chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.26
Sex: F
Vaccine: DTAP, MMR, VARCEL, VARCEL
Symptoms: Skin lesion
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a 1 year old female patient with no pertinent medical history and no drug reactions or allergies. On 27-MAR-2013, the patient was vaccinated with a 0.5 ml dose of VARIVAX (Merck) (Lot # H017243, expiration date 17-SEP-2014) SQ. There was no concomitant medication. The medical assistant reported that on 27-MAR-2013, the patient received VARIVAX (Merc) and had fever greater than 100.3F, soreness at the site, patient not acting herself, lethargic, right upper thigh blistering, developed a red lesion at the injection site that got bigger. The patient came into the office on 09-APR-2013, due to fever and soreness at the injection site. On 03-MAY-2013, the patient was seen in the office regarding conjunctival edema from the eyes, enlargement of lymph nodes and watery discharge from the eye. The patient was treated with TYLENOL and MOTRIN. There were no Lab diagnosis/studies performed. At the time of the report, the patient had not recovered. The medical assistant requested a lot check. This is one of several reports received from the same source. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: TYP, TYP
Symptoms: Dysphagia, Dyspnoea
Clinical narrative: This case was forwarded by Crucell with the reference number: CVAE-029-2013. An initial report was received from a nurse on 30.May.2013 and concerns an 18-year-old female patient, who in 12.May.2013 received the first dose of VIVOTIF (batch no.: not available). The second dose of VIVOTIF was administered on 14.May.2013. Medical history included many allergies and sensitivity to medications (not specified). Concomitant medication was not reported. On 13.May.2013, the patient woke up with difficulty breathing. On 14.May.2013, she had difficulty swallowing the second capsule of VIVOTIF and went to the Emergency Room. On an unspecified date, the patient also experienced abdominal discomfort, fatigue and facial rash. No other information was reported for this case. At the time of the reporting, the patient was recovering from the events. The case was reported as serious (medically significant).
Age: 18.0
Sex: F
Vaccine: TYP, TYP
Symptoms: Abdominal discomfort, Dysphagia, Dyspnoea, Fatigue, Rash
Clinical narrative: This case was forwarded by Crucell with the reference number: CVAE-029-2013. An initial report was received from a nurse on 30.May.2013 and concerns an 18-year-old female patient, who in 12.May.2013 received the first dose of VIVOTIF (batch no.: not available). The second dose of VIVOTIF was administered on 14.May.2013. Medical history included many allergies and sensitivity to medications (not specified). Concomitant medication was not reported. On 13.May.2013, the patient woke up with difficulty breathing. On 14.May.2013, she had difficulty swallowing the second capsule of VIVOTIF and went to the Emergency Room. On an unspecified date, the patient also experienced abdominal discomfort, fatigue and facial rash. No other information was reported for this case. At the time of the reporting, the patient was recovering from the events. The case was reported as serious (medically significant).
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Serum sickness
Clinical narrative: Ot serum react d/t vacc on 2013-05-18.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Serum sickness
Clinical narrative: Ot serum react d/t vacc on 2013-05-23.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Rash
Clinical narrative: Nonspecif skin erupt NEC on 2013-05-30, clinician comment: maybe vaccination related rash.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Urticaria
Clinical narrative: Intense itch, wheal the size of 2 silver dollars.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a physician refers to a 20 year old female patient. On 07-JUL-2011 the patient was vaccinated with dose 1, standard 0.5 milliliter (ml) GARDASIL (lot# 1561z, expiration date 23-MAR-2013). On 02-APR-2013, the patient was vaccinated with dose 2 0.5 milliliters (ml) GARDASIL (lot# H015555, 13-APR-2015) intramuscular. No adverse effects reported. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site inflammation, Injection site pruritus, Injection site rash, Injection site vesicles
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 69 year old female patient with penicillin allergy and no pertinent medical history. On 03-JUN-2013 the patient was vaccinated with a dose of ZOSTAVAX (lot # J000494, exp date 14-APR-2014). Concomitant therapies included CELEBREX. The pharmacist reported tat on 04-JUN-2013, the patient presented to pharmacy with a red rash the "size of a softball" around the injection site with a small blistered area within the rash. The pharmacist stated the blistered area looked like a water blister the size of a "half dollar"; the area was inflamed, "hot to the touch" and itchy. Topical cortisone was given for the events. No lab diagnostics studies were performed. The outcome of the events was reported as not recovered. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 69 year old female patient with penicillin allergy and no pertinent medical history. On 03-JUN-2013 the patient was vaccinated with a dose of ZOSTAVAX (lot # J000494, exp date 14-APR-2014). Concomitant therapies included CELEBREX. The pharmacist reported tat on 04-JUN-2013, the patient presented to pharmacy with a red rash the "size of a softball" around the injection site with a small blistered area within the rash. The pharmacist stated the blistered area looked like a water blister the size of a "half dollar"; the area was inflamed, "hot to the touch" and itchy. Topical cortisone was given for the events. No lab diagnostics studies were performed. The outcome of the events was reported as not recovered. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site mass, Injection site pruritus, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 69 year old female patient with penicillin allergy and no pertinent medical history. On 03-JUN-2013 the patient was vaccinated with a dose of ZOSTAVAX (lot # J000494, exp date 14-APR-2014). Concomitant therapies included CELEBREX. The pharmacist reported tat on 04-JUN-2013, the patient presented to pharmacy with a red rash the "size of a softball" around the injection site with a small blistered area within the rash. The pharmacist stated the blistered area looked like a water blister the size of a "half dollar"; the area was inflamed, "hot to the touch" and itchy. Topical cortisone was given for the events. No lab diagnostics studies were performed. The outcome of the events was reported as not recovered. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a female patient of unknown age. On 11-DEC-2006 the patient was vaccinated with her first dose of GARDASIL (intramuscular, injection 120 Y, lot#, dose/frequency, route and duration were unspecified). Her second dose of was on 31-JAN-2008 and third dose on 19-MAY-2013. No adverse effects reported. The outcome was unknown. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Confusional state, Convulsion, Depressed level of consciousness, Electroencephalogram abnormal, Nuclear magnetic resonance imaging brain normal
Clinical narrative: The morning after vaccination she became febrile and had decreased level of alertness and confusion. She may have had an unwitnessed seizure. Over the course of that day she had 2 more seizures when she was not febrile. She was started on TRILEPTAL. No seizures since starting TRILEPTAL.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Pyrexia
Clinical narrative: The morning after vaccination she became febrile and had decreased level of alertness and confusion. She may have had an unwitnessed seizure. Over the course of that day she had 2 more seizures when she was not febrile. She was started on TRILEPTAL. No seizures since starting TRILEPTAL.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Balance disorder, Dizziness, Feeling hot, Heart rate increased, Nausea
Clinical narrative: I received the first shot of GARDASIL on 06/07/13. I became faint, dizzy, nauseous, my heart rate went up, and I felt extremely hot right after getting the shot. I had to stay in the emergency room for most of the night due to how bad my symptoms were. The day after receiving the shot I am still dizzy and feel off balance. I would have NEVER gotten this shot if I knew that was going to happen, and I don't know how long I will have this dizziness.
Sex: U
Vaccine: HPV4
Symptoms: Adverse event
Clinical narrative: This spontaneous report as received from an unspecified reporter via field representative refers to a patient of unknown age. Field representative mentioned an unspecified adverse event with GARDASIL (strength, formulation, lot#, dose/frequency, route and duration were unspecified) and the call was disconnected before questions could be asked. The outcome of adverse event was unknown. Additional information is not expected.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Blood creatine phosphokinase normal, Myalgia
Clinical narrative: This spontaneous report was received from a physician refers to a female patient of unknown age. On an unknown date the patient was vaccinated with dose 1, of GARDASIL (lot #, expiration date and route not reported). On an unknown date the patient experienced all over muscle aches. Creatinine Protein Kinase (CPK) was normal. The patient sought medical attention by contacting the physician. The outcome of all over muscle aches was reported as recovered/resolved on an unknown date. Causality was not reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant refers to a patient of unknown age and gender. On an unknown date in 2011, the patient was vaccinated with dose 1, GARDASIL (lot#, expiration date and route not reported). On 02-MAY-2012, the patient was vaccinated with dose 2, GARDASIL (lot#, expiration date and route not reported). The patient was in the office on 12-JUN-2013 (reported as today) to receive dose 3, GARDASIL. No adverse effect reported. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Laboratory test abnormal, Polymerase chain reaction
Clinical narrative: This spontaneous report as received from a physician via CDC refers to a patient of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX (lot # unknown). On an unknown date the patient experienced herpes zoster. Polymerase chain reaction (PCR) testing performed at the CDC was found to the OKA vaccine strain. The outcome of herpes zoster was unknown. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Varicella virus test positive
Clinical narrative: This spontaneous report as received from a physician via CDC refers to a patient of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX (lot # unknown). On an unknown date the patient experienced herpes zoster. Polymerase chain reaction (PCR) testing performed at the CDC was found to the OKA vaccine strain. The outcome of herpes zoster was unknown. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Herpes zoster disseminated
Clinical narrative: This spontaneous report as received from Sanofi pasteur refers to a child of unknown age. On an unknown date the patient was vaccinated with (merck) VARIVAX (lot # was not reported). On an unknown date the patient  experienced was disseminated zoster. The child was not very ill and was not immunosuppressed. The outcome of was disseminated zoster was unknown. Additional information is not expected.
Sex: U
Vaccine: VARCEL
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a 3 patients of unknown age and gender. On an unknown date patients were vaccinated with VARIVAX (Merck) (lot # and expiration date unspecified) injection (dose, therapy route and anatomical location unspecified) to prevent chickenpox. The physician reported that the 3 patients received an expired VARIVAX (Merck) and no adverse effect was reported. Patients sought medical attention, laboratory tests were not performed. At the time of the report the outcome of 3 patients was unknown. Additional information has been requested.
Age: 15.0
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Nodule, Pain, Pruritus, Swelling
Clinical narrative: Vaccine given on 6/11/13, redness, swelling, knot noted by patient and parent. Itchy - pain - redness measuring 4.75" x 5".
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Musculoskeletal discomfort
Clinical narrative: This spontaneous report as received from a 70 year old male consumer refers to himself. The patient had no drug allergies. On 29-MAY-2013 the patient was vaccinated with ZOSTAVAX (lot # not reported) (strength and total daily dose not reported). Concomitant therapies included ALEVE, 81 mg aspirin (reported as "aspirin"), omeprazole, multi vitamin, CRESTOR, sotalol 75 mg and finasteride (manufacturer unknown) (reported as "Finesteribe"). Approximately "6 days" after the shot was given, on 06-JUN-2013, he started to feel discomfort on his joints. The discomfort started with toe joints, progressively moved to his knees both left and right and finger joints. When the patient turned his neck looking back and forth felt discomfort. The patient sought for unspecified medical attention. Unspecified treatment was given. The patient felt it was getting better. Additional information has been requested.
Age: 49.0
Sex: U
Vaccine: VARZOS
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a doctor of pharmacy via company representative refers to unknown number of patients of under 50 years of age and unknown gender. On an unknown date the patients were vaccinated with a dose of ZOSTAVAX (lot #, expiration date and route not reported). No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
Age: 17.0
Sex: M
Vaccine: TDAP
Symptoms: Arthralgia, Headache, Malaise, Myalgia, Vomiting
Clinical narrative: Patient had Tdap and felt ok until he went swimming and diving, got headache. The next day sick and emesis and myalgias, after taco, for a day, then better. Patient traveling, not seen before or since. Patient's mother called said that two hours after patient received Tdap he got a headache and is now vomiting and has pain in his knees.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Antibody test, Varicella
Clinical narrative: Developed chicken pox 20 days after getting the shingles shot. Saw doctor 5/31 and 6/7/13. Titers blood draw 3.9. Took acyclovir 400mg and doxycycline hyclate 100mg.
Age: 29.0
Sex: F
Vaccine: VARCEL
Symptoms: Exposure during pregnancy, Human chorionic gonadotropin positive, Pregnancy test positive
Clinical narrative: Information has been received from a Doctor of osteopathic for (Merck), a Pregnancy Registry product, concerning a 29 year old female patient with no allergies and a history recently discovered of heart murmur an asymptomatic an atrial septal defect who on 09-JUL-2011 was vaccinated with a SQ dose of VARIVAX (Merck) (Lot # 669920/0342AA,  Expiry date 07-MAR-2013) (does not reported). There was no concomitant medication. The doctor stated that the patient had been exposed to varicella by a co-worker who had chickenpox. The doctor mentioned that the patient might or might not had been pregnant when administered the VARIVAX (Merck). On 11-OCT-2011 via positive pregnancy test, the doctor confirmed that the patient was pregnant. The doctor also described that two positive pregnancy tests were performed. The patient performed a home pregnancy test and the physician had a "positive blood serum HCG". The patient was seen in the physician's office. At the time of the report, the patient had 6 weeks of gestation (LMP on 28-AUG-2011; EDD on 03-JUN-2012). Follow up information has been received from the clinic coordinator indicating that the patient had a healthy full term baby boy in June 2012 without any congenital anomalies. There was no other information received about her pregnancy or her child. Additional information is not expected.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain
Clinical narrative: This spontaneous report as received from a 54 year old female nurse (reporting on herself), with a pertinent medical history of low platelets and upper respiratory infection. On 03-MAY-2013 the patient was vaccinated with the second dose of ZOSTAVAX (Lot # not reported) (dose and route not reported) for shingles vaccination. Concomitant therapy was not reported. On 28-MAY-2013, the patient started to feel pain and developed an outbreak of shingles on the left side of her hip after receiving the second shot of ZOSTAVAX. it was unspecified when the patient received the first shot of ZOSTAVAX. The patient sought unspecified medical attention and LYRICA (dosage and manufacturer unspecified) was given as a treatment for the adverse events. The patient recovered from shingles and pain on an unspecified date. Additional information has been requested.
Age: 17.0
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Local swelling
Clinical narrative: This spontaneous report as received from a nurse practitioner via a company representative refers to a 17 year old male patient. On 03-MAY-2013 the patient was vaccinated with VARIVAX (Merck) lot # H007704, subcutaneous in the upper right outer arm for prophylaxis. The dose number was not reported. Between 06-MAY-2013 and 06-MAY-2013 the patient returned to the office and had developed a swelling and redness over an area covering 12 by 17 centimeter. The patient experienced no pain, itching, discomfort or systemic symptoms. Treatment for the events included oral BENADRYL, dose and manufacturer were not reported. The outcome of the swelling and redness was not reported. Additional information has been requested.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Chest pain, Injection site pain, Injection site warmth, Paraesthesia oral, Slow speech
Clinical narrative: After vaccine pt reported injection site pain that radiated to neck, pt felt hot, thirsty, chest pain, tingling of lips. Pt's blood pressure was 140/82, then 160/100 pt exhibited slowed speech. Paramedics contacted, they evaluated her and took her to hospital.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Thirst
Clinical narrative: After vaccine pt reported injection site pain that radiated to neck, pt felt hot, thirsty, chest pain, tingling of lips. Pt's blood pressure was 140/82, then 160/100 pt exhibited slowed speech. Paramedics contacted, they evaluated her and took her to hospital.
Age: 18.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Loss of consciousness, Syncope
Clinical narrative: Patient fainted and regained consciousness within a minute. He was taken to an exam room and stayed until he felt well enough to leave.
Age: 11.0
Sex: F
Vaccine: HEPA
Symptoms: Abdominal discomfort, Dizziness, Immediate post-injection reaction, Loss of consciousness, Malaise
Clinical narrative: Dizzy-faint-upset stomach. She passed out after nurse popped needle out of her arm and has complained of feeling ill since. Asked if it was okay to go to sleep.
Age: 11.0
Sex: F
Vaccine: HEPA
Symptoms: Somnolence, Syncope
Clinical narrative: Dizzy-faint-upset stomach. She passed out after nurse popped needle out of her arm and has complained of feeling ill since. Asked if it was okay to go to sleep.
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Swelling, soreness and redness at site of injection along pain with difficulty raising vaccinated arm (left deltoid).
Age: 55.0
Sex: F
Vaccine: HEPAB, IPV, TDAP, TYP, YF
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Large red non-tender bump where yellow fever was administered. Size of a silver dollar. Slightly warm to the touch.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Immunoglobulin therapy, Myelitis transverse, Nuclear magnetic resonance imaging abnormal
Clinical narrative: Transverse myelitis.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Redness/swelling/pain/warm, right upper arm (RD). Pt was seen by one of the providers.
Age: 24.0
Sex: F
Vaccine: JEV1
Symptoms: Headache, Hypoaesthesia, Injection site anaesthesia, Injection site pain, Pain in extremity
Clinical narrative: Headache and sore arm. Intermittent numbness, tingling of left arm.  Persistent numbness at injection site.  "Fire" pain at injection site.  Episodes of numbness right arm and lower back.  Tinnitus left ear (tapering).
Age: 24.0
Sex: F
Vaccine: JEV1
Symptoms: Paraesthesia, Tinnitus
Clinical narrative: Headache and sore arm. Intermittent numbness, tingling of left arm.  Persistent numbness at injection site.  "Fire" pain at injection site.  Episodes of numbness right arm and lower back.  Tinnitus left ear (tapering).
Age: 16.0
Sex: F
Vaccine: UNK
Symptoms: Dizziness, Headache, Injection site pain, Nausea
Clinical narrative: Headache, nausea, soreness at injection site, dizziness.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Laceration, Syncope
Clinical narrative: Pt had syncopal episode at time of vaccination, falling off exam table and lacerating her chin.  Pt treated for laceration.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Inflammation, Pain, Pruritus, Skin warm
Clinical narrative: Approximately 24 hours after vaccination patient noticed the area was red, hot, inflamed, itchy and painful.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Paraesthesia, Rash
Clinical narrative: Pt received scheduled shingles vaccination on 6/6. Waited 15 min after felt fine. About 1-2 hrs later started to feel tingling about 4 days later pt cont MD felt bumps on chin. MD diag shingles on right side. Pt on VALTREX 1 gm tid.
Age: 47.0
Sex: M
Vaccine: TDAP
Symptoms: Full blood count, Injection site cellulitis, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Cellulitis. Severe pain and swelling w/red hard knot at site.
Age: 47.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site swelling
Clinical narrative: Cellulitis. Severe pain and swelling w/red hard knot at site.
Age: 63.0
Sex: U
Vaccine: TDAP
Symptoms: Injection site nodule, Injection site pruritus, Injection site swelling
Clinical narrative: Right arm swollen at site along with itching and knot.
Age: 1.51
Sex: M
Vaccine: DTAP, HIBV, MMR, PNC13, VARCEL
Symptoms: Injection site swelling
Clinical narrative: Left tricep swelling post varicella vaccine administered.
Age: 0.18
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Diarrhoea, Irritability
Clinical narrative: Diarrhea for 5 days post vaccination no blood in stool. Fussy for 2 days.
Age: 41.0
Sex: F
Vaccine: TDAP
Symptoms: Asthenia, Hypoaesthesia
Clinical narrative: Numbness and weakness moments after injection.
Age: 40.0
Sex: U
Vaccine: VARCEL
Symptoms: Antibody test abnormal, No therapeutic response
Clinical narrative: Information has been received from a physician concerning a 40 year-old patient, who, on an unspecified date (when the patient was a child), received one dose of VARIVAX (Merck). It was reported that the patient had low titer when it was drawn recently (date not specified). At the time of the report, the outcome for low titer was unknown. Relatedness for low titer was not reported for VARIVAX (Merck). Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a female patient of unknown age. It was reported that "2 years ago", in approximately June 2011, the patient was vaccinated with GARDASIL (lot # not reported) (dose 2, strength and total daily dose not reported). And the patient was in the office on 06-JUN-2013 to receive her third dose of GARDASIL. No adverse effect was reported. It was unspecified whether the patient sought medical attention. The outcome was unknown. Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Erythema, Injection site induration, Injection site reaction, Injection site warmth, Pain
Clinical narrative: Local reaction right thigh. Erythema 3in in diameter. Site hard and hot to touch. C/o mild pain. Prednisone 20mg, 1 tab x 5 days and amoxicillin 500/125 x 10 days.
Age: 14.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Hypoaesthesia, Somnolence
Clinical narrative: This spontaneous report was received from a physician via a company representative concerning an approximately 14 year old male patient. On 26-MAR-2013, the patient was vaccinated with the first dose of GARDASIL (lot number and expiry date reported as H014645 and 27-MAR-2015 respectively, dose unspecified), intramuscularly in the right arm. Concomitant therapy included MENACTRA (manufacturer, lot number, expiry date, dose and route unspecified) which was administered on 26-MAR-2013 (on the same day) in the left arm. On 26-MAR-2013, after receiving the vaccination, the patient experienced sleepiness and numbness in the right arm. It was unspecified if the patient sought any medical attention. No treatment was given and no lab tests were performed. Approximately on an unknown date in 2013, the patient recovered from the events. The relatedness for the events was unknown for GARDASIL. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: (L) arm erythema, warmth & swelling
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Large swollen red area (plate sized on leg).
Age: 23.0
Sex: F
Vaccine: TYP
Symptoms: Oral administration complication, Vomiting
Clinical narrative: Patient vomited after 4th capsule. Took first 3 capsule.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Hypersensitivity, Influenza like illness, Injection site pain, Injection site reaction, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 66 year old female patient. The reaction was described as itching and hurts. Pertinent medical history was unspecified by the reporter. On MAY-1993 (20 years ago), the patient was vaccinated with a dose of (manufacturer unknown) injection (lot number, expiration date, route and dose were not reported). On approximately May 2013, the patient had an allergic reaction to a "pneumonia vaccine" and pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) could not be ruled out. The patient experienced high fever of 104.6F, she felt as if she had the flu, and there was approximately a 4 inch area at the site of injection. The site was hot, swollen and very sore. After the third day, on an unspecified date, the redness, swelling and pain started to dissipate and were eventfully gone. Pharmacist also stated that the patient had a reaction to neomycin in the past. Patient's status was reported as recovered. No treatment was given. It was not reported if the patient sought medical attention. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site warmth, Pyrexia, Vaccination complication
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 66 year old female patient. The reaction was described as itching and hurts. Pertinent medical history was unspecified by the reporter. On MAY-1993 (20 years ago), the patient was vaccinated with a dose of (manufacturer unknown) injection (lot number, expiration date, route and dose were not reported). On approximately May 2013, the patient had an allergic reaction to a "pneumonia vaccine" and pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) could not be ruled out. The patient experienced high fever of 104.6F, she felt as if she had the flu, and there was approximately a 4 inch area at the site of injection. The site was hot, swollen and very sore. After the third day, on an unspecified date, the redness, swelling and pain started to dissipate and were eventfully gone. Pharmacist also stated that the patient had a reaction to neomycin in the past. Patient's status was reported as recovered. No treatment was given. It was not reported if the patient sought medical attention. Additional information has been requested.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Dermatitis contact, Injection site erythema, Injection site pain, Rash pruritic
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 54 year old female patient. On 05-JUN-2013, the patient was vaccinated with ZOSTAVAX, 0.65 ml, subcutaneous (lot number not reported). The patient developed redness (a 3 cm area) and mild pain at injection site the next day, on 06-JUN-2013. The patient developed a rash on her face that itched, but did not burn. The nurse practitioner suspected a poison ivy rash, because the rash crossed the midline on her face and prescribed calamine lotion which did bring some relief for the patient. The nurse practitioner cultured the lesions, but did not have the results back at the time of the report. The patient's outcome was reported as recovering. The patient sought medical attention via an office visit. Additional information has been requested.
Age: 0.16
Sex: F
Vaccine: HIBV, PNC
Symptoms: Apnoea, Bradycardia
Clinical narrative: Infant received vaccines at 16:24 and 16:26. Apnea 01:58 (approx 10 hrs). Bradycardia/required increased oxygen at 00:20 and 03:23 approx 8 hrs and 16 hrs later. (This is a preemie on a high flow nasal cannula).
Age: 1.35
Sex: F
Vaccine: DTAP
Symptoms: Injection site reaction, Skin reaction
Clinical narrative: Localized reaction 3 x 3 in size Lt. thigh. Monitor.
Age: 1.01
Sex: M
Vaccine: MMRV, PNC13
Symptoms: Aphasia
Clinical narrative: Mom states patient stopped talking and using sign language after he received his vaccines. Referred to speech therapy.
Age: 65.0
Sex: F
Vaccine: PPV, TDAP, VARZOS
Symptoms: Induration, Rash macular, Skin warm
Clinical narrative: Large palm-sized macural indurated, hot to touch. No fever.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Induration, Injection site induration, Pain in extremity, Skin warm, Swelling
Clinical narrative: Severe arm pain, swelling, warmth, from deltoid to hand.
Age: 63.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Swelling
Clinical narrative: S/S: Swelling, cellulitis of arm. Treatment: BENADRYL 50 mg/mL injection DEPO MEDROL 80 mg/mL injection KEFLEX 500 mg 1 po tid x 10 days.
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Back pain, CSF test normal, Demyelination, Hypoaesthesia, Laboratory test normal
Clinical narrative: (R) chest wall/back paresthesias/pain -> severe spinal pain, (R) leg and foot numbness. MRI showed demyelination T4->T11. Sxs started 4 days following Tdap vaccine. So far labs and lumbar puncture CSF results negative for other causes. Brain MRI negative for multiple sclerosis.
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Musculoskeletal chest pain, Myelitis transverse, Nuclear magnetic resonance imaging brain normal, Nuclear magnetic resonance imaging spinal abnormal, Paraesthesia
Clinical narrative: (R) chest wall/back paresthesias/pain -> severe spinal pain, (R) leg and foot numbness. MRI showed demyelination T4->T11. Sxs started 4 days following Tdap vaccine. So far labs and lumbar puncture CSF results negative for other causes. Brain MRI negative for multiple sclerosis.
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Spinal pain
Clinical narrative: (R) chest wall/back paresthesias/pain -> severe spinal pain, (R) leg and foot numbness. MRI showed demyelination T4->T11. Sxs started 4 days following Tdap vaccine. So far labs and lumbar puncture CSF results negative for other causes. Brain MRI negative for multiple sclerosis.
Age: 36.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Guillain-Barre syndrome, Immunoglobulin therapy, Intensive care, Miller Fisher syndrome
Clinical narrative: Vaccine administered on 1/14/13. Pt developed symptoms of blurred vision and weakness which progressed to paralysis all within 9 days. Pt was Dx with Miller Fisher variant Guillain-Barre syndrome. Supported in ICU. Discharged 2/6/13, received Gamma globulin and plasmapheresis.
Age: 36.0
Sex: M
Vaccine: FLU3
Symptoms: Paralysis, Plasmapheresis, Vision blurred
Clinical narrative: Vaccine administered on 1/14/13. Pt developed symptoms of blurred vision and weakness which progressed to paralysis all within 9 days. Pt was Dx with Miller Fisher variant Guillain-Barre syndrome. Supported in ICU. Discharged 2/6/13, received Gamma globulin and plasmapheresis.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Injection site pain, Nausea, Pain, Pyrexia
Clinical narrative: Fever (104.3); N/V; Bodyaches; Dizziness and Pain at Injection site.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Vomiting
Clinical narrative: Fever (104.3); N/V; Bodyaches; Dizziness and Pain at Injection site.
Age: 33.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: 5/27 vaccine administered. 5/29 Pt c/o swelling, tenderness, erythema R upper arm post vaccination. MD dx of Cellulitis. Bactrim ordered. 5/30 Per MD cellulitis improved. 5/31 Continues to improve. 6/1 Resolving continues to improve. 6/2 Continue Bactrim until complete. Pt discharged to home.
Age: 36.0
Sex: F
Vaccine: VARCEL
Symptoms: Periorbital oedema, Rash generalised, Tachycardia, Urticaria
Clinical narrative: 6/10 Hives-went to ED and was prescribed Prednisone and Vistaril. 6/11 Generalized rash, tachycardia, periorbital edema. Was given IV steroid and IV Benadryl.
Age: 67.0
Sex: M
Vaccine: YF, YF
Symptoms: Pain in extremity
Clinical narrative: Approx. 3 days after receiving the vac. my mouth and bottom of my left foot began to hurt/sore. This continue, so we contacted the office the vac. was administered and they set me up to visit one of their doctors.
Age: 67.0
Sex: M
Vaccine: YF, YF
Symptoms: Gingival pain, Lip pain, Oral discomfort, Oral pain
Clinical narrative: Approx. 3 days after receiving the vac. my mouth and bottom of my left foot began to hurt/sore. This continue, so we contacted the office the vac. was administered and they set me up to visit one of their doctors.
Age: 50.0
Sex: F
Vaccine: TDAP
Symptoms: Amylase, Blood electrolytes, Chills, Decreased appetite, Dizziness
Clinical narrative: Fever to 101.6, chills, headache, swelling at injection site, headache, nausea, dizziness, decreased appetite.
Age: 50.0
Sex: F
Vaccine: TDAP
Symptoms: Headache, Injection site swelling, Liver function test, Nausea, Pyrexia
Clinical narrative: Fever to 101.6, chills, headache, swelling at injection site, headache, nausea, dizziness, decreased appetite.
Age: 30.0
Sex: M
Vaccine: DTAP, HEP, MMR
Symptoms: Arthralgia, Oedema peripheral, Urticaria, Wheezing
Clinical narrative: Joint pain, hives, mild swelling of fingers, mild wheezing per patient. Treated with antihistamine and albuterol inhaler.
Age: 58.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Redness, swelling, tenderness at site of injection, fever and chills.  Started on antibiotics.
Age: 2.0
Sex: M
Vaccine: HIBV
Symptoms: Constipation, Erythema, Irritability, Pyrexia, Somnolence
Clinical narrative: High fever. Swelling. Red welt. Not able to use the restroom (constiptated x3 days) so far. Extremely Irritable. Excessive sleepiness.
Age: 2.0
Sex: M
Vaccine: HIBV
Symptoms: Swelling, Urticaria
Clinical narrative: High fever. Swelling. Red welt. Not able to use the restroom (constiptated x3 days) so far. Extremely Irritable. Excessive sleepiness.
Age: 53.0
Sex: F
Vaccine: UNK, VARZOS
Symptoms: Blister, Myalgia, Neuralgia, Pyrexia, Rash
Clinical narrative: Skin rash/blisters on buttocks; 100 degree fever; muscle aches; nerve pain in thigh and near tailbone.  Doctor prescribed anti-viral medication for a period of 7 days.
Age: 53.0
Sex: F
Vaccine: UNK, VARZOS
Symptoms: Herpes zoster
Clinical narrative: Skin rash/blisters on buttocks; 100 degree fever; muscle aches; nerve pain in thigh and near tailbone.  Doctor prescribed anti-viral medication for a period of 7 days.
Age: 2.0
Sex: M
Vaccine: MMRV
Symptoms: Antibody test negative, Febrile convulsion, Hypotonia, Mononucleosis heterophile test negative, Pharyngitis
Clinical narrative: This spontaneous report as received from a physician refers to a 2 year old male patient with allergic rhinitis and no known drug reactions/allergies. On 29-MAY-2013 the patient was vaccinated with a dose of PROQUAD (merck) lot # H015638 (dose and route not reported). Concomitant therapies included TYLENOL and MOTRIN. On 07-JUN-2013, during his office visit 9 days after vaccination the patient stilled and had a fever of 103 degrees accompanied febrile seizure and generalized tonic-clonic movements and exudative pharyngitis with thick nasal yellow discharge and sinusitis. The paramedics were called, however the child did not require transport to the hospital. Treating physician marked the onset date of symptoms for this event as 06-JUN-2013, however no additional information was provided as to what the initial symptoms were other than the symptoms described that occurred on 07-JUN-2013 during the child's office visit. Upon internal review, the events of generalized tonic-clonic movements and febrile seizure were considered medically significant. The outcome of the events was reported as recovered/resolved on 08-JUN-2013. The causal relationship was not reported. Additional information has been requested.
Age: 2.0
Sex: M
Vaccine: MMRV
Symptoms: Pyrexia, Rhinorrhoea, Sinusitis, Tonic clonic movements
Clinical narrative: This spontaneous report as received from a physician refers to a 2 year old male patient with allergic rhinitis and no known drug reactions/allergies. On 29-MAY-2013 the patient was vaccinated with a dose of PROQUAD (merck) lot # H015638 (dose and route not reported). Concomitant therapies included TYLENOL and MOTRIN. On 07-JUN-2013, during his office visit 9 days after vaccination the patient stilled and had a fever of 103 degrees accompanied febrile seizure and generalized tonic-clonic movements and exudative pharyngitis with thick nasal yellow discharge and sinusitis. The paramedics were called, however the child did not require transport to the hospital. Treating physician marked the onset date of symptoms for this event as 06-JUN-2013, however no additional information was provided as to what the initial symptoms were other than the symptoms described that occurred on 07-JUN-2013 during the child's office visit. Upon internal review, the events of generalized tonic-clonic movements and febrile seizure were considered medically significant. The outcome of the events was reported as recovered/resolved on 08-JUN-2013. The causal relationship was not reported. Additional information has been requested.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Febrile convulsion, Full blood count normal, Lumbar puncture normal, Pyrexia, Urine analysis normal
Clinical narrative: Febrile seizure, fever to 104.7 - eval by ER.
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Body temperature increased, Pain in extremity, Rash
Clinical narrative: Started with silver dollar size bump day after 6/11 - and was itchy. 6/12 - bigger and painful and a rash around it. Got steroid cream 6/14. Rash spread and got antibiotic.
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Hypersensitivity, Injection site pain, Injection site pruritus, Injection site rash
Clinical narrative: Started with silver dollar size bump day after 6/11 - and was itchy. 6/12 - bigger and painful and a rash around it. Got steroid cream 6/14. Rash spread and got antibiotic.
Age: 84.0
Sex: F
Vaccine: TDAP
Symptoms: Haemorrhage, Injection site induration, Injection site swelling, Limb discomfort
Clinical narrative: Patient states that on 6/10/13 (6 days after vaccination) she had a massage for the tense arm. After she got home she had blood on her shirt and now it swollen and hard at the injection site.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, VARCEL
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Injection site erythema and tenderness local on anterior left thigh. No fever.
Age: 22.0
Sex: F
Vaccine: HEP, VARCEL, HEP, VARCEL
Symptoms: Injection site erythema, Injection site nodule
Clinical narrative: 6-14-13 at 0800 patient noticed small red knot on back of left arm, painless to touch. Throughout the course of the day the knot enlarged and at 16:00 knot was size of an egg and decided to notify Health Dept at 16:00.
Age: 17.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Asthenia, Dizziness, Dysphagia, Electrocardiogram abnormal, Full blood count normal
Clinical narrative: Approximately 7 minutes after giving MENVEO patient started to complain of tightness in her throat and mild difficulty swallowing. She was given BENADRYL 50 mg and monitored for another 30 minutes. Patient was feeling better and her symptoms were gone. She was sent home. On June 8th patient woke up at 1235 AM feeling dizzy, weak, and tightness in her throat. She was given a CLARITIN 10 mg and went back to sleep. Patient woke that morning and ate a normal breakfast but continued to have dizziness, weakness, and tightness in throat. It became worse around 130 and she was taken to an Urgent care. Upon arriving patient continued to complain of dizziness, weakness, and difficulty swallowing. An EKG showed that the patient had tachycardia. She was sent to the hospital via EMS for suspected allergic reaction to vaccine. In the ER she had several labs drawn which were all normal. She was given an IV bolus of saline, ANTIVERT, TORADOL, and monitored in the ER. By 1515 she was "feeling better" and released from the ER. She was told to FUP in PCP office.
Age: 17.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Hypersensitivity, Metabolic function test normal, Pregnancy test urine negative, Tachycardia, Throat tightness
Clinical narrative: Approximately 7 minutes after giving MENVEO patient started to complain of tightness in her throat and mild difficulty swallowing. She was given BENADRYL 50 mg and monitored for another 30 minutes. Patient was feeling better and her symptoms were gone. She was sent home. On June 8th patient woke up at 1235 AM feeling dizzy, weak, and tightness in her throat. She was given a CLARITIN 10 mg and went back to sleep. Patient woke that morning and ate a normal breakfast but continued to have dizziness, weakness, and tightness in throat. It became worse around 130 and she was taken to an Urgent care. Upon arriving patient continued to complain of dizziness, weakness, and difficulty swallowing. An EKG showed that the patient had tachycardia. She was sent to the hospital via EMS for suspected allergic reaction to vaccine. In the ER she had several labs drawn which were all normal. She was given an IV bolus of saline, ANTIVERT, TORADOL, and monitored in the ER. By 1515 she was "feeling better" and released from the ER. She was told to FUP in PCP office.
Age: 17.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Urine analysis normal
Clinical narrative: Approximately 7 minutes after giving MENVEO patient started to complain of tightness in her throat and mild difficulty swallowing. She was given BENADRYL 50 mg and monitored for another 30 minutes. Patient was feeling better and her symptoms were gone. She was sent home. On June 8th patient woke up at 1235 AM feeling dizzy, weak, and tightness in her throat. She was given a CLARITIN 10 mg and went back to sleep. Patient woke that morning and ate a normal breakfast but continued to have dizziness, weakness, and tightness in throat. It became worse around 130 and she was taken to an Urgent care. Upon arriving patient continued to complain of dizziness, weakness, and difficulty swallowing. An EKG showed that the patient had tachycardia. She was sent to the hospital via EMS for suspected allergic reaction to vaccine. In the ER she had several labs drawn which were all normal. She was given an IV bolus of saline, ANTIVERT, TORADOL, and monitored in the ER. By 1515 she was "feeling better" and released from the ER. She was told to FUP in PCP office.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Erythema and swelling (L) lateral thigh DPT injection site.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Grand mal convulsion, Urinary incontinence
Clinical narrative: Pt presented for a requested Human Papilloma Virus vaccine. She stated she was in good health. But hadn't eaten and drank today. The VIS form and consent forms for pts review and completion- The HPV virus vaccine was given to the pt in the (L) deltoid IM. After 5-10 the pt had a tonic clonic seizure. Suddenly, she became incontinent of urine within 5 min of last clonic. 911 called immediately and was on seat for observation and transported to hospital. Her mother called for transport accompaniment. BP 124/70, p 77 RRR. Conscious on pick up ambulance.
Age: 11.0
Sex: M
Vaccine: HPV4, MEN
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a 11 years old male patient with no pertinent medical history reported. On 25-MAR-2013, the patient was vaccinated with a dose of improperly stored GARDASIL (Lot number, expiry date, route and dose were not reported) in the left arm. The patient also received meningococcal conj vaccine (unspecified) (manufacturer unknown) (Lot number, expiry date, and dose were not reported) in the right arm on the same day. Certified Medical assistant reported that both vaccines were exposed to temperature of 26 F (Fahrenheit) for a total of 135 hours. No adverse effects reported. It was reported that the patient did not seek medical attention. This is one of the several reports from the same source. Additional information is not expected.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, IPV, PNC13
Symptoms: Unevaluable event
Clinical narrative: No symptoms. Temp 98.3.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Dysgeusia, Headache, Immediate post-injection reaction, Neck pain
Clinical narrative: Immediately following administration of vaccine pt reported feeling lightheaded and said they felt like they were going to pass out. Pt. was given a drink of water and a chance to rest. Pt never lost consciousness. Pt. reported severe headache afterwards and metallic taste in mouth that subsided minutes after. Followed up with pt and headache was getting better, but pt. reported neck pain as well that was getting better but had not subsided.