chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Depressed level of consciousness
Clinical narrative: Child began to lose consciousness as he was leaving clinic. Mother assisted to floor feet were elevated and he was given juice and candy when he was able to swallow. Observed 20 minutes, left ambulatory.
Age: 36.0
Sex: M
Vaccine: UNK
Symptoms: Muscle strain, Musculoskeletal pain, Rotator cuff syndrome
Clinical narrative: After receiving shot on 5-31-12 my shoulder has been hurting. I have gone to doctors 2x the last month for the pain. They said its a rotator cuff injury. I asked for xray the doctor said no. He gave me info. on stretches to do and ibuprofen.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain lower, Headache, Hypoaesthesia, Nasal congestion
Clinical narrative: Called s/o with headache, lower abdominal pain, nasal stuffiness, (R) arm numbness. Pt. advised further evaluation in an urgent care.
Age: 16.0
Sex: M
Vaccine: HEPA, HPV4, IPV, MNQ
Symptoms: Asthenia, Dizziness, Immediate post-injection reaction, Nausea, Vomiting
Clinical narrative: Felt faint & had nauseated with vomiting. Gave GARDASIL last. Prior to GARDASIL C/O "a little weakness", but threw up immediately after GARDASIL.
Age: 1.08
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Injection site rash, Irritability, Poor quality sleep, Pyrexia, Rash erythematous
Clinical narrative: About 30 small red bumps that are varicella like, fever, rash worse at the injection site, fussy, not sleeping well.
Age: 1.08
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Rash vesicular
Clinical narrative: About 30 small red bumps that are varicella like, fever, rash worse at the injection site, fussy, not sleeping well.
Age: 1.02
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Vaccination site induration, Vaccination site warmth, Varicella post vaccine
Clinical narrative: Large warm area around vaccine site, mild induration with many small varicella spots all over and spreading. No treatment.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: Pt reports zoster-like rash after receiving ZOSTAVAX.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: VIIth nerve paralysis
Clinical narrative: 10/17/2011. ZOSTAVAX injection. Patient had Bells Palsy 12/1/2011. Patient convinced his immune system is not working as well as before ZOSTAVAX. ZOSTAVAX received via Pharmacy.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Ear pain, Headache, Pain in jaw
Clinical narrative: I had the shingles vaccine (ZOSTAVAX) by my doctor. One hour later the pain in my right jaw was so intense it brought me to my knees. Then my right ear had an intense pain. Plus a severe headache (I never get headaches). I saw a nurse who said I was having a severe reaction. This continues for 7 more months although not as severe. I have had flu shots, pneumonia shot with no problems at all. Jan 2012 saw Dr. again with continuing pain particularly on right jaw - it felt like 20 root canals - great pain.
Age: 1.33
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Cough, Culture throat positive, Pharyngitis streptococcal, Pyrexia, Varicella post vaccine
Clinical narrative: This spontaneous report was received from a registered nurse refers to a 16 month old female patient without any pertinent medical history and drug reactions/allergies. The patient was vaccinated subcutaneously with the first dose of 0.5 ml VARIVAX (Lot# reported as 0495AE) on 16-JUL-2012. Other suspect therapies included the first dose of M-M-R II (lot # reported as 0426AE) 0.5ml subcutaneously on the same day. The patient developed chickenpox lesions "48 to 72 hours after vaccination", which was on approximately 18-JUL-2012. The patient had an office visit on 20-JUL-2012 regarding the lesions. The patient returned to the office again on 24-JUL-2012 because the patient had a cough and low-grade fever. A throat culture was done and the patient was diagnosed with strep throat. Unspecified treatments were given for the AE. At the time of reporting, the patient was not recovered. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site pain
Clinical narrative: This spontaneous report as received from a registered nurse refers to two patients of an unknown age and gender. Patients were vaccinated with lot # (672962/0025AE) PNEUMOVAX23 in May 2012 (dose, route and site of administration not reported). No other co-suspects were reported. No concomitant medications were reported. On an unknown date, both patients experienced pain at the injection site. No treatment information was reported. The outcome of pain at the injection site was unknown. The relatedness for pain at the injection site is unknown for PNEUMOVAX23. This is one of several reports from the same source. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available.
Age: 87.0
Sex: F
Vaccine: PPV
Symptoms: Injection site oedema, Injection site swelling
Clinical narrative: This spontaneous report as received from a registered pharmacist refers to a now 88 year old female patient. The patient was vaccinated with a dose of PNEUMOVAX23 on approximately 31-JUL-2011 (reported as "1 year ago") (lot# not reported). On an unknown date the patient experienced swelling and edema at the injection site. It was unknown if the patient sought medical attention. The outcome of swelling and edema at the injection site was reported as recovered. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site mass
Clinical narrative: This spontaneous report was received from a doctor of pharmacy refers to a female patient of unknown age. The patient was vaccinated with a dose of ZOSTAVAX (dose, route and Lot# not reported) on 24-JUL-2012. On an unknown date (time frame development of the lump was unspecified) the patient experienced lump at the injection site (reported as injection site reaction described as a lump at the injection site following vaccination). The patient sought unspecified medical attention in pharmacy. The patient did not received any treatment. None laboratory diagnostic tests were performed. At the time of the report patient's status was not recovered. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a 68 years old female consumer refers to herself with shingles in March and drug allergy to unspecified drug. The patient had shingles originally in March 2012 subcutaneously the patient was vaccinated with a dose of ZOSTAVAX (lot number not provided) subcutaneous on 25-MAY-2012. No other co-suspects were reported. Concomitant medications included CRESTOR. On 15-JUL-2012, a few weeks later the patient developed the shingles. The patient felt the vaccine lessened the severity of this case. The patient had sought medical attention and acyclovir was given as a treatment for the adverse event. The outcome of shingles was unknown. Additional information is not expected.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Hyperhidrosis, Paraesthesia
Clinical narrative: This spontaneous report as received from a consumer refers to his 62 years old wife with drug reaction/allergy to sulfa and no pertinent medical history, who on 27-JUL-2012 was vaccinated with a dose of ZOSTAVAX (dose not reported and route not reported) (lot # 0562AE - in validation process). No other co-suspects were reported. No concomitant medications were reported. The reporter stated that on 27-JUL-2012 his wife developed redness in her hands and feet. She also had tingling and she broke out in sweats after getting ZOSTAVAX. No treatment was given for an AE. At the time of the report the events did not improve. There were no laboratory diagnostic studies performed. The patient did not seek medical attention. Additional information is not expected.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site induration, Injection site reaction, Injection site vesicles, Injection site warmth, Skin lesion
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age with allergy to sulfa and metoprolol. The patient was vaccinated SQ with a 0.65 ml dose of ZOSTAVAX on JUL-2012. There were no concomitant medications. On an unknown date the patient developed a hard, warm to touch lesion at the injection site, after receiving ZOSTAVAX. The patient developed a fluid filled blister close to the injection site. Therapy with BENADRYL was given for the adverse events. No lab diagnostics studies performed. The patient sought medical attention by contacting the pharmacist. The outcome of the patient was unknown. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Incorrect dose administered
Clinical narrative: This spontaneous report as received from a male patient of unknown age, concerning himself. The patient reported that on an unknown date ("a few years ago") he had Shingles and got the ZOSTAVAX shot at that time (dose, route and lot # not reported). Recently he had a reoccurrence of Shingles and got ZOSTAVAX shot again (dose, route and lot # not reported) on 19-JUL-2012. The patient did not consult his primary care physician before getting the most recent shot, he just went directly to the pharmacy and had the injection. The patient stated that he is still experiencing Shingles symptoms. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a nurse (L.P.N.) concerning unspecified patients who on an unspecified date were vaccinated with improperly stored RECOMBIVAX HB. The patients were not experiencing any known symptoms. This is one of several reports received from the same source. MARRS number 1206USA04796. All telephone attempts to obtain follow-up information have been unsuccessful. A message was left with the receptionist requesting return the call. Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Rash erythematous, Rash pruritic
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 72 years old female patient with high blood pressure. The patient was vaccinated with ZOSTAVAX (subcutaneous, dose and lot# were not reported) on 04-AUG-2012. No other co-suspects were reported. No concomitant medications were reported. On 06-AUG-2012 the patient developed "an itchy red circle/rash at the site of injection." No treatment information was reported. The outcome of an itchy red circle/rash at the site of injection was reported as recovering/resolving. No lab diagnostics studies performed. The patient sought medical attention via speaking to pharmacist. Additional information has been requested.
Age: 33.0
Sex: M
Vaccine: PPV
Symptoms: Decreased appetite, Diarrhoea, Erythema, Nausea, Oedema peripheral
Clinical narrative: This spontaneous report has been received from a registered nurse refers to a 33 years old male patient with allergy to penicillin and medical history of abscess who was vaccinated SC with a 0.5 ml dose of PNEUMOVAX23 (Exp Date: 20-OCT-2013) on 25-JUL-2012. No other co-suspects were reported. Concomitant medications included ZANTAC, HYPROMELLOSE (artificial tears), calcium (unspecified) and ribavirin. Nurse reporting the patient was received PNEUMOVAX23 and the right arm was swollen to the elbow, red and hot to touch and patient experiencing nausea, vomiting, diarrhea, and loss of appetite on 27-JUL-2012. The patient was seen on 20-JUL-2012 for an abscess and given ROCEPHIN prior to vaccination. Patient sought medical attention by calling to nurse. There was no lab diagnostics performed. At the time of report, the patient was recovering. This is one of the several reports with the same reporter and the other two were 1208USA000450 and 1208USA001635. Additional information has been requested.
Age: 33.0
Sex: M
Vaccine: PPV
Symptoms: Skin warm, Vomiting
Clinical narrative: This spontaneous report has been received from a registered nurse refers to a 33 years old male patient with allergy to penicillin and medical history of abscess who was vaccinated SC with a 0.5 ml dose of PNEUMOVAX23 (Exp Date: 20-OCT-2013) on 25-JUL-2012. No other co-suspects were reported. Concomitant medications included ZANTAC, HYPROMELLOSE (artificial tears), calcium (unspecified) and ribavirin. Nurse reporting the patient was received PNEUMOVAX23 and the right arm was swollen to the elbow, red and hot to touch and patient experiencing nausea, vomiting, diarrhea, and loss of appetite on 27-JUL-2012. The patient was seen on 20-JUL-2012 for an abscess and given ROCEPHIN prior to vaccination. Patient sought medical attention by calling to nurse. There was no lab diagnostics performed. At the time of report, the patient was recovering. This is one of the several reports with the same reporter and the other two were 1208USA000450 and 1208USA001635. Additional information has been requested.
Age: 59.0
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 59 years old patient with allergy to cephalosporins, quinolones and penicillin DARVOCET. The patient was vaccinated subcutaneously with a dose of 0.65 ml improperly stored ZOSTAVAX (lot number 671786/0254AE, expire date 08-MAR-2013) on 07-JUL-2012. No other co-suspects were reported. No concomitant medications were reported. The vaccine had been exposed to a total of 17 hours at 60F. No adverse effect has been observed or reported. It was unspecified if the patient had sought medical attention. Additional information has been requested.
Age: 17.0
Sex: M
Vaccine: HPV4
Symptoms: Injection site anaesthesia, Pain, Paraesthesia
Clinical narrative: Information has been received from a registered nurse concerning a 17 year old male with no pertinent medical history and with no known drug reaction or allergies who on 13-JUN-2012 was vaccinated intramuscularly with the first 0.5ml dose of GARDASIL (Lot# 666162/0565Z, expired date 15-SEP-2012). Concomitant therapy included PAXIL. On 13-JUN-2012 20 minutes after injection the patient complained of stinging but also later experienced numbness and a tingling feeling from elbow to the upper arm region in the same area of the injection site. The patient was seen in the office for medical attention. There was no lab diagnostics studies performed. No treatment was given. At the time of this report the patient had not recovered. Follow-up information was received from a registered nurse concerning a 17 year old male student with no illness at time of vaccination and no pre-existing allergies or medical conditions who on 13-JUN-2012 at 09:55 AM, was vaccinated intramuscularly with the first 0.5ml dose of GARDASIL in right deltoid. No other co-suspects were reported. It was reported that on 13-JUN-2012 at 09:55 the patient experienced numbness and tingling of right arm. The patient did not seek medical attention. On 13-JUN-2012, the patient recovered from numbness and tingling of right arm. The relatedness for the patient's events was not provided for GARDASIL. This is one of several reports received from a same source. Additional information is not expected.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Blood test, Injection site discolouration, Insomnia, Pain
Clinical narrative: This spontaneous report as received from a consumer refers to himself, a 65 years old male patient with unspecified sleep issues and no drug reactions or allergies. The patient was vaccinated with a dose of PNEUMOVAX23 (lot # 672057/1417AA, exp. date 22-JUN-2013) on 06-AUG-2012. Concomitant medications included ZYPREXA. On 06-AUG-2012 while on PNEUMOVAX23 the patient could not not sleep and his arm turned black and blue near the injection site. No treatment information was given for adverse events. The patient did unspecified blood work. The patient visited the doctor. The doctor advised him to take TYLENOL for the pain. The outcome of the patient was reported as not recovered. Additional information is not expected.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site rash
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 66 years old female patient with congestion from a cold. The patient was vaccinated with lot # (672962/0025AE) dose 1, 0.5 ml PNEUMOVAX23, IM into her left arm on 12-JUL-2012. No other co-suspects were reported. No concomitant medications were reported. On 12-JUL-2012, since administration the patient experienced pain at the injection site. Redness and rash developed at the injection site on 13-JUL-2012. The patient self-treated with unspecified topical steroid cream and the rash improved. The patient called the office on 16-JUL-2012 and was advised to take ibuprofen or TYLENOL for pain relief. There was no lab diagnostic studies performed. The outcome of rash, redness and pain at the injection site was reported as recovering/resolving. The relatedness for pain, rash and redness at the injection site is unknown for PNEUMOVAX23. This is one of several reports from the same source. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site vesicles
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. The patient was vaccinated with ZOSTAVAX (Lot#, dose/frequency, duration and route were unspecified) on an unknown date. No other co-suspects were reported. No concomitant medications were reported. The pharmacist reported that the patient experienced blisters around the injection site after having been given ZOSTAVAX. The patient had sought unspecified medical attention. No treatment information was reported. At the time of the report, the outcome was unknown. This is one of the several reports received from same reporter. Additional information has been requested.
Age: 16.0
Sex: U
Vaccine: VARCEL
Symptoms: Erythema multiforme, Pyrexia
Clinical narrative: This spontaneous report as received from a physician assistant refers to a 16 years old patient of an unknown gender. The patient was vaccinated with VARIVAX (merck) on 10-JUL-2012 (dose, route, site of administration and lot # not reported). No other co-suspects were reported. No concomitant medications were reported. It was reported that on the following day on 13-JUL-2012, the patient had a fever up to 103 degrees. On 14-JUL-2012, the patient developed erythema multiforme. No treatment information was reported. The patient sought medical attention. The outcome of erythema multiforme and fever up to 103 degrees is unknown. The relatedness for erythema multiforme and fever up to 103 degrees is unknown for VARIVAX (Merck). Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a Doctor of Pharmacy concerning a patient who on 23-APR-2012 was vaccinated with a dose of ZOSTAVAX (dose and route not provided) (lot # 670542/0619AA, expiration date on 26-JUL-2012) that had been stored at an average temperature of 6 degrees Fahrenheit since an unspecified date in April 2012. No symptoms were reported. This is one of several reports received from the same source. Additional information is not expected.
Age: 1.0
Sex: M
Vaccine: HEPA, HIBV, MMR, PNC, VARCEL
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant referring a current 1 year old male patient who was vaccinated with an expired dose 1 of M-M-R II, (lot # 667737/0603Z) (Expired date 23-APR-2012), right leg on 09-MAY-2012. No other co-suspects were reported. No concomitant medications were reported. No adverse effects were reported.
Sex: M
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant referring a male patient of unknown age who on an unspecified date was vaccinated with an expired dose of M-M-R II (lot # 667737/0603Z (Expired date 23-APR-2012). No other co-suspects were reported. No concomitant medications were reported. No adverse effects were reported.
Age: 5.0
Sex: M
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant referring a current 5 year old male patient who was vaccinated with an expired dose 2 of M-M-R II, (lot # 667737/0603Z) (Expired date 23-APR-2012) on 31-MAY-2012. No other co-suspects were reported. No concomitant medications were reported. No adverse effects were reported.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site inflammation, Injection site warmth
Clinical narrative: Information has been received from a registered pharmacist concerning a 63 year old female patient with cancer in remission and no drug reactions or allergies who on 22-JUN-2012 was vaccinated subcutaneously with 0.65 ml dose of ZOSTAVAX (Merck) (lot# 671786/0254AE; expiration date 08-MAR-2013). In June 2012, the patient developed injection site reaction of erythema, inflammation and warmth. The area was about 6 inches long on the patient's arm. The pharmacist said there was no rash. The patient sought unspecified medical attention in the pharmacy. No laboratory diagnostic studies were performed. At the time of the report, the patient had not recovered. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a register nurse concerning a patient of unknown age and gender who on 02-AUG-2012 was vaccinated with the third dose of GARDASIL subcutaneously (lot number and expiration date were not provided). No adverse event were reported. Additional information had been requested.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Fungal infection, Genital burning sensation, Genital disorder female, Lichen sclerosus, Pruritus genital
Clinical narrative: This spontaneous report as received from a 73 years old female consumer reporting on herself with diabetes, 3 pacemakers and drug hypersensitivity to codein, cortisone and phenobarbital. The patient's medical history included stroke. The patient was vaccinated subcutaneously with a 0.65 ml dose of ZOSTAVAX (lot # not reported) on 11-JUL-2012. No other co-suspects were reported. Concomitant medications included CORDARONE, metformin and SYNTHROID. About 3 days after getting the vaccine (approximately on 14-JUL-2012, she experienced severe itching and burning of her genital area. She had a yeast infection and a fungal infection of the area and had now been diagnosed with lichen sclerosus. She also had shrinkage of her genitals. Her health care professional put her on clobetasol and niacin. No lab diagnostic tests were performed. The patient saw the doctor 3 times. The adverse event did not improve and the outcome of lichen sclerosus was reported as not recovered. The relatedness for lichen sclerosus was not provided for ZOSTAVAX. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age. The patient was vaccinated with an expired 0.5 ml dose of M-M-R II (lot # 667879/0788Z expiration date 16-JUN-2012), SQ on 11-JUL-2012. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Delivery, Inappropriate schedule of drug administration, Laboratory test, Maternal exposure during pregnancy, Normal newborn
Clinical narrative: Information has been received from a physician, for GARDASIL, a Pregnancy Registry product, concerning a 24 year old female with depression, gestation for 14 weeks and 5 days and no drug allergies who on 09-OCT-2010, 17-OCT-2011 were vaccinated with the first and second dose of GARDASIL, respectively. Concomitant therapy included prenatal vitamins (unspecified). On an unspecified date, routine lab blood work was performed with unspecified results. The patient contacted physician to seek medical attention. No treatment was given for the adverse event. The last menstrual period was on 07-JUL-2011, and estimated delivery date was on 12-APR-2012. At the time of the report, the patient's outcome was unknown. Follow up information has been received from an outreach specialist who reported that the patient gave birth on 19-APR-2012 at 40 weeks, to a healthy baby boy via vaginal delivery. The infant weighted 8 lb 5 oz. There were no complications with delivery or infant congenital anomalies reported. Follow-up information has been received from a physician concerning a patient with obesity and depression and a history of two previous pregnancies and two elective abortions. Concomitant medication was reported as "prenatal vitamins". It was reported that the patient gave birth on 19-APR-2012 at 41 weeks (previously reported 40), to a male infant without congenital anomalies; it was also reported that the baby was not normal. Apgar scare 8/9. Diagnostic tests included ultrasound scan (Date:unknown, result: normal). There is no complication and infections or illness during pregnancy. No further information is available.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Ultrasound scan normal
Clinical narrative: Information has been received from a physician, for GARDASIL, a Pregnancy Registry product, concerning a 24 year old female with depression, gestation for 14 weeks and 5 days and no drug allergies who on 09-OCT-2010, 17-OCT-2011 were vaccinated with the first and second dose of GARDASIL, respectively. Concomitant therapy included prenatal vitamins (unspecified). On an unspecified date, routine lab blood work was performed with unspecified results. The patient contacted physician to seek medical attention. No treatment was given for the adverse event. The last menstrual period was on 07-JUL-2011, and estimated delivery date was on 12-APR-2012. At the time of the report, the patient's outcome was unknown. Follow up information has been received from an outreach specialist who reported that the patient gave birth on 19-APR-2012 at 40 weeks, to a healthy baby boy via vaginal delivery. The infant weighted 8 lb 5 oz. There were no complications with delivery or infant congenital anomalies reported. Follow-up information has been received from a physician concerning a patient with obesity and depression and a history of two previous pregnancies and two elective abortions. Concomitant medication was reported as "prenatal vitamins". It was reported that the patient gave birth on 19-APR-2012 at 41 weeks (previously reported 40), to a male infant without congenital anomalies; it was also reported that the baby was not normal. Apgar scare 8/9. Diagnostic tests included ultrasound scan (Date:unknown, result: normal). There is no complication and infections or illness during pregnancy. No further information is available.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Diplopia, Herpes zoster, Vision blurred
Clinical narrative: This spontaneous report as received from a 75 years old male consumer with no drug reactions or allergies refers to himself. The patient was vaccinated with a dose of ZOSTAVAX in November, 2011. On 09-JUL-2012 the patient developed shingles on the left side of the top of his head and around his left eye following vaccination. The consumer has experienced blurred and double vision in his left eye. The consumer was seeing an eye doctor and his regular physician for consulting. BLEPHAMIDE and unspecified medication ("pills") were given for the adverse events. Magnetic resonance imaging (MRI) was performed for lab diagnostics studies (result unknown). The outcome of the patient was reported as not recovered. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a health care worker concerning unspecified number of patients, who on unspecified dates were vaccinated with the second dose of GARDASIL (Lot # not reported) late. No adverse reactions were reported. Attempts are being made to obtain additional information to distinguish individual patients mentioned in this report. Additional information will be provided if available. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report was received from a Doctor of Pharmacy concerning a patient who on 20-MAY-2012 was vaccinated with a dose of ZOSTAVAX (dose and route not provided) (lot # 670542/0619AA, expiration date on 26-JUL-2012) that had been stored at an average temperature of 6 degrees Fahrenheit since and unspecified date in April 2012.. No symptoms were reported. This is one of several reports received from the same source. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant concerning a patient who on 29-NOV-2010 was vaccinated with the first dose of GARDASIL (dose, route and lot # not provided), on 07-FEB-2011 received the second dose of GARDASIL (dose, route and lot # not provided) and on 11-APR-2011 received the third dose of GARDASIL (dose, route and lot # not provided). No other co-suspects were reported. No concomitant medications were reported. The medical assistant stated that on 10-JUL-2012, the patient received the fourth dose of GARDASIL (dose, route and lot # not provided). No adverse reactions were reported. Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a Doctor of Pharmacy concerning two patients who on 06-JUN-2012 were vaccinated with a dose of ZOSTAVAX (dose and route not provided) (lot # 670542/0619AA, expiration date on 26-JUL-2012) that had been stored at an average temperature of 6 degrees Fahrenheit since an unspecified date in April 2102.. No symptoms were reported. This is one of several reports received from the same source. Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a Doctor of Pharmacy concerning a patient who on 11-JUN-2012 was vaccinated with a dose of ZOSTAVAX (dose and route not provided) (lot # 670542/0619AA, expiration date on 26-JUL-2012) that had been stored at an average temperature of 6 degrees Fahrenheit since an unspecified date in April 2012. No symptoms were reported. This is one of several reports received from the same source. Additional information is not expected.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Rash
Clinical narrative: This spontaneous report was received from a consumer concerning her 14 year old daughter with no pertinent medical history or drug reactions/allergies who in February 2012 was vaccinated with the second dose of GARDASIL 0.5 mL, IM (lot # not provided). There were no concomitant medications. In February 2012, the patient developed a rash on her arms and legs after receiving her second dose of GARDASIL. On 09-FEB-2012, the patient was vaccinated with the third dose of GARDASIL, 0.5 mL, IM (lot # not provided), and started having headaches and the rash had begun again on her arms and legs. No laboratory tests were performed. The patient was treated with over the counter (OTC) pain medicines. At the time of the report, the patient had not recovered from the events. The relatedness for the events was unknown for GARDASIL. The patient did not seek medical attention. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Soft tissue disorder
Clinical narrative: This spontaneous report as received from a physician refers to a currently 63 years old female patient who was asthmatic. The patient was vaccinated with a dose of PNEUMOVAX23 (Lot #, dose and route not reported) on 28-JUN-2012. No other co-suspects were reported. No concomitant medications were reported. It was reported that the patient was using PNEUMOVAX23 and experienced a soft tissue reaction in 2012. The patient was given antibiotics as treatment for the event. At the time of the report, the patient's outcome was unknown. The patient sought medical attention by an office visit. The relatedness for soft tissue reaction was unknown for PNEUMOVAX23. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (dose, route and Lot# not reported). The reporter stated that the patient experienced an "adverse event" with ZOSTAVAX. The outcome was not reported. Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Oedema peripheral, Rash
Clinical narrative: This spontaneous report as received from a physician refers to a male patient of unknown age who on an unknown date was vaccinated with a dose of PNEUMOVAX 23 (dose, route and lot number not reported). No other co-suspects were reported. No concomitant medications were reported. It was reported that on an unknown date the patient experienced a rash and swelling on the arm that was vaccinated. No treatment information was reported. At the time of the report, the patient's outcome was unknown. The relatedness for patient experienced a rash and swelling on the arm that was vaccinated was unknown for PNEUMOVAX 23. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event, Physical product label issue, Product quality issue
Clinical narrative: This spontaneous report as received from a doctor of pharmacy refers to a female patient of unknown age who on 01-JUL-2012, was vaccinated with a dose of PNEUMOVAX 23 (lot # 667912/0933Z) (dose and route not reported) that was expired. It was reported that the expiration date on the vial label was smudged and illegible. The vaccine expired on 25-Feb-2012, this date was obtained from the Order Management Center. No adverse effects were reported. A PQC was involved. The pharmacist reported that the affected vial had been previously opened, and that multiple doses have been withdrawn from the vial. No outer packaging remained with the vial. The expiration date on the label was smudged and illegible, the pharmacist stated that she did not whether that occurred prior to receipt of the vial by the pharmacy or during storage, handling and administration of the product. Primary vial label was affected. It was reported that lot number was legible, expiration was not legible. No other vials from the lot were available to check. No boxes were available to check the affected vial contained lot number 667912/0933Z. The product was received "a long time ago". Crimp and stopper of the multidose vial looked intact and appeared as they normally do; doses of vaccine had been administered previously. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: This spontaneous report as received from a physician refers to a female patient of unknown age. The patient was vaccinated with a dose of GARDASIL (lot #, dose and route not reported) on an unspecified date. No other co-suspects and no concomitant medications were reported. Since an unknown date the patient had been experiencing periodic syncopal episodes. The patient was seen by a pediatric cardiologist for the syncopal events. The parent of the patient was told by the cardiologist that he has seen an increase in adolescent patients coming to him with syncope events post vaccination with GARDASIL. No treatment information was reported. The outcome of periodic syncopal episodes was unknown. The relatedness for the reported event was unknown for GARDASIL. Additional information is not expected.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a physician refers to a patient of unknown age. On unspecified dates in 2002, the patient received the first and second dose of RECOMBIVAX HB (dose, route and lot # not provided). No other co-suspects were reported. No concomitant medications were reported. In 2012 "recently", the patient received the third dose of RECOMBIVAX HB (dose, route and lot # not provided). No symptoms were reported. This is one of several reports from the same patient. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Expired drug administered
Clinical narrative: This spontaneous report was received from a healthcare professional concerning a patient of unknown age and gender who on 24-JUL-2012 was vaccinated with a expired dose of VARIVAX (merck), subdermal (lot number 668404/0972Z, expiration date 21-JUL-2012). Additional information is not expected.
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age. The patient was vaccinated with an expired 0.5 ml dose of M-M-R II (lot # 667879/0788Z expiration date 16-JUN-2012), SQ on 11-JUN-2012. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 7.0
Sex: M
Vaccine: FLUN3, FLUN3
Symptoms: Convulsion
Clinical narrative: Generalized seizures 20 days after received imms.
Age: 7.0
Sex: M
Vaccine: FLUN3, FLUN3
Symptoms: Convulsion, Electroencephalogram, Nuclear magnetic resonance imaging
Clinical narrative: Generalized seizures 20 days after received imms.
Age: 18.0
Sex: M
Vaccine: HEPA, HPV4, TDAP, VARCEL, HEPA, HPV4, TDAP, VARCEL
Symptoms: Injection site erythema, Pruritus
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the Food and Drug Administration (FDA) (VAERS ID number 451282-1) under the Freedom of Information Act concerning a 18 year old male patient with none medical history and none previous illness vaccinated with the first dose of GARDASIL (lot number 670049/1171AA) (dose not provided) and the first dose of VAQTA (lot number reported as 1228AA) (dose not provided) both intramuscular at his left arm on 26-FEB-2012. Secondary suspect therapies included the second dose of VARIVAX (Merck) (lot number reported as 1090AA) (dose not provided) subcutaneous into the right arm and the fifth dose of ADACEL (lot number C3837BA) intramuscular at his right arm on 26-FEB-2012. On 28-FEB-2012, the patient had redness at injection site with size of 50 cent piece. The patient also had itching, no induration. Ibuprofen and apply ice locally to area were given to patient. At the time of reporting, the outcome was unknown. The original reporting source was not provided. Additional information is not expected.
Age: 7.0
Sex: M
Vaccine: FLUN3, FLUN3
Symptoms: Electroencephalogram abnormal, Fall
Clinical narrative: Seizure 5 weeks after receiving FLUMIST.
Age: 7.0
Sex: M
Vaccine: FLUN3, FLUN3
Symptoms: Convulsion
Clinical narrative: Seizure 5 weeks after receiving FLUMIST.
Age: 14.0
Sex: F
Vaccine: HEPA, HPV4, TDAP, HEPA, HPV4, TDAP
Symptoms: Syncope
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 14 years old female patient with no previous illness and penicillin allergy was vaccinated with a dose 1 GARDASIL (Lot # 672193/1524AA), left arm on 02-APR-2012. No other co-suspects were reported. Concomitant medications included a dose of HAVRIX and a dose of ADACEL. There were no concomitant medications. It was reported that on 02-APR-2012 the patient fainted post administration of GARDASIL, HAVRIX and ADACEL, patient waited 20 minutes accessed and was ok to leave the office. This report was considered non serious with not conditions by the agency. The original reporting source was not provided. The VAERS ID # is 453161-1. Additional information is not expected.
Age: 23.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Injection site rash, Rash
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 23 years old female patient with no previous illnesses and no medical history was vaccinated with a dose 1 of GARDASIL (Lot # 672192/1524AA), Right arm, Unknown route on 05-APR-2012. No other co-suspects were reported. Concomitant medications included: BEYAZ. It was reported that on 05-APR-2012 the patient developed pin point rash that started on bilateral forearms approximately 6 hours after vaccination. On 06-APR-2012 the patient developed rash around injection site, arms, chest, and bilateral lower extremities. The patient was in observation only was started on MEDROL DOSEPACK. The outcome of the events mentioned above was unknown. This report was considered non serious with not conditions by the agency. The original reporting source was not provided. The VAERS ID# is 453242-1. Additional information is not expected.
Age: 24.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Urticaria
Clinical narrative: This report was obtained on request by the Company from the FDA under the Freedom of Information Act. A 24 years old female patient with penicillin and sea food allergies was vaccinated with dose 2 of GARDASIL, (lot # 665607/1333Y), Right arm, IM on 07-FEB-2012. No other co-suspects were reported. Concomitant medications included DEPO-PROVERA. It was reported that on 07-FEB-2012 (09-FEB-2012 also reported) patient called and stated that she "got hives all over" and took BENADRYL with relief. The patient was advised not to receive more GARDASIL. This report was considered not serious with not conditions by the agency. The original reporting source was not provided. The VAERS ID# is 453252-1. Additional information is not expected.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Muscle tightness, Nausea, Throat tightness
Clinical narrative: This report was obtained on request by the company from the FDA under the Freedom of Information Act. A 16 years old female patient with hypothyroidism and no previous illnesses was vaccinated with a dose 2 of GARDASIL (lot # 672653/1860AA), IM on 09-APR-2012. No other co-suspects were reported. Concomitant medications included levonorgestrel, loratadine and LUVOX CR. Past medical drug included bee venom. It was reported that on 09-APR-2012, the patient had tightness in her neck and throat and felt nauseated. BENADRYL 50 mg was given. a blood pressure (BP) and heart rate (HR) were checked in sitting and supine position (no results provided). The outcome of patient's events mentioned above was unknown. This report was considered non serious with not conditions by the agency. The original reporting source was not provided. The VAERS ID# is 453274-1. Additional information is not expected.
Age: 0.2
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5
Symptoms: Intussusception
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 2 months old male patient treated with dose 1 of ROTATEQ lot # (671218/0922AA) on 30-MAR-2012 experienced intussusception, vomiting projectile and barium enema, Lab test result, abdominal ultrasound was normal, CHEM-Creatinine 0.30L. No further information is available.
Age: 0.2
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5
Symptoms: Barium enema normal, Blood creatinine normal, Intussusception, Laboratory test normal, Ultrasound abdomen abnormal
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 2 months old male patient treated with dose 1 of ROTATEQ lot # (671218/0922AA) on 30-MAR-2012 experienced intussusception, vomiting projectile and barium enema, Lab test result, abdominal ultrasound was normal, CHEM-Creatinine 0.30L. No further information is available.
Age: 0.2
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5
Symptoms: Ultrasound scan abnormal, Vomiting projectile
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 2 months old male patient treated with dose 1 of ROTATEQ lot # (671218/0922AA) on 30-MAR-2012 experienced intussusception, vomiting projectile and barium enema, Lab test result, abdominal ultrasound was normal, CHEM-Creatinine 0.30L. No further information is available.
Age: 25.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Nausea, Rash, Sensation of foreign body
Clinical narrative: This report was obtained on request by the Company from the FDA under the Freedom of Information Act. A 25 years old female patient on 09-APR-2012 at 10:10 AM was vaccinated IM with the third dose of GARDASIL (lot # 672547/1745AA) into the left arm. No other co-suspects were reported. Concomitant medications included ethinyl estradiol, NORDETTE 28 and hormonal contraceptives (unspecified) (BCP; manufacturer unspecified). On 09-APR-2012, at noon, the patient felt nausea and returned to health services at 2PM with foreign body sensation in throat. It was given Epinephrine, BENADRYL for the treatment of the adverse events and was sent to ER and discharged. The patient required a service at 4 am on 10-APR-2012 with foreign body sensation - not as intense. Also, the patient was treated with prednisone, ZYRTEC in the office on 10-APR-2012 at 11:30. It was reported that the patient was better next 24 hours. Also, it was mentioned that on an unspecified date the patient had rash 10 days after Meningococcal vaccines. The patient required an emergency room visit. This report was considered non serious by the agency. The original reporting source was not provided. The VAERS ID# is 4563666.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Rash
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 16 year old female patient with no known significant medical history and no known allergies history, treated with the first dose of GARDASIL (lot # reported as 1537AA) intramuscular on left arm on 16-MAR-2012 experienced rash on arms on an unknown date. Other medications included: AVIANE (ocp). Whether the patient sought for medical attention was not reported. The original reporting source was not provided. The VAERS ID# was 454075. No further information is available.
Age: 16.0
Sex: M
Vaccine: HPV4, MNQ, HPV4, MNQ
Symptoms: Syncope, Tonic clonic movements
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act refers to a 16 years old male patient with no medical history. The patient was vaccinated IM in right arm with the first dose of GARDASIL (lot # 667194/1271Z) on 17-APR-2012. Before that the patient was vaccinated IM in left arm with MENACTRA (lot# U4040AA). Concomitant medications also included: gabapentin and hemp. On 17-APR-2012 the patient experienced syncope and tonic clonic reaction. The adverse events were considered to be non-serious. There was no illness at the time of vaccination. This lasted for approximate 20-30 seconds. His vitals were stable post event. He had not eaten breakfast so he was given a complex carb and a drink. He quickly recovered. He was monitored for 1 hour and discharged home. A call was placed to check on patient the next day and he was doing well. It was reported that sibling had similar reaction. Additional information is not expected. The original reporting source was not provided. The VAERS ID # is 454253-1.