chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown demography. The patient's concurrent conditions and relevant medical history was not reported. On 03-APR-2015, the patient was vaccinated with expired dose of ZOSTAVAX (lot number: K003601 with expiration date of 19-MAR-2015) (dose, frequency and route unspecified). Concomitant medications were not reported. No adverse effects were reported. The outcome of the events was unknown. The causality of the events with ZOSTAVAX was not reported. Product quality issue was not involved. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood test, Injection site erythema, Injection site pain, Injection site pruritus, Injection site rash
Clinical narrative: This spontaneous report was received from a 68 year old female patient, regarding herself. Pertinent medical history was reported as atrial fibrillation, cardiac ablation, blood pressure and blood cholesterol. On 04-APR-2015 the patient received a one time injection of ZOSTAVAX in the left arm for the prevention of shingles. Concomitant therapies included hydrochlorothiazide, DIOVAN HCT, VYTORIN, metoprolol succinate, vitamin d (unspecified), XARELTO and NEXIUM. On 06-APR-2015, patient started to experience itching, soreness, pain and a red rash at site of injection. On an unknown date, blood work was performed, results of which were unspecified. As of yet, the patient did not sought medical attention. Outcome of the events were unknown. Causality assessment was not provided. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Amnesia, Attention deficit/hyperactivity disorder, Disturbance in attention, Enuresis, Obsessive-compulsive disorder
Clinical narrative: I brought my son to a psychiatrist doctor for medication for his: repetive movements, loss of memory/can't remember, hyperactivity, loss of concentration, social withdrawal, bed wetting, compulsive disorder, ODD, ADHD that only started 5 years ago. He was fine before vaccinations.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Oppositional defiant disorder, Psychomotor hyperactivity, Social avoidant behaviour, Stereotypy
Clinical narrative: I brought my son to a psychiatrist doctor for medication for his: repetive movements, loss of memory/can't remember, hyperactivity, loss of concentration, social withdrawal, bed wetting, compulsive disorder, ODD, ADHD that only started 5 years ago. He was fine before vaccinations.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. On an unknown dates the patients were vaccinated with a dose of ROTATEQ (lot#, strength, dose, route and frequency were not reported). The doses of ROTATEQ were exposed to temperature below the recommended storage temperature. No adverse experience had been observed or reported. The outcome of event was not reported. This is one of two reports from the same reporter. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Alopecia, Blood test
Clinical narrative: This spontaneous report as received from a consumer regarding a 11 year old female patient. The patient's concurrent conditions and relevant medical history was not reported. The patient had no drug allergies/reactions or pertinent medical history. On 17-JUL-2014, the patient was vaccinated with first dose of GARDASIL (lot number, dose and frequency unspecified) in the arm. Concomitant therapies included Tdap. Approximately on an unknown date in September 2014 (reported as two months after vaccination with GARDASIL), the patient experienced alopecia. The patient was treated with unspecified topical corticosteroids. The patient sought medical attention. The patient undergone unspecified blood work of which results were not provided. The outcome of alopecia was reported as not recovered/not resolved. The causality of the events with GARDASIL vaccine was not reported. Product quality issue was not involved. Additional information has been requested.
Age: 56.0
Sex: F
Vaccine: TDAP
Symptoms: Bronchitis, Impaired work ability, Pyrexia
Clinical narrative: Had Tdap vaccine in MD offic at 10:30 am on a Wednesday. The next day had 7 days of fever requiring MOTRIN around the clock. This went into bronchitis requiring an antibiotic and cough syrup. Missed 2 weeks work.
Age: 72.0
Sex: F
Vaccine: TDAP
Symptoms: Constipation, Cough, Diarrhoea, Fatigue, Headache
Clinical narrative: Severe cough w/wheezing. Severe headache-extreme tiredness constipation-numbness in left hand and arm diarrhea.
Age: 72.0
Sex: F
Vaccine: TDAP
Symptoms: Hypoaesthesia, Wheezing
Clinical narrative: Severe cough w/wheezing. Severe headache-extreme tiredness constipation-numbness in left hand and arm diarrhea.
Age: 81.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Erythema, warmth, swelling around injection site (L) upper arm.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Body temperature increased, Injection site rash, Rash, Rash erythematous, Rash maculo-papular
Clinical narrative: Rash and 99. Strep rash face, trunk, ext, maculopapular pink, seen on 2/16 and 2/19/15. Rash cleared on face and became more prominant on ext. by 2/18/15, then resolved.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker (office manager) and from medical assistant refers to unspecified patients of unknown ages and genders who on unknown dates were vaccinated with improperly stored doses of ROTATEQ (dose, lot # and expiration date were not reported) by oral route. No symptoms were reported. It was unknown if the patients sought medical attention. This is one of several reports from the same source. Additional information is not expected because there is not permission for the physician to be contact.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. On an unknown dates the patient were vaccinated with a dose of GARDASIL (lot#, strength, dose, route and frequency were not reported). The doses of GARDASIL were exposed to temperatures below the recommended storage temperature. No adverse experience had been observed or reported. The outcome of event was not reported. This is one of two reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Administration site erythema
Clinical narrative: This spontaneous report as received from a pharmacist via Company Representative refers to a patient of unknown age and gender. There were no concomitant medications, concurrent condition and medical history reported. On approx 09-DEC-2014 (also reported as date unspecified four months ago), the patient was vaccinated with ZOSTAVAX subcutaneous (strength, dose, frequency, lot number, expiration and date were not reported). On an unknown date the patient experienced redness at the site of administration. Patient sought medical attention from pharmacist by coming to the pharmacy. The patient recovered from the redness at the site of administration on an unspecified date. The relatedness between the event and ZOSTAVAX was not reported. Additional information has been requested.
Age: 16.0
Sex: M
Vaccine: HEPA, HPV4
Symptoms: Adverse event, Hallucination, visual, Incomplete course of vaccination
Clinical narrative: Information has been received from a Nurse Practitioner via field employee referring to a 16 year old male patient. Information regarding medical history and concurrent condition was not reported. On 26-SEP-2014 the patient was vaccinated with the first dose of GARDASIL (lot # K006191, expiration date, dose and route unknown) and the second dose of VAQTA (lot number K004856, expiration date 07-DEC-2016, dose and route unknown). There were no concomitant medications. In the evening of 26-SEP-2014, after leaving the office of the healthcare professional, the patient saw "a racoon carrying a rabbit like it was right in front of him". The patient also had "issues" since an unspecified date after the reported event. Nurse practitioner stated she did not plan on the administration of any additional doses of GARDASIL to this patient. The patient sought medical attention at the office of the nurse practitioner on 02-APR-2015 for an annual visit. The outcome and causality of the events were unknown. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: HEPAB, TDAP, VARCEL
Symptoms: Local reaction, Pruritus, Rash
Clinical narrative: Rash in the back and stomach. Localized reaction and pruritus.
Age: 6.0
Sex: F
Vaccine: MMR
Symptoms: Cough, Fatigue, Gastrointestinal disorder, Injection site rash, Irritability
Clinical narrative: Rash around shot site began to develop, child also reported feeling tired and irritable.  Rash got progressively worse over about 4 days.  It spread from the top of her shoulder down to her elbow and was densely broken out with rough small red bumps. It took a full three weeks to subside.  Child has has a number of Dr. visit's since the shot due to coughing, has had STAPH, and had a severe gastrointestinal illness for 5 days about one week after the rash went away.  She has also had an increase in defiant behavior and consistently reports being tired and irritable.
Age: 6.0
Sex: F
Vaccine: MMR
Symptoms: Oppositional defiant disorder, Rash erythematous, Staphylococcal infection
Clinical narrative: Rash around shot site began to develop, child also reported feeling tired and irritable.  Rash got progressively worse over about 4 days.  It spread from the top of her shoulder down to her elbow and was densely broken out with rough small red bumps. It took a full three weeks to subside.  Child has has a number of Dr. visit's since the shot due to coughing, has had STAPH, and had a severe gastrointestinal illness for 5 days about one week after the rash went away.  She has also had an increase in defiant behavior and consistently reports being tired and irritable.
Age: 11.0
Sex: M
Vaccine: HPV4
Symptoms: Erythema, Injection site erythema, Injection site pain, Radioallergosorbent test
Clinical narrative: Redness at injection site 35mm in size.  Red, flat areas on chest 10-14mm in size, pain at injection site, no itching.
Age: 29.0
Sex: F
Vaccine: HEP, HEPA, MMR, TDAP, VARCEL
Symptoms: Syncope
Clinical narrative: Came in to get vaccinations. Received 5 vaccines no problems noted in room when left to pay cashier after few minutes fainted in hallway-ck'ed client-monitored v/s. B/P 1115am 102/42; 1125am 108/60 P 68 assisted to waiting room.
Age: 28.0
Sex: F
Vaccine: HEPA, TDAP, TYP
Symptoms: Blood pressure decreased, Electrocardiogram, Fall, Head injury
Clinical narrative: Time of incident 10:38 am. Patient was seen in clinic for vaccines. Returned to office 15 minutes later. Pt states she felt her BP drop, fell and hit her head of the floor.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker (office manager) and from medical assistant refers to a patient of unknown age and gender who on 06-MAR-2015 was vaccinated with improperly stored dose of GARDASIL (dose, lot #, expiration date and route were not reported). No symptoms were reported (no adverse event). It was unknown if the patient sought medical attention. This is one of several reports from the same source. Additional information is not expected because there is not permission for the physician to be contact.
Sex: F
Vaccine: HPV4
Symptoms: Anxiety, Infection
Clinical narrative: This spontaneous report was received from a patient mother refers to her daughter as a female patient of unknown age. No pertinent medical history was reported. On an unknown date, the patient was vaccinated with GARDASIL (dose, route, lot # were not reported). On an unknown date, the patient experienced infection (type unspecified) that required an antibiotic. Also reported that the patient was 2 weeks behind from received the third dose of GARDASIL vaccine at the 6 month mark. On an unknown date, the patient experienced anxiety due to not being able to get the 3rd dose of GARDASIL vaccine right away. No Product Quality Complaint (PQC) was involved. Action taken was not applicable. The outcome of events was unknown. Causality was not assessed by the reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker (office manager) and from medical assistant refers to a patient of unknown age and gender who on 20-MAR-2015 was vaccinated with improperly stored dose of GARDASIL (dose, lot #, expiration date and route were not reported). No symptoms were reported (no adverse event). It was unknown if the patient sought medical attention. This is one of several reports from the same source. Additional information is not expected because there is not permission for the physician to be contact.
Age: 4.0
Sex: U
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a non licensed healthcare worker refers to a 4 years and 11 months (59 months) old patient of unknown gender. The patient's pertinent medical history was not reported. On 17-APR-2015, the four years and eleven months old patient was inadvertently administered with GARDASIL (lot #, expiration date, dose and route of administration were not provided). No adverse effects were reported. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain upper, Constipation, Dizziness, Headache, Hypertension
Clinical narrative: Dizziness, high blood pressure, stomach ache, headache, noise in my ears, pain all over. I lost 6 1/2 lbs. Almost fell down many times. Constipation, nausea on 11/2/14 I almost passed out. Could not move my bowels for many days. I was never so sick in my life. MIRALAX and other laxatives were given by my 2nd doctor.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Malaise, Nausea, Pain, Tinnitus, Weight decreased
Clinical narrative: Dizziness, high blood pressure, stomach ache, headache, noise in my ears, pain all over. I lost 6 1/2 lbs. Almost fell down many times. Constipation, nausea on 11/2/14 I almost passed out. Could not move my bowels for many days. I was never so sick in my life. MIRALAX and other laxatives were given by my 2nd doctor.
Sex: M
Vaccine: DTAP, HEP, HIBV
Symptoms: Diarrhoea, Pyrexia, Vomiting
Clinical narrative: This spontaneous report was received from the patient's mother refers to her son of unknown age. Patient's concurrent conditions and medical history were not reported. On 14-MAY-2008 the patient was vaccinated with hepatitis b vaccine (manufacturer unknown) (dose, route of administration and lot # were not reported). Concomitant therapies included DTAP, IPV (unspecified) and hib conj vaccine (unspecified carrier). On an unknown date the patient experienced vomiting, diarrhoea and fever of 103F. After this, the patient spoke with his physician. The outcome of the events was unknown. Additional information has been requested.
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Tdap given 4/21/15-area is red, swollen and warm to touch.
Age: 74.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Urticaria
Clinical narrative: Patient developed soreness and redness at the site of the injection on 4/20/15. The area did improve the next day, but then patient developed hives on 4/22/15 and patient denied any additional symptoms. He was advised to take BENADRYL, advised to monitor for side effects from the BENADRYL, and to continue to monitor for additional allergic reaction side effects. He will continue to monitor his symptoms and follow up with our office as needed. Provider was notified and agreed to the plan of action as well.
Age: 65.0
Sex: M
Vaccine: PNC13
Symptoms: Cellulitis, Confusional state, Dizziness, Injection site induration, Injection site mass
Clinical narrative: Pt had swelling, size of grapefruit at injection site, pain dizziness and confusion. Hard lump at site. Pt went to ER MD sent pt him with no treatment just instructions to ice area. Pt went to primary MD-who prescribed BACTRIM DS 4/13/15 for cellulitis.
Age: 65.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site swelling, Pain
Clinical narrative: Pt had swelling, size of grapefruit at injection site, pain dizziness and confusion. Hard lump at site. Pt went to ER MD sent pt him with no treatment just instructions to ice area. Pt went to primary MD-who prescribed BACTRIM DS 4/13/15 for cellulitis.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker (office manager) and from medical assistant refers to a patient of unknown age and gender who on 02-APR-2015 was vaccinated with improperly stored GARDASIL (dose, lot #, expiration date and route were not reported). No symptoms were reported (no adverse event). It was unknown if the patient sought medical attention. This is one of several reports from the same source. Additional information is not expected because there is not permission for the physician to be contact.
Age: 1.97
Sex: F
Vaccine: DTP, HEPA, HIBV, PNC13
Symptoms: Hypermetropia, Strabismus
Clinical narrative: Esotropia, hyperopia after DTP, PREVNAR 13, Hib, and Hep A (Referred to ophthalmology MD on 4-20-15).
Age: 46.0
Sex: F
Vaccine: HEP
Symptoms: Arthralgia, Decreased appetite, Fatigue, Peripheral swelling, Swelling face
Clinical narrative: 4/10/15 1030 patient received Hep B #2, she stated that night she was having joint pain to both hands, moderate swollen fingers and face, fatigue and no appetite, sign and symptoms peak on Saturday. Stated by Sunday sign and symptoms went away. She denied chest pain, shortness of breath nor fever.
Age: 38.0
Sex: F
Vaccine: PPV
Symptoms: Dizziness, Erythema, Fatigue, Feeling hot, Injection site erythema
Clinical narrative: Pain in affected arm. Injection site pain, redness, burning, itching, feeling hot at 4:00 PM. Swelling of the arm 5:00 PM. On 04/24/2015 low grade fever redness, swelling and pain spread up and down arm (6" x 3") defined area, nausea, dizziness, fatigue, malaise which continued to worsen. Visited Urgent Care on 04/26/2015 and was treated for possible allergic reaction/cellulitis. Medications prescribed were Zyrtec 10mg Tablets daily and Cipro 500mg Tablets twice daily for 7 days. Swelling improved but not resolved 04/28/2015. Itchiness, redness, pain, burning, nausea, fatigue, dizziness and malaise still on-going.
Age: 38.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site pruritus, Malaise, Nausea, Pain in extremity
Clinical narrative: Pain in affected arm. Injection site pain, redness, burning, itching, feeling hot at 4:00 PM. Swelling of the arm 5:00 PM. On 04/24/2015 low grade fever redness, swelling and pain spread up and down arm (6" x 3") defined area, nausea, dizziness, fatigue, malaise which continued to worsen. Visited Urgent Care on 04/26/2015 and was treated for possible allergic reaction/cellulitis. Medications prescribed were Zyrtec 10mg Tablets daily and Cipro 500mg Tablets twice daily for 7 days. Swelling improved but not resolved 04/28/2015. Itchiness, redness, pain, burning, nausea, fatigue, dizziness and malaise still on-going.
Age: 38.0
Sex: F
Vaccine: PPV
Symptoms: Peripheral swelling, Pyrexia
Clinical narrative: Pain in affected arm. Injection site pain, redness, burning, itching, feeling hot at 4:00 PM. Swelling of the arm 5:00 PM. On 04/24/2015 low grade fever redness, swelling and pain spread up and down arm (6" x 3") defined area, nausea, dizziness, fatigue, malaise which continued to worsen. Visited Urgent Care on 04/26/2015 and was treated for possible allergic reaction/cellulitis. Medications prescribed were Zyrtec 10mg Tablets daily and Cipro 500mg Tablets twice daily for 7 days. Swelling improved but not resolved 04/28/2015. Itchiness, redness, pain, burning, nausea, fatigue, dizziness and malaise still on-going.
Age: 79.0
Sex: M
Vaccine: PNC13
Symptoms: Arthralgia, Asthenia, Blood test, Cough, Joint swelling
Clinical narrative: Per pt. developed the following after vaccination: dry cough, pain in lungs, joints in knee/hip painful, some feet/ankle swelling, feet uncomfortable, "weak" feeling, dr ran xray, blood work, hasn't received results.
Age: 79.0
Sex: M
Vaccine: PNC13
Symptoms: Limb discomfort, Peripheral swelling, Pulmonary pain, X-ray
Clinical narrative: Per pt. developed the following after vaccination: dry cough, pain in lungs, joints in knee/hip painful, some feet/ankle swelling, feet uncomfortable, "weak" feeling, dr ran xray, blood work, hasn't received results.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Insomnia, Muscular weakness, Pain in extremity
Clinical narrative: Pain in right arm - unable to lift above shoulder level. Weakness when holding an object heavier than a glass. Causes sleepless nights because of the pain.
Age: 94.0
Sex: F
Vaccine: PNC13
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site pain
Clinical narrative: Had pain at left upper arm site of injection immediately, and noticed redness one week later (had not inspected it prior).
Age: 53.0
Sex: M
Vaccine: MMR
Symptoms: Dry eye, Dry mouth, Fatigue
Clinical narrative: Chronic, severe, dry eyes, dry mouth, and fatigue.
Age: 1.28
Sex: M
Vaccine: DTAPIPVHIB, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Otitis media, Pyrexia
Clinical narrative: 2 hrs after immunizations, mom noticed redness in (L) deltoid after removing band aids, 6x3cm oval swollen, red, warmth. Possible fever 6 hrs later. Temp not taken, fever 101. 36hrs later but diagnosed with OM at subsequent visit 4/22/15.
Age: 40.0
Sex: F
Vaccine: HEP, HEPA, TYP
Symptoms: Abdominal pain, Diarrhoea, Nausea, Vomiting
Clinical narrative: Patient started having "diffuse abdominal cramping, nausea, vomiting and diarrhea that began approximately 2 am last night" according to ER note from 2/13/15 at 9:46 am. She was given normal saline 1L IV bolus along with ZOFRAN 4 mg IV and BENTYL 20 mg IM.
Age: 72.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: Patient has red area, swollen and itchy.
Age: 79.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Infection
Clinical narrative: Redness, gradually getting bigger over the weekend and now involving half of arm. Dr thinks it is an infection but isn't sure so is treating with antibiotic and steroid.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Rash erythematous, Urticaria
Clinical narrative: PT SAID HE HAS A BIG WELT RASH (RED) THE NEXT DAY. HE CALLED US ON SUNDAY TO REPORT AND COME IN ON MONDAY EVENING FOR ME TO LOOK AT.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant refers to a 23 year old female patient. The patient's medical history and concurrent conditions were not reported. When the patient was 16 years old (unknown date due to date of birth was not reported), the patient received her first two doses of GARDASIL (dose, route of administration and lot # were not reported). On 27-APR-2015, the patient was vaccinated in the physician's office with GARDASIL dose 3 (dose, route of administration and lot # were not reported). No adverse effects reported. Additional information has been requested.
Age: 2.0
Sex: M
Vaccine: DTAP, VARCEL
Symptoms: Pyrexia, Vomiting
Clinical narrative: Fever x 2 days. Vomiting x 1.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 15-APR-2015, the patient was vaccinated with a dose of MMR II, expiration date: 12-APR-2015, subcutaneous (lot number was not provided). No concomitant therapies were reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist via a company representative refers to a female patient of unknown age with no medical history, drug reactions or allergies reported. On 06-APR-2015, the patient was vaccinated with ZOSTAVAX (route, dose and lot number were not reported) for shingles prevention. Concomitant medication was not reported. On approximately 07-APR-2015, the patient experienced itching, redness and swelling at injection site, so the patient contacted the pharmacy to seek medical attention and was prescribed BENADRYL. At the time of this report, the outcome of itching, redness and swelling at injection site was unknown. Additional information has been requested.
Sex: F
Vaccine: FLUN4, HPV4
Symptoms: Loss of consciousness, Seizure, Tremor
Clinical narrative: A spontaneous report has been received from a Physician concerning a female patient. Patient relevant history was not provided. Patient had been receiving FLUMIST QUADRIVALENT (intranasal), started on an unknown date. It was reported by reporter that patient received her "second or third" dose of GARDASIL on an unspecified date, concomitantly with FLUMIST, experienced a seizure, with full-body shaking and loss of consciousness after she received the dose of GARDASIL. The patient was 11 or 12 years old, at the time of the event. The reporter states that no intervention was provided; the patient recovered spontaneously. When the patient regained consciousness, she did not have any memory of the event. Action taken with FLUMIST QUADRIVALENT was not applicable. The patient recovered in the office on the same day that the seizure occurred. The reporter assessed the event of seizure to be serious with the seriousness criteria of important medical event.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles on right forehead/face.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Culture, Diarrhoea, Herpes zoster, Nausea, Rash
Clinical narrative: Shingles on right forehead/face.
Age: 0.34
Sex: F
Vaccine: PNC13
Symptoms: Immediate post-injection reaction, Injection site pain, Injection site swelling
Clinical narrative: Patient received 2nd PCV #13 on 4/20/15 patient immediately developed a (L) medial thigh puffiness which was about 4 cm diameter total 2 cm each side of shot site, pain. On 4/21/15, pt's swelling was down only 1 cm each side of shot site. Playful, active.
Sex: F
Vaccine: VARCEL
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 26.0
Sex: M
Vaccine: FLU4, HEPA, HPV4, TD
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Patient was given Gardasil vaccine after the recommended age for first dosing.
Age: 43.0
Sex: M
Vaccine: FLU3
Symptoms: Fatigue, Gastroenteritis viral, Pain in extremity, Pyrexia
Clinical narrative: This case was reported by a consumer via market research programs and described the occurrence of fever in a 43-year-old male patient who received FLUARIX. Co-suspect products included salbutamol sulphate unknown for chronic obstructive pulmonary disease. Concurrent medical conditions included asthma. On 3rd October 2014, the patient received Influenza vaccine unspecified 201-2015 season. On an unknown date, the patient started salbutamol sulphate at an unknown dose and frequency. In October 2014, less than a week after receiving Influenza vaccine unspecified 2014-2015 season and not applicable after starting salbutamol sulphate, the patient experienced fever, pain in arm, stomach virus and tiredness. Influenza vaccine unspecified 2014-2015 season was discontinued. Salbutamol sulphate was continued with no change. On an unknown date, the outcome of the fever, pain in arm, stomach virus and tiredness were recovered/resolved. It was unknown if the reporter considered the fever, pain in arm, stomach virus and tiredness to be related to Influenza vaccine unspecified 2014-2015 season. The reported considered the fever, pain in arm, stomach virus and tiredness to be unrelated to salbutamol sulphate. Additional details provided as follows: The market research program number is ADVAIR00165. The flu vaccine took only 15 minutes and was painless. The patient felt a little feverish for a days or so after. His arm was alittle bit sore. The patient described a terrible stomach bug. The patient decided that will not take the flu shot next year.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: Redness at injection site.
Age: 63.0
Sex: F
Vaccine: HEPAB, MM
Symptoms: Burning sensation, Discomfort, Dizziness, Feeling abnormal, Headache
Clinical narrative: WITHIN 5 MINUTES OF RECEIVING MMR AND TWINRIX VACCINATIONS, PT STATED FEELING "WEIRD." PT WAS TOLD TO HAVE A SEAT IN THE IMMUNIZATIONS WAITING ROOM FOR 15 TO 20 MINUTES. DURING THIS TIME, CLINIC STAFF REPEATEDLY CHECKED ON THE PT. PT COMPLAINED OF A HEADACHE, DIZZINESS, AND STATED " IT BURNS SLIGHTLY TO BREATHE, MY BODY FEELS HEAVY, AND MY HANDS ARE TINGLING." PT REMAINED CALM THROUGH OUT THE DURATION OF LISTED SYMPTOMS. CLINIC STAFF DID NOT OBSERVE ANY SIGNS OF LABORED BREATHING OR ALTERED MENTAL STATUS.  SPOKE WITH THE PATIENT AND ASKED THE PAITENT TO WAIT AND EXTRA 10-15 MINUTES IN THE WAITING AREA.  PT WAS OFFERED TO SEE PROVIDER.  APPROXIMATELY 20-25 MINUTES AFTER RECEIVING THE VACCINATIONS, THE PT INFORMED THE STAFF THAT SHE WAS FEELING "MUCH BETTER", AND THAT SHE WAS READY TO DRIVE HOME.
Age: 63.0
Sex: F
Vaccine: HEPAB, MM
Symptoms: Paraesthesia
Clinical narrative: WITHIN 5 MINUTES OF RECEIVING MMR AND TWINRIX VACCINATIONS, PT STATED FEELING "WEIRD." PT WAS TOLD TO HAVE A SEAT IN THE IMMUNIZATIONS WAITING ROOM FOR 15 TO 20 MINUTES. DURING THIS TIME, CLINIC STAFF REPEATEDLY CHECKED ON THE PT. PT COMPLAINED OF A HEADACHE, DIZZINESS, AND STATED " IT BURNS SLIGHTLY TO BREATHE, MY BODY FEELS HEAVY, AND MY HANDS ARE TINGLING." PT REMAINED CALM THROUGH OUT THE DURATION OF LISTED SYMPTOMS. CLINIC STAFF DID NOT OBSERVE ANY SIGNS OF LABORED BREATHING OR ALTERED MENTAL STATUS.  SPOKE WITH THE PATIENT AND ASKED THE PAITENT TO WAIT AND EXTRA 10-15 MINUTES IN THE WAITING AREA.  PT WAS OFFERED TO SEE PROVIDER.  APPROXIMATELY 20-25 MINUTES AFTER RECEIVING THE VACCINATIONS, THE PT INFORMED THE STAFF THAT SHE WAS FEELING "MUCH BETTER", AND THAT SHE WAS READY TO DRIVE HOME.
Age: 24.0
Sex: F
Vaccine: VARCEL
Symptoms: Feeling hot, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Per ER Notes: Patient is a 24 y.o. female who presents concerned about possible reaction to chickenpox shot left arm. Since the shot she is experiencing redness swelling and pain and warmth in the area. It's involving the left tricep area. The pain is moderate in severity worse with range of motion. Denies alleviating factors. She feels as though she may have had a low-grade temperature. Also with complaints of some aches and pains.
Age: 24.0
Sex: F
Vaccine: VARCEL
Symptoms: Pain
Clinical narrative: Per ER Notes: Patient is a 24 y.o. female who presents concerned about possible reaction to chickenpox shot left arm. Since the shot she is experiencing redness swelling and pain and warmth in the area. It's involving the left tricep area. The pain is moderate in severity worse with range of motion. Denies alleviating factors. She feels as though she may have had a low-grade temperature. Also with complaints of some aches and pains.
Age: 2.0
Sex: M
Vaccine: HEPA
Symptoms: Injection site erythema, Injection site rash, Swelling face
Clinical narrative: REPORTED REDNESS AND RASH AT INJECTION SITE.  REPORTED FACIAL SWELLING. PT BACK TO OFFICE AT 2:00 PM--NO VISIBLE SYMPTOMS WHEN BACK IN OFFICE.
Age: 54.0
Sex: F
Vaccine: MMR
Symptoms: Arthralgia, Injection site erythema, Injection site induration, Injection site mass, Injection site swelling
Clinical narrative: About a week after vaccination, injection site in left arm had hard lump with an area 5" in diameter that is red, swollen and hot.  Joint pain and malaise also present.  Treated with antibiotic and ice.
Age: 54.0
Sex: F
Vaccine: MMR
Symptoms: Injection site warmth, Malaise
Clinical narrative: About a week after vaccination, injection site in left arm had hard lump with an area 5" in diameter that is red, swollen and hot.  Joint pain and malaise also present.  Treated with antibiotic and ice.
Age: 77.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site pruritus, Rash erythematous, Vaccination site reaction, Vaccination site warmth
Clinical narrative: Patient developed a red rash in the area where the vaccine was given.  She said it itchess and it is warm to touch.
Age: 4.0
Sex: F
Vaccine: FLUN3
Symptoms: Chest X-ray, Ear pain, Pain in extremity, Pneumonia
Clinical narrative: Ear pain, leg pain, pneumonia diagnosed.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site irritation, Injection site pruritus
Clinical narrative: Site itchy and irritated around vaccination site.  Has continued x 5 months.  Using hydrocortisone cream and warm soaks with improvement at site.  Patient purchased over the counter "animal" ointment/cream and has been using that with even more improvement.  Refuses to complete injury report and to see occupational health physician.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Fatigue, Headache, Injection site erythema
Clinical narrative: Fatigue 4/21/2015; chills, joint pain, burning nerve pain along waistline, headache, hot tender swelling at injection site 4/22 & 4/23/2015, with increasing swelling 4/23/2015 entire upper arm length; Dr. visit 4/24/2015 recommended cool compresses & Benadryl; applied compresses & self-administered L-Lysine 500 MG BOD & ibuprofen as needed for pain from 4/24-4/27/2015. As of 4/28/2015 only small red bump at injection site, but some nerve discomfort & muscle weakness in left arm & hand.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling, Injection site warmth, Muscular weakness, Neuralgia
Clinical narrative: Fatigue 4/21/2015; chills, joint pain, burning nerve pain along waistline, headache, hot tender swelling at injection site 4/22 & 4/23/2015, with increasing swelling 4/23/2015 entire upper arm length; Dr. visit 4/24/2015 recommended cool compresses & Benadryl; applied compresses & self-administered L-Lysine 500 MG BOD & ibuprofen as needed for pain from 4/24-4/27/2015. As of 4/28/2015 only small red bump at injection site, but some nerve discomfort & muscle weakness in left arm & hand.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling, Swelling face, Urticaria
Clinical narrative: Hives. Swelling in face and lower extremities.
Age: 67.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site urticaria, Urticaria
Clinical narrative: 2 hives at injection site, 1 in left groin and 1 on left leg appeared Monday 4/27/15.
Age: 73.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: Erythema at injection site measuring 9.5 inches by 5 inches one week after injection, pain, itchy, warm to touch.  The patient has been instructed to continue to watch and report any changes.
Age: 92.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site hypoaesthesia, Injection site reaction, Rash erythematous
Clinical narrative: Pt came in approximately 1 week after admin, reported oval-shaped red rash, appx 2" in width, 4" in height, with numbness, at injection site. No swelling, warmth, tenderness. Pt husband noticed last night, so exact onset unknown.
Age: 80.0
Sex: F
Vaccine: PNC13
Symptoms: Dyspnoea, Flushing, Pruritus, Wheezing
Clinical narrative: Pt received her Prevnar. About dinner time (6:00 PM) Pt started wheezing and felt very short of breath. Her face was flushed and she states "I didn't think I was gonnna make it". Pt reports itching but mild. Pt used her serevent and Proair inhalers and felt better without activity. This morning her symptoms have resolved. Pt denies redness, swelling or rash.
Age: 19.0
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 19 year old (gender not reported) whose concurrent or historical conditions were not reported. On 19-MAR-2015 and on 17-APR-2015 the patient received the second and third dose of GARDASIL (Lot # reported as K014891 for the second and the third dose) respectively. The patient had not reported or demonstrated any adverse effects. Additional information has been requested.
Age: 0.17
Sex: F
Vaccine: DTAPH
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling at injection site.
Age: 88.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Started day of immunization with Prevnar 13, pt had increasing redness, heat and itching around injection site. Returned to provider office 3 days after immunization with redness extending from top of shoulder down lateral aspect of left arm to approximately 3 inches above elbow.
Age: 74.0
Sex: M
Vaccine: PPV
Symptoms: Arthralgia, Body temperature increased, Cough, Fatigue
Clinical narrative: Fatigue, joint pain, unproductive cough, elevated temperature. Made appointment for follow up but symptoms got worse over next few days. Applied for Emergency Room admission on 04/13/2015 about 8:00 PM.
Age: 68.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Local swelling
Clinical narrative: L POST ARM REDNESS AND SWELLING LOCALLY.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Discomfort, Injection site erythema, Injection site swelling
Clinical narrative: Red Swollen at injection site. Not untypical. Patient uncomfortable.
Age: 22.0
Sex: M
Vaccine: JEV1
Symptoms: Fatigue, Myalgia, Nausea, Pyrexia
Clinical narrative: FEVER, INTENSE MUSCLE ACHES, FATIGUE, NAUSEA.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Injection site warmth
Clinical narrative: Skin rash and pruritis, warmth, redness at site of injection. Diphenhydramine.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant regarding a patient of an unknown age and gender. The patient's medical history or concurrent conditions were not provided. On 20-APR-2015, the patient was vaccinated with an expired dose of PNEUMOVAX 23 (0.5 mL, intramuscular, lot # J008799, expiration date 16-APR-2015). Concomitant medications were not provided. No adverse events were reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to multiple unspecified patients of unknown ages and genders who on an unknown dates were vaccinated with improperly stored dose of PNEUMOVAX 23 (dose, lot #, expiration date and route were not reported). No adverse effects were reported. It was unknown if the patients sought medical attention. This is one of several reports from the same source. Additional information is not expected because the physician cannot be contact.
Age: 79.0
Sex: F
Vaccine: PNC13
Symptoms: Asthenia, Chills, Dyspnoea exertional, Erythema, Feeling cold
Clinical narrative: Received PREVNAR 13 on 4/20/15. On 4/21/15 had chills, felt cold, face was very red. Wednesday, she slept all day. Friday (4/24/15) had red rash at injection site down arm, halfway to elbow. 4/27/`5 legs hurt, dyspnea with exertion, no energy.
Age: 79.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site reaction, Pain in extremity, Rash erythematous, Somnolence
Clinical narrative: Received PREVNAR 13 on 4/20/15. On 4/21/15 had chills, felt cold, face was very red. Wednesday, she slept all day. Friday (4/24/15) had red rash at injection site down arm, halfway to elbow. 4/27/`5 legs hurt, dyspnea with exertion, no energy.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered
Clinical narrative: This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. Concurrent conditions, medical history and allergies were not reported. On an unknown date, the patient was vaccinated with a dose of (Oka/Merck) VARIVAX, (strength, dose, frequency, route, anatomical location and lot number were not reported) which was expired on 27-MAR-2015. Other suspect and concomitant therapies were not reported. The reporter asked if the patient needed a second dose. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site pain, Paralysis
Clinical narrative: Left upper arm pain, paralysis.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Local reaction, Peripheral swelling, Skin warm
Clinical narrative: Localized reaction on arm. Swelling and heat.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Cold sweat, Nausea, Pallor, Visual impairment
Clinical narrative: A few minutes after receiving HPV #1, child described black dots in front of her eyes, felt extremely nauseous, was pale and clammy. She did not vomit, laid down for 10 min, then sat up and felt much better. Left office after 25 minutes.
Age: 14.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site reaction, Rash pruritic, Urticaria
Clinical narrative: Patient noticed raised, red welts over the left deltoid during the morning of 4/24/15. The area covered the entire deltoid about 4 cm below the shoulder. The patient also complained that the rash was higly pruritic. Temperature was 98.7 F.
Age: 54.0
Sex: F
Vaccine: HEP, PPV
Symptoms: Erythema, Oedema, Pain, Rash, Rash maculo-papular
Clinical narrative: Edema and pain reported at 04/21/15 at 0930 am. Decreased edema and maculopapular erythema reported at 04/22/15 1844 maculopapular erythema reported on (L) arm and (L) upper torso.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to multiple unspecified patients of unknown ages and genders who on an unknown dates were vaccinated with improperly stored dose of GARDASIL (dose, lot #, expiration date and route were not reported). No adverse effects were reported. It was unknown if the patients sought medical attention. This is one of several reports from the same source. Additional information is not expected because the physician cannot be contact.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to multiple unspecified patients of unknown ages and genders who on an unknown dates were vaccinated with improperly stored dose of VARIVAX (Merck) (dose, lot #, expiration date and route were not reported). No adverse effects were reported. It was unknown if the patients sought medical attention. This is one of several reports from the same source. Additional information is not expected because the physician cannot be contact.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a licensed vocational nurse, refers to a patient of unknown age and gender. Medical history and concurrent conditions were not reported. The reporter informed that on an unknown date in March 2014 the patient was vaccinated with the first dose of GARDASIL 0.5 ml, intramuscular, (lot # and expiration date were not reported) and on an unspecified date in March 2015 received the second dose of GARDASIL 0.5 ml, intramuscular, (lot # and expiration date were not reported). No adverse experience reported. Additional information has been requested.
Age: 6.0
Sex: M
Vaccine: MMR
Symptoms: Hypersensitivity, Loss of consciousness
Clinical narrative: This spontaneous report was received from Novartis and was assigned manufacturer report # PUS2015US037699 concerning a 6 year old male patient. On an unspecified date in approximately 1985, the patient was vaccinated with a dose of M-M-R II (dose, route and lot # not reported). On an unspecified date in approximately 1985, the patient experienced an allergic reaction (passed out) to the M-M-R II and wanted to get a flu shot now at the age of 36. At the time of the report, the patient's outcome was unknown. This was originally reported by a physician. Additional information is not expected. There is no complete contact information.
Age: 63.0
Sex: F
Vaccine: PNC13
Symptoms: Activities of daily living impaired, Fatigue, Mobility decreased, Pain, Swelling face
Clinical narrative: This is a spontaneous report from a contactable consumer. A 63-year-old female patient received PREVNAR 13 (batch number unknown), via an unspecified route of administration at single dose on 04Oct2014 due to her history of cystic fibrosis, kidney transplant, immunosuppression and insulin dependent diabetes. Medical history included renal transplant, double lung transplant in 1998, cystic fibrosis, immunosuppression. Concomitant medication included tacrolimus, prednisone taken daily from 04May1998 after her double lung and kidney transplant as anti-rejection medication, CELLCEPT from 02Jan1999, hydrochlorothiazide from 05Apr2007, spironolactone from 07May2008, venlafaxine hydrochloride from Jun2004, lorazepam from 2004, ursodiol from 2000, DIOVAN from 25Jul2007, MILK OF MAGNESIA from 2002, Vitamin C from Jun1998, multivitamins, stool softeners, MIRALAX from 2013, Insulin R from 04Mar1998, insulin injection, insulin NPH from 04May1998, and prednisolone from 04May1998. On 11Oct2014, the patient was extremely exhausted that she could not get out of bed and could not get up and could not do anything. The following day the left side of the face swollen, she was experiencing extreme pain and extreme exhaustion, she stayed in bed the whole day. The patient stated that all 3 events extreme exhaustion, left side face swollen and extreme pain involved hospitalization. Therapeutic measures were taken as a result of the events. The patient was treated with prednisone (45 mg decreased to 5 mg in two week period) for face swelling and pain. The outcome of the event extremely exhausted was recovered. Follow-up attempts are completed. No further information is expected. Follow-up (16Dec2014): New information obtained from the same contactable consumer includes: additional events "Facial Swelling" and "Pain aggravated", concomitant medications, treatment, outcome. Follow up (16Apr2015): New information obtained from the contactable consumer includes: course of events; vaccination date; concomitant medications.