chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Information was received from a pharmacist who stated that a female patient "received either one or two injections of GARDASIL, intramuscular, about three years ago, then she received another injection on 09-AUG-2012." No known adverse effects. No further information was available. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner refers to an unknown number of patients. The nurse practitioner reported that an unknown number of doses of GARDASIL that were improperly stored at -5 degrees centigrade for 1 to 2 months, may have been administered. No concomitant medications were reported. No adverse effect was reported. It was unknown if the patients sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Age: 35.0
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 35 years old female patient. The patient was inadvertently vaccinated with a 0.5 ml PROQUAD (Lot # reported as H015631, exp 23-FEB-2014) subcutaneously in the left arm on 12-OCT-2012 instead of MMR II. No adverse effects were reported at this time. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Incorrect route of drug administration, Injection site pain
Clinical narrative: This spontaneous report was received from a certified medical assistant refers to a 61 years old female patient who on 11-OCT-2012, was vaccinated subcutaneously with a 0.65 ml dose of ZOSTAVAX (lot number 0468AE, Exp. Date: 04-APR-2013). No other co-suspects were reported. No concomitant medications were reported. It was stated that route of administration was documented as subcutaneous but the patient believed the vaccination was given into her muscle. The patient now, in October 2012, had a sore right arm. No treatment information was reported. At the time of the report, the patient's outcome was unknown. The patient sought medical attention by calling to the office. The relatedness for patient had a sore right arm unknown for ZOSTAVAX. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain in extremity
Clinical narrative: This spontaneous report was received from a certified medical assistant refers to a 61 years old female patient who on 11-OCT-2012, was vaccinated subcutaneously with a 0.65 ml dose of ZOSTAVAX (lot number 0468AE, Exp. Date: 04-APR-2013). No other co-suspects were reported. No concomitant medications were reported. It was stated that route of administration was documented as subcutaneous but the patient believed the vaccination was given into her muscle. The patient now, in October 2012, had a sore right arm. No treatment information was reported. At the time of the report, the patient's outcome was unknown. The patient sought medical attention by calling to the office. The relatedness for patient had a sore right arm unknown for ZOSTAVAX. Additional information has been requested.
Sex: U
Vaccine: RV5
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 and gender. The patient was vaccinated with dose 2 of ROTATEQ (lot number 1807AA; expiry date 29-AUG-2013) on 01-OCT-2012. Dose and route of administration were not reported. The vaccine had been improperly stored (not further specified). No adverse event was reported. The nurse reported 4 other patients who received incorrectly stored ROTATEQ (case IDs 1210USA002302, 1210USA006259, 1210USA006260, and 1210USA006262) and 1 patient who received incorrectly stored M-M-R II (case ID 1210USA006263), all on the same day. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test negative
Clinical narrative: This spontaneous report as received from a consumer refers to a 4 years old female patient. The patient was vaccinated with a dose of VARIVAX (lot #, dose and route not reported) in 2010. No other co-suspects were reported. No concomitant medications were reported. The patient's mother reported that after recent testing on an unknown date, she learned that her daughter had no immunity to chicken pox virus. No treatment information was reported. The outcome of the event was unknown. The relatedness for the event was no provided for VARIVAX. It was unspecified if the patient sought medical attention. The twin brother's event is reported in Case # 1210USA008465. Additional information is not expected.
Sex: U
Vaccine: PPV
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse concerning a patient of unknown age who was inadvertently administered a dose of 1 ml PNEUMOVAX23, IM on 15-OCT-2012. No other co-suspects were reported. No concomitant medications were reported. No adverse effect was reported. Additional information is not expected.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Syringe issue, Underdose
Clinical narrative: This spontaneous report as received from a certified nurse practitioner refers to a patient of unknown age and gender. The patient was vaccinated with first dose of PNEUMOVAX23, intramuscularly, on 11-OCT-2012. No other co-suspects were reported. No concomitant medications were reported. Nurse reported that patient was being administered PNEUMOVAX23 when some of the dose came out of the barrel of the syringe while the needle was in the arm of the patient. No adverse effect reported. Additional information has been requested.
Age: 29.0
Sex: F
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 29 years old female patient. The patient was vaccinated with a dose of M-M-R II (lot # 669017/1250Z) on 12-OCT-2012 that expired on 28-SEP-2012. The patient had not demonstrated or reported any adverse effects. Additional information has been requested.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Back pain, Ear pain, Musculoskeletal chest pain, Neck pain
Clinical narrative: This spontaneous report as received from a consumer refers to her 78 years old husband with no pertinent medical history and no drug reactions or allergies. The patient was vaccinated with a 0.65 ml dose of ZOSTAVAX (Lot # not reported) SQ "4 years ago", in October 2008. No other co-suspects were reported. Concomitant medications included unspecified other medications. The consumer reported that "3 months ago", in July 2012, the patient experienced pain over his right back and ribcage, and on his left neck and ear. The consumer stated that the patient had this pain for 3 months and it currently being treated with acetaminophen, VICODIN for the pain. The treatment was working however the symptoms occurred frequently and especially after eating. There were no Lab diagnosis or studies performed. Additional information is not expected.
Age: 13.0
Sex: U
Vaccine: VARCEL
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse concerning to an approximately 13 years old patient who was vaccinated with an expired 0.5 ml VARIVAX (merck), SQ, right arm, (Lot # 1003Z, Exp 28-JUL-2012) on 15-OCT-2012. No other co-suspects were reported. No concomitant medications were reported. No adverse effects were reported. Additional information has been requested.
Age: 88.0
Sex: M
Vaccine: PPV
Symptoms: Injection site reaction, Soft tissue inflammation
Clinical narrative: This spontaneous report as received from a doctor of pharmacy refers to a 88 years old male patient with codeine, morphine, and penicillin allergy. The patient was vaccinated with a 0.5 ml dose PNEUMOVAX23 (lot # not reported) IM into the right arm on 09-OCT-2012. No other co-suspects were reported. No concomitant medications were reported. On 12-OCT-2012, the patient was evaluated at the emergency room, the patient was diagnosed with moderate inflammatory reaction of the soft tissue at the injection site. No treatment information was reported. The outcome of the event was not reported. The relationship between the event and PNEUMOVAX23 was not reported. Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: This spontaneous report as received from a doctor of pharmacy refers to a 74 years old female patient. The patient was vaccinated with a 0.65 ml dose of ZOSTAVAX (Lot # not reported) SQ on 27-JUN-2011. No other co-suspects were reported. No concomitant medications were reported. The pharmacist reported that "within the last week or two", in approximately September 2012, the patient experienced shingles. The patient received an unspecified antiviral medication. The outcome of shingles was reported as not recovered/not resolved. Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Arthritis, Bursitis
Clinical narrative: This spontaneous reports as received from a doctor of pharmacy refers to a 72 year old female patient. The patient was vaccinated with a 0.5 ml dose of PNEUMOVAX23 (Lot # reported as H01066, exp 02-FEB-2012, route not reported) on 10-OCT-2012. No other co-suspects were reported. No concomitant medications were reported. In October 2012, the patient was evaluated in the emergency room and was diagnosed with severe bursitis and arthritis. The location on of bursitis and arthritis was unknown. No treatment information was reported. The outcome of the events was not reported. The relationship between the events and PNEUMOVAX23 was not reported. This is one of several reports from the same source. 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 registered pharmacist refers that unspecified number of doses of M-M-R II (lot# not reported) that reached 69F for 18 hours may have been administered to the patient on an unspecified date. No adverse event was reported. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report was received from an office manager refers to a 3 patient of unknown ages who on 24-SEP-2012, were vaccinated with a dose of VAQTA (lot number 0271AE) (dose and route not reported) that was improperly stored. No symptoms reported. Attempts are being made to obtain additional information identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available. This is one of several from the same source. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash pruritic, Vaccination failure
Clinical narrative: This spontaneous report as received from a 60 years old female consumer penicillin allergy, tetracycline allergy, morphine allergy and celiac disease reporting on herself. The patient was vaccinated with a dose of ZOSTAVAX (Lot # not reported) on 05-OCT-2012. No other co-suspects were reported. Concomitant medications included antihistamine (unspecified), SYNTHROID, PROTONA and estrogens (unspecified. The consumer reported that on 11-OCT-2012, "six days after receiving the vaccination", she started to see little itchy bumps all over her body and they were increasing. The consumer went back to the pharmacy to show the pharmacist the bumps and they said he had shingles. The patient did not receive treatment for the adverse event. There were no Lab diagnosis or studies performed. At the time of the report, the patient had not recovered. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a doctor of pharmacy refers to a male patient of unknown age. The patient was vaccinated with a dose of ZOSTAVAX (lot #, dose and route not reported) on an unspecified date when the vaccine first became available. No other co-suspects were reported. No concomitant medications were reported. The pharmacist reported that the patient stated he had two mild cases of shingles since he received ZOSTAVAX. The patient sought unspecified medical attention and no treatment information was reported. At the time of the report the patient did not have shingles and the outcome of the event was reported as recovered on an unspecified date. The relatedness for has had two mild cases of shingles was not provided for ZOSTAVAX. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash erythematous, Rash papular, Rash pruritic, Wrong drug administered
Clinical narrative: This spontaneous report was received from a 62 years old female patient concerning herself. The patient's medical history included mycobacterium avium intracellulare lymphadenitis (MAI), obsessive-compulsive disorder (OCD) and migraines. The patient was vaccinated with VARIVAX on 16-AUG-2012. The dose, route and lot number were not provided. No other co-suspects were reported. Concomitant medications included fluvoxamine maleate, topiramate, azithromycin, ethambutol hydrochloride, rifampin, vitamin D (unspecified), VENTOLIN and oyster shell calcium (unspecified).  The patient mentioned she supposedly had the ZOSTAVAX administered on 16-AUG-2012 and on 27-AUG-2012 they called her from the clinic and informed her that they did not have ZOSTAVAX in stock. The patient then told them she had the vaccine administered on 16-AUG-2012 and the nurse told her she did not have the vaccine because they did not have it in stock and contacted pharmacy to call in that prescription and mentioned that they were checking to see if the insurance would cover it. The patient then informed the nurse that she had the vaccine administered on 16-AUG-2012 and was given a print out for the chicken pox vaccine. Physician told her it was the same identical vaccine. The patient called the pharmacy and they confirmed the prescription was on file. The patient did not know if it was ok to have had chicken pox vaccine administered and was concerned because she did not know if it was the same as ZOSTAVAX. The patient mentioned she had been diagnosed with Mycobacterium avium intracellulare lymphadenitis (MAI), and did not know if there would be contraindications. She also mentioned the vaccine was not administered intramuscularly. On 15-OCT-2012, the patient called again and expressed that she was administered (Merck) VARIVAX on 16-AUG-2012 when she wanted to be administered ZOSTAVAX.  Since (Merck) VARIVAX had been administered, the consumer stated that on 27-AUG-2012 she had red spots itched really badly and she developed white bumps on her face. The physician prescribed her Fluocinonide 0.05% cream for the excessive itching. At the time of reporting the patient's outcome was unknown. Additional information is not expected.
Sex: U
Vaccine: RV5
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 and gender. The patient was vaccinated with dose 3 of ROTATEQ oral (lot number 1807AA; expiry date 29-AUG-2013) on 01-OCT-2012. Dose and route of administration were not reported. The vaccine had been improperly stored (not further specified). No adverse event was reported. The nurse reported 4 other patients who received incorrectly stored ROTATEQ oral (case IDs 1210USA002302, 1210USA006259, 1210USA006261, and 1210USA006262) and 1 patient who received incorrectly stored M-M-R II (case ID 1210USA006263), all on the same day. Additional information has been requested.
Age: 3.0
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown gender. The patient was vaccinated with dose 1 of M-M-R II (reported lot number 1769AA; expiry date 10-NOV-2013) on 01-OCT-2012. Dose and route of administration were not reported. The vaccine had been improperly stored (not further specified). No adverse event was reported. The nurse reported 5 patients who received incorrectly stored ROTATEQ oral (case IDs 1210USA002302, 1210USA006259, 1210USA006260, 1210USA006261, and 1210USA006262), all on the same day. Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Eye pain, Keratitis herpetic
Clinical narrative: This spontaneous report was received from a 60 years old male consumer reporting on himself with no pertinent medical history, any history of any eye problems and no drug reactions or allergies, who on 23-APR-2012, was vaccinated with one dose vial of ZOSTAVAX (dose, route and lot number not reported). No other co-suspects were reported. No concomitant medications were reported. The consumer reported that on 26-APR-2012, he had started to have an adverse experience. The consumer's unspecified eye had started to hurt him. The consumer went to his ophthalmologist and he diagnosed him with herpes keratitis. Then, on 07-MAY-2012, the ophthalmologist confirmed that the patient had recurrent herpes simplex virus. Then from May 14th to today, 15-OCT-2012, the consumer had not have any outbreaks of this eye trouble. ZIRGAN was given as a treatment for the experience. No lab diagnostics studies were performed. On 14-MAY-2012, the patient recovered from the experience. The relatedness for patient was diagnosed with herpes keratitis was unknown for ZOSTAVAX. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a physician refers to 2 patients of unknown age. The patients were vaccinated subcutaneously with a 0.65 ml single dose of ZOSTAVAX (lot # not reported) on an unspecified date. No other co-suspects were reported. No concomitant medications were reported. The physician reported that on an unknown date the patient developed shingles subsequent to receiving their vaccination. No treatment information was reported. Both patients improved and the outcome of shingles was reported as recovered. The relatedness for the event was not provided for ZOSTAVAX. Additional information is not expected.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Herpes zoster, Pharyngeal erythema, Pruritus, Scab
Clinical narrative: This spontaneous report was received from a 69 years old female patient concerning herself. The patient's medical history included shingles and allergy to anti-cholesterol drugs. The patient was vaccinated subcutaneously with a 0.65 ml dose of ZOSTAVAX on 06-OCT-2012. No other co-suspects were reported. Concomitant medications included: DETROL. On 07-OCT-2012 the patient developed itching on the ear after receiving ZOSTAVAX. The itching worsened and on 10-OCT-2012 the back of her ear was "crusty" and she had developed a red circle on her throat. The patient was diagnosed with shingles on 10-OCT-2012. The patient sought medical attention. The patient was told by her physician to use CLARITIN, isopropyl alcohol, IVY DRY and an unspecified anti-itch cream as treatment. No laboratory tests were performed. The outcome of shingles was reported as not recovered/not resolved. The relatedness for shingles was unknown for ZOSTAVAX. Additional information has been requested.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Rash
Clinical narrative: This spontaneous report was received from a 78 years old female consumer reporting on herself who on 11-OCT-2012, was vaccinated subcutaneously with a dose ZOSTAVAX (dose and lot number not reported). No other co-suspects were reported. Concomitant medications included estradiol, citalopram and lovastatin (manufacturer unknown). The consumer reported that on 13-OCT-2012, she developed a rash on her left arm and swelling developed at the injection point where ZOSTAVAX was administered. On 14-OCT-2012, the consumer developed a rash on her face. No treatment was given for the experience. At the time of the report, the patient's outcome was unknown. The patient did not seek medical attention. The relatedness for patient developed a rash on her left arm, rash on her face and patient developed swelling at the injection point was unknown for ZOSTAVAX. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: No therapeutic response, Varicella virus test negative
Clinical narrative: This spontaneous report as received from a consumer refers to a 4 years old male patient. The patient was vaccinated with a dose of VARIVAX (merck) (lot #, dose and route not reported) in 2012. No other co-suspects were reported. No concomitant medications were reported. The patient's mother reported that after recent testing on an unknown date, she learned that her son had no immunity to chicken pox virus. No treatment information was reported. The outcome of the event was unknown. The relatedness for the event was not provided for VARIVAX (Merck). It was unspecified if the patient sought medical attention. The twin sister's event is reported in Case # 1210USA007903. Additional information is not expected.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash erythematous
Clinical narrative: This spontaneous report was received from a physician refers to a 81 years old female patient with allergy to penicillin and sulfa who on 11-OCT-2012, was vaccinated subcutaneously on her left arm with a 0.65 ml dose of ZOSTAVAX (lot number H01436). No other co-suspects were reported. Concomitant medications included several medications but physician would not specify which ones. The physician reported that on 12-OCT-2012, the patient developed itching on the right side of her chest which then developed into red bumps and a rash. No treatment information was reported. At the time of the report, the patient had not recovered. The physician thought the expiration date of the vaccine was November 6th but she did not know the year because she could not get her computer to bring up the information. The relatedness for patient developed itching on the right side of her chest, red bumps and a rash was unknown for ZOSTAVAX. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Anxiety, Inappropriate schedule of drug administration, Injection site swelling, Injection site warmth, Insomnia
Clinical narrative: This spontaneous report as received from a registered pharmacist refers to a 66 years old female patient with sulfa drugs allergy. The patient was vaccinated with a 0.5 ml dose of PNEUMOVAX 23 IM into the right deltoid (Lot # not reported) on 10-OCT-2012. No other co-suspects were reported. No concomitant medications were reported. On approximately 10-OCT-2012, "sometime on 10-OCT-2012 or early on 11-OCT-2012", the patient experienced swelling and heat at the injection site and pain in the lower extremity, fever of 100 F, some anxiety, and it was hard to sleep. The pharmacist stated that the patient called her doctor who asked why she got another dose of PNEUMOVAX 23 since she already had a dose in January 2012, so the patient had 2 doses of PNEUMOVAX 23 within 9 months time. No treatment was given for the events although the pharmacist stated comfort measure of compress was recommended. The reporter stated that the patient was feeling a little bit better on 11-OCT-2012. The relationship of the events with PNEUMOVAX 23 was not reported. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: This spontaneous report as received from a registered pharmacist refers to a 66 years old female patient with sulfa drugs allergy. The patient was vaccinated with a 0.5 ml dose of PNEUMOVAX 23 IM into the right deltoid (Lot # not reported) on 10-OCT-2012. No other co-suspects were reported. No concomitant medications were reported. On approximately 10-OCT-2012, "sometime on 10-OCT-2012 or early on 11-OCT-2012", the patient experienced swelling and heat at the injection site and pain in the lower extremity, fever of 100 F, some anxiety, and it was hard to sleep. The pharmacist stated that the patient called her doctor who asked why she got another dose of PNEUMOVAX 23 since she already had a dose in January 2012, so the patient had 2 doses of PNEUMOVAX 23 within 9 months time. No treatment was given for the events although the pharmacist stated comfort measure of compress was recommended. The reporter stated that the patient was feeling a little bit better on 11-OCT-2012. The relationship of the events with PNEUMOVAX 23 was not reported. Additional information has been requested.
Sex: U
Vaccine: RV5
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 and gender. The patient was vaccinated with dose 3 of ROTATEQ (lot number 1807AA; expiry date 29-AUG-2013) on 01-OCT-2012. Dose and route of administration were not reported. The vaccine had been improperly stored (not further specified). No adverse event was reported. The nurse reported 4 other patients who received incorrectly stored ROTATEQ (case IDs 1210USA006259, 1210USA006260, 1210USA006261, and 1210USA006262) and 1 patient who received incorrectly stored MMR II (case ID 1210USA006263), all on the same day. Additional information has been requested.
Sex: U
Vaccine: RV5
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 and gender. The patient was vaccinated with dose 1 of ROTATEQ (lot number 1807AA; expiry date 29-AUG-2013) on 01-OCT-2012. Dose and route of administration were not reported. The vaccine had been improperly stored (not further specified). No adverse event was reported. The nurse reported 4 other patients who received incorrectly stored ROTATEQ (case IDs 1210USA002302, 1210USA006259, 1210USA006260, and 1210USA006261) and 1 patient who received incorrectly stored MMR II (case ID 1210USA006263), all on the same day. Additional information has been requested.
Sex: U
Vaccine: RV5
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 and gender. The patient was vaccinated with dose 2 of ROTATEQ (lot number 1807AA; expiry date 29-AUG-2013) on 01-OCT-2012. Dose and route of administration were not reported. The vaccine had been improperly stored (not further specified). No adverse event was reported. The nurse reported 4 other patients who received incorrectly stored ROTATEQ (case IDs 1210USA002302, 1210USA006260, 1210USA006261, and 1210USA006262) and 1 patient who received incorrectly stored MMR II (case ID 1210USA006263), all on the same day. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Injection site erythema, Injection site swelling, Nausea, Vomiting
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 65 years old female patient. Pertinent medical history was not reported. The patient had no history of drug reactions/allergies. The patient was vaccinated with ZOSTAVAX subcutaneously on 24-SEP-2012. Reported lot number was H011049 with expiry date 05-SEP-2013. No other co-suspects were reported. No concomitant medications were reported. On 25-SEP-2012 the patient experienced redness and swelling at the injection site, nausea, vomiting, lightheadedness, and dizziness. No treatment was given for the events. The patient sought medical attention; she called the reporting pharmacist. At the time of report the patient was recovering. The relatedness per reporter for the events was unknown for ZOSTAVAX. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report was received from a nurse refers to a patient of unknown age who one year after received the first dose of MMR II, on an unknown date, was vaccinated with the second dose of MMR II before he reached age of 4-6 as per prescribing information. No adverse effects were reported. Additional information has been requested.
Age: 53.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Measles post vaccine
Clinical narrative: This spontaneous report was received from a healthcare worker refers to a 53 years old female patient who on 21-SEP-2012, was vaccinated subcutaneously on her left arm with a 0.5 ml dose of MMR II (lot number 0851AA, Exp. Date 03-JUN-2013). No other co-suspects were reported. No concomitant medications were reported. It was reported that two weeks after receiving a dose of MMR II, on approximately 05-OCT-2012, the patient was diagnosed with measles. No treatment information was reported. At the time of the report, the patient recovered (date not provided). The patient received MMR II because it was an employment requirement. The relatedness for the patient was diagnosed with measles was unknown for MMR II. Additional information has been requested.
Age: 53.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Chills, Laboratory test abnormal, Malaise, Measles antibody positive, Measles post vaccine
Clinical narrative: This spontaneous report was received from a healthcare worker refers to a 53 years old female patient who on 21-SEP-2012, was vaccinated subcutaneously on her left arm with a 0.5 ml dose of MMR II (lot number 0851AA, Exp. Date 03-JUN-2013). No other co-suspects were reported. No concomitant medications were reported. It was reported that two weeks after receiving a dose of MMR II, on approximately 05-OCT-2012, the patient was diagnosed with measles. No treatment information was reported. At the time of the report, the patient recovered (date not provided). The patient received MMR II because it was an employment requirement. The relatedness for the patient was diagnosed with measles was unknown for MMR II. Additional information has been requested.
Age: 53.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Mumps antibody test negative, Polymerase chain reaction, Pyrexia, Rash generalised, Rubella antibody negative
Clinical narrative: This spontaneous report was received from a healthcare worker refers to a 53 years old female patient who on 21-SEP-2012, was vaccinated subcutaneously on her left arm with a 0.5 ml dose of MMR II (lot number 0851AA, Exp. Date 03-JUN-2013). No other co-suspects were reported. No concomitant medications were reported. It was reported that two weeks after receiving a dose of MMR II, on approximately 05-OCT-2012, the patient was diagnosed with measles. No treatment information was reported. At the time of the report, the patient recovered (date not provided). The patient received MMR II because it was an employment requirement. The relatedness for the patient was diagnosed with measles was unknown for MMR II. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Expired drug administered
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient was vaccinated with an expired dose of PEDVAXHIB on 02-OCT-2012. Route was not reported. Lot # was 666299/1515Y with an expiry date of 27-SEP-2012. No symptoms were reported. Additional information is not expected.
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity
Clinical narrative: This spontaneous report as received from a doctor of pharmacy refers to a female patient of unknown age. The patient was vaccinated with a dose of PNEUMOVAX 23 (dose, route and lot # not reported) in her shoulder joint on 09-OCT-2012. No other co-suspects were reported. There was no concomitant medications. On 09-OCT-2012, the patient had a sore arm. There was no treatment given for the event. The patient did not seek medical attention. There was no lab diagnostic/studies performed. The outcome of the event was reported as recovered. The relationship between the event and PNEUMOVAX 23 was not reported. Additional information is not expected.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site erythema, Injection site swelling, Rash
Clinical narrative: This spontaneous report was received from a healthcare worker regarding a 61 year old female patient. On 11-SEP-2012, the patient was vaccinated with 0.65 ml ZOSTAVAX subcutaneous injection, lot # (0240AE), expiration date 15-MAR-2013. Concomitant medications were not reported. On 17-SEP-2012, the patient was redness around the eyes and a skin rash. It was reported at this appointment she also complained of redness and swelling at the ZOSTAVAX injection site. There was no treatment given for the events. The outcome of the events were unknown. The patient sought unspecified medical attention (through an office visit). Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age without drug reactions or allergies. The patient has medical history of shingles. The patient was vaccinated with ZOSTAVAX (lot number, dose and injection site were not reported) intramuscular on 15-OCT-2012. No other co-suspects were reported. No concomitant medications were reported. On 15-OCT-2012 the patient received ZOSTAVAX via intramuscular route and felt little sore at the injection site. There was no treatment given for adverse events and no laboratory diagnostics study performed. The patient was not recovered at the time of report. The patient had seen the pharmacist for medical attention. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash
Clinical narrative: This spontaneous report was received from a doctor of pharmacy regarding two female patients of unknown age. On an unknown date, the patient were vaccinated with 0.65 ml ZOSTAVAX subcutaneously (lot number was not reported). No concomitant medications were reported. On an unknown date, the patient received ZOSTAVAX and got a rash at injection site that was itchy and a red patch, no treatment was given. The patient sought medical attention (visit to pharmacy). On an unknown date, the patient recovered from the events. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue, Herpes zoster, Pain
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a patient of unknown age and gender with a history of chickenpox as child. On unspecified date around 2010, the patient was vaccinated subcutaneously on left deltoid with ZOSTAVAX (lot# and dose information were unknown). The patient developed herpes zoster on 13-AUG-2012. No rash occurred at the site of injection. Lesions were located at left anterior and posterior chest wall, and lesions were too numerous to count. It took 25 days for rash to resolve. The patient's max temperature was 98.0. Pain was quantified as 9. Other systemic symptom included fatigue. There was no recent exposure to chickenpox or herpes zoster. There was no direct fluorescent antibody done. There was no specimen collected for PCR. On an unknown date, the patient  recovered. This is one of several reports received from the same source (1209USA002361, 1210USA004890). Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: Decreased appetite, Fatigue, Herpes zoster, Pain, Painful respiration
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a patient of unknown age and gender with a history of chickenpox as child. On unspecified date around 2006, the patient was vaccinated subcutaneously with ZOSTAVAX (lot# and dose information were unknown). The patient developed herpes zoster on 05-SEP-2012. No rash occurred at the site of injection. Lesions were located at right anterior and posterior chest wall, and lesions were too numerous to count. It took 20 days for rash to resolve. The patient's max temperature was 97.9. Pain was quantified as 8. Other systemic symptoms included fatigue, no appetite, and pain with inspiration. There was no recent exposure to chickenpox or herpes zoster. There was no direct fluorescent antibody done. There was no specimen collected for PCR. On an unspecified date, the patient recovered. This is one of several reports received from the same source (1209USA002361, 1210USA004891). Additional information is not expected.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. The patient was vaccinated with ZOSTAVAX (lot number, dose and injection site were not reported) by subcutaneous injection in June 2008. No other co-suspects were reported. No concomitant medications were reported. In June 2008 (also reported as the patient later had an outbreak in July 2012) the patient experienced broke out with herpes zoster on the face. The rash did clear up but the pain still exist. The patient was given prescription included VALTREX, prednisone, NEURONTIN, ATIVAN, LIDODERM, acetaminophen, VICODIN, erythromycin. The outcome was unknown at the time of report. The patient had sought unspecified medical attention. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Diarrhoea
Clinical narrative: This spontaneous report as received from a registered nurse refers to a child of unknown age. On an unknown date, the patient was vaccinated with a dose of ROTATEQ (dose, route, lot number not reported). No other co-suspects were reported. No concomitant medications were reported. On an unknown date, the patient developed severe diarrhea after receiving a dose of ROTATEQ. No treatment information was reported. At the time of the report, the patient's outcome of severe diarrhea was unknown. The relatedness for severe diarrhea was not reported for ROTATEQ. It was unknown if the patient sought medical attention. Additional information is not expected.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a registered pharmacist refers to a 76 years old male patient with drug reactions/allergies of niacin and with a prior history of shingles (date of shingles was unspecified, but prior to vaccination with ZOSTAVAX). The patient was vaccinated with a dose of ZOSTAVAX (route, dose and lot# not reported) about 3 years ago, about in 2009. There was no concomitant therapy. Recently (about a week to 10 days ago) on approximately 29-SEP-2012 the patient felt like he was having another case of shingles. There was no treatment given for the AE. There was no lab diagnostics studies performed. At the time of reporting, the outcome of the patient was unknown. The patient sought medical attention by contacting the pharmacist. Additional information has been requested.
Age: 70.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Rash
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 70 years old male patient with no pertinent medical history and no drug reactions/allergies. The patient was vaccinated with ZOSTAVAX (lot number: H011049, expiration date: 05-SEP-2013) on 10-OCT-2012. There were no concomitant medications. The patient developed rash behind both knees and on the left shoulder following vaccination with ZOSTAVAX. The rashes were described as dime size on 15-OCT-2012. The patient did not remember exactly when the rash developed. The patient had contacted pharmacist for medical attention. No treatment or laboratory diagnostics studies were given. The outcome of rash was reported as not recovered/not resolved.  Additional information is not expected.
Age: 70.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Varicella
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 70 years old male patient with no pertinent medical history and no drug reactions/allergies. The patient was vaccinated with ZOSTAVAX (lot number: H011049, expiration date: 05-SEP-2013) on 10-OCT-2012. There were no concomitant medications. The patient developed rash behind both knees and on the left shoulder following vaccination with ZOSTAVAX. The rashes were described as dime size on 15-OCT-2012. The patient did not remember exactly when the rash developed. The patient had contacted pharmacist for medical attention. No treatment or laboratory diagnostics studies were given. The outcome of rash was reported as not recovered/not resolved.  Additional information is not expected.
Age: 70.0
Sex: M
Vaccine: PPV
Symptoms: Expired drug administered
Clinical narrative: This spontaneous report was received from a pharmacist concerning a 70 year old male patient. On 17-SEP-2012, the patient was vaccinated with an expired dose of 0.5 milliliter PNEUMOVAX 23, intramuscularly. Lot number was reported as 669579/0595AA and the expiry date was reported as 30-AUG-2012. No concomitant medications were reported. No other adverse effect was reported. Additional information has been requested.
Age: 43.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Case number PHEH2012US020422, is an initial spontaneous report received from a health care professional on 17 Oct 2012. This report refers to an adult female patient. Her medical history included allergy to egg white. Concomitant medications included NEXIUM, fluoxetine and PROAIR. She was vaccinated with FLUVIRIN (batch number: 12242P), at a dose of 0.5 ml, intramuscular, into the left deltoid, on 24 Sep 2012. On an unspecified date post vaccination the patient experienced left upper arm swelling with pain and redness, diagnosed as cellulitis. Event outcome, seriousness and causality were not reported.
Age: 43.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Case number PHEH2012US020422, is an initial spontaneous report received from a health care professional on 17 Oct 2012. This report refers to an adult female patient. Her medical history included allergy to egg white. Concomitant medications included NEXIUM, fluoxetine and PROAIR. She was vaccinated with FLUVIRIN (batch number: 12242P), at a dose of 0.5 ml, intramuscular, into the left deltoid, on 24 Sep 2012. On an unspecified date post vaccination the patient experienced left upper arm swelling with pain and redness, diagnosed as cellulitis. Event outcome, seriousness and causality were not reported.
Age: 46.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Asthenia, Hypersensitivity, Pain, Rash, Syncope
Clinical narrative: Case number PHEH2012US020530, is an initial spontaneous report received from a nurse on 17 Oct 2012. This report refers to an adult female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 1205001), intramuscular on 05 Oct 2012. It was reported that, the nurse withdrew dose of FLUVIRIN from MDV into plastic syringes for a time period of 1 minute to a maximum of 30 minutes prior to patient administration. The patient was hospitalized from 09 Oct 2012 until 13 Oct 2012 for weakness, body aches, hypotension with blood pressure 70/40 mmHg, fainting and a rash (unspecified). The patient returned to work on 15 Oct 2012. The attending physician told her that the cause of hospitalization was most likely due to the administration of flu vaccine that was stored at room temperature. Event and outcome and causality assessment was not reported.
Age: 46.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Asthenia, Hypotension, Incorrect storage of drug, Pain, Rash
Clinical narrative: Case number PHEH2012US020530, is an initial spontaneous report received from a nurse on 17 Oct 2012. This report refers to an adult female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 1205001), intramuscular on 05 Oct 2012. It was reported that, the nurse withdrew dose of FLUVIRIN from MDV into plastic syringes for a time period of 1 minute to a maximum of 30 minutes prior to patient administration. The patient was hospitalized from 09 Oct 2012 until 13 Oct 2012 for weakness, body aches, hypotension with blood pressure 70/40 mmHg, fainting and a rash (unspecified). The patient returned to work on 15 Oct 2012. The attending physician told her that the cause of hospitalization was most likely due to the administration of flu vaccine that was stored at room temperature. Event and outcome and causality assessment was not reported.
Age: 46.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Syncope
Clinical narrative: Case number PHEH2012US020530, is an initial spontaneous report received from a nurse on 17 Oct 2012. This report refers to an adult female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 1205001), intramuscular on 05 Oct 2012. It was reported that, the nurse withdrew dose of FLUVIRIN from MDV into plastic syringes for a time period of 1 minute to a maximum of 30 minutes prior to patient administration. The patient was hospitalized from 09 Oct 2012 until 13 Oct 2012 for weakness, body aches, hypotension with blood pressure 70/40 mmHg, fainting and a rash (unspecified). The patient returned to work on 15 Oct 2012. The attending physician told her that the cause of hospitalization was most likely due to the administration of flu vaccine that was stored at room temperature. Event and outcome and causality assessment was not reported.
Age: 51.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Anaphylactic reaction, Confusional state, Hyperhidrosis, Swollen tongue, Tongue discolouration
Clinical narrative: This patient has received the flu vaccine every year. Within 15 min of the vaccine this year he became diaphoretic, extremely shaky, and confused. His blood pressure went to 150/100 and was afebrile. Within another 5-10 min his tongue became discolored and enlarged. This patient was rushed to the ER where his vitals were BP 185/100, O2 93%, P 85. Epinephrine, BENADRYL, steroids, and PEPCID were administered for an anaphylactic reaction. He was kept for 2 hrs for observation to ensure the medications were effective and that there were no further adverse reactions.
Age: 51.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Tremor
Clinical narrative: This patient has received the flu vaccine every year. Within 15 min of the vaccine this year he became diaphoretic, extremely shaky, and confused. His blood pressure went to 150/100 and was afebrile. Within another 5-10 min his tongue became discolored and enlarged. This patient was rushed to the ER where his vitals were BP 185/100, O2 93%, P 85. Epinephrine, BENADRYL, steroids, and PEPCID were administered for an anaphylactic reaction. He was kept for 2 hrs for observation to ensure the medications were effective and that there were no further adverse reactions.
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Syncope, Urticaria
Clinical narrative: Case number PHEH2012US020393, is an initial spontaneous report received from a consumer on 17 Oct 2012. This report refers to a male patient of unknown age. His medical history and concomitant medications were not reported. He was vaccinated with FLUVIRIN (batch number: unknown) on an unspecified date. On an unspecified date post vaccination the patient passed out. Later the patient was fine, so not pursuing any legal action. The final outcome of the event was condition improving, seriousness and causality of the event was not reported.
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Loss of consciousness
Clinical narrative: Case number PHEH2012US020393, is an initial spontaneous report received from a consumer on 17 Oct 2012. This report refers to a male patient of unknown age. His medical history and concomitant medications were not reported. He was vaccinated with FLUVIRIN (batch number: unknown) on an unspecified date. On an unspecified date post vaccination the patient passed out. Later the patient was fine, so not pursuing any legal action. The final outcome of the event was condition improving, seriousness and causality of the event was not reported.