chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 28.0
Sex: F
Vaccine: VARCEL
Symptoms: Abortion spontaneous, Exposure during pregnancy, Pregnancy test positive
Clinical narrative: Information has been received for VARIVAX (Merck), a Pregnancy Registry product, from a physician concerning a 28 year old female with no drug allergy and no medical history who on 14-NOV-2011 was vaccinated subcutaneously with a 0.5 ml dose of VARIVAX (Merck) (Lot# not reported). There was no concomitant medication. The physician reported that the patient contacted her and informed her that she did a home pregnancy test and was pregnant. No adverse effect reported. There was no laboratory studies performed. The patient sought medical attention by contacting physician and was given no treatment for AE. It was also reported that at the time of the report, the patient had not recovered. Follow up information has been received from the registered nurse, who reported that the patient had a spontaneous miscarriage in the first trimester. The registered nurse reported there was no knowledge or information of any known congenital anomalies with the fetus. Upon internal review abortion spontaneous was considered to be a medically significant event. Additional information is not expected.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Blister, Rash, Varicella post vaccine
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a 13 month old male patient with no pertinent medical history and no drug reactions or allergies. On 27-JUN-2013 the patient was vaccinated with VARIVAX (Merck) (lot # H007142, expiration date 21-MAR-2014) injection. Other suspect therapies included M-M-R II administered the same day. The Registered Nurse reported that on 08-JUL-2013, the patient experienced rash, blisters and bumps across face and was seen in the office on the same day and physician diagnosed it as a mild case of chickenpox. Patient did not receive treatment and laboratory tests were not performed. At the time of the report the chickenpox was reported as not recovered/not resolved. Additional information has been requested.
Age: 0.19
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Allergy test negative, Generalised erythema, Rash generalised, Skin lesion
Clinical narrative: Within 4 hours of receiving routine 2-month-old immunizations, she presented with total body erythema and rash with round lesions with darker edge and different sizes up to a half-dollar size that coalesced, slightly raised around the edges. Began on the trunk, then progressed to the legs, arms, face, and scalp. Very irritable and rubbing face alot as if puritic, rubbing the lesions calmed her. No provider saw reaction, and patient was not brought back in during reaction period. Mom gave a cool bath and aquaphor, but it didnt help. Following 2 days of extreme rash, it completely resolved in 3-4 days. Went to clinic a week later, but rashes has already resolved. Patient returned to normal.
Age: 55.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Throat tightness
Clinical narrative: Left clinic immediately after receiving vaccines, instead of waiting per instructions. Drove about 3 miles from clinic and had the feeling of throat closing. Returned to clinic.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Bilat RVL & LVL areas where injections administered, red, warm to touch and swollen.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Behcet's syndrome
Clinical narrative: Per mom, adminstration of the first dose of vaccine may have unmasked or otherwise been associated with the development of Behcets Syndrome. Upon receipt of second dose, symptoms returned more strongly and a questionable, causal association was made between the development of Behcets and the Gardasil vaccine. Mom is against further vaccination with gardasil for patient.
Age: 25.0
Sex: F
Vaccine: TDAP
Symptoms: Headache, Injection site erythema, Injection site oedema, Injection site pain, Injection site swelling
Clinical narrative: 7/9/13 she was unable to move arm and noticed increase pain with swelling and redness around site. Developed fever, headaches, buzzing to Lt ear, body aches on 7/9/13 in the afternoon. Taking Tylenol 2 tablets last dose was last night. Patient was seen in our office on7/11/13 with the above complaints. On physical examination left deltoid was (approximately 5 in x 4 in area) red, slightly edematous and warm to the touch. Patient instructed to continue Tylenol 325 mg tabs 2 tabs every 6 hours. May take Benadryl 25 mg every 6 hours as needed and use aloe vera ointment on the affected for comfort.
Age: 25.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site warmth, Mobility decreased, Pain, Pyrexia, Tinnitus
Clinical narrative: 7/9/13 she was unable to move arm and noticed increase pain with swelling and redness around site. Developed fever, headaches, buzzing to Lt ear, body aches on 7/9/13 in the afternoon. Taking Tylenol 2 tablets last dose was last night. Patient was seen in our office on7/11/13 with the above complaints. On physical examination left deltoid was (approximately 5 in x 4 in area) red, slightly edematous and warm to the touch. Patient instructed to continue Tylenol 325 mg tabs 2 tabs every 6 hours. May take Benadryl 25 mg every 6 hours as needed and use aloe vera ointment on the affected for comfort.
Age: 3.0
Sex: M
Vaccine: MMR
Symptoms: Abdominal pain upper, Dyspnoea, Feeling abnormal, Haematemesis, Pyrexia
Clinical narrative: Red Rash on palms of hands and bottom of feet, along with fever between 99-100, followed by rash with bumps on arms. Along with vomiting, and shortness of breath, (labored breathing), alot of stomach pain and fever has reached as high as 106.2 and has reached over 104 for the 5 days straight. Has continued to vomit every day since 7/2/13. Has vomited blood on one occasion. Since this started. Fever is still present today on 7/11/13. We are still monitoring the situation and hoping that there is some resolve in the very near future as we are on day 9 right now and our son is miserable and complaining of alot of stomach pain.
Age: 3.0
Sex: M
Vaccine: MMR
Symptoms: Rash, Rash erythematous, Vomiting
Clinical narrative: Red Rash on palms of hands and bottom of feet, along with fever between 99-100, followed by rash with bumps on arms. Along with vomiting, and shortness of breath, (labored breathing), alot of stomach pain and fever has reached as high as 106.2 and has reached over 104 for the 5 days straight. Has continued to vomit every day since 7/2/13. Has vomited blood on one occasion. Since this started. Fever is still present today on 7/11/13. We are still monitoring the situation and hoping that there is some resolve in the very near future as we are on day 9 right now and our son is miserable and complaining of alot of stomach pain.
Age: 36.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Axillary pain, Discomfort, Dysphonia, Erythema
Clinical narrative: Sore throat, hoarse voice, strange overall feeling by evening half of arm, armpit, and underchest was swollen, sore and uncomfortable; next day arm from elbow to shoulder swollen, arm pit swollen on same arm, hot to touch, red rash & large red patches hot to touch, low grade fever 99.6, pain from elbow to shoulder, pain in armpit & overall body fatigue.
Age: 36.0
Sex: F
Vaccine: PPV
Symptoms: Feeling abnormal, Musculoskeletal pain, Oedema peripheral, Oropharyngeal pain, Pain
Clinical narrative: Sore throat, hoarse voice, strange overall feeling by evening half of arm, armpit, and underchest was swollen, sore and uncomfortable; next day arm from elbow to shoulder swollen, arm pit swollen on same arm, hot to touch, red rash & large red patches hot to touch, low grade fever 99.6, pain from elbow to shoulder, pain in armpit & overall body fatigue.
Age: 36.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Pyrexia, Rash erythematous, Skin warm, Swelling
Clinical narrative: Sore throat, hoarse voice, strange overall feeling by evening half of arm, armpit, and underchest was swollen, sore and uncomfortable; next day arm from elbow to shoulder swollen, arm pit swollen on same arm, hot to touch, red rash & large red patches hot to touch, low grade fever 99.6, pain from elbow to shoulder, pain in armpit & overall body fatigue.
Age: 19.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Headache, Injection site pain
Clinical narrative: As per reported by patients mom, patient complaining of severe arm pain in (L) arm where Pneumovax vaccine was given on 07/09/2013. Patient stated she was also experiencing a headache. No SOB was reported.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Dizziness, Face injury, Loss of consciousness, Muscle rigidity
Clinical narrative: After vaccine admin, pt. walking and felt lightheaded, lost consciousness for a few seconds, struck nose and face on door knob and stiffened, father caught and placed on bed, child aroused and observed for 45 min.
Age: 0.57
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Abdominal pain, Allergy test negative, Coeliac disease, Colonoscopy normal, Crying
Clinical narrative: Baby became fussy in evening after shots. Immediately began developing red spots on body and distended stomach. Colic like symptoms began. Serious food intolerances began overnight and persist. Baby started screaming inconsolably and developed persistent fatty, mucus filled diarrhea. Was tested multiple times for allergies, none exist. Evaluated by head allergist and immunologist and GI at Hospital. No disease is present. Suffers severely if ingests gluten, soy, soy derivatives, corn, corn derivatives, grains, dairy and most fruit. Baby has neurological tics, acid reflux, skin lesions leading to scarring.
Age: 0.57
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Diarrhoea, Endoscopy normal, Endoscopy upper gastrointestinal tract normal, Food intolerance, Gastric dilatation
Clinical narrative: Baby became fussy in evening after shots. Immediately began developing red spots on body and distended stomach. Colic like symptoms began. Serious food intolerances began overnight and persist. Baby started screaming inconsolably and developed persistent fatty, mucus filled diarrhea. Was tested multiple times for allergies, none exist. Evaluated by head allergist and immunologist and GI at Hospital. No disease is present. Suffers severely if ingests gluten, soy, soy derivatives, corn, corn derivatives, grains, dairy and most fruit. Baby has neurological tics, acid reflux, skin lesions leading to scarring.
Age: 0.57
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Gastrooesophageal reflux disease, Immediate post-injection reaction, Irritability, Mucous stools, Rash erythematous
Clinical narrative: Baby became fussy in evening after shots. Immediately began developing red spots on body and distended stomach. Colic like symptoms began. Serious food intolerances began overnight and persist. Baby started screaming inconsolably and developed persistent fatty, mucus filled diarrhea. Was tested multiple times for allergies, none exist. Evaluated by head allergist and immunologist and GI at Hospital. No disease is present. Suffers severely if ingests gluten, soy, soy derivatives, corn, corn derivatives, grains, dairy and most fruit. Baby has neurological tics, acid reflux, skin lesions leading to scarring.
Age: 0.57
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Scar, Screaming, Skin lesion, Steatorrhoea, Tic
Clinical narrative: Baby became fussy in evening after shots. Immediately began developing red spots on body and distended stomach. Colic like symptoms began. Serious food intolerances began overnight and persist. Baby started screaming inconsolably and developed persistent fatty, mucus filled diarrhea. Was tested multiple times for allergies, none exist. Evaluated by head allergist and immunologist and GI at Hospital. No disease is present. Suffers severely if ingests gluten, soy, soy derivatives, corn, corn derivatives, grains, dairy and most fruit. Baby has neurological tics, acid reflux, skin lesions leading to scarring.
Age: 0.33
Sex: M
Vaccine: DTAP, HIBV, PNC13, RV5
Symptoms: Blood calcium normal, Blood glucose normal, Blood magnesium increased, Blood potassium normal, Blood sodium normal
Clinical narrative: Patient diagnosed with an otitis media 2 days after imms, was recovering but continued to have congestion and some antibiotic associated diarrhea. On 7/7 he had a generalized unprovoked seizure he was afebrile seizure lasted 90 seconds. He has now had 6 seizures between 7/7 and 7/10, started KEPPRA and phenobarbital. Spent 1 night in the hospital. EEG is.
Age: 0.33
Sex: M
Vaccine: DTAP, HIBV, PNC13, RV5
Symptoms: Computerised tomogram head normal, Convulsion, Diarrhoea, Electroencephalogram, Otitis media
Clinical narrative: Patient diagnosed with an otitis media 2 days after imms, was recovering but continued to have congestion and some antibiotic associated diarrhea. On 7/7 he had a generalized unprovoked seizure he was afebrile seizure lasted 90 seconds. He has now had 6 seizures between 7/7 and 7/10, started KEPPRA and phenobarbital. Spent 1 night in the hospital. EEG is.
Age: 0.33
Sex: M
Vaccine: DTAP, HIBV, PNC13, RV5
Symptoms: Respiratory tract congestion, Rotavirus test negative
Clinical narrative: Patient diagnosed with an otitis media 2 days after imms, was recovering but continued to have congestion and some antibiotic associated diarrhea. On 7/7 he had a generalized unprovoked seizure he was afebrile seizure lasted 90 seconds. He has now had 6 seizures between 7/7 and 7/10, started KEPPRA and phenobarbital. Spent 1 night in the hospital. EEG is.
Age: 0.52
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Blood culture, C-reactive protein, Full blood count, Pyrexia, Urine analysis
Clinical narrative: Fever to 103.4 rectally.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Dermatitis contact
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 70 year old male patient. On 02-JUL-2013 the patient was vaccinated with a dose of ZOSTAVAX lot # J000495, 0.65 ml, subcutaneous in the left arm. On 03-JUL-2013, the patient presented to the doctor office with confirmed poison ivy. The patient was seen by physician for medical attention. Prednisone was recommended for treatment. The outcome of poison ivy was reported as not recovered. The causal relationship was not reported. Additional information is not expected.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Dyspnoea, Injection site pruritus, Injection site swelling, Respiratory tract congestion, Urticaria
Clinical narrative: First GARDASIL injection given on 7/1/13, on 7/8/13 patient called to report that on 7/4 the injection site was swollen and itchy, on 7/6 she started to have hives and was dyspneic. Did not go to ER, took BENADRYL with relief of hives and dyspnea. At this time she is c/o being congested, hives disappearing and no dyspnea.
Age: 1.35
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Rash, Varicella post vaccine
Clinical narrative: Pt dx with (chicken pox) varicella on 7-9-13. Rash face, neck, chest, abdomen, back. Temp: 98.7 degrees.
Age: 51.0
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site urticaria, Injection site warmth
Clinical narrative: "1 big hive" at site of injection raised area, red, a little warm. 7/8/13 update pt says looking better not hard.
Age: 31.0
Sex: M
Vaccine: HEPA, HEPA
Symptoms: Asthenia, Fall, Immediate post-injection reaction
Clinical narrative: Hep A Lot # 4G7P2 given in (L) deltoid and within 30 sec. and fell floor. Water given, client laying down. BENADRYL 50mg IM given. After 30 min. he's sitting up and feeling improvement. Walked and weak again. Sat in chair. Someone here to drive him home. Feeling better.
Age: 31.0
Sex: M
Vaccine: HEPA, HEPA
Symptoms: Feeling abnormal, Flushing, Hyperventilation, Malaise, Nervousness
Clinical narrative: Hep A Lot # 4G7P2 given in (L) deltoid and within 30 sec. and fell floor. Water given, client laying down. BENADRYL 50mg IM given. After 30 min. he's sitting up and feeling improvement. Walked and weak again. Sat in chair. Someone here to drive him home. Feeling better.
Age: 31.0
Sex: M
Vaccine: HEPA, HEPA
Symptoms: Palpitations, Paraesthesia, Pruritus
Clinical narrative: Hep A Lot # 4G7P2 given in (L) deltoid and within 30 sec. and fell floor. Water given, client laying down. BENADRYL 50mg IM given. After 30 min. he's sitting up and feeling improvement. Walked and weak again. Sat in chair. Someone here to drive him home. Feeling better.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Pt. developed redness and swelling 2x2 cm on right deltoid (injection site for KINRIX). Noted 3 days after vaccine and redness and swelling 0.5cm on left arm (injection site for PROQUAD) 2 days after vaccine given. No treatment.
Age: 4.0
Sex: M
Vaccine: FLUX
Symptoms: Pruritus, Rash generalised, Speech disorder
Clinical narrative: Patient could not speak for many hours after flu shot. Next day complained he was itchy and could not control himself. Speech returned. Body had a rash. ADHD? Still struggles and has issues!
Age: 0.36
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC13, RV5
Symptoms: Pyrexia, Urine analysis normal
Clinical narrative: Fever 104.
Age: 1.02
Sex: M
Vaccine: HEPA, MMRV, PNC13
Symptoms: Rash generalised
Clinical narrative: Full body rash six days after PROQUAD vaccine.
Age: 14.0
Sex: F
Vaccine: TYP, YF
Symptoms: Urticaria
Clinical narrative: Notes: 2 PM email from NP supervisor. Called. Mom claimed hives all over body got better after took BENADRYL. Denied vomiting but damp, her mom mentioned that she had egg allergy when she was little same as her son too, but both of them eating egg now as overcome, so never mention nowday like her son is ok now. I urged to both of them to go ER now. Allergy reaction could be deleted, better be safety side b/c YF vaccine is egg base a 2:30.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a pediatric patient of unknown age. On 05-JUL-2013 the patient was vaccinated with VAQTA, (intramuscular, 1 ml; lot number unknown). The medical assistant noted that the pediatric patient was administered an adult dose of VAQTA. No adverse event was reported. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Pain, Pain in extremity
Clinical narrative: This case was reported by a healthcare professional (nurse) via a sales representative and described the occurrence of red welt at injection site in a 60-year-old female subject who was vaccinated with FLUARIX (GlaxoSmithKline). On 13 September 2012 the subject received dose of FLUARIX (.5 ml, unknown, left arm). On 13 September 2012, less than one day after vaccination with FLUARIX, the subject experienced pain shooting down arm. On 14 September 2012, one day after vaccination with FLUARIX, she experienced red welt at injection site, swelling injection site and injection site redness. The subject was treated with BENADRYL and antihistamine. It was reported that the subject developed a red welt on her arm about 5 cm across and 4 cm down, right below the deltoid, with shooting and stabbing pain going down her arm. The subject returned to the office the day after the vaccination (14 September 2012) and the physician recommended BENADRYL and a cold compress, with an antihistamine daily to treat the reaction. The subject stated the pain started "shortly" after the vaccination. The physician's office followed up with her on 19 September 2012 and the swelling had dissipated and the redness was going down. At the time of reporting, the outcome of the pain shooting down arm was unspecified.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: This case was reported by a healthcare professional (nurse) via a sales representative and described the occurrence of red welt at injection site in a 60-year-old female subject who was vaccinated with FLUARIX (GlaxoSmithKline). On 13 September 2012 the subject received dose of FLUARIX (.5 ml, unknown, left arm). On 13 September 2012, less than one day after vaccination with FLUARIX, the subject experienced pain shooting down arm. On 14 September 2012, one day after vaccination with FLUARIX, she experienced red welt at injection site, swelling injection site and injection site redness. The subject was treated with BENADRYL and antihistamine. It was reported that the subject developed a red welt on her arm about 5 cm across and 4 cm down, right below the deltoid, with shooting and stabbing pain going down her arm. The subject returned to the office the day after the vaccination (14 September 2012) and the physician recommended BENADRYL and a cold compress, with an antihistamine daily to treat the reaction. The subject stated the pain started "shortly" after the vaccination. The physician's office followed up with her on 19 September 2012 and the swelling had dissipated and the redness was going down. At the time of reporting, the outcome of the pain shooting down arm was unspecified.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Computerised tomogram, Syncope
Clinical narrative: This case was reported by a healthcare professional, who was also the subject, and described the occurrence of syncopal attack in a 75-year-old female subject who was vaccinated with FLUARIX (GlaxoSmithKline). Concurrent medical conditions included severe allergy to sulfites. Concurrent medications included PROSCAR and LIPITOR. On 8 November 2011 at 13:00 the subject received dose of FLUARIX (details unknown). On 8 November 2011, 2 hours after vaccination with FLUARIX, the subject experienced syncopal attack. She was taken to the emergency room and was hospitalized for one night. The healthcare professional considered the event was clinically significant (or requiring intervention). Relevant test results included a CAT scan. Results were unspecified. At the time of reporting the outcome of the event was unspecified. No further information was provided.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Crepitations, Injection site reaction
Clinical narrative: This case was reported by a healthcare professional (nurse) and described the occurrence of bubbles under skin at site of injection in a 35-year-old female subject (also a nurse) who was vaccinated with FLUARIX (GlaxoSmithKline). On 16 October 1012 at 15:30 the subject received a dose of FLUARIX (.5 ml, unknown route, right deltoid). On 16 October 2012 at 20:00, 4 and a half hours after vaccination with FLUARIX, the subject experienced bubbles under skin described as "crepitus at the injection site". The subject received FLUARIX at employee health and "that same evening noticed crepitus at the injection site." The subject went to the emergency department to have the "crepitus at the injection site" evaluated. On 16 October 2012, later in the evening, the event was resolved. Follow-up received 25 October 2012 from healthcare professional (nurse). "Upon further discussion with the reporter, there was no quality complaint since the FLUARIX vaccine has an air bubble and it was no different than usual." The nurse stated that "the patient experienced air bubbles under the skin which she stated was crepitus." Follow-up received from healthcare professional (nurse) on 17 December 2012. The nurse documented that this case was not considered to be serious. The nurse noted that the event could not have been associated with medical history, lack of efficacy, erroneous administration, or suspected transmission of an infectious agent via a medicinal product. The nurse provided the following feedback "GSK should include in its vaccine information sheet that excess air in syringe should be expelled prior to administration of vaccine (with administration instructions)." The nurse documented that a biopsy was not performed. The immunization series was not delayed or discontinued. The nurse stated that this case has been reported to a Regulatory Agency however, a reference number was not provided.
Age: 9.0
Sex: M
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injection site discolouration, Injection site erythema, Injection site rash, Injection site vesicles
Clinical narrative: This case was reported by a physician and described the occurrence of injection site blisters in a 9-year-old male subject who was vaccinated with FLUARIX (GlaxoSmithKline). Concurrent medical conditions included mouth sores, sore throat, stomatitis and throat swelling. Concurrent medications included PROAIR HFA and QVAR. On 22 October 2012 at 17:00 the subject received a dose of FLUARIX (.5 ml, unknown route, left deltoid). On 23 October 2012, one day after vaccination with FLUARIX, the subject experienced injection site blisters, injection site rash, injection site redness, injection site discoloration and on 22 October 2012, less than one day after [described as "right after"] vaccination with FLUARIX, the subject experienced lip swelling. "The rash (injection site rash) was purplish in color (injection site discoloration) with several  flaccid blisters (injection site blisters) on a slightly erythematous base (injection site redness)." The physician stated "that it looked like someone poured hot water on the area." The subject's past medical history included episodic stomatitis with sore throat, sores in mouth and throat swelling that started a couple of months ago. Per the physician, the subject's lips "swelled up again right after the vaccine and the [physician] does not know if the vaccination triggered it or if it was separate." The physician also stated that "the patient's parents thought it was separate." On 31 October 2012, the physician first saw the subject and the physician stated that "it was already looking better based on the pictures the mother provided." On 6 November 2012, the physician saw the subject again and stated that "it was almost healed." At the time of reporting the events of injection site blisters, injection site rash, injection site redness, and injection site discoloration had improved. The lip swelling had resolved. The physician considered the events of injection site blisters, injection site rash, injection site redness, and injection site discoloration were probably related to vaccination with FLUARIX. The physician stated that it was unknown if the lip swelling was related to vaccination with FLUARIX.
Age: 9.0
Sex: M
Vaccine: FLU3
Symptoms: Lip swelling
Clinical narrative: This case was reported by a physician and described the occurrence of injection site blisters in a 9-year-old male subject who was vaccinated with FLUARIX (GlaxoSmithKline). Concurrent medical conditions included mouth sores, sore throat, stomatitis and throat swelling. Concurrent medications included PROAIR HFA and QVAR. On 22 October 2012 at 17:00 the subject received a dose of FLUARIX (.5 ml, unknown route, left deltoid). On 23 October 2012, one day after vaccination with FLUARIX, the subject experienced injection site blisters, injection site rash, injection site redness, injection site discoloration and on 22 October 2012, less than one day after [described as "right after"] vaccination with FLUARIX, the subject experienced lip swelling. "The rash (injection site rash) was purplish in color (injection site discoloration) with several  flaccid blisters (injection site blisters) on a slightly erythematous base (injection site redness)." The physician stated "that it looked like someone poured hot water on the area." The subject's past medical history included episodic stomatitis with sore throat, sores in mouth and throat swelling that started a couple of months ago. Per the physician, the subject's lips "swelled up again right after the vaccine and the [physician] does not know if the vaccination triggered it or if it was separate." The physician also stated that "the patient's parents thought it was separate." On 31 October 2012, the physician first saw the subject and the physician stated that "it was already looking better based on the pictures the mother provided." On 6 November 2012, the physician saw the subject again and stated that "it was almost healed." At the time of reporting the events of injection site blisters, injection site rash, injection site redness, and injection site discoloration had improved. The lip swelling had resolved. The physician considered the events of injection site blisters, injection site rash, injection site redness, and injection site discoloration were probably related to vaccination with FLUARIX. The physician stated that it was unknown if the lip swelling was related to vaccination with FLUARIX.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Exposure during pregnancy, Laboratory test normal, Rash
Clinical narrative: This prospective pregnancy case was reported by a consumer and described the occurrence of rash on ear in a 29-year-old female subject who was vaccinated with FLUARIX (GlaxoSmithKline) during pregnancy. A physician or other health care professional has not verified this report. The subject's medical history included no previous pregnancies. The subject was not using contraception and the conception was by normal methods. There was no provided maternal or paternal medical history that may have an impact on the outcome of this pregnancy. No other medication history was provided. On 5 December 2012 the subject received a dose of FLUAIRX (.5 ml, intramuscular, unknown site) and experienced vaccine exposure during the second trimester of pregnancy. The gestational age at the time of vaccination was calculated to be approximately 15 weeks. Date of last menstrual period was reported as 22 August 2012 and the estimated delivery date was reported as 28 May 2013. There was no evidence of defects from prenatal testing. At the time of reporting, the pregnancy was ongoing. On 6 December 2012, 1 day after vaccination with FLUARIX, the subject experienced rash on ear. The subject stated that she noticed "a rash on the left ear on the morning of 6 December 2012, attributed [the rash] to her exposure to FLUARIX." The subject stated that she "did not apply a pharmacological treatment to the rash." No other adverse events were noted. At the time of reporting the event was improved. The subject stated that, on 6 December 2012, "the rash has shown improvement over the course of the day."
Age: 22.0
Sex: M
Vaccine: ANTH, SMALL, TYP, ANTH, SMALL, TYP
Symptoms: Back pain, Chest discomfort, Chest pain, Feeling abnormal, Muscle tightness
Clinical narrative: This study case was received from the investigator in the trial on 03 July 2013. A 22 year-old male subject with no significant past medical history was found to have unspecified disease of pericardium and non-specific myocarditis 19 days after the subject had received the following vaccines on 17 April 2013: an injection of ACAM2000 (lot number, route and site of administration not reported), TYPHIM Vi (lot number, route and site of administration not reported) and anthrax 1 (manufacturer, lot number, route and site of administration not reported). On 06 May 2013, Troponin I result was abnormal with highest recorded value of 10.91 with an abnormal ECG. On 07 May 2013, the subject was found to have a normal echocardiogram. Lumbar puncture (spinal tap) and MRI of the brain, spinal cord and heart were not performed. Treatments were not reported. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: none.
Age: 22.0
Sex: M
Vaccine: ANTH, SMALL, TYP, ANTH, SMALL, TYP
Symptoms: Swelling
Clinical narrative: This study case was received from the investigator in the trial on 03 July 2013. A 22 year-old male subject with no significant past medical history was found to have unspecified disease of pericardium and non-specific myocarditis 19 days after the subject had received the following vaccines on 17 April 2013: an injection of ACAM2000 (lot number, route and site of administration not reported), TYPHIM Vi (lot number, route and site of administration not reported) and anthrax 1 (manufacturer, lot number, route and site of administration not reported). On 06 May 2013, Troponin I result was abnormal with highest recorded value of 10.91 with an abnormal ECG. On 07 May 2013, the subject was found to have a normal echocardiogram. Lumbar puncture (spinal tap) and MRI of the brain, spinal cord and heart were not performed. Treatments were not reported. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: none.
Age: 22.0
Sex: M
Vaccine: ANTH, SMALL, TYP, ANTH, SMALL, TYP
Symptoms: Echocardiogram normal, Electrocardiogram abnormal, Myocarditis, Pericardial disease, Troponin I increased
Clinical narrative: This study case was received from the investigator in the trial on 03 July 2013. A 22 year-old male subject with no significant past medical history was found to have unspecified disease of pericardium and non-specific myocarditis 19 days after the subject had received the following vaccines on 17 April 2013: an injection of ACAM2000 (lot number, route and site of administration not reported), TYPHIM Vi (lot number, route and site of administration not reported) and anthrax 1 (manufacturer, lot number, route and site of administration not reported). On 06 May 2013, Troponin I result was abnormal with highest recorded value of 10.91 with an abnormal ECG. On 07 May 2013, the subject was found to have a normal echocardiogram. Lumbar puncture (spinal tap) and MRI of the brain, spinal cord and heart were not performed. Treatments were not reported. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: none.
Age: 7.0
Sex: M
Vaccine: DTAP, FLU3
Symptoms: Injection site swelling
Clinical narrative: This case was reported by a pharmacist (mother of subject) and described the occurrence of hives in a 7-year-old male subject who was vaccinated with FLUARIX (GlaxoSmithKline). Concurrent medical conditions included reactive airway disease. Historic vaccination included DTaP; manufacturer unspecified; unknown; unknown given on an unspecified date. Concurrent medications included SINGULAIR, NASONEX and ZYRTEC. On 9 October 2012 at 16:00 the subject received a dose of FLUARIX (.5 ml, unknown route, right arm). On 11 October 2012, 2 days after vaccination with FLUARIX, the subject experienced hives. The reporter "noticed the hives when she came home from work around 6pm. The hives continued to get worse through Sunday [14 October 2012]. He [the subject] went to the doctor's office". The subject was treated with Steroids. The hives have improved since he had started steroids. At the time of reporting the event was improved "but not resolved." The pharmacist considered the event was probably related to vaccination with FLUARIX. Additional adverse events were reported with the DTaP. See case A0998237B for details.
Age: 7.0
Sex: M
Vaccine: DTAP, FLU3
Symptoms: Urticaria
Clinical narrative: This case was reported by a pharmacist (mother of subject) and described the occurrence of hives in a 7-year-old male subject who was vaccinated with FLUARIX (GlaxoSmithKline). Concurrent medical conditions included reactive airway disease. Historic vaccination included DTaP; manufacturer unspecified; unknown; unknown given on an unspecified date. Concurrent medications included SINGULAIR, NASONEX and ZYRTEC. On 9 October 2012 at 16:00 the subject received a dose of FLUARIX (.5 ml, unknown route, right arm). On 11 October 2012, 2 days after vaccination with FLUARIX, the subject experienced hives. The reporter "noticed the hives when she came home from work around 6pm. The hives continued to get worse through Sunday [14 October 2012]. He [the subject] went to the doctor's office". The subject was treated with Steroids. The hives have improved since he had started steroids. At the time of reporting the event was improved "but not resolved." The pharmacist considered the event was probably related to vaccination with FLUARIX. Additional adverse events were reported with the DTaP. See case A0998237B for details.
Age: 87.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blood folate normal, Blood iron normal, Blood magnesium normal, Exercise tolerance decreased, Injection site erythema
Clinical narrative: This spontaneous report as received via a letter from a 87 year old female consumer refers to herself. Patient's concurrent conditions included: abnormal blood pressure and underactive thyroid. On 29-APR-2013 the patient was vaccinated with ZOSTAVAX (dose, route and lot number not reporter). Concomitant therapies included levothyroxine, ramipril, diltiazem, aspirin, caltrate 400-D and calcium and vitamin D. The patient reported that on 30-APR-2013 she found her arm had an area approximately 3-inch wide and 1-inch deep (also reported as 1.5 inch deep) at the injection side. She added that the area was warm, had a reddish hue, had a rash and she pain and sensitivity at this place. On 02-MAY-2013 the patient visited the clinic and was seen by the physician who told her that the injection site was infected. The patient was prescribed hydrocortisone cream to help the infection. In 2013 (also reported as by this time) the patient experienced a pain deep in her legs and the back of head on the left side, she stated that it was extremely painful and she tried to treat it by walking (the movement relieved the situation but only during the time she was walking). On 15-MAY-2013 the patient visited another physician who thought the patient might have restless legs. The patient was given instructions and information to help restless legs. The physician also performed lab diagnostics studies on 15-MAY-2013: blood work, iron binding capacity unsaturated (UIBC), iron binding capacity total (TIBC), %sat, magnesium, vitamin B12, folate and the tests came back fine. On 31-MAY-2013 the patient discussed the lab diagnostic test results with the first physician and she was prescribed doxycycline as a cautionary measure for a tick fever that patient might have. On an unspecified date, in approximately May 2013 the patient became extremely nauseous, she had dry heaves up until noon, every time she drank water or tried to eat. She complained that could no longer performed her exercises because it was exhausting and painful. In July 2013 the patient experienced a brain bleed and she lost her vision and then it came back. She reported that she had also atrial fibrillation (started on an unspecified date) in which her heart goes in and out off. The patient reported that at the time of the letter the injection site was slowly diminishing, the redness was pale and area was smaller. It was also no longer painful when rubbed. The patient's outcome was not reported. The reporter considered restless legs, retching, injection site infection, nausea, injection site pain, injection site warmth, injection site redness, injection site rash, fatigue and pain to be related to the therapy with ZOSTAVAX. Upon internal review brain bleed was considered to be medically significant. Additional information has been requested.
Age: 87.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pruritus, Injection site swelling, Insomnia, Iron binding capacity total normal, Pain in extremity
Clinical narrative: This spontaneous report as received via a letter from a 87 year old female consumer refers to herself. Patient's concurrent conditions included: abnormal blood pressure and underactive thyroid. On 29-APR-2013 the patient was vaccinated with ZOSTAVAX (dose, route and lot number not reporter). Concomitant therapies included levothyroxine, ramipril, diltiazem, aspirin, caltrate 400-D and calcium and vitamin D. The patient reported that on 30-APR-2013 she found her arm had an area approximately 3-inch wide and 1-inch deep (also reported as 1.5 inch deep) at the injection side. She added that the area was warm, had a reddish hue, had a rash and she pain and sensitivity at this place. On 02-MAY-2013 the patient visited the clinic and was seen by the physician who told her that the injection site was infected. The patient was prescribed hydrocortisone cream to help the infection. In 2013 (also reported as by this time) the patient experienced a pain deep in her legs and the back of head on the left side, she stated that it was extremely painful and she tried to treat it by walking (the movement relieved the situation but only during the time she was walking). On 15-MAY-2013 the patient visited another physician who thought the patient might have restless legs. The patient was given instructions and information to help restless legs. The physician also performed lab diagnostics studies on 15-MAY-2013: blood work, iron binding capacity unsaturated (UIBC), iron binding capacity total (TIBC), %sat, magnesium, vitamin B12, folate and the tests came back fine. On 31-MAY-2013 the patient discussed the lab diagnostic test results with the first physician and she was prescribed doxycycline as a cautionary measure for a tick fever that patient might have. On an unspecified date, in approximately May 2013 the patient became extremely nauseous, she had dry heaves up until noon, every time she drank water or tried to eat. She complained that could no longer performed her exercises because it was exhausting and painful. In July 2013 the patient experienced a brain bleed and she lost her vision and then it came back. She reported that she had also atrial fibrillation (started on an unspecified date) in which her heart goes in and out off. The patient reported that at the time of the letter the injection site was slowly diminishing, the redness was pale and area was smaller. It was also no longer painful when rubbed. The patient's outcome was not reported. The reporter considered restless legs, retching, injection site infection, nausea, injection site pain, injection site warmth, injection site redness, injection site rash, fatigue and pain to be related to the therapy with ZOSTAVAX. Upon internal review brain bleed was considered to be medically significant. Additional information has been requested.
Age: 87.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Vitamin B12 normal
Clinical narrative: This spontaneous report as received via a letter from a 87 year old female consumer refers to herself. Patient's concurrent conditions included: abnormal blood pressure and underactive thyroid. On 29-APR-2013 the patient was vaccinated with ZOSTAVAX (dose, route and lot number not reporter). Concomitant therapies included levothyroxine, ramipril, diltiazem, aspirin, caltrate 400-D and calcium and vitamin D. The patient reported that on 30-APR-2013 she found her arm had an area approximately 3-inch wide and 1-inch deep (also reported as 1.5 inch deep) at the injection side. She added that the area was warm, had a reddish hue, had a rash and she pain and sensitivity at this place. On 02-MAY-2013 the patient visited the clinic and was seen by the physician who told her that the injection site was infected. The patient was prescribed hydrocortisone cream to help the infection. In 2013 (also reported as by this time) the patient experienced a pain deep in her legs and the back of head on the left side, she stated that it was extremely painful and she tried to treat it by walking (the movement relieved the situation but only during the time she was walking). On 15-MAY-2013 the patient visited another physician who thought the patient might have restless legs. The patient was given instructions and information to help restless legs. The physician also performed lab diagnostics studies on 15-MAY-2013: blood work, iron binding capacity unsaturated (UIBC), iron binding capacity total (TIBC), %sat, magnesium, vitamin B12, folate and the tests came back fine. On 31-MAY-2013 the patient discussed the lab diagnostic test results with the first physician and she was prescribed doxycycline as a cautionary measure for a tick fever that patient might have. On an unspecified date, in approximately May 2013 the patient became extremely nauseous, she had dry heaves up until noon, every time she drank water or tried to eat. She complained that could no longer performed her exercises because it was exhausting and painful. In July 2013 the patient experienced a brain bleed and she lost her vision and then it came back. She reported that she had also atrial fibrillation (started on an unspecified date) in which her heart goes in and out off. The patient reported that at the time of the letter the injection site was slowly diminishing, the redness was pale and area was smaller. It was also no longer painful when rubbed. The patient's outcome was not reported. The reporter considered restless legs, retching, injection site infection, nausea, injection site pain, injection site warmth, injection site redness, injection site rash, fatigue and pain to be related to the therapy with ZOSTAVAX. Upon internal review brain bleed was considered to be medically significant. Additional information has been requested.
Age: 87.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Atrial fibrillation, Blindness, Blood folate normal, Blood magnesium normal, Blood test normal
Clinical narrative: This spontaneous report as received via a letter from a 87 year old female consumer refers to herself. Patient's concurrent conditions included: abnormal blood pressure and underactive thyroid. On 29-APR-2013 the patient was vaccinated with ZOSTAVAX (dose, route and lot number not reporter). Concomitant therapies included levothyroxine, ramipril, diltiazem, aspirin, caltrate 400-D and calcium and vitamin D. The patient reported that on 30-APR-2013 she found her arm had an area approximately 3-inch wide and 1-inch deep (also reported as 1.5 inch deep) at the injection side. She added that the area was warm, had a reddish hue, had a rash and she pain and sensitivity at this place. On 02-MAY-2013 the patient visited the clinic and was seen by the physician who told her that the injection site was infected. The patient was prescribed hydrocortisone cream to help the infection. In 2013 (also reported as by this time) the patient experienced a pain deep in her legs and the back of head on the left side, she stated that it was extremely painful and she tried to treat it by walking (the movement relieved the situation but only during the time she was walking). On 15-MAY-2013 the patient visited another physician who thought the patient might have restless legs. The patient was given instructions and information to help restless legs. The physician also performed lab diagnostics studies on 15-MAY-2013: blood work, iron binding capacity unsaturated (UIBC), iron binding capacity total (TIBC), %sat, magnesium, vitamin B12, folate and the tests came back fine. On 31-MAY-2013 the patient discussed the lab diagnostic test results with the first physician and she was prescribed doxycycline as a cautionary measure for a tick fever that patient might have. On an unspecified date, in approximately May 2013 the patient became extremely nauseous, she had dry heaves up until noon, every time she drank water or tried to eat. She complained that could no longer performed her exercises because it was exhausting and painful. In July 2013 the patient experienced a brain bleed and she lost her vision and then it came back. She reported that she had also atrial fibrillation (started on an unspecified date) in which her heart goes in and out off. The patient reported that at the time of the letter the injection site was slowly diminishing, the redness was pale and area was smaller. It was also no longer painful when rubbed. The patient's outcome was not reported. The reporter considered restless legs, retching, injection site infection, nausea, injection site pain, injection site warmth, injection site redness, injection site rash, fatigue and pain to be related to the therapy with ZOSTAVAX. Upon internal review brain bleed was considered to be medically significant. Additional information has been requested.