chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 6.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Cellulitis, Erythema, Oedema peripheral, Tenderness
Clinical narrative: Received Dtap and Varicella in Left deltoid on 6/27/2012. Presented to ER on 6/29/2012 with redness, swelling and tenderness in left arm. Diagnosed with cellulitis secondary to receiving vaccinations.  Gave Keflex.  Returned to health department for health check on 7/6/2012 and stated had gone to ER for above problem. Records requested from ER and report made.  No further problems noted.
Age: 57.0
Sex: M
Vaccine: DTAP
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Pt. was given a DTaP instead of Tdap. No adverse rxn, pt. was adequately immunized.
Age: 11.0
Sex: U
Vaccine: VARCEL
Symptoms: Herpes zoster, Herpes zoster ophthalmic, Scar, Visual acuity reduced
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of 11 years old. The pharmacist reports that a patient developed shingles in the eye and face following vaccination with VARIVAX (Merck) (lot # not reported). The events occurred about 2 months ago (in approximately May 2012). The pharmacist stated that the patient received VARIVAX (Merck) at one year of age (date unspecified) and again at four years of age (date unspecified). The shingles in the eye was reported to had almost caused blindness in the eye and the shingles on the face caused scaring on the cheek. The pharmacist and the physician in the case did not administer the VARIVAX (Merck) to the patient. At the time of reporting, the outcome of the patient was unknown. The adverse events were considered to be disabling by the reporter. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Raised red area just below injection site about the size of half-dollar coin. Warm to the touch, but she denies pain, temperature, or oozing fluid from site.  Instructed to keep clean and call provider if it gets worse.
Age: 21.0
Sex: M
Vaccine: HPV4
Symptoms: Eye pain, Fatigue, Headache, Lethargy, Myalgia
Clinical narrative: Received vaccine 07/18/12 began having lethargy and myalgias about 24 hours later. Headache, fatigue, lethargy, myalgias, and bilateral orbit soreness for 4 1/2 days. Then red papular skin eruption on limbs, hands, feet, face, slightly pruritic, no fever.
Age: 21.0
Sex: M
Vaccine: HPV4
Symptoms: Rash erythematous, Rash papular, Rash pruritic
Clinical narrative: Received vaccine 07/18/12 began having lethargy and myalgias about 24 hours later. Headache, fatigue, lethargy, myalgias, and bilateral orbit soreness for 4 1/2 days. Then red papular skin eruption on limbs, hands, feet, face, slightly pruritic, no fever.
Age: 70.0
Sex: F
Vaccine: TDAP
Symptoms: Anxiety, Dizziness, Paraesthesia
Clinical narrative: 3:15 Vaccine administered. 3:30 Pt feeling light headed & arms tingly. 3:35 RN spoke to patient & she reported feeling better. 3:45 Pt decided that she'd prefer we call the ambulance. No SOB. Not faint. Pt feel very anxious perhaps. 3:55 Paramedics arrive.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV4, HEPA, HPV4
Symptoms: Syncope
Clinical narrative: Patient fainted.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV4, HEPA, HPV4
Symptoms: Cold sweat, Dizziness, Face injury, Hyperhidrosis, Joint injury
Clinical narrative: Patient fainted.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV4, HEPA, HPV4
Symptoms: Pallor, Syncope
Clinical narrative: Patient fainted.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age. The patients were vaccinated with a dose of GARDASIL on unspecified date (lot number, dose and route not reported). The medical assistant reported that the office did not monitor the temperature of the freezer and refrigerator from 18-JUN-2012 through 01-JUL-2012 so the office did not know for sure if their vaccines were stored at the proper temperature. No symptoms were reported. This is one of several reports received from the same source. Additional information is not expected.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Papule, Rash generalised, Rash maculo-papular, Vaccine breakthrough infection, Varicella post vaccine
Clinical narrative: Information has been received from a registered nurse concerning a 5 year old female patient with no pertinent medical history, who on 13-NOV-2007 and on 03-MAR-2012, was vaccinated with the first and second dose of VARIVAX (Merck) (doses, routes and lot numbers not reported). There was no concomitant medication. It was reported that, on 01-MAY-2012, the patient developed chicken pox described as mild, about 50 papules scattered all over the body without vesicles, just a macular papular rash. The patient sought unspecified medical attention ("nurse"). No treatment was given for the symptoms. No diagnostic studies were performed. At the time of the report, the patient's outcome was recovering. This is one of the several reports from the same source. Follow-up information as received from a nurse refers to female patient with no illness at time of vaccination and no adverse events following prior vaccination. No other co-suspects were reported. No concomitant medications were reported. It was reported that on 03-MAY-2012, the patient experienced broke through disease after "2 varicella vaccines". On an unspecified date the patient recovered. Additional information is not expected.
Age: 62.0
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a Licensed Practical Nurse (L.P.N.) concerning a 62 year old patient, who on 25-APR-2012 was vaccinated with a dose of VARIVAX (Merck) (lot # 670551/0738AA, Expiration date 17-MAY-2013) (dose and route not reported), rather than ZOSTAVAX (Merck). No adverse effects reported. Follow-up has been received from a Licensed Practical Nurse (L.P.N.) provided the patient's gender as female. Reported did not remember the patient's name or date of birth. Also she stated that the patient did not receive any other vaccinations at the same time as VARIVAX (Merck). The L.P.N. reported that the patient was fine and there was no adverse event. She mentioned that she previously contacted the company to inquire whether the patient should receive the ZOSTAVAX (Merck) in addition to the VARIVAX (Merck). Additional information is not expected.
Sex: M
Vaccine: HPV4
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report as received from an office manager refers to a male patient of unknown age. The patient was vaccinated with a dose of CERVARIX on 14-JUN-2012. On 16-JUL-2012, the patient was vaccinated with a dose of GARDASIL (vaccination site unknown), lot number not reported. No adverse effect reported. It was unspecified if the patient had sought medical attention. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: MMR
Symptoms: Mumps antibody test negative
Clinical narrative: This spontaneous report was received from a registered pharmacist concerning a 24 year old female patient who on an unknown date was vaccinated with a dose of MMR II (dose, route and lot # not provided). No other co-suspects were reported. No concomitant medications were reported. The pharmacist stated the patient might have had a negative titer for mumps but the pharmacist could not confirm that titer result. The pharmacist was not sure if patient received MMR II as a child or MUMPSVAX. The pharmacist stated that the patient went in for a booster shot for mumps (unspecified) only. The outcome of negative titers for mumps was unknown. The relatedness for negative titers for mumps was unknown for MMR II. Additional information has been requested.
Age: 0.61
Sex: M
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a physician concerning a 7 month old (reported as a 31.5 week old infant) patient who on 17-APR-2012, was vaccinated with the first dose of ROTATEQ, oral (lot number 672244/1847AA, expiration date 17-AUG-2013) (dose not reported). No adverse effects reported. Follow-up information has been received from the registry nurse concerning the 7 month old male patient and whose birth weight was 7lbs. The patient was vaccinated with ROTATEQ (lot number 672244/1847AA, expiration date: 17-AUG-2013) on 17-APR-2012. The patient did not seek medical attention. Additional information is not expected.
Age: 13.0
Sex: M
Vaccine: TDAP
Symptoms: Dyskinesia, Loss of consciousness, Pallor
Clinical narrative: Patient had become pale, unconscious with some involuntary muscle jerking movements shortly after receiving Tdap. Was placed in supine position with legs elevated. Became conscious in approx 1-2 min. Cool pack to neck. Vital signs monitored @ 2:45 pm BP 140/72 P60 with mucus membranes pink moist. Reported by patient that he had not eaten this day Gave sips of Soda Pop. @ 2:55 pm 112/62 P60 R14.  @3:10 pm BP 110/70 P64 R12. Sat upright and then slowly stood - walking out of facility.
Age: 50.0
Sex: M
Vaccine: MMR
Symptoms: Arthralgia, Influenza like illness, Joint stiffness, Laboratory test normal
Clinical narrative: As requirement for my employment, they stated my blood test showed no immunity to mumps, even though had been working there for 16 years, so they said in order to keep working there I was required a booster. I received the booster in Nov 2011 3 weeks later I had flu like symptoms and joint pains that persisted. I Went to my Family Dr. about 3 or 4 months later with this chronic complaint. I didn't mention that I had a vaccine 3 or 4 months before.
Age: 6.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Left thigh pain and swelling after injection administration.
Age: 32.0
Sex: M
Vaccine: VARCEL
Symptoms: Activities of daily living impaired, Fatigue, Pruritus, Pyrexia, Varicella post vaccine
Clinical narrative: Contracted chicken pox. Raised sores, open sores, fever, fatigue, itching. Officially diagnosed and sent home from work until virus has ran its course. Home remedies is only treatment available, doctor stated it was too late for Valtrex.
Age: 10.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site pain
Clinical narrative: Severe pain at the site of injection.
Age: 42.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Cardiac stress test, Erythema, Induration, Lymphadenopathy, Skin warm
Clinical narrative: Large swollen area above left clavical bone.   3mm round hard area.  Tender to touch.  Warm and Red. 7-21-2012 she reported lymph node under right arm swollen.  Referred to Primary MD.
Age: 42.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Swelling, Tenderness
Clinical narrative: Large swollen area above left clavical bone.   3mm round hard area.  Tender to touch.  Warm and Red. 7-21-2012 she reported lymph node under right arm swollen.  Referred to Primary MD.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash
Clinical narrative: Information has been received from a pharmacist concerning a 64 year old female patient who on 14-MAY-2012 was vaccinated with a dose of ZOSTAVAX (Merck) (lot # 669863/0365AA, expiration: 09-JUN-2012) (dose and route not reported). The patient developed a "rash", described as 3 inches around, pinkish red and itchy at the injection site (no pain). The pharmacist did not know how soon after vaccination the patient developed the "rash". On 16-MAY-2012 the patient contacted the pharmacist. No lab diagnostics studies were performed. No treatment was given for the adverse events. At the time of the report, the patient did not recover. Follow-up information has been received from the pharmacist concerning a 64 year old female patient with no illness at time of vaccination who on 14-MAY-2012, 14:35, was vaccinated with the first dose of ZOSTAVAX (Merck) (lot # 669863/0365AA, expiration: 09-JUN-2012) (s.c., dose not reported). On 17-MAY-2012, 16:45, the patient reported that rash was around injection site 3 inch around, itchy but no pain. The pharmacist told the patient that it was possible injection site adverse reactions and she might see doctor if it was too much concern to her. The pharmacist checked with patient on next day found she is fine but still had pinkish rash. Later the patient said rash was gone after 4 days. The patient took BENADRYL. No relevant diagnostic tests and laboratory data. Additional information is not expected.
Age: 0.18
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Dyskinesia, Intensive care, Seizure like phenomena, Unresponsive to stimuli
Clinical narrative: Woke from nap, arms and legs jerking and patient unresponsive x 5 mins. Seizure like activity.
Age: 31.0
Sex: F
Vaccine: HEPAB, TDAP
Symptoms: Dyspnoea, Pyrexia, Rash
Clinical narrative: 07/19/12 - vaccine administered by public health department. 07/20/2012 - Hospital reports client history indicates visit to Acute Care Express with symptoms of: rash (arms and legs), shortness of breath, and fever of 103. Also states prescriptions: antibiotics and steroids given by acute care physician, started 07/23/2012. 07/24/2012 - To ED with c/o - continued and worsening shortness of breath per nurse. Report received by public health representative.
Age: 49.0
Sex: M
Vaccine: TTOX
Symptoms: Blood pressure increased, Dizziness, Heart rate irregular, Nausea, Tenderness
Clinical narrative: Light headed, Nausea, Elvated BP, irregurlar heart beat, arm tenderness lasting up to 3 days.
Age: 54.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site swelling, Rash erythematous
Clinical narrative: Pt noted increasing swelling to maximum of 8 inches by 5 inches at site of injection. smaller area -- @inch dimater of redness w "bumps".
Age: 1.3
Sex: M
Vaccine: HIBV, MMR, PNC13, VARCEL
Symptoms: Blood culture, Chest X-ray, Full blood count, Pyrexia, Tremor
Clinical narrative: FEVER AND "SHAKING" 12-14 HOURS AFTER VACCINATION/ TOOK TO EMERGENCY ROOM EARLY AM; NORMAL EXAM IN ER AS WELL AS FOLLOW UP AT MD OFFICE.
Age: 40.0
Sex: F
Vaccine: PPV
Symptoms: Axillary pain, Cellulitis, Inflammation, Injection site pain, Pain
Clinical narrative: This spontaneous report as received from a doctor of pharmacy concerning a 40 year old female nurse practitioner with irregular menstrual bleeding, tachycardia, uterine fibroids and cardioversion and erythromycin allergy who on 04-JUL-2012, was vaccinated IM in the left deltoid with a 0.5 ml dose of PNEUMOVAX 23 (lot# 0491AE). The patient did not have concomitant medications. The pharmacist reported that the patient who received PNEUMOVAX 23 had "immediate excruciating pain" when she received the injection. The pharmacist read the emergency room report: "the pain was lateral at the anterior aspect of the left axillary region. There was a burning and stinging pain primarily at the anterior fold but not at the site of injection. Subsequently the left upper arm and axillary area became more sore, tenderness increased. Redness began to appear at the axillary area where pain was felt during the injection. The affected area seemed to be lateral and axillary but not at the actual site of injection". On 05-JUL-2012, the affected area became more inflamed and there was heat. Redness increased. On 06-JUL-2012, the patient went to the emergency room and was diagnosed with cellulitis. She was prescribed AUGMENTIN 875 mg twice a day for 5 days. When she was discharged from the emergency room there was "an area of induration working up her shoulder that was confluent, red and growing and increasing in pain". The patient said after her second dose of AUGMENTIN the affected site was responding to the treatment and warmth, redness and pain were decreasing. A sonogram of left upper arm was performed to rule out the thrombosis; the result was negative as the sonogram showed no thrombosis. The relationship between cellulitis and PNEUMOVAX 23 was unknown. The pharmacist would like a lot check. At the time of the report, in July 2012 the patient recovered. A lot check has been initiated. Additional information has been requested.
Age: 40.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Skin warm, Tenderness, Ultrasound scan normal
Clinical narrative: This spontaneous report as received from a doctor of pharmacy concerning a 40 year old female nurse practitioner with irregular menstrual bleeding, tachycardia, uterine fibroids and cardioversion and erythromycin allergy who on 04-JUL-2012, was vaccinated IM in the left deltoid with a 0.5 ml dose of PNEUMOVAX 23 (lot# 0491AE). The patient did not have concomitant medications. The pharmacist reported that the patient who received PNEUMOVAX 23 had "immediate excruciating pain" when she received the injection. The pharmacist read the emergency room report: "the pain was lateral at the anterior aspect of the left axillary region. There was a burning and stinging pain primarily at the anterior fold but not at the site of injection. Subsequently the left upper arm and axillary area became more sore, tenderness increased. Redness began to appear at the axillary area where pain was felt during the injection. The affected area seemed to be lateral and axillary but not at the actual site of injection". On 05-JUL-2012, the affected area became more inflamed and there was heat. Redness increased. On 06-JUL-2012, the patient went to the emergency room and was diagnosed with cellulitis. She was prescribed AUGMENTIN 875 mg twice a day for 5 days. When she was discharged from the emergency room there was "an area of induration working up her shoulder that was confluent, red and growing and increasing in pain". The patient said after her second dose of AUGMENTIN the affected site was responding to the treatment and warmth, redness and pain were decreasing. A sonogram of left upper arm was performed to rule out the thrombosis; the result was negative as the sonogram showed no thrombosis. The relationship between cellulitis and PNEUMOVAX 23 was unknown. The pharmacist would like a lot check. At the time of the report, in July 2012 the patient recovered. A lot check has been initiated. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of an unknown age. The patients were vaccinated with a dose of ROTATEQ on unspecified date (lot number, dose and route not reported). The medical assistant reported that the office did not monitor the temperature of the freezer and refrigerator from 18-JUN-2012 through 01-JUL-2012 so the office did not know for sure if their vaccines were stored at the proper temperature. No symptoms were reported. This is one of several reports received from the same source. Additional information is not expected.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Breast pain, Induration, Rash erythematous, Rash pruritic, Skin lesion
Clinical narrative: Information has been received from a registered pharmacist (from a completed questionnaire) concerning his a 64 year old father with no known drug reactions or allergies and Barrett's oesophagus and hypertension who on 08-JUN-2012, was vaccinated with a dose of ZOSTAVAX (Merck), 0.65 mL, subcutaneously in the arm (lot number 672606/1655AA, expiration date 21-JAN-2013). Concomitant therapy included NORVASC, NEXIUM, ZANTAC, LIPITOR and TOPROL. The patient was not recently exposured to chickenpox or shingles. On 09-JUN-2012 (also reported as 11-JUN-2012), the patient experienced two lesions with a hard, itchy, red rash and painful area next to his left nipple (breast) the size of a "thumbnail". The second spot was an inch below the first and it was the size of a "pinky nail", but did not itch as much. A rash did not occur at the site of injection post-vaccination. There was no treatment given for adverse events. At the time of the report the patient recovered. No laboratory tests were performed. The patient sought medical attention via phone. Follow-up information has been received from an other professional refers to his dad, a 64 year old male patient. On 09-JUN-2012 the patient experienced adverse event after receiving ZOSTAVAX. On 12-JUN-2012 the patient had recovered. Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: This spontaneous report as received from a pharmacist refers to an unspecified number of patients of unknown age. The patients were vaccinated SQ with a 0.65 ml dose of ZOSTAVAX (lot number not reported). It was reported that the patients in the past experienced pain at the injection sites as ZOSTAVAX was being injected. The pain was temporary and went away when the injections were completed. The patients sought medical attention by speaking with the pharmacist. At the time of the report, the patients had recovered from the events. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Oedema peripheral, Pyrexia
Clinical narrative: Information has been received from a nurse practitioner concerning a currently 25 year old female patient who on unspecified dates was vaccinated with all 3 shots of GARDASIL (Lot # and route not reported). The nurse reported that after all 3 shots of GARDASIL the patient's hand opposite the shot was swelling and she had a headache and fever within 24 hours after the final shot. The patient did not seek medical attention. NO treatment was given. Subsequently, the patient was recovered in an unknown date. Follow up information has been received from nurse practitioner, initial reporter, concerning about 25 year old student patient with perennial allergies, none illness at the time of the report who at 13:37 on 13-MAR-2012 was vaccinated intramuscularly in left deltoid with a third dose of GARDASIL (dose not reported, Lot # 17226AA during verification process). On 14-MAR-2012 the patient experienced hand swelling - opposite hand from arm which shot was given. In about 24 hours the patient experienced also headache and fever. It was reported that the patient had the same reactions after 2 first doses of GARDASIL (dates, doses, route and Lot number not reported). It was reported that after the first dose of GARDASIL, the patient saw urgent care (not specified) and was given antibiotics (not specified). On the other had it was also reported that the patient had none adverse event following prior vaccination. The patient did not undergo any lab diagnostic test. At the time of the report the patient's status was recovered (recovery date was not reported - it was mentioned that patient recovered after 24 hours). No further information is expected.
Age: 37.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site reaction, Skin lesion
Clinical narrative: Received Varicella on 7/13/12. Next day - mosquito bite lesion at site which enlarged to 3 in oval area of redness - no pain is clearing now. Need to know if she can receive 2nd dose.
Age: 19.0
Sex: M
Vaccine: MNQ
Symptoms: Headache, Pyrexia
Clinical narrative: Client reports started "running a fever" during the night (7/29/12 early morning) temperature was 101 at 0600. Client reports took ALEVE and is no longer febrile. Client also c/o headache. Client instructed to notify PCP of sx. Client verbalized understanding and reports will call at the end of call.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Over anterior (L) thigh - 2 circular bands of erythema surrounding injection site. Min. raised, tender. No violaceous discoloration. No deep hematoma.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Oedema peripheral, Pruritus
Clinical narrative: Approx. 1 week post vaccination pt states he experienced itching sensations in (L) & (R) hands, occasional swelling of fingers. Sx are intermittent.
Age: 43.0
Sex: M
Vaccine: TDAP
Symptoms: Rash generalised
Clinical narrative: Patient develops rash through out body. No swollen gland. Adverse event appears to be topical rash only.
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Dyspnoea, Muscular weakness, Pain in extremity, Rash erythematous
Clinical narrative: Pt said her arm was a bit sore after the shot. Next day it spreads from arm to her upper back. Her left arm was weak & sore when she coughs, she had a little difficult breathing. I repeatedly asked her to go to dr to check on 7/23/12 7/24/12 called pt & she said she is getting better. Her arm is still sore but not as bad & her back is better. There is a little red rash below the bandage which she didn't remove. I recommended she continues ADVIL for few days. Pt took 7/23/12 per #2 ADVIL & arm 7/24/12
Age: 17.0
Sex: M
Vaccine: HPV4
Symptoms: Electrocardiogram, Electroencephalogram, Gaze palsy, Muscle twitching, Pallor
Clinical narrative: Pr received 1st HPV vaccine and eyes rolled back and had syncopal episode lasting < 10 seconds. Mom reports a mild twitch after syncope pallor noted.
Age: 17.0
Sex: M
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Pr received 1st HPV vaccine and eyes rolled back and had syncopal episode lasting < 10 seconds. Mom reports a mild twitch after syncope pallor noted.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site pruritus, Injection site rash
Clinical narrative: Pt developed a red rash swollen & itchy at injection site, approximately 3-4 inches & redness is starting to spread along the backside of the arm (left arm), some soreness as well.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site swelling, Rash erythematous
Clinical narrative: Pt developed a red rash swollen & itchy at injection site, approximately 3-4 inches & redness is starting to spread along the backside of the arm (left arm), some soreness as well.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Rash erythematous
Clinical narrative: Pt developed a red rash swollen & itchy at injection site, approximately 3-4 inches & redness is starting to spread along the backside of the arm (left arm), some soreness as well.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash erythematous, Skin irritation
Clinical narrative: Patient called 7/23/12 to report small oblong red irritating spot on left side of mid back (about 2"). Pt contacted doctor and was diagnosed with shingles.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Grip strength decreased
Clinical narrative: Pt experienced loss of grip in injection arm between thumb & pointer finger. It has self resolved approximately 50% since injection but is not back to normal.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a female patient of unknown age. The patient was vaccinated with dose 2 and 3 of GARDASIL in 209 and on 02-JUL-2012 respectively (lot number, dose and route not reported). No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age. The patient was vaccinated with ZOSTAVAX (lot # 664444/0722Y, exp 21-NOV-2010) on 11-JUN-2012. It was reported that the patient was inadvertently administered ZOSTAVAX that had expired on 21-NOV-2010. No adverse effects reported. Whether the patient sought for medical attention was not reported. The outcome was unknown. Additional information is not expected.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Scab
Clinical narrative: This spontaneous report received from a 66 years old female with fibromyalgia and chronic fatigue syndrome and no drug reactions/allergies. The patient was vaccinated SC with a dose of ZOSTAVAX on OCT-2009. No other co-suspects were reported. Concomitant medications included CRESTOR 5 mg, OXYCONTIN 20 mg bid and CYMBALTA 60 mg. Since 03-JUL-2012 the patient had had 4 outbreaks of the shingles. She stated that she was currently in an outbreak but that the rash had crusted over. She stated that the severity of the pain had gotten worse with each outbreak. She had sought medical attention. Treatment included VALACYCLOVIR HYDROCHLORIDE 500 mg 3 times daily, IBUPROFEN 800 mg and "Odenaston" 4 mg. No lab diagnostics studied were performed. The outcome of the AE was unknown. Additional information has been requested.
Age: 62.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Muscle spasms, Pain, Swelling
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 62 years old male patient with WELLBUTRIN allergy, depression and sulfonamides allergy. The patient was intramuscularly vaccinated on left arm with lot # (672673/0492AE), 0.5 ml PNEUMOVAX 23 on 10-JUL-2012. Concomitant medications included LEXAPRO and omega-3 marine triglycerides. On 10-JUL-2012 the patient developed redness, swelling, pain, and muscle spasms 5 hours after administration. The patient was seen in the office on 11-JUL-2012 and it was noted that the reaction involved the entire circumference of the left upper arm. The patient was advised to apply ice compresses, BENADRYL cream, and cortisone cream to the area of reaction. The outcome of the patient was reported as not recovered/not resolved. No lab diagnostics study was performed. The nurse was requesting a lot check. This is one of several reports received from the same source. (MARRS#1207USA002943). Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. The patient was vaccinated with one dose of 0.65 ml ZOSTAVAX (lot number 672429/1606AA, expiration date 13-JAN-2013) (expiration date 30-APR-2012 as reported) subcutaneously on 15-MAY-2012. No other co-suspects were reported. No concomitant medications were reported. On 15-MAY-2012 the patient experienced expired dose of ZOSTAVAX administered. No adverse effects reported. It was unspecified if the patient had sought medical attention. This is one of several reports received from the same source. Additional is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Condition aggravated, Confusional state, Hyperhidrosis, Syncope
Clinical narrative: This spontaneous report as received from a physician refers to his daughter in her early teens. The patient's medical history of similar reaction (vasovagal syncope, confusion and sweating) while getting blood drawn. The patient was recently vaccinated IM with the first 0.5 ml dose of GARDASIL (lot number not reported). Recently on an unknown date after getting the vaccination the patient experienced the vasovagal syncope. After about 4-6 hours the patient experienced sweating and confusion, which went away within 24 hours. The patient was given BENADRYL for the adverse events. No lab diagnostics studies performed. The patient sought unspecified medical attention. At the time of the report, the patient had recovered from the events. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: RV5
Symptoms: Food aversion, Gastrointestinal disorder
Clinical narrative: This spontaneous report as received from a consumer refers to a 5 years old male patient. The patient was vaccinated with ROTATEQ (lot #, dose and route not reported). No other co-suspects and no concomitant medications were reported. The consumer reported that since an unknown date while on ROTATEQ the patient (her son) did not eat eggs any longer. The patient also had unspecified bowel issues. The patient visited the doctor and no treatment was given for the reported events. The outcome of the events was reported as not recovered. The relatedness for the reported events was not provided for ROTATEQ. 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 medical assistant refers to a patient of unknown age. The patient received doses of GARDASIL outside of recommended schedule. The patient was vaccinated with dose 1 GARDASIL (route, dose, frequency, lot# and expiration date were reported) in December 2009 and the second dose was given in July 2011. No other co-suspects were reported. No concomitant medications were reported. No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: HBHEPB
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a certified medical assistant concerning a patient, who on 12-SEP-2007 and 14-JAN-2008, was vaccinated with the first and second dose of COMVAX (dose, route and lot number not reported). Concomitant therapy included a dose of Hep B (manufacturer unspecified) administered on 12-JUL-2007. It was reported that the patient received COMVAX off schedule. The patient experienced no adverse events. Additional information has been requested.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Oral pain, Paraesthesia oral
Clinical narrative: This spontaneous report as received from a nurse refers to her husband a 62 year old male patient with no medical history or drug reactions. The patient was vaccinated with ZOSTAVAX (lot number not reported) at some time after 11-JUN-2012. No other co-suspects were reported. There was no concomitant medications. In 2012 the patient experienced tingling and pain in his mouth at an unspecified time after receiving after receiving ZOSTAVAX. The patient went to an unspecified dentist, who found no dental problems. The patient was treated with ibuprofen. On an unspecified date, the patient was recovered. This is one of the several reports received from the same source. Additional information has been requested.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Disorientation, Dizziness, Immediate post-injection reaction
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 67 years old male patient with no pertinent medical history. The patient was vaccinated with a dose of ZOSTAVAX on 12-JUL-2012 (Lot# reported as 0240AE, expired date 13-MAR-2015, dose and route not reported). No other co-suspects were reported. No concomitant medications were reported. On 12-JUL-2012 the patient was vaccinated and immediately became dizzy and disoriented. At the time of this report the patient was resting in the pharmacy. The patient sought medical attention in the pharmacy. No lab diagnostics studies performed. No treatment was given. The patient had not recovered. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a physician refers to 5 patients of unknown age. The patients were vaccinated with a dose of 0.65 ml ZOSTAVAX (lot number and route not reported). No other co-suspects and no concomitant medications were reported. The physician reported that on unknown dates the 5 patients developed shingles within one year of getting vaccinated with ZOSTAVAX. The patients sought unspecified medical attention. No treatment information was reported. The outcome of shingles within one year of getting vaccinated with ZOSTAVAX was unknown. The relatedness of the event was not reported for ZOSTAVAX. 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.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Condition aggravated, Nausea
Clinical narrative: This spontaneous report was received from a physician concerning an 11 year old female consumer with chronic proteinuria who on an unknown date was vaccinated with the first dose of GARDASIL 0.5 mL (route and lot # not provided) and on 11-JUN-2012 received the second dose of GARDASIL 0.5 mL (route and lot # not provided). Concomitant therapy included chronic treatment (unspecified) for protein in the urine. The physician stated that on 11-JUN-2012, the patient became extremely nauseated for 10 days. The patient was treated with REGLAN. On 21-JUN-2012, the patient recovered from the event. The patient sought medical attention. The patient's mother was curious and wanted to know if her daughter should continued with the third dose since she had the adverse experience with the second dose. The patient's mother wanted to seek the advice of her primary care physician. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Anogenital warts
Clinical narrative: Information has been received from a physician concerning a 21 year old female patient with a history of other unspecified sexually transmitted diseases (STDs) who on an unspecified date was vaccinated with a 0.5 ml dose of GARDASIL (route and lot # not reported). The physician reported that 2 weeks after getting her first dose of GARDASIL, the patient had an outbreak of genital warts. The patient had sought unspecified medical attention. No treatment was given for the event. Vaccination with GARDASIL had not reintroduced. At the time of the report, the patient's outcome was unknown. Follow up information has been received from the vaccine administering health professional refers to the female student patient. The patient was vaccinated with the first dose of 0.5 ml GARDASIL (lot #672193/1524AA) intramuscular at left deltoid on 12-APR-2012. No other co-suspects were reported. Concomitant medications included LEVORA and dicyclomine hydrochloride. Approximately on 26-APR-2012, two weeks after onset of therapy, the patient had outbreak of condyloma acuminatum. Patient thought outbreak was caused by the GARDASIL. Patient was reassured that it is not likely, but reporter would discuss it further with the Merck representative. The outcome of condyloma acuminatum was unknown. The patient did not sought medical attention. Additional information is not expected.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: This spontaneous report as received from a consumer refers to a 72 years old female patient with asthma, arthritis, osteoporosis, ulcers, drug hypersensitivity to LYRICA and CYMBALTA. The patient was vaccinated subcutaneously with a dose of ZOSTAVAX (lot # and dose not reported) on 06-JUL-2012. No other co-suspects were reported. Concomitant medications included levothyroxine sodium, NEXIUM, SKELAXIN, acetaminophen, PERCOCET and COUMADIN On 08-JUL-2012 the patient developed a red soreness at the injection site, 3 days after onset of therapy. The patient did not seek medical attention but was going to check with her physician, no treatment was given for the reported events and no lab diagnostic tests were performed. The outcome of red soreness at the injection site was unknown. The relatedness for red soreness at the injection site was not provided for ZOSTAVAX. 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 practitioner refers to a female patient of unknown age. The patient was vaccinated IM with her first 0.5ml 2 doses of GARDASIL (lot number not reported), more than a year ago, in approximately 2011, and was vaccinated IM with her third 0.5ml dose of GARDASIL (lot number not reported) on 12-JUL-2012. No adverse effect reported. No other co-suspects were reported. No concomitant medications were reported. No treatment information was reported. Additional information is not expected.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Herpes zoster, Rash
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to an 81 years old female patient with codeine allergy. On an unspecified date the patient was vaccinated SC with 1 dose, 0.65 ml ZOSTAVAX (lot number not reported). No other co-suspects were reported. No concomitant medications were reported. On 02-AUG-2011 the patient developed shingles that characterized by a burning rash in her left breast and left arm area. The patient had contacted physician and was treated with VALTREX and recovered "a week later", on approximately 09-AUG-2011. This is one of several reports received from the same source. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug
Clinical narrative: Information has been received from medical assistant concerning an unspecified number of patients who on unknown dates, might be vaccinated with GARDASIL (doses, routes, lot numbers not reported). Medical assistant reported that their office did not record temperature readings of their refrigerator from 24-MAY-2012 through 21-JUN-2012 so the office did not know if their vaccines were stored properly. Medical assistant was not sure if any patients were vaccinated with this product which possibly might have been stored improperly. This is one of several reports from the same source. No further information is available.
Age: 61.0
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a physician refers to a 61 years old male patient. It was reported that the patient was given VARIVAX (Lot# not reported) instead of ZOSTAVAX due to an office error on 03-JUL-2012. No adverse events reported. Whether the patient sought for medical attention was not reported. The outcome was unknown. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age. The patients were vaccinated with a dose of VARIVAX (Merck) on unspecified date (lot number, dose and route not reported). The medical assistant reported that the office did not monitor the temperature of the freezer and refrigerator from 18-JUN-2012 through 01-JUL-2012 so the office did not know for sure if their vaccines were stored at the proper temperature. No symptoms were reported. This is one of several reports received from the same source. Additional information is not expected.
Sex: U
Vaccine: HEP
Symptoms: Inflammation, Pruritus
Clinical narrative: An website editor reported that a consumer of unknown age said that he was vaccinated with Hep B (manufacturer was unknown). No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient experienced arm was inflamed and itching. No treatment information was reported. The outcome of arm was inflamed and arm is itching was unknown. The relatedness for arm was inflamed and arm was itching was unknown for Hep B. Additional information has been requested.
Age: 1.02
Sex: F
Vaccine: MMR, PNC13, VARCEL
Symptoms: Irritability, Pyrexia, Rash generalised, Rash macular
Clinical narrative: Information has been received from a healthcare worker concerning an approximately 12 month old (reported as "one-year-old") female patient with mold allergy and no pertinent medical history who on 30-MAY-2012 was vaccinated SQ with a 0.5mL dose of MMR II (lot #: 671485/1450AA, exp. date: 30-SEP-2013) by a physician. There was no concomitant medication. On approximately 06-JUN-2012 the patient experienced a rash and fever. There was unspecified treatment for the adverse events. No lab diagnostics studies were performed. The patient sought unspecified medical attention. The healthcare worker reported that the patient might had recovered from the events, but she was not one-hundred-percent sure. Follow-up information has been received from a physician concerning a 13 month old female patient with no illness at time of vaccination who on 30-MAY-2012 was vaccinated with the first dose of MMR II (lot # 671485/1450AA), 0.5 mL), the first dose of VARIVAX (Lot# reported as "1912AA") and the fourth dose of PREVNAR 13 (Lot# 917243). On 06-JUN-2012 the patient experienced irritable and fever. On 11-JUN-2012 the patient broke out in a rash. Spotty blotches all over body for about a day or two. At the time of reporting, the patient recovered. Additional information is not expected.
Age: 0.3
Sex: U
Vaccine: DTAPIPVHIB, HIBV
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 4 month old patient. The patient was vaccinated with 2 HIB vaccines concomitantly, a 0.5ml dose of LIQUID PEDVAXHIB and a dose of PENTACEL when while there for a 4 month check up. No other concomitant medications were reported. No adverse event reported. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Rash
Clinical narrative: This spontaneous report as received from a physician concerning a female patient who on an unspecified date, was vaccinated with the second 0.5 ml dose of GARDASIL (lot # not provided). The physician stated that the patient developed facial rash about a week after she received her second dose of GARDASIL. There was no adverse event after the first dose. The patient had decided she would not complete the series. At the time of the report, the patient recovered. The patient sought unspecified medical attention. She did not receive any treatment. The relatedness for facial rash was unknown for GARDASIL. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. The patient was vaccinated with expired ZOSTAVAX (Lot # 665528/0710Z, exp date 28-APR-2011) on 17-JUL-2012. No other co-suspects were reported. No concomitant medications were reported. No adverse event reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, HEP, HIBV, PNC13, RV5
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Information has been received from a certified medical assistant concerning a pediatric patient who on an unspecified date was inadvertently vaccinated with a dose of PEDIARIX during the same visit. No symptoms reported. Follow-up information has been received from vaccine adverse experience report refers to a 6 months old female patient with birth weight 8lbs 1ozs. On 26-JUN-2012 the patient was 19lbs 4ozs. The patient was vaccinated with RECOMBIVAX HB on 26-JUN-2012. On the same day, the patient was vaccinated with PEDIARIX (Intramuscular, lot # 1481AA), PREVNAR 13 (Intramuscular, lot # 917243 and Expiration Date was unspecified), ACTHIB (Intramuscular, lot # UH412AA and Expiration Date was unspecified) and ROTATEQ (oral, lot # 671576/1240AA and Expiration Date 29-MAY-2013 00:00). Additional information is not expected.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse concerning unknown number of patients who on an unknown dates were vaccinated with doses of RECOMBIVAX HB (doses, routes and lot numbers not reported) which were stored at lower than recommended temperatures on multiple occasions. No adverse effect reported. This is one of several reports received from the same source. Attempts are being made to obtain additional information to distinguish individual patients mentioned in this report. All telephone attempts to obtain follow-up information have been unsuccessful. The health care professional contacted during telephone follow-up could not supply the following information: dates of vaccination/therapy, dose number (if applicable), lot number (if applicable), date of event, recovery status, healthcare provider name and contact information. Additional information has been requested.