chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Vaccination complication
Clinical narrative: Horribly, not sure how long it took for me to decided to go, because weeks before I was having, Bells palsy signs then thoat with white spots swelling, ears, infected, heart, hurting so bad, and lungs felt like my body was swelled so bad that I was getting where I was having a hard time moving hurt inside. First was given Indocin and shot of pencicillin, and Augmentin to take, was not getting better went back on  October 30, inflammation was so bad, and I was so sick and hurting I went back to the clinic, they then gave me preidsone an Zpak, the N.P. called me the next morning to check on me, I could not believe after taking the prescription he gave me I felt my body relieve. Felt like person came out of me.
Age: 18.0
Sex: F
Vaccine: TDAP
Symptoms: Pain, Pyrexia, Vomiting
Clinical narrative: Fever 100, body aches, vomited in am reported by patient. Fluids and Tylenol. 3/19/2014 reported feeling better.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Cough, Urticaria, Vomiting
Clinical narrative: COUGH, HIVES, VOMITING 15 MINUTES AFTER VACCINE ADMINISTRATION. EPIPEN JR AND 7.5ML OF BENADRYL ADMINISTERED. PATIENT RESPONDED WELL TO TREATMENT. PATIENT SENT TO ER BY AMBULANCE.
Age: 20.0
Sex: M
Vaccine: SMALL
Symptoms: Rash pruritic
Clinical narrative: 20 y/o male presents for smallpox reaction. Pt received the smallpox vaccine on 24 Feb 14. Pt has for the past 6 days noticed red itchy bumps to his lower arms, toes, and lower legs. Pt was seen by both Urgent Care and the ER over this last weekend. Pt was given a Medrol pack 4mg for 6 days (on day 3), clobetasol cream, and hydroxyzine. Pt states the itching has greatly reduced since starting the Medrol as well as the overall scope of the outbreak. He does live in the dorms and shares a bathroom with someone else. He has also been going to work. He does not have a history of skin disease. He denies any fever, chills, nausea, or vomiting.
Age: 1.29
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Rash erythematous, Swelling
Clinical narrative: Red rash and egg-sized swelling developed within minutes of vaccine administration on bilateral legs and on chest. Patient was administered Synagis for RSV, Hepatitis A vaccine and DTap vaccines. 25mg PO Benadryl was given and patient was observed for 20 minutes post-Benadryl, reaction was subsiding, patient was discharged with instructions for further care.
Age: 10.0
Sex: F
Vaccine: HPV4
Symptoms: Cold urticaria, Ear pain, Erythema, Laboratory test abnormal, Swelling
Clinical narrative: Erythema, swelling and pain of ears while playing outdoors in cold weather; this occurred same day after receiving her third HPV vaccine. Since then has also had additional episodes of cold urticaria with positive ice cube test.
Age: 1.09
Sex: M
Vaccine: DTAPIPVHIB, MMR, PNC13, RV5, VARCEL
Symptoms: Drug administration error, Incorrect dose administered
Clinical narrative: Vaccine administered in error at 13 months of age.
Age: 34.0
Sex: F
Vaccine: TDAP
Symptoms: Fatigue, Injection site erythema, Injection site induration, Injection site swelling, Myalgia
Clinical narrative: REDNESS, SWELLING AND INDURATION IN INJECTION SITE, ERYTHEMATOUS PAPULAR RASH ON CHEST, MYALGIAS, FATIGUE, NECK PAIN.
Age: 34.0
Sex: F
Vaccine: TDAP
Symptoms: Neck pain, Rash, Rash papular
Clinical narrative: REDNESS, SWELLING AND INDURATION IN INJECTION SITE, ERYTHEMATOUS PAPULAR RASH ON CHEST, MYALGIAS, FATIGUE, NECK PAIN.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Dyspnoea, Eye pruritus, Eye swelling, Pruritus
Clinical narrative: Itching skin and eyes, swollen eyes, throat tightness, sob, dizziness began 8 hours after injection. Progressed x 2 days. Tx with Advil, no relief. Second night took Benadryl with relief next morning.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Throat tightness
Clinical narrative: Itching skin and eyes, swollen eyes, throat tightness, sob, dizziness began 8 hours after injection. Progressed x 2 days. Tx with Advil, no relief. Second night took Benadryl with relief next morning.
Age: 34.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Red raised hard area on arm where vaccine was given, itchy, warm to touch, entire arm sore.
Age: 34.0
Sex: F
Vaccine: VARCEL
Symptoms: Pain in extremity
Clinical narrative: Red raised hard area on arm where vaccine was given, itchy, warm to touch, entire arm sore.
Age: 31.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site pain, Mobility decreased, Pain
Clinical narrative: Increasing pain in shoulder where vaccine was administered by the time I went to bed. By the next morning the pain was severe and I could not lift my arm above my head or across my body. I took ibuprofen and began icing my shoulder at least twice a day for 15 minutes. After nine weeks, it has improved but I still have pain if I bend my arm or move it across my body.
Age: 6.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site induration, Injection site pain, Injection site reaction, Macule, Skin lesion
Clinical narrative: Dtap injection was given in the left deltoid. One day after the injection a 4 cm x 3 cm indurated oval shape macular lesion appeared in the upper left arm where injection was given and is associated with mild tenderness. No fever or other issues. Recommendation: Benadryl and Tylenol PRN and instructions to watch the progression/improvement of the lesion site.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Febrile convulsion, Pyrexia, Rash erythematous
Clinical narrative: Febrile seizure occurred. Lasted about 1-2 minutes. Patient was transported by EMS to emergency room; fever of 103. Lasted 2 days. also with caudal erythematous rash. Now well.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Hypersensitivity, Injection site erythema, Injection site pruritus, Pruritus
Clinical narrative: Noticed redness, swelling and itching early in the morning.  This area kept expanding for about 4 days.  It remains red and itchy at the site of the injection.  I went to the doctors who said it was an allergic reaction and to wait for it to subside.   It has considerably.  I have photos if these would be helpful.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling
Clinical narrative: Noticed redness, swelling and itching early in the morning.  This area kept expanding for about 4 days.  It remains red and itchy at the site of the injection.  I went to the doctors who said it was an allergic reaction and to wait for it to subside.   It has considerably.  I have photos if these would be helpful.
Age: 43.0
Sex: M
Vaccine: PPV
Symptoms: Arthralgia, Headache, Injection site pain, Musculoskeletal stiffness, Neck pain
Clinical narrative: Pain in arm, at injection site, joint pain in shoulder, neck pain and headache.  Took Advil and applied heat and massage to area.  Next day, broke out mid morning in facial rash with red raised bumps on checks, nose and chin.  Pain in arm worsened with more stiffness when moving arm.  Took Benadryl with Advil for pain.
Age: 43.0
Sex: M
Vaccine: PPV
Symptoms: Rash, Rash erythematous
Clinical narrative: Pain in arm, at injection site, joint pain in shoulder, neck pain and headache.  Took Advil and applied heat and massage to area.  Next day, broke out mid morning in facial rash with red raised bumps on checks, nose and chin.  Pain in arm worsened with more stiffness when moving arm.  Took Benadryl with Advil for pain.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age and unknown gender. No medical history was reported. On 11-MAR-2014 the patient was vaccinated with the expired dose of PNEUMOVAX 23 (lot # H013399, expiration date 07-MAR-2013) (dose, route were not reported). No concomitant medications were reported. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Antibody test negative
Clinical narrative: This spontaneous report was received from a registered nurse via company representative concerning an unknown number of patients (No patient's demographics provided). On unspecified dates, the patients were vaccinated with 2 doses of MMR II, dose 0.5 ml, subcutaneous route (frequency and lot numbers not provided). Co-suspect or concomitant therapies were not reported. On unspecified dates, the patients have had negative antibody titers after administration of 2 doses of MMR II. Antibody titers tests were performed. Patients sought medical attention through office visits.At the time of the report, the outcome of the event was unknown. The causal relationship between doses of MMR II and the event was unknown. Additional information has been requested.
Age: 7.0
Sex: M
Vaccine: IPV, VARCEL
Symptoms: Rash
Clinical narrative: Non-raised rash on face, abd and legs x 5 days. No fever.
Age: 16.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Dizziness, Vomiting
Clinical narrative: Light headed, vomiting.
Age: 1.01
Sex: M
Vaccine: DTAP, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Injection site mass, Injection site pain, Rash erythematous, Rash generalised
Clinical narrative: Rash - all over the body x 4 days, red raised above the skin. No fever, painful welt looking lump right thigh - Scabies exposure.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Immediate post-injection reaction, Myalgia
Clinical narrative: After the first HPV injection, I feel left leg muscle soreness, start immediately after injection and last for several hours constantly while walking.
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Injection site swelling, Local swelling, Lymphadenopathy
Clinical narrative: Severe deltoid pain at site of injection, swelling of deltoid, supraclavicular adenopathy.
Age: 24.0
Sex: F
Vaccine: PPV
Symptoms: Body temperature increased, Decreased appetite, Erythema, Headache, Malaise
Clinical narrative: Temperature 104 degrees F, severe headache, 6 inch arm reaction w/ erythema (? Arthus reaction - not true hemorrhage though), nausea, anorexia, malaise, body aches. Still febrile at 101 degrees on 3/17 and large arm reaction still visible.
Age: 24.0
Sex: F
Vaccine: PPV
Symptoms: Nausea, Pain
Clinical narrative: Temperature 104 degrees F, severe headache, 6 inch arm reaction w/ erythema (? Arthus reaction - not true hemorrhage though), nausea, anorexia, malaise, body aches. Still febrile at 101 degrees on 3/17 and large arm reaction still visible.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Rash
Clinical narrative: Bumps/rash at injection site, down arm and adjacent torso.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Doctor of pharmacy refers to 3 patients of unknown ages. On an unknown date, the patients were vaccinated with doses of ZOSTAVAX (route and lot # not reported) that might have been improperly stored. No adverse effect was reported. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 4 year old patient of unkonwn gender. The patient's current conditions or medical history were not reported. On 14-MAR-2014, the patient was vaccinated with an expired dose of PROQUAD (Merck) 0.5 ml intramuscular lot # H015622 expiry 21-FEB-2014. No adverse effect reported. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. The patient's current conditions or medical history were not reported. On 01-MAR-2014 the patient was vaccinated by staff error with a dose of PNEUMOVAX 23 (dose and route were not reported) lot number 0291AE expiry 25-JAN-2014. No adverse effect reported. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to an unspecified number of patients. On unspecified dates, the unspecified number of patients might have been administered up to 0.6mL of GARDASIL, (lot#, expiry date, route and indication not reported). No adverse effects reported. No patient contact details provided. The nurse stated that a single dose vial of GARDASIL contained approximately 0.6 ml, sometimes more. And the nurse asked "Is the whole amount that is drawn up, given? or should only 0.5 ml be given?". Additional information is not expected.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. Medical history and concurrent conditions were not reported. On 24-FEB-2014, the patient was vaccinated with ZOSTAVAX Lot # J021658; Expiration date: 10-JAN-2015, subcutaneous. Secondary and concurrent therapies were not reported. On 25-FEB-2041, the patient developed redness at the ZOSTAVAX injection site. At the time of the report, the patient had not recovered. Patient did not received treatment for the adverse event. No lab diagnostics studies were not performed. It was reported that the patient sought medical attention by seeing two physicians. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Blood glucose increased, Blood test abnormal, Cough, Diabetes mellitus, Glucose tolerance impaired
Clinical narrative: This case was reported by a male consumer aged between 60 and 69 years old regarding himself. Concurrent medical conditions included acid reflux, allergy to animals and allergy to citrus, dairy allergy, iodine allergy, osteoporosis (October 2010), peanut allergy, shellfish allergy and walnut allergy. On 24-SEP-2010 the patient was vaccinated with PCV (manufacturer unknown) (dose, route, lot# not reported). Other suspect therapies included ADVAIR multi dose powder inhaler for lung congestion and influenza virus vaccine (unspecified). It was reported that the physician or other health care professional has not verified this report. Concomitant medications included Metformin, Vitamin D (manufacturer unknown), Multivitamins (manufacturer unknown) and NEXIUM. It was reported that within months of vaccination with Influenza vaccine unspecified and PNEUMOVAX23, the patient reported that I got serum sickness when I received PCV (manufacturer unknown) and Flu shot that was given 24-SEP-2010. The patient states he still suffering and seeing doctor. On 15-NOV-2013 the patient started ADVAIR (inhaled) 500/50, prescribed to be taken 1 puff, twice daily for lung congestion secondary to serum sickness. He was concerned about taking a steroid medication so he reduced his dose to ADVAIR 250/50 on 24-NOV-2013 and would taken the medication on an as needed basis. He would take the product one puff at night before bedtime when he would feel a buildup in his chest of phlegm and he would start to cough. The ADVAIR product allowed him to sleep [not sleeping well] and he was pleased with the medication. In late December 2013, the patient experienced diabetes and borderline diabetes. The patient "was diagnosed with diabetes in late December 2013 but also stated that his doctor said he was right on the edge of having diabetes. Two weeks prior to this report (approximately 23 December 2013,), he received a blood test and his blood sugar numbers increased to 5.8 (units not provided) during treatment with ADVAIR diskus. At the time of reporting the outcome of the not sleeping well resolved. The outcome of diabetes, borderline diabetes and increased blood sugar were unresolved. The outcome of serum sickness, lung congestion and mucus increased in chest and coughs were unspecified. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Increased upper airway secretion, Insomnia, Pulmonary congestion, Serum sickness
Clinical narrative: This case was reported by a male consumer aged between 60 and 69 years old regarding himself. Concurrent medical conditions included acid reflux, allergy to animals and allergy to citrus, dairy allergy, iodine allergy, osteoporosis (October 2010), peanut allergy, shellfish allergy and walnut allergy. On 24-SEP-2010 the patient was vaccinated with PCV (manufacturer unknown) (dose, route, lot# not reported). Other suspect therapies included ADVAIR multi dose powder inhaler for lung congestion and influenza virus vaccine (unspecified). It was reported that the physician or other health care professional has not verified this report. Concomitant medications included Metformin, Vitamin D (manufacturer unknown), Multivitamins (manufacturer unknown) and NEXIUM. It was reported that within months of vaccination with Influenza vaccine unspecified and PNEUMOVAX23, the patient reported that I got serum sickness when I received PCV (manufacturer unknown) and Flu shot that was given 24-SEP-2010. The patient states he still suffering and seeing doctor. On 15-NOV-2013 the patient started ADVAIR (inhaled) 500/50, prescribed to be taken 1 puff, twice daily for lung congestion secondary to serum sickness. He was concerned about taking a steroid medication so he reduced his dose to ADVAIR 250/50 on 24-NOV-2013 and would taken the medication on an as needed basis. He would take the product one puff at night before bedtime when he would feel a buildup in his chest of phlegm and he would start to cough. The ADVAIR product allowed him to sleep [not sleeping well] and he was pleased with the medication. In late December 2013, the patient experienced diabetes and borderline diabetes. The patient "was diagnosed with diabetes in late December 2013 but also stated that his doctor said he was right on the edge of having diabetes. Two weeks prior to this report (approximately 23 December 2013,), he received a blood test and his blood sugar numbers increased to 5.8 (units not provided) during treatment with ADVAIR diskus. At the time of reporting the outcome of the not sleeping well resolved. The outcome of diabetes, borderline diabetes and increased blood sugar were unresolved. The outcome of serum sickness, lung congestion and mucus increased in chest and coughs were unspecified. Additional information has been requested.
Age: 0.2
Sex: F
Vaccine: RV5
Symptoms: Infantile spitting up, Oral administration complication
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 2 month old patient. On 10-MAR-2014 the patient was vaccinated with ROTATEQ (oral, dose#1, 2 ml; lot number unknown). The Medical assistant reported that on 10-MAR-2014 the patient spit up after being administered a partial first dose of ROTATEQ. Patient had just eaten and was crying piror to the administration of partial dose of ROTATEQ. Remainder  of ROTATEQ dose was administered. The outcome of the events was unknown. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a register nurse concerning an unspecified number of patient on unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with GARDASIL (lot number, expiration date and route were not reported) dose 3. Register nurse reported that on an unknown date an unspecified number of patients may have been administered GARDASIL with an interval of only 8 weeks between dose two and three. No adverse effects reported. Additional information has been requested.
Age: 52.0
Sex: M
Vaccine: PPV, TDAP, VARZOS
Symptoms: Blood pressure increased, Chills, Feeling cold
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 52 year old male patient. Relevant medical history and concomitant medication were not provided. On 17-DEC-2013 the patient was vaccinated with PNEUMOVAX 23 lot # J011651, subcutaneously in the right arm. Dose and frequency were not provided. Other suspect therapies included ZOSTAVAX lot # J011338, subcutaneously in the right arm and BOOSTRIX (GlaxoSmithKline) lot # 3JS2B, intramuscularly in the right deltoid. Dose and frequency were not provided. On 17-DEC-2013, the patient experienced chills, blood pressure was elevated and freezing. The outcome of freezing, chills and blood pressure was elevated was reported as recovered/resolved. The reporter causality was unknown. Additional information has been requested.
Age: 1.81
Sex: F
Vaccine: FLUN4, FLUN4
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: No adverse event/reaction. Flumist inadvertently given at age 21 mos-younger than recommended age of 2.
Age: 1.81
Sex: F
Vaccine: FLUN4, FLUN4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: No adverse event/reaction. Flumist inadvertently given at age 21 mos-younger than recommended age of 2.
Age: 32.0
Sex: M
Vaccine: SMALL
Symptoms: Rash, Skin lesion, Vaccination complication
Clinical narrative: Diffuse abdominal and flank rash, lesions less than 1mm in size, no lymph nodes.  Vaccinia reaction likely.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Condition aggravated, Deafness, Erythema, Herpes zoster
Clinical narrative: This spontaneous report as received from patient and a pharmacist refers to a 63 year old female patient with diabetes, thyroid, heart disease, and pre-existing hearing loss condition. The consumer reported that she has had reactions to many other drugs (dates unspecified) such as BENADRYL makes her aggressive, sulfa drugs and all antibiotics give her rash, CIPRO gave her C.diff, Lynexa gives her TIA, NOVOCAINE causes heart problems, all Opiates cause anaphylaxis, latex causes ulceration and possibly anaphylaxis if inserted in throat, Nickel causes ulcerations well. The patient's concomitant medications were reported as many (unspecified drugs). The patient stated that she has had Herpes 1 for most of her life, and treats it with VALTREX and LYSINE. The patient's medical history included ear drum reconstruction (1982) and cold symptoms (unspecified) in January 2014. On 27-FEB-2014 the patient was vaccinated with ZOSTAVAX lot # J006832 exp 01-SEP-2014, dose 1, 0.65 ml (1 shot), subcutaneous. On FEB-2014 the patient experienced worsening of hearing from pre-existing hearing loss (disability and medically significant) and cannot hear in one ear (medically significant). On 28-FEB-2014 the patient developed Herpes Zoster (the day after she received ZOSTAVAX). The patient did not receive any treatment for the event, but self medicated with LYSINE. She described the situation as being a bright red blister from the bottom of her spine to her hip. The patient reported that now she couldn't hear in one ear (start date unspecified). The pharmacist reported that the patient had pre-existing hearing loss condition and her ear drum was replaced in 1982. Pharmacist stated that patient did not experience hearing loss but rather worsening of hearing from pre-existing hearing loss. Pharmacist also stated that the patient had suffered from cold symptoms (unspecified) in January 2014 for about a month prior to receiving ZOSTAVAX, but on the day of vaccination, the patient told pharmacist that she felt fine and did not mention cold symptoms. The date therapy started was reported as 26-FEB-2014, but according to pharmacy report, patient received ZOSTAVAX, on 27-FEB-2014. The outcome of the events worsening of hearing from pre-existing hearing loss, cannot hear in one ear and herpes zoster is unknown. The reporter's causality assessments were not provided. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus
Clinical narrative: This spontaneous report as received from a female patient of unknown age. On 15-MAR-2014 the patient was vaccinated with ZOSTAVAX (lot number and frequency unknown) (dosing regimen and frequency unknown). No concomitant medications were reported. On an unknown date in March 2014 the patient experienced slight itch at the injection site. The outcome of slight itch at the injection site was reported as recovered. The action taken with the therapy with ZOSTAVAX was unknown. There was no product quality issue reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. On 04-MAR-2014 the patient was vaccinated subcutaneously with an unknown date of ZOSTAVAX. In March 2014, reported as after receiving ZOSTAVAX, the patient experienced red injection site reaction the size of a quarter. The outcome of red injection site reaction the size of a quarter was unknown. The relatedness between ZOSTAVAX and adverse event was unknown. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. In March 2011 (reported as 3 years ago) the patient was vaccinated with a dose of ZOSTAVAX (lot#, dose, route unspecified), and then patient developed a bulls-eye rash. The reporter did not know where the rash was located on the patient. Patient contacted pharmacist for medical attention. Treatment, BENADRYL, cold compresses, was given for the event. The outcome of the event was reported as recovered/resolved on an unknown date. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a other professional refers to an unknown number of patients of unknown age and gender. On an unknown date the patient was vaccinated with GARDASIL (lot number and frequency unknown) (dosing regimen and frequency unknown) which under went temperature excursions outside recommended temperatures. No concomitant medications were reported. No adverse event was reported. No product quality issue was reported. This case is related to case numbers 1403USA009542, 1403USA009543 and 1403USA009541 via same reporter link. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to an unknown number of patients of unknown age and gender. On an unknown date the patient was vaccinated with PEDVAXHIB (lot number and frequency unknown) (dosing regimen and frequency unknown) which under went temperature excursions outside recommended temperatures. No concomitant medications were reported. No adverse event was reported. No product quality issue was reported. This case is related to case numbers 1403USA009542, 1403USA009427 and 1403USA009541 via same reporter link. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received form a other health professional refers to an unknown number of patients of unknown age and gender. On an unknown date the patient was vaccinated with RECOMBIVAX HB (lot number and frequency unknown) (dosing regimen and frequency unknown) which under went temperature excursions outside recommended temperatures. No concomitant medications were reported. No adverse event was reported. No product quality issue was reported. This case is related to case numbers 1403USA009427, 1403USA009543 and 1403USA009541 via same reporter link. 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 other health professional refers to an unknown number of patients of unknown age and gender. On an unknown date the patient was vaccinated with ROTATEQ (lot number and frequency unknown) (dosing regimen and frequency unkonwn) which under went temperature excursions outside recommended temperatures. No concomitant medications were reported. No adverse event was reported. No product quality issue was reported. This case is related to case numbers 1403USA009427, 1403USA009542 and 1403USA009543 via same reporter link. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a consumer regarding himself, refers to a 65 year old male patient. The patient's medical history included BPH and drug allergy to ADVIL cold and sinus. Concomitant therapies included NEXIUM, FLOMAX, CIALIS, and ANDROGEL. Approximately on 2012 (reported as 2 years ago) the patient was vaccinated with ZOSTAVAX dose 1 (dose/frequency reported as 1 time vaccine). On 13-MAR-2014 the patient stated that he might had shingles after getting ZOSTAVAX. The patient also stated that he had a dime size area followed by smaller area on his right side. The outcome of shingles is unknown. The patient has not sought any medical attention. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practitioner nurse and referred to a patient of unknown age and sex. No pertinent medical history, drug reactions or allergies were reported. On 14-MAR-2014, the patient was vaccinated with RECOMBIVAX HB (lot # 670230/1047AA, expiration date: 15-DEC-2013) third dose. Dates of first and second doses of RECOMBIVAX HB were unspecified. No adverse event reported. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age and gender. On 10-MAR-2014 the patient was vaccinated with GARDASIL (lot number, dose and frequency not provided), intramuscular. The patient received the vaccine which was exposed to 49 degrees F for 1 hour. No known adverse effects. Additional information has been requested.
Age: 20.0
Sex: U
Vaccine: HEP
Symptoms: Antibody test negative, Hepatitis B surface antibody negative
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 20 year old unspecified patient. On 16-MAR-2014, the patient was vaccinated with first dose of RECOMBIVAX HB Intramuscular Injection, that was 5 microgram (mcg) in strength, intramuscular. Concomitant medication was unspecified. Nurse practitioner also mentioned that the unspecified patient had a blood titer drawn (on an unknown date) and it was negative for antibodies. No product quality complaint was involved. Outcome of th e event was unknown. No further information was provided. Additional information is not expected.
Age: 41.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Client called on 03/12/2014 stating that she has a raised area at the injection site from her vaccine given on 03/11/2014 and is experiencing excruciating pain at the injection site as well.
Age: 28.0
Sex: F
Vaccine: FLU4, HEP, MMR, VARCEL
Symptoms: Abdominal pain upper, Diarrhoea, Fatigue, Headache, Musculoskeletal stiffness
Clinical narrative: Diarrhea, headache, "eyes feel puffy" (though no visible swelling), fever of 100.0F, tired, generalized aches, stomach pain, nausea without vomiting, stiff neck, slight photophobia.
Age: 28.0
Sex: F
Vaccine: FLU4, HEP, MMR, VARCEL
Symptoms: Nausea, Pain, Photophobia, Pyrexia
Clinical narrative: Diarrhea, headache, "eyes feel puffy" (though no visible swelling), fever of 100.0F, tired, generalized aches, stomach pain, nausea without vomiting, stiff neck, slight photophobia.
Age: 33.0
Sex: F
Vaccine: TYP
Symptoms: Aphthous stomatitis, Incomplete course of vaccination
Clinical narrative: Aphthous ulcers began to appeared on 03/14/14, the day after the first dose of Oral Typhoid taken 03/13/14.  Pt continued with the scheduled dose on 03/15/14, when more appeared under the tongue on same day.  Pt stopped taking the oral typhoid and did not take dose 3 or dose 4.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse concerning a patient of unknown age and gender. No medical history or concurrent conditions were reported. On 20-MAR-2012, patient was vaccinated with the first dose of GARDASIL. (Dose, strength and route not provided). Co-suspect or concomitant therapies were not reported. On 11-MAR-2014, patient received the second dose of GARDASIL. No adverse event reported. Additional information is not expected.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, HEP, HEPA, MMR, VARCEL
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Pt given 4th Hep B and 3rd Hep A because the card had not been updated properly; no adverse reaction at this time noted.
Sex: U
Vaccine: HEP
Symptoms: Antibody test negative
Clinical narrative: This spontaneous report was received from a registered nurse via company representative concerning an unknown number of patients (No patient demographics provided). On unspecified dates, the patients were vaccinated with the 3 doses of RECOMBIVAX HB, dose 1 ml, intramuscular route (frequency and lot numbers not provided). Co-suspect or concomitant therapies were not reported. On unspecified dates, the patients have had negative antibody titers after administration of 3 doses of RECOMBIVA HB. Antibody titers tests were performed. Patients sought medical attention through office visits. At the time of the report, the outcome of the event was unknown. The causal relationship between RECOMBIVAX HB and the event was unknown. Additional information has been requested.
Age: 61.0
Sex: M
Vaccine: FLU4
Symptoms: Colitis ulcerative
Clinical narrative: Experienced ulcerative colitis starting 2/5/14, about 2 months after receiving vaccine.
Age: 55.0
Sex: F
Vaccine: HEPA, MNQ, TD
Symptoms: Angiogram, Anxiety, Blood pressure increased, Blood test, Cardiac function test
Clinical narrative: Panic/anxiety - immediately. Heart rate increase - blood pressure increase. Burning sensation in hands and eyes. Irrational thoughts - labored speech. I've had 3 MRI's and an MRA; blood tests; vestibular tests, EKG etc - heart tests etc.
Age: 55.0
Sex: F
Vaccine: HEPA, MNQ, TD
Symptoms: Electrocardiogram, Eye irritation, Heart rate increased, Nuclear magnetic resonance imaging, Panic reaction
Clinical narrative: Panic/anxiety - immediately. Heart rate increase - blood pressure increase. Burning sensation in hands and eyes. Irrational thoughts - labored speech. I've had 3 MRI's and an MRA; blood tests; vestibular tests, EKG etc - heart tests etc.
Age: 55.0
Sex: F
Vaccine: HEPA, MNQ, TD
Symptoms: Speech disorder, Thinking abnormal, Tilt table test, Vestibular function test
Clinical narrative: Panic/anxiety - immediately. Heart rate increase - blood pressure increase. Burning sensation in hands and eyes. Irrational thoughts - labored speech. I've had 3 MRI's and an MRA; blood tests; vestibular tests, EKG etc - heart tests etc.
Age: 0.35
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Abdominal pain, Pyrexia
Clinical narrative: Fever, abdominal pain.
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Muscle injury, Myalgia, Nuclear magnetic resonance imaging abnormal
Clinical narrative: One week after administering vaccine patient calls complaining for severe muscle pain. Since then patient has seeked 3 medical opinions, an MRI and Tramadol 50mg for pain.
Age: 39.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Body temperature increased, Erythema, Injection site rash, Tenderness, Urticaria
Clinical narrative: Received PNEUMOVAX 3. 4. 14. 3. 6-14 developed rash on left upper arm, arm red/tender. Temp up to 101.8 on exam had several well-demarcated raised red welts, 2-3 cm in diameter. Injection site was not red/swollen. Treated with heat/cold compress, ibuprofen, BENADRYL, ZYRTEC.
Age: 26.0
Sex: M
Vaccine: TDAP
Symptoms: Borrelia test, C-reactive protein, Diarrhoea, Headache, Influenza A virus test
Clinical narrative: Severe aches pain\muscle weakness N\V\D. Neck pain\head pain\HA.
Age: 26.0
Sex: M
Vaccine: TDAP
Symptoms: Influenza B virus test, Muscular weakness, Nausea, Neck pain, Nuclear magnetic resonance imaging
Clinical narrative: Severe aches pain\muscle weakness N\V\D. Neck pain\head pain\HA.
Age: 26.0
Sex: M
Vaccine: TDAP
Symptoms: Pain, Red blood cell sedimentation rate, Rheumatoid factor, Streptococcus test, Vomiting
Clinical narrative: Severe aches pain\muscle weakness N\V\D. Neck pain\head pain\HA.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus
Clinical narrative: Redness surrounding injection site started day after injection given and increased to approximately 4-6 cm. Site hard to palpation and itchy. Pt seen in clinic on 03-17-14. At that time area of redness was approximately 2-3 cm, shallowly indurated surrounding injection site. Treatment with CLARITIN 5 mg daily and Ibuprofen prn.
Age: 19.0
Sex: M
Vaccine: HPV4
Symptoms: Pruritus, Rash
Clinical narrative: Pt came for last HPV vaccine but stated that he had 2 reactions after the vaccines. Bilateral arm and hand rash/itching for 3-4 days where he went to ER for eval and it resolved on own.
Age: 40.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Induration, Pain, Pyrexia
Clinical narrative: Redness, swelling, high fever, induration, pain -> cellulitis, seen in emergency room.
Age: 40.0
Sex: F
Vaccine: PPV
Symptoms: Swelling
Clinical narrative: Redness, swelling, high fever, induration, pain -> cellulitis, seen in emergency room.
Age: 26.0
Sex: F
Vaccine: IPV
Symptoms: Erythema, Injection site rash
Clinical narrative: Vaccine received on the 18th (SC, left arm). On the 19th, I noticed redness on both hands and 3 spots on left arm (10, 5 and 15 mm). No spot on injection site. On the 20th -> spot on injection site (48 mm diameter).
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Abnormal behaviour, Anxiety, Body temperature increased, Fear, Injection site reaction
Clinical narrative: 102 degree temperature for 12 hours peaking at 104 degrees at middle of time period. Muscle ache at site and other arm. Behavior change - of fear and anxiety occurred at 36-48 hours after shot admin.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Myalgia
Clinical narrative: 102 degree temperature for 12 hours peaking at 104 degrees at middle of time period. Muscle ache at site and other arm. Behavior change - of fear and anxiety occurred at 36-48 hours after shot admin.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Skin ulcer, Urticaria
Clinical narrative: 7-10 days after shot, face broke out in small "sores" which went away but sprouted elsewhere on face for about 2 months; then got itchy welts on abdomen, carbe: 1-2" wide, 6" to 9" long on 3 occasions but still getting itchy welts on abdomen now.
Age: 4.0
Sex: U
Vaccine: DTAP, IPV, MMR, PNC13
Symptoms: Wrong drug administered
Clinical narrative: In ordering vaccines, I selected PNEUMOVAX from the list instead of VARIVAX. The nurse administered PREVNAR (Pneumococcal 13) and then called it to my attention when she could not enter it into the electronic record.
Age: 18.0
Sex: F
Vaccine: MNQ, PPV
Symptoms: Chills, Decreased appetite, Dizziness, Fatigue, Headache
Clinical narrative: High fever (102.6 F oral), chills, nausea/vomiting, headache, anorexia, fatigue, (L) deltoid induration at vaccination site. Seen in urgent care clinic 3/14/14 and 3/15/15. Follow up with MDs on 3/17 and 3/19. Pt reported nausea started 3/13. Dizziness 3/12 at night. Tx: Pt received IV fluids, ZOFRAN, ice/heat to injection site.
Age: 18.0
Sex: F
Vaccine: MNQ, PPV
Symptoms: Ketonuria, Leukocytosis, Nausea, Pyrexia, Red blood cells urine negative
Clinical narrative: High fever (102.6 F oral), chills, nausea/vomiting, headache, anorexia, fatigue, (L) deltoid induration at vaccination site. Seen in urgent care clinic 3/14/14 and 3/15/15. Follow up with MDs on 3/17 and 3/19. Pt reported nausea started 3/13. Dizziness 3/12 at night. Tx: Pt received IV fluids, ZOFRAN, ice/heat to injection site.
Age: 18.0
Sex: F
Vaccine: MNQ, PPV
Symptoms: Urine ketone body present, Vaccination site induration, Vomiting, White blood cell count increased
Clinical narrative: High fever (102.6 F oral), chills, nausea/vomiting, headache, anorexia, fatigue, (L) deltoid induration at vaccination site. Seen in urgent care clinic 3/14/14 and 3/15/15. Follow up with MDs on 3/17 and 3/19. Pt reported nausea started 3/13. Dizziness 3/12 at night. Tx: Pt received IV fluids, ZOFRAN, ice/heat to injection site.
Age: 61.0
Sex: F
Vaccine: PPV
Symptoms: Pain, Rash, Swelling
Clinical narrative: Swelling, localized rash, achiness morning after vaccine administered.
Age: 1.02
Sex: M
Vaccine: HEPA, MMRV, PNC13
Symptoms: Pyrexia, Rash generalised
Clinical narrative: Fever on 3-18-14. Presented in the doctor's office w/a full body rash on 3-20-14.
Sex: U
Vaccine: PPV
Symptoms: Wrong drug administered
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age and gender with leukemia. On an unknown date, the patient was vaccinated with the second dose of PNEUMOVAX 23 (route, lot #, expiration date were not provided). On an unknown date, the physician wanted to give PREVNAR 13, a second dose of second dose of PNEUMOVAX 23 was given. The physician inquired how long to wait until get the PREVNAR 13. At the time of the report, the patient's status was unknown. Additional information has been requested.
Age: 1.5
Sex: F
Vaccine: HIBV
Symptoms: Crying, Fall
Clinical narrative: Pt was standing in hallway after getting her HIB vaccine; While sister got a drink of water. Pt fell forward on to face/trunk. No LOC pt didn't appear to trip. she was crying after the fall but was very upset with getting the HIB vaccine. Exam was normal, pt was alert and fine afterwards.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Convulsion, Electroencephalogram abnormal, Infantile spasms
Clinical narrative: Patient received 2 month vaccines ROTATEQ, ENGERIX B 10 mcg/0.5 mL, PENTACEL, and PREVNAR 13 on 10/2/13. Pt had no adverse effects in office after vaccines. Per mom, pt developed seizures and infantile spasms 11 days after vaccines were given. Pt was admitted to hospital 12/17/13 with seizures.
Age: 4.0
Sex: F
Vaccine: DTAPHEPBIP, MMRV, VARCEL
Symptoms: No adverse event
Clinical narrative: NONE.
Age: 1.29
Sex: M
Vaccine: DTAP
Symptoms: Injection site discolouration, Injection site swelling
Clinical narrative: Health Department, not sure which nurse or provider, gave pt a Dtap on left arm. Pt was then seen 2 days later and the area was swollen and black and blue the size of a baseball.
Age: 31.0
Sex: M
Vaccine: MNQ
Symptoms: Chills, Headache, Pyrexia, Viral infection
Clinical narrative: Fever 100.8 Chills Head Ache. Tylenol 325mg 2T PO q4-6hrs for fever. Rest.
Age: 0.18
Sex: F
Vaccine: RV1
Symptoms: Haematochezia
Clinical narrative: Blood in stool after rotavirus vaccine for 5 days, healthy thriving infant.
Age: 2.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site pruritus, Pruritus, Rash generalised
Clinical narrative: dTAP Vaccination - Right away - Small Bumps all over left side of chest and arm. Bumps have expanded and now are all over her body, legs included, not on the hands or feet yet. Every day she has more and more bumps. Her arm where the shot was administered is itchy, and so is under her armpit and her left side - and that is where there is clusters of these bumps. We took her to the doctor on 03/18/2014 doctor prescribed a childrens type benedryl and a cortisone - steroid cram for the itchy areas. We started with this treatment yesterday. Nothing is changing. DR said the bumps will go away in 7-10 days - but this is a severe reaction - and not on your list of normal reactions. We are going on 2 weeks and it seems to be getting worse.
Age: 38.0
Sex: F
Vaccine: RAB, TDAP
Symptoms: Injection site pain, Joint range of motion decreased, Mobility decreased, Nuclear magnetic resonance imaging, X-ray
Clinical narrative: Severe Pain in Left Shoulder radiating down through the upper arm region. Sharp and throbbing with decreased range of motion and mobility. Increasing pain daily.
Age: 7.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Local swelling, Oedema, Pruritus
Clinical narrative: Pt began with itchy skin, then skin became erythematous and edematous. Pt received loratadine for other allergies. Pt presented to clinic on 3/20 for well child check and arm still swollen and erythematous but much improved.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Biopsy skin abnormal, Hypoaesthesia, Laboratory test normal, Nerve conduction studies abnormal, Nuclear magnetic resonance imaging normal
Clinical narrative: Received the flu shot for the first time ever on 11/1/2001.  Night of 11/2/2001, woke up from sleeping feeling ascending numbness and tingling in my feet and legs.  Felt my arms randomly falling "completely" asleep".  went to the emergency room at around 2 am after symptoms did not resolve, for evaluation.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Paraesthesia, Small fibre neuropathy
Clinical narrative: Received the flu shot for the first time ever on 11/1/2001.  Night of 11/2/2001, woke up from sleeping feeling ascending numbness and tingling in my feet and legs.  Felt my arms randomly falling "completely" asleep".  went to the emergency room at around 2 am after symptoms did not resolve, for evaluation.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Guillain-Barre syndrome, Immunoglobulin therapy
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to an 18 years old female patient. On an unspecified date in February in 2014 the patient was vaccinated with the second dose of GARDASIL (lot# unspecified) (strength, dose, route and location unspecified). The patient developed Guillain-Barre syndrome "shortly after receiving the GARDASIL" on an unspecified date as reported (estimated on the same date of the vaccination). The patient was hospitalized on an unspecified date in 2014, the physician stated that the Guillain-Barre syndrome was life threatening and caused a significant disability in the patient. The patient was eventually transferred to an unspecified rehabilitation center on an unspecified date and it was unknown if the patient was still at the rehabilitation center. Patient was administered immunoglobulin on an unspecified date in 2014 as treatment for the Guillain-Barre syndrome. At the time of the report, the patient was not recovered from the event. Upon internal review, Guillain-Barre syndrome was considered as medically significant. The reporting physician considered the Guillain-Barre syndrome to be disability and life threatening. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Lupus-like syndrome, Wheelchair user
Clinical narrative: This spontaneous report as received from a physician via a field employee refers to a female teenager of unknown age. In June 2013 (9 months ago) the patient was vaccinated with a dose of GARDASIL (lot #, expiration date and dose unspecified). The representative did not know which dose in the GARDASIL series the patient received "9 months ago". In June 2013 (9 months ago) the patient developed lupus-like symptoms and the patient was "basically wheel-chair bound". The field employee did not know any other details of the patient's condition beyond the fact that the patient had not received a confirmed diagnosis. The patient had sought medical attention. The event outcome was reported as not recovered/not resolved. The reporter considered the event to be disability. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Anaphylactic reaction
Clinical narrative: Pt came into office. Patient got flu/pneumonia vaccines. 15 min after administration she went into an anaphylactic reaction. The nurse was called in where she was given epi/ and BENDARYL. O2 was applied. Ambulance was called and patient was taken to the hospital.