chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, VARCEL
Symptoms: Cellulitis, Culture negative
Clinical narrative: Cellulitis developed 56 hr after vaccine administration.
Age: 40.0
Sex: F
Vaccine: MMR
Symptoms: Dizziness, Heart rate increased
Clinical narrative: Patient called clinic to report dizziness and a fast heartbeat after receiving MMR vaccine. Advised patient to report to Emergency Room if symptoms worsen.
Age: 13.0
Sex: F
Vaccine: FLU3, HPV4
Symptoms: Body temperature increased, Feeling cold, Nausea, Pallor, Paraesthesia
Clinical narrative: 10am on 10/22/12 vaccinated arm hurt did not go back to school. 11am 10/22/12 felt cold, was pale, ibuprofen given. By 4:30pm pt nauseous and vomiting, index finger (left) 4th finger (right) feeling cold; all fingers left hand tingly. Bad headache all over head. Temp 103.3 at 6:30pm.
Age: 13.0
Sex: F
Vaccine: FLU3, HPV4
Symptoms: Peripheral coldness, Urine analysis normal, Vaccination site pain, Vomiting
Clinical narrative: 10am on 10/22/12 vaccinated arm hurt did not go back to school. 11am 10/22/12 felt cold, was pale, ibuprofen given. By 4:30pm pt nauseous and vomiting, index finger (left) 4th finger (right) feeling cold; all fingers left hand tingly. Bad headache all over head. Temp 103.3 at 6:30pm.
Age: 50.0
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 50's plus years old female patient. The patient was vaccinated with PROQUAD (lot #, dose and route were unknown) instead of ZOSTAVAX today (on 11-OCT-2012). No other co-suspects were reported. No concomitant medications were reported. Pharmacist states error only, when occurred at the local clinic. No adverse effects reported. At the report time the outcome of event was unknown. It was unknown if the patient sought medical attention. Additional information is not expected.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Smear cervix abnormal
Clinical narrative: This spontaneous report as received from a physician refers to an approximately 22 years old female patient. The patient was vaccinated when she was 14 years old with a dose of GARDASIL (lot #, dose and route not reported) on an unspecified date and was vaccinated with dose 2 of GARDASIL (lot #, dose and route not reported) on 18-OCT-2012, No other co-suspects were reported. No concomitant medications were reported. The physician reported that the patient had a positive PAP smear about 6 months ago (approximately in April 2012). A repeat PAP smear performed about 3 weeks ago (approximately in September 2012) was negative. No treatment was given for the event. The relatedness for positive PAP smear was not provided for GARDASIL. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 7 years old and 11 month old female patient. On unknown dates, the patient received 3 doses of GARDASIL (dose, route and lot # not reported) when she was 7 year 11 month, 8 year 2 months, and 8 year and 4 month old when the patient was in a different country. The name of the country was unknown. No concomitant medication was reported. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered pharmacist refers to an unknown number of patients. The reporter stated that improperly stored GARDASIL (lot number, dose and route not reported) may have been administered to patients. The reporter had no information how many doses were administered that were improperly stored. The improperly stored GARDASIL, may have been administered from 24-AUG-2012 to 01-OCT-2012. No adverse event reported. This case is linked to case reports 1210USA010099 and 1210USA010100 (same reporter link; same event also reported for other vaccines). Additional information has been requested.
Age: 41.0
Sex: F
Vaccine: HPV4
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 41 years old female patient. On 11-OCT-2012 the patient was inadvertently administered intramuscularly an expired dose of GARDASIL (lot # 666162/0565Z, expiration date 15-SEP-2012). It was not known which dose in the GARDASIL vaccination schedule this was. No adverse event was reported. It was unspecified whether the patient sought for medical attention. The outcome was unknown. Additional information has been requested.
Age: 13.0
Sex: M
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a registered nurse concerning a patient of unknown age and gender, who on 28-MAR-2012, was vaccinated with the first dose of GARDASIL (dose, route and lot # not reported), on 30-MAY-2012 the patient received the second dose of GARDASIL (dose, route and lot # not reported) and the third dose of GARDASIL (dose, route and lot # not reported) on 20-JUN-2012. The patient was not experiencing any known symptoms. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Expired drug administered
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a patient of unknown age (no details provided). Information regarding medical history was not provided. On 15-OCT-2012 the patient was vaccinated with ROTATEQ (lot number, dose number and route not provided). No other co-suspects were reported. No concomitant medications were reported. On 15-OCT-2012 the patient was administered an expired dose: the dose of ROTATEQ had expired on 03-OCT-2012. No treatment information was reported. Additional information has been requested.
Age: 0.29
Sex: M
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse refers to a 15 week old male patient. On approximately 10-JUL-2012, the patient was vaccinated with the first dose of ROTATEQ (lot # not reported) which was taken orally (dose 1 tube). No concomitant medications were reported. No adverse effect has been observed or reported. The nurse had informed her representative who had told her that she would take care of reporting the administration of ROTATEQ vaccine outside of the Prescribing Information (PI). Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On an unknown date in 2007 the patient was vaccinated with dose 1 GARDASIL (lot # not reported), dose and route not reported. On an unknown date in 2007 the patient was vaccinated with dose 2 GARDASIL (lot # not reported), dose and route not reported. No concomitant medications were reported. The nurse stated that patient was in the office on 25-SEP-2012 to receive the third dose of GARDASIL (lot # not reported), dose and route not reported. No adverse event reported. No other information to report. Additional information is not expected.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Malaise, Nasopharyngitis
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 66 years old female patient with drug induced lupus, anxiety and hypertension. The patient's medical history included muscle spasms. The patient had none drug allergies. On 03-OCT-2012 the patient was vaccinated subcutaneously with a dose of 0.65 ml ZOSTAVAX (lot # reported as H01132, expiration date reported as 08-SEP-2013). The pharmacist stated that the patient was taking prednisone, PLAQUENIL, and IMURAN, when she received ZOSTAVAX, and may also have been taking VALTREX at that time. The pharmacist reported that he received a call on 12-OCT-2012, from the patient who reported that she was "not feeling well" and felt like she might be getting a cold or the flu. No treatment was given. Lab diagnostics studies performed were reported as none. The outcome was reported as not recovered. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Rash
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 64 year old female patient with no medical history and no allergies. The patient was vaccinated with ZOSTAVAX (lot # was unknown) in December 2011. No concomitant therapy included. The pharmacist reported that patient was diagnosed with cellulitis for rash she had after receiving ZOSTAVAX back in December 2011. The patient saw physician for medical attention. The outcome of the adverse events was unknown. Additional information has been requested.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Cough, HIV infection, HIV test positive, Hyperhidrosis, Lethargy
Clinical narrative: This spontaneous report was received from a Doctor of pharmacy refers to an approximately 54 year old female patient. On 11-SEP-2012, the patient was vaccinated with a dose of ZOSTAVAX. Concomitant medications were not reported. On unknown date the patient was diagnosed with HIV. At the time the patient received ZOSTAVAX she did not know that she was positive for HIV. On an unknown date, the patient experienced "cold symptoms" of sweating, coughing, and lethargy. The reporter was unaware when these symptoms started or if the patient had communicated her receipt of ZOSTAVAX or her current symptoms to her primary physician. No treatment was reported. The patient sought medical attention (consulted pharmacist). At the time of this report the events were reported as not recovered. Additional information has been requested.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Nasopharyngitis
Clinical narrative: This spontaneous report was received from a Doctor of pharmacy refers to an approximately 54 year old female patient. On 11-SEP-2012, the patient was vaccinated with a dose of ZOSTAVAX. Concomitant medications were not reported. On unknown date the patient was diagnosed with HIV. At the time the patient received ZOSTAVAX she did not know that she was positive for HIV. On an unknown date, the patient experienced "cold symptoms" of sweating, coughing, and lethargy. The reporter was unaware when these symptoms started or if the patient had communicated her receipt of ZOSTAVAX or her current symptoms to her primary physician. No treatment was reported. The patient sought medical attention (consulted pharmacist). At the time of this report the events were reported as not recovered. Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Acne, Injection site reaction
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 73 year old female patient with no drug reactions or allergies. The patient was vaccinated with a dose of PNEUMOVAX 23 3 months ago in July 2012 (lot#, dose and route not reported). No other co-suspects were reported. No concomitant medications were reported. In 2012 the patient experienced an injection site reaction that looked like "a raised pimple with a dot in the middle". The entire affected area was about 7 or 8 mm wide. There was no pain at the site. No treatment was given to the patient. No laboratory diagnostic studies were performed. The patient had not contacted her physician about the event, she had visited a pharmacy. The outcome of the event was reported as not recovered/not resolved. The relatedness for the event was unknown for PNEUMOVAX 23. Additional information has been requested.
Age: 17.0
Sex: U
Vaccine: VARZOS
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 17 year old patient. The reporter reported that the patient was inadvertently vaccinated with ZOSTAVAX (SQ, 0.65 ml) (lot# was unknown) on 10-OCT-2012. No adverse effect was reported. It was unspecified if the patient sought medical attention. Additional information is not expected.
Sex: M
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a male patient of unknown age. The patient was vaccinated with a dose of PNEUMOVAX 23, (lot number was reported as 0595AA, expiration date 30-AUG-2012) on 26-SEP-2012. Concomitant medications were not reported. No adverse event was reported. This is one of the reports received from the same reporter. Additional information has been requested.
Age: 48.0
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Rash pustular, Rash vesicular, Skin lesion, Varicella post vaccine
Clinical narrative: This spontaneous report as received from a physician refers to a 48 year old male patient. The patient's medical history included bone marrow transplant 5 years ago. The patient was vaccinated with 0.5 ml  (Merck) VARIVAX (lot# unspecified) subcutaneously on 26-SEP-2012 with no concomitant medications. No other co-suspects were reported. on 17-OCT-2012, the patient was diagnosed with widespread varicella. The patient had widely distributed lesions of varying stages. Some lesions were papular/pustular with an erythematosus base and some lesions were vesicular. The patient had been prescribed VALTREX. The outcome of widespread varicella was reported as recovering. The patient had sought medical attention via office visit. Additional information is not expected.
Sex: F
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a female patient of unknown age. The patient was vaccinated with a dose of PNEUMOVAX 23, (lot number was reported as 0595AA, expiration date 30-AUG-2012) on 26-SEP-2012). Concomitant medications were not reported. No adverse event was reported. this is one of the reports received from the same reporter. Additional information has been requested.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Injection site anaesthesia
Clinical narrative: This spontaneous report was received from a doctor of pharmacy refers to a 59-year-old female patient. Current condition included allergic to sulfa drugs. The patient was vaccinated with, 0.65 milliliter ZOSTAVAX (lot  #0566AE, expiration date 01-APR-2013) (validation request sent) subcutaneously once on 17-SEP-2012. Concomitant medications included FLEXERIL, SYNTHROID and NAMENDA. Pharmacist reported that on 17-SEP-2012 the patient experienced numbness from the injection site down to the fingers, on her right arm after she was administered the ZOSTAVAX. Pharmacist advised the patient to call back if there was no improvement. The patient had not called back. Treatment was not given for the event. It was unspecified whether medical attention was sought by the patient. The outcome of the event was unknown. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Oedema peripheral
Clinical narrative: This spontaneous report as received from a medical assistant refers to a now 97 years old female patient with diabetes and no drug allergy. The patient was vaccinated with PNEUMOVAX 23 (lot# unspecified) years ago (unspecified date). No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient experienced swelling of the arm. No treatment information was reported. The outcome of swelling of the arm was reported as recovered. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered pharmacist refers to an unknown number of patients. The reporter stated that improperly stored VAQTA (lot number, dose and route not reported) may have been administered to patients. The reporter had no information how many doses were administered that were improperly stored. The improperly stored VAQTA may have been administered from 24-AUG-2012 to 01-OCT-2012. No adverse event reported. This case is linked to case reports 1210USA001745 and 1210USA010099 (same reporter link; same event also reported for other vaccines). Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to a patient of unknown age and gender. On 16-SEP-2011 the patient was vaccinated with dose 1 of VAQTA (lot # not reported). No concomitant medications were reported. The health care worker stated that patient received two doses of VAQTA one each on 16-SEP-2011 and dose 2 VAQTA (lot # not reported) on 15-DEC-2011. No adverse effects reported. No further information available. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Accidental exposure, No adverse event, Product quality issue
Clinical narrative: This spontaneous report as received from a female pharmacist of unknown age concerning herself. The pharmacist called to report of topical skin exposure and eye exposure to herself after some reconstituted ZOSTAVAX (lot# was unknown) sprayed out during withdrawing of the solution in a syringe on 16-OCT-2012. No adverse effect reported. PQC filed. Additional information is not expected.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a doctor of pharmacy refers to a patient of unknown age and gender. On an unknown date in September 2012 (reported as past week) the patient was vaccinated with PNEUMOVAX 23 injection (lot # not reported, expiration date unspecified), unspecified dose. No concomitant medications were reported. The pharmacist reported that an unspecified patient received an expired dose of PNEUMOVAX 23 on an unspecified date in the past week (approximately on an unknown date in September 2012). No adverse effect reported. No further information is available. Additional information has been requested.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Facial pain, Headache, Herpes zoster, Hypertension
Clinical narrative: This spontaneous report as received from a pharmacist refers to her 56 years old mother with penicillin allergy, neomycin allergy, pork allergy, hypercholesterolemia and hypertension. The patient was vaccinated with a dose ZOSTAVAX on 24-SEP-2012. No other co-suspects were reported. Concomitant medications included: DIOVAN. On 25-SEP-2012, the patient experienced increased blood pressure, red, raised area at the injection site and headache within 24 hours of administration of ZOSTAVAX on 24-SEP-2012. The injection site reaction was resolved and the hypertension was controlled by adjustment the dosage of the patient's DIOVAN. The patient continued to have headache as well as dull, persistent pain on one side of her face, extending into the hairline. This had been diagnosed as a shingles-like pain by the patient's unspecified physician. There were no lesions. No further information was provided. The outcome of increased blood pressure, shingles-like pain, headache and red, raised area at the injection site was unknown for ZOSTAVAX. Additional information has been requested.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to her 56 years old mother with penicillin allergy, neomycin allergy, pork allergy, hypercholesterolemia and hypertension. The patient was vaccinated with a dose ZOSTAVAX on 24-SEP-2012. No other co-suspects were reported. Concomitant medications included: DIOVAN. On 25-SEP-2012, the patient experienced increased blood pressure, red, raised area at the injection site and headache within 24 hours of administration of ZOSTAVAX on 24-SEP-2012. The injection site reaction was resolved and the hypertension was controlled by adjustment the dosage of the patient's DIOVAN. The patient continued to have headache as well as dull, persistent pain on one side of her face, extending into the hairline. This had been diagnosed as a shingles-like pain by the patient's unspecified physician. There were no lesions. No further information was provided. The outcome of increased blood pressure, shingles-like pain, headache and red, raised area at the injection site was unknown for ZOSTAVAX. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Erythema, Immediate post-injection reaction, Irritability, Swelling
Clinical narrative: This spontaneous report was received from a physician purchasing agent via a company representative concerning two patients of unknown age and gender (query pending). On an unknown date, patients were vaccinated with single dose of 0.5 milliliter PNEUMOVAX23, intramuscularly. No concomitant medications were reported. On an unknown date, immediately after the vaccination in the office, both the patients experienced redness, puffiness and became irritable. The physician questioned regarding the lot and requested for lot check. The physician wanted a replacement of that lot. The outcome of redness, puffiness and became irritable was unknown. The relatedness for redness, puffiness and became irritable was unknown for PNEUMOVAX23. This is one of the two reports from the same reporter. Additional information has been requested.
Age: 0.51
Sex: M
Vaccine: HIBV, IPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a physician refers to a patient of unknown age (gender unspecified). On 28-SEP-2012, the patient was vaccinated with a dose of expired PEDVAXHIB (lot # reported as 666243/1617Y, expiry 23-SEP-2012, route not reported). No concomitant medications were reported. No adverse effects were reported. Additional information has been requested.
Age: 46.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to 46-year-old patient of unknown gender. On 23-SEP-2012 the patient was vaccinated with a dose of 0.5 milliliters (ml) PNEUMOVAX23 lot # (667915/1111Z, expiration date 02-MAR-2012) intramuscularly. No concomitant medications were reported. On 23-SEP-2012 the patient was administered expired dose of PNEUMOVAX23. No adverse effects reported. No further information is available. This was 1 of 2 cases being reported by the pharmacist regarding expired dose of PNEUMOVAX23 administered to a patient. This is one of several reports from the same source. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV, VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a doctor of pharmacy refers to an approximately 68-year-old patient of unknown gender. On 23-SEP-2012 the patient was vaccinated with a dose of 0.5 milliliters (ml) PNEUMOVAX23 lot # (667915/1111Z, expiration date 02-MAR-2012) intramuscularly. No concomitant medications were reported. On 23-SEP-2012 the patient was administered expired dose of PNEUMOVAX23. No adverse effects reported. No further information is available. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a registered pharmacist refers to a patient of unknown age and gender. The pharmacist reported that the patient was vaccinated with VARIVAX subcutaneous (SC) on 19-OCT-2012 (lot not reported) instead of ZOSTAVAX. No other co-suspects were reported. No concomitant medications were reported. The pharmacist discovered the mistake right after administration of the (Merck) VARIVAX. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered pharmacist refers to a patient of unknown age. The patient was vaccinated intramuscularly with an expired dose of lot # (669579/0595AA: exp date 30-AUG-2012) of PNEUMOVAX 23 (dose not reported) on 18-OCT-2012. No other co-suspects were reported. No concomitant medications were reported. No adverse effects were reported. Additional information has been requested.
Age: 54.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site erythema, Injection site mass, Injection site swelling, Rash vesicular
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 54 years old female patient with intermittent bronchitis, carcinoma, abnormal blood pressure and no known drug allergies. The patient's medical history included hysterectomy for uterine cancer. The patient was vaccinated subcutaneously in the right deltoid with lot # (672428/1599AA), 0.65 ml dose of ZOSTAVAX on 16-OCT-2012. No other co-suspects were reported. Concomitant medications included an unspecified blood pressure medication. The registered nurse reported that within 24 hours of receipt of the dose the patient contacted the nurse and reported that she was experiencing redness, swelling and lumpiness of the injection site, her right deltoid. On 18-OCT-2012 the patient appeared to be developing a vesicular rash. The patient was given BENADRYL and was applied cold compresses as treatment for the events. No lab diagnostic tests were performed. At the time of the report the injection site appeared to be worsening. The relatedness for vesicular rash, lumpiness, swelling and redness of the injection site was not provided for ZOSTAVAX. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered pharmacist refers to an unknown number of patients. The reporter stated that improperly stored RECOMBIVAX HB (lot number, dose and route not reported) may have been administered to patients. The reporter had no information how many doses were administered that were improperly stored. The improperly stored  RECOMBIVAX HB may have been administered from 24-AUG-2012 to 01-OCT-2012. No adverse event reported. This case is linked to case reports 1210USA001745 and 1210USA010100 (same reporter link; same event also reported for other vaccines). Additional information has been requested.
Age: 68.0
Sex: M
Vaccine: VARZOS
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 11-SEP-2012 the patient was vaccinated with a dose of ZOSTAVAX (lot # 671004/0729AA; Exp Date 17-AUG-2012) which was expired on 17-AUG-2012. Pharmacist stated that no adverse effects reported that she knew of. It was unknown if the patient sought medical attention. Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Rash, Rash vesicular
Clinical narrative: This spontaneous report as received from a 73 years old female consumer refers to herself. The patient was vaccinated with ZOSTAVAX (lot number, dose, route not reported) on an unknown date. No other co-suspects were reported. no concomitant medications were reported. On an unknown date the patient developed smallpox like rash in her arm and small round blisters. It was unspecified if the patient had sought medical attention. No treatment information was reported. The outcome of small round blisters and smallpox like rash was unknown. Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Diarrhoea, Discomfort, Headache
Clinical narrative: This spontaneous report as received from a 73 years old female consumer refers to herself. The patient was vaccinated with ZOSTAVAX (lot number, dose, route not reported) on an unknown date. No other co-suspects were reported. no concomitant medications were reported. On an unknown date the patient developed smallpox like rash in her arm and small round blisters. It was unspecified if the patient had sought medical attention. No treatment information was reported. The outcome of small round blisters and smallpox like rash was unknown. Additional information has been requested.
Age: 0.13
Sex: F
Vaccine: DTPPHIB, PPV
Symptoms: Computerised tomogram head, Cyanosis, Dyspnoea, Electrocardiogram, Electroencephalogram
Clinical narrative: Loss of consciousness, was unresponsive and had abnormal breathing, cyanosis and pallor. Eyes closed. Had first episode at home child was brought to pediatrician second episode happened and pediatrician had patient taken may ambulance to Hospital.
Age: 0.13
Sex: F
Vaccine: DTPPHIB, PPV
Symptoms: Loss of consciousness, Lumbar puncture, Pallor, Unresponsive to stimuli, X-ray
Clinical narrative: Loss of consciousness, was unresponsive and had abnormal breathing, cyanosis and pallor. Eyes closed. Had first episode at home child was brought to pediatrician second episode happened and pediatrician had patient taken may ambulance to Hospital.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from doctor of pharmacy refers to a 62 years old female patient with AUGMENTIN and sulfa allergy. The patient was vaccinated with, 0.65 ml ZOSTAVAX subcutaneously in the back of the left arm on 07-SEP-2012 (lot number reported as 0073AE and expiry date reported as 03-APR-2013). No other co-suspects were reported. No concomitant medications were reported. On 07-SEP-2012 the patient experienced injection site reaction that was red, warm and little tender all the way down the whole back of the arm. No treatment was given for the event. The patient has sought medical attention and visited to the pharmacy. No laboratory diagnostic studies was performed. The outcome of the event was reported as not recovered. The relatedness for the event was unknown for ZOSTAVAX. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Injection site warmth
Clinical narrative: This spontaneous report as received from doctor of pharmacy refers to a 62 years old female patient with AUGMENTIN and sulfa allergy. The patient was vaccinated with, 0.65 ml ZOSTAVAX subcutaneously in the back of the left arm on 07-SEP-2012 (lot number reported as 0073AE and expiry date reported as 03-APR-2013). No other co-suspects were reported. No concomitant medications were reported. On 07-SEP-2012 the patient experienced injection site reaction that was red, warm and little tender all the way down the whole back of the arm. No treatment was given for the event. The patient has sought medical attention and visited to the pharmacy. No laboratory diagnostic studies was performed. The outcome of the event was reported as not recovered. The relatedness for the event was unknown for ZOSTAVAX. Additional information has been requested.
Age: 29.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Erythema, Oedema peripheral, Pain in extremity, Paraesthesia, Skin warm
Clinical narrative: Bruising, swelling, itchy, irritated skin on right arm. Lasted over a week.
Age: 29.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Contusion, Pruritus, Skin irritation, Swelling
Clinical narrative: Bruising, swelling, itchy, irritated skin on right arm. Lasted over a week.
Age: 5.0
Sex: M
Vaccine: FLUN3, FLUN3
Symptoms: Asthenia, Dizziness, Pallor, Presyncope, Sluggishness
Clinical narrative: A report has been received from a Health Professional concerning a 5 year old, male patient. No relevant history and concomitant medication was provided. The patient received nasal FLUMIST on 09-Oct-2012. Patient received FLUMIST, and immediately after fainted in mother's arms. Transported to emergency room. Low blood pressure and low heart rate. Epinephrine was administered at time of reaction. Had 3 previous influenza vaccinations with TIV with no reaction. First FLUMIST vaccination. The outcome of the event of patient fainted, low blood pressure and low heart rate is unknown. According to the company physician the assessment of the Serious criteria for the report was as follows: Important medical event.
Age: 5.0
Sex: M
Vaccine: FLUN3, FLUN3
Symptoms: Heart rate decreased, Hypotension, Immediate post-injection reaction, Syncope
Clinical narrative: A report has been received from a Health Professional concerning a 5 year old, male patient. No relevant history and concomitant medication was provided. The patient received nasal FLUMIST on 09-Oct-2012. Patient received FLUMIST, and immediately after fainted in mother's arms. Transported to emergency room. Low blood pressure and low heart rate. Epinephrine was administered at time of reaction. Had 3 previous influenza vaccinations with TIV with no reaction. First FLUMIST vaccination. The outcome of the event of patient fainted, low blood pressure and low heart rate is unknown. According to the company physician the assessment of the Serious criteria for the report was as follows: Important medical event.
Age: 83.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Back pain, Musculoskeletal stiffness, Neck pain, Pain in extremity, Paraesthesia
Clinical narrative: Initial report was received from consumer, who was also the patient, on 12 October 2012. An 84-year-old female patient had received an intramuscular injection in the left deltoid of FLUZONE HIGH-DOSE, lot number not reported, on 31 August 2012. Two days after vaccination on 02 September 2012, the patient began having neck stiffness, neck was tender to touch and pain moved down her left side, which felt like it was in the tissue and muscle, not the joints. The patient was also in constant pain, had a hard time getting out of bed, was very fatigued and her left arm at the deltoid area was still tender to touch. The patient was diagnosed with Polymyalgia Rheumatica and put on a course of prednisone. The patient had x-rays done and they were negative. The patient had no illness at the time of vaccination and a history of seasonal allergies. The patient's outcome was not recovered. Documents held by sender: None.
Age: 83.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Activities of daily living impaired, Fatigue, Injection site pain, Musculoskeletal stiffness, Myalgia
Clinical narrative: Initial report was received from consumer, who was also the patient, on 12 October 2012. An 84-year-old female patient had received an intramuscular injection in the left deltoid of FLUZONE HIGH-DOSE, lot number not reported, on 31 August 2012. Two days after vaccination on 02 September 2012, the patient began having neck stiffness, neck was tender to touch and pain moved down her left side, which felt like it was in the tissue and muscle, not the joints. The patient was also in constant pain, had a hard time getting out of bed, was very fatigued and her left arm at the deltoid area was still tender to touch. The patient was diagnosed with Polymyalgia Rheumatica and put on a course of prednisone. The patient had x-rays done and they were negative. The patient had no illness at the time of vaccination and a history of seasonal allergies. The patient's outcome was not recovered. Documents held by sender: None.
Age: 83.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Pain, Polymyalgia rheumatica, Tenderness, X-ray normal
Clinical narrative: Initial report was received from consumer, who was also the patient, on 12 October 2012. An 84-year-old female patient had received an intramuscular injection in the left deltoid of FLUZONE HIGH-DOSE, lot number not reported, on 31 August 2012. Two days after vaccination on 02 September 2012, the patient began having neck stiffness, neck was tender to touch and pain moved down her left side, which felt like it was in the tissue and muscle, not the joints. The patient was also in constant pain, had a hard time getting out of bed, was very fatigued and her left arm at the deltoid area was still tender to touch. The patient was diagnosed with Polymyalgia Rheumatica and put on a course of prednisone. The patient had x-rays done and they were negative. The patient had no illness at the time of vaccination and a history of seasonal allergies. The patient's outcome was not recovered. Documents held by sender: None.
Age: 80.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Diarrhoea, Hyperhidrosis, Vomiting
Clinical narrative: Severe malaise, vomiting, diarrhea, chills/hot, uncontrolled tremors & body shaking. Dizziness, inability to walk, trouble controlling body movement, requiring hospitalization.
Age: 80.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Abasia, Blood test normal, Chills, Diarrhoea, Dizziness
Clinical narrative: Severe malaise, vomiting, diarrhea, chills/hot, uncontrolled tremors & body shaking. Dizziness, inability to walk, trouble controlling body movement, requiring hospitalization.
Age: 80.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Dyskinesia, Feeling hot, Laboratory test normal, Malaise, Tremor
Clinical narrative: Severe malaise, vomiting, diarrhea, chills/hot, uncontrolled tremors & body shaking. Dizziness, inability to walk, trouble controlling body movement, requiring hospitalization.
Age: 80.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Urine analysis normal, Vomiting, X-ray normal
Clinical narrative: Severe malaise, vomiting, diarrhea, chills/hot, uncontrolled tremors & body shaking. Dizziness, inability to walk, trouble controlling body movement, requiring hospitalization.
Age: 36.0
Sex: F
Vaccine: FLU3, PPV, TDAP, FLU3, PPV, TDAP
Symptoms: Haematoma, Pain in extremity, Palpitations, Tenderness
Clinical narrative: Patient developed right upper arm pain and swelling within six hours of her immunizations. She had increasing pain for two days and was seen in clinic on 10/15/12 and was sent to ER. She had swelling and exquisite pain in the right upper arm. US showed fluid in the soft tissues below the deltoid muscle. Patient was treated with prednisone and hydrocodone and heat. Fever 102.
Age: 36.0
Sex: F
Vaccine: FLU3, PPV, TDAP, FLU3, PPV, TDAP
Symptoms: Injection site pain, Injection site swelling, Pyrexia, Soft tissue disorder, Ultrasound scan abnormal
Clinical narrative: Patient developed right upper arm pain and swelling within six hours of her immunizations. She had increasing pain for two days and was seen in clinic on 10/15/12 and was sent to ER. She had swelling and exquisite pain in the right upper arm. US showed fluid in the soft tissues below the deltoid muscle. Patient was treated with prednisone and hydrocodone and heat. Fever 102.
Age: 50.0
Sex: M
Vaccine: FLU3, VARZOS, VARZOS
Symptoms: Erythema, Local swelling, Pain, Tenderness
Clinical narrative: This spontaneous report was received from a 50 years old male patient with no pertinent medical history and no drug reaction/allergy. The patient was vaccinated with ZOSTAVAX subcutaneously on 03-OCT-2012. Lot# was unspecified for he was recommended to take it. Concomitant medications included baby aspirin and PROPECIA. On 13-OCT-2012, "approximately 10 days after receiving ZOSTAVAX", the patient developed a hot, red, swollen, painful and raised area "about the size of a softball" above the injection site. No treatment was given. No lab diagnostic study performed. The outcome of patient was reported as recovering/resolving. The patient sought medical attention via office visit to physician. Additional information is not expected.
Age: 50.0
Sex: M
Vaccine: FLU3, VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report was received from a 50 years old male patient with no pertinent medical history and no drug reaction/allergy. The patient was vaccinated with ZOSTAVAX subcutaneously on 03-OCT-2012. Lot# was unspecified for he was recommended to take it. Concomitant medications included baby aspirin and PROPECIA. On 13-OCT-2012, "approximately 10 days after receiving ZOSTAVAX", the patient developed a hot, red, swollen, painful and raised area "about the size of a softball" above the injection site. No treatment was given. No lab diagnostic study performed. The outcome of patient was reported as recovering/resolving. The patient sought medical attention via office visit to physician. Additional information is not expected.
Age: 58.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Muscular weakness, Pain
Clinical narrative: Pain in my left arm where the flu shot was administered.  Feel stabbing pain when moving or raising my left arm.  The pain is near where the shot was given. Feel pain in the left arm/shoulder when I sleep on my left side. I have started to take Celebrex for this pain on 10/22/2012 as prescibed by Dr.
Age: 58.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injection site pain, Musculoskeletal pain, Pain, Tenderness
Clinical narrative: Pain in my left arm where the flu shot was administered.  Feel stabbing pain when moving or raising my left arm.  The pain is near where the shot was given. Feel pain in the left arm/shoulder when I sleep on my left side. I have started to take Celebrex for this pain on 10/22/2012 as prescibed by Dr.
Age: 42.0
Sex: M
Vaccine: FLU3
Symptoms: Hypoaesthesia, Immediate post-injection reaction, Injection site pain, Injection site pruritus, Injection site reaction
Clinical narrative: Instantaneous burning and pain during injection. Numbness, tingling and weakness in arm to wrist x 3 days. Itchy welt at injection site size of silver dollar x 5 days. Pain at injection site ongoing.
Age: 42.0
Sex: M
Vaccine: FLU3
Symptoms: Muscular weakness, Paraesthesia, Urticaria
Clinical narrative: Instantaneous burning and pain during injection. Numbness, tingling and weakness in arm to wrist x 3 days. Itchy welt at injection site size of silver dollar x 5 days. Pain at injection site ongoing.
Age: 45.0
Sex: F
Vaccine: FLUN3
Symptoms: Asthenia, Chills, Cough, Decreased appetite, Fatigue
Clinical narrative: Nose irritation, runny nose, Sneezing, painful coughing, sore chest and lungs, awful headache, extremely tired and weak, cold chills, loss of appetite.
Age: 45.0
Sex: F
Vaccine: FLUN3
Symptoms: Headache, Musculoskeletal chest pain, Nasal discomfort, Rhinorrhoea, Sneezing
Clinical narrative: Nose irritation, runny nose, Sneezing, painful coughing, sore chest and lungs, awful headache, extremely tired and weak, cold chills, loss of appetite.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Guillain-Barre syndrome
Clinical narrative: This spontaneous report as received from a physician refers to a 26 years old female patient. The patient was vaccinated with the second dose of GARDASIL. Lot # and route were no reported. In early September 2012, the patient developed Guillain Barre after receiving her second dose of GARDASIL. It was unspecified whether the patient received her second dose on time, and it was indicated that the patient would not be receiving a third dose. The patient was hospitalized in unspecified hospital. Unspecified treatment was given for the events. The outcome of Guillain Barre was reported as recovering/resolving. Additional information has been requested.
Age: 30.0
Sex: F
Vaccine: FLUN3
Symptoms: Asthenia, Chills, Cough, Decreased appetite, Diarrhoea
Clinical narrative: Nose irritation and swelling, runny nose, Sneezing, coughing, headache, extremely tired and weak, chills, loss of appetite. Diarrhea.
Age: 30.0
Sex: F
Vaccine: FLUN3
Symptoms: Fatigue, Headache, Nasal discomfort, Rhinorrhoea, Sneezing
Clinical narrative: Nose irritation and swelling, runny nose, Sneezing, coughing, headache, extremely tired and weak, chills, loss of appetite. Diarrhea.
Age: 30.0
Sex: F
Vaccine: FLUN3
Symptoms: Swelling
Clinical narrative: Nose irritation and swelling, runny nose, Sneezing, coughing, headache, extremely tired and weak, chills, loss of appetite. Diarrhea.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Feeling abnormal, Feeling hot, Headache, Hypoaesthesia, Malaise
Clinical narrative: Client received vaccines on 10/23/12 am.  About 2:30 am on 10/24/12 patient awoke and complained of being hot, his head felt "funny" and had a headache, said his legs felt "funny" like he couldn't feel them.  He was able to walk to his aunt's bedroom.  She gave him extra strength Tylenol at about 3:30 am.  Patient then took a warm bath because his legs were still feeling "funny".  He went back to bed after his bath and fell asleep.  He woke at 6:30 am for school but was still not feeling well so he stayed home.  He now feels nauseated.  His aunt said that his legs are feeling better as is his head.  He is still hot and generally not feeling well.  Explained to his aunt that he needs to be seen by a physician.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Nausea
Clinical narrative: Client received vaccines on 10/23/12 am.  About 2:30 am on 10/24/12 patient awoke and complained of being hot, his head felt "funny" and had a headache, said his legs felt "funny" like he couldn't feel them.  He was able to walk to his aunt's bedroom.  She gave him extra strength Tylenol at about 3:30 am.  Patient then took a warm bath because his legs were still feeling "funny".  He went back to bed after his bath and fell asleep.  He woke at 6:30 am for school but was still not feeling well so he stayed home.  He now feels nauseated.  His aunt said that his legs are feeling better as is his head.  He is still hot and generally not feeling well.  Explained to his aunt that he needs to be seen by a physician.
Age: 16.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Hives began as small spots around 8:30 pm.  Benadryl was given.  Hives grew to cover much of her arms, legs and torso by morning.  Benadryl continued as prescribed.  Hives persisted for several days.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: C-reactive protein normal, Full blood count normal, Hypoaesthesia, Laboratory test normal, Muscular weakness
Clinical narrative: Right Lower extremity aching that progressed to bilateral Lower extremity tingling and numbness with physical exam changes the morning following the administration of the flu vaccine.  Later that day (10/16/2012), weakness of right lower extremity developed and numbness/tingling progressed to bilateral hands.  I went to the Emergeny Room, where physical exam showed R foot weakness and changes in sensory exam of bilateral lower extremities (right foot worse than left foot).
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity, Paraesthesia, Red blood cell sedimentation rate normal, Sensory disturbance, Spinal X-ray normal
Clinical narrative: Right Lower extremity aching that progressed to bilateral Lower extremity tingling and numbness with physical exam changes the morning following the administration of the flu vaccine.  Later that day (10/16/2012), weakness of right lower extremity developed and numbness/tingling progressed to bilateral hands.  I went to the Emergeny Room, where physical exam showed R foot weakness and changes in sensory exam of bilateral lower extremities (right foot worse than left foot).
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Acoustic stimulation tests, Ear tube insertion, Sudden hearing loss
Clinical narrative: Sudden hearing loss, left ear - Z-PACK - decongestant - steroid nose spray (NASONEX) (1 week) Prednisone (2 weeks). Tube in ear for (5 steroid treatments in ear).
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Deafness
Clinical narrative: Sudden hearing loss, left ear - Z-PACK - decongestant - steroid nose spray (NASONEX) (1 week) Prednisone (2 weeks). Tube in ear for (5 steroid treatments in ear).
Age: 5.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Cough, Injection site swelling, Injection site warmth, Pneumonia, Pyrexia
Clinical narrative: Arm very warm & swollen. Fever, cough. Pneumonia (hospitalized).
Age: 5.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: X-ray
Clinical narrative: Arm very warm & swollen. Fever, cough. Pneumonia (hospitalized).