. The patient complete the course of sulfamethoxazole (manufacturer unknown) on an unknown date of December 2016. On 05-DEC-2016, the symptoms resolved. The causality between VARIVAX and the event was not provided. Upon internal review, the event of cellulitis was considered to be medically significant. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Incorrect route of drug administration, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a registered nurse referring to a 21 years old female patient. The patient had no concomitant medication, pertinent medical history nor drug reactions/allergies. Since the patient had no vaccination history of varicella for a medical clearance form for her internship, a titer was performed on an unspecified date. Since the results indicated a low titer for varicella, on 30-NOV-2016, the patient was vaccinated with VARIVAX (lot #, expiration date and dose not reported) intramuscularly for prophylaxis. On 02-DEC-2016, the patient contacted the office and reported symptoms of swelling, redness and pain at the injection site, which was considered as possible cellulitis. The patient was treated with sulfamethoxazole (manufacturer unknown) 800 mg/160 mg, 1 tablet twice daily for possible cellulitis. The patient complete the course of sulfamethoxazole (manufacturer unknown) on an unknown date of December 2016. On 05-DEC-2016, the symptoms resolved. The causality between VARIVAX and the event was not provided. Upon internal review, the event of cellulitis was considered to be medically significant. Additional information has been requested.
Age: 62.0
Sex: M
Vaccine: FLU3
Symptoms: Lip swelling, Local swelling, Swelling face
Clinical narrative: Slight swelling of L neck, face and lip on the left side (same side as flu shot injection in arm).
Age: 35.0
Sex: M
Vaccine: ANTH
Symptoms: Hyperhidrosis, Loss of consciousness, Syncope
Clinical narrative: The patient had a syncopal episode in the waiting area after receiving an anthrax vaccine.  He was unconscious for several seconds, without recollection of events.  He reports no history of similar events associated with giving blood in the past.  He denies any pain. He did not hit his head. Taken to the emergency room to be evaluated.  Where he was seen to be in no acute distress, he did not appear uncomfortable.  Vital signs were normal.  Skin was diaphoretic.   Diagnosed by ER physician as having a vasovagal syncope likely secondary to needlestick.  Discharged with return precautions given to him.
Age: 61.0
Sex: M
Vaccine: FLUX
Symptoms: Hypoaesthesia, Injection site reaction, Pain in extremity, Rash erythematous
Clinical narrative: Bright red raised rash around injection site only on the arm, the left arm where injection was administered. Pain and numbness in left arm.
Age: 70.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a patient of an unknown age and gender. The patient's relevant medical history, concurrent condition and concomitant medication were not reported. On 15-SEP-2016, the patient was vaccinated with a dose of ZOSTAVAX via intramuscular route in error for prophylaxis (lot number/expiry date and dosage not reported). No known adverse effects. No Product Quality Complaint (PQC) was involved. Follow up information has been received from the pharmacist on 04-DEC-2016. Patient's demographics were reported as a 70 year old female patient. It was reported that on 15-SEP-2016 the patient was administered with a co suspect of influenza virus whole virion 3v vaccine inactivated FLUZONE intramuscular, the same day as ZOSTAVAX. It was unknown where the vaccine was purchased or vaccinated at. Vaccine administrator details were reported. Additional information has been requested. Patient, product, event and narrative updated.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to patients of unknown age and gender. It was reported that on unknown dates, doses of RECOMBIVAX HB (lot number M020926, expiration date 11-AUG-2018) which were exposed to temperatures outside of the recommended range, were administered to the patients. No adverse experience had been reported. Temperature and time frame were: 1.2 degrees Celsius (C) for 22 minutes; 1.3C for 1 hour and 57 minutes; 1.4C for 2 hours and 15 minutes; 0.9C for 36 minutes; 1.3C for 21 minutes (duration: 331min). There were no previous temperature excursions. This was reported because of a data logger. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1611USA009626: US-009507513-1611USA009625: US-009507513-1611USA009623: US-009507513-1611USA008904.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to patients of unknown age and gender. It was reported that on unknown dates, doses of GARDASIL 9 (lot number reported as M011840, expiration date 01-FEB-2018) which were exposed to temperatures outside of the recommended range, were administered to the patients. No adverse experience had been reported. Temperature and time frame were: 1.2 degrees Celsius (C) for 22 minutes; 1.3C for 1 hour and 57 minutes; 1.4C for 2 hours and 15 minutes; 0.9C for 36 minutes; 1.3C for 21 minutes (duration: 331min). There were no previous temperature excursions. This was reported because of a data logger. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1611USA009624: US-009507513-1611USA009626: US-009507513-1611USA009623: US-009507513-1611USA008904.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to patients of unknown age and gender. It was reported that on unknown dates, doses of PEDVAXHIB (lot number M032148, expiration date 18-APR-2019) which were exposed to temperatures outside of the recommended range, were administered orally to the patients. No adverse experience had been reported. Temperature and time frame were: 1.3 degrees Celsius (C) for 1 hour and 57 minutes; 1.4C for 2 hours and 15 minutes; 0.9C for 36 minutes; 1.3C for 21 minutes (duration: 309 min). There were no previous temperature excursions. This was reported because of a data logger. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1611USA009624: US-009507513-1611USA009625: US-009507513-1611USA009623: US-009507513-1611USA008904.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to an unspecified patient of unknown age and gender. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On 15-NOV-2016, the patient was inadvertently vaccinated with a 0.5 ml dose of expired PNEUMOVAX 23 intramuscularly (frequency reported as "once", lot # L022795 with expiration date at 05-NOV-2016) for prophylaxis. There were no adverse effects reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Certified Medical Assistant refers to patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored PROQUAD (one dose: lot number M032497, expiration date 02-JAN-2018; 4 doses: lot number reported as M031943, expiration date 27-DEC-2017) (dose and route not reported). Temperature and time frame was (-)minus 9.7 degrees Celsius (C) for 1 hour. There were no previous temperature excursions. This was reported because of a data logger. No adverse events have been reported. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to unknown number of patients of unknown age and gender. On unknown dates, the patients received improperly stored doses of PEDVAXHIB  (lot number M020102, expiration date 08-MAR-2019) (dose and route not reported). The temperature excursion was 34.02 Fahrenheit for 8 hours. There were no previous temperature excursions. This was reported because of a data logger. No adverse events have been reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA008780.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to unspecified number of patients of unknown gender and age. The patients' pertinent medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of ZOSTAVAX lot# M017294, expiration date 28-JUN-2017 (dose and route of administration were not reported) for prophylaxis. Administered doses of ZOSTAVAX were stored in -11.96 degrees Celsius for 15 hours, -11.5 degrees Celsius for 15 hours and in -14.61 degrees Celsius for 15 hours. There was no previous temperature excursion. No adverse event was reported. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1611USA011250.
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse via company representative referring to a female patient of unknown age. The patient's pertinent medical history, current conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX23 intramuscularly (dose, lot# and expiration date were not reported) for prophylaxis. On an unspecified date after administration, the patient returned to the office and the arm which had received the vaccination was in a sling. The patient could move her arm sideways but she could not move it up and down and that was why the patient had put her arm in the sling. The physician did not provide any treatment but advised the patient to remove the sling and to apply warm compresses to her arm. The physician encouraged the patient to "try and get movement with her arm". The outcome of the event and the relatedness between the event and PNEUMOVAX23 were not reported. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse referring to a patient of unknown age and gender. The patient's pertinent medical history included completed serie of GARDASIL approximately in 2014 (reported as "two years ago", it was unknown if the series previously administered was GARDASIL quadrivalent or GARDASIL 9). Drugs reactions/allergies and concomitant medication were not reported. On 22-NOV-2016, the patient was vaccinated with dose number 4 of GARDASIL 9 lot # M023169 with expiration date: 13-JUN-2018 (route and dosage were not reported) for prophylaxis. No adverse effects were reported. There was no Product Quality Complaint (PQC) involved. 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 and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical histories provided. On 28-NOV-2016, the patient was vaccinated with improperly stored dose of VARIVAX injection, subcutaneously, lot # M031970, expiration date 30-JUN-2018 (dose was not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 6.4 degrees Fahrenheit for 24 hours. Data logger was not involved. There were no previous excursions reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to multiple (unspecified how many) unidentified patients of unknown ages and genders. No information about the patients' medical history, concomitant medications, concurrent conditions or drug reactions and allergies was provided. On an unknown dates, the patients were vaccinated with incorrectly stored doses of RECOMBIVAX HB (lot number: M020926, expiry date: 11-AUG-2018, dose and route of administration were not reported). No adverse effects were reported. Digital Data Logger was involved, the storage temperature was reported as 48.52 degrees Fahrenheit in a 20-minute timeframe. On an unknown date. No previous temperature excursion was reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1612USA008794: US-009507513-1612USA008795:
Sex: M
Vaccine: PPV
Symptoms: Burning sensation, Erythema, Pain in extremity, Peripheral swelling, Pruritus
Clinical narrative: This spontaneous report was received from a male patient of unknown age via Poison & Drug Center and refers to himself. The patient's past medical and drug history included receiving PREVNAR 13 a couple of years before the report with no reaction. On 29-NOV-2016, the patient was vaccinated with a dose of PNEUMOVAX23, intramuscularly in the left deltoid, one time (dose, lot # and expiration date were not provided). The patient's concomitant medications were unknown. On 29-NOV-2016, the patient experienced arm swelling, rash, pain, burning, redness and itching in his left arm. The patient reported the left arm had swelled up really bad and is "50 percent bigger" than his right arm. The patient experienced he was not experiencing trouble breathing or anything like that where he needed to call an ambulance or anything but the symptoms were getting worse every few minutes. Laboratory data was unknown. At the time of the report, it was unknown if the patient continued to receive PNEUMOVAX23. The patient continued to experience worsening symptoms of arm swelling, rash, pain, burning, redness and itching in his left arm (outcome of the events was considered as not recovered). The causality was not reported. Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Rash
Clinical narrative: This spontaneous report was received from a male patient of unknown age via Poison & Drug Center and refers to himself. The patient's past medical and drug history included receiving PREVNAR 13 a couple of years before the report with no reaction. On 29-NOV-2016, the patient was vaccinated with a dose of PNEUMOVAX23, intramuscularly in the left deltoid, one time (dose, lot # and expiration date were not provided). The patient's concomitant medications were unknown. On 29-NOV-2016, the patient experienced arm swelling, rash, pain, burning, redness and itching in his left arm. The patient reported the left arm had swelled up really bad and is "50 percent bigger" than his right arm. The patient experienced he was not experiencing trouble breathing or anything like that where he needed to call an ambulance or anything but the symptoms were getting worse every few minutes. Laboratory data was unknown. At the time of the report, it was unknown if the patient continued to receive PNEUMOVAX23. The patient continued to experience worsening symptoms of arm swelling, rash, pain, burning, redness and itching in his left arm (outcome of the events was considered as not recovered). The causality was not reported. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Haemoglobin normal, Incorrect product storage
Clinical narrative: This spontaneous report was received from a registered nurse via Poison & Drug Center and refers to a 12 month old male patient. The patient's relevant medical history included candidal diaper rash and "no active problems". On 28-NOV-2016, the patient was vaccinated with a dose of VARIVAX, 0.5 ml, subcutaneously, once, lot # reported as M028546, expiration date 07-JUN-2016 (anatomical location was not reported), for routine health care. The dose of vaccine had undergone a temperature excursion on an unknown date. The patient's concomitant medications included nystatin cream started on 23-NOV-2016 for candidal diaper rash. The patient's laboratory values included a point of care hemoglobin of 10.3 (units not provided) on 28-NOV-2016. The patient did not experience an adverse reaction and no treatments were provided. At the time of the report, it was unknown if the patient continued to receive VARIVAX. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA000108: US-009507513-1612USA000002.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, pertinent medical history, concomitant medications, drug reactions, or allergies was provided. On 30-NOV-2016, the patient was vaccinated with a dose of VAQTA, intramuscularly, injection (dose, lot# and expiration date were not provided), instead of RECOMBIVAX HB. No adverse effects were reported. Additional information has been requested.
Age: 18.0
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a medical assistant via poison center refers to a 18-year-old male patient. The patient's concurrent conditions, medical history, past drug history and concomitant medications were unknown. On 24-OCT-2016, the patient was vaccinated subcutaneously with the one 0.5 ml dose of PROQUAD (lot # M029595 with expiry date on 10-DEC-2017), for prophylaxis (reason for use reported as "vaccination") instead of prescribed one dose of M-M-R II. It was unknown if the patient had any previous varicella vaccination. According to the medical assistant's knowledge, the patient did not have any adverse effects after receiving the PROQUAD. Relevant laboratory data was unknown. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered, Injection site discomfort, Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a male patient of unknown age. His pertinent medical history and drug reactions or allergies were not reported. On an unknown date (reported as approximately between two and four years ago), the patient was vaccinated with the first dose of properly stored ZOSTAVAX (exact dose, route of administration, anatomical location, lot # and expiration date were not reported). The pharmacist reported that the patient had been taking acyclovir, approximately 400 mg daily, at the time of the first administration of ZOSTAVAX and he wished to repeat the immunization without concurrent antiviral medication. That patient discontinued his daily dose of acyclovir on an unknown date, prior to receiving his second immunization with ZOSTAVAX. On an unknown date in November 2016 (reported as approximately seven to 10 days ago), the patient was vaccinated with the second dose of properly stored ZOSTAVAX (exact dose, route of administration and anatomical location were not reported, lot # M013377, expiration date: 25-MAY-2017). On an unknown date in November 2016, the patient experienced some redness, a small red raised area and a little discomfort around the injection site of the second ZOSTAVAX dose. The outcome of the events was unknown. The relatedness between the events and ZOSTAVAX was not reported. Additional information is not expected as the pharmacist did not wish to be contacted.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX (lot # M024677, expiry date 18-MAY-2018; dose and route were not reported). The dose was stored under temperature of -11 Celsius degrees for 8 hours and 30 minutes. The previous temperature excursion was -9.3 Celsius degrees for 8 hours and 30 minutes and -10.6 Celsius degrees for 4 hours. The call was because of a data logger. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA008781.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to multiple patients of unknown age and gender. No information regarding their concurrent conditions, pertinent medical history, concomitant medications, drug reactions, or allergies was provided. On unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD injection (lot# reported as M033210, expiration date: 09-JAN-2018; lot# M031944, expiration date: 27-DEC-2017; doses and routes of administration were not provided). There were no adverse effects reported. Administered doses of vaccine experienced the temperature excursion of -13.5 degrees Celsius for 1 hour and 13 minutes. There was no previous temperature excursion. Digital Data Logger was involved. This is one of two reports received from the same reporter. Additional information has been requested; Sender's Comments: US-009507513-1612USA008696.
Sex: F
Vaccine: PPV
Symptoms: Injection site cellulitis
Clinical narrative: This spontaneous report was received from a pharmacist via a company representative and refers to a female patient in her 60's. The patient's historical drugs included PREVNAR, received about a year prior to PNEUMOVAX23. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX23 injection (dose, route of administration, lot# and expiration date were not reported) for prophylaxis. On an unknown date, the patient developed cellulitis at the injection site. She was seen by her unspecified physician (unspecified date) for the cellulitis and was treated with unspecified antibiotics. The outcome of injection site cellulitis was reported as resolved on an unspecified date. The relatedness between the event and PNEUMOVAX23 was not reported. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA002353.
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain, Back pain, Herpes zoster, Pain of skin
Clinical narrative: Information has been received from a female consumer of unknown age referring to herself. The patient's concurrent conditions included high blood (unspecified), diabetes and cholesterol. The patient had no concomitant medication or drug reactions/allergies. In 2013, the patient was vaccinated with ZOSTAVAX (1 time vaccination, dose, lot #, expiration date and route not reported) in arm to prevent shingles. On 24-NOV-2016 (reported as "Thanksgiving 2016"), the patient started feeling tenderness on the skin on her back, back pain and abdominal pain. The patient was taken to the emergency room (ER) (24-NOV-2016 reported as "Thanksgiving Day") and the doctor advised her that she had symptoms of shingles, but there was no rash. Unspecified treatment was given for the event. No laboratory test was performed. The outcome of the event was unknown. The causality between ZOSTAVAX and the event was not provided. Additional information is not expected as there was no consent to contact the physician.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: This spontaneous report was received from a pharmacist via a company representative and refers to a 78-year-old female patient. The patient's concomitant therapies, pertinent medical history and drug reactions or allergies were not reported. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX subcutaneously (dose, site of injection, lot# and expiration date were not reported). On an unknown date, the patient experienced redness that localized at the injection site following the administration of ZOSTAVAX. It was unknown if the patient sought medical attention. The outcome of adverse event was not reported. The relatedness between the adverse event and ZOSTAVAX was not reported. Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: MMR
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 50-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 02-DEC-2016, the patient was inadvertently vaccinated with PROQUAD (lot # M012986, expiration date was not provided) (dose and route of administration were not provided). The patient was scheduled to receive M-M-R II. No adverse effects were reported. Product quality complaint was not involved. This is one of the two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA008788.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse, refers to a patient of unknown age and gender. Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported. The nurse reported that on 01-DEC-2016, the patient was given an improperly stored dose of VARIVAX (lot #M024683, expiration date: 18-MAY-2018; dose and route of administration were not provided). No adverse effect reported. Temperature excursion details: Data logger was involved Temperature: -12.63 *C Time frame: 11 hours 45 minutes. Previous temperature excursion? No. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of an unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions or allergies were not reported. On 02-DEC-2016 (reported also as today), the patient was vaccinated with an expired dose of RECOMBIVAX HB intramuscularly, lot # K022265, expiration date: 22-OCT-2016 (dose and site of injection were not reported). No adverse experience had been reported. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to an unknown number of patient of unknown age and gender. The patients' medical history and concurrent conditions were not reported. On an unknown date, the patients were vaccinated with improperly stored GARDASIL 9 (lot # M016193, expiry date: 24-APR-2018) (dose and route of administration were not reported). No concomitant therapy was reported. The temperature excursion was 31F for 14 hours. No adverse effect was reported. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 68 year old female patient with asthma. No relevant medical history and concomitant medications were reported. On 02-DEC-2016, the patient was vaccinated with an expired dose of ZOSTAVAX (lot # L032184, expiry date 25-NOV-2016) dose 0.65 ml, once for prevention (prophylaxis). The patient has not experienced any adverse event. It is unknown if there is relevant lab work. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Vaccination complication
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. Patient's pertinent medical history, concurrent condition and concomitant medication were not reported. No previous drug reactions/ allergies were reported. The pharmacist reported that about 4 years ago, the patient gave an account of receiving ZOSTAVAX (vaccination date unknown), via intramuscular for prophylaxis at an unspecified pharmacy (strength, dosing details, anatomical location, lot# and expiration date were unknown). On an unknown date patient had a "strong reaction" to the vaccine which produced unspecified symptoms. The pharmacist reported that the patient did not appear to be experiencing any adverse effects at the time of their interaction. No product quality complaint was involved. Additional information is not expected as the reporter did not wish to be contacted.
Sex: F
Vaccine: PPV
Symptoms: Injection site cellulitis
Clinical narrative: This spontaneous report was received from a pharmacist via a company representative and refers to a female patient in her 60's. The patient's historical drug included PREVNAR, received about a year prior to PNEUMOVAX 23. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX 23 injection (dose, route of administration, lot# and expiration date were not reported) for prophylaxis. On an unknown date, the patient developed cellulitis at the injection site. She used over the counter medicine (unspecified) for the cellulitis but it was not specified if this patient was seen by a physician. The outcome of injection site cellulitis was reported as resolved (date was not reported). The relatedness between the event and PNEUMOVAX 23 was not reported. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA001166.
Sex: U
Vaccine: UNK
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On an unknown date, the patient might have received an improperly stored dose of either VAQTA 25/0.5 lot# M036459 with expiration date: 18-JAN-2018, lot # M030598 with expiration date 11-AUG-2018, RECOMBIVAX HB lot # M020926 with expiration date 11-AUG-2018, lot # M033334 with expiration date 11-AUG-2018, M-M-R II, lot # M010426 with expiration date 01-MAR-2018, lot # M016233 with expiration date 31-MAR-2018, lot # L041456 with expiration date 22-OCT-2017, GARDASIL 9 lot # M009378 with expiration date 23-APR-2018, lot # L037554 with expiration date 25-DEC-2017 or rotavirus ROTATEQ lot # M004726 with expiration date 19-OCT-2017, lot # reported as M016918 with expiration date reported as 15-FEB-2018). No adverse effects were reported. The vaccines experienced the temperature excursion of 17.7 degrees Celsius for 1 hour 5 minutes. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 61 year old female patient. On an unknown date in December 2014 (reported as about two years ago) the patient was vaccinated with ZOSTAVAX (dose, route and frequency were not reported) for vaccination. The reporter reported the patient had "recurrent shingles outbreaks", number of outbreaks, duration and severity not specified, since receiving the vaccine. The outcome of herpes zoster was unknown. The reporter did not provide the causality between the event and the vaccine. Additional information has been requested.
Sex: M
Vaccine: HPV9
Symptoms: Incomplete course of vaccination, No adverse event
Clinical narrative: Information has been received from a male consumer of unknown age referring to himself. There was no information about concurrent condition, concomitant medication and medical history. On unknown dates in March 2016 and May 2016, the patient was vaccinated with the first and the second doses of GARDASIL 9 (0.5 ml, intramuscular) (lot# and expiration date unknown) respectively for prophylaxis. The patient moved GARDASIL 9 was not available. The patient had missed the third dose of of GARDASIL 9. There was no adverse event reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Muscular dystrophy
Clinical narrative: This spontaneous report received from a nurse practitioner referred to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. The nurse practitioner reported that the patient who received a dose of M-M-R II (dose, route, lot number and expiry date not reported) on an unspecified date experienced muscle dystrophy after receiving the vaccination. Outcome of the event was unknown and causality assessment was not reported. Additional information is not possible as permission to contact the reporter was not available.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from an administrator referring to unspecified patients of unknown ages and genders. No information regarding the patients' medical history, concurrent conditions or concomitant therapies was provided. On an unknown date, the patients were vaccinated with a dose of improperly stored M-M-R II lot # M004063, expiration date on 25-JAN-2018 (strength, dose number, route and anatomical location were not provided) for prophylaxis. Nevertheless, no adverse effects were reported. The vaccines experienced the following temperature excursions during 14 hours: 74.5 grades Fahrenheit. Furthermore, no product quality complaint was involved. It was reported that the vaccine M-M-R II was not supported. Also the reporter was not sure if the vaccine was administered or not. This is one of several reports received from the same reporter. Additional information is not expected, since no consent to contact the reporter was provided. Sender's Comments: US-009507513-1612USA008792: US-009507513-1612USA008791.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from an office manager refers to unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with unspecified number of doses of PEDVAXHIB lot# K008873 with expiration date 06-FEB-2017 (dose and route of administration were not reported). Administered doses of PEDVAXHIB experienced a temperature excursion at 47 Fahrenheit degrees for 1 hour, with a prior excursion at 33 Fahrenheit degrees for 15 hours. No adverse effects were reported. Product quality complaint (PQC) was not reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA008786: US-009507513-1612USA008787.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Department of Health Agency Service Representative refers to patients of unknown age. On unknown dates, the patients might have received improperly stored doses of GARDASIL 9 (dose, route lot number and expiration date not reported). No adverse events have been reported. Temperature excursion was 0.5 C for 1209 hours and 30 minutes. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA008793.
Age: 5.0
Sex: M
Vaccine: MMRV
Symptoms: Herpes zoster, Injection site reaction, Local reaction, Pruritus, Rash
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to a 5 year and 8 month-old male patient. There was no information about the patient's concurrent conditions and medical history provided. On 02-AUG-2016, the patient was vaccinated with PROQUAD (lot # M006105, expiration date: 01-AUG-2017), subcutaneously for immunization. Concomitant therapies included BENADRYL. On 02-AUG-2016, the patient experienced localized injection site reaction. On an unknown date in approximately 2016, the patient experienced shingles with a rash and itching. An unspecified treatment was given for the adverse events. The healthcare professional was interested in Varicella zoster virus (VZV) analysis by polymerase chain reaction (PCR) and wanted to send viral isolates. The outcome of the events was not reported. The relatedness between the events and PROQUAD was not provided. 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 nurse referring to a patient of an unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On 18-NOV-2016, the patient was vaccinated with a dose of improperly stored ZOSTAVAX subcutaneously, lot # of M024700 and an expiration date of 18-JUL-2017 (strength, dose number, and anatomical location were not provided) for prophylaxis. Nevertheless, no adverse effects were reported. The vaccines experienced the following temperature excursions during 10 minutes: 11 grades Fahrenheit. Reportedly, there had been no previous temperature excursions and the aforementioned ones were identified due to a data logger. Furthermore, no product quality complaint was involved. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Pneumonia
Clinical narrative: This spontaneous report was received from a pharmacist referring to her mother of unknown age. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. Approximately in December 2000 (reported as: "16 years ago"), the patient was vaccinated with a dose of PNEUMOVAX23 (strength, dose number, route of administration, lot number and expiration date were not provided) for prophylaxis. On an unknown date the patient experienced pneumonia. Therefore on an unspecified date in November 2015, the patient was admitted to an unknown hospital. On an unknown date in 2015 (reported as: "9 days later") the patient recovered and was discharged from the hospital. Upon internal review, the event pneumonia was considered to be a medically significant event. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA005477: US-009507513-1612USA005475: US-009507513-1612USA005476: US-009507513-1612USA005473: US-009507513-1612USA005474.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug allergies / reactions and concomitant medication were unknown. On 08-DEC-2016, the patient was vaccinated with an improperly stored dose of ZOSTAVAX (Lot number reported as M035148, expiration date 25-OCT-2017) dose, route and anatomical location were not provided for prophylaxis.        No adverse effects were reported. There was no previous excursion reported. The temperature time excursion was 17F for 48 hours and 8F for 120 hours. No data logger was reported. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Basophil count increased, Expired product administered, Lymphocyte count increased, Nervousness, White blood cell count increased
Clinical narrative: This spontaneous report was received from a nurse practitioner via Poison and Drug Center concerning a 62 year old female patient with chronic lymphocytic leukaemia, hypercholesterolaemia and brain meningioma. Concomitant therapies included LIPITOR, ZETIA, aspirin, ANUCORT and calcium (unspecified) (+) vitamin d (unspecified). On an unknown date, relevant lab work included white blood cell count (WBC): 23.6 (units not reported) (elevated), absolute basophils elevated, "MPB" 12.0 (units not reported), absolute lymphocytes 17,228. On 10-DEC-2016, the patient was vaccinated with expired dose of PNEUMOVAX 23 (lot # reported as 7002681500, expiration date: 05-NOV-2016) one prefilled syringe, once, intramuscularly for prevention. The patient was nervous about receiving expired vaccine but was not experiencing any other effects from receiving the expired vaccine. As of 10-DEC-2016, it was unknown if the patient would continue on the PNEUMOVAX 23 and the outcome of receiving an expired PNEUMOVAX 23 was unknown however the patient continued to experience nervousness regarding receiving the expired vaccine. The relatedness between nervousness and PNEUMOVAX 23 was not reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's pertinent medical history, current conditions and concomitant medications were not reported. No previous drug reactions or allergies were reported. On 08-DEC-2016 the patient received an expired dose of GARDASIL (dosing details were not reported) (lot # L001442; expiration: 04-NOV-2016) intramuscularly for prophylaxis (expired product administered). No known adverse effects. There was no product quality complaint involved. Additional information is not expected as the reporter did not wish further contact.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 64 year old patient of unknown gender. There was no information about the patient's pertinent medical history, drug reactions or allergies provided. On 28-MAY-2016, the patient was vaccinated with first dose of RECOMBIVAX HB (frequency, indication, lot #, expiration date and therapy type were not reported), intramuscularly for prophylaxis. On 22-AUG-2016, the patient was vaccinated with second dose of RECOMBIVAX HB (frequency, indication, lot #, expiration date and therapy type were not reported) intramuscularly for prophylaxis. No side effects were reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report received from a medical assistant referred to unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. The medical assistant reported that unspecified patients were administered improperly stored vaccines ROTATEQ (lot: M007298; expiry date: 19-NOV-2017) on an unspecified date. No adverse effects were reported. The vaccine was stored at 35.52F for 8 hours and 2 minutes. There was no previous temperature excursion and the call was because of digital data logger. This is one of the several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1612USA008775: same reporter US-009507513-1612USA008776: same reporter US-009507513-1612USA009010: same reporter.