chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Lymphadenopathy, Musculoskeletal chest pain, Musculoskeletal stiffness, Nodule, Pain
Clinical narrative: This medically confirmed spontaneous report (initial receipt 29-Oct-2013) concerns a 46-year-old female patient with a history of asthma. The patient had no drug reactions/allergies. It was reported that the patient last received a flu vaccination 5-6 years ago and at that time she developed a pustule at the injection site, which then developed a scab on it and left a scar (see 2013038828). On 27-Oct-2013 at 12:00am, the patient was administered intramuscular AFLURIA (batch R54908) into the left deltoid, at a dose of 0.5 mL indicated for vaccination. The same afternoon, the patient developed significant nodular swelling under her left arm, chest wall pain, neck stiffness, tingling of the arm, a fever of 99.9F and stabbing pains at an unspecified location in her body. The patient's lymph nodes in her left arm were swollen to the size of a baseball. The patient was treated with ibuprofen. No lab diagnostics studies were performed. It was reported that the patient had recovered from some of her symptoms, however her lymph nodes were still swollen. Outcome was reported as recovering. Case correction (14-Nov-2013) - case upgraded to serious.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Paraesthesia, Pyrexia
Clinical narrative: This medically confirmed spontaneous report (initial receipt 29-Oct-2013) concerns a 46-year-old female patient with a history of asthma. The patient had no drug reactions/allergies. It was reported that the patient last received a flu vaccination 5-6 years ago and at that time she developed a pustule at the injection site, which then developed a scab on it and left a scar (see 2013038828). On 27-Oct-2013 at 12:00am, the patient was administered intramuscular AFLURIA (batch R54908) into the left deltoid, at a dose of 0.5 mL indicated for vaccination. The same afternoon, the patient developed significant nodular swelling under her left arm, chest wall pain, neck stiffness, tingling of the arm, a fever of 99.9F and stabbing pains at an unspecified location in her body. The patient's lymph nodes in her left arm were swollen to the size of a baseball. The patient was treated with ibuprofen. No lab diagnostics studies were performed. It was reported that the patient had recovered from some of her symptoms, however her lymph nodes were still swollen. Outcome was reported as recovering. Case correction (14-Nov-2013) - case upgraded to serious.
Age: 0.22
Sex: M
Vaccine: DPP, IPV
Symptoms: Crying, Gastrooesophageal reflux disease, Irritability, Vomiting
Clinical narrative: Severe reflux, vomiting, crying, irritability.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Cervical dysplasia, Smear cervix abnormal
Clinical narrative: Pap smear result LSIL cervical dysplasia.
Age: 26.0
Sex: F
Vaccine: FLUN4
Symptoms: Dizziness, Immediate post-injection reaction, Musculoskeletal stiffness, Sinus headache, Temporomandibular joint syndrome
Clinical narrative: Facial sinus pain. TMJ pain.  Stiffness and tenderness on the back of neck and head. lightheadedness immediately after administration that continued for about 2 hours.
Age: 26.0
Sex: F
Vaccine: FLUN4
Symptoms: Tenderness
Clinical narrative: Facial sinus pain. TMJ pain.  Stiffness and tenderness on the back of neck and head. lightheadedness immediately after administration that continued for about 2 hours.
Sex: M
Vaccine: VARZOS
Symptoms: Bacterial sepsis, Bacterial test positive, Blood test abnormal, Herpes zoster, Leukaemia
Clinical narrative: This spontaneous report as received from a physician refers to a male patient in his late 60's with no pertinent medical history and no drug reactions or allergies. In October 2013, reported as about five and a half weeks ago, the patient was vaccinated with a dose of ZOSTAVAX injection, subcutaneously (dose and lot number not provided). On 31-OCT-2013 reported as three weeks ago, after receiving ZOSTAVAX the patient noticed a rash and saw his primary care physician who diagnosed patient with shingles. The patient was advised by his primary care physician to go to an unspecified hospital, in which he was admitted for a few days. A treatment at this hospital for the shingles was acyclovir therapy. While at the hospital, the patient had unspecified blood work drawn, which showed he was positive for leukemia. On 12-NOV-2013 the patient was transferred from the unspecified hospital to other hospital to treat the leukemia. The physician noted that when the patient arrived on 12-NOV-2013 the patient's lesions were crusted and unspecified blood work was drawn. The physician reported that the patient had bacteria in his blood, which probably developed from the shingles. The patient was put on an unspecified antibiotic. The physician stated that the patient was not being treated for leukemia, rather they were waiting for the sepsis to clear up. Upon the physician review because of the events the patient had a significant disability and the sepsis was a life threatening event. Upon internal review the leukemia and sepsis were considered to be serious as other medically significant events. The outcome of the patient was reported as not recovered. The patient relatedness between vaccination with ZOSTAVAX and events was not reported. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Rash, Scab, Skin lesion
Clinical narrative: This spontaneous report as received from a physician refers to a male patient in his late 60's with no pertinent medical history and no drug reactions or allergies. In October 2013, reported as about five and a half weeks ago, the patient was vaccinated with a dose of ZOSTAVAX injection, subcutaneously (dose and lot number not provided). On 31-OCT-2013 reported as three weeks ago, after receiving ZOSTAVAX the patient noticed a rash and saw his primary care physician who diagnosed patient with shingles. The patient was advised by his primary care physician to go to an unspecified hospital, in which he was admitted for a few days. A treatment at this hospital for the shingles was acyclovir therapy. While at the hospital, the patient had unspecified blood work drawn, which showed he was positive for leukemia. On 12-NOV-2013 the patient was transferred from the unspecified hospital to other hospital to treat the leukemia. The physician noted that when the patient arrived on 12-NOV-2013 the patient's lesions were crusted and unspecified blood work was drawn. The physician reported that the patient had bacteria in his blood, which probably developed from the shingles. The patient was put on an unspecified antibiotic. The physician stated that the patient was not being treated for leukemia, rather they were waiting for the sepsis to clear up. Upon the physician review because of the events the patient had a significant disability and the sepsis was a life threatening event. Upon internal review the leukemia and sepsis were considered to be serious as other medically significant events. The outcome of the patient was reported as not recovered. The patient relatedness between vaccination with ZOSTAVAX and events was not reported. Additional information has been requested.
Age: 0.52
Sex: F
Vaccine: RV5
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age. On 26-SEP-2013 the patient was vaccinated with the third dose of ROTATEQ (lot# reported as 0055AE; expiry date: 13-SEP-2013) 2ml, oral. No adverse effects reported. The outcome of the event was unknown. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Injection site extravasation
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a patient of unknown age. On 28-OCT-2013 the patient was vaccinated with partial dose of GARDASIL (lot# unspecified), intramuscular. After intramuscular administration, some of the vaccine leaked out of the injection site on the patient's arm. No adverse effects reported. The outcome of the event was unknown. Additional information has been requested.
Age: 18.0
Sex: M
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a medical assistant (healthcare worker) refers to a 18 year old male patient. On 12-NOV-2013 the patient was vaccinated with ZOSTAVAX, 0.5 ml, via subcutaneous route. Lot and expiry date was not reported. The patient was intended to receive his second dose of VARIVAX, was inadvertently administered ZOSTAVAX. No adverse effects reported. Additional information has been requested.
Age: 0.99
Sex: M
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a nurse,refers to a male patient who was 3 days from completing 12 months of age. On 06-NOV-2013 the patient was vaccinated with VAQTA, dose: 0.5 ml, route: intramuscular, lot and expiry date: unknown. The patient was inadvertently administered with VAQTA 3 days before his twelfth month birthday. No adverse effects were reported. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site bruising, Nausea
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 24 year old female patient. The patient's medical history included anemia, anxiety, depression, allergic rhinitis and condyloma. The patient also had a history of hives after acetaminophen (manufacturer unknown) use (dates unspecified) and had recovered from the hives (linked case 1311USA009438). On 19-JUL-2013, the patient was vaccinated with GARDASIL (dose sequence unspecified) (dose unknown, lot # H105859, expiry date 26-JUN-2015) intramuscular to prevent HPV. On 01-OCT-2013 the patient was vaccinated with GARDASIL of same lot and via same route (dose sequence unspecified). Concomitant medications were none. On 08-OCT-2013 (reported as starting about 2 weeks before 22-OCT-2013), the patient developed bruising at the site of injections. On about 22-OCT-2013 the patient experienced nausea. The outcome of events was unknown. No treatment was given for the events. No lab test was performed. The patient had called the nurse practitioner to seek medical attention. This case is linked to 1311USA009438 (same patient). Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: This spontaneous report as received from a pharmacist via a representative refers to a patient of unknown age. On an unknown date, the patient was vaccinated with ZOSTAVAX. No concomitant medications were reported. On an unknown date, the patient developed a shingles looking rash on their arm, post vaccination. The outcome of developed a shingles looking rash on their arm was unknown. The rash extended for 7 days duration. No other information provided. Patient sought medical attention by contacting pharmacy. Causality assessment was not provided by reporter. Additional information is not expected.
Age: 1.0
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from an healthcare student refers to a 1 year old patient of unspecified gender. On 05-NOV-2013 the patient was vaccinated with PROQUAD (route, dose and lot number unknown) and with VARIVAX (route, dose and lot number unknown). No other suspect therapy or concomitant medication was reported. On 05-NOV-2013 an unspecified nurse administered PROQUAD and VARIVAX in error on 05-NOV-2013. No adverse event. Additional information has been requested.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Dry skin, Erythema, Skin swelling
Clinical narrative: This spontaneous report was received from a 50 year old male consumer refers to himself. The patient had high blood pressure and was allergic to penicillin. On 19-OCT-2013 the patient was vaccinated with ZOSTAVAX (lot# and expiry date not provided) 1 time vaccine. Concomitant therapies included COMPLERA, WELLBUTRIN, Basics Water Pills and lisinopril. On 26-OCT-2013, the patient had a reaction to ZOSTAVAX and described it as raised red areas which was dry (similar to warts or a callous which he stated was no shingles or a rash) on the palms of both hands and inside his fingers on both hands and on the bottoms of both his feet. He further stated that he had a follow up with his clinician. No lab diagnostic studies performed, no treatment received for the events and the patient sought medical attention. No product quality complaint involved. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Premature menopause
Clinical narrative: This spontaneous report as received from a registered nurse refers to a female patient of unknown age (currently 19 years old, age at the time of event unspecified. Nurse stated that other patient's mother told her that she recently (date unspecified) saw on the internet a news story about 2 women who are sisters, the first 19 years old. On an unknown date, the patient was vaccinated with GARDASIL series (dose, route, dates not specified) and on an unknown date, the patient experienced early menopause. The outcome of early menopause was unknown. Relatedness was not reported. This is one of several reports from the same source (MARRS # 1311USA009480 sibling, MARRS # 1311USA004306). Additional information has been requested.
Age: 54.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pain
Clinical narrative: This spontaneous report as received from a pharmacist refers to an approximately 54 year old male patient. On 14-NOV-2013 the patient was vaccinated with PNEUMOVAX23 (lot # J006921, expiry date 09-AUG-2014 (also reported as August 2014)) 1.5 ml intramuscular. The patient was taking unspecified concomitant medications. On 14-NOV-2013, the patient experienced injection hurt. It was reported that the patient was not treated for the events. There was no lab diagnostics performed. The outcome of injection hurt was reported as not recovered. The relatedness of the events to the therapy with PNEUMOVAX23 was unknown. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: This spontaneous report as received from a pharmacist via MVCC representative refers to a patient of unknown age. On an unknown date a couple of years ago, the patient was vaccinated with ZOSTAVAX (dose, lot and expiry date unknown). Patient experienced an injections site reaction a couple years ago after vaccination. The pharmacist also reported that the site was red. The outcome of events was unknown. Reporter's causality assessment was not provided. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. On 15-NOV-2013, the patient was vaccinated with GARDASIL lot # 670050/1229AA. It was reported that the patient received GARDASIL on 15-NOV-2013 which was expired on 12-NOV-2013 (Lot number was reported as 670050/1229AA). No adverse event reported. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Premature menopause
Clinical narrative: This spontaneous report as received from a registered nurse refers to a female patient of unknown age (currently 20 years old, age at the time of event unspecified). Nurse stated that other patient's mother told her that she recently (date unspecified) saw on the internet a news story about 2 women who are sisters, the second of 20 years old. On an unknown date, the patient was vaccinated with GARDASIL series (dose, route, dates not specified) and on an unknown date, the patient experienced early menopause. The outcome of early menopause was unknown. Relatedness was not reported. This is one of several reports from the same source (MARRS # 1311USA009479 sibling, MARRS # 1311USA004306). Additional information has been requested.
Age: 7.0
Sex: F
Vaccine: FLUN4
Symptoms: Rash generalised, Urticaria
Clinical narrative: Patient received FLUMIST. She has had flu injection in past. She has no h/o allergies. Soon after within 5-10 minutes, she developed urticarial rash on face, upper chest, neck, upper arms. She was given BENADRYL, prednisone and ZYRTEC.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Neck pain, Pain in extremity
Clinical narrative: Patient called the pharmacy about 1 1/2 hour after vaccine. Symptom left arm hurt all the way to her hand and had started on her neck, primary care was called. Staff said Dr would tell her to go to ER.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: This spontaneous report as received from a pharmacist via public representative refers to unknown number of patients of unknown demographics. On an unknown date the patients were vaccinated with ZOSTAVAX (dose, route, lot, expiry date unknown). Pharmacist stated that most of his patients had injection site soreness and redness after the vaccination with ZOSTAVAX. The outcome of the events injection site soreness and redness after vaccination was unknown. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a health care worker refers to a patient of unknown demographics. On 23-OCT-2013, the patient was vaccinated with unsupported dose of MMR II (lot number J000201 and expiry date 09-JAN-2015). No concomitant therapy was administered. No adverse effects reported. This report is one of the four patients reported from same source. This case is linked to 1311USA008915, 1311USA008914 and 1311USA008744 (same reporter link). Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: VARCEL
Symptoms: Fatigue, Headache, Injection site erythema, Injection site pain, Injection site reaction
Clinical narrative: This spontaneous report as received from a nurse refers to a 19 year old female patient with drug reactions/allergies of shellfish. No concomitant medications and pertinent medical history were reported. On 29-OCT-2013 the patient was vaccinated with the first dose of VARIVAX, (lot# J006572, Exp date 07-JUN-2015), injections, subcutaneous in the left arm (strength and indication not reported). On 11-NOV-2013, the patient developed headache and fatigue. She developed a red, raised and sore lesion at the injections site and 2 other itchy lesions on her right arm and 1 itchy lesion on her left arm. The lesions were red raised and less than 5 mm in diameter. They were not vesicular. No lab diagnostic studies were performed. The patient had seen in office. Claritin and hydrocortisone cream were given to treat the adverse events. At the time of reporting, the outcome of the events was not recovered. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site swelling, Skin lesion
Clinical narrative: This spontaneous report as received from a nurse refers to a 19 year old female patient with drug reactions/allergies of shellfish. No concomitant medications and pertinent medical history were reported. On 29-OCT-2013 the patient was vaccinated with the first dose of VARIVAX, (lot# J006572, Exp date 07-JUN-2015), injections, subcutaneous in the left arm (strength and indication not reported). On 11-NOV-2013, the patient developed headache and fatigue. She developed a red, raised and sore lesion at the injections site and 2 other itchy lesions on her right arm and 1 itchy lesion on her left arm. The lesions were red raised and less than 5 mm in diameter. They were not vesicular. No lab diagnostic studies were performed. The patient had seen in office. Claritin and hydrocortisone cream were given to treat the adverse events. At the time of reporting, the outcome of the events was not recovered. Additional information has been requested.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Convulsion
Clinical narrative: Pt states that 1 1/2 hrs after flu shot administered experienced symptom of a seizure. Was not severe enough for patient to feel need to consult physician.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a health care worker refers to a patient of unknown demographics. On 23-OCT-2013, the patient was vaccinated with unsupported dose of MMR II (lot number J000201 and expiry date 09-JAN-2015). No concomitant therapy was administered. No adverse effects reported. This report is one of the four patients reported from same source. This case is linked to 1311USA008914, 1311USA008916 and 1311USA008744 (same reporter link). Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a health care worker refers to a patient of unknown demographics. On 17-OCT-2013, the patient was vaccinated with unsupported dose of MMR II (lot number J002934 and expiry date 01-MAR-2014). No concomitant therapy was administered. No adverse effects reported. This report is one of the four patients reported from same source. This case is linked to 1311USA008915, 1311USA008916 and 1311USA008914 (same reporter link). Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Drug administration error, Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse and refers to a patient of unknown age and gender. On 30-OCT-2013 the patient was vaccinated with MMR II lot # H020255 (expiry date: 08-NOV-2014), 0.5 ml, subcutaneous. Dose number, anatomical location and indication were not reported. It was reported that the administered dose of MMR II was incorrectly administered. On 29-OCT-2013, there was exposure at a temperature of 14 degrees C for 1.5 hours and 9.4 degrees C for 1.5 hours. On 30-OCT-2013, the dose was exposed to a temperature of 10 degrees for 3 hours. No adverse event or treatment information was reported. Additional information has requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Amenorrhoea
Clinical narrative: This spontaneous report as received from a registered nurse refers to a female patient (currently 13 years old, age at the event onset unknown) with Cefzil and Suprax hives reaction/allergy and constipation. The patient was vaccinated with the first, the second and the third dose of GARDASIL lot # 0420AE exp. Date: 12-JAN-2014, 0.5 ml, intramuscular, on 07-JUN-2012, 13-AUG-2012 and 17-JAN-2013, respectively. Concomitant therapies included vitamins (unspecified) (reported as multivitamin). It was reported that recently (date unspecified), the patient's mother called the office because she was concerned that her daughter has not started to menstruate yet. The patient has not ever had a period yet. There was no treatment given for the patient's event. No lab diagnostic studies were performed. The physician offered to refer the patient to an OB/GYN specialist but the patient's mother declined. Relatedness was not reported. At the time of report, the outcome of the patient was reported as: not started to menstruating yet (not recovered/not resolved). This is one of several reports from the same source (1311USA009479, 1311USA009480). Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Diabetes mellitus inadequate control
Clinical narrative: This spontaneous report as received from a pharmacist via a company representative refers to an unknown number of diabetic patients of unknown age. The pharmacist stated that during a first aid class, an "emergency medical technician (EMT" stated that an unknown number of diabetic patients had experienced loss of glycemic control after receipt of ZOSTAVAX (dose, route and lot # unspecified). It was unknown if the patients sought medical attention or not. The outcome of loss of glycemic control was unknown. Additional information is not expected.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Depression, Headache, Insomnia, Maternal exposure before pregnancy, Ultrasound antenatal screen
Clinical narrative: Information has been received from a nurse practitioner, for GARDASIL, a Pregnancy Registry product, concerning a 16 year old female who on 13-DEC-2011 was vaccinated with third dose of GARDASIL (Lot# and dose not reported), intramuscularly. The nurse reported that the patient was determined to be 6 weeks and 3 days pregnant. The date of conception had been calculated to be approximately 13 days after the vaccine was administered. The patient did not seek any medical attention. No treatment was given. There were no adverse events reported. Follow-up information has been received from the nurse practitioner concerning the 16 year old female with a history of acid reflux and there were no previous deliveries who on 13-DEC-2011 was vaccinated with the third dose of GARDASIL. On 26-JAN-2012, the patient experienced depression and she was treated with CELEXA at 20 mg daily. It was reported that on 14-FEB-2012, the patient experienced insomnia and she was treated with BENADRYL one time. On 20-FEB-2012 and 21-FEB-2012, the patient experienced headache and she was treated with TYLENOL 325-450 mg, three times. Concomitant therapy included prenatal vitamins (unspecified) daily since 26-JAN-2012. On 26-JAN-2012, ultrasound was preformed and the patient had been pregnant for 6 weeks and 3 days. The date of estimated conception was 25-DEC-2011 (LMP: 12-DEC-2011, EDD: 17-SEP-2012). Follow-up information has been received. Patient was no longer at the practice and there was no additional information to provided. Pregnancy outcome was updated to lost to follow up. All telephone attempts to obtain follow-up information have been unsuccessful. All scheduled correspondence was canceled.
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Erythema, Injection site erythema, Injection site pain, Pain in extremity
Clinical narrative: This spontaneous report via field representative refers to a female patient of unknown age who is also a pharmacist (reporter). On 26-AUG-2013 the patient was vaccinated with ZOSTAVAX vial in the right arm for vaccination by her husband, also a pharmacist. Dose, lot and expiry date were not reported. Concomitant therapies included influenza (manufacturer unknown) administered in opposite arm. Post vaccination, on the same day, the patient developed pain and redness at the injection site, which cascaded down her right arm to below her right elbow. No rash was reported. The patient was fine at the time of report. The outcome of events was reported as recovered/resolved. No treatment was given for events. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a health care worker refers to a patient of unknown demographics. On 24-OCT-2013, the patient was vaccinated with unsupported dose of MMR II (lot number J000202 and expiry date 09-JAN-2015). No concomitant therapy was administered. No adverse effects reported. This report is one of the four patients reported from same source. This case is linked to 1311USA008915, 1311USA008916 and 1311USA008744 (same reporter link). Additional information has been requested.
Sex: M
Vaccine: MMR
Symptoms: Autism
Clinical narrative: This spontaneous report as received from a consumer refers to his son of unknown age. On an unknown date the patient was vaccinated with MMR II (lot# was not reported). The caller stated that his wife was "convinced" that "her son" had "high-functioning autism" because he was vaccinated with MMR II when he was young. The outcome of high-functioning autism was unknown. Additional information is not expected.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age. On 11-NOV-2013 the patient was vaccinated with a dose of improperly stored PROQUAD, (lot # J008574, exp date 12-JAN-2015), 0.5 ml, subcutaneous. No adverse effects reported. Additional information has been requested.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 57 year old female patient. The patient had no medical history or drug reactions/allergies. On 16-NOV-2013 the patient was vaccinated with ZOSTAVAX lot # J006832, expiry date 14-SEP-2013, dose 0.65 ml, route subcutaneous for immunization. Concomitant medications were none. On 18-NOV-2013, 2 days after vaccination, the patient developed a red area about a half dollar big around the injections site and some mild itching. At the time of report no treatment had been administered, and the patient had not yet seen her physician. The patient had sought medical attention by pharmacy visit. The outcome of events some mild itching and red area about a half dollar big around the injections site was reported as not resolved. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Healthcare Worker refers to unknown patients of unknown age. The healthcare worker reported that an unknown number of doses of MMR II (lot# was not reported) that were exposed to a prolonged peroid of light exposure (2-7 days at the front of a glass door refrigerator, not in boxes) might have been administered. No adverse effect reported. Additional information has been administered. No adverse effectc reported. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Mobility decreased, Musculoskeletal pain, Pain in extremity
Clinical narrative: This spontaneous report as received from a pharmacy student refers to a 60 year old female patient with no pertinent medical history or drug reactions/allergies. On 28-OCT-213 (reported as 2 weeks ago) the patient was vaccinated with a 0.65 ml dose of ZOSTAVAX, subcutaneously (lot # unspecified). On 11-NOV-2013 the patient came into the pharmacy to report adverse reactions. Patient had pain from the shoulder to her elbow (unspecified which shoulder and which elbow). Pharmacy student stated "the pain was to the point that the patient could not pick up her arm." The outcome of events was reported as not recovered/not resolved. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 13-NOV-2013 the patient was vaccinated with PROQUAD, (lot number H015791) (dosing regimen and frequency unknown) injection subcutaneously which had expired on 12-NOV-2013. No adverse events were reported. Additional information has been requested.
Age: 59.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Incorrect route of drug administration, Injection site swelling, Injection site warmth, Paraesthesia
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 59 year old female patient with none of pertinent medical history and none of drug reactions/allergies. On 01-NOV-2013 the patient was intradermally vaccinated with a dose of 0.65 ml ZOSTAVAX (lot # J004270, exp. 12-JUL-2014). None of concomitant medication was reported. The patient felt it was given intradermally because it was given under the arm and because of "the sensation". The area was swollen, hot to the touch and there is tingling down an unspecified pinky finger which was transient and not there now. The swelling went down. The patient called pharmacist for seek medical attention. No treatment was given for AE. None lab diagnostics studies performed. Additional information has been requested.
Age: 59.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Burning sensation, Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 59 year old female patient with none of pertinent medical history and none of drug reactions/allergies. On 01-NOV-2013 the patient was intradermally vaccinated with a dose of 0.65 ml ZOSTAVAX (lot # J004270, exp. 12-JUL-2014). None of concomitant medication was reported. The patient felt it was given intradermally because it was given under the arm and because of "the sensation". The area was swollen, hot to the touch and there is tingling down an unspecified pinky finger which was transient and not there now. The swelling went down. The patient called pharmacist for seek medical attention. No treatment was given for AE. None lab diagnostics studies performed. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Feeling abnormal, Hypoaesthesia oral
Clinical narrative: Pt received flu shot at 930a, around 1130a patient felt "woozy". Her head felt funny. She had numbness in her nose, upper lips, and ears. She took chlorpheniramine, then BENADRYL at bedtime. Still had symptoms 3 days later.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Headache, Insomnia
Clinical narrative: Chills, severe headache, insomnia.
Age: 0.34
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Abdominal X-ray, Body temperature increased, Irritability, Urine analysis
Clinical narrative: 3 am - Temp 102 (R) - mom called night nurse for advice - give TYLENOL - cranky after shots - not consolable. Had office visit and 2 ER visits.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Pruritus, Urticaria
Clinical narrative: Received flu vaccine 11/8/13 at approx 0730, at employee's end of shift, went home to bed, woke up about 2 hrs later. Reports trouble breathing, itching and hives. Called at 1100 to employee health, was instructed to seek care. Husband took her to urgent care at 1400. Treated with epinephrine, steroids, and pain med.
Age: 0.13
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Blood test, Irritability, Pyrexia, Urine analysis
Clinical narrative: Had 6 wk vaccines in office and later Dad called as has a fever of 101.4 (rectal) - fussy/calmness episodes. Sent to the ER.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Dysphagia, Fatigue, Rhinorrhoea, Throat irritation
Clinical narrative: On 11/15/13 pt received High Dose Influenza vaccine 1 hour later felt very tired, then around 6 pm throat felt tight and itchy. She had difficulty swallowing. Took aspirin and drank water after two hours she felt better but had a lingering dry cough through the next day. Also had a runny nose along with throat tightness.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Throat tightness
Clinical narrative: On 11/15/13 pt received High Dose Influenza vaccine 1 hour later felt very tired, then around 6 pm throat felt tight and itchy. She had difficulty swallowing. Took aspirin and drank water after two hours she felt better but had a lingering dry cough through the next day. Also had a runny nose along with throat tightness.
Age: 29.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Immunisation reaction
Clinical narrative: Pt came to the pharmacy with a severe type of reaction to the immunization.
Age: 12.0
Sex: M
Vaccine: FLU3
Symptoms: Lymphadenopathy
Clinical narrative: 48 hours post vaccine patient has swollen lymph nodes.
Age: 70.0
Sex: F
Vaccine: TD
Symptoms: Dizziness, Laboratory test, Loss of consciousness, Similar reaction on previous exposure to drug
Clinical narrative: Initial information received from a consumer on 12 November 2013. The reporter who is also the patient reported another event which is captured in case # 2013SA117468. A 70 year old patient was vaccinated with Td vaccine at her doctor's office in 1999, date, manufacturer, route and site not reported. The patient experienced lightheadedness and passed out approximately 15 minutes after vaccination. The patient had a history of receiving Td vaccination in 1965, 1969 and 1985 and also passed out after these vaccinations. The patient reported having the same reaction after having had polio vaccines in 1956, 1957 and 1962. The patient reported having YF-VAX, date not reported and passed out after vaccination. The patient's medical history and concomitant medications were not reported. Treatment details were not reported. The patient recovered on an unreported date. Further details were not available at the time of this report. Documents held by sender: None.
Age: 0.67
Sex: F
Vaccine: FLU3, HEP, IPV
Symptoms: Acute disseminated encephalomyelitis, Angiogram, Blood test, Cerebral haemorrhage, Convulsion
Clinical narrative: 24 hours after vaccine, baby woke up paralyzed on left side. 5 days later seizures and bleeding in the brain. Hospitalized for 5 weeks. Given steroids and seizure meds. Diagnosed with ADEM.
Age: 0.67
Sex: F
Vaccine: FLU3, HEP, IPV
Symptoms: Echocardiogram, Electroencephalogram, Hemiplegia, Lumbar puncture, Nuclear magnetic resonance imaging
Clinical narrative: 24 hours after vaccine, baby woke up paralyzed on left side. 5 days later seizures and bleeding in the brain. Hospitalized for 5 weeks. Given steroids and seizure meds. Diagnosed with ADEM.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Pharyngeal oedema, Urticaria
Clinical narrative: Hives, sensation of throat swelling and diarrhea 3 days after receiving ZOSTAVAX - Denies other possible contributory factors - Rx with BENADRYL Prednisone and PEPCID reports complete resolution during visit of 11/20/13.
Sex: M
Vaccine: TD
Symptoms: Loss of consciousness, Pallor
Clinical narrative: Initial information received from a consumer on 12 November 2013. The reporter who is the patient's parent also reported another event which is captured in case # 2013SA117464. A male patient in his 20's was vaccinated in 1989 with a Td vaccine (manufacturer, lot number, route and site not reported). The patient turned white and passed out 10 - 15 minutes after vaccination. The patient's medical history and concomitant medications were not reported. Treatment details were not reported. The patient recovered on an unreported date. Further details were not available at the time of this report. Documents held by sender: None.
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Cough, Headache, Malaise, Myalgia, Pyrexia
Clinical narrative: Became ill with fever one week post vaccination. Headache, Myalgia, Fever and Cough Wheeze.
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Wheezing
Clinical narrative: Became ill with fever one week post vaccination. Headache, Myalgia, Fever and Cough Wheeze.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a patient of unknown age. On 31-MAY-2013, the patient was vaccinated with the first dose of GARDASIL (dose, route and lot number were not reported). On 29-JUL-2013, patient was vaccinated with the second dose of GARDASIL (dose, route and lot number were not reported) and on 18-OCT-2013 the patient was vaccinated with the third dose of GARDASIL (dose, route and lot number were not reported). No concomitant medications were reported. The nurse practitioner stated that the patient received doses of GARDASIL at less than minimum intervals. Nurse practitioner stated that doses were administered in an unspecified location. No adverse effects reported.
Age: 77.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Contusion, Injection site pain
Clinical narrative: Patient complained of soreness on her injection site. i.e. of pneumonia on 11/18/13. She was advised to do warm compress. On 11/21/13, she came to the pharmacy showing bruises on both arms, more on the left. Bruises came up 2 days after the shot. She said it's waning though.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Body temperature increased, Dizziness, Fatigue, Headache, Pain
Clinical narrative: Approx 48 hours after vaccine, pt felt fatigue causing excessive sleepiness, then HA, body aches developed. Low grade temp on day 3 with fatigue, dizziness. No S.T., no cough, no rash. No exposure to anyone will illness. Similar sx last yr 48 after flu shot.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Somnolence
Clinical narrative: Approx 48 hours after vaccine, pt felt fatigue causing excessive sleepiness, then HA, body aches developed. Low grade temp on day 3 with fatigue, dizziness. No S.T., no cough, no rash. No exposure to anyone will illness. Similar sx last yr 48 after flu shot.
Age: 29.0
Sex: M
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injection site bruising, Injection site induration, Injection site swelling
Clinical narrative: Upon withdrawal of needle, a large, dark, raised bruise appeared roughly 1/4 inch at peak. After several minutes, the size decreased but it still remained raised and hard to touch.
Age: 66.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: 2 golf ball sized red, itchy, slightly warm patch at injection site on right arm.
Age: 78.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Influenza like illness, Injection site erythema, Injection site swelling
Clinical narrative: Patient noticed redness and swelling at injection, redness radiating down front of arm. Also had flu-like symptoms.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Deafness, Hypoacusis, Tinnitus
Clinical narrative: Decreased hearing loss and humming in left ear.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, RV5
Symptoms: Fatigue, Listless
Clinical narrative: Pt now lives in another city and 8 mos. old. Pt mother states pt became listless, fatigued for 48 hours post vaccines.
Age: 39.0
Sex: F
Vaccine: FLUC3, PPV
Symptoms: Muscle spasms, Pain
Clinical narrative: The pneumonia shot given to me caused severe muscle spasms in my left arm, they were so bad I went to the ER. The muscle relaxers didn't work. I know can only lift my arm up a few inches as it's still very painful, hot and is sensitive.
Age: 8.0
Sex: M
Vaccine: FLU3
Symptoms: Flushing, Immediate post-injection reaction, Pruritus, Skin warm
Clinical narrative: Almost immediately following injection pt. developed severe itching on the back of his neck. His face, ears, feet, and legs below the knee became flushed and warm. Mother put a cool compress on his neck, gave him a bath, and put topical BENADRYL on affected areas. Symptoms disappeared within an hour of onset. (No redness/swelling at injection site).
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Discomfort, Nerve injury, Pain in extremity
Clinical narrative: Excruciating pain soon after. Arm has been sore ever since. Doctor said pharmacist hit a nerve. He said I was injured. It has been 4 weeks. I have had much discomfort and had to pay $20 to my Dr.
Age: 6.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Local reaction, Pyrexia, Vomiting
Clinical narrative: Local reaction at site 5 x 7 cm redness 2 x 2 cm node in (lt) arm pit. After flu shot fever to 101.7, vomiting w/in 24 hours.
Age: 0.51
Sex: F
Vaccine: DTAP, HIBV, PNC13, RV5
Symptoms: Rash macular
Clinical narrative: Child developed macular rash within 3 days of vaccination.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus generalised
Clinical narrative: 11/16/13 c/o severe itching since receiving influenza vaccine originally to (L) arm but spreading to rest of body. No rash noted.
Age: 60.0
Sex: M
Vaccine: FLUX
Symptoms: Parotid gland enlargement, Swelling face
Clinical narrative: R sided facial swelling, R sided parotid gland enlargement.  Vaccine administered on R arm as per patient.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: Area of redness measuring 70mmx80mm; itchy, tenderness/pain at site, heat.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Chest pain, Discomfort, Dizziness, Presyncope
Clinical narrative: Near syncope, lightheadedness, throat discomfort, chest pain, palpitations.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Vaccination complication
Clinical narrative: Pt stated she developed a red bump at injection site. She went to doctor told her to monitor she went home next day bump had grown in size MD gave steroid shot bump resolved next day.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Blepharospasm, Eye irritation, Eye swelling
Clinical narrative: The morning after I received the Fluvirin Multidose Vial 2013-14 5 ML in my left arm, I woke up with my left eye swollen and irritated.  The swelling lasted 7 days.  An eye twitch onset around the 7 day mark and continues, without improvement.
Age: 44.0
Sex: F
Vaccine: FLUX
Symptoms: Feeling jittery, Flushing, Urticaria
Clinical narrative: Hives, flush face, jitters; Benadryl.
Age: 1.93
Sex: F
Vaccine: FLU3
Symptoms: Injection site rash, Rash
Clinical narrative: Rash from injection site and all over abdomen and torso, moving up the neck to the face.  Treatment was 2.5ml of Zyrtec to treat the rash.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU3, MMRV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site vesicles
Clinical narrative: Swelling, tenderness, redness of left shoulder started evening of 11/21/13 and progressed until visit 11/22/13.  A single clear fluid filled vesicle appeared also AM 11/22/13.
Age: 52.0
Sex: M
Vaccine: FLUX
Symptoms: Arthralgia, Fatigue, Myalgia, Vertigo
Clinical narrative: Joint & muscle pain, burning pains in joints, fatigue, vertigo.
Age: 51.0
Sex: M
Vaccine: HEPAB, MNQ, TDAP, YF
Symptoms: Convulsion, Dizziness, Loss of consciousness
Clinical narrative: Approximately two minutes after vaccinations, patient said they were feeling dizzy.  The patient lost consciousness and appeared to have a seizure.  This lasted approximately 20 seconds.  The patient then opened his eyes and asked what happened.  I explained that he had passed out.  He then lost consciousness again and appeared to have another seizure.  At this point, I called for help from other nursing staff and called 911.  We then got the patient to the floor where he came around again. He then lost consciousness again and appeared to have another seizure.  We turned the patient on his side and started oxygen.  The paramedics arrived and he was conscious at that point.  He was not recovering very quickly and the paramedics sat with the patient for 20 minutes before deciding to take the patient to the hospital emergency room for further examination by a physician.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Dizziness, Dyspnoea, Rash
Clinical narrative: MOM CALLED ON 11/18/2013 AND PATIENT FEELS LIGHTHEADEDNESS AND DIZZY WITH HARD TIME BREATHING, AFTER THE MENACTRA SHOT ON THE SAME DAY, PATIENT NOTICED RASH ON THE FACE ON THE SAME NIGHT, NO RASH ON THE BODY, MOM GAVE BENADRYL, NO SWELLING ON THE FACE OR COUGHING.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient reported she had gone to Urgent Care the day after she had her PNEUMOVAX immunization. She had pain, redness, and swelling in a 4-inch band from the injection site to her elbow. Patient was given TYLENOL with codeine, a steroid cream, and "another medication". Symptoms lasted 4 days.
Age: 54.0
Sex: F
Vaccine: FLUX
Symptoms: Back pain, Chills, Headache, Pain
Clinical narrative: Approximately 12 hr later, back pain, aches, chills and headache lasting 48 hours.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site infection, Pyrexia
Clinical narrative: Fever 103 - Rt arm red at site and hard. Went to Urgent Care Dx infection and put on doxycycline 100mg BID x 10 days.
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Allergy test negative, Rash, Wheezing
Clinical narrative: Rash, wheezing (respiratory) 5 follow up visits as of 11/19/13 (albuterol) VENTOLIN and spirometry required.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Ear discomfort
Clinical narrative: Patient stated that about 2 hours after the immunization she started experiencing echoing sensation in her ears when someone was speaking to her. Her symptoms resolved after 1 week.