chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 15.0
Sex: F
Vaccine: FLU4, HPV4, HPV4, FLUX, HPV4
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: This spontaneous prospective pregnancy report was received from a physician via company representative refers to an approximately 15 year old female patient. On 23-AUG-2011, the patient was vaccinated with 1st dose of GARDASIL (lot # and expiry date unknown). On 29-SEP-2012, the patient was vaccinated with 2nd dose of GARDASIL (lot # 0629AE and expiry date unknown). On 15-FEB-2014, the patient was vaccinated with 3rd dose of GARDASIL (lot # J008423, expiry date 21-JAN-2016). Concomitant therapies included influenza virus vaccine (unspecified) administered on 15-FEB-2014. The patient was found to be 5 months pregnant on 15-FEB-2014 after the third dose of GARDASIL was administered with LMP of 18-SEP-2013 and EDD of 25-JUN-2014. No adverse event was reported. The patient sought medical attention. Additional information has been requested.
Age: 1.02
Sex: M
Vaccine: MMR, PNC13, VARCEL
Symptoms: Blood calcium normal, Blood culture negative, Blood glucose normal, Blood sodium normal, Culture urine negative
Clinical narrative: Complex febrile seizures and fever likely due to PROQUAD vaccination.
Age: 1.02
Sex: M
Vaccine: MMR, PNC13, VARCEL
Symptoms: Febrile convulsion, Pyrexia, White blood cell count normal
Clinical narrative: Complex febrile seizures and fever likely due to PROQUAD vaccination.
Age: 10.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Abdominal pain upper, Headache
Clinical narrative: I noticed changes after the second dose, leading up to today (02/24/2014). She has had headaches, a few a week sometimes. She is maturing at an alarming rate after these shots at this young of an age. She has complained about stomach cramping since the second shot.
Age: 10.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Headache, Pain
Clinical narrative: I noticed changes after the second dose, leading up to today (02/24/2014). She has had headaches, a few a week sometimes. She is maturing at an alarming rate after these shots at this young of an age. She has complained about stomach cramping since the second shot.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a female patient of unknown age. The nurse had documented that the patient was vaccinated with her first dose of GARDASIL on 18-JUL-2013 and her second dose on 12-FEB-2014. The patient informed her that she received another dose of GARDASIL between 18-JUL-2013 and 12-FEB-2014 on an unspecified date. All dose and route for three doses were 0.5 ml intramuscularly (lot # for three doses not reported). No adverse effect reported. The patient's outcome was unknown. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Bedridden, Blood test, Influenza like illness, Injected limb mobility decreased, Mycobacterium tuberculosis complex test
Clinical narrative: This spontaneous report refers to an approximately 62 years old female patient who was also the reporter. Patient had pertinent medical history of high blood pressure. Drug allergy was reported as none. On 27-JAN-2014, the patient was vaccinated with ZOSTAVAX, injection, dose (unspecified), frequency (unspecified), in the arm. Concomitant therapies were reported as ALLEGRA and unspecified high blood pressure medication. On 27-JAN-2014, patients arm was sore and patient explained that in the arm she had the shot in she has had trouble moving and using the arm. Patient stated that the soreness lasted for a few days. On an unknown date in 2014, patient had begun to develop an increase in overall body achiness. The patient described the achiness as like having the flu but without the fever and cold symptoms, like she had aged 100 years overnight. The patient sought medical attention due to office visit. Patient explained that she was initially bedridden due to these symptoms. Patient initiated use with OTC ADVIL to help alleviate these symptoms, however due to the severity of the symptoms she asked her physician to increase her treatment to prescription strength IB Profin, 600mg. Patient also stated that this symptom had affected the quality of her sleep. Laboratory diagnostic studies performed were unspecified blood test and urine test. No product quality complaint was involved. The outcome of arm was sore was reported as recovered. Outcome of other events was reported as not recovered. Causality was not provided. On an unknown date in 2014 (around the time of vaccination), tuberculosis test was performed. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity, Poor quality sleep, Urine analysis
Clinical narrative: This spontaneous report refers to an approximately 62 years old female patient who was also the reporter. Patient had pertinent medical history of high blood pressure. Drug allergy was reported as none. On 27-JAN-2014, the patient was vaccinated with ZOSTAVAX, injection, dose (unspecified), frequency (unspecified), in the arm. Concomitant therapies were reported as ALLEGRA and unspecified high blood pressure medication. On 27-JAN-2014, patients arm was sore and patient explained that in the arm she had the shot in she has had trouble moving and using the arm. Patient stated that the soreness lasted for a few days. On an unknown date in 2014, patient had begun to develop an increase in overall body achiness. The patient described the achiness as like having the flu but without the fever and cold symptoms, like she had aged 100 years overnight. The patient sought medical attention due to office visit. Patient explained that she was initially bedridden due to these symptoms. Patient initiated use with OTC ADVIL to help alleviate these symptoms, however due to the severity of the symptoms she asked her physician to increase her treatment to prescription strength IB Profin, 600mg. Patient also stated that this symptom had affected the quality of her sleep. Laboratory diagnostic studies performed were unspecified blood test and urine test. No product quality complaint was involved. The outcome of arm was sore was reported as recovered. Outcome of other events was reported as not recovered. Causality was not provided. On an unknown date in 2014 (around the time of vaccination), tuberculosis test was performed. Additional information has been requested.
Sex: M
Vaccine: MMR
Symptoms: Anaemia megaloblastic, Autologous bone marrow transplantation therapy, Brain neoplasm malignant, Injection site abscess sterile, Injection site cellulitis
Clinical narrative: This spontaneous report was received from a physician assistant referring to a male patient (reporter's son) of unknown age. On an unknown date the patient was vaccinated with M-M-R II [lot # not reported]. Other suspect therapies included MENACTRA which was received in August or September 2013. On an unknown date patient was diagnosed at an unspecified time with "megaloblastoma" (medically significant) after he had received MMR. The patient received an autologous bone marrow transplant as part of his treatment. The reporter stated that the patient developed cellulitis and a sterile abscess of his left arm at the injection site after receiving MENACTRA in August or September 2013. He stated that his son's arm was edematous with "dark tissue" from his shoulder to his elbow (dates unspecified). The patient sought medical attention (methods unspecified). The action taken of the event with the suspect drug M-M-R II was assessed as not applicable. The causality of the events was unspecified. The outcome of the events was unknown. Additional information has been requested.
Sex: M
Vaccine: MMR
Symptoms: Oedema peripheral, Skin discolouration
Clinical narrative: This spontaneous report was received from a physician assistant referring to a male patient (reporter's son) of unknown age. On an unknown date the patient was vaccinated with M-M-R II [lot # not reported]. Other suspect therapies included MENACTRA which was received in August or September 2013. On an unknown date patient was diagnosed at an unspecified time with "megaloblastoma" (medically significant) after he had received MMR. The patient received an autologous bone marrow transplant as part of his treatment. The reporter stated that the patient developed cellulitis and a sterile abscess of his left arm at the injection site after receiving MENACTRA in August or September 2013. He stated that his son's arm was edematous with "dark tissue" from his shoulder to his elbow (dates unspecified). The patient sought medical attention (methods unspecified). The action taken of the event with the suspect drug M-M-R II was assessed as not applicable. The causality of the events was unspecified. The outcome of the events was unknown. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Back pain, Herpes zoster, Post herpetic neuralgia, Rash
Clinical narrative: This spontaneous report as received from a physician refers via company representative to a male patient of unknown age. On an unknown date several years ago the patient was vaccinated with ZOSTAVAX vial (strength, lot number and expiry date unknown) single dose subcutaneously for vaccination. Approximately on 30-JAN-2014 (about 3 weeks ago), the patient developed low back pain and received unspecified steroid injection and muscle relaxants as treatment initially. On 31-JAN-2014 (next day), the patient called the office to report the development of a rash on his lower back. The patient was diagnosed with shingles and was prescribed acyclovir (manufacturer unknown) and NEURONTIN. On an unknown date the patient experienced postherpetic neuralgia. No laboratory test was performed. The outcome of low back pain, postherpetic neuralgia and shingles was reported as not recovered/not resolved. No further information provided. Additional information has been requested.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Death, Incorrect dose administered
Clinical narrative: This spontaneous report as received from a health care worker via a field representative refers to her mother, a 75 year old female patient. On an unspecified date the patient was vaccinated with ZOSTAVAX (dose, frequency, route, lot # unknown) and then received a second dose of ZOSTAVAX "a year later" on an unspecified date. No untoward effects reported. The patient had since died. Healthcare worker stated that the cause of death of patient was unrelated to the ZOSTAVAX. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a female pediatric patient of unknown age. On an unknown date, the patient was vaccinated with first dose of VARIVAX (merck) (strength, dose number, lot number and expiry date unknown). On an unknown date patient received second dose of VARIVAX (merck) (strength, dose number, lot number and expiry date unknown). Approximately in 1994 (20 years ago), patient developed shingles after receiving 2 doses of VARIVAX (merck). The outcome of shingles was unknown. This case # 1402USA010748 was linked to case # 1402USA007533 via same reporter link. Additional information has been requested.
Age: 14.0
Sex: M
Vaccine: HPV4
Symptoms: Asthenia
Clinical narrative: This spontaneous report as received from a nurse via a representative refers to a 14 year old male patient. On an unknown date the patient was vaccinated with a dose of GARDASIL injection, 0.5 ml, intramuscular (lot # and expiry date unknown). The patient developed weakness in the knees after standing up "shortly" after receiving GARDASIL. The nurse reported that the patient was instructed to lay back on the table and the patient was monitored for an unspecified amount of time and then sent home the same day after he was better. The patient was recovered. No treatment was given for the event. Lab diagnostics studies were not performed. Additional information is not expected.
Age: 64.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site rash
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 64 year old female patient. Patient had no pertinent medical history or drug allergic reactions. On 17-FEB-2014 the patient was vaccinated with ZOSTAVAX, 1 standard package vial of 1, 0.65 ml, subcutaneously. Other suspect therapies included PNEUMOVAX23 (strength, dose number, dose unit, lot# and expiry date unknown) was administered to the patient on same day. On 17-FEB-2014, in the morning after receiving ZOSTAVAX, patient developed injection site rash that was bright red, itching and painful. Patient contacted pharmacist and was received treatment for the events with over the counter topical hydrocortisone cream. No laboratory test was performed. The pharmacist reported that rash was less red. The outcome of injection site rash that was bright red, itching and painful was reported as recovering/resolving. The outcome of ZOSTAVAX and PNEUMOVAX23 was given on same day was unknown. Additional information has been requested.
Age: 75.0
Sex: M
Vaccine: FLU3
Symptoms: Dyspnoea
Clinical narrative: According to wife pt began having difficulty breathing and had to be taken to hospital.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal pain, Pain in extremity
Clinical narrative: SHOULDER AND ARM PAIN LASTING LONG TIME.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Abdominal discomfort, Abdominal pain, Chills, Diarrhoea, Lethargy
Clinical narrative: Severe abdominal cramping/discomfort followed by diarrhea, vomiting, chills, lethargy, muscle aches, fever of 102.5 with Tylenol.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Myalgia, Pyrexia, Vomiting
Clinical narrative: Severe abdominal cramping/discomfort followed by diarrhea, vomiting, chills, lethargy, muscle aches, fever of 102.5 with Tylenol.
Age: 22.0
Sex: F
Vaccine: TDAP
Symptoms: Abnormal behaviour, Cough, Dizziness, Headache, Heart rate increased
Clinical narrative: Fever, headache, hives, sore/swollen throat, swollen face, behavior changes, light headed/dizziness, cough, rapid heart rate, lethargy.
Age: 22.0
Sex: F
Vaccine: TDAP
Symptoms: Lethargy, Oropharyngeal pain, Pharyngeal oedema, Pyrexia, Swelling face
Clinical narrative: Fever, headache, hives, sore/swollen throat, swollen face, behavior changes, light headed/dizziness, cough, rapid heart rate, lethargy.
Age: 22.0
Sex: F
Vaccine: TDAP
Symptoms: Urticaria
Clinical narrative: Fever, headache, hives, sore/swollen throat, swollen face, behavior changes, light headed/dizziness, cough, rapid heart rate, lethargy.
Age: 29.0
Sex: M
Vaccine: TDAP
Symptoms: Miliaria, Rash erythematous
Clinical narrative: Pt. noticed a small rash first on his finger of his right hand. A little later in the same day he noticed the same rash on his forehead and lower back.  He described it as a "heat rash".  He said the bumps were small about the size of a ballpoint pen point, with all of them being raised and all just red, no pus or drainage.
Age: 1.25
Sex: F
Vaccine: DTAP, MMR, VARCEL
Symptoms: Local swelling
Clinical narrative: Bump in groin - 1 cm diameter non-tender lymph node.
Age: 60.0
Sex: M
Vaccine: PPV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a male patient of unknown age. On an unknown date in October 2013, the patient was vaccinated with first dose of PNEUMOVAX23 (lot#, expiration date, dose, route, indication not reported). On 09-DEC-2013 the patient was vaccinated with second dose of PNEUMOVAX23 (lot#, expiration date, route, indication not reported). No adverse effects reported. Follow up information has been received from the registered nurse refers to the 61 year old patient, (weight 149 unit unknown, height 71 inch). On 09-DEC-2013 (at 09:46 am), the patient was vaccinated with second dose of PNEUMOVAX23 (lot number J010332, expired date 14-JAN-2015) into left deltoid (dosage and route unknown). The patient did not require emergency room/doctor visit. Additional information is not expected.
Age: 27.0
Sex: U
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a 27 year old patient. On an unknown date the patient was vaccinated with the third dose of GARDASIL (lot#, dose and route unspecified). Patient was administered the third dose of GARDASIL at the age of 27 years. No adverse effects reported. Additional information is not expected.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site vesicles
Clinical narrative: This spontaneous report as received from a female patient of unknown age regarding herself. On an unknown date in 2009 (also reported as 5 years ago) the patient was vaccinated with ZOSTAVAX (dosing regimen and frequency unknown) (lot number and expiry date unknown). No concomitant medications were reported. On an unknown date in 2009 (also reported as a couple of days later) the patient experienced blister on the site of vaccination and blister on the site of vaccination also itched for a couple of days. The outcome of the events was unknown. The action taken with the therapy with ZOSTAVAX was unknown. The relatedness of the events to the therapy with ZOSTAVAX was unknown. No product quality issue was reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Mumps
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with M-M-R II (dosing regimen and frequency unknown) (lot number and expiry date unknown). No concomitant medications were reported. On an unknown date the patients experienced mumps outbreak at an unspecified college. It was also reported that the nurse was unsure of how many patients developed the mumps or how many patients have received M-M-R II prior to getting the mumps. The outcome of mumps outbreak was unknown. The action taken with the therapy with M-M-R II was unknown. The relatedness of the events to the therapy with M-M-R II was unknown. No product quality issue was reported. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Pt states that shortly after administration her arm was sore and became progressively worse over following 3 weeks. Shot given 2/1/14.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist and from pharmacist via company representative, concerning a patient of unknown age and gender. On 13-FEB-2014 the patient was vaccinated with expired dose of ZOSTAVAX vial (lot # H018510, expire date: 15-JAN-2014) (strength, dose, frequency not reported). No adverse effects reported. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site reaction, Urticaria
Clinical narrative: This spontaneous report as received from a male pharmacist, via company representative, refers to himself. On an unknown date the patient was vaccinated with ZOSTAVAX (dose, strength, site and route of administration not reported). On an unknown date the patient and few other unspecified patients (MARRS # 1402USA011058) experienced a welt approximately 1-2 inches in diameter around the injection site after receiving ZOSTAVAX. The outcome was reported as resolved in 2-3 days (on an unspecified date). The relatedness between ZOSTAVAX and event was not reported. This is one of two reports from the same reporter (other case MARRS # 1402USA011058). Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site urticaria
Clinical narrative: This spontaneous report as received from a pharmacist, via company representative, refers to few unspecified patients. On an unknown date the patients were vaccinated with ZOSTAVAX (dose, strength, site and route of administration not reported). On an unknown date the patient experienced a welt approximately 1-2 inches in diameter around the injection site after receiving ZOSTAVAX. The outcome of event was unknown. The relatedness between ZOSTAVAX and event was not reported. This is one of two cases from the same reporter (other case MARRS # 1402USA003972). Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Local swelling, Rash
Clinical narrative: This spontaneous report as received from a consumer as part of a marketing research program refers, to a 70 year old female patient. Approximately in February 2011, reported as 3 years ago, the patient was vaccinated with ZOSTAVAX (lot#, dose, strength, frequency, route not reported). Approximately in February 2011, reported as one day after the vaccine (about 3 years ago) the patient experienced slight rash on left shoulder which went away after 3 days (also reported that after 2-3 days). It was reported that the shoulder was also swollen for that time. The outcome of both adverse events was reported as recovered with sequelae (approximately in 2011). Relatedness between the events and the ZOSTAVAX was not assessed by the reporter. Additional information is not expected.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unknown number of patients of unknown ages and genders. Nurse mentioned an unknown number of patients might have received GARDASIL injection (lot #, expiry date, dose and route unknown) that was improperly stored. No adverse symptoms reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Adverse reaction
Clinical narrative: This spontaneous report as received from a female consumer reporting on herself, of unknown age. Medical history and concurrent conditions were not reported. On 30-DEC-2013, the patient was vaccinated with a dose of ZOSTAVAX (dose, route and lot number were not reported). The patient reported that she developed unspecified adverse reactions after receiving ZOSTAVAX. The outcome of the event was unkonwn. Causality was not reported. Additional information is not expected.
Sex: F
Vaccine: PPV
Symptoms: Herpes zoster, Pneumonia
Clinical narrative: This spontaneous report as received from a current 48 year old female consumer refers to herself. The patient's medical history included "Surgical menopause, degenerative disc disease, autoimmune thyroid". In the unspecified past, the patient was vaccinated with PNEUMOVAX23 (manufacturer/brand not specified by consumer), (lot#, expiry date, dose, frequency and indication not reported) several times, and developed pneumonia at an unspecified time post vaccination in "2009 or 2010". The patient stated this vaccination was suggested by her unspecified rheumatologist. On 04-FEB-2014, the patient developed shingles (captured in the case 1402USA008849). This is one of several reports received from the same patient. Additional information has been requested.
Age: 86.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Blood test, Drug ineffective, Erythema, Rash
Clinical narrative: This spontaneous report as received from a consumer's wife refers to an 86 years old male patient. The patient's medical history included polycythemia vera, pulmonary fibrosis and prostate cancer. On 18-JAN-2014 the patient was vaccinated with ZOSTAVAX (dose, route, lot number and expiration date were not provided). Concomitant medications included: unspecified blood pressure medication and various unspecified medications. The patient had no drug allergies or reactions. It was reported that on 18-JAN-2014 (also reported as a day after the vaccination) the patient broke out in a rash on the front of his body and his back. The rash blistered and then scabbed. At the time of this report the patient still had deep red blisters and most of the scabs were gone. It appeared that he would be scarred. The reporter felt that this medication was ineffective. The patient was given tramadol as a treatment. His outcome was reported as recovering. Lab diagnostic studies included blood work performed on an unknown date (results not provided). The relatedness between the patient's adverse events and the vaccination with ZOSTAVAX was not reported. The patient sought medical attention via a doctor visit. Additional information has been requested.
Age: 86.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash vesicular, Scab
Clinical narrative: This spontaneous report as received from a consumer's wife refers to an 86 years old male patient. The patient's medical history included polycythemia vera, pulmonary fibrosis and prostate cancer. On 18-JAN-2014 the patient was vaccinated with ZOSTAVAX (dose, route, lot number and expiration date were not provided). Concomitant medications included: unspecified blood pressure medication and various unspecified medications. The patient had no drug allergies or reactions. It was reported that on 18-JAN-2014 (also reported as a day after the vaccination) the patient broke out in a rash on the front of his body and his back. The rash blistered and then scabbed. At the time of this report the patient still had deep red blisters and most of the scabs were gone. It appeared that he would be scarred. The reporter felt that this medication was ineffective. The patient was given tramadol as a treatment. His outcome was reported as recovering. Lab diagnostic studies included blood work performed on an unknown date (results not provided). The relatedness between the patient's adverse events and the vaccination with ZOSTAVAX was not reported. The patient sought medical attention via a doctor visit. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a consumer refers to a 70 year old female patient. The patient had no pertinent medical history and no known drug reactions and allergies. In approximately 2009, 5 years ago, the patient was vaccinated with a dose of ZOSTAVAX, one time vaccine to prevent shingles (route, lot #, expiration date were not provided). There was no concomitant medication. The patient received ZOSTAVAX vaccine 5 years ago but on 18-FEB-2014, the patient developed shingles. On 19-FEB-2014, the patient went to doctor and received acyclovir, 800 mg table, 5 a day for 7 days. There were no laboratory diagnostic studies performed. At the time of the report, the patient's status was unknown. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Vaccination complication
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with a dose of GARDASIL (route, dose and lot number not provided). On an unknown date the patient was having problems due to receiving GARDASIL. The physician did not give the specifics of the problem. The patient's outcome was unkonwn. Additional information is not expected.
Age: 15.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Cellulitis
Clinical narrative: Seen in ER for cellulitis of (R) arm. Given note to take ibuprofen for pain. Put on doxycycline prescribed. Given varicella in (R) arm.
Sex: M
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a male patient of unknown age. The patient was administered the first dose of GARDASIL, intramuscularly (lot number and site of administration were not reported) in August 2012 and the second dose of GARDASIL on 27-AUG-2013. No adverse effects were reported. Therapy with GARDASIL was not discontinued. Additional information has been requested.
Age: 1.07
Sex: M
Vaccine: IPV, MMR, VARCEL
Symptoms: Contusion, Epidermoid cyst excision, Full blood count, Idiopathic thrombocytopenic purpura, Immunoglobulin therapy
Clinical narrative: Parents noted excessive bruising after dermoid cyst removal 2-14-2014. CBC performed 2/18 showed platelet count 11K. Referred to Hematology and treated with IVIG for ITP.
Age: 1.07
Sex: M
Vaccine: IPV, MMR, VARCEL
Symptoms: Platelet count decreased
Clinical narrative: Parents noted excessive bruising after dermoid cyst removal 2-14-2014. CBC performed 2/18 showed platelet count 11K. Referred to Hematology and treated with IVIG for ITP.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling
Clinical narrative: Patient got ZOSTAVAX vaccination. Had injection site reaction. The area around injection was red, swollen, and painful.
Age: 71.0
Sex: M
Vaccine: PPV
Symptoms: Chest pain, Chills, Erythema, Myalgia, Pain in extremity
Clinical narrative: Within 6 hrs of immunization, I began to have chills and fever that lasted for approximately 12 hrs. This was accompanied with throbbing pain from the left upper arm across the pectoralis major to the sternum and redness and hot to the touch across my entire upper left arm.
Age: 71.0
Sex: M
Vaccine: PPV
Symptoms: Pyrexia, Skin warm
Clinical narrative: Within 6 hrs of immunization, I began to have chills and fever that lasted for approximately 12 hrs. This was accompanied with throbbing pain from the left upper arm across the pectoralis major to the sternum and redness and hot to the touch across my entire upper left arm.
Age: 13.0
Sex: M
Vaccine: FLU3
Symptoms: Dyspnoea
Clinical narrative: Shortness of breath - start from 24 hrs after received the vaccination.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Angiogram, Blood folate, Computerised tomogram head, Dizziness, Hypoaesthesia
Clinical narrative: After pt. was given shingles vaccine on 2-26-13 she developed numbness and tingling in her face (right side). Later she developed dizziness and intermittent numbness of feet and hands. Continued to have persistent/chronic paresthesias of Rt. face.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Paraesthesia, Vitamin B12
Clinical narrative: After pt. was given shingles vaccine on 2-26-13 she developed numbness and tingling in her face (right side). Later she developed dizziness and intermittent numbness of feet and hands. Continued to have persistent/chronic paresthesias of Rt. face.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site pain, Nuclear magnetic resonance imaging normal, Pain
Clinical narrative: Same day of vaccination - injection site pain. Pain continued for next 2 days. Had few days of no pain but pain returned cannot lift arm sometimes. Pain on lifting things with that arm and pain continues or gets severe. Next day burning sensation in that area.
Age: 55.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site induration, Injection site inflammation, Injection site pain, Injection site swelling, Nausea
Clinical narrative: Injection site sore and stiff, felt nausea, inflamed/swelling at injection site.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal disorder, Pain in extremity
Clinical narrative: Pt describes pain in arm (left) so severe. Can't lift child. Went to see physician about 1 week after 1/7/14 shot who ruled out infection. Pain still persists.
Age: 77.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Erythema, Local swelling
Clinical narrative: Pt. rec'd flu and pneumonia shots in (L) arm on 10/23. Pt. presented to pharmacy on 10/26 with redness/swelling in (L) arm at lower elbow to wrist region. RPh recommended BENADRYL. Pt. had existing appt with MD and consulted. MD called 10/29 and said pt. to continue ZYRTEC. Redness and swelling had decreased.
Age: 5.0
Sex: M
Vaccine: FLU4, HEP, MMR
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Child received a Td based on incorrect hx card provided. Td should not be given before age 7 yrs and client is only 5 yrs 11 mo.
Age: 0.52
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC13, RV5
Symptoms: Crying
Clinical narrative: Vaccine given at 1:30 PM on Friday 2/21/14. Baby was crying inconsolably from 7 PM Friday nite to 9:30 Saturday morning when she fell asleep. No localized reaction noticed and no increased temperature.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Eye pain, Headache, Ophthalmological examination, Rash
Clinical narrative: Pain in one eye - Right. Rash on forehead - one side - Right. Headache.
Age: 1.03
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Rash generalised, Rash maculo-papular, Rash morbilliform, Rash vesicular
Clinical narrative: 2 distinctly different rashes - maculopapular morbilliform rash on trunk and neck and 5 vesicles on face and arms.
Age: 11.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP
Symptoms: Cellulitis, Erythema, Local swelling
Clinical narrative: Swelling and redness / cellulitis right arm.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Lymphadenopathy
Clinical narrative: About 3-4 weeks after getting the shingles vaccine I developed a blistery rash on scalp (and it continues) and an enlarged lymph node on back of neck. I have been going to dermo doctors several times and can't seem to clear up the rash.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Varicella
Clinical narrative: Had chicken pox as a child. Now 73 years old. Received shingles vaccine 6 days ago. Now have the chicken pox. Vaccine administered at pharmacy.
Age: 32.0
Sex: M
Vaccine: PNC13
Symptoms: Chest discomfort, Dyspnoea, Streptococcus test positive
Clinical narrative: Squeezing sensation in chest and SOB about 3 hours after injection lasting about 24 hours.
Age: 49.0
Sex: M
Vaccine: FLU3
Symptoms: Guillain-Barre syndrome, Mobility decreased, Pain
Clinical narrative: Developed Guillain-Barre within a few days of administered. Woke up with aches, couldn't get out of bed. No treatment given, recommended rest.
Age: 0.18
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Pyrexia
Clinical narrative: Parent called office reporting a fever 102.8 rectal after vaccines on 2/20/14.
Age: 1.04
Sex: F
Vaccine: HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: 8 cm x 8 cm area of redness and warmth (R) anterior thigh encompassing shot sites where Hep A and PREVNAR were given. No tenderness or induration.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: 2/19/14 soreness at injection site (L) arm, itchy, warm. 2/20/14 red circle at injection site, itchy, sore. 2/24/14 subsiding, pt feeling better with itchy and redness.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLU3, HEPA, MMRV
Symptoms: Cellulitis
Clinical narrative: MMRV and FLUARIX given in left thigh in a pt with recent diagnosis of Type 1 Diabetes (1 month ago), with cellulitis several hours after vaccine given at injection site.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Dry throat, Fatigue, Feeling of body temperature change, Headache, Injection site erythema
Clinical narrative: Within 15 minutes of receiving the shot, I felt really achy all over, tired, nauseated and wanted to vomit, but couldn't, cold one minute and hot the next, bad headache and my arm started to hurt and itch real bad. I looked at my arm and noticed redness and a rash developing around the injection site. My throat got dry and tight.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site rash, Nausea, Pain, Pain in extremity, Pruritus
Clinical narrative: Within 15 minutes of receiving the shot, I felt really achy all over, tired, nauseated and wanted to vomit, but couldn't, cold one minute and hot the next, bad headache and my arm started to hurt and itch real bad. I looked at my arm and noticed redness and a rash developing around the injection site. My throat got dry and tight.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Throat tightness
Clinical narrative: Within 15 minutes of receiving the shot, I felt really achy all over, tired, nauseated and wanted to vomit, but couldn't, cold one minute and hot the next, bad headache and my arm started to hurt and itch real bad. I looked at my arm and noticed redness and a rash developing around the injection site. My throat got dry and tight.
Age: 0.18
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC13
Symptoms: Body temperature increased, Pallor, Unresponsive to stimuli, Yellow skin
Clinical narrative: Went to ER via ambulance, around 22:30 - 21:00 the baby was being held when he became yellow, pale and didn't respond appropriately for a couple of minutes. Patient had second episode while waiting for ambulance. For EMS and on arrival pt awake, alert in no apparent distress.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Bursitis, Injection site pain, Tendonitis, X-ray limb
Clinical narrative: Pain (L) shoulder ongoing seen by Occ. Health MD Dx. R/O tendonitis/bursitis. Pt ordered X-ray done.
Age: 2.0
Sex: M
Vaccine: MMRV
Symptoms: Pyrexia
Clinical narrative: Fever - had glassy stare and lip quiver? Possible seizure x couple minutes.
Age: 27.0
Sex: F
Vaccine: VARCEL
Symptoms: Asthenia, Dizziness, Lymphadenopathy, Night sweats, Pruritus
Clinical narrative: Lymph node swelling on the back of her neck on the left side. Rash from knees up to her face with itching. Night sweats, weakness, lightheadedness.
Age: 27.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash
Clinical narrative: Lymph node swelling on the back of her neck on the left side. Rash from knees up to her face with itching. Night sweats, weakness, lightheadedness.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Back pain, Local swelling, Neuralgia, Pain in extremity
Clinical narrative: Patient described acute sharp pain radiating from right upper back to right leg similar to sciatic nerve pain. Resolved past taking 3-baby aspirin. Said very scary, almost went to ER. Injection site right arm swelled to size of baseball per patient.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Feeling hot, Flushing, Hyperaesthesia
Clinical narrative: Joint pain in elbow, flushing, warmth in area surrounding elbow.  Severe sensitivity to touch on elbow necessitating high dose NSAID tx. Escalating to narcotic meds.  Now resolving (5 days post injection) but not gone.  It feels as though recovery will continue based on decreased symtoms the last day but complete recovery cannot be assured at this time.
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR, VARCEL
Symptoms: Herpes zoster, Pain, Polymerase chain reaction, Rash, Varicella virus test
Clinical narrative: Herpes zoster diagnosis in a two-dose varicella vaccine recipient. Unilateral, one dermatome: inner thigh, left leg. Painful rash, no antiviral treatment. Lasted <4 weeks. No history of varicella.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Anaphylactic reaction
Clinical narrative: Anaphylaxis.
Age: 1.27
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Urticaria
Clinical narrative: 3 hives noted on cheek, left wrist and right arm. Given Benadryl and they resolved quickly.
Age: 42.0
Sex: M
Vaccine: VARZOS
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Patient received higher dose, no adverse event occurred.
Age: 10.0
Sex: F
Vaccine: FLUN3
Symptoms: Alanine aminotransferase increased, Antinuclear antibody negative, Aspartate aminotransferase increased, Blood alkaline phosphatase normal, Blood bilirubin increased
Clinical narrative: A report from VAERS concerns a 10 year old female. No concomitant medication or relevant history was provided. The patient received nasal FLUMIST on 28-Oct-2009. She developed hepatitis, thrombocytopenia, and her liver function test was abnormal. The outcomes of the hepatitis, liver function test abnormal, and thrombocytopenia were unknown. The following lab data were provided: On 16-Nov-2009 AST 435, ALT 1331, Alk phos 237, T bili 11.7, Hepatitis A, B and ANA (Antinuclear antibody) were negative, WBC (White blood cell count) 1.3. ANC (Absolute neutrophil count) 0.0, AST (Aspartate aminotransferase) 198, ALT (Alanine aminotransferase) 207, GGT (Gamma-glutamyltransferase) 483, T bili (Total bilirubin) 5.8 on 18-Nov-2009. Assessment of the serious criteria for the events was as follows by the reporter: hospitalised.
Age: 10.0
Sex: F
Vaccine: FLUN3
Symptoms: Gamma-glutamyltransferase increased, Hepatitis, Hepatitis A antibody negative, Hepatitis B antibody negative, Liver function test abnormal
Clinical narrative: A report from VAERS concerns a 10 year old female. No concomitant medication or relevant history was provided. The patient received nasal FLUMIST on 28-Oct-2009. She developed hepatitis, thrombocytopenia, and her liver function test was abnormal. The outcomes of the hepatitis, liver function test abnormal, and thrombocytopenia were unknown. The following lab data were provided: On 16-Nov-2009 AST 435, ALT 1331, Alk phos 237, T bili 11.7, Hepatitis A, B and ANA (Antinuclear antibody) were negative, WBC (White blood cell count) 1.3. ANC (Absolute neutrophil count) 0.0, AST (Aspartate aminotransferase) 198, ALT (Alanine aminotransferase) 207, GGT (Gamma-glutamyltransferase) 483, T bili (Total bilirubin) 5.8 on 18-Nov-2009. Assessment of the serious criteria for the events was as follows by the reporter: hospitalised.
Age: 10.0
Sex: F
Vaccine: FLUN3
Symptoms: Neutrophil count decreased, Thrombocytopenia, White blood cell count decreased
Clinical narrative: A report from VAERS concerns a 10 year old female. No concomitant medication or relevant history was provided. The patient received nasal FLUMIST on 28-Oct-2009. She developed hepatitis, thrombocytopenia, and her liver function test was abnormal. The outcomes of the hepatitis, liver function test abnormal, and thrombocytopenia were unknown. The following lab data were provided: On 16-Nov-2009 AST 435, ALT 1331, Alk phos 237, T bili 11.7, Hepatitis A, B and ANA (Antinuclear antibody) were negative, WBC (White blood cell count) 1.3. ANC (Absolute neutrophil count) 0.0, AST (Aspartate aminotransferase) 198, ALT (Alanine aminotransferase) 207, GGT (Gamma-glutamyltransferase) 483, T bili (Total bilirubin) 5.8 on 18-Nov-2009. Assessment of the serious criteria for the events was as follows by the reporter: hospitalised.
Age: 15.0
Sex: M
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: No adverse event. Patient aged 15 was vaccinated with FLUCELVAX: approved for 18 + y/o.
Age: 66.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Diarrhoea, Gastrointestinal disorder, Injection site bruising, Injection site erythema, Local reaction
Clinical narrative: She noted bruising and redness in her left deltoid the day after receiving immunizations as well as body aches and also developed diarrhea 2/20. Local reaction was mild. GI symptoms and myalgias seem more likely related to a norovirus.
Age: 66.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Myalgia, Pain, Viral infection
Clinical narrative: She noted bruising and redness in her left deltoid the day after receiving immunizations as well as body aches and also developed diarrhea 2/20. Local reaction was mild. GI symptoms and myalgias seem more likely related to a norovirus.
Age: 5.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Abdominal pain, C-reactive protein abnormal, Colitis, Computerised tomogram abdomen normal, Computerised tomogram abnormal
Clinical narrative: A report has been received from VAERS concerning a 5 year old male patient. No information regarding relevant history, concomitant disease, and concomitant medications was provided. Patient received H1N1 nasal mist vaccine on 26-Oct-2009. On 05-Nov-2009, patient was hospitalized for 1 week history of fever, abdominal pain, diarrhea, and vomiting. Appendicitis was ruled out. Patient was discharged 07-Nov-2009. The same day 11-Nov-2009, patient developed purpuric rash with bloody stool, readmitted to hospital with presumed diagnosis of HSP (vasculitis). Discharged home 10-Nov-2009. Patient presented initially with abdominal pain, diarrhea, vomiting. Appendicitis ruled out by surgery and discharged home with presumptive diagnosis of HSP. Later developed purpuric rash on buttocks, thighs, ears, neck and feet bilaterally and grossly bloody stools. Readmitted, treated with prednisone which helped abdominal pain. Stools became negative for blood. KUB -unremarkable; CT of abdomen/ pelvic showed no signs of intussusception; Labs: LFT's (abnormal), CRP (abnormal), ESR, (abnormal), CBC with diff (Abnormal; Urinalysis (abnormal). The patient recovered from the event of the Henoch Schonlein purpura and liver function test abnormal on unspecified date. The reporter considered the events to be serious due to hospitalization.
Age: 5.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Culture stool negative, Diarrhoea, Differential white blood cell count abnormal, Full blood count abnormal, Haematochezia
Clinical narrative: A report has been received from VAERS concerning a 5 year old male patient. No information regarding relevant history, concomitant disease, and concomitant medications was provided. Patient received H1N1 nasal mist vaccine on 26-Oct-2009. On 05-Nov-2009, patient was hospitalized for 1 week history of fever, abdominal pain, diarrhea, and vomiting. Appendicitis was ruled out. Patient was discharged 07-Nov-2009. The same day 11-Nov-2009, patient developed purpuric rash with bloody stool, readmitted to hospital with presumed diagnosis of HSP (vasculitis). Discharged home 10-Nov-2009. Patient presented initially with abdominal pain, diarrhea, vomiting. Appendicitis ruled out by surgery and discharged home with presumptive diagnosis of HSP. Later developed purpuric rash on buttocks, thighs, ears, neck and feet bilaterally and grossly bloody stools. Readmitted, treated with prednisone which helped abdominal pain. Stools became negative for blood. KUB -unremarkable; CT of abdomen/ pelvic showed no signs of intussusception; Labs: LFT's (abnormal), CRP (abnormal), ESR, (abnormal), CBC with diff (Abnormal; Urinalysis (abnormal). The patient recovered from the event of the Henoch Schonlein purpura and liver function test abnormal on unspecified date. The reporter considered the events to be serious due to hospitalization.
Age: 5.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Haemoglobin normal, Henoch-Schonlein purpura, Liver function test abnormal, Occult blood positive, Purpura
Clinical narrative: A report has been received from VAERS concerning a 5 year old male patient. No information regarding relevant history, concomitant disease, and concomitant medications was provided. Patient received H1N1 nasal mist vaccine on 26-Oct-2009. On 05-Nov-2009, patient was hospitalized for 1 week history of fever, abdominal pain, diarrhea, and vomiting. Appendicitis was ruled out. Patient was discharged 07-Nov-2009. The same day 11-Nov-2009, patient developed purpuric rash with bloody stool, readmitted to hospital with presumed diagnosis of HSP (vasculitis). Discharged home 10-Nov-2009. Patient presented initially with abdominal pain, diarrhea, vomiting. Appendicitis ruled out by surgery and discharged home with presumptive diagnosis of HSP. Later developed purpuric rash on buttocks, thighs, ears, neck and feet bilaterally and grossly bloody stools. Readmitted, treated with prednisone which helped abdominal pain. Stools became negative for blood. KUB -unremarkable; CT of abdomen/ pelvic showed no signs of intussusception; Labs: LFT's (abnormal), CRP (abnormal), ESR, (abnormal), CBC with diff (Abnormal; Urinalysis (abnormal). The patient recovered from the event of the Henoch Schonlein purpura and liver function test abnormal on unspecified date. The reporter considered the events to be serious due to hospitalization.