chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse regarding a patient of unknown age and gender with no pertinent medical history reported. On 05-AUG-2009 the patient was vaccinated with the first dose of GARDASIL (lot number and expiration date not reported) (dose and route not specified). On 05-MAY-2011 the patient was vaccinated with the second dose of GARDASIL (lot number and expiration date not reported) (dose and route not specified). On 12-AUG-2013 the patient was vaccinated with the third dose of GARDASIL (lot number and expiration date not reported) (dose and route not specified). The nurse reported that the patient was administered a fourth dose of GARDASIL (lot number and expiration date not reported) (dose and route not specified) by an unspecified physician. No adverse effect was reported. Additional information has been requested.
Age: 0.2
Sex: M
Vaccine: RV5
Symptoms: Crying, Diarrhoea, Dysphonia, Irritability
Clinical narrative: Mother states 4 days after dose of ROTATEQ baby became fussy, drawing up legs, cry seemed hoarse. This lasted from 8/13/13 until 8/19/13. No fever-Had diarrhea 9 times on day 4 and 5 after vaccine. Day 6 and 7 some loose stools - day 8 normal.
Sex: F
Vaccine: HPVX
Symptoms: Fatigue, Pain, Pyrexia, Tachycardia
Clinical narrative: Fever, body aches, tachycardia, fatigue.
Age: 47.0
Sex: U
Vaccine: FLUX, VARZOS
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: This spontaneous report was received from a physician regarding a 47 year old patient with no pertinent medical history reported who on 19-AUG-2013 was vaccinated with ZOSTAVAX (lot number and expiration date not reported) (dose and route not specified). Concomitant medications included an unspecified influenza virus vaccine (manufacturer unknown) administered on 19-AUG-2013. Additional information has been requested.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a 56 year old male consumer (reporting on himself), with a current condition of diabetes. On 14-FEB-2013 the patient was vaccinated with a dose of ZOSTAVAX (lot # H019042, exp date 17-JAN-2014) (dose reported as 1 rod, every 3 years, subcutaneous route). Concomitant therapy was not reported. In July 2013, the patient got shingles after receiving the ZOSTAVAX vaccine. He stated it was isolated to his left ear. The patient did not sought medical attention and no treatment was given for the adverse event. Laboratory diagnostic studies were not performed. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: VIIth nerve paralysis
Clinical narrative: Bell's palsy treated with oral prednisolone.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site anaesthesia, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 58 year old female patient. On 14-AUG-2013 the patient was vaccinated with ZOSTAVAX (dose, route and lot number were not reported). Concomitant medications were not reported. On approximately 14-AUG-2013, the patient developed an injection site reaction following vaccination with ZOSTAVAX. The injection site reaction was described as a swollen, raised, red area, hot to the touch, with numbness and tingling. The raised, red area started at the injection site, but at the moment of the report it had extended up to the armpit. The patient did not received any treatment for the adverse events. Patient contacted the office. No lab diagnostics were performed. The outcome of the events was reported as not recovered/not resolved. The relationship between ZOSTAVAX and the events was not reported. Additional information has been requested.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth, Local swelling
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 58 year old female patient. On 14-AUG-2013 the patient was vaccinated with ZOSTAVAX (dose, route and lot number were not reported). Concomitant medications were not reported. On approximately 14-AUG-2013, the patient developed an injection site reaction following vaccination with ZOSTAVAX. The injection site reaction was described as a swollen, raised, red area, hot to the touch, with numbness and tingling. The raised, red area started at the injection site, but at the moment of the report it had extended up to the armpit. The patient did not received any treatment for the adverse events. Patient contacted the office. No lab diagnostics were performed. The outcome of the events was reported as not recovered/not resolved. The relationship between ZOSTAVAX and the events was not reported. Additional information has been requested.
Age: 32.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant regarding a 32 year old female patient with no pertinent medical history reported. On 20-FEB-2013 the patient was vaccinated with the first dose of GARDASIL (lot number and expiration date not reported) (dose and route not specified). On 17-MAY-2013 the patient was vaccinated with the second dose of GARDASIL (lot number and expiration date not reported) (dose and route not specified). The medical assistant reported that on 16-AUG-2013 the patient was in the office and wanted to receive her third dose of GARDASIL, but it was earlier than what was prescribed. No concomitant medications were reported. No adverse effect reported. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Electrocardiogram normal, Heart rate increased, Nausea, Nervousness
Clinical narrative: Very rapid, pounding heartbeat for about 20 minutes, then felt queasy, shakey.  By the time I saw a doctor, about an hour later, all was normal (pulse, blood pressure, ECG).
Age: 1.31
Sex: F
Vaccine: DTAP, PNC
Symptoms: Blood test, Chest X-ray, Computerised tomogram, Convulsion, Electroencephalogram
Clinical narrative: Awoke from sleep & began having a seizure. Continued for 20 minutes until it was stopped by lorazepam administered in the hospital emergency room.
Age: 1.31
Sex: F
Vaccine: DTAP, PNC
Symptoms: Urine analysis
Clinical narrative: Awoke from sleep & began having a seizure. Continued for 20 minutes until it was stopped by lorazepam administered in the hospital emergency room.
Age: 1.54
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR, VARCEL
Symptoms: Body temperature increased, Rash generalised
Clinical narrative: RASH OVER HER BODY, TEMPERATURE 99.9. CETIRIZINE HCL 1 MG/ML SYRUP.
Age: 0.57
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site mass, Injection site reaction, Injection site warmth, Rash macular
Clinical narrative: Red at injection site and dollar coin size warm lump around injection with red splotching throughout.  Applied warm pack and massaged.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site mass, Injection site rash
Clinical narrative: Rash, lump at site of injection. Headache next 2 days.
Age: 57.0
Sex: F
Vaccine: TDAP
Symptoms: Laryngeal pain, Oral discomfort, Oral pain, Pain, Trismus
Clinical narrative: Two reactions, post TDaP: 1) I know it's 'inactivated,' but within six hours of the TDaP vaccine, I developed--and still have--a peppery-stinging sensation in my mouth/larynx. It has yet to go away. This is why I write, to notify you of this symptom. 2) The next morning, post-vaccine, and for 3-4 days hence, I actually had lockjaw on the opposite side. Vaccine given on the left; temporary lockjaw in the right jaw x 3-4 days--now resolved.
Age: 0.16
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Apnoea
Clinical narrative: One episode of apnea 8/23/13 at 2335 and one episode apnea 8/24/13 at 0215.
Age: 3.0
Sex: F
Vaccine: FLUN4
Symptoms: Vomiting
Clinical narrative: Vomiting.
Age: 12.0
Sex: M
Vaccine: DTAP
Symptoms: Erythema, Injection site swelling, Muscle rigidity, Pain, Tenderness
Clinical narrative: Initial onset of severe pain to vaccination site that has not resolved. Severe swelling at injection site, continued severe pain; arm tender, red and muscle rigid; unable to move shoulder without severe pain. Swelling observed 8/24/13 AM by patient.
Age: 12.0
Sex: M
Vaccine: DTAP
Symptoms: Vaccination site pain
Clinical narrative: Initial onset of severe pain to vaccination site that has not resolved. Severe swelling at injection site, continued severe pain; arm tender, red and muscle rigid; unable to move shoulder without severe pain. Swelling observed 8/24/13 AM by patient.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Redness, warmth, pain, and swelling close to injection site.
Age: 59.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chills, Headache, Injection site swelling, Mobility decreased, Oedema peripheral
Clinical narrative: Headache, fever, chills, swelling of arm from injection site to elbow, arm hot, difficult to move arm due to pain/swelling, body aches, visited doctor 2x prescribed 2 different antibodics and prednisone.
Age: 59.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pain, Pain in extremity, Pyrexia, Skin warm
Clinical narrative: Headache, fever, chills, swelling of arm from injection site to elbow, arm hot, difficult to move arm due to pain/swelling, body aches, visited doctor 2x prescribed 2 different antibodics and prednisone.
Age: 13.0
Sex: M
Vaccine: HPV4
Symptoms: Dizziness, Fall, Headache, Syncope, Vision blurred
Clinical narrative: Fainted and fell in bathroom. Woke up to dog licking her face on the ground and hit a hard trash can on chest when fell. Was feeling dizzy with blurred vision during the day. Headache and blurred vision next day also.
Age: 13.0
Sex: M
Vaccine: HPV4
Symptoms: Visual impairment
Clinical narrative: Fainted and fell in bathroom. Woke up to dog licking her face on the ground and hit a hard trash can on chest when fell. Was feeling dizzy with blurred vision during the day. Headache and blurred vision next day also.
Age: 22.0
Sex: F
Vaccine: VARCEL
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a other health care worker refers to a 22 year old female patient on a unspecified birth control therapy and low varicella titer. On 14-AUG-2013 the patient was vaccinated with VARIVAX (Merck) due to lower titer, .5ml, subcutaneous (lot 3 and exp date unknown). On 14-AUG-2013, the reporter stated that VARVIVAX (Merck) administered was expired. No adverse effects were noted by patient. The patients outcome was unknown. The patient sought medical attention. No treatments were give to the patient, and no labs were performed after vaccination. Additional information has been requested.
Sex: M
Vaccine: MMR
Symptoms: Measles antibody negative
Clinical narrative: This spontaneous report as received from a physician refers to a male patient of unknown age. On an unknown date the patient was vaccinated with twice the M-M-R II, (dose, route, frequency application site unspecified) (lot # and expiration date unknown). On an unknown date the patient has negative titer for measles. The patient's outcome was unknown. Additional information is not expected.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Site of injection was hard and swollen, sore like a size of a silver dollar happened on Sunday (8/18/13) 2 days after inj. Put only ice every 10 min (4 x a day). 8/21/13 better but still a size of a quarter. Flat and warm.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Bacterial infection, Injection site pruritus, Injection site rash
Clinical narrative: Pt got the rash and itchy skin at the site of injection on Wednesday. It spread down to her elbow and below and showed a physician. Per doctor she has a bacterial infection and was prescribed cephalexin on Friday.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a patient's friend refers to the 67 year old female patient with osteoporosis. The patient's medical history included thyroid disorder and thyroid surgery. "About four years ago", in approximately August 2009 the patient was vaccinated with ZOSTAVAX (lot # not reported) (strength and total daily dose not reported). Concomitant medication included unspecified "osteoporosis shot". "Sometime in June, 2013", the patient developed shingles after receiving ZOSTAVAX. It was unspecified whether the patient sought for medical attention. Unspecified "anti-viral medication" was given as treatment. The outcome of shingles was unknown. Additional information has been requested.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Neuropathy peripheral, Pain
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 67 year old male patient. The patient had allergy to penicillin. On 01-JUL-2013 the patient was vaccinated with a dose of ZOSTAVAX (dose, strength, site and route of administration not reported). On 09-AUG-2013 the patient experienced shingles. The pharmacist reported that the patient stated that the shingles came on fast. The patient initially noticed a blister that really hurt on the back left scalp area. The rash spread from the top of his head down to the hairline of the neck. The reporter stated that the patient reported neuropathy. The patient was seen by an unspecified physician who diagnosed the patient with shingles after visual inspection. The patient received treatment with VALTREX and gabapentin (manufacturer unknown). The outcome of shingles and neuropathy was reported as not recovered/not resolved. The relatedness between ZOSTAVAX and adverse events was not reported. The patient sought medical attention via call to pharmacist. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Influenza like illness, Pain, Respiratory tract congestion, Rhinorrhoea
Clinical narrative: This spontaneous report as received from a 60 year old female patient with chronic obstructive pulmonary disease, congestive heart failure, anxiety attacks, depression, degenerative disc disease, diabetes, high blood pressure, hypoglycemia, sleep apnea, fibromyalgia, porphyria, osteoarthritis, osteoporosis, irritable bowel syndrome, restless legs syndrome, burning mouth syndrome, acute gastroesophageal reflux disease, latex allergy which caused skin irritation. On 13-AUG-2013 the patient was vaccinated with a dose of ZOSTAVAX dose and route unspecified. Concomitant therapies included METANX, LOPRESSOR, AMBIEN, ADVAIR, LASIX, PHENERGAN, PROZAC, REQUIP, SYNTHROID, XANAX and DEXILANT. On the evening of 13-AUG-2013 the patient had a headache. The next morning (14-AUG-2013) the patient stated she woke up and her face was flushed, and she was covered with sweat and felt nauseous. She took extra strength TYLENOL and aspirin to threat her symptoms. On 15-AUG-2013, the patient felt bad and sick, felt like "she was going to die". The patient spoke to the pharmacist for medical attention. The outcome of the events was unknown. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Feeling abnormal, Flushing, Headache, Hyperhidrosis, Malaise
Clinical narrative: This spontaneous report as received from a 60 year old female patient with chronic obstructive pulmonary disease, congestive heart failure, anxiety attacks, depression, degenerative disc disease, diabetes, high blood pressure, hypoglycemia, sleep apnea, fibromyalgia, porphyria, osteoarthritis, osteoporosis, irritable bowel syndrome, restless legs syndrome, burning mouth syndrome, acute gastroesophageal reflux disease, latex allergy which caused skin irritation. On 13-AUG-2013 the patient was vaccinated with a dose of ZOSTAVAX dose and route unspecified. Concomitant therapies included METANX, LOPRESSOR, AMBIEN, ADVAIR, LASIX, PHENERGAN, PROZAC, REQUIP, SYNTHROID, XANAX and DEXILANT. On the evening of 13-AUG-2013 the patient had a headache. The next morning (14-AUG-2013) the patient stated she woke up and her face was flushed, and she was covered with sweat and felt nauseous. She took extra strength TYLENOL and aspirin to threat her symptoms. On 15-AUG-2013, the patient felt bad and sick, felt like "she was going to die". The patient spoke to the pharmacist for medical attention. The outcome of the events was unknown. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Nausea
Clinical narrative: This spontaneous report as received from a 60 year old female patient with chronic obstructive pulmonary disease, congestive heart failure, anxiety attacks, depression, degenerative disc disease, diabetes, high blood pressure, hypoglycemia, sleep apnea, fibromyalgia, porphyria, osteoarthritis, osteoporosis, irritable bowel syndrome, restless legs syndrome, burning mouth syndrome, acute gastroesophageal reflux disease, latex allergy which caused skin irritation. On 13-AUG-2013 the patient was vaccinated with a dose of ZOSTAVAX dose and route unspecified. Concomitant therapies included METANX, LOPRESSOR, AMBIEN, ADVAIR, LASIX, PHENERGAN, PROZAC, REQUIP, SYNTHROID, XANAX and DEXILANT. On the evening of 13-AUG-2013 the patient had a headache. The next morning (14-AUG-2013) the patient stated she woke up and her face was flushed, and she was covered with sweat and felt nauseous. She took extra strength TYLENOL and aspirin to threat her symptoms. On 15-AUG-2013, the patient felt bad and sick, felt like "she was going to die". The patient spoke to the pharmacist for medical attention. The outcome of the events was unknown. Additional information has been requested.
Age: 2.0
Sex: F
Vaccine: MMR
Symptoms: Lymphadenopathy, Pyrexia, Rash
Clinical narrative: Rash in face, 101 fever for 3 days. 05/31/2013 -> swollen groin lymph node (right side); lasted for 3 weeks; brussel sprout sized swelling; verified with physician abroad (on vacation) to be common side effect of mumps portion of the MMR.
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Fever 100.4, chills, body aches.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling hot, Headache, Pain, Swelling
Clinical narrative: Extreme soreness, heat, headaches, all over achyness, area is raised.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PPV, RVX
Symptoms: Crying
Clinical narrative: Several hours of inconsolable high pitched crying treated with infant Tylenol.
Age: 1.08
Sex: M
Vaccine: HBHEPB, MMR, PNC
Symptoms: Aphasia, Asterixis, Blood test abnormal, Crying, Developmental delay
Clinical narrative: Immediate: rash, fever, crying, no sleep, sounds of distress, diarrhea. The same week of vaccine: lower muscle tone, regression of development, lost skills, lost speech, staring, flapping of hands, spinning, no longer responded when called by name, fixation on objects
Age: 1.08
Sex: M
Vaccine: HBHEPB, MMR, PNC
Symptoms: Diarrhoea, Emotional distress, Encephalopathy, Hypotonia, Immediate post-injection reaction
Clinical narrative: Immediate: rash, fever, crying, no sleep, sounds of distress, diarrhea. The same week of vaccine: lower muscle tone, regression of development, lost skills, lost speech, staring, flapping of hands, spinning, no longer responded when called by name, fixation on objects
Age: 1.08
Sex: M
Vaccine: HBHEPB, MMR, PNC
Symptoms: Immune system disorder, Immunology test abnormal, Insomnia, Laboratory test abnormal, Mitochondrial cytopathy
Clinical narrative: Immediate: rash, fever, crying, no sleep, sounds of distress, diarrhea. The same week of vaccine: lower muscle tone, regression of development, lost skills, lost speech, staring, flapping of hands, spinning, no longer responded when called by name, fixation on objects
Age: 1.08
Sex: M
Vaccine: HBHEPB, MMR, PNC
Symptoms: Movement disorder, Nuclear magnetic resonance imaging brain abnormal, Psychomotor skills impaired, Pyrexia, Rash
Clinical narrative: Immediate: rash, fever, crying, no sleep, sounds of distress, diarrhea. The same week of vaccine: lower muscle tone, regression of development, lost skills, lost speech, staring, flapping of hands, spinning, no longer responded when called by name, fixation on objects
Age: 1.08
Sex: M
Vaccine: HBHEPB, MMR, PNC
Symptoms: Smear buccal abnormal, Staring, Unresponsive to stimuli, Urine analysis abnormal
Clinical narrative: Immediate: rash, fever, crying, no sleep, sounds of distress, diarrhea. The same week of vaccine: lower muscle tone, regression of development, lost skills, lost speech, staring, flapping of hands, spinning, no longer responded when called by name, fixation on objects
Age: 30.0
Sex: F
Vaccine: HEP
Symptoms: Asthenia, Chills, Confusional state, Decreased appetite, Dizziness
Clinical narrative: ABOUT A MINUTE AFTER GETTING THE VACCINE I FELT DIZZY AND FAINTED. I DO NOT KNOW HOW LONG I WAS UNCONSCIOUS. I HAD HARD TIME TALKING AND BREATHING. FELT BETTER AFTER 5 MINUTES BUT WAS WEAK, HOT AND SWEATING, LIGHTHEADED, AND CONFUSED. COUPLE HOURS LATER I HAD CHILLS AND DID NOT SLEEP ALL NIGHT. NEXT DAY HAD TERRIBLE HEADACHE, VOMITED, LOSS OF APPETITE AND GOT IREGGULAR MENSTRUAL PERIOD. FELT VERY WEAK ALL DAY AND CONFUSED. BODY ACHING.
Age: 30.0
Sex: F
Vaccine: HEP
Symptoms: Dyspnoea, Feeling hot, Headache, Hyperhidrosis, Insomnia
Clinical narrative: ABOUT A MINUTE AFTER GETTING THE VACCINE I FELT DIZZY AND FAINTED. I DO NOT KNOW HOW LONG I WAS UNCONSCIOUS. I HAD HARD TIME TALKING AND BREATHING. FELT BETTER AFTER 5 MINUTES BUT WAS WEAK, HOT AND SWEATING, LIGHTHEADED, AND CONFUSED. COUPLE HOURS LATER I HAD CHILLS AND DID NOT SLEEP ALL NIGHT. NEXT DAY HAD TERRIBLE HEADACHE, VOMITED, LOSS OF APPETITE AND GOT IREGGULAR MENSTRUAL PERIOD. FELT VERY WEAK ALL DAY AND CONFUSED. BODY ACHING.
Age: 30.0
Sex: F
Vaccine: HEP
Symptoms: Loss of consciousness, Menstruation irregular, Pain, Speech disorder, Syncope
Clinical narrative: ABOUT A MINUTE AFTER GETTING THE VACCINE I FELT DIZZY AND FAINTED. I DO NOT KNOW HOW LONG I WAS UNCONSCIOUS. I HAD HARD TIME TALKING AND BREATHING. FELT BETTER AFTER 5 MINUTES BUT WAS WEAK, HOT AND SWEATING, LIGHTHEADED, AND CONFUSED. COUPLE HOURS LATER I HAD CHILLS AND DID NOT SLEEP ALL NIGHT. NEXT DAY HAD TERRIBLE HEADACHE, VOMITED, LOSS OF APPETITE AND GOT IREGGULAR MENSTRUAL PERIOD. FELT VERY WEAK ALL DAY AND CONFUSED. BODY ACHING.
Age: 30.0
Sex: F
Vaccine: HEP
Symptoms: Vomiting
Clinical narrative: ABOUT A MINUTE AFTER GETTING THE VACCINE I FELT DIZZY AND FAINTED. I DO NOT KNOW HOW LONG I WAS UNCONSCIOUS. I HAD HARD TIME TALKING AND BREATHING. FELT BETTER AFTER 5 MINUTES BUT WAS WEAK, HOT AND SWEATING, LIGHTHEADED, AND CONFUSED. COUPLE HOURS LATER I HAD CHILLS AND DID NOT SLEEP ALL NIGHT. NEXT DAY HAD TERRIBLE HEADACHE, VOMITED, LOSS OF APPETITE AND GOT IREGGULAR MENSTRUAL PERIOD. FELT VERY WEAK ALL DAY AND CONFUSED. BODY ACHING.
Age: 74.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site inflammation, Injection site pruritus, Injection site rash
Clinical narrative: Rash, inflammation, pruritis at site of immunization and spreading down toward the elbow.
Age: 56.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site rash
Clinical narrative: Patient describes developing a red, itching, burning rash at site of injection. The rash has increased in size over a day's time. Two days after, she describes it to be 3 inches wide by 10 in long.
Age: 56.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: Patient describes developing a red, itching, burning rash at site of injection. The rash has increased in size over a day's time. Two days after, she describes it to be 3 inches wide by 10 in long.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site exfoliation, Injection site swelling
Clinical narrative: Injection site reaction. Swollen, red, and skin peeling. 1 week.
Age: 18.0
Sex: F
Vaccine: VARCEL
Symptoms: Dyskinesia, Syncope
Clinical narrative: Patient fainted approx. 5 minutes after receiving vaccine then had tonic jerks. Patient was taken by ambulance to hospital emergency department.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Hypertension
Clinical narrative: 3 days after pt had extremely high BP about 190/110 and went to ER. He never had this reaction with any previous vaccinations.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to 30 unspecified patients received doses of GARDASIL (lot H020910, exp 18-JUN-2015) on unspecified dates, that were exposed to the same temperature excursion(28.8F for 8 minutes). No adverse effect reported. This is one of several reports received from the same source (related case #1307USA015230; 1308USA005499). Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Pain, Rash
Clinical narrative: This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. On 20-AUG-2013, the patient was vaccinated with 0.5 milliliter (ml) of PNEUMOVAX23 (lot number and expiry date reported as H021941 and 11-JUL-2014 respectively), intramuscularly. No concomitant therapy was reported. On 21-AUG-2013, the patient came back into the office to report the adverse event. Approximately on an unknown date in August 2013, the patient experienced a large raised rash near the bottom of the muscle, near the elbow which was very painful after receiving the PNEUMOVAX23. The patient sought an unspecified medical attention. It was unspecified if any treatment was provided or if any lab tests were performed. The patient was not recovered from the events. The medical assistant was requesting a lot check for the PNEUMOVAX23. The relatedness for the events was unknown for PNEUMOVAX23. This is one of the two reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Expired drug administered, Injection site erythema
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a patient of unknown age. ON 12-AUG-2013 the patient was vaccinated with a dose of expired VARIVAX (Merck) (dose, frequency and route unknown) (lot# was reported as 10888AA which was confirmed as not valid for VARIVAX (Merck), Exp 06-JUL-2013). There was a little redness at the injection site after administration. It was unknown if the patient had sought medical attention. The outcome of the event was unknown. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a registered pharmacist concerning two patients of unknown demographics. On 30-JUL-2013, two unspecified patients were vaccinated with doses of GARDASIL (lot number and expiry date reported as H020692 and 15-AUG-2015 respectively, dose and route unspecified) which were improperly stored at temperatures below 32 degrees Fahrenheit (F). No concomitant therapy was reported. No adverse effects were reported. This is one of the several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a registered pharmacist concerning a patient of unknown age and gender. On 17-JUL-2013, the patient was vaccinated with a dose of PEDVAXHIB (lot number reported as H0257D, expiry date, dose and route unspecified) which was improperly stored at temperatures below 32 degrees Fahrenheit (F). No concomitant therapy was reported. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a registered pharmacist concerning a patient of unknown age and gender. On 02-JUL-2013, the patient was vaccinated with a dose of PEDVAX (lot number reported as H0257D, expiry date, dose and route unspecified) which was improperly stored at temperatures below 32 degrees Fahrenheit (F). No concomitant therapy was reported. No adverse effects were reported. This is one of the several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Pain, Rash
Clinical narrative: This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. On 19-AUG-2013, the patient was vaccinated with 0.5 milliliter (ml) of PNEUMOVAX23 (lot number and expiry date reported as H021941 and 11-JUL-2014 respectively), intramuscularly. No concomitant therapy was reported. On 20-AUG-2013, the patient came back into the office to report the adverse event. Approximately on an unknown date in August 2013, the patient experienced a large raised rash near the bottom of the muscle, near the elbow which was very painful after receiving the PNEUMOVAX23. The patient sought an unspecified medical attention. It was unspecified if any treatment was provided or if any lab tests were performed. The patient was not recovered from the events. The medical assistant was requesting a lot check for the PNEUMOVAX23. The relatedness for the events was unknown for PNEUMOVAX23. This is one of the two reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a Nurse refers to unspecified number of adult patients. The reporter reported that at a "sister facility", an unspecified number of adult patients has been administered two pediatric doses of VAQTA (lot # was not reported) in place of one adult dose of VAQTA. Nurse reported that there were not adverse effects reported that she was aware of. 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 physician refers to a patient of unknown age. The patient received the first dose of GARDASIL 2 years ago (in approximately August 2011) (dose, route and lot# unknown). The patient came into the office on the date of report (14-AUG-2013) to receive the second dose of GARDASIL (Lot#, dose and route unspecified). No adverse effect reported. Additional information has been requested.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 55 years old female patient. On 05-AUG-2013 the patient was vaccinated with a 0.65ml dose of ZOSTAVAX (lot# H021292, expiration date: 23-FEB-2014), subcutaneous at unspecified location. Concomitant therapies included with CYMBALTA, SINGULAIR, hydrochlorothiazide, XANAX, prednisone, PEPCID, NEURONTIN, trazodone hydrochloride, albuterol, DUONEB, PERCOCET and metoprolol. The pharmacist reported that patient received ZOSTAVAX and had an injection site reaction that was swollen and "half dollar size" that was also "hot to the touch" on an unspecified date. The patient had sought medical attention via pharmacy visit. None lab diagnostics studies was performed. No treatment was given. At the time of report, the outcome was not recovered. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Anxiety, Arthralgia, Coeliac disease, Depression, Myalgia
Clinical narrative: This spontaneous report was received from a consumer refers to her pediatric of unknown age. She reported that her daughter developed extreme depression, anxiety, panic attack, celiac disease, joint pain, and muscle pain since the GARDASIL (lot# unspecified), route, dose and location unspecified was given 7 years ago (approximately in August 2006). The reporter was experiencing these long term side effects from her GARDASIL. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Panic attack
Clinical narrative: This spontaneous report was received from a consumer refers to her pediatric of unknown age. She reported that her daughter developed extreme depression, anxiety, panic attack, celiac disease, joint pain, and muscle pain since the GARDASIL (lot# unspecified), route, dose and location unspecified was given 7 years ago (approximately in August 2006). The reporter was experiencing these long term side effects from her GARDASIL. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to 9 unspecified patients received doses of GARDASIL (lot H012643, exp 30-MAR-2015) on unspecified dates, that were exposed to the same temperature excursion(28.8F for 8 minutes). No adverse effect reported. This is one of several reports received from the same source (related case # 137USA015230). Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a physician assistant concerning a patient of unknown age and gender. Approximately on an unknown date in August 2011 (reported as about two years ago), the patient was vaccinated with the first dose of 0.5 milliliter (ml) of GARDASIL (lot number, expiry date and route unspecified) by an unspecified physician. On 22-AUG-2013, the patient was vaccinated with the second dose of 0.5 milliliter (ml) of GARDASIL (lot number, expiry date and route unspecified). No concomitant therapy was reported. No adverse effect was reported. Additional information has been requested.
Age: 33.0
Sex: M
Vaccine: RAB, RAB
Symptoms: Dyskinesia, Erythema, Hypoaesthesia oral, Musculoskeletal stiffness, Palmar erythema
Clinical narrative: Case number PHHY2013US084019, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 492981) website on 06 Aug 2013, with a follow up received from the QA department on 19 Aug 2013. This report refers to a 33-year-old male patient. His medical history and concomitant medications was not reported. He was vaccinated with the second dose of RABAVERT (batch number: 51901C) intramuscularly in the left arm on 31 May 2013. On the same day, 30 minutes after vaccination, he experienced numbness of perioral area with the reporter noting some decreased movement of the mouth. He visited the emergency room. It was also reported that he experienced tongue numbness, red hands (palms) and face, stiff hands and it was hard to flex, pruritus all over and headache. His blood pressure was 118/72 and pulse was 100. He was observed for 30 minutes, after that there was no facial movement abnormality and tongue movements became normal. The patient felt like he was wheezing but his breathing was fine, non-labored and sounds equally bilateral and there were no wheezes. It was reported that redness and rash was initially on palms, which spread to the whole body with clear urticarial on upper arms and axilla. He was prescribed BENADRYL at a dose of 50 mg orally and observed. At 03:15, he had growing skin rash, but no other advancement of symptoms noted. He was sitting upright, talking with wife. As per physician advice he was given BENADRYL 25 mg intramuscularly. At 3:46, he was breathing fine, urticarial on arm decreasing, feels fine, lungs clear. His pulse rate was 80 and respiratory rate was 20. His face was normal in color and he could make a fist. It was reported that she had an option of changing to ZYRTEC or CLARITIN or steroids if the symptoms last for couple of days. The event outcome was complete recovery. The physician told the patient that in future he should only get rabies vaccination, where they had excellent care and set up for severe reaction. The seriousness and causality was not reported. The QA department confirmed that the reported RABAVERT batch number was not a valid batch, hence investigation could not be performed. No additional information was available. Follow up received from the QA department on 19 Aug 2013: QA investigation cannot be performed as the batch number is not valid.
Age: 33.0
Sex: M
Vaccine: RAB, RAB
Symptoms: Pruritus generalised, Rash, Rash generalised, Urticaria
Clinical narrative: Case number PHHY2013US084019, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 492981) website on 06 Aug 2013, with a follow up received from the QA department on 19 Aug 2013. This report refers to a 33-year-old male patient. His medical history and concomitant medications was not reported. He was vaccinated with the second dose of RABAVERT (batch number: 51901C) intramuscularly in the left arm on 31 May 2013. On the same day, 30 minutes after vaccination, he experienced numbness of perioral area with the reporter noting some decreased movement of the mouth. He visited the emergency room. It was also reported that he experienced tongue numbness, red hands (palms) and face, stiff hands and it was hard to flex, pruritus all over and headache. His blood pressure was 118/72 and pulse was 100. He was observed for 30 minutes, after that there was no facial movement abnormality and tongue movements became normal. The patient felt like he was wheezing but his breathing was fine, non-labored and sounds equally bilateral and there were no wheezes. It was reported that redness and rash was initially on palms, which spread to the whole body with clear urticarial on upper arms and axilla. He was prescribed BENADRYL at a dose of 50 mg orally and observed. At 03:15, he had growing skin rash, but no other advancement of symptoms noted. He was sitting upright, talking with wife. As per physician advice he was given BENADRYL 25 mg intramuscularly. At 3:46, he was breathing fine, urticarial on arm decreasing, feels fine, lungs clear. His pulse rate was 80 and respiratory rate was 20. His face was normal in color and he could make a fist. It was reported that she had an option of changing to ZYRTEC or CLARITIN or steroids if the symptoms last for couple of days. The event outcome was complete recovery. The physician told the patient that in future he should only get rabies vaccination, where they had excellent care and set up for severe reaction. The seriousness and causality was not reported. The QA department confirmed that the reported RABAVERT batch number was not a valid batch, hence investigation could not be performed. No additional information was available. Follow up received from the QA department on 19 Aug 2013: QA investigation cannot be performed as the batch number is not valid.
Age: 33.0
Sex: M
Vaccine: RAB, RAB
Symptoms: Dyskinesia, Erythema, Headache, Hypoaesthesia oral, Hypotension
Clinical narrative: Case number PHHY2013US084019, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 492981) website on 06 Aug 2013, with a follow up received from the QA department on 19 Aug 2013. This report refers to a 33-year-old male patient. His medical history and concomitant medications was not reported. He was vaccinated with the second dose of RABAVERT (batch number: 51901C) intramuscularly in the left arm on 31 May 2013. On the same day, 30 minutes after vaccination, he experienced numbness of perioral area with the reporter noting some decreased movement of the mouth. He visited the emergency room. It was also reported that he experienced tongue numbness, red hands (palms) and face, stiff hands and it was hard to flex, pruritus all over and headache. His blood pressure was 118/72 and pulse was 100. He was observed for 30 minutes, after that there was no facial movement abnormality and tongue movements became normal. The patient felt like he was wheezing but his breathing was fine, non-labored and sounds equally bilateral and there were no wheezes. It was reported that redness and rash was initially on palms, which spread to the whole body with clear urticarial on upper arms and axilla. He was prescribed BENADRYL at a dose of 50 mg orally and observed. At 03:15, he had growing skin rash, but no other advancement of symptoms noted. He was sitting upright, talking with wife. As per physician advice he was given BENADRYL 25 mg intramuscularly. At 3:46, he was breathing fine, urticarial on arm decreasing, feels fine, lungs clear. His pulse rate was 80 and respiratory rate was 20. His face was normal in color and he could make a fist. It was reported that she had an option of changing to ZYRTEC or CLARITIN or steroids if the symptoms last for couple of days. The event outcome was complete recovery. The physician told the patient that in future he should only get rabies vaccination, where they had excellent care and set up for severe reaction. The seriousness and causality was not reported. The QA department confirmed that the reported RABAVERT batch number was not a valid batch, hence investigation could not be performed. No additional information was available. Follow up received from the QA department on 19 Aug 2013: QA investigation cannot be performed as the batch number is not valid.
Age: 33.0
Sex: M
Vaccine: RAB, RAB
Symptoms: Mobility decreased, Musculoskeletal stiffness, Palmar erythema, Pruritus generalised, Rash generalised
Clinical narrative: Case number PHHY2013US084019, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 492981) website on 06 Aug 2013, with a follow up received from the QA department on 19 Aug 2013. This report refers to a 33-year-old male patient. His medical history and concomitant medications was not reported. He was vaccinated with the second dose of RABAVERT (batch number: 51901C) intramuscularly in the left arm on 31 May 2013. On the same day, 30 minutes after vaccination, he experienced numbness of perioral area with the reporter noting some decreased movement of the mouth. He visited the emergency room. It was also reported that he experienced tongue numbness, red hands (palms) and face, stiff hands and it was hard to flex, pruritus all over and headache. His blood pressure was 118/72 and pulse was 100. He was observed for 30 minutes, after that there was no facial movement abnormality and tongue movements became normal. The patient felt like he was wheezing but his breathing was fine, non-labored and sounds equally bilateral and there were no wheezes. It was reported that redness and rash was initially on palms, which spread to the whole body with clear urticarial on upper arms and axilla. He was prescribed BENADRYL at a dose of 50 mg orally and observed. At 03:15, he had growing skin rash, but no other advancement of symptoms noted. He was sitting upright, talking with wife. As per physician advice he was given BENADRYL 25 mg intramuscularly. At 3:46, he was breathing fine, urticarial on arm decreasing, feels fine, lungs clear. His pulse rate was 80 and respiratory rate was 20. His face was normal in color and he could make a fist. It was reported that she had an option of changing to ZYRTEC or CLARITIN or steroids if the symptoms last for couple of days. The event outcome was complete recovery. The physician told the patient that in future he should only get rabies vaccination, where they had excellent care and set up for severe reaction. The seriousness and causality was not reported. The QA department confirmed that the reported RABAVERT batch number was not a valid batch, hence investigation could not be performed. No additional information was available. Follow up received from the QA department on 19 Aug 2013: QA investigation cannot be performed as the batch number is not valid.
Age: 33.0
Sex: M
Vaccine: RAB, RAB
Symptoms: Urticaria
Clinical narrative: Case number PHHY2013US084019, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 492981) website on 06 Aug 2013, with a follow up received from the QA department on 19 Aug 2013. This report refers to a 33-year-old male patient. His medical history and concomitant medications was not reported. He was vaccinated with the second dose of RABAVERT (batch number: 51901C) intramuscularly in the left arm on 31 May 2013. On the same day, 30 minutes after vaccination, he experienced numbness of perioral area with the reporter noting some decreased movement of the mouth. He visited the emergency room. It was also reported that he experienced tongue numbness, red hands (palms) and face, stiff hands and it was hard to flex, pruritus all over and headache. His blood pressure was 118/72 and pulse was 100. He was observed for 30 minutes, after that there was no facial movement abnormality and tongue movements became normal. The patient felt like he was wheezing but his breathing was fine, non-labored and sounds equally bilateral and there were no wheezes. It was reported that redness and rash was initially on palms, which spread to the whole body with clear urticarial on upper arms and axilla. He was prescribed BENADRYL at a dose of 50 mg orally and observed. At 03:15, he had growing skin rash, but no other advancement of symptoms noted. He was sitting upright, talking with wife. As per physician advice he was given BENADRYL 25 mg intramuscularly. At 3:46, he was breathing fine, urticarial on arm decreasing, feels fine, lungs clear. His pulse rate was 80 and respiratory rate was 20. His face was normal in color and he could make a fist. It was reported that she had an option of changing to ZYRTEC or CLARITIN or steroids if the symptoms last for couple of days. The event outcome was complete recovery. The physician told the patient that in future he should only get rabies vaccination, where they had excellent care and set up for severe reaction. The seriousness and causality was not reported. The QA department confirmed that the reported RABAVERT batch number was not a valid batch, hence investigation could not be performed. No additional information was available. Follow up received from the QA department on 19 Aug 2013: QA investigation cannot be performed as the batch number is not valid.
Age: 29.0
Sex: F
Vaccine: MMR, TDAP, VARCEL, MMR, TDAP, VARCEL, MMR, VARCEL
Symptoms: Exposure during pregnancy
Clinical narrative: This patient was approximately 8 weeks pregnant. We have suggested she contact her OBGYN physician. She has had no known adverse symptoms to date.
Age: 29.0
Sex: F
Vaccine: MMR, TDAP, VARCEL, MMR, TDAP, VARCEL, MMR, VARCEL
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: This patient was approximately 8 weeks pregnant. We have suggested she contact her OBGYN physician. She has had no known adverse symptoms to date.
Sex: M
Vaccine: PPV, TDAP, DTAP, PPV, DTAP, PPV, DTAP, PPV
Symptoms: Breath odour, Chest X-ray, Cough, Decreased appetite, Dysphonia
Clinical narrative: This spontaneous report was received from a physician, concerning a male patient of unknown age. On an unknown date the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(manufacturer unknown) (Lot #, dose and route not reported). Other suspect therapy included diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid (manufacturer unknown) (Lot #, dose and route not reported). Concomitant therapy was not reported. The physician reported that he read in the obituary section of the newspaper, on 21-AUG-2013 that the patient died from an illness that began on 11-APR-2013 after receiving the vaccines (whether the vaccinations precipitated the exacerbation of a possible lime disease infection was still in question). It was reported that the physician was not the patient's physician and that the physician just read it in the obituary section of the newspaper. It was reported that the patient died on 18-AUG-2013 and the case of death was reported as illness. This report was serious due to life threatening (considered by the physician) and death. Additional information is not expected.