chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a Medical Assistant refers to a female patient of unknown age. It was reported that the patient received GARDASIL on 20-SEP-2011 and 09-NOV-2011 and was in the office to receive her third dose today on 19-OCT-2012. No adverse symptoms reported. No treatment information was reported. The outcome was unknown. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal discomfort
Clinical narrative: This spontaneous report was received from a registered nurse concerning a 25 years old female patient who on an unknown date was vaccinated with a dose of GARDASIL, intramuscular (lot # 16288A, expiration date on 21-JUN-2014). On 24-FEB-2012, the patient suffered from an upset stomach after receiving the GARDASIL. At the time of the report, the event outcome was unknown. The relatedness for the event was unknown for GARDASIL. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from an Office Manager refers to unknown number of patients of unknown age. It was reported that since approximately 05-SEP-2012, doses of improperly stored GARDASIL might have been administered to patients (doses, route and lot numbers not reported). The vaccine was exposed to 24F for more than two excursions since 05-SEP-2012, the exact period of time that the vaccines were exposed to 24F is uncertain at this time, but the number of excursions totaled more than 2. This is one of several reports received from the same source (MARRS # 1210USA013248, 1210USA013249, 1210USA013250). Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Lymphadenopathy, Swelling face
Clinical narrative: This spontaneous report was received from a doctor of pharmacy concerning to an unspecified patient of unknown age and gender. On an unknown date, the patient was vaccinated with the first dose of GARDASIL. No other co-suspects were reported. No concomitant medications were reported. On an unknown date, the patient experienced facial swelling and lymph nodes enlarged after received GARDASIL. On an unknown date, the patient recovered from facial swelling and lymph nodes enlarged. The relationship between the events and GARDASIL was not reported. Additional information has been requested.
Age: 0.18
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Tongue discolouration
Clinical narrative: This spontaneous report as received from a physician refers to a 2 months old female patient. The patient was vaccinated with dose 1, 2 ml ROTATEQ on 27-SEP-2012 (Lot # not reported). No other co-suspects were reported. Concomitant medications included PENTACEL, PREVNAR 13 and vitamin D (unspecified). No allergies were reported. On an unknown date in 2012 the patient experienced black tongue. The physician stated that he knows that pink colored liquids can sometimes cause a black tongue. No treatment information was reported. The outcome of black tongue was reported as not recovered/not resolved. The relatedness for black tongue was unknown for ROTATEQ. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to a patient of unknown age and gender. The patient was vaccinated with expired dose 2 GARDASIL (lot # 666121/1778Y) expiration date 19-AUG-2012) (dose and route not reported) on 28-SEP-2012. No concomitant medications were reported. The patient was not experiencing any known symptoms. No further information is available. Additional information has been requested.
Age: 0.34
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 concerning to a 17 weeks old male patient. On 22-OCT-2012, the patient was vaccinated with the first dose, of 0.2 ml ROTATEQ (lot not reported). No other co-suspects were reported. No concomitant medications were reported. No adverse effect reported. Additional information has been requested.
Sex: M
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a male patient of unknown age. The patient was vaccinated with a dose of GARDASIL (lot # 672652/0022AE; expiry date 28-SEP-2014) on 15-OCT-2012. Route was unknown. No other co-suspects were reported. No concomitant medications were reported. On 15-OCT-2012 the patient received GARDASIL that was improperly stored at 28 F for 8.5 hours. No adverse effect was reported. This is 1 of 2 cases from the same source (other case number 1210USA008284). Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a patient of unknown age. The patient was intramuscularly vaccinated with 0.5 ml expired dose of GARDASIL (lot # 666598/0786, exp date 18-OCT-2012) on 22-OCT-2012 for patient's third dose. No adverse effects reported. Additional information is not expected.
Age: 68.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Induration, Injected limb mobility decreased, Oedema peripheral, Pain in extremity
Clinical narrative: This spontaneous report as received from a 68 years old female patient with no drug allergy, high cholesterol and high blood pressure refers to herself. The patient was vaccinated with ZOSTAVAX (lot#unknown) and PNEUMOVAX 23 (lot# unknown) concomitantly in the same arm on 17-SEP-2012. Concomitant medications included ZETIA, levothyroxine sodium and losartan potassium. On 17-SEP-2012 the patient experienced her arm was swollen and hard. The reporter mentioned her arm was painful and difficult to move. BENADRYL was reported as treatment information. The patient sought medical attention by spoken with pharmacist and no lab information for the event. The outcome was reported as recovered on an unknown date. Additional information has been requested.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 76 years old male patient with no drug allergy and a concurrent condition of high blood pressure. The patient was vaccinated with a dose of ZOSTAVAX on approximately 03-OCT-2012 (reported as "last week"). Concomitant medications were unspecified high blood pressure medication. On 08-OCT-2012 the patient noticed rash around groin area and was experiencing pain. The patient came into the office on 09-OCT-2012 and was seen by the physician who confirmed diagnosis of shingles. Patient sought medical attention and VALTREX and VICODIN were given to patient as treatment. There was no lab diagnostics performed. The outcome of shingles was reported as not recovered/not resolved. Additional information has been requested.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Blood count, Injection site cellulitis, Injection site erythema, Injection site swelling, Laboratory test
Clinical narrative: This spontaneous report as received from a office manager refers to a 67 years old male patient. Pertinent medical history, Drug reactions and allergies were reported as none. On 19-SEP-2012, the patient was vaccinated with PNEUMOVAX 23 0.5 milliliter (ml) intramuscularly once. Dose number was unspecified. Lot number was 0225AE and expiry date was 03-JUN-2013. Concomitant medications included lovastatin and LUMIGAN. Approximately on 19-SEP-2012, the patient experienced redness and swelling at the injection site after he was administered PNEUMOVAX 23 on 19-SEP-2012. BENADRYL was not effective. The patient was seen in the emergency room on 21-SEP-2012 and blood count and blood chemistry tests were performed (results were not specified). Then the patient was diagnosed with cellulitis and was treated with CLEOCIN and piperacillin and ZOSYN. The patient was not admitted but was only seen in the physician's office on 25-SEP-2012 and the injection site was improving. The outcome of cellulitis was reported as recovering/resolving. This is one of several reports from the same source (MARSS#12010USA000140, MARSS# 1210USA012892): Additional information has been requested.
Age: 75.0
Sex: F
Vaccine: TTOX, VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age (gender not specified). On 12-OCT-2012, the patient was inadvertently administered an expired dose of ZOSTAVAX, lot number 671596/1056AA, exp. date 05-OCT-2012 (dose and route not reported). No other co-suspects were reported. No concomitant medications were reported. No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Injection site inflammation, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. On 15-OCT-2012, the patient was vaccinated with PNEUMOVAX 23 (dose, route of administration and lot was not provided). No concomitant medications were reported. The pharmacist stated that on 15-OCT-2012 an unspecified patient, who received a dose of PNEUMOVAX 23, returned to the pharmacy on 18-OCT-2012, with a large inflamed area at the injection site that was swollen and hot to the touch. The patient sought medical attention. The outcome of adverse events was reported as not recovered/not resolved. The relatedness for adverse events was unknown for PNEUMOVAX 23. Additional information has been requested.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Expired drug administered
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age (gender not reported). On 19-OCT-2012, the patient was inadvertently administered an expired dose of ZOSTAVAX, lot number 671596/1056AA, exp. date 02-OCT-2012 (dose and route not reported). No other co-suspects were reported. No concomitant medications were reported. No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered
Clinical narrative: This spontaneous report as received from a physician refers to a patent of unknown age (gender not reported). On 19-OCT-2012, the patient was inadvertently administered an expired dose of ZOSTAVAX, lot number 671596/1056AA, exp. date 02-OCT-2012 (dose and route not reported). No other co-suspects were reported. No concomitant medications were reported. No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a registered pharmacist concerning a 63 year old female patient. On 12-OCT-2012, the patient was vaccinated with a 0.65 ml dose of ZOSTAVAX, just one shot (route and dose was not reported) (lot # 672675/0068AE; Expiration date: 03-APR-2013). On 12-OCT-2012 the patient developed a red, swollen, hot area at the injection site, after the ZOSTAVAX was administered. It was reported that the patient events lasted for 4 or 5 days and then resolved. At the time of the report, the patient had recovered from all of the events. The relatedness for red area at the injection site, hot area at the injection site and swollen area at the injection site was unknown for ZOSTAVAX. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a registered nurse refers to a patient of unknown age and gender. On 19-SEP-2012, the patient received a dose of (Merck) VARIVAX subcutaneously (lot # not reported) in error. No concomitant medications were reported. No adverse effects was reported. Additional information has been requested.
Age: 0.5
Sex: U
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a 5 months old patient. The patient was vaccinated intramuscularly with first dose of 0.5 ml pediatric VAQTA (lot number not reported) on 25-OCT-2012. No other co-suspects were reported. No concomitant medication were reported. The patient was not experiencing any known symptoms. It was unspecified if the patient sought medical attention. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacy intern refers to an unspecified number of patients. The pharmacy intern reported that a clinic was improperly storing PNEUMOVAX 23 for over one month. It was possible that the improperly stored PNEUMOVAX 23 was administered to an unspecified number of patients but the pharmacy intern was not sure. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Eye pain, Injection site pain, Injection site warmth
Clinical narrative: This spontaneous report as received from a 66 years old female consumer with no pertinent medical history or drug reactions/allergies, reporting on herself. The patient was vaccinated with a 0.5 ml dose of PNEUMOVAX 23 (dose #, and lot not reported) subcutaneously or intramuscularly on 22-OCT-2012. Concomitant medications included: unspecified heart medications, "FLEXIX", lovastatin and omeprazole. On 22-OCT-2012, at night, her injection site arm was hot and sore. On the next day, it was still sore and hot, her temperature was 99.8 degrees. The soreness moved toward elbow, exhibiting a sunburn appearance. Her elbow felt tight and sore, and the patient also had eye pain. On 24-OCT-2012, her temperature was 99.5 degrees. The patient called the pharmacist for medical attention. The patient self medicated with over the count TYLENOL. There were no labs/diagnostic studies performed. The outcome of the events was reported as not recovered. The relationship between PNEUMOVAX 23 and the events was not reported. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a 74 years old female consumer reporting on herself with codeine allergy and no pertinent medical history. The patient was vaccinated with a dose of ZOSTAVAX (Lot number and dose) SQ in approximately February 2008, 4.5 years ago. No other co-suspects were reported. The patient took unspecified medication for blood pressure and gout; she also took vitamin D (unspecified) and PAXIL. Consumer reported that she had developed a shingles outbreak that started on 26-JUN-2012, 2 weeks ago, after having had the vaccine 4.5 years ago. No Labs Diagnostics were performed. The patient was treated with prednisone, gabapentin, unspecified narcotic and valacyclovir for shingles. At the time of report, the patient's outcome was unknown. The patient sought unspecified medical attention. The relatedness for shingles outbreak was unknown for ZOSTAVAX. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from an Office Manager refers to unknown number of patients of unknown age. It was reported that since approximately 05-SEP-2012, doses of improperly stored VAQTA might have been administered to patients (doses, route and lot numbers not reported). The vaccine was exposed to 24F for more than two excursions since 05-SEP-2012, the exact period of time that the vaccines were exposed to 24F is uncertain at this time, but the number of excursions totaled more than 2. This is one of several reports received from the same reporter (MARRS # 1210USA002523, 1210USA013248, 1210USA013250). Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from an Office Manager refers to unknown of patients of unknown age. It was reported that since approximately 05-SEP-2012, doses of improperly stored RECOBIVAX HB might have been administered to patients (doses, route and lot numbers not reported). The vaccine was exposed to 24F for more than two excursions since 05-SEP-2012, the exact period of time that vaccines were exposed to 24F is uncertain at this time, but the number of excursions totaled more than 2. This is one of several reports received from the same reporter (MARRS # 1210USA002523, 1210USA013249, 1210USA013250). Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Extensive swelling of vaccinated limb, Injection site warmth
Clinical narrative: This spontaneous report was received from a female nurse of unknown age via a company representative concerning herself. The patient's medical history included chemotherapy. On an unknown date in December 2011, the patient was vaccinated with a single dose of 0.5 ml PNEUMOVAX23 (lot # not reported). No concomitant medications were reported. On an unknown date in December 2011, while on PNEUMOVAX23 the patient arm was very hot around the injection site. There was massive swelling from her neck to her arm and wrist. The patient sought Medical Attention(unspecified). No treatment information was reported. This swelling cleared in about one week. On an unspecified date, the patient had recovered from the events. Additional information is not expected.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from an Office Manager refers to unknown number of patients of unknown age. It was reported that since approximately 05-SEP-2012, doses of improperly PNEUMOVAX 23 might have been administered to patients (doses, route and lot numbers not reported. The vaccine was exposed to 24F for more than two excursions since 05-SEP-2012, the exact period of time that the vaccine was exposed to 24F is uncertain at this time, but the number of excursions totaled more than 2. This is one several reports received from the same reporter (MARRS # 1210USA002523, 1210USA013248, 1210USA13249). Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. The patient was vaccinated with an expired dose of PNEUMOVAX 23 on 23-OCT-2012 (lot# 669776/0614AA; expiration date 27-SEP-2012; dose and route not reported). No other co-suspects were reported. No concomitant medications were reported. No adverse symptoms were reported. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. The patient was vaccinated with dose 1 PNEUMOVAX 23. No other co-suspects were reported. No concomitant medications were reported. The pharmacist reported that a patient told him she had an injection-site reaction after receiving PNEUMOVAX 23 sometime last year. The patient stated she developed redness and a rash at the injection site. She was treated with prednisone. The outcome of redness at the injection site and rash at the injection site was reported as recovered/resolved. The relatedness for redness at the injection site and rash at the injection site is unknown for PNEUMOVAX 23. The pharmacist was busy and not able to answer further questions. Additional information has been requested.
Age: 34.0
Sex: F
Vaccine: VARZOS
Symptoms: Drug administered to patient of inappropriate age, Human chorionic gonadotropin positive, Maternal exposure before pregnancy, Viral test positive
Clinical narrative: Information has been received from a physician, for ZOSTAVAX (Merck), a Pregnancy Registry product, concerning a 34 year old female study participant in a clinical study with no medical history and no drug reactions/allergies who on 23-AUG-2011 was subcutaneously vaccinated with a 0.65 ml dose of ZOSTAVAX (Merck) (lot # 669746/0356AA, exp:09-JUN-2012). Concomitant therapy included OXY ELITE PRO, GNC WOMENS ULTRA MEGA ACTIVE and TONALIN CLA. The reporter stated that the patient participated in a non Merck clinical study received ZOSTAVAX (Merck) and was pregnant. The patient was given a urine pregnancy test on 23-AUG-2011 before ZOSTAVAX (Merck) vaccination and it was negative. The patient was told not to be pregnant at least 3 months after vaccination with ZOSTAVAX (Merck). The patient did a urine pregnancy test at home on 26-JAN-2012 that was positive but the patient did not follow up with an obstetrician until the end of March, 2012. An unspecified obstetrician did an ultrasound end of March, 2012 an estimated LMP was 23-DEC-2011 and due date was 28-SEP-2012. Physician reported patient did have 2 children, had a 'VZV serology that was positive which was an inclusion criteria for the study" and having a "pregnancy that qualifies as normal". Additional information has been requested. Update (10-OCT-2012): follow-up information received from the reporting physician. The physician informed that the patient delivered a healthy baby girl on 28-SEP-2012 and left the hospital about 48 hours later. No additional information was provided.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from an 83 year old female registered nurse, concerning herself. Early in 2000, the patient was vaccinated with a dose of ZOSTAVAX (dose, route and frequency were not reported) (Lot # and expiration date were not reported). In the summer of 2010, the patient broke out with a moderately-severe case of shingles, which lasted 9 months (in approximately 2010). The patient sought unspecified medical attention. Unspecified medication was given for the event as she did not recall what they gave her. At the time of the report, the patient's outcome of broke out with a moderately severe case of shingles was recovered. The relatedness for broke out with a moderately severe case of shingles was unknown for ZOSTAVAX. Additional information has been requested.
Age: 37.0
Sex: F
Vaccine: VARCEL
Symptoms: Blister, Pruritus generalised, Varicella post vaccine
Clinical narrative: Information has been received from a healthcare worker, concerning a 37 year old female patient with allergy to penicillin. The patient had no pertinent medical history. On 01-OCT-2012, the patient was vaccinated with a dose of VARIVAX (Merck), subcutaneous (dose was not reported) (Lot #: G007060; expiration date: 24-FEB-2014). There were no concomitant medications reported. On 14-OCT-2012, the patient developed chickenpox, after receiving VARIVAX (Merck). Healthcare worker stated that patient developed itchy vesicles all over the body. The patient sought medical attention through office call. No treatment was given for the event. No lab diagnostic studies were performed. At the time of the report, the patient's outcome for chickenpox was reported as not recovered/not resolved. The relatedness for chickenpox was unknown for VARIVAX (Merck). Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. The patient was vaccinated with 1st of 0.5 ml VARIVAX (Merck), (lot number was not reported), subcutaneously on an unknown date in 1998 and the second dose of VARIVAX (Merck), on an unknown date in 2010. Concomitant medications were not reported. No adverse effects were reported. 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 pharmacist refers to a patient of unknown age (gender unspecified). On 01-OCT-2012, the patient was vaccinated with a dose of expired PNEUMOVAX 23 (lot #669579/0595AA, expiry 30-AUG-2012, route-not reported). No concomitant medications were reported. No adverse effect were reported. Additional information has been requested.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Injection site streaking
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 67 years old male patient. The patient had none pertinent medical history. The patient had none drug allergies. "A couple of years ago" the patient was vaccinated with his one and only dose of PNEUMOVAX 23 (lot # not reported). Concomitant medications were reported as none. It was reported that "the next day" after the vaccination the patient developed red streaks down the arm where the vaccine was administered. The patient sought for unspecified medical attention and was treated with outpatient antibiotics. Lab diagnostics studies performed were reported as none. The present patient status was recovered. Additional information has been requested.
Age: 0.08
Sex: U
Vaccine: HEP
Symptoms: Oedema peripheral, Rash erythematous, Rash generalised
Clinical narrative: This spontaneous report was received from a registered nurse refers to a 1 month old patient with no pertinent medical history and no drug allergy. On 19-SEP-2012, the patient was vaccinated intramuscularly with 0.5 ml RECOMBIVAX HB (Lot # reported as 0293AE, expiry 01-SEP-2014). There was no concomitant medication. On 20-SEP-2012, a day after vaccination with RECOMBIVAX HB the patient experienced bilateral hands and feet swelling, with a head to toe fine red rash. The patient sought medical attention and was evaluated in the office. No treatment has been prescribed at the time of the report. No laboratory test was done. The outcome of events was reported as not recovered. The nurse has requested a lot check. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 73.0
Sex: M
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 73 year old patient of unknown gender. On 28-SEP-2012, the patient was vaccinated with a dose of PNEUMOVAX 23 (lot number was reported as 0595AA expiration date 30-AUG-2012). Concomitant medications were not reported. The reporter stated that the patient received PNEUMOVAX 23 on 28-SEP-2012 that had expired on 30-AUG-2012. The patient did not have a prior history of vaccination with PNEUMOVAX 23. No adverse event was reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Flushing
Clinical narrative: This spontaneous report was received from a physician refers to a 61 year old male patient. On 06-SEP-2011, the patient was vaccinated with a single dose of 0.65 ml ZOSTAVAX subcutaneous injection, (lot number reported as 669866/0360AA, expiration date as 09-SEP-2012, Batch number 9989115). Concomitant medications included CRESTOR, hydrochlorothiazide, HYZAAR, omeprazole and VERAMYST spray. In December 2011 ("3 months after the vaccination was initiated"), the patient experienced flushing from head to trunk lasting 3 hours in duration several times per week. Though the symptoms had subsided in the last 6 to 9 months (approximately January or April 2012)< but had not stopped completely. The outcome of the event was reported as recovering at the time of this report. The patient sought medical attention (office visit). Additional information has been requested.
Age: 50.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 50 years old patient. The patient was vaccinated with VARIVAX (Merck) (lot# was unknown) instead of ZOSTAVAX on 24-OCT-2012. No adverse symptoms reported. Additional information has been requested.
Age: 14.0
Sex: M
Vaccine: FLU3
Symptoms: Dysphemia
Clinical narrative: Patient is autistic. His mother reported today that within 24 hours of receiving a dose of trivalent, attenuated influenza vaccine, patient began to stutter when saying the letter "s". This occurred last year when he received his influenza vaccine. Mother reports that patient had the same stuttering reaction after he received his influenza vaccine last year (2011). Denies he had any kind of seizure activity or neurological events following either the 2011 or 2012 vaccination. She did not consult patient's physician and hadn't planned to do so this time. In 2011, the stuttering gradually subsided. She also noted that patient is not enunciating his "th" sound very well and this had also occurred last year. He had no other signs or symptoms following the vaccination. I have attached a copy of the consent form patient's mother completed prior to the influenza vaccine clinic at patient's school. She did not mention anywhere on the form, nor did she alert any staff, to patient's previous reaction to an injection of influenza vaccine. I will be consulting with patient's physician to determine if he should receive influenza vaccine in the future and will communicate his recommendations to patient's Mother, the nurse at the school patient attends, and have it noted in the Immunization Registry.
Age: 51.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Cellulitis, Local swelling, Pruritus, Urticaria
Clinical narrative: This spontaneous report was received from a physician assistant refers to a 51 years old female patient. The patient's current conditions included food color allergy, cinnamon allergy and dye allergy. The patient was vaccinated subcutaneously in the left arm with ZOSTAVAX (lot # reported as H12409) on 01-SEP-2012. No concomitant medications were reported. On 03-SEP-2012, the patient experienced had rash, lesion and tender area after ZOSTAVAX. Laboratory test revealed cellulitis and rash. No treatment information was reported. On 05-SEP-2012, the patient had recovered from the events. A signed informed consent form had not been obtained. Additional information has been requested.
Age: 51.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Rash, Skin lesion, Tenderness
Clinical narrative: This spontaneous report was received from a physician assistant refers to a 51 years old female patient. The patient's current conditions included food color allergy, cinnamon allergy and dye allergy. The patient was vaccinated subcutaneously in the left arm with ZOSTAVAX (lot # reported as H12409) on 01-SEP-2012. No concomitant medications were reported. On 03-SEP-2012, the patient experienced had rash, lesion and tender area after ZOSTAVAX. Laboratory test revealed cellulitis and rash. No treatment information was reported. On 05-SEP-2012, the patient had recovered from the events. A signed informed consent form had not been obtained. Additional information has been requested.
Age: 51.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Cellulitis
Clinical narrative: This spontaneous report was received from a physician assistant refers to a 51 years old female patient. The patient's current conditions included food color allergy, cinnamon allergy and dye allergy. The patient was vaccinated subcutaneously in the left arm with ZOSTAVAX (lot # reported as H12409) on 01-SEP-2012. No concomitant medications were reported. On 03-SEP-2012, the patient experienced had rash, lesion and tender area after ZOSTAVAX. Laboratory test revealed cellulitis and rash. No treatment information was reported. On 05-SEP-2012, the patient had recovered from the events. A signed informed consent form had not been obtained. Additional information has been requested.
Age: 28.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Hyperhidrosis, Pallor, Paraesthesia
Clinical narrative: Got pale and sweaty.
Age: 28.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Hyperhidrosis, Pallor
Clinical narrative: Got pale and sweaty.
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Acoustic stimulation tests, Ear tube insertion, Sudden hearing loss
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 71 years old female patient with cancer and no drug allergy. The patient was vaccinated with ZOSTAVAX (lot# 671786/0254AE, exp 03-AUG-2013) at an unspecified time in last few months. No other co-suspects were reported. Concomitant medications included: prednisone. The reporter stated the patient experienced loss in hearing after received ZOSTAVAX. It was unknown that if the patient had sought medical attention. The outcome of loss in hearing was unknown. Upon interview loss in hearing was considered as medically significant. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Deafness
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 71 years old female patient with cancer and no drug allergy. The patient was vaccinated with ZOSTAVAX (lot# 671786/0254AE, exp 03-AUG-2013) at an unspecified time in last few months. No other co-suspects were reported. Concomitant medications included: prednisone. The reporter stated the patient experienced loss in hearing after received ZOSTAVAX. It was unknown that if the patient had sought medical attention. The outcome of loss in hearing was unknown. Upon interview loss in hearing was considered as medically significant. Additional information has been requested.
Age: 3.0
Sex: M
Vaccine: FLUX, FLU3
Symptoms: Dysphemia
Clinical narrative: Stuttering.
Age: 38.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Musculoskeletal pain, Neck pain, Oedema peripheral, Pain in extremity
Clinical narrative: Swollen upper arm, pain in arm radiating to neck, shoulder, arm and forearm.
Age: 30.0
Sex: M
Vaccine: FLUX
Symptoms: Injection site haematoma, Injection site pain, Injection site swelling, Musculoskeletal pain
Clinical narrative: Itchy, painful, swollen and bruised area of injection.  Area of injection looks like a bee sting on top of a swollen bruise.  Shoulder is very sore. Side effects are tolerable for an adult, only reporting because the side effects may not be so tolerable for a child.
Age: 28.0
Sex: F
Vaccine: HPV4
Symptoms: Cervix carcinoma, Incorrect drug administration duration
Clinical narrative: This spontaneous report as received from a 28 years old female registered nurse refers to herself. The patient was vaccinated with GARDASIL (lot number, expired date and injection site were not reported) (0.5 ml suspension, 0, 2 and 6 months, intramuscular injection) for prevention of HPV on an unknown date at the patient's age of 25. No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient received 2 doses of GARDASIL at age 25 but did not complete the regimen and was "diagnosed with Cervical cancer at age 28". Unspecified treatment type was performed. The therapy was discontinued. The outcome of cervical cancer was reported as recovered on unspecified date. The reporter considered the cervical cancer was a life threatening event. The patient had sought unspecified medical attention. Additional information is not expected.
Age: 42.0
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Chills, Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Redness, swelling, induration of site, continued expansion despite antibiotics, fever and chills and generalized weakness.
Age: 42.0
Sex: F
Vaccine: PPV
Symptoms: Nuclear magnetic resonance imaging normal, Pyrexia
Clinical narrative: Redness, swelling, induration of site, continued expansion despite antibiotics, fever and chills and generalized weakness.
Age: 0.36
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Grand mal convulsion, Pyrexia
Clinical narrative: Fever 103, tonic-clonic seizure lasting less than one min. Tylenol given at time of fever.
Age: 38.0
Sex: F
Vaccine: TDAP
Symptoms: Injected limb mobility decreased, Musculoskeletal pain
Clinical narrative: My right arm is immobile and pain on top of shoulder.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Abasia, Activities of daily living impaired, Balance disorder, Blood test, Carpal tunnel decompression
Clinical narrative: Before Oct 6, 2011, I was an active person. I took care of 160 acres of land, 50 head of cattle and 20 goats. My husband worked for 14 days and then home 14 days. On Oct. 6 I had the shot and felt the first effects on Oct. 15. Was sitting on a bale of hay and could not get up. My husband had to help. Later that evening my legs started to ache. I had started taking a cholesterol pill in Sept and I figured from what I had heard and read that this was causing it. This continued through November when I fell and the numbness & tingling started. Even into December, this kept up, but by January 2012 my balance went. This is when I went to dr, my family doctor. He did blood work and sent me to another dr who ordered MRI's and did part of an EMG on my right side. The MRI showed a mass in my stomach, so I was sent to a dr & had surgery on Feb. 14, 2012, no cancer was found. She referred me to dr (neurologist) who saw me in the hospital the next day Feb. 15. He examined me and told me I had GBS. No one ever mentioned flu shot until April 4 when I had CTS surgery with dr. The nurse with me and some of her friend had gotten it about 10 years before right after flu shots. That is when my time line all fell into place. No one would comment on it, so we started checking on our own. Dr had told me after the EMG that what I had was permanent. There was nothing that could be done for me. I now am walking with a cane or walker, can't step up without help, and live with the numbness, tingling and pain. I can no longer take care of the land and cattle and we had to sell my goats. The worst part is telling my little 2 1/2 year old grandson I can't sit on the floor and play, run or walk with him. I now sit back and watch others have fun. So much for the golden years.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Decreased activity, Dysstasia, Electromyogram abnormal, Fall, Guillain-Barre syndrome
Clinical narrative: Before Oct 6, 2011, I was an active person. I took care of 160 acres of land, 50 head of cattle and 20 goats. My husband worked for 14 days and then home 14 days. On Oct. 6 I had the shot and felt the first effects on Oct. 15. Was sitting on a bale of hay and could not get up. My husband had to help. Later that evening my legs started to ache. I had started taking a cholesterol pill in Sept and I figured from what I had heard and read that this was causing it. This continued through November when I fell and the numbness & tingling started. Even into December, this kept up, but by January 2012 my balance went. This is when I went to dr, my family doctor. He did blood work and sent me to another dr who ordered MRI's and did part of an EMG on my right side. The MRI showed a mass in my stomach, so I was sent to a dr & had surgery on Feb. 14, 2012, no cancer was found. She referred me to dr (neurologist) who saw me in the hospital the next day Feb. 15. He examined me and told me I had GBS. No one ever mentioned flu shot until April 4 when I had CTS surgery with dr. The nurse with me and some of her friend had gotten it about 10 years before right after flu shots. That is when my time line all fell into place. No one would comment on it, so we started checking on our own. Dr had told me after the EMG that what I had was permanent. There was nothing that could be done for me. I now am walking with a cane or walker, can't step up without help, and live with the numbness, tingling and pain. I can no longer take care of the land and cattle and we had to sell my goats. The worst part is telling my little 2 1/2 year old grandson I can't sit on the floor and play, run or walk with him. I now sit back and watch others have fun. So much for the golden years.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Mobility decreased, Nuclear magnetic resonance imaging abnormal, Pain in extremity, Paraesthesia
Clinical narrative: Before Oct 6, 2011, I was an active person. I took care of 160 acres of land, 50 head of cattle and 20 goats. My husband worked for 14 days and then home 14 days. On Oct. 6 I had the shot and felt the first effects on Oct. 15. Was sitting on a bale of hay and could not get up. My husband had to help. Later that evening my legs started to ache. I had started taking a cholesterol pill in Sept and I figured from what I had heard and read that this was causing it. This continued through November when I fell and the numbness & tingling started. Even into December, this kept up, but by January 2012 my balance went. This is when I went to dr, my family doctor. He did blood work and sent me to another dr who ordered MRI's and did part of an EMG on my right side. The MRI showed a mass in my stomach, so I was sent to a dr & had surgery on Feb. 14, 2012, no cancer was found. She referred me to dr (neurologist) who saw me in the hospital the next day Feb. 15. He examined me and told me I had GBS. No one ever mentioned flu shot until April 4 when I had CTS surgery with dr. The nurse with me and some of her friend had gotten it about 10 years before right after flu shots. That is when my time line all fell into place. No one would comment on it, so we started checking on our own. Dr had told me after the EMG that what I had was permanent. There was nothing that could be done for me. I now am walking with a cane or walker, can't step up without help, and live with the numbness, tingling and pain. I can no longer take care of the land and cattle and we had to sell my goats. The worst part is telling my little 2 1/2 year old grandson I can't sit on the floor and play, run or walk with him. I now sit back and watch others have fun. So much for the golden years.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Stomach mass, Surgery, Walking aid user
Clinical narrative: Before Oct 6, 2011, I was an active person. I took care of 160 acres of land, 50 head of cattle and 20 goats. My husband worked for 14 days and then home 14 days. On Oct. 6 I had the shot and felt the first effects on Oct. 15. Was sitting on a bale of hay and could not get up. My husband had to help. Later that evening my legs started to ache. I had started taking a cholesterol pill in Sept and I figured from what I had heard and read that this was causing it. This continued through November when I fell and the numbness & tingling started. Even into December, this kept up, but by January 2012 my balance went. This is when I went to dr, my family doctor. He did blood work and sent me to another dr who ordered MRI's and did part of an EMG on my right side. The MRI showed a mass in my stomach, so I was sent to a dr & had surgery on Feb. 14, 2012, no cancer was found. She referred me to dr (neurologist) who saw me in the hospital the next day Feb. 15. He examined me and told me I had GBS. No one ever mentioned flu shot until April 4 when I had CTS surgery with dr. The nurse with me and some of her friend had gotten it about 10 years before right after flu shots. That is when my time line all fell into place. No one would comment on it, so we started checking on our own. Dr had told me after the EMG that what I had was permanent. There was nothing that could be done for me. I now am walking with a cane or walker, can't step up without help, and live with the numbness, tingling and pain. I can no longer take care of the land and cattle and we had to sell my goats. The worst part is telling my little 2 1/2 year old grandson I can't sit on the floor and play, run or walk with him. I now sit back and watch others have fun. So much for the golden years.
Age: 56.0
Sex: M
Vaccine: HEPAB, PPV, HEPAB
Symptoms: Condition aggravated, Diarrhoea, Motor dysfunction, Muscle spasms, Nausea
Clinical narrative: Nausea, cramps, diarrhea, exacerbated pre-existing conditions - magnified pain 1st & 2nd week. 3rd & 4th week - intermittent fever, transitory paralysis which escalated to loss of motor control, 2nd week they ran tests on my pain, which insurance would not cover 4 treatment. 3rd & 4th weeks I called 2 & 3 times a week, but was ignored and allowed to speak to the (a) doctor or any nurse or assistant, and was allowed to suffer alone.
Age: 56.0
Sex: M
Vaccine: HEPAB, PPV, HEPAB
Symptoms: Pain, Paralysis, Pyrexia, Testicular disorder, Ultrasound testes abnormal
Clinical narrative: Nausea, cramps, diarrhea, exacerbated pre-existing conditions - magnified pain 1st & 2nd week. 3rd & 4th week - intermittent fever, transitory paralysis which escalated to loss of motor control, 2nd week they ran tests on my pain, which insurance would not cover 4 treatment. 3rd & 4th weeks I called 2 & 3 times a week, but was ignored and allowed to speak to the (a) doctor or any nurse or assistant, and was allowed to suffer alone.
Age: 56.0
Sex: M
Vaccine: HEPAB, PPV, HEPAB
Symptoms: Abdominal discomfort, Abdominal distension, Abdominal pain upper, Activities of daily living impaired, Condition aggravated
Clinical narrative: Nausea, cramps, diarrhea, exacerbated pre-existing conditions - magnified pain 1st & 2nd week. 3rd & 4th week - intermittent fever, transitory paralysis which escalated to loss of motor control, 2nd week they ran tests on my pain, which insurance would not cover 4 treatment. 3rd & 4th weeks I called 2 & 3 times a week, but was ignored and allowed to speak to the (a) doctor or any nurse or assistant, and was allowed to suffer alone.
Age: 56.0
Sex: M
Vaccine: HEPAB, PPV, HEPAB
Symptoms: Diarrhoea, Diplegia, Disorientation, Fall, Hyperacusis
Clinical narrative: Nausea, cramps, diarrhea, exacerbated pre-existing conditions - magnified pain 1st & 2nd week. 3rd & 4th week - intermittent fever, transitory paralysis which escalated to loss of motor control, 2nd week they ran tests on my pain, which insurance would not cover 4 treatment. 3rd & 4th weeks I called 2 & 3 times a week, but was ignored and allowed to speak to the (a) doctor or any nurse or assistant, and was allowed to suffer alone.
Age: 56.0
Sex: M
Vaccine: HEPAB, PPV, HEPAB
Symptoms: Mobility decreased, Motor dysfunction, Photophobia, Spinal cord paralysis, Testicular pain
Clinical narrative: Nausea, cramps, diarrhea, exacerbated pre-existing conditions - magnified pain 1st & 2nd week. 3rd & 4th week - intermittent fever, transitory paralysis which escalated to loss of motor control, 2nd week they ran tests on my pain, which insurance would not cover 4 treatment. 3rd & 4th weeks I called 2 & 3 times a week, but was ignored and allowed to speak to the (a) doctor or any nurse or assistant, and was allowed to suffer alone.
Age: 56.0
Sex: M
Vaccine: HEPAB, PPV, HEPAB
Symptoms: Thinking abnormal, Victim of crime
Clinical narrative: Nausea, cramps, diarrhea, exacerbated pre-existing conditions - magnified pain 1st & 2nd week. 3rd & 4th week - intermittent fever, transitory paralysis which escalated to loss of motor control, 2nd week they ran tests on my pain, which insurance would not cover 4 treatment. 3rd & 4th weeks I called 2 & 3 times a week, but was ignored and allowed to speak to the (a) doctor or any nurse or assistant, and was allowed to suffer alone.
Age: 25.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Cough, Injection site pain, Injection site swelling, Malaise
Clinical narrative: Vaccine given 10/3 -> to ED 10/6 with aches, N/V, cough, malaise for 2 days. Site swollen & tender. Received IV antibiotics for cellulitis as well as ongoing CF therapy. D/C home with home health 10/10 with PO clindamycin.
Age: 25.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Nausea, Pain, Vomiting
Clinical narrative: Vaccine given 10/3 -> to ED 10/6 with aches, N/V, cough, malaise for 2 days. Site swollen & tender. Received IV antibiotics for cellulitis as well as ongoing CF therapy. D/C home with home health 10/10 with PO clindamycin.
Age: 32.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Diarrhoea, Headache, Nausea, Pyrexia, Vomiting
Clinical narrative: Admitted 9/23 for fevers, N/V, diarrhea, HA. Seen by infectious disease, received IV fluids and discharged home 9/24.