chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 6.0
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Injection site warmth
Clinical narrative: Approximately a 3-inch wide circle surrounding the injection site became red, splotchy, bumpy, hard, raised, hot and very itchy.  Child was taken to urgent care where the doctor stated that it was in fact a reaction to the injection.  A steroid cream was prescribed and is being used twice daily.  After three days of using the cream the spot is beginning to dissipate.  It is still hot, red, raised and itchy, but not as badly as it was a few days ago.
Age: 31.0
Sex: F
Vaccine: VARCEL
Symptoms: Abortion spontaneous, Antibody test negative, Maternal exposure before pregnancy, Varicella virus test negative
Clinical narrative: Initial information has been received from a pharmacist concerning a 31 years old female patient. In August 2012, the patient was vaccinated subcutaneously with the first dose of (Merck) VARIVAX (dose, lot number and expiration date were not reported). No other co-suspects were reported. No concomitant medications were reported. In September 2012 the patient became pregnant 1 month after her first vaccination with (Merck) VARIVAX. She was not pregnant when she administered the first dose of (Merck) VARIVAX. On an unknown date in 2012, the patient miscarried (medically significant). On an unspecified date in 2012, the patient was subsequently tested and her titers showed no immunity for varicella. On 23-JAN-2013, the patient was vaccinated with the second dose of (Merck) VARIVAX subcutaneously (lot #, expiration date not reported). At the time of report, the patient was not pregnant. No treatment information was reported. The patient's outcome was unknown. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient (unknown age and gender), who on August 2011 was vaccinated with a only dose of GARDASIL (dose, route and lot number were not reported). No other co-suspects were reported. No concomitant medications were reported. The medical assistant reported that the patient had not received any additional doses of GARDASIL, and there was no adverse effect had been observed or reported. At the time of the report, the patient's outcome for the adverse event was unknown. This is one of two reports from the same reporter. Additional information has been requested.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Dizziness, Eye pruritus, Lacrimation increased, Oropharyngeal pain
Clinical narrative: 1-4-13 Pt here for flu vaccine inj via split dose for a reaction pt had 10+ years ago after a flu shot. Pt has been off her B-blocker since Dec 29th. Pt BS CTA VSS with slight tachycardia. Skin clear. Pt stated she has not been sick and feels fine today. Dr. examined pt prior to first inj of 0.05ml FLUZONE (R) deltoid. Pt received first inj & waited 30 min per protocol and felt fine after first dose, VSS, skin clear, BSCTA. Dr. aware pt completed first dose and was asymptomatic. He agreed we could proceed with 2nd dose. Pt given .45ml FLUZONE in (L) deltoid. About 10 min late pt informed front desk she was coughing a lot, sore throat, watery/itchy eye, general itchiness, and feeling dizzy. Brought pt to exam room - Dr. immediately had pt lie down on table & began exam. See anaphylaxis flow sheet. Pt had stable VSS throughout treatment. At 1120 pt was sitting up in chair eating & drinking. C/o slight dizziness but much better than before. Husband came to pick up pt. At 1145 had 2 XOPENEX per Dr d/t cough. VS = 99% RA HR=138 BP = 108/70. Completed PFT per Dr. Skin clear. Pt states she feels good. Pt up walking around eating & drinking waiting for d/c to go home.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus generalised
Clinical narrative: 1-4-13 Pt here for flu vaccine inj via split dose for a reaction pt had 10+ years ago after a flu shot. Pt has been off her B-blocker since Dec 29th. Pt BS CTA VSS with slight tachycardia. Skin clear. Pt stated she has not been sick and feels fine today. Dr. examined pt prior to first inj of 0.05ml FLUZONE (R) deltoid. Pt received first inj & waited 30 min per protocol and felt fine after first dose, VSS, skin clear, BSCTA. Dr. aware pt completed first dose and was asymptomatic. He agreed we could proceed with 2nd dose. Pt given .45ml FLUZONE in (L) deltoid. About 10 min late pt informed front desk she was coughing a lot, sore throat, watery/itchy eye, general itchiness, and feeling dizzy. Brought pt to exam room - Dr. immediately had pt lie down on table & began exam. See anaphylaxis flow sheet. Pt had stable VSS throughout treatment. At 1120 pt was sitting up in chair eating & drinking. C/o slight dizziness but much better than before. Husband came to pick up pt. At 1145 had 2 XOPENEX per Dr d/t cough. VS = 99% RA HR=138 BP = 108/70. Completed PFT per Dr. Skin clear. Pt states she feels good. Pt up walking around eating & drinking waiting for d/c to go home.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site haematoma
Clinical narrative: Patient presented with hematoma at injection site. Applied ice. (Size of 50 cent piece).
Age: 12.0
Sex: M
Vaccine: HPV4, MNQ, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Swelling and redness to left upper arm left upper arm also warm to touch. Pt. given ROCEPHIN IM and oral clindamycin. Pt went to urgent care on 01/24/13 and followed up with PCP on 1/25/13. Left arm better on 1/25/13. During administration of vaccines pt struggled and fought. Pt had to be restrained. That is the reason all 4 vaccines were placed in one arm.
Age: 17.0
Sex: F
Vaccine: FLU3, HEPA, HPV4, MNQ, TDAP
Symptoms: Dizziness, Pallor
Clinical narrative: 10:30 am - Vaccine given, client reports dizziness. Instructed client to remain seated, glass of water given. 10:45 - Client states "I'm ok" & leaves room. Nurse finds client pale & dizzy. Instructs client to lay down on exam table. BP taken. NP assesses client, BP taken q 5 mins. 11:00am NP reports client stable. Client eats crackers and reports "feeling better". Client leaves office.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Chest pain, Hypoaesthesia
Clinical narrative: This spontaneous report as received from a register nurse refers to a patient of unknown age and gender, who in 17-JAN-2013, was vaccinated with the fourth dose of GARDASIL (dose, route and lot number were not reported). No other co-suspects were reported. No concomitant medications were reported. The nurse reported that on 21-JAN-2013, the patient developed chest pain and right arm numbness. No treatment information was reported. At the time of the report, the patient's outcome for the adverse event was unknown. The relatedness for the adverse event was unknown for GARDASIL. Additional information has been requested.
Age: 61.0
Sex: M
Vaccine: FLU3
Symptoms: Dyspnoea, Paraesthesia oral, Throat tightness
Clinical narrative: 1 1/2 hours post I.M. influenza vaccine felt tingling in lips, S.O.B. some tightening in throat.
Age: 52.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site warmth, Pain in extremity, Pyrexia
Clinical narrative: T.C. call from patient states (L) shoulder hot & red at site with pain down her arm into the fingers. Running fever 100-101 degrees for 48 hrs. Advised Dr feels fine 1-28-13.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Incorrect storage of drug, Medication error, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age. The patient was vaccinated with a dose of live (Merck) VARIVAX (Lot # H016715 expiration date 07-SEP-2014) and a dose of M-M-R II (Lot # H015624 expiration date 21-FEB-2014) that were refrozen after the reconstitution on 22-JAN-2013, The nurse reported that the patient initially did not want to get the vaccines so the syringes that contained the reconstituted vaccinates were put back in a freezer. But the patient went back to the office and the vaccines were thawed and given to the patient on 22-JAN-2013. No adverse effect was reported. Additional information has been requested.
Age: 18.0
Sex: M
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, Urticaria
Clinical narrative: This spontaneous report as received from a physician refers to a 18 years old male patient, who in April 2012 was vaccinated with the second dose of 0.65 ml GARDASIL subcutaneously (lot number was not reported) and on 22-JAN-2013, was vaccinated with the third dose of 0.65 ml GARDASIL subcutaneously (lot number was not reported). No other co-suspects were reported. Concomitant medications included: influenza virus vaccine (unspecified). The physician reported that received the third dose of GARDASIL and 4-6 hours later, had urticaria. The patient took BENADRYL for the adverse event. It was reported that the patient was going to check in with HCP on 23-JAN-2013. The patient  sought medical attention, she called to the office. At the time of the report, the patient's outcome for the adverse events was unknown. The relatedness for urticaria was unknown for GARDASIL. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a multiple number of patients. The patients were vaccinated with doses of GARDASIL (Lot # not reported) on an unspecified dates that were off schedule between their first, second and third doses. No adverse symptoms were reported. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age. The patient was vaccinated with dose 1 GARDASIL (dose, route, lot # and Exp unknown) on an unspecified date 4 years ago (approximately in January 2009) and would like to receive the second dose today on 18-JAN-2013. No adverse symptoms. No other co-suspects were reported. No concomitant medications were reported. It was unspecified if the patient sought medical attention. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Accidental exposure to product, Eye pruritus
Clinical narrative: This spontaneous report as received from a male pharmacist of unknown age who was the patient. Pharmacist states he got splashed with live ZOSTAVAX on his skin and in his left eye. Pharmacist stated this occurred 10minutes ago, and his left eye was itchy. The pharmacist hung up the phone so that he could flush his eye with water. It was unknown if the patient sought medical attention. Unknown if this occurred while he was administering the vaccine; unknown if a client received less than a standard dose of live ZOSTAVAX. At the time if report, the outcome of patient was unknown. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age. The patient was respectively vaccinated three doses of GARDASIL (lot number unspecified) intramuscularly on 15-OCT-2012, 18-DEC-2012 and 22-JAN-2013. No other co-suspects were reported. No concomitant medications were reported. No adverse effect reported. It was unknown if the patient had sought medical attention. Additional information has been requested.
Sex: M
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a health care worker refers to a male patient of unknown age. The patient was vaccinated with the first dose of VAQTA 50/1.0 U/ML (dose, route and lot not reported) on 02-OCT-2009 and the second dose of VAQTA on 24-JAN-2013. No other co-suspects were reported. No concomitant medications were reported. No adverse event reported. The outcome of the event reported is unknown. The event reported was not related to VAQTA. Additional information is not expected.
Age: 21.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Injection site pain, Injection site rash, Injection site swelling, Pain, Pyrexia
Clinical narrative: Severe pain in muscle where injected, fever, swelling, throbbing, concentrated rash, all symptoms constant. Right deltoid area rash, swelling, & tenderness extending to axilla.
Age: 21.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Rash, Swelling
Clinical narrative: Severe pain in muscle where injected, fever, swelling, throbbing, concentrated rash, all symptoms constant. Right deltoid area rash, swelling, & tenderness extending to axilla.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Condition aggravated, Injection site pruritus, Seasonal allergy, Sneezing
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 53 years old male patient with seasonal allergy, no pertinent medical history and no drug reactions or allergies. The patient was vaccinated with a 0.65 ml dose of ZOSTAVAX (Lot # 0423AE expiration date 02-APR-2013) SQ on 31-AUG-2012. No other co-suspects were reported. Concomitant medications included NASONEX and PATANOL. The pharmacist reported that on an unknown date, "several months" after administration of ZOSTAVAX, the patient experienced severe itching around injection site. The patient described the itching to pharmacist as internal itching where there was no other rash or lesion but patient had been experiencing itching on and off since the administration back in August 2012. The patient also complained that he had been sneezing a lot more and experienced worsening of his seasonal allergy symptoms since ZOSTAVAX administration. There were no Lab diagnosis/studies performed. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse refers to a patient of unknown age and gender. The patient received subcutaneously live ZOSTAVAX in error (dose and lot not reported) on 24-JAN-2013. No other co-suspects were reported. No concomitant medications were reported. No known adverse effects. No treatment information was reported. The outcome of the event was unknown. The event was not related to live ZOSTAVAX. Additional information is not expected.
Sex: F
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender, who in 18-JAN-2013 (also reported as 18-JAN-2012), was vaccinated intramuscularly (IM) with a expired dose of 0.5 PNEUMOVAX 23 (lot number reported as 0595AA, expiration date: 30-AUG-2012). No other co-suspects were reported. No concomitant medications were reported. No treatment information was reported. At the time of the report, the patient's outcome for the adverse event was unknown. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Dizziness
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a multiple number of patients. The patients were vaccinated with a dose of GARDASIL (Lot # not reported) on an unspecified date. No other co-suspects were reported. No concomitant medications were reported. The medical assistant reported that on an unknown date, the patients had felt faint and lightheaded after receiving GARDASIL. At the time of the report, the patients' outcomes were unknown. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available. This is one of several reports received from the same source. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Erythema, Injection site reaction, Local reaction, Swelling
Clinical narrative: 1/25/13 Fri Local reaction at each site - pt. advised to take BENADRYL & apply cool packs to each site. 1/28/13 Mon Areas of redness & swelling have gotten smaller - child did attend school today.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Nodule
Clinical narrative: 2-3 days post injection a "nodule" was noted. She presents today, 1/28/2013, with complaint of warmth, redness, and pain to the area of injection that has worsened. Treated with BACTRIM DS #28 1 PO BID x 14 days.
Age: 19.0
Sex: F
Vaccine: FLU3, HPV4, FLU3, HPV4, MNQ
Symptoms: Convulsion, Diplopia, Headache, Nuclear magnetic resonance imaging brain abnormal, Paraesthesia
Clinical narrative: Seizure - 11-15-12. Headaches - ongoing since August 2012. Paresthesias of digits. Intermittent double vision.
Age: 19.0
Sex: F
Vaccine: FLU3, HPV4, FLU3, HPV4, MNQ
Symptoms: White matter lesion
Clinical narrative: Seizure - 11-15-12. Headaches - ongoing since August 2012. Paresthesias of digits. Intermittent double vision.
Age: 19.0
Sex: F
Vaccine: FLU3, HPV4, FLU3, HPV4, MNQ
Symptoms: Blood test, Convulsion, Demyelination, Electrocardiogram, Hypoaesthesia
Clinical narrative: Seizure - 11-15-12. Headaches - ongoing since August 2012. Paresthesias of digits. Intermittent double vision.
Age: 19.0
Sex: F
Vaccine: FLU3, HPV4, FLU3, HPV4, MNQ
Symptoms: Loss of consciousness, Migraine, Nuclear magnetic resonance imaging brain abnormal, Psychomotor skills impaired
Clinical narrative: Seizure - 11-15-12. Headaches - ongoing since August 2012. Paresthesias of digits. Intermittent double vision.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Burning sensation, Hypoaesthesia, Muscle disorder, Oral discomfort, Throat irritation
Clinical narrative: Patient complained of throat burning and burning lips, the left side of her face was burning & numb. She felt she could not control the muscles in left side of face.
Age: 42.0
Sex: F
Vaccine: TDAP
Symptoms: Hypoaesthesia, Paraesthesia, Sensation of heaviness
Clinical narrative: Pt's arm felt heavy and fingers tingled and felt numb shortly after immunization was administered.
Age: 3.0
Sex: M
Vaccine: HIBV, MMR, VARCEL, MMR, VARCEL
Symptoms: Incorrect dose administered
Clinical narrative: This spontaneous report as received from an office manager refers to a 3 years old male child. The child was vaccinated with his first dose of M-M-R II (dose and lot# not reported) and live (Merck) VARIVAX (dose and lot# not reported) on 26-JUL-2010 and his second dose of M-M-R II (dose and lot# not reported) and live (Merck) VARIVAX (dose and lot# not reported) on 30-NOV-2012. Child also was vaccinated with five doses of ACTHIB on unspecified dates, due to staff and doctor miscommunication. No adverse effects reported. Additional information has been requested.
Age: 3.0
Sex: M
Vaccine: HIBV, MMR, VARCEL, MMR, VARCEL
Symptoms: Inappropriate schedule of drug administration, Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from an office manager refers to a 3 years old male child. The child was vaccinated with his first dose of M-M-R II (dose and lot# not reported) and live (Merck) VARIVAX (dose and lot# not reported) on 26-JUL-2010 and his second dose of M-M-R II (dose and lot# not reported) and live (Merck) VARIVAX (dose and lot# not reported) on 30-NOV-2012. Child also was vaccinated with five doses of ACTHIB on unspecified dates, due to staff and doctor miscommunication. No adverse effects reported. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain, Asthenia, Fatigue, Liver function test abnormal, Pyrexia
Clinical narrative: Febrile illness with abdominal pain elevate LFTs 2 weeks after ZOSTAVAX. Followed by prolonged recovery. Fatigue/weakness.
Age: 32.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash
Clinical narrative: Rash, itching, redness left deltoid area 30-40 minutes after injections. As reported by patient on 1/28/13 1600.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site mass
Clinical narrative: This spontaneous report as received from a now 64 years old female patient with azithromycin allergy and cimetidine allergy refers to herself. The patient's medical history included really bad reaction to an unspecified flu shot when she was twelve years of age. The patient was vaccinated with live ZOSTAVAX on 26-DEC-2012. Route and lot# unspecified. Concomitant medications included: EVISTA. On an unknown date the patient experienced small, red bump on her arm at the injection-site after receiving live ZOSTAVAX. The patient stated that the swelling had gone down since she initially noticed it, but the area was still red. No treatment was given. No lab test was done. The patient was recovering. This report was linked with 1301USA012938 as refers to the same patient. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test abnormal, Haematochezia, Laboratory test
Clinical narrative: This spontaneous report as received from a consumer refers to her daughter, an approximately 5 year old female patient (currently 22 year old) with no pertinent history and no drug reactions/allergies. In 1996, the patient was vaccinated with a dose of live (Merck) VARIVAX (dose, route and lot # not reported). There were no concomitant medications. Since approximately 1996 when she was a child (the third week after the vaccination), the patient had been experienced blood in stool every time she went to the restroom. Her recent test of antibody IgG to varicella was 1129 (normally 0-165). The patient saw many doctors and had many tests but could not determine the cause of the blood in stool. The patient was treated with prednisone, FLAGYL, PENTASA and ROWASA for the event. The outcome of blood in stool was reported as not recovered. The relatedness for blood in stool was unknown for live (Merck) VARIVAX. Additional information has been requested.
Sex: M
Vaccine: HEP
Symptoms: Hepatitis B surface antibody negative, No therapeutic response
Clinical narrative: This spontaneous report as received from a physician (M.D.) refers to a male patient of unknown age who on unknown date was vaccinated with a series dose of hepatitis b vaccine (recombinant) (reporter was unsure whether the utilized vaccine RECOMBIVAX (dose and route not reported). No other co-suspects were reported. No concomitant medications were reported. The patient did not respond to an unspecified hepatitis B vaccine series as the patient's titers were negative. Sought of medical attention was unknown. No treatment information was reported. The outcome was unknown. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Dyspepsia, Pyrexia, Vomiting
Clinical narrative: This spontaneous report as received from a 71 years old female patient refers to herself. The patient's medical history included cancer. The patient was vaccinated with a dose of live ZOSTAVAX (route, dose and lot # were unknown) on 22-JAN-2013. No other co-suspects were reported. No concomitant medications were reported. On 24-JAN-2013 the patient woke up with indigestion pains and experienced fever, diarrhea and vomiting. No treatment was given for adverse event. The outcome of events were unknown. The relatedness for events were unknown for live ZOSTAVAX. The patient did not sought medical attention. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant concerning an approximately 18 year old female patient. The patient was vaccinated with dose 1 GARDASIL (lot number, expiry date, dose, route unspecified) on 16-AUG0-2012, On an unknown date in October 2012, the patient was vaccinated with dose 2 GARDASIL (lot #, expiration date and route not reported) and on 10-JAN-2013, the patient was vaccinated with dose 3 GARDASIL (lot #, expiration date and route not reported). The patient forgot that she had received a dose of GARDASIL in October at her college. No concomitant medications were reported. No adverse effect was observed or reported at the time of reporting. Additional information has been requested.
Age: 44.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site nodule, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 44 years old female patient. The patient was allergic to penicillin. The patients medical history included rheumatoid arthritis. On 22-JAN-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot number H019997 and expiry date was February 2014. Dose was not reported) subcutaneously. Concomitant medications included CHANTIX, BACTRIM, promethazine, omeprazole, acetaminophen, PERCOCET, methadone hydrochloride, tizanidine hydrochloride, gabapentin, sumatriptan, lisinopril, clonazepam and levothyroxine sodium. On 23-JAN-2013, the injection site of the patient who received ZOSTAVAX was swollen, red, hot to touch and it felt like there was a knot there. The patient sought medical attention (details unspecified) and was treated with ice. The events were not recovered. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 27-JUL-2012, the patient was vaccinated with a first dose of 0.5 milliliter (ml) of GARDASIL (lot number and expiry date were not reported) intramuscularly. On 09-NOV-2012, the patient received second dose of GARDASIL (lot number and expiry date were not reported) and on 14-DEC-2012 received the third dose of GARDASIL (lot number and expiry date were not reported) intramuscularly. No concomitant medications were reported. No adverse effect was reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Local swelling
Clinical narrative: This spontaneous report as received from a pharmacist via a company representative refers to a female patient of unknown age. On an unknown date, the patient was vaccinated with live ZOSTAVAX (lot # not reported). The patient developed swelling around the lips underneath the nose a year later from the date of her vaccination. The patient sought for medical attention by going to the pharmacist. The outcome of swelling around the lips underneath the nose was unknown. The relatedness for swelling around the lips underneath the nose was unknown for live ZOSTAVAX. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: HEPA
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 12 year old male patient. On 22-JAN-2013, the patient was vaccinated with the adult 1ml dose of VAQTA (lot number reported as H010269, Exp 03-NOV-2014, number of prior dose not reported) in his left deltoid, and also the pediatric 0.5ml dose of VAQTA (lot number reported as H010145, Exp 27-FEB-2015) in his right deltoid. No adverse effects at the time of reporting. Additional information has been requested.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Pain, Pain in extremity
Clinical narrative: This spontaneous report was received from an approximately 64 year old male patient regarding himself. The patient had no pertinent medical history and no drug reactions or allergies. On an unknown date, in November 2012 (reported as early November 2012), the patient was vaccinated with a dose of live ZOSTAVAX (lot number, expiry dose unspecified) intramuscularly (confirmed with consumer the therapy was intramuscularly). Concomitant medication included CELEBREX. Approximately on an unknown date in November 2012 (3 or 4 days after vaccination), the patient experienced pain in his arm that increased in intensity as time went on. It had been at least 2 months since he received the injection and he stated that when he turns his arm or reaches for something he gets severe, sharp pain that emanates from the injection site and radiates outward. He was going to take an adverse experience report and submit the information to the CDC. He sought a medical attention (saw his physician) and he was treated with VOLTAREN gel (manufacturer unknown), as needed. No laboratory tests were performed. The patient had not recovered from the event at the time of reporting. The relatedness for the event was unknown for live ZOSTAVAX. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: MNQ, TDAP, MNQ, TDAP
Symptoms: Anti-ganglioside antibody, Asthenia, Benign intracranial hypertension, Blood immunoglobulin G, Chronic inflammatory demyelinating polyradiculoneuropathy
Clinical narrative: 2 wks after vaccine tingling in feet & sides of hands. To local hospital - 3 tx of IVIG & sent home on steroids (5/10/12) - 6/12 Progressive weakness - to hospital Guillain Barre Syndrome. In & out of hospital almost monthly since (19 admissions). 7/12 dx with CIDP. 11/2/12 had G01B IGG Antibody, EIA serum. Now dx with pseudotumor of brain from steroids.
Age: 16.0
Sex: F
Vaccine: MNQ, TDAP, MNQ, TDAP
Symptoms: Electromyogram, Guillain-Barre syndrome, Immunoglobulin therapy, Immunology test, Lumbar puncture
Clinical narrative: 2 wks after vaccine tingling in feet & sides of hands. To local hospital - 3 tx of IVIG & sent home on steroids (5/10/12) - 6/12 Progressive weakness - to hospital Guillain Barre Syndrome. In & out of hospital almost monthly since (19 admissions). 7/12 dx with CIDP. 11/2/12 had G01B IGG Antibody, EIA serum. Now dx with pseudotumor of brain from steroids.
Age: 16.0
Sex: F
Vaccine: MNQ, TDAP, MNQ, TDAP
Symptoms: Neurological examination, Nuclear magnetic resonance imaging, Paraesthesia, Venogram
Clinical narrative: 2 wks after vaccine tingling in feet & sides of hands. To local hospital - 3 tx of IVIG & sent home on steroids (5/10/12) - 6/12 Progressive weakness - to hospital Guillain Barre Syndrome. In & out of hospital almost monthly since (19 admissions). 7/12 dx with CIDP. 11/2/12 had G01B IGG Antibody, EIA serum. Now dx with pseudotumor of brain from steroids.
Age: 16.0
Sex: F
Vaccine: MNQ, TDAP, MNQ, TDAP
Symptoms: Antibody test, Asthenia, Benign intracranial hypertension, Blood immunoglobulin G, Chronic inflammatory demyelinating polyradiculoneuropathy
Clinical narrative: 2 wks after vaccine tingling in feet & sides of hands. To local hospital - 3 tx of IVIG & sent home on steroids (5/10/12) - 6/12 Progressive weakness - to hospital Guillain Barre Syndrome. In & out of hospital almost monthly since (19 admissions). 7/12 dx with CIDP. 11/2/12 had G01B IGG Antibody, EIA serum. Now dx with pseudotumor of brain from steroids.
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Injection site erythema, Injection site swelling, Pain, Pyrexia
Clinical narrative: Vaccine admin approx 0950 1/22/13. Pt. developed chills & body aches (systemic) approx 2230 1/22/13. Early AM 1/23/13 Pt. developed a fever 102.7 that lasted until the afternoon of 1/24/13. She noted a pea sized area of erythema around injection site & a large amt. of swelling in the deltoid.
Age: 66.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Pain, Pain in extremity, X-ray limb
Clinical narrative: Soreness in upper left arm. Ice and Ibuprofen (800 mg) relieved pain for a short time, but never completely. Alternated TYLENOL (2-650 mg) first few days patient could not elevate arm without severe pain. Got better, but not completely.
Age: 49.0
Sex: M
Vaccine: FLUX
Symptoms: Chest X-ray, Laboratory test, Nausea, Pyrexia, Vomiting
Clinical narrative: Within 4-5 hours, patient became nauseated, vomited, had a fever of 101.8 degrees. Ended up at our hospital ER.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Patient stated about 24 hours after receiving injection developed redness heat and pain in arm around injection site. Received shot on 1-18-13 and reported event on 1-24-13 and stated arm still sore a bit.
Age: 7.0
Sex: M
Vaccine: FLU3
Symptoms: Bruxism, Circulatory collapse, Seizure like phenomena
Clinical narrative: After immunization, pt got up & walked away from pharmacy. A minute later, pt collapsed with clenching teeth, seizure like reaction. Ambulance was called & pt was transported to hospital. Pt was released same day. Attempted to contact pt for follow up but no answer from pt.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Gait disturbance
Clinical narrative: Pt phoned today stating that the day after receiving the flu vaccine she could hardly walk due to pain across her lower back. Stated had to go to doctor for medication. States after taking medication lasted for about 7 days.
Sex: M
Vaccine: HEP
Symptoms: Antibody test negative, Inappropriate schedule of drug administration, Measles antibody negative
Clinical narrative: This spontaneous report as received from a registered nurse refers to a male patient of unknown age. The patient was vaccinated with the first dose of RECOMBIVAX HB (Lot # 1742A2) on 15-JAN-1995, second dose of RECOMBIVAX HB (Lot # 1742A2) on 10-JUL-1995 and third dose of RECOMBIVAX HB (Lot # not reported) on 18-MAR-1996. This is one of several reports received from the same source. Additional information is not expected.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Scar
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 62 years old female patient. The patient received an unspecified inactivated flu vaccine in mid-October 2012. The patient was vaccinated subcutaneously with lot # (H013023), exp. date: 09-OCT-2013, 0.65 ml ZOSTAVAX on 01-NOV-2012. No other co-suspects were reported. No concomitant medications were reported. On an unknown date, the patient developed an unspecified rash after receiving ZOSTAVAX and the time of the report had a scar from the rash. No treatment information was reported. The patient was unspecified dermatologist. The outcome of the event was unknown. The relatedness for the event was unknown for ZOSTAVAX. Additional information has been requested.
Age: 1.53
Sex: F
Vaccine: DTAP
Symptoms: Urticaria
Clinical narrative: Developed hives 10-15 minutes after immunization. Examine by Dr BENADRYL given.
Age: 8.0
Sex: F
Vaccine: FLU3
Symptoms: Myalgia
Clinical narrative: Myalgia.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Blister, Herpes zoster, Rash, Rash erythematous
Clinical narrative: Pt. called to report that she has physician - diagnosed shingles in spite of having received ZOSTAVAX 5 1/2 yrs ago. On 1/20/13 had onset of severe (L) side back pain. On 1/24/13 noted 2 red spots on (L) breast which progressed to multiple spots on (L) chest, back & axilla - spots progressed to blisters - pain subsided somewhat - seen at urgent care with dx of shingles on 1/26/13. Rx - Prednisone, acyclovir, hydrocodone.
Age: 20.0
Sex: F
Vaccine: HEP
Symptoms: Injection site pruritus, Pruritus, Rash erythematous, Urticaria
Clinical narrative: Pt. did not report this until today 1/23/13 when she asked if OK to get 2nd dose of Hep B. Within 1 hour of receiving 1st dose 2 months ago, the injection site became itchy, then other areas began to itch - both arms & neck. Noted red bumps in some areas, then hives with itching. No hives on trunk. Took BENADRYL x3 over the next 24 hours & symptoms resolved by the following night. Did not see a doctor. Advised not to receive any more Hep B vaccine. Unless authorized by a doctor.
Age: 1.15
Sex: M
Vaccine: FLU3, HEPA, MMR, VARCEL
Symptoms: Injection site urticaria
Clinical narrative: Small, dime sized, raised welt at injection site for Varicella (RA/SC). Welt appeared 10 days after injection.
Age: 1.15
Sex: F
Vaccine: FLU3, HEPA, MMR, VARCEL
Symptoms: Injection site swelling
Clinical narrative: Very small raised spot at injection site for Varicella (RA/SC). Spot appeared 10 days after injection.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Influenza like illness, Mass, Pain, Pruritus
Clinical narrative: Red hot lump x3 days then rash, itchy & achy & had Flu like symptoms. Resolved 1-28-2013.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Skin warm
Clinical narrative: Red hot lump x3 days then rash, itchy & achy & had Flu like symptoms. Resolved 1-28-2013.
Age: 1.15
Sex: M
Vaccine: FLU3, HEPA, MMR, VARCEL
Symptoms: Injection site erythema, Injection site urticaria
Clinical narrative: Small, dime size, raised red welt at injection site for Varicella (RA/SC). Welt appeared 10 days after injection.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Redness, itchiness, and painful to touch at the site of injection - " Palm sized".
Sex: M
Vaccine: VARCEL
Symptoms: Antibody test negative, Measles antibody negative
Clinical narrative: This spontaneous report as received from a registered nurse refers to a male patient of unknown age. The patient was vaccinated with the first 0.5 ml dose of VARIVAX (Merck) (Lot # 03880) SQ in July 1995 and second 0.5 ml dose of VARVIAX (Merck) (Lot # 1253Z) SQ in October 2007. The patient was also vaccinated with the first dose of MMR II (Lot # not reported) on 05-MAR-1991 and the second dose of MMR II (Lot # 0902W) on 28-MAR-1994. No concomitant medications were reported. The nurse reported that on 15-JAN-2013, on recent blood work, the patient was found to have negative antibody titers to varicella and negative titers for all components of the MMR II. The outcome for negative antibody titers to varicella and negative titers for all components of the MMR II was reported as not recovered/not resolved. The relatedness for negative antibody titers to varicella and negative titers for all components of the MMR II was unknown for VARIVAX (Merck) and MMR II. This is one of several reports received from the same source. Additional information is not expected.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Hot, swollen area around site of injection.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Local reaction
Clinical narrative: Approx 36 hours after vaccine administration, (L) arm is red, swollen & getting bigger. No fever. Seen at local ER & dx with localized reaction. ER prescribed BENADRYL.
Age: 77.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Swelling, redness and pain that started this morning. Patient taking OTC pain medication.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Swelling
Clinical narrative: 11 yo healthy male, received Tdap & MENACTRA on 1/25/13; had significant swelling. Redness to (L) upper arm starting the next day.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, HIBV, MMR
Symptoms: Injection site pruritus, Injection site swelling
Clinical narrative: Left thigh swelling after MMR. Itching the night of administration and then swelling the next morning.
Age: 18.0
Sex: F
Vaccine: FLU3, HEP, HEPA, VARCEL
Symptoms: Incorrect dose administered
Clinical narrative: Vaccine Administration Error: Client was given adult Havrix/Hep A vaccine instead of what she should have received, Pediatric Havrix.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Lacrimation increased, Vision blurred
Clinical narrative: Pt states she experienced excessive watery eyes with occasional blurred vision that started approx. 1 hour post vaccination and continued on and off for approx. 3 hours.  This has since resolved per pt account.
Age: 15.0
Sex: F
Vaccine: HEP
Symptoms: Dyspnoea, Urticaria
Clinical narrative: Hives on neck, spread to face, eyes,  1/25/2013 gave Benadryl around 7 PM, before kicked in couldn't breathe, took 3-4 more times before hives stopped coming back.
Age: 1.8
Sex: M
Vaccine: DTAP
Symptoms: Crying, Gait disturbance, Swelling
Clinical narrative: Physical pain.  Child refusing to walk, crying, swelling.  Continued into the next morning and same symptoms at 7:00 AM on 1/29/2012.
Age: 16.0
Sex: F
Vaccine: FLU3
Symptoms: Posture abnormal, Tremor
Clinical narrative: Patient slumped forward after receiving flu shot, was shaking after being sat back upright.
Age: 0.34
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV1
Symptoms: Acne, Rash erythematous
Clinical narrative: Red, raised rash on both upper thighs.  "Pimple like" appearance. Afebrile.  No treatment given.
Age: 14.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site discharge, Injection site haemorrhage, Needle issue
Clinical narrative: Patient given Fluzone IM with 5/8" needle in LA per protocol.  As needle was removed; blood, exudate and vaccine poured frrom site.  Replacement dose given with 1" needle in RA without incident.
Age: 0.94
Sex: M
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injection site urticaria
Clinical narrative: Patient developed a welt at injection site almost immediately. He was given 0.05mL of the pediatric dose per facility instructions. He was supposed to be given 0.20mL after 30 minutes of observation time but it wasn't given because of the immediate reaction.
Age: 52.0
Sex: F
Vaccine: FLUX
Symptoms: Muscle spasms, Pain in extremity
Clinical narrative: I developed a severe pain in the mid anterior area of my humerus on my left arm (the shot was given in the L deltoid), where the deltoid tuberosity is.  It initially felt like a muscular spasm and there was a knot in the muscle.  Pain was worse at night and was not relieved by ibuprofen.  Pain has continued to vary from being spasm-my to achy at rest and I can not do normal range of motion without pain.  I have never had a pain like this previously.  This was the second year I got the injectable flu vaccine.
Age: 50.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site mass
Clinical narrative: Lump to biceps in area of injection.
Age: 0.92
Sex: F
Vaccine: FLUX, IPV
Symptoms: Atypical pneumonia, Pyrexia, Varicella
Clinical narrative: After she received this the chicken pox and flu vaccination, she got walking pneumonia 2 days later and had very high fevers. Now she has chicken pox.
Age: 41.0
Sex: M
Vaccine: FLU3
Symptoms: Loss of consciousness, Presyncope
Clinical narrative: Vasovagal response, 911 responded, pt retained consciousness.
Age: 51.0
Sex: F
Vaccine: HEP
Symptoms: No adverse event, Underdose
Clinical narrative: No, adverse reaction. Pediatric dose administered to adult patient. Adult dose will be administered at next visit.
Age: 6.0
Sex: M
Vaccine: DTAPIPV, FLU3, MMRV
Symptoms: Erythema, Hypopnoea, Urticaria, Vomiting
Clinical narrative: Pt recd vaccines at 2:30pm wi 30 min pt developed full body erythema, hives, vomiting shallow breath pt recd EPIPEN Jr IM, 25mg BENADRYL, 45mg Prednisone -> improved -> D/C home.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Pain
Clinical narrative: Pain at site of injection - dull, annoying pain - persisted for 3 days. Pain with range of motion that patient describes as sharp stabbing pain. Started approx 2 weeks ago.
Age: 1.72
Sex: M
Vaccine: HEPA, MNQ, TDAP, VARCEL
Symptoms: Injection site erythema
Clinical narrative: Red (L) deltoid onset.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Blood immunoglobulin G, Blood immunoglobulin M, Varicella post vaccine
Clinical narrative: Pt Dx. with varicella on 1/23/13 office visit.
Age: 16.0
Sex: F
Vaccine: IPV
Symptoms: Nausea, Vomiting
Clinical narrative: Patient waited in office for 15 minutes and denied reactions when checking out. Upon exiting building she felt nauseated and vomited. Mother brought her back into building to report reaction.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Bone scan, Electromyogram, Nausea, Nuclear magnetic resonance imaging, Pain
Clinical narrative: Received shot on 1/27/12. Arm very tender. 1/28/12 severe sharp, burning pain went to emergency room. Very nauseous right arm has frozen shoulder and sharp (brachial neuritis) pain ever since.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity, Periarthritis, Radiculitis brachial, Tenderness, X-ray
Clinical narrative: Received shot on 1/27/12. Arm very tender. 1/28/12 severe sharp, burning pain went to emergency room. Very nauseous right arm has frozen shoulder and sharp (brachial neuritis) pain ever since.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Pain
Clinical narrative: Patient complained of burning and stinging during administration of Fluzone intradermal injection.
Age: 32.0
Sex: F
Vaccine: HEPAB, TD, HEPAB, TDAP
Symptoms: Dyspnoea, Loss of consciousness, Swollen tongue, Throat tightness, Urticaria
Clinical narrative: I passed out when I got outside the facility. As I got to the car I broke out into hives on my upper extremities and then it began to break out all over. My breathing became labored and I passed out again. My throat started to close up and my tongue started to swell.
Age: 32.0
Sex: F
Vaccine: HEPAB, TD, HEPAB, TDAP
Symptoms: Cold sweat, Loss of consciousness, Pharyngeal oedema, Pruritus, Rash
Clinical narrative: I passed out when I got outside the facility. As I got to the car I broke out into hives on my upper extremities and then it began to break out all over. My breathing became labored and I passed out again. My throat started to close up and my tongue started to swell.
Age: 32.0
Sex: F
Vaccine: HEPAB, TD, HEPAB, TDAP
Symptoms: Swollen tongue, Wheezing
Clinical narrative: I passed out when I got outside the facility. As I got to the car I broke out into hives on my upper extremities and then it began to break out all over. My breathing became labored and I passed out again. My throat started to close up and my tongue started to swell.
Age: 57.0
Sex: M
Vaccine: FLU3
Symptoms: Diplegia, Fatigue, Narcolepsy
Clinical narrative: Patient states that she experienced symptoms of narcolepsy (fell asleep at table with head down and felt very fatigued) and paralysis (couldn't move lower extremities).  Lasted about 10 hours and resolved on own with no lasting symptoms.  Patient called clinic on 1/23 and did not seek medical attention during episode.
Age: 1.56
Sex: F
Vaccine: HEPA
Symptoms: Pyrexia
Clinical narrative: Started with a low grade fever a few hours after the shot, but the next morning it continued to rise.  By evening on 1/10/13 it was up to 103.6.  On 1/11/13 she continued to have a fever but it was low grade.  No other symptoms.  She saw a doctor on 1/10/13 to rule out any other cause of fever.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Discomfort, Rash erythematous, Rash pruritic, Skin warm
Clinical narrative: 2 "50-cent piece sized" red rashes appeared. Rashes were itchy, warm, and uncomfortable. Patient used hydrocortisone cream on rash to stop itch.  Seems to be improving over time.
Age: 29.0
Sex: M
Vaccine: ANTH
Symptoms: Burning sensation, Hyperaesthesia, Hypoaesthesia, VIIth nerve paralysis
Clinical narrative: Woke up to numbness in the face and "drooping" mouth. Felt like I had been to the dentist. Numbness progressively got better throughout the day, but felt numbness/sensitivity/burning sensation in the face all day. No other side-effects or symptoms.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration
Clinical narrative: Zoster vaccine was given IM instead of SQ.
Age: 9.0
Sex: M
Vaccine: FLU3
Symptoms: Local reaction
Clinical narrative: Severe local reaction.
Age: 72.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Discomfort, Injection site erythema, Injection site induration, Injection site pruritus, Injection site warmth
Clinical narrative: Pt. reported incident via pc on 1-28-13. She came into clinic on 1-29-13 for the nurse to complete the VAERS form and evaluate the pt. She reports that she noticed redness and itching at the site on 1-23-13. The redness spread to the size of her hand with firmness. She also reports fever at the site. On 1-26-13 she reports that it began to improve. On 1-29-13, RN observed that the area is normal color, no fever at site, there is firmness measuring 3 inches x 2.5 inches. Discomfort has resolved. Advised her if she had any problem to notify the clinic and to see her PMD.