chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 3.0
Sex: F
Vaccine: VARCEL
Symptoms: Incorrect route of drug administration, Injection site erythema, Skin reaction
Clinical narrative: This spontaneous report was received from a registered nurse refers to a 3 year old female patient. The nurse reported that on 15-FEB-2013, the patient was vaccinated with a dose of VARIVAX (Merck), 0.5 ml, intradermally because it was mistake for TB MANTAUX injection (manufacturer unknown). MANTAUX injection had not been given at the time of the call. The VARIVAX (Merck) was indicated for the patient at that visit, and the patient was still in the office. The vaccine was injected under the sin and formed a small bubble and was red around the injection site. the outcome of the events was unknown. The relatedness between the events and VARIVAX (Merck) was unknown. Additional information has been requested.
Age: 39.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: 10 cm patch of erythema at injection site with induration, no drainage and warm, swollen and tender x 5 days and progressing. Pt sent to ER.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising
Clinical narrative: This spontaneous report as received from a registered pharmacist refers to a female patient of unknown age. On an unknown date, "over the last couple years", the patient was vaccinated with a 0.65 ml dose of ZOSTAVAX (Lot # not reported) subcutaneously. The pharmacist reported that on an unknown date, "over the last couple of years", the patient experienced bruising around the injection site as she described as profuse bruising between the elbow and shoulder. The patient did not receive treatment for the adverse event. The outcome of bruising around the injection site was reported as recovered/resolved. This is one of several reports received from the same source. Additional information is not expected.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a pharmacist refers to a male patient of unknown age and gender. In February 2013 within the last 10 days, the patient was vaccinated with ZOSTAVAX. The pharmacist reported that a physician told him that the patient developed shingles after receiving ZOSTAVAX. The outcome of the event was reported as not recovered/not resolved. The relatedness between the event and ZOSTAVAX was unknown. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age with HIV infection. On an unknown date the patient was vaccinated with a higher than normal dose of RECOMBIVAX HB (lot number unspecified). No adverse symptoms reported. The outcome of the patient was unknown. It was unknown if the patient sought medical attention. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site bruising
Clinical narrative: This spontaneous report as received from a registered pharmacist refers to two patients of unknown age. On an unknown date, "over the last couple years", the patients were vaccinated with a 0.65 ml dose of ZOSTAVAX (Lot # not reported) subcutaneously. The pharmacist reported that on an unknown date, "over the last couple years", the patients experienced bruising around the injection site. The patients did not receive treatment for the adverse event. The outcome of bruising around the injection site was reported as recovered/resolved. This is one of several reports received from the same source. Additional information is not expected.
Sex: U
Vaccine: RV5
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a patient of unknown age. The patient was vaccinated with ROTARIX as the first dose of the rotavirus series on an unspecified date and the patient was vaccinated with oral ROTATEQ (lot number, dose and route were not reported0 as the second dose on 21-FEB-2013. No adverse effect reported. The action taken and outcome were not provided. It was unspecified if the patient sought any medical attention. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Attention deficit/hyperactivity disorder, Autism, Developmental delay, Nervous system disorder
Clinical narrative: This spontaneous report was received from a consumer refers to a multiple patients (age and gender unknown). On an unknown date, the patients were vaccinated with MMR II. Concomitant medication was not reported. On an unknown date, the patient experienced neurological disorder, autism, attention deficit/hyperactivity disorder (ADHD) and developmental disorder. At the time of the report, the outcome of neurological disorder, autism, ADHD and developmental disorder was unknown. The reporter considered neurological disorder, autism, ADHD and developmental disorder to be related to MMR II. Additional information has been requested.
Age: 52.0
Sex: F
Vaccine: FLUX
Symptoms: Allergy test, Anaphylactic reaction, Dysphonia, Dyspnoea, Throat tightness
Clinical narrative: Approximately an hour after receiving the vacination, noticed tightness in throat, hoarseness, difficulty breathing.  Went back to hospital to ER.  Treated for anaphylaxis and sent home.  Approximately one and a half hours after getting home, had second attack with same symptoms.  Admitted to hospital for five days.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Headache, Paraesthesia
Clinical narrative: This spontaneous report as received from a 61 year old female nurse refers to herself. The patient had hypothyroidism and drug allergy to sulfa. On "Monday" 11-FEB-2013, the patient was vaccinated subcutaneously with 0.5 ml live ZOSTAVAX (lot # not reported). Concomitant therapies included SYNTHROID. On 13-FEB-2013, she was drinking a warm drink and developed a sharp stabbing pain on right side of face and behind right ear (also reported as "right side of face nerve pain after drinking warm behind ear, stabbing sensation" and "may be nerve pain (since) slightest touch=exaggerated response and numbness"). The stabbing pain became numbness and traveled down to right side of neck. She reported it then turned into a severe headache on the right side of the head which lasted 4 hours  before resolving. She reports that "this morning", on 14-FEB-2013, she experienced the same progression of face pain to headache, but this time on the left side of her face. She had not sought any medical attention at this time. She has only taken MOTRIN (manufacturer unspecified) to treat the headache, with relief. Lab diagnostics studies performed were reported as none. The outcome of other adverse events except headache was unknown. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Facial pain, Headache, Hyperaesthesia, Hypoaesthesia, Pain
Clinical narrative: This spontaneous report as received from a 61 year old female nurse refers to herself. The patient had hypothyroidism and drug allergy to sulfa. On "Monday" 11-FEB-2013, the patient was vaccinated subcutaneously with 0.5 ml live ZOSTAVAX (lot # not reported). Concomitant therapies included SYNTHROID. On 13-FEB-2013, she was drinking a warm drink and developed a sharp stabbing pain on right side of face and behind right ear (also reported as "right side of face nerve pain after drinking warm behind ear, stabbing sensation" and "may be nerve pain (since) slightest touch=exaggerated response and numbness"). The stabbing pain became numbness and traveled down to right side of neck. She reported it then turned into a severe headache on the right side of the head which lasted 4 hours  before resolving. She reports that "this morning", on 14-FEB-2013, she experienced the same progression of face pain to headache, but this time on the left side of her face. She had not sought any medical attention at this time. She has only taken MOTRIN (manufacturer unspecified) to treat the headache, with relief. Lab diagnostics studies performed were reported as none. The outcome of other adverse events except headache was unknown. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Oedema peripheral, Oral herpes, Paraesthesia, Pruritus
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 60 year old female patient with no drug reactions/allergies. The patient's medical history included cold sores. On 06-FEB-2013 the patient was vaccinated with a dose of live ZOSTAVAX (lot # H019998, exp 02-FEB-2014), subcutaneous in the arm. The pharmacist reported that within 45 minutes the patient experienced a welt on her arm at the injection site. With 2 days after the injection, on approximately 08-FEB-2013, the patient's arm was swollen and red. The patient went to see her unspecified physician because of this reaction an was advised to put ice on her arm. The patient came into the pharmacy on 13-FEB-2013 and the redness and swelling went down, but now the patient was reporting that she was experiencing tightness, itchiness and a pins and needles feeling in her arm. The patient also experienced two cold sores since the vaccine was administered on an unspecified date. No lab diagnostics studies performed. The outcome of the patient was reported as not recovered. The relatedness for the events to live ZOSTAVAX was unknown. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Skin tightness, Skin warm, Swelling, Urticaria
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 60 year old female patient with no drug reactions/allergies. The patient's medical history included cold sores. On 06-FEB-2013 the patient was vaccinated with a dose of live ZOSTAVAX (lot # H019998, exp 02-FEB-2014), subcutaneous in the arm. The pharmacist reported that within 45 minutes the patient experienced a welt on her arm at the injection site. With 2 days after the injection, on approximately 08-FEB-2013, the patient's arm was swollen and red. The patient went to see her unspecified physician because of this reaction an was advised to put ice on her arm. The patient came into the pharmacy on 13-FEB-2013 and the redness and swelling went down, but now the patient was reporting that she was experiencing tightness, itchiness and a pins and needles feeling in her arm. The patient also experienced two cold sores since the vaccine was administered on an unspecified date. No lab diagnostics studies performed. The outcome of the patient was reported as not recovered. The relatedness for the events to live ZOSTAVAX was unknown. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Injection site urticaria, Oedema peripheral, Oral herpes, Paraesthesia
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 60 year old female patient with no drug reactions/allergies. The patient's medical history included cold sores. On 06-FEB-2013 the patient was vaccinated with a dose of live ZOSTAVAX (lot # H019998, exp 02-FEB-2014), subcutaneous in the arm. The pharmacist reported that within 45 minutes the patient experienced a welt on her arm at the injection site. With 2 days after the injection, on approximately 08-FEB-2013, the patient's arm was swollen and red. The patient went to see her unspecified physician because of this reaction an was advised to put ice on her arm. The patient came into the pharmacy on 13-FEB-2013 and the redness and swelling went down, but now the patient was reporting that she was experiencing tightness, itchiness and a pins and needles feeling in her arm. The patient also experienced two cold sores since the vaccine was administered on an unspecified date. No lab diagnostics studies performed. The outcome of the patient was reported as not recovered. The relatedness for the events to live ZOSTAVAX was unknown. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pruritus, Skin tightness
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 60 year old female patient with no drug reactions/allergies. The patient's medical history included cold sores. On 06-FEB-2013 the patient was vaccinated with a dose of live ZOSTAVAX (lot # H019998, exp 02-FEB-2014), subcutaneous in the arm. The pharmacist reported that within 45 minutes the patient experienced a welt on her arm at the injection site. With 2 days after the injection, on approximately 08-FEB-2013, the patient's arm was swollen and red. The patient went to see her unspecified physician because of this reaction an was advised to put ice on her arm. The patient came into the pharmacy on 13-FEB-2013 and the redness and swelling went down, but now the patient was reporting that she was experiencing tightness, itchiness and a pins and needles feeling in her arm. The patient also experienced two cold sores since the vaccine was administered on an unspecified date. No lab diagnostics studies performed. The outcome of the patient was reported as not recovered. The relatedness for the events to live ZOSTAVAX was unknown. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Abdominal pain, Abnormal sensation in eye, Blood 25-hydroxycholecalciferol decreased, Blood potassium decreased, Body temperature increased
Clinical narrative: Dizziness, headache, temple pain, left TMJ pain, diarrhea, vomiting, photosensitivity, muscle twitches, pain on injection site radiating down to her lower arm since vaccine; nausea.
Age: 60.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: C-reactive protein increased, Chills, Dizziness, Fatigue, Feeling hot
Clinical narrative: Dizziness, headache, temple pain, left TMJ pain, diarrhea, vomiting, photosensitivity, muscle twitches, pain on injection site radiating down to her lower arm since vaccine; nausea.
Age: 60.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Headache, Injection site pain, Intermittent claudication, Malaise, Muscle contractions involuntary
Clinical narrative: Dizziness, headache, temple pain, left TMJ pain, diarrhea, vomiting, photosensitivity, muscle twitches, pain on injection site radiating down to her lower arm since vaccine; nausea.
Age: 60.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Muscular weakness, Myalgia, Nausea, Nerve root lesion, Night sweats
Clinical narrative: Dizziness, headache, temple pain, left TMJ pain, diarrhea, vomiting, photosensitivity, muscle twitches, pain on injection site radiating down to her lower arm since vaccine; nausea.
Age: 60.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Pain in extremity, Photosensitivity reaction, Tachycardia, Vitamin B12 decreased, Vomiting
Clinical narrative: Dizziness, headache, temple pain, left TMJ pain, diarrhea, vomiting, photosensitivity, muscle twitches, pain on injection site radiating down to her lower arm since vaccine; nausea.
Age: 60.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Diarrhoea, Dizziness, Headache, Injection site pain, Muscle twitching
Clinical narrative: Dizziness, headache, temple pain, left TMJ pain, diarrhea, vomiting, photosensitivity, muscle twitches, pain on injection site radiating down to her lower arm since vaccine; nausea.
Age: 60.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Nausea, Pain in extremity, Photosensitivity reaction, Temporomandibular joint syndrome, Vomiting
Clinical narrative: Dizziness, headache, temple pain, left TMJ pain, diarrhea, vomiting, photosensitivity, muscle twitches, pain on injection site radiating down to her lower arm since vaccine; nausea.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Oropharyngeal pain, Pain, Pyrexia, Vomiting
Clinical narrative: States she had body aches, 101 fever, vomiting and sore throat.
Age: 0.01
Sex: M
Vaccine: HEP
Symptoms: Feeding disorder neonatal, Lethargy, Somnolence, Weight decrease neonatal
Clinical narrative: Extreme lethargy, frequently impossible to wake, sudden drop in weight, more difficulty breastfeeding than in the hospital.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a patient of unknown age. On 27-FEB-2012 the patient was vaccinated with the first dose of 0.5ml GARDASIL (lot number unspecified) intramuscularly. The patient was in office today, on 21-FEB-2013, to receive second dose of 0.5ml GARDASIL (lot number unspecified) intramuscularly. No adverse effect reported. It was unknown if the patient had sought medical attention. The outcome of the patient was unknown. Additional information is not expected.
Age: 21.0
Sex: F
Vaccine: VARZOS
Symptoms: Accidental exposure to product, Eye pain, Ocular hyperaemia
Clinical narrative: This spontaneous report as received from a medical assistant referred to her co-worker who a 21 year old female patient. On 22-FEB-2013 the patient was drawing up a dose of live ZOSTAVAX (lot # H019040, exp date as 17-JAN-2014). Patient was flicking the syringe to remove airbubbles and inadvertently splashed live ZOSTAVAX in her right eye. The eye was red and painful, and an eyewash was done for 15 minutes. The eye was no longer painful after washing, but continued to be red. The coworker had not yet seen a physician concerning eye exposure. No lab diagnostics studies performed and no treatment was given for events. The relationship was not provided. Additional information is not expected.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Paraesthesia
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 69 year old female patient. On 06-FEB-2013, the patient was vaccinated with a dose of 0.65 ml of live ZOSTAVAX (lot # H019998, expiry:02-FEB-2014) subcutaneously in the left arm. On 09-FEB-2013, the patient experienced tingling, sharp pain 3 days after vaccination which started in the back area and now (more than 2 weeks post vaccination) moving to hip area. No treatment was received. Patient sought medical attention(contacted pharmacy). No laboratory diagnostics studies were performed. The outcome of tingling, sharp pain 3 days after vaccination which started in the back area was reported as not recovered. The causality for the event was live ZOSTAVAX was unknown. Additional information has been requested.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Cough, Herpes zoster
Clinical narrative: This spontaneous report was received from a 53 year old female patient who is also a nurse reporting about herself. On 29-OCT-2012, the patient was vaccinated subcutaneously with dose 1 of live ZOSTAVAX(lot#, dose not reported). On 05-NOV-2012, the patient was administered dose 2 live ZOSTAVAX (lot#, dose not reported). Concomitant therapies included PRAVACHOL, XANAX and AMBIEN. On an unknown date in 2012, the patient experienced shingles that ripped the skin off the side of her butt. Those went away at some point in January 2013 but now there are other spots where there are shingles. The location and onset date of these "other spots" were not specified. Since an unknown date, the patient had a cough. Patient received treatment with gabapentin and acyclovir. Patient sought medical attention(she was treated by her physician). No laboratory diagnostics studies were performed. The present patient status was not recovered. VZVIP Packet was faxed. The causality for the event shingles that ripped the skin off the side of her butt with live ZOSTAVAX was unknown. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Myalgia, Rash
Clinical narrative: Bumpy rash on opposite arm of injection. Site with some myalgias 9 day after vaccination administered for shingles. Rash not generalized.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Medication error, Neuralgia
Clinical narrative: This spontaneous report as received from a 68 year old female consumer refers to herself. The patient had no drug allergies. The patient had had nerve pain due to chemotherapy for colon cancer. On 29-JAN-2013, the patient was once vaccinated with live ZOSTAVAX (lot # not reported). Concomitant therapies included gabapentin. On 31-JAN-2013 (also reported as "31-JAN-2012"), the patient experienced nerve pain increased. The patient did not seek medical attention. No treatment was given. No lab diagnostics studies were performed. The outcome was unknown. Additional information has been requested.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pruritus, Injection site reaction, Rash macular
Clinical narrative: "Flare" red, splotchy itchy from injection site to shoulder and neck.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 65 year old male patient with lichen planus, elevated cholesterol and unspecified thyroid condition. The patient had no drug allergy. On 13-FEB-2013 the patient was vaccinated with ZOSTAVAX lot # H019999, 0.65 ml, one time subcutaneous in the left arm. Concomitant therapies included atorvastatin, levothyroxine sodium (manufacturer unknown) and SORIATANE. On 14-FEB-2013, the patient experienced redness, swelling and soreness of his left arm at the injection site. No treatment was given. No lab test was done. At reporting time, the patient was not recovered from the events. The patient went back to pharmacy to seek medical attention. Additional information is not expected.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Pancreatitis
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to an 18 year old female patient. The patient had no pertinent medical history and no drug reactions/allergies. On an unknown date the patient was vaccinated with GARDASIL. Dose, route, frequency and lot number were not provided. Concomitant therapies included "Birth Control Pills". On an unknown date, "one or two weeks after vaccination" the patient developed pancreatitis and was hospitalized (unknown name and address). She was treated with "IV antibiotics" and was released after treatments. The outcome of pancreatitis was reported as recovered/resolved (date unspecified). No reporter causality was provided. Pancreatitis was determined medically significant upon internal review. Additional information has been requested.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Back pain, Herpes zoster, Musculoskeletal pain, Neck pain
Clinical narrative: This spontaneous report as received from year old male patient with no drug reaction or allergies and with no pertinent medical history. Concurrent condition included high blood pressure. On 15-JAN-2013 the patient was vaccinated with a dose of ZOSTAVAX (Lot#, dose and route not reported). Concomitant therapies included LIPITOR and "high blood pressure medication". On 18-JAN-2013, the patient broke out in a shingles rash after receiving ZOSTAVAX. The rash was on his left side and spreads from his neck to "about a foot" down his back and the back of his left arm. The patient added that he had been experiencing severe pain in his shoulder, back and neck. The patient saw health care professional (HCP) to seek medical attention and was given VALTREX and SILVADENE for treatment. No lab diagnostics studies were performed. At the time of this report the patient had not recovered. Additional information has been requested.
Age: 82.0
Sex: M
Vaccine: TDAP, VARZOS
Symptoms: Cardiac arrest, Death, Multi-organ failure
Clinical narrative: This spontaneous report as received from a consumer refers to an 82 year old male patient. The patient's medical history and concurrent conditions were not provided. On 15-NOV-2012 the patient was vaccinated with a dose of ZOSTAVAX. Dose, route and lot number were not provided. No concomitant medications were reported. On an unknown date the patient experienced multi-organ failure and cardiac arrest. The outcome of multi-organ failure and cardiac arrest was reported as fatal. The patient died on 13-DEC-2012 at 1515 (military time) in the hospital. The cause of death was reported as cardiac arrest and multi-organ failure, according to the Death Certificate. No reporter causality was provided. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to unknown number of patients (age and gender unknown). On 06-DEC-2012, the patients were vaccinated with a dose of improperly stored VARIVAX (Merck) (lot number H016600, expiration date on 05-SEP-2014) (route not reported) and on 19-DEC-2012, VARIVAX (Merck) (lot number H17705, expiration date on 25-SEP-2014) (route not reported). VARIVAX (Merck) were exposed in addition to 4 hours at room temperature and 45 hours at refrigerated temperature also exposed to 5.86 F to 15F for 5 minutes and it was doing this 3 times in 1 hour every day since the received dates of the VARIVAX (Merck). No adverse effect reported. This is one of the two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered pharmacist refers to 4 patients of unknown age and gender. On unknown dates the 4 patients were possibly vaccinated with 4 doses of expired ZOSTAVAX (lot # 671611/1161AA, exp. 18-OCT-2012)(dose and route not reported). No adverse effect reported. Attempts are being made to obtain additional identifying information to distinguish the individual patients in this report. Additional information will be provided if available.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Pyrexia
Clinical narrative: Headache, fever at 100 degrees per wife, started 2/26/2013.
Age: 56.0
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 56 year old patient, who on  12-FEB-2013, was vaccinated with M-M-R II, 0.5 ml, subcutaneous (lot 1113Z, expired on 25-AUG-2012). The primary reporter stated that a 56 years old patient received an expired dose of M-M-R II on 12-FEB-2013. No adverse event was reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding an unspecified number of patients greater than 26 years old age, who was vaccinated with a dose of GARDASIL (dose, route and lot number were not provided). No adverse symptoms reported. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned on this report. Additional information will be provided if available. Additional information has been requested.
Age: 28.0
Sex: U
Vaccine: ANTH, HEP
Symptoms: Swelling
Clinical narrative: Patient developed a LLR to SQ anthrax with each vaccine given. Subsequent doses with less severe LLR.
Age: 18.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Dizziness, Fatigue, Haemorrhage
Clinical narrative: This spontaneous report was received from a physician concerning an approximately 18 year old female patient with no pertinent medical history and no drug reactions/allergies. On 20-FEB-2013 the patient was reinserted with 68 milligrams (mg) of NEXPLANON (lot number reported as 102176/173940, expiry date unspecified) for contraception after the removal of the NEXPLANON due to insertion failure on the same day. Other suspect therapy included GARDASIL (lot number, expiry date, dose and route unspecified) received on 20-FEB-2013. Concomitant therapies included Tdap and MENACTRA received on 20-FEB-2013. On 20-FEB-2013, the patient was spooked. The physician was sure that the patient would have had a bruise since the insertion site was bleeding more than other patients she had performed insertions on in the past. On 20-FEB-2013, after the patient went to home after getting NEXPLANON, the patient felt like faint and tired while standing up from sitting. No lab tests were performed. Therapy with NEXPLANON was continued. The outcome of all the events was reported as resolving. The relatedness for all the events was unknown for NEXPLANON and GARDASIL. This is one of the two reports of the same patient. Additional information is not expected.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Oedema peripheral, Pain in extremity
Clinical narrative: Pain and swelling in left arm at point of injection. Still painful 2/10/2013. Met with physician.
Age: 53.0
Sex: F
Vaccine: FLUN3
Symptoms: Computerised tomogram normal, Guillain-Barre syndrome, Hypoaesthesia, Nuclear magnetic resonance imaging normal, Paraesthesia
Clinical narrative: A report has been received from a health professional concerning an adult female patient. The patient's medical history and concomitant medications were not reported. The patient took FLUMIST in Dec-2011 and developed Guillain Barre symptoms. Four hours after administration of FLUMIST she had numbness and tingling on right side of body, then at eight hours her whole body was affected. The symptoms lasted through Jan-2012. The symptoms still occurred off and on. She had been hospitalized on occasion. Doctor ran a CT scan, MRI, and ultrasound while hospitalized and nothing could be found. At the time of reporting, the event of numbness, tingling and Guillain Barre symptoms was ongoing. Assessment of the serious criteria for the report was as follows: hospitalized as per reporter.
Age: 53.0
Sex: F
Vaccine: FLUN3
Symptoms: Ultrasound scan normal
Clinical narrative: A report has been received from a health professional concerning an adult female patient. The patient's medical history and concomitant medications were not reported. The patient took FLUMIST in Dec-2011 and developed Guillain Barre symptoms. Four hours after administration of FLUMIST she had numbness and tingling on right side of body, then at eight hours her whole body was affected. The symptoms lasted through Jan-2012. The symptoms still occurred off and on. She had been hospitalized on occasion. Doctor ran a CT scan, MRI, and ultrasound while hospitalized and nothing could be found. At the time of reporting, the event of numbness, tingling and Guillain Barre symptoms was ongoing. Assessment of the serious criteria for the report was as follows: hospitalized as per reporter.
Age: 19.0
Sex: F
Vaccine: FLU3
Symptoms: Blood test, Fall, Guillain-Barre syndrome, Hypoaesthesia, Lumbar puncture
Clinical narrative: 12/30/12: tingling numbness in feet & hands. 12/31/12: began falling down. 1/1/13: ER visit / admitted to hospital / diagnosed with Guillain-Barre Syndrome - 1/24/13 D/C.
Age: 19.0
Sex: F
Vaccine: FLU3
Symptoms: Nerve conduction studies, Paraesthesia
Clinical narrative: 12/30/12: tingling numbness in feet & hands. 12/31/12: began falling down. 1/1/13: ER visit / admitted to hospital / diagnosed with Guillain-Barre Syndrome - 1/24/13 D/C.
Age: 1.54
Sex: M
Vaccine: DTAP
Symptoms: Injection site induration, Injection site nodule, Injection site swelling, Injection site warmth
Clinical narrative: Dtap vaccine administered on 02/25. Morning of 02/26 at 0700 mother noticed normal knot and swelling of site. Morning of 02/27 child woke with whole left lateral thigh swollen, hard and hot to touch.
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 refers to a patient of unknown age and gender. ON 07-AUG-2012, the patient was vaccinated with the first dose of GARDASIL (dose, route and lot not reported) and on 02-JAN-2013 was vaccinated with the second dose of GARDASIL (dose, route and lot not reported). No adverse effect reported. The outcome of the event was unknown. The reporter considered the event to be not related to GARDASIL. Additional information has been requested.
Age: 27.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Patient received Varicella vaccine SQ. Approximately 20 min post injection, patient noticed 1-4 mm reddened raised area on (R) forearm and 1-2 mm reddened, raised area. Also noticed 1-4 mm reddened raised area on (L) inner elbow. Patient stated areas itched mildly, BENADRYL 25mg po given, instructed patient to take second 25mg capsule once arrived at home. To ER if increased breakout. Called, left message to call to update.
Age: 10.0
Sex: M
Vaccine: FLU3, HEP, MMR, TD
Symptoms: Arthralgia, Blood test, Joint swelling, Rash generalised
Clinical narrative: Child c/o joint pain through out the day. On 2/21/13, developed a rash on ankles on 2/22/13, swelling of joints and worsening of rash on 2/23/13, all over body rash and lower extremety joint pain/swelling on 2/24/13-2/27/13.
Age: 27.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Abortion spontaneous, Maternal exposure during pregnancy, Rash, Urticaria
Clinical narrative: Severe rash and hive but found out she was pregnant after the flu shot and later miscarriage.
Age: 27.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Abortion spontaneous, Exposure during pregnancy, Rash, Urticaria
Clinical narrative: Severe rash and hive but found out she was pregnant after the flu shot and later miscarriage.
Age: 24.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Erythema, Pruritus, Pruritus genital
Clinical narrative: Itching in groin and thigh area. Itching redness on hands started on 24 Feb 13.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Normal initial injection soreness had been gone for several days, then began having problems lifting arm, deep pain at injection site, that has continued, and is gradually worsening, and spreading down arm, and into shoulder joint.
Age: 70.0
Sex: U
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: Information has been received from a pharmacist via a sales representative. Sales representative stated the pharmacist reported that 2 anonymous patients developed a varicella like rash around their eyes within a day after receiving ZOSTAVAX vial (19400 PFU) (dose #, lot # and route of administration not reported) approximately one year ago. The patients sought medical attention. Sales representative stated the pharmacist mentioned both patients were approximately 70 years of age and both patients may have been treated with acyclovir or VALTREX. On an unspecified date, the patients recovered from varicella like rash around their eyes. VZVID packet was faxed to the pharmacist. Additional information has been requested.
Age: 31.0
Sex: M
Vaccine: FLUX
Symptoms: Abdominal pain lower, Asthenia, Chills, Decreased appetite, Dizziness
Clinical narrative: This 61 year old retired patient, reported receipt of influenza vaccine in 1976 "that had the wrong strength". He remembers about 20 minutes after the vaccination he complained of nausea, vomiting and had a fever that resulted in a three day hospital admission. He denied any muscle weakness, tingling, loss of sensation or paralysis. He advised he was there for a modified 3 week Basic Training Course in November 1976 when he received the influenza vaccination. He stated he has been unable to obtain or locate these 1976 records or records for a 1985 Influenza vaccination that also resulted in 3-4 days of headaches, nausea, vomiting, runny nose and congestion. He remembers being told never to get the influenza vaccine. He did receive other vaccinations during his career and lifetime without difficulty, including 4 other influenza vaccinations (per medical records). He denied any egg, food, chemical or latex allergies. He does have seasonal allergies. A review of archived medical records showed scattered records from 1969 to 1995. However there were no records for the 1976 or 1985 events. His records document handwritten receipt of influenza TIV vaccinations in 1990, 1991, 1992, and 1994 with no adverse event. At this time, he advised he worked in immunizations and reported he was administering vaccinations; however, he does not recall receiving any influenza vaccination since 1985. His records did documents reported symptoms of nausea, vomiting, hot/cold chills, lower abdominal cramping, weakness and dizziness, headache and/or loss of appetite with diagnoses of acute gastroenteritis (AGE) and migraines on 10/19/1980, 1/4/1981, 12/19/1984, and 4/15/1986. A review of limited 1985 records listed 4 evaluation for chronic left Achilles tendonitis (onset 1983) treated with various NSAIDs (MOTRIN, INDOCIN, TOLECTIN DS and oral prednisone and IM KENALOG (to joints)). There were no exacerbations of health issues between 1990-1994 vaccinations (treated for chronic bilateral achilles tendonitis). He began documenting "severe flu symptoms in 1976" to his SF93 annual physical forms in 1995. In 2013, he reported he had not received any influenza vaccination since 1985.
Age: 31.0
Sex: M
Vaccine: FLUX
Symptoms: Drug dispensing error, Feeling of body temperature change, Gastroenteritis, Headache, Influenza
Clinical narrative: This 61 year old retired patient, reported receipt of influenza vaccine in 1976 "that had the wrong strength". He remembers about 20 minutes after the vaccination he complained of nausea, vomiting and had a fever that resulted in a three day hospital admission. He denied any muscle weakness, tingling, loss of sensation or paralysis. He advised he was there for a modified 3 week Basic Training Course in November 1976 when he received the influenza vaccination. He stated he has been unable to obtain or locate these 1976 records or records for a 1985 Influenza vaccination that also resulted in 3-4 days of headaches, nausea, vomiting, runny nose and congestion. He remembers being told never to get the influenza vaccine. He did receive other vaccinations during his career and lifetime without difficulty, including 4 other influenza vaccinations (per medical records). He denied any egg, food, chemical or latex allergies. He does have seasonal allergies. A review of archived medical records showed scattered records from 1969 to 1995. However there were no records for the 1976 or 1985 events. His records document handwritten receipt of influenza TIV vaccinations in 1990, 1991, 1992, and 1994 with no adverse event. At this time, he advised he worked in immunizations and reported he was administering vaccinations; however, he does not recall receiving any influenza vaccination since 1985. His records did documents reported symptoms of nausea, vomiting, hot/cold chills, lower abdominal cramping, weakness and dizziness, headache and/or loss of appetite with diagnoses of acute gastroenteritis (AGE) and migraines on 10/19/1980, 1/4/1981, 12/19/1984, and 4/15/1986. A review of limited 1985 records listed 4 evaluation for chronic left Achilles tendonitis (onset 1983) treated with various NSAIDs (MOTRIN, INDOCIN, TOLECTIN DS and oral prednisone and IM KENALOG (to joints)). There were no exacerbations of health issues between 1990-1994 vaccinations (treated for chronic bilateral achilles tendonitis). He began documenting "severe flu symptoms in 1976" to his SF93 annual physical forms in 1995. In 2013, he reported he had not received any influenza vaccination since 1985.
Age: 31.0
Sex: M
Vaccine: FLUX
Symptoms: Migraine, Nausea, Pyrexia, Respiratory tract congestion, Rhinorrhoea
Clinical narrative: This 61 year old retired patient, reported receipt of influenza vaccine in 1976 "that had the wrong strength". He remembers about 20 minutes after the vaccination he complained of nausea, vomiting and had a fever that resulted in a three day hospital admission. He denied any muscle weakness, tingling, loss of sensation or paralysis. He advised he was there for a modified 3 week Basic Training Course in November 1976 when he received the influenza vaccination. He stated he has been unable to obtain or locate these 1976 records or records for a 1985 Influenza vaccination that also resulted in 3-4 days of headaches, nausea, vomiting, runny nose and congestion. He remembers being told never to get the influenza vaccine. He did receive other vaccinations during his career and lifetime without difficulty, including 4 other influenza vaccinations (per medical records). He denied any egg, food, chemical or latex allergies. He does have seasonal allergies. A review of archived medical records showed scattered records from 1969 to 1995. However there were no records for the 1976 or 1985 events. His records document handwritten receipt of influenza TIV vaccinations in 1990, 1991, 1992, and 1994 with no adverse event. At this time, he advised he worked in immunizations and reported he was administering vaccinations; however, he does not recall receiving any influenza vaccination since 1985. His records did documents reported symptoms of nausea, vomiting, hot/cold chills, lower abdominal cramping, weakness and dizziness, headache and/or loss of appetite with diagnoses of acute gastroenteritis (AGE) and migraines on 10/19/1980, 1/4/1981, 12/19/1984, and 4/15/1986. A review of limited 1985 records listed 4 evaluation for chronic left Achilles tendonitis (onset 1983) treated with various NSAIDs (MOTRIN, INDOCIN, TOLECTIN DS and oral prednisone and IM KENALOG (to joints)). There were no exacerbations of health issues between 1990-1994 vaccinations (treated for chronic bilateral achilles tendonitis). He began documenting "severe flu symptoms in 1976" to his SF93 annual physical forms in 1995. In 2013, he reported he had not received any influenza vaccination since 1985.
Age: 31.0
Sex: M
Vaccine: FLUX
Symptoms: Tendonitis, Vomiting
Clinical narrative: This 61 year old retired patient, reported receipt of influenza vaccine in 1976 "that had the wrong strength". He remembers about 20 minutes after the vaccination he complained of nausea, vomiting and had a fever that resulted in a three day hospital admission. He denied any muscle weakness, tingling, loss of sensation or paralysis. He advised he was there for a modified 3 week Basic Training Course in November 1976 when he received the influenza vaccination. He stated he has been unable to obtain or locate these 1976 records or records for a 1985 Influenza vaccination that also resulted in 3-4 days of headaches, nausea, vomiting, runny nose and congestion. He remembers being told never to get the influenza vaccine. He did receive other vaccinations during his career and lifetime without difficulty, including 4 other influenza vaccinations (per medical records). He denied any egg, food, chemical or latex allergies. He does have seasonal allergies. A review of archived medical records showed scattered records from 1969 to 1995. However there were no records for the 1976 or 1985 events. His records document handwritten receipt of influenza TIV vaccinations in 1990, 1991, 1992, and 1994 with no adverse event. At this time, he advised he worked in immunizations and reported he was administering vaccinations; however, he does not recall receiving any influenza vaccination since 1985. His records did documents reported symptoms of nausea, vomiting, hot/cold chills, lower abdominal cramping, weakness and dizziness, headache and/or loss of appetite with diagnoses of acute gastroenteritis (AGE) and migraines on 10/19/1980, 1/4/1981, 12/19/1984, and 4/15/1986. A review of limited 1985 records listed 4 evaluation for chronic left Achilles tendonitis (onset 1983) treated with various NSAIDs (MOTRIN, INDOCIN, TOLECTIN DS and oral prednisone and IM KENALOG (to joints)). There were no exacerbations of health issues between 1990-1994 vaccinations (treated for chronic bilateral achilles tendonitis). He began documenting "severe flu symptoms in 1976" to his SF93 annual physical forms in 1995. In 2013, he reported he had not received any influenza vaccination since 1985.
Age: 0.19
Sex: M
Vaccine: DTAP, HEP, HEPA, HIBV, IPV, MMR
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: 10 week old infant patient was given a hepatitis A vaccine as well as a MMR vaccine that were not scheduled to be given until after 12 months of age in addition to the scheduled Hib, hep B, DTap and IPV vaccines.
Age: 46.0
Sex: F
Vaccine: HEPA, TYP
Symptoms: Abdominal distension, Abdominal pain upper, Abdominal rigidity, Constipation, Diarrhoea
Clinical narrative: Stomach cramps, nausea, constipation, bloated abdomen, abdomen hard to touch, some diarrhea. The symptoms continued daily and are just starting to subside as of today, 2/27/13.
Age: 46.0
Sex: F
Vaccine: HEPA, TYP
Symptoms: Nausea
Clinical narrative: Stomach cramps, nausea, constipation, bloated abdomen, abdomen hard to touch, some diarrhea. The symptoms continued daily and are just starting to subside as of today, 2/27/13.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Red, swollen and warm to touch, area was the size of golf ball at top and baseball at the bottom.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient developed erythema, swelling, and pain around injection site. Patient took diphenhydramine and erythema and swelling subsided but pain remains.
Age: 14.0
Sex: F
Vaccine: FLU3, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Itching and redness at injection site.
Age: 28.0
Sex: M
Vaccine: TYP, YF
Symptoms: Anaphylactic reaction, Dyspnoea, Urticaria
Clinical narrative: After receiving two vaccinations the morning of the incident at or about 0945. The patient returned to the Aid station at 1200 After suffering from an anaphylactic reaction. With the chief complaint of for hives that had broken out all over his head and around his neck and shoulders. The patient was also complaining of shortness of breath. The patient was treated for his shortness of breath and was given oral antihistamines, all medications and doses have been documented. EMS was contacted and patient was transported to hospital.
Age: 30.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site papule, Injection site pruritus, Injection site vesicles
Clinical narrative: Local injection site redness, induration, warmth, itch and 2 vesicular papules inside redness.  Redness measures about 5 x 5 cm along right tricep area.
Age: 30.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Injection site warmth
Clinical narrative: Local injection site redness, induration, warmth, itch and 2 vesicular papules inside redness.  Redness measures about 5 x 5 cm along right tricep area.
Age: 30.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site vesicles
Clinical narrative: Local injection site redness, induration, warmth, itch and 2 vesicular papules inside redness.  Redness measures about 5 x 5 cm along right tricep area.
Age: 57.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Inflammation, Inflammatory marker increased, Mobility decreased, Pain in extremity, Pyrexia
Clinical narrative: Pain in right arm after pneumon shot low grade fever. Some swelling.   I call the office they said it is normal for the shot to hurt a few days.  I went back to to office the next Tues.  Dr. pers. prednisone, Tramadol and Keflex.  I slowly was better but still could not lift my arm to the side or above my head. The pain worsened on 2-26.  I went back in to the office.  Perscribed Prednisone - Percocet.
Age: 57.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Swelling, Ultrasound scan normal
Clinical narrative: Pain in right arm after pneumon shot low grade fever. Some swelling.   I call the office they said it is normal for the shot to hurt a few days.  I went back to to office the next Tues.  Dr. pers. prednisone, Tramadol and Keflex.  I slowly was better but still could not lift my arm to the side or above my head. The pain worsened on 2-26.  I went back in to the office.  Perscribed Prednisone - Percocet.
Age: 10.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Dyskinesia, Electroencephalogram normal
Clinical narrative: 4 days after FLUMIST nasal, his legs started jerking & this happened for 1 month. He saw neuro & had a normal EEG.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Chest X-ray normal, Chest pain, Dyspnoea, Headache, Laboratory test normal
Clinical narrative: 1 week after shot lupus like reaction with myalgias, SOB, CP, pleuritic CP, headaches.