chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: HPVX
Symptoms: Off label use
Clinical narrative: This literature marketed report as received from a health professional refers to unspecified number of 27-39 years old female patients who started therapy with quadrivalent human papillomavirus (type 6, 11, 16, 18) recomb. vaccine (manufacture unknown) (dose, route and lot# not reported) on an unspecified dates. The literature background was to describe population-based rates of quadrivalent human papillomavirus (HPV4) vaccine uptake and coverage from its licensure in June 2006 through December 2008. In this period, quadrivalent human papillomavirus (types 6, 11, 16, 18) recomb. vaccine (manufacturer unknown) was licensed for use in 9-26 year old females. Methods: Data were from 4 managed care organizations in the Vaccine Safety Data link. It was described uptake of quadrivalent human papillomavirus (types 6, 11, 16, 18) recomb. vaccine (manufacturer unknown) (number of doses given per month) in all persons aged 0-39, and coverage (percentage of eligible persons who received 2:1 dose) in all females aged 0-39, stratified by age and history of HPV-related disease. Results: In this study period, 166,975 quadrivalent human papillomavirus (types 6, 11, 16, 18) recomb. vaccine (manufacturer unknown) doses were administered to 79,235 persons, with the greatest number given in the 3rd and 4th quarters of 2007. The therapy of quadrivalent human papillomavirus (types 6, 11, 16, 18) recomb. vaccine (manufacturer unknown) coverage increased steadily; by December 2008, coverage rates were 1% (female 9-10 years old), 34% (11-12), 55% (13-17), and 36% (18-26). The rate of increase in coverage was reduced by late 2008. After mid-2007, female aged 9-26 with a history of HPV-related disease had significantly lower rates of HPV4 vaccination than those without HPV disease. It was reported that minimal off-label use occurred: 6 males received vaccine; 153 doses were given to girls < 9years, and 3,518 doses to women 27-39 years old. A copy of the published article is attached as further documentation of the patient's experience. This is one the several reports from the same reporter. 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 Licensed Vocational Nurse (L.V.N), refers to a patient of unknown age and gender. No pertinent medical history or drug reactions/allergies were reported. On an unknown date in 2008, the patient was vaccinated with the first dose of with GARDASIL (dose, route and lot number were not provided). No co-suspect or concomitant therapies were reported. On 07-FEB-2014, the patient was to receive the second dose of GARDASIL. No adverse effect was 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 medical assistant, via a company representative, refers to a patient of unknown age and gender. On 31-JAN-2014 the patient was vaccinated with ZOSTAVAX lot # J000492 (was reported as "J0000492") expiry date 19-JAN-2014, 0.65 ml, subcutaneous. The patient was vaccinated with expired vaccine. No adverse effect was reported. Additional information has been requested.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: This spontaneous report as received from a physician of 53 year old concerning herself. On an unknown date patient developed hives after administering penicillin. Patient had no other previous medical history. On 07-FEB-2014 the patient was vaccinated with ZOSTAVAX, (dose number unknown) 0.65ml with lot # J011882 and expiry date 04-JAN-2015, 0.65 ml, subcutaneously. No concomitant medications were administered to the patient. On 07-FEB-2014, within 24 hours patient developed erythema and a little itching at injection site after receiving ZOSTAVAX. Patient hasn't sought medical attention and no treatment was given for the events. No laboratory tests were performed. On an unknown date of February 2014 (3 to 4 days later), patient recovered from erythema and a little itching at injection site. The outcome of she developed erythema and a little itching at injection site was reported as recovered/resolved. This case # 1402USA007605 is linked to case # 1402USA007610 via same reporter link. Additional information is not expected.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Pain
Clinical narrative: This spontaneous report as received from a physician refers to a 58 year old male patient with aspirin allergy concerning her husband. On an unknown date, patient developed hives to aspirin. On 07-FEB-2014 the patient was vaccinated with ZOSTAVAX, (dose number unknown) with lot # J011882 and expiry date 04-JAN-2015, 0.65 ml, subcutaneously. Other suspect therapies included PNEUMOVAX23 0.5 ml (dose number, lot number and expiry date unknown) was administered on 12-FEB-2014. On 07-FEB-2014 within 24 hours, patient developed erythema and pain after receiving ZOSTAVAX. Approximately on 11-FEB-2014 (within 3-4 days), patient recovered from erythema and pain. The outcome of developed erythema and pain within 24 hours was reported as recovered/resolved. The outcome of received a dose of ZOSTAVAX on 07-FEB-2014 and a dose of PNEUMOVAX23 0.5ml on 12-FEB-2014 was unknown. This case # 1402USA007610 is linked to case # 1402USA007605 via same reporter link. Additional information is not expected.
Age: 11.0
Sex: M
Vaccine: FLU3, HPV4
Symptoms: Injection site swelling
Clinical narrative: This spontaneous report was received from a physician via company representative refers to a 11 year old male patient. On an unknown date, the patient was vaccinated with AFLURIA (dose, route and frequency was not reported) and first shot of GARDASIL (route and frequency was not reported) at the same time. On an unknown date, after receiving both the vaccines at the same time, the patient experienced swelling at the injection site. It was also reported that the patient had not yet received the second and third dose of GARDASIL. The outcome of the event swelling at the injection site was unknown. The reporter did not provide the causality between the event and the suspect drug. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Local swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 65 year old female patient. The patient's medical history included unspecified reactions after receiving penicillin and clindamycin. On 22-JAN-2014 the patient was vaccinated with ZOSTAVAX (subcutaneous injection, site of administration not reported, lot # J007209 exp. date. 20-SEP-2014). Concomitant therapies included hydrochlorothiazide, DYAZIDE and levothyroxine sodium(manufacturer unknown). On an unknown date in January 2014 the patient experienced redness and swelling of an unspecified arm after receiving ZOSTAVAX. The outcome of redness and swelling of an unspecified arm after receiving ZOSTAVAX was reported as not recovered/not resolved. The relatedness between ZOSTAVAX and event was not reported. It was reported that the patient spoke with the pharmacist over the phone on 31-JAN-2014. Additional information has been requested.
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Dementia, Eating disorder, Gait disturbance
Clinical narrative: This spontaneous report was received from a physician concerning her 85 year old mother with dementia, congestive heart failure and a shunt in her brain, who on 04-FEB-2014 was vaccinated with ZOSTAVAX, 0.65 ml, subcutaneous. Concomitant medications were not reported. The physician reported that her mother's dementia progressed after receiving ZOSTAVAX. She also reported that her mother was eating slower and also walking slower after ZOSTAVAX was given. The patient did not seek medical attention. At the time of the report, the patient was recovering from the event. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Patient presented on 2/11/14 with complaints of pain in left shoulder increased erythema that migrates to her elbow. Denies fever, fatigue or malaise. Pt stated she had no problem at time of injection but developed symptoms and they were worst they had been today 2/11/14.
Sex: M
Vaccine: MMR
Symptoms: Measles antibody positive, Mumps antibody test positive, Rubella antibody negative
Clinical narrative: This spontaneous report was received from a registered nurse refers to a male patient of unknown age. No relevant medical history was reported. On an unknown date, an unspecified patient was vaccinated with a dose of M-M-R II (dose and route of administration was not provided). No concomitant medication was provided. On an unknown date, the patient was tested for titers sometime last week which showed that the patient had immunity to measles and mumps but not to rubella. The nurse did not feel comfortable providing patient information. No treatment was given for the event. The outcome of the event was unknown. Additional information has been requested.
Age: 57.0
Sex: M
Vaccine: FLU3
Symptoms: Gastrointestinal tube insertion, Guillain-Barre syndrome, Immunoglobulin therapy, Lumbar puncture, Malaise
Clinical narrative: Vaccine - 11/25/13. Sick - 12/1/13 (diag. pneumonia). 12/12 - admitted - Guillain Barre on vent., feeding tube and very little muscle movement.
Age: 57.0
Sex: M
Vaccine: FLU3
Symptoms: Mechanical ventilation, Muscle disorder, Plasmapheresis, Pneumonia
Clinical narrative: Vaccine - 11/25/13. Sick - 12/1/13 (diag. pneumonia). 12/12 - admitted - Guillain Barre on vent., feeding tube and very little muscle movement.
Age: 2.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Local swelling
Clinical narrative: Received flu vaccine on 2/14/14. Went to Hosp ER on 2/15/14 due to large, red, swollen area on thigh. Treated with KEFLEX, increased in size returned to ER give KEFLEX and IV oral clindamycin. Improved - went to ER another dose.
Age: 17.0
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Back pain, Dizziness, Injection site pain, Injection site swelling
Clinical narrative: Pt has swelling/pain over the injection site next day developed low back pain/dizziness/weakness sent to the ED due to symptoms.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Influenza, Malaise, Oropharyngeal pain, Palpitations
Clinical narrative: Racing heart, cough, mild symptoms of flu. No headache, sore throat, no sore muscles, general malaise.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain, Chest pain, Hypoaesthesia, Mobility decreased, Musculoskeletal pain
Clinical narrative: Left arm and shoulder felt heavy and painful.  Had difficulty moving same.  Had numbmees to left hand and electrical currents running down arm to fingers.  Also experienced abdomen/chest pain and went to emergency department and was admitted.  Cardiac problems ruled out but arm and shoulder continued and continues to hurt.  Seeing ortho and neurologist.  Have had MRI, xrays and medication.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Nuclear magnetic resonance imaging, Pain in extremity, Paraesthesia, Sensation of heaviness, Spinal X-ray
Clinical narrative: Left arm and shoulder felt heavy and painful.  Had difficulty moving same.  Had numbmees to left hand and electrical currents running down arm to fingers.  Also experienced abdomen/chest pain and went to emergency department and was admitted.  Cardiac problems ruled out but arm and shoulder continued and continues to hurt.  Seeing ortho and neurologist.  Have had MRI, xrays and medication.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: X-ray limb
Clinical narrative: Left arm and shoulder felt heavy and painful.  Had difficulty moving same.  Had numbmees to left hand and electrical currents running down arm to fingers.  Also experienced abdomen/chest pain and went to emergency department and was admitted.  Cardiac problems ruled out but arm and shoulder continued and continues to hurt.  Seeing ortho and neurologist.  Have had MRI, xrays and medication.
Age: 27.0
Sex: F
Vaccine: FLU4
Symptoms: Blood potassium decreased, Hypoaesthesia oral, Pruritus generalised, Throat tightness
Clinical narrative: Itching all over body, numbness in lips, throat closing.
Age: 1.0
Sex: F
Vaccine: FLU4, HEPA, HIBV, MMRV
Symptoms: Petechiae
Clinical narrative: Petechial rash all over face that occurred within 15 minutes of vaccine.  No difficulty breathing, vomiting or wheezing.  No rash on another part of the body other than rash that was present when she came in.  Had normal respiratory rate and O2 sats of 98%, even after 20 minutes of observation.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pruritus, Skin warm, Swelling
Clinical narrative: Area became raised, warm to touch, red swollen, itchy.  Site was 6 inches by 4 inches.  Lasted four days.
Age: 22.0
Sex: M
Vaccine: SMALL
Symptoms: Rash generalised, Rash pruritic, White blood cell count increased
Clinical narrative: Developed widespread pruritic rash over chest, abdomen, back, scalp, forehead, and then arms and legs sparing the palms and soles.  He was seen 4 days later, treated with Prednisone with improvement.
Age: 62.0
Sex: F
Vaccine: TYP
Symptoms: Abdominal discomfort, Abdominal distension, Diarrhoea, Irritable bowel syndrome
Clinical narrative: Diarrhea, bloating, GI pressure typically of irritable bowel syndrome (IBS).
Age: 0.15
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Enema administration, Intussusception, Surgery, Ultrasound abdomen abnormal
Clinical narrative: Intussusception on 02/18/2014.
Age: 53.0
Sex: F
Vaccine: DTAP
Symptoms: Herpes zoster, Lip pain, Oral herpes
Clinical narrative: Herpes zoster corner of right upper lip with pain radiating back to right ear. Went to Dr. and treated for shingles with Valtrex. MD told her it was caused by vaccine.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Activities of daily living impaired, Coeliac disease, Dysphagia, Dyspnoea, Feeling abnormal
Clinical narrative: First cross country meet as a freshman in high school.  Patient complained of shortness of breath and kept saying there was something wrong with her body.  She said her legs feel weird and weak'.  With multiple stops along the path she was able to finish the race.  (Patient did not have this issue when running cross country last year).  She just kept saying, "Something is wrong with my body".
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Gait disturbance, Muscle disorder, Muscular weakness, Myasthenia gravis, Speech disorder
Clinical narrative: First cross country meet as a freshman in high school.  Patient complained of shortness of breath and kept saying there was something wrong with her body.  She said her legs feel weird and weak'.  With multiple stops along the path she was able to finish the race.  (Patient did not have this issue when running cross country last year).  She just kept saying, "Something is wrong with my body".
Age: 65.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site pruritus, Injection site swelling
Clinical narrative: Severe itching to site of arm where vaccine administered, no hives or redness per patient, extreme swelling of arm at injection side and surrounding area, no treatment per patient.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Fluzone HD administered to a patient under the age of 65. No adverse symptoms.
Age: 15.0
Sex: M
Vaccine: HPV4
Symptoms: Depression, Feeling abnormal, Social avoidant behaviour
Clinical narrative: Patient became withdrawn and began to experience what he described as depression.  He shared these feelings with his Mom that he just didn't feel like his old self and that he was feeling very depressed.  Patient remembers sharing some very depressive feelings with his Mom on the night before his 16th birthday March 18, 2011.
Age: 2.0
Sex: M
Vaccine: HEPA
Symptoms: Discomfort, Pruritus, Urticaria
Clinical narrative: The morning after the vaccine, my son woke up with several patches of hives (knees, forehead, cheek). These patches continued to come and go all day over various parts of his body, to include knees, feet, ankles, cheeks, forehead. He said they were itchy, and he was very uncomfortable, with an extremely poor appetite all day. He continued to have a few smaller patches of hives into the next day (02/15/2014).
Age: 15.0
Sex: M
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Pt mother reported hives.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Burning sensation, Rash erythematous, Rash pruritic
Clinical narrative: Raised red rash, small red bumps throughout rash. Rash is roughly the size of a half-dollar. Rash was itching and burning.
Age: 20.0
Sex: M
Vaccine: HEPAB, MMR, TYP
Symptoms: Eye pruritus, Eye swelling, Rash, Rash pruritic
Clinical narrative: Itchy rash on arms, abdomen and neck then left eye swelling and itch.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site reaction, Muscle tightness, Myalgia, Vaccination site bruising
Clinical narrative: The vaccine shot area was very sore and bruised from day 1. Muscle pain and limited movement started about a week later.  It has been sore and unable to move my left arm fully.  Can not fully extend arm over my head. It's like a very sore/tight muscle pain that I can not seem to get relief from, or improve. It started mostly around the shot area and moved up to my shoulder, and almost down to my elbow.  When I over extend, it is excruciatingly painful.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Vaccination site pain
Clinical narrative: The vaccine shot area was very sore and bruised from day 1. Muscle pain and limited movement started about a week later.  It has been sore and unable to move my left arm fully.  Can not fully extend arm over my head. It's like a very sore/tight muscle pain that I can not seem to get relief from, or improve. It started mostly around the shot area and moved up to my shoulder, and almost down to my elbow.  When I over extend, it is excruciatingly painful.
Age: 15.0
Sex: F
Vaccine: FLU4, HPV4, HPV4, FLUX, HPV4
Symptoms: Dyspnoea, Fatigue, Haemoglobin decreased, Menorrhagia, Oligomenorrhoea
Clinical narrative: PATIENT WAS SEEN IN THE CLINIC TODAY FOR CONSULTATION RELATED TO MENSTRUAL PERIOD FOR 2 MONTHS. MENSTRUAL PERIOD EVERY DAY FOR 2 MONTHS. SOMETIMES BLEEDING IS HEAVY REQUIRING 4 TO 5 PADS IN ONE DAY. SHE HAS FELT TIRED RECENTLY AND GETS SHORT OF BREATH RAPIDLY. PATIENT STATES THE SYMPOTMS WERE OF ACUTE ONSET. SHE INITIALLY WAS AWARE OF A PROBLEM APPROXIMATELY 1 MONTH AGO.
Age: 15.0
Sex: F
Vaccine: FLU4, HPV4, HPV4, FLUX, HPV4
Symptoms: Exposure during pregnancy, Haemoglobin decreased, Vaginal haemorrhage
Clinical narrative: PATIENT WAS SEEN IN THE CLINIC TODAY FOR CONSULTATION RELATED TO MENSTRUAL PERIOD FOR 2 MONTHS. MENSTRUAL PERIOD EVERY DAY FOR 2 MONTHS. SOMETIMES BLEEDING IS HEAVY REQUIRING 4 TO 5 PADS IN ONE DAY. SHE HAS FELT TIRED RECENTLY AND GETS SHORT OF BREATH RAPIDLY. PATIENT STATES THE SYMPOTMS WERE OF ACUTE ONSET. SHE INITIALLY WAS AWARE OF A PROBLEM APPROXIMATELY 1 MONTH AGO.
Age: 15.0
Sex: F
Vaccine: FLU4, HPV4, HPV4, FLUX, HPV4
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: PATIENT WAS SEEN IN THE CLINIC TODAY FOR CONSULTATION RELATED TO MENSTRUAL PERIOD FOR 2 MONTHS. MENSTRUAL PERIOD EVERY DAY FOR 2 MONTHS. SOMETIMES BLEEDING IS HEAVY REQUIRING 4 TO 5 PADS IN ONE DAY. SHE HAS FELT TIRED RECENTLY AND GETS SHORT OF BREATH RAPIDLY. PATIENT STATES THE SYMPOTMS WERE OF ACUTE ONSET. SHE INITIALLY WAS AWARE OF A PROBLEM APPROXIMATELY 1 MONTH AGO.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Injection site erythema, Injection site induration, Injection site pain, Lethargy
Clinical narrative: Patient experienced weak, lethargic, tender, sore, red, hard at the left arm injection site.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Vaccination site induration, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Vaccination area became extremely hot, itchy, red, swollen, hardened and coverered an area 6" x 8". I applied ice compresses.
Age: 12.0
Sex: F
Vaccine: UNK
Symptoms: Blood test, Constipation, Diarrhoea, Hepatomegaly, Liver function test abnormal
Clinical narrative: Violent diarrhea & throwing up for both shots, much worse and longer on 2nd shot, then returning for one day here and there. Enlarged spleen found by ultrasound after complaining of side pain. Only 2 menses in 19 months now gets heavy clots every 3 weeks following first Gardasil vaccine on 10/25/2013. Liver is enlarged as well as liver studies showing liver is overworked...currently waiting on studies. Vitamin D deficient. Constipated.
Age: 12.0
Sex: F
Vaccine: UNK
Symptoms: Menstruation irregular, Pain, Splenomegaly, Ultrasound abdomen, Vitamin D deficiency
Clinical narrative: Violent diarrhea & throwing up for both shots, much worse and longer on 2nd shot, then returning for one day here and there. Enlarged spleen found by ultrasound after complaining of side pain. Only 2 menses in 19 months now gets heavy clots every 3 weeks following first Gardasil vaccine on 10/25/2013. Liver is enlarged as well as liver studies showing liver is overworked...currently waiting on studies. Vitamin D deficient. Constipated.
Age: 12.0
Sex: F
Vaccine: UNK
Symptoms: Vomiting, X-ray
Clinical narrative: Violent diarrhea & throwing up for both shots, much worse and longer on 2nd shot, then returning for one day here and there. Enlarged spleen found by ultrasound after complaining of side pain. Only 2 menses in 19 months now gets heavy clots every 3 weeks following first Gardasil vaccine on 10/25/2013. Liver is enlarged as well as liver studies showing liver is overworked...currently waiting on studies. Vitamin D deficient. Constipated.
Age: 3.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site movement impairment, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: His leg was severely swollen, red and hot to the touch. He couldn't walk or move it without screaming in pain. He threw up at midnight and had a low grade fever. It would have been high if I didn't have him on Motrin for pain relief. It took him 3 days to finally start trying to put pressure on it.
Age: 3.0
Sex: M
Vaccine: PPV
Symptoms: Pain, Pyrexia, Screaming, Vomiting, Weight bearing difficulty
Clinical narrative: His leg was severely swollen, red and hot to the touch. He couldn't walk or move it without screaming in pain. He threw up at midnight and had a low grade fever. It would have been high if I didn't have him on Motrin for pain relief. It took him 3 days to finally start trying to put pressure on it.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Local swelling, Pain in extremity
Clinical narrative: Pt notes that after she received her pneumonia vaccine she developed marked swelling, redness and pain in her entire arm soon after, lasted about 3 days and then spontaneously resolved.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Erythema, Feeling abnormal, Injection site pruritus, Lip exfoliation
Clinical narrative: Vaccine given on 2-10-14. On 2-11-14 about lunch time - started feeling bad and chilling. Took 800mg ibuprofen. (L) arm red, swollen, aches, blotchy rash and itches from shoulder to elbow. Had fever of 101 to 102 for several days. Skin on lips and roof of mouth peeled. On 2-15-14 started feeling better and fever gone. Arm still has blotchy rash - not as bad is getting better.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Local swelling, Oral mucosal exfoliation, Pain in extremity, Pyrexia, Rash macular
Clinical narrative: Vaccine given on 2-10-14. On 2-11-14 about lunch time - started feeling bad and chilling. Took 800mg ibuprofen. (L) arm red, swollen, aches, blotchy rash and itches from shoulder to elbow. Had fever of 101 to 102 for several days. Skin on lips and roof of mouth peeled. On 2-15-14 started feeling better and fever gone. Arm still has blotchy rash - not as bad is getting better.
Age: 0.36
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Abscess sterile, Culture, Debridement, Purulent discharge, Skin discolouration
Clinical narrative: Injection given on 12/13/13 - patient developed a approx dime size soft tissue density with discoloration and post inflammatory changes - non-tender - noted on exam 1-13-14 R/O sterile abscess. 2-18-14 - on exam noted dime size density - debrided and expressed large amount of drainage - purulent oral and topically antibiotics started - culture taken.
Age: 39.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pain, Pain in extremity, Pain of skin, Pyrexia, Swelling
Clinical narrative: Body aches, arm pain and swelling, fever, skin tenderness of affected arm.
Age: 7.0
Sex: M
Vaccine: FLU3
Symptoms: Rash, Urticaria
Clinical narrative: 6 days after inoculation began to exhibit rash/hives. Seen in ED and tx with IV meds BENADRYL, PEPCID, SOLU-MEDROL. Meds after ED visit = BENADRYL, Felodipine, Prednisone taper.
Age: 65.0
Sex: F
Vaccine: FLUC3
Symptoms: Pain in extremity, Rotator cuff syndrome, Vaccination complication
Clinical narrative: Severe pain through her arm. When she saw the doctor she was told it was a rotator cuff injury from the shot.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 55 year old female patient with no medical history or drug reaction/allergies. On 21-JAN-2014, the patient was vaccinated with ZOSTAVAX vial, subcutaneous, single dose (lot # J011339 exp. Date 13-DEC-2014). There was no concomitant medication. On 22-JAN-2014, the patient developed redness, swelling, pain and warmth at the injection site, and treated herself with BENADRYL. On 23-JAN-2014, the patient was evaluated in the office, it was noted that the area of reaction was about the size of a 50 cent piece. The patient was treated with Dexamethasone injection (manufacturer unknown). On 24-JAN-2014, the patient called the office and reported that the pain was decreasing but the redness was extended down her arm. The patient was prescribed Doxycycline and a Prednisone (manufacturer unkonwn) dose pack. At the time of the report the patient was recovering from swelling, pain and warmth of injection site. No lab diagnostics were performed. IT was noted that the medical assistant was requesting a lot check. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 66 year old female patient with chronic obstructive pulmonary disease. On 22-NOV-2013, the patient was vaccinated with a dose of ZOSTAVAX (dose, frequency, route, lot #, expiration date and indication were not provided). Since December 2013, prednisone (manufacturer unknown) was prescribed to the patient for an unspecified reason. On 30-DEC-2013, the patient was prescribed an unspecified dose of prednisone (manufacturer unknown) and an unspecified dose of prednisone  (manufacturer unknown) in January 2014 for an unspecified reason. On 14-FEB-2014, the patient was also prescribed prednisone (manufacturer unknown) 80 mg/day for an unspecified reason. The prescription for prednisone (manufacturer unknown) 80 mg/day had not been filled yet. At the time of the report, the patient's status was not recovered, reported as not improved. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report sa received from a medical assistant refers to multiple unspecified patients of unknown age. On unknown dates, the multiple unspecified patients were vaccinated with VAQTA, (lot#, expiry date, dose, frequency, route and indication not reported). The medical assistant reported that the multiple unspecified patients were administered VAQTA that went through an unsupported temperature excursion. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 15.0
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 multiple unspecified patients of unknown age. On unknown dates, the multiple unspecified patients were vaccinated with GARDASIL, (lot#, expiry date, dose, frequency, route and indication not reported). The medical assistant reported that he multiple unspecified patients were administered GARDASIL that went through an unsupported temperature excursion. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to multiple unspecified patients of unknown age. On unknown dates, the multiples unspecified patients were vaccinated with RECOMBIVAX HB, (lot#, expiry date, dose, frequency, route and indication not reported). The medical assistant reported that the multiple unspecified patients were administered RECOMBIVAX HB that went through an unsupported temperature excursion. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 15.0
Sex: M
Vaccine: FLU3, HPV4, FLUX, HPV4
Symptoms: Syncope, Tonic clonic movements
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a 15 year old male patient. The patient had no known pertinent medical history. The patient had no known drug reactions/allergies. On 06-FEB-2014, the patient was vaccinated with the first dose of GARDASIL (lot # J012212, expiry date 18-FEB-2016) injection 120 Y (dose and route not reported). The patient also received a dose of influenza virus vaccine (manufacturer unknown) (lot#, expiry date, dose, frequency, strength and route not reported) concomitantly with the GARDASIL. No concomitant medication was reported. On 06-FEB-2014, the patient fainted and developed tonic clonic movements after receiving the first dose of GARDASIL. The patient went to the physician's office for seek medical attention. No lab diagnostics studies were performed. The patient was treated with ice packs and "alcohol smelling capsules". The patient recovered from the adverse events on 06-FEB-2014. Additional information has been requested.
Age: 0.34
Sex: F
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Head titubation
Clinical narrative: Head tremors - approx. 30 seconds. 10 episodes in the past 6 months.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Myalgia
Clinical narrative: The muscle that the shot was given is hurt real bad.
Age: 66.0
Sex: M
Vaccine: PPV, VARZOS, PPV, VARZOS
Symptoms: Blood culture, Body temperature increased, C-reactive protein, Chest X-ray, Erythema
Clinical narrative: PPSV and shingles vaccine given in RUA. Pt arrived to ER with temp of 104. RUA developed redness size of grapefruit with warmth to touch.
Age: 66.0
Sex: M
Vaccine: PPV, VARZOS, PPV, VARZOS
Symptoms: Full blood count, Metabolic function test, Pneumonitis, Sepsis, Urine analysis
Clinical narrative: PPSV and shingles vaccine given in RUA. Pt arrived to ER with temp of 104. RUA developed redness size of grapefruit with warmth to touch.
Age: 66.0
Sex: M
Vaccine: PPV, VARZOS, PPV, VARZOS
Symptoms: Blood culture, Blood magnesium, Body temperature increased, C-reactive protein, Chest X-ray
Clinical narrative: PPSV and shingles vaccine given in RUA. Pt arrived to ER with temp of 104. RUA developed redness size of grapefruit with warmth to touch.
Age: 66.0
Sex: M
Vaccine: PPV, VARZOS, PPV, VARZOS
Symptoms: Full blood count, Injection site erythema, Injection site warmth, Metabolic function test, Urine analysis
Clinical narrative: PPSV and shingles vaccine given in RUA. Pt arrived to ER with temp of 104. RUA developed redness size of grapefruit with warmth to touch.
Age: 2.0
Sex: M
Vaccine: FLU3, HEP
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Pt was receiving his seasonal flu vaccination and the administering technician resourced the correct dosage and vaccine in Immunizations Tool Kit (in both the green and pink section). After administering the dosage it was noticed that on the vaccination box it was advised that this vaccination (Afluria) is not to be given to children under the age of 5 years old. Parents of patient were notified and advised of warning signs to look out for. Parents were also educated on what to do if a fever develops.
Age: 46.0
Sex: F
Vaccine: HEP
Symptoms: Rash generalised
Clinical narrative: RASH ALL OVER BODY. TOOK 25MG BENADRYL AND RASH RESOLVED.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Febrile convulsion
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a patient of unknown age. Reporter stated that she had a patient come in two months ago for follow up visit and reported that in October 2013 the patient was vaccinated with VARIVAX (Merck) or M-M-R II, reporter was unsure which vaccine was administered to the patient. Approximately in 2013, the patient experienced febrile seizure (medically significant). The patient sought medical attention for the same. The outcome of febrile seizure was reported as recovered. The relation between the drug and the event was unknown. Upon internal review event Febrile seizure was considered medically significant. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Immediate post-injection reaction, Sensation of heaviness
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 19 year old female patient with no drug reactions/allergies. The patient received her first dose of GARDASIL injection (lot# and expiry date unknown) on 23-SEP-2013 and her second dose of GARDASIL injection (lot# J006857 and expiration: 06-AUG-2015) on 13-FEB-2014 (both 0.5ml, route intramuscular, indication reported as preventative). There was no concomitant medication and pertinent medical history. The pharmacist stated that the patient developed a "heavy arm" "immediately" after receiving her first dose of GARDASIL on 23-SEP-2013. No treatment was given for the event. No lab diagnostics studies were performed. The patient did not seek medical attention. "A couple days later", the patient was recovered. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a male patient of unknown age. The patient was vaccinated with a dose of ZOSTAVAX (0.65 ml, subcutaneous for prevent shingles (lot #, expiry date and strength not reported)) "when it first came out" developed singles "six years later". The reporter stated that the patient was diagnosed with the shingles by an Allergist on an unspecified date and prescribed VALTREX. The patient went to see the physician on an unspecified date after seeing the allergist and prescribed an unspecified pain medication for pain. The outcome of the events was unknown. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Exposure during pregnancy, Human chorionic gonadotropin positive, Nausea
Clinical narrative: This spontaneous prospective pregnancy report as received from a nurse practitioner refers to a female patient of unknown age. On 08-NOV-2013, the patient was vaccinated with MMR II and VARIVAX (Merck). No concomitant therapy was reported. The patient became pregnant with last menstrual period of 26-DEC-2013 and estimated delivery date of 02-OCT-2014. The patient had a qualitative HCG test on 03-FEB-2014 which showed that she was pregnant. The patient was seen by a physician on the same day. She also reported that the patient received ZOFRAN 4mg on 03-FEB-2014 for nausea. the outcome of the event was unknown. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy
Clinical narrative: This spontaneous pregnancy report as received from a registered nurse refers to a 25 years old female patient. The patient's history of previous pregnancies and live births is not known. The patient was vaccinated with dose 1, .5 ml GARDASIL on 02-OCT-2012. No other co-suspects were reported. No concomitant medications were reported. The LMP and EDD is not known. Initial exposure to GARDASIL was at "6 weeks". The patient was exposed to GARDASIL during trimester 1. The outcome of drug exposure during pregnancy is unknown. Drug exposure during pregnancy is not related to GARDASIL. Follow up information has been received. Estimated date of delivery was reported as 2013. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Rash
Clinical narrative: This spontaneous report as received from a pharmacist refers to an approximately 62 years old female patient. Pharmacist reported that on an unknown date, his wife (patient) was vaccinated with ZOSTAVAX, dose (unknown), frequency (unknown), route of administration (unknown). No concomitants were reported. On an unknown date (also reported as the next day), she developed a rash from the site of injection to her wrist. VZV packet not sent since patient recovered on an unspecified date. Causality assessment was not provided. Pharmacist declined to answer any additional questions about himself or his wife. No further information was provided. This report is linked to 1402USA006792, 1402USA007824 and 1402USA007825 by the same reporter link. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: HEPA
Symptoms: No adverse event, Syringe issue, Underdose
Clinical narrative: This spontaneous report as received from a pharmacist refers to an unspecified adult patient of unknown age and gender. On 07-JAN-2014 the patient was vaccinated with "less than a full dose" of VAQTA (lot# unspecified) (route, dose and location unspecified). No adverse effects reported. Follow-up information has been received from pharmacist and a health care professional regarding a 65 year old female patient. The patient do not have any illness at the time of vaccination. On 07-JAN-2014, the patient was vaccinated with VAQTA in the right deltoid. During administration the syringe malfunctioned and pushed the vaccine outward instead of into the patient arm. The patient received only half of vaccine during the administration. On 14-JAN-2014 (reported as 1 week after), the patient was readministered with VAQTA for the full dose. The outcome of the events were reported as recovered on the same day (07-JAN-2014). Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a physician via a representative refers to a 61 year old female patient with hypertension and hypercholesterolemia. On 23-JAN-2014 the patient was vaccinated with a dose of ZOSTAVAX, vial, (lot #, expiration date and dose unspecified). Concomitant medication included unspecified medication for hypertension. On 04-FEB-2014, the patient was diagnosed with shingles with a distribution of the right breast radiating to her back. The patient sought medical attention via office visit. The patient was prescribed VALTREX and an unspecified pain medication. No lab diagnostics studies performed. The events outcome was reported as recovering. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This spontaneous report as received from a physician and nurse via company representative refers to two patients (age and gender unspecified). The reporter learned of 3 patients that have developed a rash after receiving ZOSTAVAX, reporter stated that at least one of the 3 patients was a female and two with unspecified demographics. Patients concurrent conditions and medical history were unspecified. It was reported that in between 27-JAN-2014 to 07-FEB-2014, each patient were vaccinated with ZOSTAVAX Subcutaneous Injection, (Lot number: J008433, expiry date: 11-OCT-2014), (dose was unspecified). Approximately in 2014 (reported as sometime after 27-JAN-2014), the patients had developed a rash after receiving ZOSTAVAX. It was reported that the most severe rash reported may have also been previously reported through the vaccine adverse experience report number (VAERS) reporting system and included a rash that was 8-10 millimeters or centimeters in diameter. The other 2 rashes reported were less severe (it was unspecified out of three patients which patient had developed the most severe rash). Lot Number for the diluents for 2 out of the 3 vials was also provided Lot J012748 for both vials. All three patients came in for follow up visits with the physician for unspecified reasons. No product quality complaint was involved. The outcome of event rash was unknown. The reporters causality for the event with the therapy of ZOSTAVAX was not reported. This case is linked with case 1402USA007867 as same reporter link. Additional information has been requested.
Age: 1.8
Sex: U
Vaccine: PPV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 22 month old patient. On 17-FEB-2014, the patient was inadvertently vaccinated with PNEUMOVAX23. No adverse effect was reported. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Blister, Erythema, Papule, Pruritus, Scab
Clinical narrative: Isolated small red papules starting on neck and erupting over extremities over 3-4 days then no more. Itchy, some papules with small vesicles centers and several scabbed. No treatment. No fever.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: This spontaneous report as received from a pharmacist refers to an unspecified patients of unknown ages. On an unknown date, the patients were vaccinated with ZOSTAVAX, dose (unknown), frequency (unknown), for unknown indication. No concomitants were reported. Pharmacist reported that 50% of unspecified patients, who were administered with ZOSTAVAX at his pharmacy, developed redness at the injection site within 2 hours and an injection site rash. The outcome of events was unknown. Casualty assessment was not provided. VZV packet was not sent as patients were unspecified. NO further information was provided. This report is linked to 1402USA006792, 1402USA007825 and 1402USA007826 by the same reporter link. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Induration, Pruritus, Swelling
Clinical narrative: Localized 3cm indurated area on left arm. Itching, swelling, and redness.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Abnormal behaviour, CSF oligoclonal band, CSF test, Computerised tomogram head, Confusional state
Clinical narrative: 1/30/14 - Received vaccine. 1/31/14 - Started KEPPRA because of history of seizure. First time seizure occurred was in week preceding vaccine, head CT was normal, patient was scheduled for brain MRI on 2/3/14. 2/4/14 Mom brought child into office - stating he had been behaving abnormally since night of 2/3/14 and deteriorating till time of visit. He was lethargic, falling asleep constantly, his speech was abnormal, no fever at the time, and was assessed as having altered mental status and transferred to hospital ER.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Lethargy, Mental status changes, Nuclear magnetic resonance imaging brain, Somnolence, Speech disorder
Clinical narrative: 1/30/14 - Received vaccine. 1/31/14 - Started KEPPRA because of history of seizure. First time seizure occurred was in week preceding vaccine, head CT was normal, patient was scheduled for brain MRI on 2/3/14. 2/4/14 Mom brought child into office - stating he had been behaving abnormally since night of 2/3/14 and deteriorating till time of visit. He was lethargic, falling asleep constantly, his speech was abnormal, no fever at the time, and was assessed as having altered mental status and transferred to hospital ER.
Age: 61.0
Sex: F
Vaccine: VARCEL, VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a 61 year old female patient refers to herself. On 17-FEB-2014 the patient was supposed to receive a dose of ZOSTAVAX injection but was inadvertently vaccinated with a dose of VARIVAX (Merck), 0.5 ml, subcutaneous (lot number not provided). The patient experienced no adverse effects. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This spontaneous report as received from a physician and nurse via company representative refers to a female patient of unknown age. The reporter learned of 3 patients that have developed a rash after receiving ZOSTAVAX. The reporter stated that at least one of the 3 patients was a female and two with unspecified demographics. Patients concurrent conditions and medical history were unspecified. It was reported that in between 27-JAN-2014 and 07-FEB-2014, each patient was vaccinated with ZOSTAVAX Subcutaneous Injection, (Lot number: J008433, expiry date: 11-OCT-2014), (dose was unspecified). Approximately in 2014 (reported as sometime after 27-JAN-2014), the patient had developed a rash after receiving ZOSTAVAX. It was reported that the most severe rash reported may have also been previously reported through the vaccine adverse experience report number (VAERS) reporting system and included a rash that was 8-10 millimeters or centimeters in diameter. The other 2 rashes reported were less severe (it was unspecified out of three patients which patient had developed the most severe rash). Lot Number for the diluents of 2 out of the 3 vials were reported as J012748 for both vials. All three patients came in for follow up visits with the physician for unspecified reasons. No product quality complaint was involved. The outcome of event rash was unknown. The reporter's causality for the event with the therapy of ZOSTAVAX was not reported. This case is linked with case 1402USA004472 as same reporter link. Additional information has been requested.
Age: 28.0
Sex: M
Vaccine: FLU3, MMR, SMALL, FLU3, MMR, SMALL
Symptoms: Discomfort, Erythema multiforme, Macule, Papule, Pruritus
Clinical narrative: Rash onset 10 days post vaccination. Rash on hands, dorsal and palmar surfaces, bil elbows, and knees. Concentric targetoid macules and papules associated with itching and discomfort. No other symptoms. Rash consistent with EM-Minor.
Age: 28.0
Sex: M
Vaccine: FLU3, MMR, SMALL, FLU3, MMR, SMALL
Symptoms: Rash generalised
Clinical narrative: Rash onset 10 days post vaccination. Rash on hands, dorsal and palmar surfaces, bil elbows, and knees. Concentric targetoid macules and papules associated with itching and discomfort. No other symptoms. Rash consistent with EM-Minor.
Age: 28.0
Sex: M
Vaccine: FLU3, MMR, SMALL, FLU3, MMR, SMALL
Symptoms: Rash
Clinical narrative: Rash onset 10 days post vaccination. Rash on hands, dorsal and palmar surfaces, bil elbows, and knees. Concentric targetoid macules and papules associated with itching and discomfort. No other symptoms. Rash consistent with EM-Minor.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to an unknown age female patient. Pertinent medical history, drug allergies or reaction were not reported. On 14-JUN-2013, the patient was vaccinated with GARDASIL dose 1, 0.5 ml, intramuscular (lot # was not reported). On 03-DEC-2013, the patient was vaccinated with GARDASIL dose 2, 0.5 ml, intramuscular (lot # was not reported). On 14-FEB-2014, the patient was vaccinated with GARDASIL dose 3, 0.5 ml, intramuscular (lot # was not reported). Concomitant medication was not reported. No adverse effect reported. This is one of two cases from the same reporter (MARRS# 1402USA009214). Additional information has been requested.