chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL (dosing information was not provided). On an unknown date, post vaccination with GARDASIL, the patient experienced syncope. The nurse asked if she needed to report syncope as an adverse event, if it is listed in the prescribing information. The outcome of syncope is unknown. Additional information is not expected.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not provided. On 22-JUN-2013 the patient was vaccinated with a dose of M-M-R II, 0.5 ml, subcutaneously (lot # H014977, expiry date: 09-AUG-2014). No concomitant medications were reported. The nurse noted that the dose of M-M-R II that was administered to the patient was unsupported due to a temperature excursion. No adverse effect was reported. No further patient information was available.
Age: 81.0
Sex: M
Vaccine: VARZOS
Symptoms: Paraesthesia
Clinical narrative: This spontaneous report as received from a consumer refers to a male patient of unknown age. The patient has no drug reactions or allergies. The patient's medical history included six hernia surgeries. On 06-FEB-2013 the patient was vaccinated with ZOSTAVAX (0.65 ml, dose number and route were not provided) lot # G013023. Concomitant therapies included LOVASTATIN and HYDROCHLORTHIAZIDE. In the beginning of June the patient experienced a "tingling sensation on his lower abdomen". The caller stated that tingling sensation is similar to the tingling sensation he felt when had a previous case of shingles. The patient did not seek medical attention and no treatment was given. The outcome of tingling sensation on lower abdomen was reported as not recovered/not resolved. No reporter causality provided. 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 medical assistant refers to a patient of unknown age and gender. No medical history, concomitant medications or drug reactions/allergies were reported. Sometime in 2011, the patient was vaccinated with the GARDASIL first dose (lot number, expiration date, route and site not reported). Now (on approximately 01-JUL-2013), the patient was in the office to receive dose 2 of GARDASIL which would be late. Additionally, no symptoms were reported. Additional information is not expected.
Age: 24.0
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test negative, Varicella virus test negative, Viral titre
Clinical narrative: This spontaneous report as received from a physician refers to a 24 year female patient. The patient's medical history included drug reaction/allergy to erythromycin. On 05-APR-2013 the patient was vaccinated with VARIVAX (Merck) lot # H017706 dose 1. On 06-MAY-2013 the patient was vaccinated with VARIVAX (Merck) lot # H017706 dose 2. Dosing information was not provided. Concomitant therapies included RECOMBIVAX HB, and diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid, dates of administration were unknown. Approximately on 17-JUN-2013, 6 weeks after the second dose of VARIVAX (Merck), the patient had a negative titer for varicella. No adverse event reported other than the negative titer. Lab diagnostics performed were the titers for varicella, which were negative, but the results were also reported as "unspecified titers for varicella". The patient sought medical attention at the office for the titers for varicella. The outcome of patient had a negative titer for varicella is unknown. Additional information is not expected.
Age: 5.0
Sex: M
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse concerning an approximately 5 year old male patient. On 09-JUL-2013, the patient was vaccinated with 0.5 milliliter (ml) of improperly stored  M-M-R II (HSA) (lot number and expiry date reported as H015833 and 24-AUG-2014 respectively), subcutaneously in the right upper leg. No concomitant medications were reported. No adverse effects were reported at the time of reporting. Additional information is not expected.
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. On 10-JUL-2013 the patient was vaccinated with an expired dose of M-M-R II (lot # 1026AA, expiration date 30-JUN-2013) (dose and route not reported). Concomitant therapy was not reported. No adverse effect 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 3 healthcare workers (1 medical assistant, other not specified) refers to an unspecified number of patients. No demographic information was provided. GARDASIL (lot number not provided) was exposed to 29-35 degrees Fahrenheit multiple times over a period of 3 months. The improper storage started on 29-DEC-2012. The improperly stored GARDASIL was administered to an unspecified number of patients on unspecified dates. Reportedly GARDASIL was "still not supported by in-house stability data". No adverse symptoms were reported. This is one of several reports received from the same source (other case IDs 1307USA008944, 1307USA008945, 1307USA008946, 1307USA008947, 1307USA008948 an d1307USA008949). Additional information has been requested.
Sex: M
Vaccine: MMR
Symptoms: Measles antibody negative
Clinical narrative: This spontaneous report as received from a health worker refers to a now 22 year old male patient with no pertinent medical history and no known drug reactions or allergies. There was no concomitant medication. The patient was vaccinated with 2 doses of M-M-R II (HSA) for required immunization on 01-JUL-1992 and 18-JUN-1996, respectively and now testing seronegative for measles. The patient sought medical attention by office visit. No treatment was given for the event. At the time of the report, the outcome of the event was reported as not recovered. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a patient of unknown age and gender. On 10-JUL-2013 the patient was vaccinated with PROQUAD (Merck) injection, 5 ml, subcutaneous (lot number and expiration date unspecified). Other suspect therapies included on 10-JUL-2013 VARIVAX (Merck) (dose, route, route unspecified) (lot number and expiration date unspecified). No adverse effect was reported. The patients outcome was unknown. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from 2 healthcare workers (1 medical assistant, the other not specified) refers to an unspecified number of patients. No demographic information was provided. ROTATEQ (lot number not provided) was exposed to 29-35 degrees Fahrenheit multiple times over a period of 3 months. The improperly stored ROTATEQ was administered to an unspecified number of patients on unspecified dates. Reportedly ROTATEQ was "supported by in-house stability data". No adverse symptoms were reported. This is one of several reports received from the same source (other cases IDs 1306USA008658, 1307USA008945, 1307USA008946, 1307USA008947, 1307USA008948 and 1307USA008949). Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: VARCEL
Symptoms: Exposure during pregnancy, Pregnancy test negative, Pregnancy test positive
Clinical narrative: Information has been received from a doctor of pharmacy (Pharm.D.) for VARIVAX (Merck), a Pregnancy Registry Product, concerning a 16 year old female patient who on an unknown date, was vaccinated with a dose of VARIVAX (Merck) (dose, route and lot number not reported). The reporter stated that the patient was administered VARIVAX (Merck) and was subsequently determined to be pregnant 2 weeks later. It was reported that the patient had a negative pregnancy test on the date of administration of the VARIVAX (Merck) but a pregnancy test 2 weeks later was positive. The patient sought medical attention, it was an office visit. Update (10-JUL-2013): A phone call was made to the doctor of pharmacy regarding the anonymous patient to pregnancy outcome information. Without patient identifiers, he could not give any information. The doctor of pharmacy stated he did not recall the patient in question. The case was lost to follow-up. Additional information is not expected. No further information is available.
Sex: U
Vaccine: VARZOS
Symptoms: Arthralgia, Feeling abnormal, Incorrect storage of drug, Injection site cellulitis, Local reaction
Clinical narrative: This spontaneous report as received from a licensed nurse practitioner refers to 10 unspecified co-workers. Medical history was not provided. On 25-JUL-2013 the patients were vaccinated with ZOSTAVAX (lot number not provided). Concomitant medication was not provided. On an unknown date in 2013 after the vaccination, the patients experienced the exact same reaction as the reporter (see linked case 1307USA002302) which were reported as: cellulitis at the injection site, felt crappy overall, had achy joints, were feverish and had local reaction. The nurse reported that ZOSTAVAX was pre-drawn into a plastic syringe that might had left out for more than 30 minutes. The outcome of the events was not reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: This spontaneous report as received from a licensed nurse practitioner refers to 10 unspecified co-workers. Medical history was not provided. On 25-JUL-2013 the patients were vaccinated with ZOSTAVAX (lot number not provided). Concomitant medication was not provided. On an unknown date in 2013 after the vaccination, the patients experienced the exact same reaction as the reporter (see linked case 1307USA002302) which were reported as: cellulitis at the injection site, felt crappy overall, had achy joints, were feverish and had local reaction. The nurse reported that ZOSTAVAX was pre-drawn into a plastic syringe that might had left out for more than 30 minutes. The outcome of the events was not reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Acne, Injection site erythema, Injection site mass, Injection site pain, Injection site pruritus
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. On 08-JUL-2013 the patient was vaccinated with ZOSTAVAX (lot # J001692, expired date 08-MAY-2014) (0.65 ml, subcutaneous) as shingles prevention. After receiving ZOSTAVAX on 08-JUL-2013, the patient experienced redness at injection site. The following day, 09-JUL-2013, the patient had "less redness" however the injection site was warm to the touch and there was a lump at the site. The patient also stated that there was pain and itching, no rash, at the injection site as well. She also stated that she had unspecified "pimples" on her tongue. There was no treatment given for adverse event. The outcome of there was reported as not recovered. It was unspecified if the patient sought any medical attention. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. On 08-JUL-2013 the patient was vaccinated with ZOSTAVAX (lot # J001692, expired date 08-MAY-2014) (0.65 ml, subcutaneous) as shingles prevention. After receiving ZOSTAVAX on 08-JUL-2013, the patient experienced redness at injection site. The following day, 09-JUL-2013, the patient had "less redness" however the injection site was warm to the touch and there was a lump at the site. The patient also stated that there was pain and itching, no rash, at the injection site as well. She also stated that she had unspecified "pimples" on her tongue. There was no treatment given for adverse event. The outcome of there was reported as not recovered. It was unspecified if the patient sought any medical attention. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Biopsy skin abnormal, Injection site granuloma
Clinical narrative: This spontaneous report as received from a healthcare professional refers to a 24 year old female patient. In 2012 the patient was vaccinated with the first dose of GARDASIL (Lot # not provided) (dose, route and frequency not reported). No other co suspects were reported. No concomitant therapy was reported. The reporter stated that the patient developed as "reaction" at the injection site (injection site unspecified). A skin biopsy was performed on 19-JUN-2013 and the result was a granulomatous reaction. The patient sought medical attention at the physician's office. Treatment was not given for the event. The outcome of granulomatous reaction was unknown. Additional information has been requested.
Sex: U
Vaccine: MMR, RV5
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a nurse refers to a unspecified number of patients of unknown age. On an unspecified date the patients were vaccinated with ROTATEQ (Lot # not provided) (dose, route and frequency not reported). Other suspect therapies included M-M-R II (Lot # not provided) (dose, route and frequency not reported). No concomitant therapy was reported. The reporter stated ROTATEQ and M-M-R II were stored outside of temperature range, that may have been administered to unspecified patients on unspecified dates. Additional information has been requested.
Age: 1.0
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a nurse (L.V.N) refers to a 12 month old patient. On 05-JUL-2013 the patient was inadvertently vaccinated with a dose of PNEUMOVAX23 (Lot#, dose and route not reported). Staff error only. No adverse effects were reported. It was not known if the patient sought medical attention. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. The pharmacist noted that the patient (it was not disclosed if there was any relationship between this patient and the pharmacist), was administered her first dose in the GARDASIL vaccination series intramuscularly in approximately July 2012, "about a year ago" and then was administered with the second dose in the GARDASIL vaccination series intramuscularly today (on 09-JUL-2013). No adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a doctor of pharmacy concerning an unspecified number of patients of unknown age and gender. It was reported that on an unknown date, an unspecified number of patient may have vaccinated with a dose of VAQTA (lot number, expiry date, dose and route unspecified) which was exposed to 10 degrees Fahrenheit (F) for 8 hours, which was an excursion that was unsupported by in-house stability data. No concomitant medications were reported. No adverse symptoms were reported. This is one of the two reports from the same source. Additional information has been requested.
Age: 1.01
Sex: M
Vaccine: HEPA, MMR, VARCEL, HEPA, MMR, VARCEL
Symptoms: Injection site rash
Clinical narrative: Ot serum react d/t vacc on 2013-07-05.
Age: 1.01
Sex: M
Vaccine: HEPA, MMR, VARCEL, HEPA, MMR, VARCEL
Symptoms: Serum sickness
Clinical narrative: Ot serum react d/t vacc on 2013-07-05.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV4, HPV4
Symptoms: Blood glucose normal, Dizziness, Fatigue, Pallor, Somnolence
Clinical narrative: This spontaneous report as received from a physician refers to a 12 year old female patient. On 16-JUL-2013 the patient was vaccinated with the first dose of GARDASIL (Lot # not reported) (dose and route not reported). Concomitant therapy was not reported. On 16-JUL-2013, the patient became immediately dizzy, tired and sleepy. The patient was arousable and never lost consciousness and after about 45 minutes with the use of smelling salts the patient was able to stand and went home. The patient's vital signs were measured in the office and were reported to be: pulse 80; blood pressure 110/60; temperature 98F and blood glucose of 90. The patient was still feeling very sleepy after returning home. At the time of the report the patient's outcome was not recovered. The physician also mentioned that there have been three other patients (two patients fainted and a boy who vomited following administration of a dose of GARDASIL (related cases MARRS 1307USA010388 and 1307USA010389). Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV4, HPV4
Symptoms: Blood glucose normal, Dizziness, Fatigue, Immediate post-injection reaction, Somnolence
Clinical narrative: This spontaneous report as received from a physician refers to a 12 year old female patient. On 16-JUL-2013 the patient was vaccinated with the first dose of GARDASIL (Lot # not reported) (dose and route not reported). Concomitant therapy was not reported. On 16-JUL-2013, the patient became immediately dizzy, tired and sleepy. The patient was arousable and never lost consciousness and after about 45 minutes with the use of smelling salts the patient was able to stand and went home. The patient's vital signs were measured in the office and were reported to be: pulse 80; blood pressure 110/60; temperature 98F and blood glucose of 90. The patient was still feeling very sleepy after returning home. At the time of the report the patient's outcome was not recovered. The physician also mentioned that there have been three other patients (two patients fainted and a boy who vomited following administration of a dose of GARDASIL (related cases MARRS 1307USA010388 and 1307USA010389). Additional information has been requested.
Age: 1.02
Sex: F
Vaccine: MMR
Symptoms: Apparent life threatening event, Contusion, Idiopathic thrombocytopenic purpura, Immunology test, Petechiae
Clinical narrative: Bruising and petichia. Admitted into hospital 2 days later for ITP and life threateningly low blood platelet level.
Age: 1.02
Sex: F
Vaccine: MMR
Symptoms: Platelet count decreased, Viral test
Clinical narrative: Bruising and petichia. Admitted into hospital 2 days later for ITP and life threateningly low blood platelet level.
Age: 32.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site cellulitis, Injection site streaking
Clinical narrative: Substantial cellulitis approx 3.5 inches in diameter around the inoculation site with streaking to medial biceps.  No constitutional symptoms.   Prophylactically treated for possible secondary infection of inoculation site and coverage for MRSA with Bactrim.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Gait disturbance, Mass, Pain
Clinical narrative: This spontaneous report was received from 68 year old female patient. The patient's medical history included multiple allergies. On 13-JUL-2013 the patient was vaccinated with PNEUMOVAX23 while in-patient and noted severe pain, lump all-over thigh redness on 14-JUL-2013. She stated now she can barely walk and also reported that she would not allow the nurse to administer the vaccine to her arm, so it was administered in her upper thigh. She was notified her primary physician wads not concerned and may not notified the physician. The patient did not seed medical attention. No treatment was given.The outcome of the events was unknown. The relatedness of the events with PNEUMOVAX23 was unknown. Consumer did not want follow up. Additional information is not expected.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Ill-defined disorder
Clinical narrative: Started with 1 on abd Sunday pm 7/14/13 then Monday - underarm, chest, back.
Age: 51.0
Sex: M
Vaccine: FLU3
Symptoms: Acute respiratory distress syndrome, Guillain-Barre syndrome, Immediate post-injection reaction, Immunoglobulin therapy, Influenza like illness
Clinical narrative: Immed follow flu like symptoms, sore throat, achiness, weakness in legs, paralysis (quad), respirator, nitric oxide, ARDS, IVIG, Rehabilitation, 91 days in hospital, neuropathy, 65 outpatient visits for rehabilitation, diagnosed with Guillain Barre.
Age: 51.0
Sex: M
Vaccine: FLU3
Symptoms: Lumbar puncture abnormal, Mechanical ventilation, Muscular weakness, Neuropathy peripheral, Oropharyngeal pain
Clinical narrative: Immed follow flu like symptoms, sore throat, achiness, weakness in legs, paralysis (quad), respirator, nitric oxide, ARDS, IVIG, Rehabilitation, 91 days in hospital, neuropathy, 65 outpatient visits for rehabilitation, diagnosed with Guillain Barre.
Age: 51.0
Sex: M
Vaccine: FLU3
Symptoms: Pain, Quadriplegia
Clinical narrative: Immed follow flu like symptoms, sore throat, achiness, weakness in legs, paralysis (quad), respirator, nitric oxide, ARDS, IVIG, Rehabilitation, 91 days in hospital, neuropathy, 65 outpatient visits for rehabilitation, diagnosed with Guillain Barre.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Computerised tomogram normal, Electrocardiogram normal, Syncope, Urinary tract infection, Urine analysis abnormal
Clinical narrative: 30 sec episode of syncope. Taken to ER. Evaluation (-) but for suggestion of UTI.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Pain, Skin warm, Swelling
Clinical narrative: Patient was given shot on 7/9/13. On the evening of 7/10/13 she was complaining of pain. Swelling was the size of a quarter. On 7/11/10 the swelling went to 2" x 2 3/4" and patient continued to take MOTRIN and use ice. On 7/12/13 swelling was larger so patient went to see doctor for pain, swelling and hot to touch.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Blood culture positive, Body temperature increased, Culture urine, Full blood count, Haemoglobin normal
Clinical narrative: Infant developed temp >102.5, became lethargic and very poorly responsive. Required EMS assistance (911). Evaluated at local hospital, had blood and urine collected. Seen in my office next day - normal exam.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Hyporesponsive to stimuli, Lethargy, Platelet count increased, Staphylococcus test positive, White blood cell count normal
Clinical narrative: Infant developed temp >102.5, became lethargic and very poorly responsive. Required EMS assistance (911). Evaluated at local hospital, had blood and urine collected. Seen in my office next day - normal exam.
Age: 0.16
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13
Symptoms: Cyanosis, Injection site erythema, Screaming
Clinical narrative: 2 month old who screamed inconsolably for over an hour after given PREVENAR 13, hepatitis B right thigh and PENTACEL left thigh. Right leg turned neon red. Feet turned blue. Better after TYLENOL.
Age: 61.0
Sex: F
Vaccine: RAB
Symptoms: Paraesthesia
Clinical narrative: Initial report was received from a healthcare professional on 06 July 2013. A 61-year-old female patient received two doses of intramuscular injections of IMOVAX, sanofi pasteur, lot number unknown (site, and side of administration not reported). The first dose was given on 02 July 2013 and the second dose was given 05 July 2013. An unreported amount of time later, the patient developed paresthesia of the right temporal area. The patient was evaluated in the emergency department on 06 July 2013 and 50% of paresthesia symptoms subsided at this time. The animal, a bat, tested negative for rabies and the physician was stopping the series. The patient's outcome was unknown. Documents held by sender: None.
Age: 47.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site induration, Injection site mass, Limb discomfort, Pain
Clinical narrative: Local discomfort in (R) arm - applied ice. Felt hard lump at site. No fever. Discomfort when raising arm. Resolved after 6 days.
Age: 6.0
Sex: F
Vaccine: TDAP
Symptoms: Diarrhoea, Headache, Injection site erythema, Injection site mass, Injection site pain
Clinical narrative: Pt became nauseated around 7 pm last night after she went home. Went to sleep. Woke up around 10:30 pm with stiff neck and severe aching on neck, head and shoulders. Site is sore with red lump present. Woke up this AM with diarrhea once and vomited x 3. Denies fever. Severe aching. Pain 6/10.
Age: 6.0
Sex: F
Vaccine: TDAP
Symptoms: Musculoskeletal pain, Musculoskeletal stiffness, Nausea, Neck pain, Pain
Clinical narrative: Pt became nauseated around 7 pm last night after she went home. Went to sleep. Woke up around 10:30 pm with stiff neck and severe aching on neck, head and shoulders. Site is sore with red lump present. Woke up this AM with diarrhea once and vomited x 3. Denies fever. Severe aching. Pain 6/10.
Age: 6.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia, Vomiting
Clinical narrative: Pt became nauseated around 7 pm last night after she went home. Went to sleep. Woke up around 10:30 pm with stiff neck and severe aching on neck, head and shoulders. Site is sore with red lump present. Woke up this AM with diarrhea once and vomited x 3. Denies fever. Severe aching. Pain 6/10.
Age: 1.52
Sex: M
Vaccine: HEPA, MNQ, TDAP
Symptoms: Erythema, Oedema peripheral, Pain in extremity
Clinical narrative: Child received 3 vaccines on 7.15.13. Had significant swelling, redness, pain in left arm on 7.16.13. Office visit with MD on 7.17.13. Given rx for antibiotics.
Age: 58.0
Sex: F
Vaccine: TDAP
Symptoms: Abdominal pain, Erythema, Headache, Induration, Muscle spasms
Clinical narrative: 1st day high fever 39 degrees C, redness, induration, pain circumference of upper arm, cramps abdomen and legs. Severe headache first 3 days.
Age: 58.0
Sex: F
Vaccine: TDAP
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: 1st day high fever 39 degrees C, redness, induration, pain circumference of upper arm, cramps abdomen and legs. Severe headache first 3 days.
Sex: U
Vaccine: HEP
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age. She reported that a pediatric patient was administered an expired dose of RECOMBIVAX HB (lot # 668558/0894AA, expiry date 17-MAY-2013, intramuscular, dose was unknown). No adverse effects were reported.
Sex: F
Vaccine: VARZOS
Symptoms: Unevaluable event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. On 18-JUN-2013 (reported as possibly 2 days ago (specific date was unspecified) the patient was vaccinated with a dose of ZOSTAVAX (dose, site of administration, route not reported). It was reported that you need an X-ray and need to take 150 mg of prednisone 1 day prior to the X-ray. Pharmacist was given this information from an unspecified person from the patient in the pharmacy at and therefore has limited information. The reporter stated ZOSTAVA was dispensed to an unspecified physician's office for administration to the patient. The reporter stated the patient will be needing to take prednisone (50mg every 6 hours) for a total of 3 doses in 1 day, to be done 1 day prior to the X-ray. The reporter feeled the patient may have had a pre-existing condition that required the X-ray but was unsure. The pharmacist feel the patient needing and X-ray was unrelated to the patient receiving ZOSTAVAX. The outcome of event was unknown. Additional information is not expected.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 63 year old female patient. Medical history was not provided. On 02-JUL-2013 the patient was vaccinated with ZOSTAVAX valid lot # J001692, 0.65 ml, subcutaneous (route not provided). Concomitant therapy was not provided. On 02-JUL-2013, after the patient received the injection, the pharmacist was putting the band aid over the injection site, the patient complained of itching. There was a small red spot which itched and the patient was given BENADRYL. After 20 minutes it continued to get bigger, and appeared to be raised in the center. The pharmacist administered prednisone and 15 minutes later the swelling went down. The pharmacist followed up by calling the patient, after the patient went home and slept for a few hours, the patient reported that the injection site reaction was gone, so patient had recovered the same day on 02-JUL-2013.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Immediate post-injection reaction, Injection site erythema, Pruritus
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 63 year old female patient. Medical history was not provided. On 02-JUL-2013 the patient was vaccinated with ZOSTAVAX valid lot # J001692, 0.65 ml, subcutaneous (route not provided). Concomitant therapy was not provided. On 02-JUL-2013, after the patient received the injection, the pharmacist was putting the band aid over the injection site, the patient complained of itching. There was a small red spot which itched and the patient was given BENADRYL. After 20 minutes it continued to get bigger, and appeared to be raised in the center. The pharmacist administered prednisone and 15 minutes later the swelling went down. The pharmacist followed up by calling the patient, after the patient went home and slept for a few hours, the patient reported that the injection site reaction was gone, so patient had recovered the same day on 02-JUL-2013.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a health worker refers to patients. The health worker stated that 10 doses of the recalled lot of RECOMBIVAX HB (dose, strength were not provided) (lot # J001183, exp unknown) were administered to unspecified patients from May 21st 2013 until the end of June 2013. No adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site nodule, Injection site rash
Clinical narrative: This spontaneous report as received from a pharmacist refers to an unknown number of patients of unknown ages and genders. On unknown dates the patient were vaccinated with ZOSTAVAX (routes, dosages, concentrations, and lot numbers unknown) for prophylaxis. The reporting pharmacist stated that some clients developed rash, or a small knot, at injection site post vaccination with ZOSTAVAX. The patient received treatment with BENADRYL. The outcomes of all events were reported as resolved. Additional information is not expected.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Cold sweat, Fall, Hyperhidrosis, Loss of consciousness, Pallor
Clinical narrative: Approx. 5 minutes after shot was given, client reported he felt like he was going to pass out, he fell over on his side with eyes closed. He was easily aroused as I shouted his name, and then he sat up. He then fainted and a 2nd time. I waived an ammonia swab under his nose and he came to. He was pale, clammy, diaphoretic and he vomited. (Client was sitting down when he fainted, laying across 2 chairs).
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Syncope, Vomiting
Clinical narrative: Approx. 5 minutes after shot was given, client reported he felt like he was going to pass out, he fell over on his side with eyes closed. He was easily aroused as I shouted his name, and then he sat up. He then fainted and a 2nd time. I waived an ammonia swab under his nose and he came to. He was pale, clammy, diaphoretic and he vomited. (Client was sitting down when he fainted, laying across 2 chairs).
Age: 59.0
Sex: M
Vaccine: PPV
Symptoms: Lymphadenopathy
Clinical narrative: This spontaneous report was received from a pharmacist via a healthcare student refers to a approximately 59 year old male patient. Approximately 2 months ago on 15-MAY-2013, the patient was vaccinated with a dose of PNEUMOVAX 23 (manufacturer unknown) (lot #, expiry not reported). On an unknown date in 2013, the patient experienced swollen lymph nodes. The patient also received a cortisone injection(manufacturer unknown). Since the pneumococcal vaccine was unknown to the healthcare student, this adverse experience was reported as Merck's PNEUMOVAX. The healthcare student did not have physician details available at the time of the call. The outcome of swollen lymph nodes was reported as recovered on an unknown date in 2013. Additional information has been requested.
Age: 0.18
Sex: F
Vaccine: RV5
Symptoms: Immediate post-injection reaction, Oral administration complication, Vomiting
Clinical narrative: This spontaneous report was received from a medical assistant regarding a 9 week old female patient with no pertinent medical history and no drug reactions or allergies. On 12-JUL-2013 the patient was vaccinated with the first and only dose ROTATEQ (lot number and expiration date not reported) (oral, dose not reported). No other suspect therapies or concomitant medications were reported. The medical assistant reported that the patient vomited immediately after being administered the ROTATEQ dose. It was reported that the patient was in the office when this occurred. The outcome for vomiting was reported as recovered on 12-JUL-2013. No treatment was given for the above mentioned event. No laboratory diagnostic studies were performed. The reporter did not assess the causality between ROTATEQ and vomiting. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: HPV4
Symptoms: Loss of consciousness, Syncope
Clinical narrative: This spontaneous report as received from a physician refers to a 11 years old male patient. On an unknown date the patient was vaccinated with GARDASIL, route, dose and lot # unspecified. Concomitant vaccines included DTAP and MENACTRA. The patient after lying for fifteen minutes upon getting up to stand fainted. Upon gaining conscious the patient's pressure was taken and was normal (No specific measurement given). The patient remained at the office another thirty minutes where he was monitored closely. The patient appeared to be completely recovered and was allowed to leave after thirty minutes. Additional information has been requested.
Age: 0.19
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a 2 month old patient. Healthcare worker stated that on 27-JUN-2013, VARIVAX (Merck) (lot number reported as H018014, exp. date 01-OCT-2014), 0.5 ml once, subcutaneous, that was stored improperly, was administered to the patient. Concomitant medications were not reported. Healthcare worker stated VARIVAX (Merck) was storage with multiple temperature excursions up to 13 F since February 2013 (vaccines were received in November 2012) exceeding one week (168 hours), then progressively up to 22F for an estimated 96 hours through June 2013. The healthcare worker did not believe overall temperature was maintained at 5F. No adverse effects reported. This case is linked to cases MARRS # 1307USA002435, 1307USA002437, 1307USA002434, 1307USA002436 via same reporter link. Additional information has been requested.
Age: 37.0
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test negative, Menstruation delayed, Pregnancy test negative, Varicella virus test negative
Clinical narrative: This spontaneous report was received from a 37 year old female patient regarding herself. The patient has cipro and penicillin allergy. On 25-JUN-2013, the patient was vaccinated with a dose of VARIVAX (Merck) (lot#, batch# not reported) because according to an unspecified physician, an unspecified blood test indicated that the patient had insufficient immunity against the varicella virus and the patient was preparing to undergo unspecified fertility treatment on an unspecified date. No concomitant medications were reported. On 12-JUL-2013, the patient noticed being late in her menstrual cycle. She was still waiting for her cycle to begin and was concerned because it had never been late before. No treatment was given for the event. She took an unspecified drug store pregnancy test on an unspecified date after noticing that she was late in beginning her cycle and the result was negative. But her late cycle was causing her to question the negative result. Patient sought medical attention. She called the office of her physician about this adverse experience and she was still waiting to hear back from her physician for clinical advice. According to the prescribing information, the adult indication is two injections, but the consumer did not specify whether or not the shot she received on 25-JUN-2013 was given as part of a two-dose series. The outcome of being late in her menstrual cycle was not recovered. Additional information has been requested.
Age: 2.0
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 2 year old patient of unknown gender. Healthcare worker stated that on 17-APR-2013, a dose improperly stored of RECOMBIVAX HB (lot number reported as 0366AE, exp. date 10-NOV-2014)(0.5 ml, intramuscular) was administered to the patient. Concomitant medications were not reported. Healthcare worker stated that RECOMBIVAX HB had multiple temperature excursions including exposure to 27F for 0.5 hours and up to 48F for 4 hours. No adverse effects reported. The case is linked to cases MARRS # 1307USA002435, 1307USA002434, 1307USA001233, 1307USA002436 via same reporter link. Additional information has been received. The lot number 0366AE, is an invalid lot number for RECOMBIVAX HB. This is a valid lot number for ZOSTAVAX. Additional information has been requested.
Age: 5.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a 5 years old patient of unknown gender. Healthcare worker stated that on 20-MAY-2013, VARIVAX (Merck) (lot number, dose and route were not reported), that was stored improperly was administered to the patient. Concomitant medications were not reported. Healthcare worker stated that VARIVAX (Merck) was storage with multiple temperature excursions up to 13F since February 2013 (vaccines were received in November 2012) exceeding one week (168 hours) then progressively up to 22F for an estimated 96 hours through June 2013. The healthcare worker did not believe overall temperature was maintained at 5F. No adverse effects reported. This case is linked to cases MARRS# 1307USA002435, 1307USA002437, 1307USA001233, 1307USA002434 via same reporter link. Additional information has been requested.
Age: 15.0
Sex: M
Vaccine: HPV4
Symptoms: Chills, Diarrhoea, Dyspnoea, Pyrexia
Clinical narrative: Low grade fever, chills, shortness of breath, diarrhea.
Age: 1.19
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Diarrhoea, Irritability, Rash
Clinical narrative: Rash, fussiness and mild diarrhea started 7/17/13.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Urticaria
Clinical narrative: Member c/o broke out with welts on bilateral arms, neck and back. Itching.
Age: 47.0
Sex: F
Vaccine: TDAP
Symptoms: Joint range of motion decreased, Pain in extremity
Clinical narrative: Pt states arm pain over one month later.  She also states limited ROM.
Age: 20.0
Sex: M
Vaccine: MNQ
Symptoms: Headache, Heart rate increased, Hypoaesthesia
Clinical narrative: Mother of client states client has numbness to left arm, headaches, and fast pulse. Advised mother to take client to doctor if had concerns.
Age: 65.0
Sex: F
Vaccine: HEP, PPV, TD
Symptoms: Injection site erythema, Injection site inflammation, Injection site pain, Injection site warmth, International normalised ratio increased
Clinical narrative: Erythematous, inflammed area about 8 cm in diameter, warm and tender to palpation on right arm at injection site. Afebrile. Applied ice to the area. Localized reaction had already begun to resolve by the following day, 6/19.
Age: 65.0
Sex: F
Vaccine: HEP, PPV, TD
Symptoms: Local reaction
Clinical narrative: Erythematous, inflammed area about 8 cm in diameter, warm and tender to palpation on right arm at injection site. Afebrile. Applied ice to the area. Localized reaction had already begun to resolve by the following day, 6/19.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Pruritus, Rash, Rash erythematous
Clinical narrative: Slowly developing, increasingly severe rash, extending from underarm to below waist, on side of vaccination site, consisting of small, red blistered bumps, close together.  No pain, but itching.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash erythematous, Rash generalised
Clinical narrative: Started developing small red spots on her face, throughout the next 5 days spots spread, developed into larger red bumps scattered all over her body.
Age: 30.0
Sex: M
Vaccine: ANTH, MNQ, TYP, YF
Symptoms: Blood glucose normal, Extremity contracture, Hyperhidrosis, Joint hyperextension, Loss of consciousness
Clinical narrative: Patient became pale, loss consciousness. Arms became tense with one extended and one flexed. Patient did not respond to painful stimuli. Awoke at 0955. Paitent pale, diaphoretic, Vital signs at 0956 were 132/84 Pulse 72, SpO2 98% RA. Denied pain, c/o nausea. Patient sat up and becaume more pale and diaphoretic, vitals remained stable. Patient had not eaten or drank any fluids since 2000 the night before.
Age: 30.0
Sex: M
Vaccine: ANTH, MNQ, TYP, YF
Symptoms: Nausea, Pallor, Unresponsive to stimuli
Clinical narrative: Patient became pale, loss consciousness. Arms became tense with one extended and one flexed. Patient did not respond to painful stimuli. Awoke at 0955. Paitent pale, diaphoretic, Vital signs at 0956 were 132/84 Pulse 72, SpO2 98% RA. Denied pain, c/o nausea. Patient sat up and becaume more pale and diaphoretic, vitals remained stable. Patient had not eaten or drank any fluids since 2000 the night before.
Age: 42.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Dyspnoea, Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: Local redness on right upper arm shortly after vaccine administration. Redness persisted and spread. Upper arm became edematous, red & warm to touch. Patient experienced some difficulty in breathing.
Age: 1.02
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Serum sickness
Clinical narrative: Ot serum react d/t vacc on 2013-07-02.
Sex: M
Vaccine: BCG, IPV
Symptoms: Guillain-Barre syndrome, Injection site discharge, No therapeutic response, Paralysis flaccid
Clinical narrative: This spontaneous report was received from a physician concerning a male infant patient of unknown age with immunodeficiency condition (unspecified). On an unknown date, the patient was vaccinated with BCG live (manufacturer unknown) (lot number, expiry date, dose and route unspecified). Other suspect therapies included poliovirus vaccine inactivated (unspecified) (manufacturer unknown) (lot number, expiry date, dose and route, date of administration unspecified). The patient was vaccinated in another country. Since an unknown date, the patient was experiencing ascending flaccid paralysis (disability) and the healthcare team who was attending the infant was suspecting that there was an immunodeficiency condition that was progressing, as the child was unable to mount an immune response to a live-virus vaccine that he received. The physician also indicated that the BCG live (manufacturer unknown) vaccine injection site of the patient was oozing approximately on an unknown date in 2013. The physician was short on time, and she did not specify if the infant was an inpatient at the hospital, but the health status of the infant was progressive and serious. Health Department was notified. The physician was contacting the company to inquire if she could enroll the infant in the compassionate use program for PLECONARIL. No product quality complaint (PQC) was identified. The events were not resolved at the time of report. The relatedness for the events was unknown for BCG live (manufacturer unknown). Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: SMALL
Symptoms: Injection site erythema, Injection site oedema, Nodule, Papule, Pruritus
Clinical narrative: Patient describes receiving her vaccinia vaccine in 1983 during basic training in her left arm. Patient reports developing erythema and edema at the vaccine site approximately 10 years ago that was associated with some local pain. She specifically denies any vesicles or pustules at the site. She also denies any associated systemic symptoms. She denies any associated myalgia, arthralgia, chest pain, dyspnea, or any other symptoms. She states the erythema and edema at this vaccine sites slowly resolved over 3-4 days, and slowly returned back to its normal state. She denies any residual changes or postinflammatory hyper/hypopigmentation. She denies any other associated lesions that developed with this lesion. ~Most currently, patient notes approximately 2 weeks ago (2 July 2013) she developed a similar reaction at the vaccine site manifested by an erythematous papule/nodule. However, this time, she endorses some pruritus with this lesion. Again, the lesion lasted approximately 3-4 days and slowly resolved. Again, she denies any associated systemic symptoms and specifically denies any myalgia, arthralgia, chest pain, dyspnea, nausea, vomiting, or diarrhea. No associated postinflammatory hypo-/hyperpigmentation with this episode as well. Patient states the lesion has completely resolved and is back to his normal baseline. She denies developing any other lesions at the time of this lesion develop. Symptoms: Rash, other nonspecific skin eruption.
Age: 16.0
Sex: M
Vaccine: HEPA, HPV4, MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: PROQUAD, a MMR and Varicella combo vaccine was administered to the patient. He is 16 years old and vaccine is indicated for children 12 months to 12 years of age only. No adverse reaction has been noted, but the patient is outside recommended age range.
Age: 33.0
Sex: M
Vaccine: HEP
Symptoms: Rash, Rash erythematous
Clinical narrative: 10 hours after injection of Hep B #1 developed erythematous rash on chest, arms, leg - took BENADRYL better today.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Dizziness, Fatigue, Hallucination, Headache
Clinical narrative: Dizziness, tired, headache within 3 hrs - then hallucinated that night - recovered within 3 days.
Age: 21.0
Sex: F
Vaccine: MNQ, PPV, MEN, PPV
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Pyrexia
Clinical narrative: Patient described swelling, hard, red area at injection site, fever.
Age: 21.0
Sex: F
Vaccine: MNQ, PPV, MEN, PPV
Symptoms: Headache, Hypersensitivity, Infection, Injection site pain, Injection site rash
Clinical narrative: Patient described swelling, hard, red area at injection site, fever.
Age: 21.0
Sex: F
Vaccine: MNQ, PPV, MEN, PPV
Symptoms: Pyrexia
Clinical narrative: Patient described swelling, hard, red area at injection site, fever.
Age: 1.01
Sex: M
Vaccine: HEPA, MMRV, PPV
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site swelling, Urticaria
Clinical narrative: Injection site swelling, redness. Large raised red welts everywhere that came and went randomly for weeks. Tenderness in leg. Gave him allergy medication and had to take him to physician as recommended on phone by nurse. Today July 18, still red injection site with red welts occasionally but infrequent.
Age: 31.0
Sex: F
Vaccine: ANTH, TYP
Symptoms: Cervical dysplasia, Injection site nodule, Injection site pain, Skin infection
Clinical narrative: Painful hanging nodule near injection site. Skin infections, many requiring antibiotics and aspiration. Later development of CIN III (Within 2 years).