chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 41.0
Sex: M
Vaccine: TDAP
Symptoms: Pyrexia, Vomiting
Clinical narrative: Pt had her Tdap done on Monday, 3/28/16 at 4:30 and was given Amoxicillin. That night she felt lightheaded and nausea, she had chills and fever and her arm was hurting.  She developed nausea, vomiting and diarrhea.  Her medication was changed to Zpak yesterday. She cannot lift her arm at all. No redness though swelling present at the site.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to a patient of currently 1 year of age and unspecified gender. The patient's pertinent medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with improperly stored dose of VARIVAX (Merck) with lot # L009205, expiry date 17-MAR-2017; dose, route of administration and anatomical location not reported). The doses of VARIVAX (Merck) underwent temperature excursion: 14.7F for 2 hours and 15 minutes. There were not previous temperature excursion. No symptoms were reported. No product quality complaint (PQC) was involved. No further information provided. This is one of several reports from the same reporter. Additional information has been requested.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to a patient of currently 1 year age and unspecified gender. The patient's pertinent medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with improperly stored dose of VARIVAX (Merck) with lot # L009205, expiry date 17-MAR-2017; dose, route of administration and anatomical location not reported). The doses of VARIVAX (Merck) underwent temperature excursion: 14.7F for 2 hours and 15 minutes. There were no previous temperature excursions. No symptoms were reported. No product quality complaint (PQC) was involved. No further information provided. This is one of several reports from the same reporter. 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 and refers to multiple unspecified patients of unknown age and gender. Patient's pertinent medical history and drug reactions or allergies were not reported. On unknown dates, patients were vaccinated with improperly stored doses of VARIVAX (Merck) (lot # L009204 and expiration date 17-MAR-2017, dose and route of administration were not reported). Concomitant therapy was not reported. No adverse effects were reported. No product quality complaint (PQC) was involved. There was no previous temperature excursion. The temperature of the excursion was 42F and the time frame was 16 hours. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site discolouration, Injection site erythema, Injection site warmth
Clinical narrative: Left thigh erythema with purplish discoloration centrally, non tender, warm about 4x6 inches in size.
Sex: U
Vaccine: HPV9
Symptoms: Extra dose administered, Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a patient of unknown age and gender. No pertinent medical history and drug reactions/allergies were reported. On 28-AUG-2014, 28-OCT-2014 and on 18-SEP-2015, the patient was previously vaccinated with GARDASIL (strength, dose and frequency were not reported) (inappropriate schedule of drug administration). On 18-MAR-2016, the patient was vaccinated with GARDASIL 9 (extra dose administered and interchange of vaccine products). Concomitant medications were not provided. No adverse effects were reported. There were no product quality complaints (PQC) involved. No further information provided. Additional information is not expected as the reporter did not wish further contact.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to a patient of currently 1 year age and unspecified gender. The patient's pertinent medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with improperly stored dose of VARIVAX with lot # L034368, expiry date 08-SEP-2017; dose, route of administration and anatomical location not reported). The doses of VARIVAX underwent temperature excursion: 14.7F for 2 hours and 15 minutes. There were no previous temperature excursions. No symptoms were reported. No product quality complaint (PQC) was involved. No further information provided. This is one of several reports from the same reporter. 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 referring to a patient of currently 1 year ago and unspecified gender. The patient's pertinent medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with improperly stored doses of (Oka/Merck) VARIVAX with lot # L009205, expiry ate 17-MAR-2017; dose, route of administration and anatomical location not reported). The doses of (Oka/Merck) VARIVAX underwent temperature excursion: 14.7F for 2 hours and 15 minutes. There were no previous temperature excursions. No symptoms were reported. No product quality complaint (PQC) was involved. No further information provided. This is one of several reports from the same reporter. 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 referring to a patient of currently 1 year age and unspecified gender. The patient's pertinent medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with improperly stored dose of VARIVAX (Merck) with lot # L034368, expiry date 08-SEP-2017; dose, route of administration and anatomical location not reported). The doses of VARIVAX (Merck) underwent temperature excursion: 14.7F for 2 hours and 15 minutes. There was no previous temperature excursions. No symptoms were reported. No product quality complaint (PQC) was involved. No further information provided. This is one of several reports from the same reporter. Additional information has been requested.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to a patient of currently 1 year age and the patient was vaccinated with improperly stored dose of VARIVAX (Merck) with lot # L034368, expiry date 08-SEP-2017; dose, route of administration and anatomical location not reported). The doses of VARIVAX (Merck) underwent temperature excursion: 14.7F for 2 hours and 15 minutes. There were no previous temperature excursions. No symptoms were reported. NO product quality complaint (PQC) was involved. No further information provided. This is one of several reports from the same reporter. Additional information has been requested.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to a patient of currently 1 year age and unspecified gender. The patient's pertinent medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with improperly stored dose of (Oka/Merck) VARIVAX with lot # L034368, expiry date 08-SEP-2017; dose, route of administration and anatomical location not reported). The doses of (Oka/Merck) VARIVAX underwent temperature excursion: 14.7F for 2 hours and 15 minutes. There were no previous temperature excursions. No symptoms were reported. No product quality complaint (PQC) was involved. No further information provided. This is one of several reports from the same reporter. Additional information has been requested.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to a patient of currently 1 year age and unspecified gender. The patient's pertinent medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with improperly stored dose of (Merck) VARIVAX with lot # L034368, expiry date 08-SEP-2017; dose, route of administration and anatomical location not reported). The doses of (Merck) VARIVAX underwent temperature excursion: 14.7F for 2 hours and 15 minutes. There were no previous temperature excursions. No symptoms were reported. No product quality complaint (PQC) was involved. No further information provided. This is one of several reports from the same reporter. Additional information has been requested.
Age: 2.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to a patient of currently 2 years age and unspecified gender. The patient's pertinent medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with improperly stored dose of VARIVAX with lot # L034368,expiry date 08-SEP-2017; dose, route of administration and anatomical location not reported). The doses of VARIVAX (Merck) underwent temperature excursion: 14.7F for 2 hours and 15 minutes. There were no previous temperature excursions. No symptoms were reported. No product quality complaint (PQC) was involved. No further information provided. This is one of several reports from the same reporter. Additional information has been requested.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to a patient of currently 1 year age and unspecified gender. The patient's pertinent medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with improperly stored dose of (Oka/Merck) VARIVAX with lot # L034368, expiry date 08-SEP-2017; dose, route of administration and anatomical location not reported). The doses of (Oka/Merck) VARIVAX underwent temperature excursion: 14.7F for 2 hours and 15 minutes. There were no previous temperature excursions. No symptom were reported. No product quality complaint (PQC) was involved. No further information provided. This is one of several reports from the same reporter. Additional information has been requested.
Age: 13.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to a patient of currently 13 years age and unspecified gender. The patient's pertinent medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with improperly stored dose of (Merck) VARIVAX with lot # L034368, expiry date 08-SEP-2017; dose, route of administration and anatomical location not reported). The doses of (Merck) VARIVAX underwent temperature excursion: 14.7F for 2 hours and 15 minutes. There were no previous temperature excursions. No symptoms were reported. No product quality complaint (PQC) was involved. No further information provided. This is one of several reports from the same reporter. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV9
Symptoms: Activities of daily living impaired, Biopsy site unspecified abnormal, Colonoscopy normal, Computerised tomogram normal, Diaphragmalgia
Clinical narrative: This spontaneous report was received from a consumer (patient's mother) regarding her 16 year old daughter. The patient's medical history included sensitive stomach. The patient had no drug reactions or allergies. Concurrent conditions were not reported. On 31-DEC-2015, the patient was vaccinated with first dose of GARDASIL 9 (lot # L025737, expiry date 28-JUL-2017) in the left deltoid, dosage regimen unknown. Concomitant therapies included cetirizine hydrochloride. On an unknown date in 2016, after patient received vaccine she began to feel unwell. On an unknown date in January 2016, 3 weeks after vaccination, the patient began to feel run down and felt like she was outside of her body. The patient was walking from the kitchen to the living room and she dropped to her knees with pain near her diaphragm. On an unspecified date in 2016, the patient was taken to the Emergency Room where a computerized tomogram (CT) scan was performed. The CT scan showed ovarian cysts on the left side. The patient was experiencing excruciating pain on her right side. The CT test also showed the patient's appendix was not enlarged. She was discharged from the Emergency Room but the pain did not diminish. The patient went back to the Emergency Room and the doctor told her that she would need to see a gastroenterologist. After a third trip to the emergency room, the patient was referred to a specialist. All the tests which patient had undergone, came back normal but it was reported that the patient was still in a lot of pain. A colonoscopy, ultrasound, biopsy and endoscopy have been performed on the patient on unspecified dates in 2016 and for unspecified reasons. The results showed the patient did not have an autoimmune disease and confirmed that it was an allergen. It was reported that the pain was located in the patient's pancreas and she was currently unable to eat due to the pain (unspecified if she is physically unable to eat or if she finds food unappealing at this time). Furthermore, the has been home schooled since early February 2016 and her walking was limited. It was also reported that the patient was not able to sit in chairs because of the pain she is experiencing (Activities of daily living impaired). It was reported that the treatment was given for the events and the treatment medication included NAUZENE. It was reported that the therapy with GARDASIL 9 was discontinued. The outcome of events were reported to be not recovered. The causality assessment for the events were unknown. The event home schooled, walking was limited and not able to sit in chairs was considered to be serious as disabling. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV9
Symptoms: Eating disorder, Endoscopy normal, Feeling abnormal, Gait disturbance, Hypersensitivity
Clinical narrative: This spontaneous report was received from a consumer (patient's mother) regarding her 16 year old daughter. The patient's medical history included sensitive stomach. The patient had no drug reactions or allergies. Concurrent conditions were not reported. On 31-DEC-2015, the patient was vaccinated with first dose of GARDASIL 9 (lot # L025737, expiry date 28-JUL-2017) in the left deltoid, dosage regimen unknown. Concomitant therapies included cetirizine hydrochloride. On an unknown date in 2016, after patient received vaccine she began to feel unwell. On an unknown date in January 2016, 3 weeks after vaccination, the patient began to feel run down and felt like she was outside of her body. The patient was walking from the kitchen to the living room and she dropped to her knees with pain near her diaphragm. On an unspecified date in 2016, the patient was taken to the Emergency Room where a computerized tomogram (CT) scan was performed. The CT scan showed ovarian cysts on the left side. The patient was experiencing excruciating pain on her right side. The CT test also showed the patient's appendix was not enlarged. She was discharged from the Emergency Room but the pain did not diminish. The patient went back to the Emergency Room and the doctor told her that she would need to see a gastroenterologist. After a third trip to the emergency room, the patient was referred to a specialist. All the tests which patient had undergone, came back normal but it was reported that the patient was still in a lot of pain. A colonoscopy, ultrasound, biopsy and endoscopy have been performed on the patient on unspecified dates in 2016 and for unspecified reasons. The results showed the patient did not have an autoimmune disease and confirmed that it was an allergen. It was reported that the pain was located in the patient's pancreas and she was currently unable to eat due to the pain (unspecified if she is physically unable to eat or if she finds food unappealing at this time). Furthermore, the has been home schooled since early February 2016 and her walking was limited. It was also reported that the patient was not able to sit in chairs because of the pain she is experiencing (Activities of daily living impaired). It was reported that the treatment was given for the events and the treatment medication included NAUZENE. It was reported that the therapy with GARDASIL 9 was discontinued. The outcome of events were reported to be not recovered. The causality assessment for the events were unknown. The event home schooled, walking was limited and not able to sit in chairs was considered to be serious as disabling. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV9
Symptoms: Laboratory test normal, Malaise, Ovarian cyst, Pain, Ultrasound scan normal
Clinical narrative: This spontaneous report was received from a consumer (patient's mother) regarding her 16 year old daughter. The patient's medical history included sensitive stomach. The patient had no drug reactions or allergies. Concurrent conditions were not reported. On 31-DEC-2015, the patient was vaccinated with first dose of GARDASIL 9 (lot # L025737, expiry date 28-JUL-2017) in the left deltoid, dosage regimen unknown. Concomitant therapies included cetirizine hydrochloride. On an unknown date in 2016, after patient received vaccine she began to feel unwell. On an unknown date in January 2016, 3 weeks after vaccination, the patient began to feel run down and felt like she was outside of her body. The patient was walking from the kitchen to the living room and she dropped to her knees with pain near her diaphragm. On an unspecified date in 2016, the patient was taken to the Emergency Room where a computerized tomogram (CT) scan was performed. The CT scan showed ovarian cysts on the left side. The patient was experiencing excruciating pain on her right side. The CT test also showed the patient's appendix was not enlarged. She was discharged from the Emergency Room but the pain did not diminish. The patient went back to the Emergency Room and the doctor told her that she would need to see a gastroenterologist. After a third trip to the emergency room, the patient was referred to a specialist. All the tests which patient had undergone, came back normal but it was reported that the patient was still in a lot of pain. A colonoscopy, ultrasound, biopsy and endoscopy have been performed on the patient on unspecified dates in 2016 and for unspecified reasons. The results showed the patient did not have an autoimmune disease and confirmed that it was an allergen. It was reported that the pain was located in the patient's pancreas and she was currently unable to eat due to the pain (unspecified if she is physically unable to eat or if she finds food unappealing at this time). Furthermore, the has been home schooled since early February 2016 and her walking was limited. It was also reported that the patient was not able to sit in chairs because of the pain she is experiencing (Activities of daily living impaired). It was reported that the treatment was given for the events and the treatment medication included NAUZENE. It was reported that the therapy with GARDASIL 9 was discontinued. The outcome of events were reported to be not recovered. The causality assessment for the events were unknown. The event home schooled, walking was limited and not able to sit in chairs was considered to be serious as disabling. Additional information has been requested.
Age: 18.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to a patient of currently 18 years age and unspecified gender. The patient's pertinent medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with improperly stored dose of (Merck) VARIVAX with lot # L034368, expiry date 08-SEP-2017; dose, route of administration and anatomical location not reported). The doses of (Merck) VARIVAX underwent temperature excursion: 14.7F for 2 hours and 15 minutes. There were no previous temperature excursions. No symptoms were reported. No product quality complaint (PQC) was involved. No further information provided. This is one of several reports from the same reporter. Additional information has been requested.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to a patient of currently 1 year age and unspecified gender. The patient's pertinent medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with improperly stored dose of (Merck) VARIVAX with lot # L009205, expiry date 17-MAR-2017; dose, route of administration and anatomical location not reported). The doses of (Merck) VARIVAX underwent temperature excursion: 14.7F for 2 hours and 15 minutes. There were no previous temperature excursions. No symptoms were reported. No product quality complaint (PQC) was involved. No further information provided. This is one of several reports from the same reporter. Additional information has been requested.
Age: 7.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to a patient of currently 7 year age and unspecified gender. The patient's pertinent medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with improperly stored dose of VARIVAX (Merck) with lot # L034368, expiry date 08-SEP-2017; dose, route of administration and anatomical location not reported). The doses of VARIVAX (Merck) underwent temperature excursion: 14.7F for 2 hours and 15 minutes. There were no previous temperature excursions. No symptoms were reported. No product quality complaint (PQC) was involved. No further information provided. This is one of several reports from the same reporter. Additional information has been requested.
Age: 14.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to a patient of currently 14 years age and unspecified gender. The patient's pertinent medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with improperly stored dose of (Merck) VARIVAX with lot # L034368, expiry date 08-SEP-2017; dose, route of administration and anatomical location not reported). The doses of (Merck) VARIVAX underwent temperature excursion: 14.7F for 2 hours and 15 minutes. There were no previous temperature excursions. No symptoms were reported. No product quality complaint (PQC) was involved. No further information provided. This is one of several reports from the same reporter. Additional information has been requested.
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report as received from a physician's assistant refers to a male patient of unknown age. The concurrent condition, medical history and concomitant medications were unknown. On an unknown date, the patient was vaccinated with GARDASIL dose 1 (route and lot details unspecified). Six months later the patient was then administered with GARDASIL 9 (route and lot details unspecified) as the second dose of the series. No adverse effects were reported. No product quality complaint was involved. Additional information has been requested.
Age: 17.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to a patient of currently 17 years age and unspecified gender. The patient's pertinent medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with improperly stored dose of (Merck) VARIVAX with lot # L034368, expiry date 08-SEP-2017; dose, route of administration and anatomical location not reported). The doses of (Merck) VARIVAX underwent temperature excursion: 14.7F for 2 hours and 15 minutes. There were no previous temperature excursions. No symptoms were reported. No product quality complaint (PQC) was involved. No further information provided. This is one of several reports from the same reporter. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Per mom left arm swollen and slightly pink. She denies pain or warm to touch.
Age: 15.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to a patient of currently 15 years age and unspecified gender. The patient's pertinent medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with improperly stored dose of (Merck) VARIVAX with lot # L034368, expiry date 08-SEP-2017; dose, route of administration and anatomical location not reported). The doses of (Merck) VARIVAX underwent temperature excursion: 14.7F for 2 hours and 15 minutes. There were no previous temperature excursions. No symptoms were reported. No product quality complaint (PQC) was involved. No further information provided. This is one of several reports from the same reporter. Additional information has been requested.
Age: 35.0
Sex: M
Vaccine: ANTH, MMR, TYP
Symptoms: Flushing, Nausea, Pruritus, Throat irritation
Clinical narrative: NAUSEA, ITCHY THROAT, FLUSH FACE, ITCHY LEGS.
Age: 45.0
Sex: F
Vaccine: HEP
Symptoms: Arthralgia, Immediate post-injection reaction, Neck pain, Pain in extremity
Clinical narrative: Patient complains of achy shoulder joint. Arm is sore from about elbow up through neck. Denies any other symptoms. Says soreness started immediately after receiving vaccine. Pain today is no better but no worse.
Age: 35.0
Sex: F
Vaccine: HEP
Symptoms: Injection site pain
Clinical narrative: Patient complains of pain in her right shoulder. Pain starts at elbow and radiates to her neck. Says it started sooner after receiving vaccine. Had no trouble with the two previous vaccines. Denies any other symptoms.
Age: 34.0
Sex: F
Vaccine: TYP
Symptoms: Agitation, Erythema, Pruritus, Rash, Skin irritation
Clinical narrative: Localized irritation (redness, rash like appearance), agitation upon contact causes itching, dilation approx. size about that of a silver dollar.
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Dyskinesia
Clinical narrative: Problems moving mouth area --mouth twisted.
Age: 20.0
Sex: M
Vaccine: MENB
Symptoms: Asthenia, Delirium, Pain, Pain in extremity, Pyrexia
Clinical narrative: Body pain and aches at onset with extreme pain at and around vaccination site (unable to move arm at all without pain). Starting at 2:00 PM, fever and weakness began to develop. Fever grew to 105F in cyclic spurts with accompanying delirium and vomiting at the peak. All symptoms resolved by 9AM 04/08/2016.
Age: 20.0
Sex: M
Vaccine: MENB
Symptoms: Vaccination site pain, Vomiting
Clinical narrative: Body pain and aches at onset with extreme pain at and around vaccination site (unable to move arm at all without pain). Starting at 2:00 PM, fever and weakness began to develop. Fever grew to 105F in cyclic spurts with accompanying delirium and vomiting at the peak. All symptoms resolved by 9AM 04/08/2016.
Age: 12.0
Sex: M
Vaccine: HEPA, HPV9, MNQ, TDAP
Symptoms: Anaemia, Haemoglobin decreased, Muscular weakness, Pain in extremity
Clinical narrative: Complaints of severe arm pain, and weakness. Lab work showed mild anemia.
Age: 20.0
Sex: M
Vaccine: MENB
Symptoms: Pain, Pain in extremity, Pyrexia
Clinical narrative: Body aches and pains progressing to fever that peaked on 02/05 at 11 PM. Aches persisted as well as a low grade fever for three days. Extreme pain on the injection arm was also present for nearly two weeks.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to a patient of currently 1 year age and unspecified gender. The patient's pertinent medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with improperly stored dose of VARIVAX (Merck) with lot # L034368, expiry date 08-SEP-2017; dose, route of administration and anatomical location not reported). The doses of VARIVAX (Merck) underwent temperature excursion: 14.7F for 2 hours and 15 minutes. There were no previous temperature excursions. No symptoms were reported. No product quality complaint (PQC) was involved. No further information provided. This is one of several reports from the same reporter. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site erythema, Malaise, Pyrexia, Tremor
Clinical narrative: This spontaneous report was received from a 60 year old female patient, who was a nurse, reporting on herself. The patient did not have any pertinent medical history. In approximately October 2014 (reported as about 18 months ago), the patient was vaccinated with a dose of ZOSTAVAX (lot #, expiration date and exact dose were not reported), subcutaneously. Concomitant therapies included unspecified calcium, vitamin D and folic acid. In approximately October 2014 (reported as 1 day after the ZOSTAVAX injection), she developed a flat, round, red area (size was unspecified) at the site of injection. About 1.5 days after the appearance of the red area, she recovered. In November 2015, the patient started therapy with IMURAN (strength, formulation, dose, frequency, route of administration and indication were not reported). On an unspecified date, she developed shaking, chills, high fever and malaise. Therapy with IMURAN was discontinued on an unspecified date. Subsequently, the patient recovered from shaking, chills, high fever and malaise on an unknown date. The patient did not seek any medical attention and no treatment was given for the events. No lab diagnostic studies were performed. The relatedness between the events and the suspect therapies was not 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 referring to a patient of currently 1 year age and unspecified gender. The patient's pertinent medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with improperly stored dose of (Oka/Merck) VARIVAX with lot # L009205, expiry date 17-MAR-2017; dose, route of administration and anatomical location not reported). The doses of (Oka/Merck) VARIVAX underwent temperature excursion: 14.7F for 2 hours and 15 minutes. There were no previous temperature excursions. No symptoms were reported. No product quality complaint (PQC) was involved. No further information provided. This is one of several reports from the same reporter. Additional information has been requested.
Age: 14.0
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse concerning a 14 year old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant therapy were not reported. On 19-FEB-2016, the patient was vaccinated with the third dose of an improperly stored GARDASIL 9 (dose and route of administration were not reported, lot # L048237 and expiration date 08-MAY-2017) (temperature: -10 degree Centigrade, time frame: over a two day period with a cumulative of 12 hours (2 cycles)). No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pain in extremity
Clinical narrative: Mother came to school to have reaction checked.  Left deltoid swollen and red at injection site.  Warm to touch.  Patient states he feels fine except that his arm hurts.
Age: 50.0
Sex: F
Vaccine: MMR
Symptoms: Abasia, Disorientation, Dizziness, Loss of consciousness
Clinical narrative: Passed out, disoriented, dizzy, unable to walk.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to multiple unspecified patients of unknown age and gender. Patient's pertinent medical history and drug reactions or allergies were not reported. On unknown dates, patients were vaccinated with improperly stored doses of RECOMBIVAX HB (lot # J013394 and expiration date 25-AUG-2016, dose and route of administration were not reported). Concomitant therapy was not reported. No adverse effects were reported. No product quality complaint (PQC) was involved. The temperature of the first excursion was 59F and the time frame was 16 hours. The temperature of the second excursion was 32F and the time frame was 120 hours. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist via company representative, regarding a patient of unknown age and gender. Information on the concurrent conditions and medical history of the patient were not reported. On 17-MAR-2106 (a week ago), the patient was vaccinated with ZOSTAVAX Vial 19400 PFU (lot, expiry date, route and anatomical location were not specified). Concomitant medications were not reported. On an unknown date, patient was being prescribed prednisone for an unspecified reason (adverse event). The reporter did not know why the patient was going to receive prednisone. There was no Product Quality Complaint (PQC) involved. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV9, HPV4
Symptoms: Blood iron decreased, Blood test, Immediate post-injection reaction, Loss of consciousness, Seizure like phenomena
Clinical narrative: This spontaneous report was received from a physician via company representative refers to a 11 year old female patient. The patient current condition included low blood iron. Information about patient's medical history, drug reactions or allergies and concomitant medications was not provided. On an unspecified date in 2016 (reported as last week), the patient was vaccinated with GARDASIL 9 (intramuscularly, dose#1, lot # L048237, expiry date not reported). It was reported that right after the first dose of GARDASIL 9 in 2016, "the patient passed out and had seizure like movement, described as tonic-clonic movements". The patient woke right up. The physician also stated that at the appointment when the patient received her first dose of GARDASIL 9, "her iron was low". On 04-APR-2016, the patient had an additional unspecified blood test and passed out again, just after the blood was drawn. The patient did not seek medical attention and no treatment was given to her for adverse events. No product quality complaint (PQC) was involved. No further information provided. The outcome of events was unknown. The reporter did not provide the causality between the events and the suspect therapy. Upon internal review, the event seizure were determined to be medically significant. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV9, HPV4
Symptoms: Tonic clonic movements
Clinical narrative: This spontaneous report was received from a physician via company representative refers to a 11 year old female patient. The patient current condition included low blood iron. Information about patient's medical history, drug reactions or allergies and concomitant medications was not provided. On an unspecified date in 2016 (reported as last week), the patient was vaccinated with GARDASIL 9 (intramuscularly, dose#1, lot # L048237, expiry date not reported). It was reported that right after the first dose of GARDASIL 9 in 2016, "the patient passed out and had seizure like movement, described as tonic-clonic movements". The patient woke right up. The physician also stated that at the appointment when the patient received her first dose of GARDASIL 9, "her iron was low". On 04-APR-2016, the patient had an additional unspecified blood test and passed out again, just after the blood was drawn. The patient did not seek medical attention and no treatment was given to her for adverse events. No product quality complaint (PQC) was involved. No further information provided. The outcome of events was unknown. The reporter did not provide the causality between the events and the suspect therapy. Upon internal review, the event seizure were determined to be medically significant. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV9, HPV4
Symptoms: Loss of consciousness
Clinical narrative: This spontaneous report was received from a physician via company representative refers to a 11 year old female patient. The patient current condition included low blood iron. Information about patient's medical history, drug reactions or allergies and concomitant medications was not provided. On an unspecified date in 2016 (reported as last week), the patient was vaccinated with GARDASIL 9 (intramuscularly, dose#1, lot # L048237, expiry date not reported). It was reported that right after the first dose of GARDASIL 9 in 2016, "the patient passed out and had seizure like movement, described as tonic-clonic movements". The patient woke right up. The physician also stated that at the appointment when the patient received her first dose of GARDASIL 9, "her iron was low". On 04-APR-2016, the patient had an additional unspecified blood test and passed out again, just after the blood was drawn. The patient did not seek medical attention and no treatment was given to her for adverse events. No product quality complaint (PQC) was involved. No further information provided. The outcome of events was unknown. The reporter did not provide the causality between the events and the suspect therapy. Upon internal review, the event seizure were determined to be medically significant. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: This spontaneous report was received from a pharmacist regarding a 71 year old female patient. Patient had no pertinent medical history or drug allergies. On 04-MAR-2015, the patient was vaccinated with ZOSTAVAX (lot and expiry date were not specified) 0.65 ml, once, subcutaneously. There was no concomitant medication reported. On an unknown date (recently), the patient was diagnosed with shingles (vaccination failure) for which the primary physician ordered anti-viral medication. The reporter had accepted the VZV packet. There were no lab diagnostics performed. Outcome of vaccination failure was unknown at the reporting time. There were no Product Quality Concerns (PQC) involved. The reporter did not assess the causality of the event with ZOSTAVAX. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Back pain, Discomfort, Rash
Clinical narrative: This spontaneous report as received from a medical assistant refers to a female patient of unknown age. There was no concurrent conditions, medical history, allergy/drug reactions and concomitant medications. On 13-OCT-2011, the patient was vaccinated with the first dose of GARDASIL lot #291AA, expiry: 12-APR-2014 (dosing details was not reported). The second dose of GARDASIL lot # and expiry were not reported), was administered on 15-DEC-2011 and the third dose of GARDASIL lot# 1561AA, expiry : 26-AUG-2014 was administered on 19-APR-2012. After the series the patient developed a rash and complained of body discomfort. As of 2015, the symptoms had progressed to joint pain and lower back pain. Primary reporter was requesting lot check for the GARDASIL (lot #291AA, expiry: 12-APR-2014 and lot# 1561AA, expiry: 26-AUG-2014). The patient sought medical attention which included an office visit. There were no lab tests done. No treatment was given for the events. The outcome of the events was unknown. The reporter did not provide the causality between the events and the suspect therapy. There were no product quality complaints (PQC) involved. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site urticaria
Clinical narrative: Localized hives at inj site following imms - resolved with BENADRYL 37.5 mg.
Age: 9.0
Sex: F
Vaccine: HEPA
Symptoms: Urticaria
Clinical narrative: Mild urticaria after imm. given 25 mg BENADRYL with resolution of sx after 15 minutes.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Insomnia
Clinical narrative: Experienced severe left arm (deltoid area) radiating into left shoulder. Pain continues. Have been treated with methylpred 4 mg - twice. Pain returns after off prednisone after 4-5 days. Difficult sleeping because of pain.
Age: 84.0
Sex: F
Vaccine: PNC13
Symptoms: Asthenia, Decreased appetite, Diarrhoea, Dyspepsia, Injection site erythema
Clinical narrative: Explosive diarrhea, short duration shock, weakness, lack of appetite, large inflamed area on arm at site lasted - 2 weeks. Digestion irregular 2 weeks. Excessive diarrhea repeated second week. Site still red, slight swelling.
Age: 84.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site inflammation, Injection site swelling, Shock
Clinical narrative: Explosive diarrhea, short duration shock, weakness, lack of appetite, large inflamed area on arm at site lasted - 2 weeks. Digestion irregular 2 weeks. Excessive diarrhea repeated second week. Site still red, slight swelling.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to multiple unspecified patients of unknown gender and age. Information regarding patients' medical history, concurrent condition, drug reactions/allergies and concomitant therapy were not provided. On unknown dates, these patients were vaccinated with improperly stored MMR II (lot # K006396, expiry date: 04-MAY-2016). Reporting nurse stated that the vaccine underwent a temperature excursion of 49.6 degree Fahrenheit for 1 hour and 17 minutes. No adverse effects were reported. Additional information has been requested.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a physician via company representative regarding a 64 year old male patient. There was no information about concurrent condition and historical medication. On an unknown date the patient developed moderate case of shingles. Patient was seen by physician to seek medical attention. The outcome of moderate case of shingles was unknown. Causality was not reported. Additional information is not expected because physician does not want to get contacted.
Age: 66.0
Sex: M
Vaccine: FLUX, PNC13, FLUX, PNC13
Symptoms: Chills, Cough, Dyspnoea, Fatigue, Paranasal sinus hypersecretion
Clinical narrative: Fever/chills. Cough/labored breathing/wheezing. Sinus (running). Hives skin problems (prolonged). Fatigue (weeks and weeks).
Age: 66.0
Sex: M
Vaccine: FLUX, PNC13, FLUX, PNC13
Symptoms: Pyrexia, Skin disorder, Urticaria, Wheezing
Clinical narrative: Fever/chills. Cough/labored breathing/wheezing. Sinus (running). Hives skin problems (prolonged). Fatigue (weeks and weeks).
Age: 35.0
Sex: F
Vaccine: DTAP, TDAP
Symptoms: Allergy to animal, Allergy to arthropod sting, Drug hypersensitivity, Food allergy, Pain
Clinical narrative: Sore, puffy.
Age: 35.0
Sex: F
Vaccine: DTAP, TDAP
Symptoms: Seasonal allergy, Swelling
Clinical narrative: Sore, puffy.
Age: 49.0
Sex: F
Vaccine: HEP
Symptoms: Pruritus, Rash erythematous
Clinical narrative: Hep B first dose given 3/24/16. Red, raised rash presented 4/1/16, starting on chest, progressing to neck and face, mild pruritus. Saw M.D. on 4/5/16 who prescribed Prednisone 4 mg for 6 d in decreasing dosage (24 mg, 20 mg, 16 mg, 12 mg, 8 mg, 4 mg) then D.C. Also Triamcinolone Cream 0.25% daily p.r.n.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Abdominal pain upper, Constipation, Decreased appetite, Gastrooesophageal reflux disease, Irritability
Clinical narrative: Extreme fussiness started evening of 4/5/16. Decreased appetite - no stool - seemed to be stomach pain. Seen in office 4/6/16 with normal exam except fussiness. Sent to ER 4/7/16 because fussiness continued. No fever - neg ultrasound of abdomen. Pain relievers no help - on ZANTAC for reflux.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Ultrasound abdomen normal
Clinical narrative: Extreme fussiness started evening of 4/5/16. Decreased appetite - no stool - seemed to be stomach pain. Seen in office 4/6/16 with normal exam except fussiness. Sent to ER 4/7/16 because fussiness continued. No fever - neg ultrasound of abdomen. Pain relievers no help - on ZANTAC for reflux.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Swelling, warmth and pain at site. No treatment.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site discharge, Injection site erythema, Injection site swelling
Clinical narrative: Left - swollen to twice the size of right upper extremity, red from shoulder to elbow, area of injection is draining serous fluids. Patient started on Cephalexin and Sulfamethoxazole-trimethoprim. This patient was a new patient to us on 4-4-16.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Papule, Rash papular, Rash pruritic
Clinical narrative: This spontaneous report as received from a nurse via company representative refers to a 55 year old female patient. The patient did not have pertinent medical history, drug allergies and concomitant medications. On an unspecified date in 2016, reported as last week, the patient was vaccinated with ZOSTAVAX, 19400 PFU, 1 shot (1 DF) (route, lot # not reported) and subsequently "developed soreness and burning at the injection site. The patient also had "a tiny itchy papule rash on her left shoulder, which spread down her arm and to her wrist". No lab test was performed. The patient sought medical attention in the nurse's office and was treated with an unspecified antihistamine. No product quality (PQC) issue involved. The outcome of injection site pain, injection site burning, rash pruritic and rash popular were unknown. The causality assessment was not provided. Additional information has been requested.