chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP, MNQ
Symptoms: Injection site erythema, Injection site induration, Injection site warmth, Local reaction
Clinical narrative: Case number PHEH2013US012000 is an initial spontaneous report received from a physician on 30 May 2013 and a follow up received from the physician on 24 Jun 2013. This report refers to a 12-year-old male patient. His medical history and concomitant medication were not reported. He was vaccinated with MENVEO (batch number: A11064) subcutaneously in his right arm on 28 May 2013. On 29 May 2013, he experienced localized reaction of redness, warmth and induration approximately 8 cm in his right upper arm. The patient was hospitalized on unspecified date due to these events. Two to three days later he had recovered completely from these events. Causality was not reported. Follow up information received from the physician on 24 Jun 2013: Updated site of vaccination, confirmed that the events redness, warmth and induration approximately 8 cm happened in right upper arm, onset date of events changed from 28 May 2013 to 29 May 2013, seriousness and outcome.
Age: 2.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Exposure to vaccinated person, Polymerase chain reaction, Skin lesion, Vaccinia test positive
Clinical narrative: Contact transmission. 2yo healthy male who brushed against his father's uncovered Smallpox vaccination site (vaccination date 5/17/13) on 5/27/13. The child was noted to have a lesion consistent with vaccinia on his left cheek on 5/31/13 and a scrap like lesion on the bridge of his nose. The child has developed no systemic symptoms. The lesion on the cheek tested positive for non-variola orthopox on 6/12/13. The lesion on the bridge of the nose scabbed over immediately and did not progress (not consistent with a vaccinia lesion).
Age: 2.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Orthopoxvirus test positive, Scab, Secondary transmission, Skin lesion, Vaccinia virus infection
Clinical narrative: Contact transmission. 2yo healthy male who brushed against his father's uncovered Smallpox vaccination site (vaccination date 5/17/13) on 5/27/13. The child was noted to have a lesion consistent with vaccinia on his left cheek on 5/31/13 and a scrap like lesion on the bridge of his nose. The child has developed no systemic symptoms. The lesion on the cheek tested positive for non-variola orthopox on 6/12/13. The lesion on the bridge of the nose scabbed over immediately and did not progress (not consistent with a vaccinia lesion).
Age: 0.89
Sex: F
Vaccine: DTAP, IPV
Symptoms: Pyrexia, Vomiting
Clinical narrative: Fever escalated over the course of the evening to 104 degrees Fahrenheit underarm, she vomited several times and I gave her infant Tylenol. Fever lasted days.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Grand mal convulsion
Clinical narrative: This spontaneous report was received from a healthcare worker regarding his sister of 17 year of age. The patient has DDAVP (reported as DDAPT-bedwetting medication) allergy. No medical history was reported. On 21-JUN-2013, the patient was vaccinated with first dose of GARDASIL (lot#, expiry, dose, frequency not reported). No concomitant medications were reported. On 21-JUN-2013, the patient experienced grand mal seizures within 45 seconds after receiving the first dose of GARDASIL. The patient's mother held her head still, and then the patient got her blood pressure checked and breathing checked. Laboratory diagnostics studies performed was none. Patient sought medical attention (doctor's visit). The outcome of the event grand mal seizures was not recovered. Patient's brother stated that the patient had not experienced any subsequent seizures. Upon internal review the event of grand mal seizures was considered to be medically significant. Additional information has been requested.
Age: 1.79
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Rash erythematous, Rash papular, Tenderness, Vaccination site rash
Clinical narrative: Red, erythematous papulovesicular rash. 1.5 x 1.5 inches, x 1 spot at site of vaccination. Tender to touch. No D/C. No drainage.
Age: 78.0
Sex: F
Vaccine: TD
Symptoms: Bone pain, Musculoskeletal stiffness, Myalgia
Clinical narrative: Pt was given Td injection on 6/12/13 10:30 AM. Pt called on 6/24/13 and left msg. Unable to reach pt until 6/25/13. Pt c/o bone/muscle aches and stiffness that occurred the morning after injection. Wrists, legs, hands, feet very stiff. No fever. Taking TYLENOL ES 500 mg 2 in AM / 2 in PM. Pt has follow up appt on 6/27/13.
Age: 78.0
Sex: F
Vaccine: FLUX
Symptoms: Apparent death
Clinical narrative: Case number PHEH2013US013483, is an initial spontaneous report from a consumer (patient) received on 19 Jun 2013. This report refers to a 78-year-old female patient. Concomitant medication included metoprolol at a dose of 100 mg. She was on treatment with DIOVAN for three to four years (see case: PHEH2013US013443). The patient reported that her body was very sensitive (unspecified). She was vaccinated with an influenza vaccine (manufacturer and batch number: unknown) on an unspecified date. The patient reported that after vaccination (on an unknown date) she nearly died. Outcome, seriousness, and causality were not reported.
Age: 29.0
Sex: F
Vaccine: RAB
Symptoms: Dyspnoea, Pain in extremity, Tachycardia
Clinical narrative: Case number PHEH2013US013486 is an initial spontaneous report received from a nurse on 20 Jun 2013. This case refers to a 29-year-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with the first three doses of post-exposure series of RABAVERT (batch number: not reported) intramuscularly on 06 Jun 2013, 09 Jun 2013 and 13 Jun 2013 respectively. After the third dose was administered on 13 Jun 2013 at 10 am, the patient experienced tachycardia, shortness of breath, and a sore arm without swelling. The patient did not take any medications to lessen the pain. The final outcome was reported as unknown. The seriousness and causality were not reported.
Sex: F
Vaccine: ANTH, HEPA, SMALL, TYP
Symptoms: Chest discomfort, Electrocardiogram normal, Injection site pruritus, Troponin increased, Vaccination site pain
Clinical narrative: Initial report was received 17 January 2013 with follow-up information received on 05 June 2013. This report was initially received by a company representative, however was not received by the Global Pharmacovigilance Department until 05 June 2013. A female subject (age and date of birth not reported) had received ACAM2000, Typhoid (manufacturer unknown), Anthrax (other manufacturer), Hepatitis A (other manufacturer) vaccines on 14 November 2012 and 13 days later on 27 November 2012, she developed possible myopericarditis of mild severity. The subject had relevant medical history of elevated troponin (start date 26 November 2012) and chest pressure (start date 14 November 2012). According to the investigator, "otherwise healthy subject with exercise associated mild chest pressure with onset date of vaccine and continuing 14 days." Concomitant therapies consisted of "LEVITRA" as an "oral contraceptive" beginning 20 November 2012. On 26 November 2012, rapid Troponin and preliminary ECG were normal, however, lab troponin was 0.11 ng/mL (mild) and the subject was referred for care. Follow-up troponin on 29 November 2012 was normal (less than 0.10 ng/mL) and ECG report was normal. During this office visit, the subject reported her last episode of chest pressure occurred on 28 November 2012. The subject also experienced a nonserious event of mild itching and burning at the smallpox vaccine site (left arm) beginning 16 November 2012 (listed as ongoing at the time of the report, stop date not reported). Outcome for the event of possible myopericarditis was recovered on 29 November 2012. According to the investigator, the event of possible myopericarditis was probably related to the study product.
Age: 15.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Acute disseminated encephalomyelitis, Asthenia, CSF culture negative, CSF white blood cell count increased, Coma
Clinical narrative: Admitted 6/13 with headache, weakness and progressive mental status changes. CSF with 120 WBC, culture negative, MRI consistent with acute disseminated encephalomyelitis. Treated with IVIG and steroids. Became comatose, required intubation. Now recovering.
Age: 15.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Endotracheal intubation, Headache, Immunoglobulin therapy, Mental status changes, Nuclear magnetic resonance imaging brain abnormal
Clinical narrative: Admitted 6/13 with headache, weakness and progressive mental status changes. CSF with 120 WBC, culture negative, MRI consistent with acute disseminated encephalomyelitis. Treated with IVIG and steroids. Became comatose, required intubation. Now recovering.
Age: 14.0
Sex: M
Vaccine: HEPA, HPV4, TDAP
Symptoms: Dizziness, Fall, Pallor
Clinical narrative: Within seconds after receiving GARDASIL vaccination pt. slumped over against nurse head to (R) et chin to chest. Within 15 sec. he aroused, very pale et c/o dizziness. No n/v. Supportive care given, drank water. Remained seated x 20'. Left with mom. Color improved, denied dizziness. Call to mom next day - doing well.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Asthenia, Pain, Pain in extremity
Clinical narrative: Received call on 6-27-13 a.m from patient mother that patient had c/o body aches and pain night of 6-26-13 after received MENACTRA vaccine earlier that day. Noted no swelling, no reported fever took MOTRIN patient in clinic on 6-28-13 for PPD reading stated side effects resolved, no reported pain or weakness anymore stated had leg pain/ache and weakness on night of 6-26-13.
Age: 83.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus, Rash generalised
Clinical narrative: Pt. assistant rash all over his body, especially the face since vx admin. in Dec. 2012. Also itching.
Age: 5.0
Sex: F
Vaccine: HEPA, IPV, MMR, TDAP, VARCEL
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: TDAP given - s/b Dtap.
Age: 41.0
Sex: U
Vaccine: TDAP
Symptoms: Asthenia, Chills, Dizziness, Malaise, Myalgia
Clinical narrative: Not feeling well. Feel like throwing up. Chills. Loss energy. Fever. Dizzy/muscle pain.
Age: 41.0
Sex: U
Vaccine: TDAP
Symptoms: Nausea, Pyrexia
Clinical narrative: Not feeling well. Feel like throwing up. Chills. Loss energy. Fever. Dizzy/muscle pain.
Age: 17.0
Sex: M
Vaccine: HEPA, HPV4, MNQ
Symptoms: Feeling cold, Loss of consciousness, Pallor
Clinical narrative: After receiving the third vaccine, pt. passed out on exam table for approx. 30 seconds. He became pale and complained of being "cold" when he woke. Dr. monitored pt's blood pressure and pulse. He left the clinic approx. 25 minutes later.
Age: 63.0
Sex: M
Vaccine: FLUX
Symptoms: Back pain, Blood test, Burning sensation, Electromyogram, Headache
Clinical narrative: Burning and clamp like sensation in feet and legs. Both hands are numb with weakness. Tremors throughout body. Lower back pain, neck pain, headaches, ED. All symptoms within 30 days of vaccination. I am under neuro care. Gabapentin and Nortriptyline as treatment.
Age: 63.0
Sex: M
Vaccine: FLUX
Symptoms: Hypoaesthesia, Limb discomfort, Lumbar puncture, Muscular weakness, Neck pain
Clinical narrative: Burning and clamp like sensation in feet and legs. Both hands are numb with weakness. Tremors throughout body. Lower back pain, neck pain, headaches, ED. All symptoms within 30 days of vaccination. I am under neuro care. Gabapentin and Nortriptyline as treatment.
Age: 63.0
Sex: M
Vaccine: FLUX
Symptoms: Nuclear magnetic resonance imaging, Tremor
Clinical narrative: Burning and clamp like sensation in feet and legs. Both hands are numb with weakness. Tremors throughout body. Lower back pain, neck pain, headaches, ED. All symptoms within 30 days of vaccination. I am under neuro care. Gabapentin and Nortriptyline as treatment.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV4, MNQ
Symptoms: Injection site reaction, Injection site swelling, Pallor
Clinical narrative: 2 days of swelling to right upper arm size of baseball, blanches, not tender.
Age: 1.54
Sex: M
Vaccine: HEPA, PNC13
Symptoms: Wrong drug administered
Clinical narrative: PREVNAR vaccine was given instead of DTaP vaccine.
Age: 24.0
Sex: F
Vaccine: RAB
Symptoms: Diarrhoea, Fatigue, Headache, Nausea, Urticaria
Clinical narrative: Patient stated had symptoms nausea, headache, fatigue x 3 days, diarrhea and hives on second day. Took TYLENOL and BENADRYL. Started recovering on third day.
Age: 83.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Injection site rash, Injection site vesicles, Pain, Rash
Clinical narrative: Rash on (L) shoulder and upper arm to elbow that formed blisters. M.D. said to use BENADRYL. Rash (red/purple) on lower arm to hand. Severe pain; pain pills. (L) shoulder, arm to hand and thumb and index finger were also very sensitive to touch. Blister subsided but still red/purple color / rash spots and periodic pain.
Age: 83.0
Sex: F
Vaccine: FLU3
Symptoms: Rash erythematous, Tenderness
Clinical narrative: Rash on (L) shoulder and upper arm to elbow that formed blisters. M.D. said to use BENADRYL. Rash (red/purple) on lower arm to hand. Severe pain; pain pills. (L) shoulder, arm to hand and thumb and index finger were also very sensitive to touch. Blister subsided but still red/purple color / rash spots and periodic pain.
Age: 5.0
Sex: M
Vaccine: MMR
Symptoms: Rash
Clinical narrative: Rash on 6/21/13 - 63 spots.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Paraesthesia oral
Clinical narrative: This spontaneous report as received from a pharmacist refers to a61 year old female patient with no known allergies. On 20-JUN-2013 the patient was vaccinated with ZOSTAVAX (lot# unspecified) 0.65 ml, subcutaneous. On 20-JUN-2013, the patient experienced tingling on the roof of her mouth and lips a 1/2 hour to 40 minutes after receiving the ZOSTAVAX. Pharmacist advised patient to take BENADRYL. The outcome of tingling on the roof of her mouth and lips was unknown. The patient had not sought medical attention. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: This spontaneous report as received from a physician via field representative refers to a patient of unknown age. On an unknown date the patient was vaccinated with the second dose of VARIVAX (Merck). On an unknown date the patient developed chicken pox after the second dose of VARIVAX (Merck). The outcome of chicken pox was unknown. The patient did not seek medical attention. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a physician via office manager refers to a patient of unknown age. On 14-MAY-2013, the patient was vaccinated with a dose of RECOMBIVAX HB, (lot # 0384AE, expiry date 02-NOV-2014), with the same lot of improperly stored RECOMBIVAX HB. Concomitant medications were not reported. No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a physician via an office manager refers to a patient of unknown age. On 23-APR-2013, the patient was vaccinated with a dose of RECOMBIVAX HB, (lot # 0384AE, expiry date 02-NOV-2014), with the same lot of improperly stored RECOMBIVAX HB. Concomitant medications were not reported. No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a physician via office manager refers to a patient of unknown age. On 17-APR-2013, the patient was vaccinated with a dose of GARDASIL, (lot # H020002, expiry date 08-AUG-2015), with the same lot of improperly stored GARDASIL. Concomitant medications were not reported. No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a physician via office manager refers to a patient of unknown age. On 18-APR-2013, the patient was vaccinated with a dose of GARDASIL (lot # H020002, expiry date 08-AUG-2015), with the same lot of improperly stored GARDASIL. Concomitant medications were not reported. No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a physician via office manager refers to a patient of unknown age. On 29-MAY-2013, the patient was vaccinated with a dose of RECOMBIVAX HB, (lot # 0384AE, expiry date 02-NOV-2014), with the same lot of improperly stored RECOMBIVAX HB. Concomitant medications were not reported. No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 53.0
Sex: M
Vaccine: TDAP
Symptoms: Erythema
Clinical narrative: Redness and possible cellulitis in (L) arm. Patient was given doxycycline 100 mg.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site anaesthesia, Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: Patient experienced erythema induration at injection site approximately 7cm in circumference, with induration/warmth/tenderness/anesthesia in area next day following injection. Improving after 48 hs. BENADRYL 5 mg.
Age: 43.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Pain in extremity, Skin warm, Urticaria
Clinical narrative: 6-21-13 reports (L) arm sore and now developed warm, hive-like welts on arm.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Activities of daily living impaired, Head injury, Syncope, Vomiting
Clinical narrative: Child received Tdap vaccine at school Tdap clinic. Child vomited 10 min after receiving vaccine, teacher stated child fainted and hit her head on floor. Child sitting up when school nurse arrived 1-2 minutes after fainting. BP 116/70. Child alert and oriented, school called parent. Parent took child home. Child returned to school on 4/30/13.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 62 year old female patient with allergic to morphine and PERCOCET and no pertinent medical history. On 15-JUN-2013 the patient was vaccinated subcutaneously with a 0.65 ml ZOSTAVAX (lot# J0022692, EXP date 30-APR-2014) in the left arm. There was no concomitant therapy. On 16-JUN-2013 the patient's left arm, at site of injection, became red, warm to the touch and sore. Patient called the physician's office today, on 17-JUN-2013, to report the adverse event. She did not come into the office. Patient did not seek medical attention. There was no treatment given to patient. At time of report, the outcome of event was reported as not recovered. Additional information has been requested.
Age: 1.03
Sex: M
Vaccine: HEPA, PNC13, VARCEL
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Injection site warmth, Urticaria
Clinical narrative: (R) leg swollen with multiple wells, red, and hot to touch. Received BENADRYL, and ORAPRED from PCP.
Age: 1.07
Sex: M
Vaccine: HEPA, MMRV, PNC13
Symptoms: Pyrexia
Clinical narrative: High fever after vaccine 102 and 103. Awoke from sleep with the fever.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Oral herpes
Clinical narrative: This spontaneous report as received from a pharmacist via another pharmacist refers to a currently 73 years old female patient with no drug reactions/allergies. On an unspecified day in August 2008 the patient was vaccinated with a 0.65 ml dose of ZOSTAVAX, subcutaneously. There was no concomitant medication. On an unknown date the patient developed shingles after the vaccine. The pharmacist reported that the patient developed the shingles infection in her mouth and had to be fed through a straw for an unspecified amount of time. The patient sought medical attention by going to physician office for a visit on an unspecified day. The outcome of shingles infection in her mouth was reported as recovered/resolved. Additional information has been requested.
Age: 10.0
Sex: M
Vaccine: MNQ
Symptoms: Induration, Oedema peripheral, Skin warm
Clinical narrative: Arm very swollen, hard and hot as mom described.
Age: 22.0
Sex: M
Vaccine: VARCEL
Symptoms: Feeling hot, Paraesthesia, Viral titre
Clinical narrative: C/O chest feeling warm and left cheek tingling.
Age: 30.0
Sex: M
Vaccine: MMR
Symptoms: Parotid gland enlargement, Rash
Clinical narrative: (R) parotid gland swelling and rashes over (R) face. MMR given as was not immune to Mumps.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Injection site erythema, Injection site pain
Clinical narrative: 3/22/13: Gave vaccine in right, posterior arm. Pt flinched and reported pain with injection. 3/24/13: Called to follow-up. Patient came in presenting with redness (2-3" area) around injection site. Instructed to ice, HC, and antihistamine and called "on-call" Dr. Dr instructed the same and worsening to go to medical care. Patient report diagnosis of cellulitis on 3/26/13 and started on antibiotics.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report as received from medical assistant refers to a 19 year old female patient. The patient was vaccinated with the first, the second and the third dose of GARDASIL (dose, route and lot number were not reported) in 2008, in 2009 and 25-JUN-2013, respectively. The patient's outcome was not reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a physician via office manager refers to a patient of unknown age. On 10-JUN-2013, the patient was vaccinated with a dose of RECOMBIVAX HB, (lot # 0384AE, expiry date 02-NOV-2014), with the same lot of improperly stored RECOMBIVAX HB. Concomitant medications were not reported. No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a physician via office manager refers to a patient of unknown age. On 18-APR-2013, the patient was vaccinated with a dose of GARDASIL, (lot # H020002, expiry date 08-AUG-2015), with the same lot of improperly stored GARDASIL. Concomitant medications were not reported. No adverse effects were reported. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report has been received from a medical assistant refers to a patient of unknown age. On 25-JUN-2013 the patient was a expired dose of 2 ml vaccinated with ROTATEQ (lot # 1539AA, expiry date 15-JUN-2013). No adverse effect reported. It was unspecified if the patient had sought medical attention. Additional information has been requested.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Rash, Rash vesicular
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 75 year old female patient with hypertension and no drug reactions/allergy. On 06-JUN-2013 the patient was vaccinated with a 0.5 ml dose of ZOSTAVAX (lot # J000495, EXP date 14-APR-2014) subcutaneously. Concomitant medication included unspecified anti-hypertensive agents. The patient experienced localized swelling at injection site after vaccination of ZOSTAVAX (on 06-JUN-2013). Pharmacist reported that seven days later (on 13-JUN-2013) the patient had a rash on both forearms made up of very tiny vesicles that did not itch or burn. Pharmacist stated that the patient reported that they went a few days later, and that now they are back. Patient sought medical attention by pharmacy visit. No treatment sought from physician at this time, no treatment used on rash. There were no labs performed. At the time of report, the localized swelling at the injection site remains unchanged. Patient had not recovered from events. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a physician via office manager refers to a patient of unknown age. On 08-JUN-2013, the patient was vaccinated with a dose of RECOMBIVAX HB, (lot # 0384AE, expiry date 02-NOV-2014), with the same lot of improperly stored RECOMBIVAX HB. Concomitant medications were not reported. No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: Symptoms: Rash and Urticaria Pruritus. Treatment: Diphenhydramine 25 mg PRN, Prednisone 5 mg MG Other.
Age: 46.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site erythema, Injection site pruritus, Livedo reticularis, Vaccination site pain, Vaccination site rash
Clinical narrative: 46 y/o patient who received AVA (1) in his left arm on 6 APR 2013. That evening he noted what he describes as a "mottled rash" surrounding the vaccination accompanied by pain, itching, redness and swelling. He did not have upper extremity weakness, and his symptoms did not restrict his duties. He denies experiencing angioedema, itching or swelling of tongue, difficulty swallowing, hives, dyspnea, and nasal symptoms. He did not self treat and his symptoms resolved in about 2 days. His physician partner, evaluated his reaction and recommended an anthrax vaccine exemption. Patient reported feeling well day of and prior to vaccinations. No known exposures. No other vaccines received on 6 APR. No history of prior vaccine reactions.
Age: 46.0
Sex: M
Vaccine: ANTH
Symptoms: Vaccination site reaction, Vaccination site swelling
Clinical narrative: 46 y/o patient who received AVA (1) in his left arm on 6 APR 2013. That evening he noted what he describes as a "mottled rash" surrounding the vaccination accompanied by pain, itching, redness and swelling. He did not have upper extremity weakness, and his symptoms did not restrict his duties. He denies experiencing angioedema, itching or swelling of tongue, difficulty swallowing, hives, dyspnea, and nasal symptoms. He did not self treat and his symptoms resolved in about 2 days. His physician partner, evaluated his reaction and recommended an anthrax vaccine exemption. Patient reported feeling well day of and prior to vaccinations. No known exposures. No other vaccines received on 6 APR. No history of prior vaccine reactions.
Age: 65.0
Sex: F
Vaccine: HEP
Symptoms: Pruritus, Urticaria
Clinical narrative: This spontaneous report was received from a Nurse Practitioner refers to a 65 year old female patient. No medical history was reported. On 24-MAY-2013, the patient was vaccinated with a dose 1 of RECOMBIVAX HB (invalid lot# 1000387, expiry:07-SEP-2014). No concomitant medications were reported. On 25-MAR-2013, the patient developed hives and pruritis after receiving the first dose of RECOMBIVAX HB. Patient sought medical attention (office visit). Patient received treatment with Allegra. The outcome of hives and pruritus was reported as recovering. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a physician via office manager refers to a patient of unknown age. On 23-APR-2013, the patient was vaccinated with a dose of GARDASIL, (lot # H02002, expiry date 08-AUG-20150, with the same lot of improperly stored GARDASIL. Concomitant medications were not reported. No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a physician via office manager refers to a patient of unknown age. On 23-APR-2013, the patient was vaccinated with a dose of GARDASIL (lot # H020002, expiry date 08-AUG-2015), with the same lot of improperly stored GARDASIL. Concomitant medications were not reported. No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a 1 year old male patient. On an unknown date the patient was vaccinated with VARIVAX (Merck) (lot# not provided) dose 1. On an unknown date, within a week of the vaccination, the patient experienced a severe case of shingles. The outcome of shingles was reported as recovered/resolved on an unspecified date. Additional information has been requested.
Age: 50.0
Sex: M
Vaccine: ANTH
Symptoms: Balance disorder, Dizziness, Pruritus
Clinical narrative: Dizziness, itching skin, loss of balance.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Autoimmune disorder, Central nervous system inflammation, Headache, Nausea, Neuralgia
Clinical narrative: Head pain, constant nausea, cycle vomiting, nerve pain, neurological inflammation, autoimmune started.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Vomiting
Clinical narrative: Head pain, constant nausea, cycle vomiting, nerve pain, neurological inflammation, autoimmune started.
Age: 34.0
Sex: M
Vaccine: RAB
Symptoms: Chills, Decreased appetite, Hypoaesthesia, Pain, Paraesthesia
Clinical narrative: 6/14/13: decreased appetite. 6/15/13:  numbness/tingling 2nd & 3rd fingers both hands & site of cat bite (L hand).  1st finger - tingling present @ this date.  Chills (6/14 only).  Body aches 6/15 - 6/18/13, severe per patient.  Almost resolved as of 6/21.  6/15 was given IV antibiotics + fluids in ER.  6/18:  saw infectious disease MD - diagnosed "serum sickness".  Given taper course of methylprednisone - 6 day course.  Began 6/18.  All symptoms not yet resolved as of 6/21.
Age: 34.0
Sex: M
Vaccine: RAB
Symptoms: Serum sickness
Clinical narrative: 6/14/13: decreased appetite. 6/15/13:  numbness/tingling 2nd & 3rd fingers both hands & site of cat bite (L hand).  1st finger - tingling present @ this date.  Chills (6/14 only).  Body aches 6/15 - 6/18/13, severe per patient.  Almost resolved as of 6/21.  6/15 was given IV antibiotics + fluids in ER.  6/18:  saw infectious disease MD - diagnosed "serum sickness".  Given taper course of methylprednisone - 6 day course.  Began 6/18.  All symptoms not yet resolved as of 6/21.
Age: 16.0
Sex: M
Vaccine: HPVX, MEN
Symptoms: Asthenia, Chills, Dizziness, Hyperhidrosis, Nausea
Clinical narrative: Fever of 102.3; chills, sweats, nausea, dizzy, weakness.
Age: 16.0
Sex: M
Vaccine: HPVX, MEN
Symptoms: Pyrexia
Clinical narrative: Fever of 102.3; chills, sweats, nausea, dizzy, weakness.
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, Injection site joint movement impairment, Injection site pain
Clinical narrative: Acute shoulder pain at injection site and limited range of motion.  Symptoms increasing in severity 5 days after initial onset with further range limitation and pain.
Age: 1.52
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Abdominal discomfort, Gastrointestinal disorder, Nausea, Pyrexia, Vaccination site swelling
Clinical narrative: Mother reports swelling around the vaccination site (DTAP) as well as patient was running 103.0 Fever.  Mother of patient also reports GI symptoms including upset stomach, nausea and vomiting for two days.
Age: 1.52
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Vomiting
Clinical narrative: Mother reports swelling around the vaccination site (DTAP) as well as patient was running 103.0 Fever.  Mother of patient also reports GI symptoms including upset stomach, nausea and vomiting for two days.
Age: 11.0
Sex: M
Vaccine: HEPA, MNQ, TDAP
Symptoms: Dizziness, Feeling cold, Vomiting
Clinical narrative: Patient given vaccines at 1145 after 15 minute wait went to facility where patient reported feeling light headed and then proceeded to vomit and feel cold. Reported back into clinic at 1235 to be seen by PCM.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema, Induration, Pyrexia, Skin warm, Swelling
Clinical narrative: Swollen, red, hard and hot to touch around area where given. Reaction area spread approx. 10 inches in width and 4 inches in height. Child also ran fever.
Age: 0.52
Sex: F
Vaccine: DTAP, HIBV, PPV
Symptoms: Decreased appetite, Fatigue, Hypersomnia, Injection site discomfort, Irritability
Clinical narrative: Feverish, discomfort at injection site. Next morning she was fatigued, slept excessively, very fussy. Poor appetite.
Age: 0.52
Sex: F
Vaccine: DTAP, HIBV, PPV
Symptoms: Pyrexia
Clinical narrative: Feverish, discomfort at injection site. Next morning she was fatigued, slept excessively, very fussy. Poor appetite.
Age: 1.27
Sex: M
Vaccine: DTAP
Symptoms: Pyrexia
Clinical narrative: NIGHT OF SHOTS STARTED FEVER OF 103.0. FEVER LAST 3 DAYS AND WILL ONLY COME DOWN WITH MOTRIN BUT AFTER 6 HOURS WILL COME RIGHT BACK UP TO 103.0 AGAIN.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema, Induration, Injection site discolouration, Injection site erythema, Injection site warmth
Clinical narrative: Red and warm from groin to knee, L thigh. Brick hard, pain to bear weight, fever x1 day. At sight of immunization, white dime-sized area with small red spot in center.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Pain, Pyrexia, Weight bearing difficulty
Clinical narrative: Red and warm from groin to knee, L thigh. Brick hard, pain to bear weight, fever x1 day. At sight of immunization, white dime-sized area with small red spot in center.
Age: 12.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Erythema, Oedema peripheral, Pain
Clinical narrative: Red circle, upper arm, sore all day, arm swollen.  Patient seen at office visit on 6/26/13 by a different provider.  Treatment Ice & Advil.  Patient seen again by another provider on 6/27/13 Tylenol & Benadryl encouraged.  Keflex prescribed for possible cellulitis.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Hard spot at site of injection and redness 4 inches around it.
Age: 19.0
Sex: M
Vaccine: SMALL
Symptoms: Chest X-ray normal, Chest pain, Electrocardiogram normal, Full blood count normal, Laboratory test normal
Clinical narrative: Patient c/o anterior cp onset 1200 noon 27 June 2013 while sitting in a briefing. Pain increased with movement and deep breathing. Non radiating, no SOB, nausea or vomiting. Patient presented to the emergency department at 1750 by private auto. BP 137/92 HR 67, Resp 18, SA02 99%. Temp 98.5. Patient was given Naproxen, Diagnostic tests: CXR, Trop, CBC, Chem, EKG.
Age: 19.0
Sex: M
Vaccine: SMALL
Symptoms: Pain, Painful respiration, Troponin normal
Clinical narrative: Patient c/o anterior cp onset 1200 noon 27 June 2013 while sitting in a briefing. Pain increased with movement and deep breathing. Non radiating, no SOB, nausea or vomiting. Patient presented to the emergency department at 1750 by private auto. BP 137/92 HR 67, Resp 18, SA02 99%. Temp 98.5. Patient was given Naproxen, Diagnostic tests: CXR, Trop, CBC, Chem, EKG.
Age: 61.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Nausea
Clinical narrative: Lightheaded, dizziness in motion, nausea all started about 0500 06/28/13. No other symptoms. Has been drinking fluids, no medications. Is still experiencing symptoms as of 12:30 pm 6/28/13.
Age: 46.0
Sex: F
Vaccine: VARCEL, PPV
Symptoms: Antibody test negative, Contusion, Injection site rash, Skin lesion, Swelling
Clinical narrative: Rash at injection site on day 10, continued increase in size of rash and swelling for the next week with bruising.  Three random lesions on trunk and one on scalp.  No eruptions noted.
Age: 46.0
Sex: F
Vaccine: VARCEL, PPV
Symptoms: Injection site bruising, Injection site swelling
Clinical narrative: Rash at injection site on day 10, continued increase in size of rash and swelling for the next week with bruising.  Three random lesions on trunk and one on scalp.  No eruptions noted.
Age: 1.26
Sex: M
Vaccine: DTAP, HIBV, PPV
Symptoms: Chest X-ray abnormal, Convulsion, Decreased appetite, Pneumonia, Pyrexia
Clinical narrative: 06/21/2013 @ 3pm - noticed slight fever. 06/22/2013 @ 10am - temperature of 101.6, given infant acetaminophen @ 6:30 pm - temperature of 103.8, taken to ER @7pm temp of 104.2, given infant acetaminophen in ER @745pm Seizure & temp of 105.3, given IV & antibiotics fever was reduced & patient was sent home. 06/24/2013 @ 845am - temperature of 105.6, taken back to ER chest X-ray from 6/22 showed bilateral pneumonia. 06/27/2013 fever is gone & patients appetite is returning. Patient has follow up appointment on 07/01/2013. Similar occurrence happened one year prior after vaccination.
Age: 1.26
Sex: M
Vaccine: DTAP, HIBV, PPV
Symptoms: Similar reaction on previous exposure to drug
Clinical narrative: 06/21/2013 @ 3pm - noticed slight fever. 06/22/2013 @ 10am - temperature of 101.6, given infant acetaminophen @ 6:30 pm - temperature of 103.8, taken to ER @7pm temp of 104.2, given infant acetaminophen in ER @745pm Seizure & temp of 105.3, given IV & antibiotics fever was reduced & patient was sent home. 06/24/2013 @ 845am - temperature of 105.6, taken back to ER chest X-ray from 6/22 showed bilateral pneumonia. 06/27/2013 fever is gone & patients appetite is returning. Patient has follow up appointment on 07/01/2013. Similar occurrence happened one year prior after vaccination.
Age: 0.39
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV1
Symptoms: Eye swelling, Swelling face
Clinical narrative: Mom states face and eye swelled--mom called covering MD--did not tell pmd until 6/26/13.  Had no pictures.
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Urticaria
Clinical narrative: URTICARIA LESIONS.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Injection site is warm to touch and reddeded, area is 6" X 3". Patient applied ice and took ibuprofen.
Age: 21.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site pain, Nausea, Pain, Pyrexia, Tenderness
Clinical narrative: Nausea and vomiting beginning am on 6/27/2013, client reported vomiting multiple times. Low grade fever (reported around 99 F), reported general achiness, especially in left deltoid where shot was given; also feeling localized tenderness in neck/collarbone area, denied sore throat. Client reported symptoms were improving when seen on 6/28/13 at 2:15 pm.
Age: 21.0
Sex: M
Vaccine: TDAP
Symptoms: Vomiting
Clinical narrative: Nausea and vomiting beginning am on 6/27/2013, client reported vomiting multiple times. Low grade fever (reported around 99 F), reported general achiness, especially in left deltoid where shot was given; also feeling localized tenderness in neck/collarbone area, denied sore throat. Client reported symptoms were improving when seen on 6/28/13 at 2:15 pm.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site rash
Clinical narrative: Rash and itchiness at site of injection.
Age: 13.0
Sex: M
Vaccine: HPV4
Symptoms: Computerised tomogram abnormal, Cytomegalovirus test negative, Epstein-Barr virus test negative, Haemoglobin normal, Hepatitis A virus test
Clinical narrative: Patient's father called through the answering service to report that patient had vomited several times and had fever of 104 on the evening of him receiving his 3rd Gardasil vaccine. The following day patient was examined and found to have splenomegaly and on US and CT he was noted to have a large hematoma that appears to be spontaneous as there is no history of trauma. He was transferred from ER to another hospital's ICU where surgery and hematology were consulted. He was admitted 6-14-13 and discharged 6-19-13. No additional treatment was needed.
Age: 13.0
Sex: M
Vaccine: HPV4
Symptoms: Hepatitis B test negative, Hepatitis C test negative, Hepatitis viral test negative, Intensive care, Parvovirus B19 test negative
Clinical narrative: Patient's father called through the answering service to report that patient had vomited several times and had fever of 104 on the evening of him receiving his 3rd Gardasil vaccine. The following day patient was examined and found to have splenomegaly and on US and CT he was noted to have a large hematoma that appears to be spontaneous as there is no history of trauma. He was transferred from ER to another hospital's ICU where surgery and hematology were consulted. He was admitted 6-14-13 and discharged 6-19-13. No additional treatment was needed.
Age: 13.0
Sex: M
Vaccine: HPV4
Symptoms: Platelet count decreased, Pyrexia, Splenomegaly, Spontaneous haematoma, Ultrasound scan abnormal
Clinical narrative: Patient's father called through the answering service to report that patient had vomited several times and had fever of 104 on the evening of him receiving his 3rd Gardasil vaccine. The following day patient was examined and found to have splenomegaly and on US and CT he was noted to have a large hematoma that appears to be spontaneous as there is no history of trauma. He was transferred from ER to another hospital's ICU where surgery and hematology were consulted. He was admitted 6-14-13 and discharged 6-19-13. No additional treatment was needed.
Age: 13.0
Sex: M
Vaccine: HPV4
Symptoms: Vomiting, White blood cell count decreased
Clinical narrative: Patient's father called through the answering service to report that patient had vomited several times and had fever of 104 on the evening of him receiving his 3rd Gardasil vaccine. The following day patient was examined and found to have splenomegaly and on US and CT he was noted to have a large hematoma that appears to be spontaneous as there is no history of trauma. He was transferred from ER to another hospital's ICU where surgery and hematology were consulted. He was admitted 6-14-13 and discharged 6-19-13. No additional treatment was needed.
Age: 1.01
Sex: F
Vaccine: HEP, MMR, PNC13, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Provider note: Pt received 1 yo vaccines on 6/7/13. Since the time of shots, mom noted redness at injection site, but since then it has been growing in size, with incr swelling, and a discrete induration in the center of an oval area of erythema. No fever, decr PO/UOP. No meds. Moving arm around.
Age: 0.51
Sex: F
Vaccine: DTAP, HIBV, PNC13, RV5
Symptoms: Crying
Clinical narrative: Inconsolable high pitched crying for the whole day including the next day.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Chest discomfort, Throat tightness
Clinical narrative: Patient reports slight tightness in throat radiating to chest. Symptoms resolved spontaneously within the hour.
Age: 18.0
Sex: M
Vaccine: HPV4
Symptoms: Injection site pain, Muscle rigidity, Muscular weakness, Syncope
Clinical narrative: Patient stood up after injection, felt burning at the sight, walked 5 feet to the door and collapsed.  His legs buckled oddly under him and Dr. came to the rescue.  He went stiff and came to.
Age: 18.0
Sex: F
Vaccine: HEPA, HPV4, MNQ
Symptoms: Fall, Head injury
Clinical narrative: This spontaneous report as received from a other health professional refers to a 18 year old female patient with none pertinent medical history or drug reaction allergies. It was reported that today, on 26-JUN-2013 (also reported as 21-JUN-2013), the patient was vaccinated with the first dose of GARDASIL (Lot # J003737, expiration date 07-NOV-2015) (0.5 ml, intramuscular route). Concomitant therapies applied on the same date included MENACTRA and HAVRIX (it was also reported that there were none concomitant medications). On 26-JUN-2013, 5 minutes after receiving GARDASIL, the patient walked into the waiting room, fell and hit her head. The patient was taken in ambulance to the emergency department and was administered oxygen (medically significant) in the ambulance. The patient was not admitted to the hospital and no injuries were determined. At the time of the report the patient's outcome was unknown. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Fall, Local swelling, Loss of consciousness
Clinical narrative: This spontaneous report as received from a physician refers to a 11 year old female patient with no known allergies who on 17-JUN-2013, was vaccinated with a dose of GARDASIL (lot number H021194, Exp. Date: 15-AUG-2015), 0.5 ml, intramuscular in the right deltoid. At the same office visit the patient also received MENACTRA and ADACEL. The physician reported that on 17-JUN-2013, the patient lost consciousness for 15 second after vaccination with GARDASIL. The patient laid down for approximately 15 minutes and after that time, pupils were equal round and reactive. The patient had minimal swelling to skull, from the fall. No treatment was given for the experience. The patient was released to go home and had recovered (date not provided) in approximately June 2013. The relatedness for lost consciousness and minimal swelling to skull from the fall and GARDASIL was unknown. Additional information has been requested.
Sex: M
Vaccine: TDAP
Symptoms: Lymphadenopathy, Pyrexia
Clinical narrative: Swollen lymph nodes affect (L) arm low grade fever.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Redness, edema of (L) upper arm, BACTRIM given.
Age: 74.0
Sex: F
Vaccine: VARCEL
Symptoms: Wrong drug administered
Clinical narrative: Administered VARIVAX (Varicella) vaccine rather than ZOSTAVAX vaccine, effectively under dosing intended vaccination. Contacting patient to return for ZOSTAVAX on or after July 10, 2013.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Raised area at injection site - 3 in x 2 in oval shape - feels hot to the touch and achy.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Swelling, redness, warm, hard bump under skin at injection site.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister
Clinical narrative: Pt has blisters on his trunk and one arm developed 6/28/13. Pt received vaccine (ZOSTAVAX) on 6/18/2013.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Erythema, Feeling of body temperature change, Injection site erythema, Injection site warmth
Clinical narrative: 24 hours after immunization - patient felt hot and dizzy - injection site red - warm to touch - much of arm and shoulder - was red - blood pressure OK and temperature OK - patient was improving 6/28/13.
Age: 31.0
Sex: F
Vaccine: HPV2
Symptoms: Death
Clinical narrative: Subject was enrolled in Vaccine Trial and received 3 doses of CERVARIX. Following closeout from CVT in 12/17/2010, patient continued in Extended Follow-up Study (since 8/1/2011). At study visit on 6/21/2013, parents-in-law of patient reported she passed away at home on 9/25/2012. Patient has hx of severe dilated cardiomyopathy starting in 2008, and suffered severe respiratory illnesses and a stroke in 2010 and 2011, respectively. Cause of death was believed to be related to her underlying heart condition and not related to vaccination.
Age: 1.76
Sex: M
Vaccine: HEPA, HIBV
Symptoms: Erythema, Injection site vesicles
Clinical narrative: Received Hib in (L) deltoid 6/25. Increasing redness the following day, then developed large blisters surrounding the injection site later on 6/26/ and 6/27.
Age: 1.01
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Rash generalised, Rash vesicular
Clinical narrative: Pt had full body vesicular rash.