chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: RV5
Symptoms: Crying, Product taste abnormal, Underdose
Clinical narrative: This spontaneous report as received from a licensed visiting nurse refers to an unspecified number of babies of unknown age. The patients were vaccinated with lot # (670243/0921AA, exp date 15-DEC-2012) dose of ROTATEQ on unspecified dates. No other co-suspects were reported. No concomitant medications were reported. The nurse stated that when the medical assistants were giving ROTATEQ with lot number 0921AA, the babies cried like it did not taste good spitting it out. The nurse reported that babies seem to cry more and spit the product out more with the lot number in description above. No treatment information was reported. The outcome of crying like it did not taste good was unknown. The nurse felt that the events were related to ROTATEQ lot number 0921AA. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site discolouration
Clinical narrative: This spontaneous report was received from a physician assistant refers to a 25 years old female patient who on 12-JUL-2012 was vaccinated with the third dose of GARDASIL, route was reported as injection, Lot number 1860AA, Expiration date: unknown. No other co-suspects were reported. No concomitant medications were reported. The company representative was informed by the PA that the patient was taking GARDASIL and on 15-JUL-2012, "after dose 3 there was hypo pigmentation and hyper pigmentation around the injection site. The size was 3.1 centimeters. The patient visited the physician's office. No treatment was given to the patient. No additional information was provided. At the time of reporting, the patient was recovering. Action taken was not applicable. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Alopecia
Clinical narrative: This spontaneous report was received from a physician refers to a physician's daughter's friend of unknown age, who in an unknown date was vaccinated with a dose of GARDASIL (dose, route and lot number not reported). No other co-suspects were reported. No concomitant medications were reported. The physician reported that on an unknown date, the patient developed hair loss after receiving GARDASIL. At the time of the report, the patient's outcome was unknown. It was unspecified if the patient sought medical attention. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered pharmacist refers to a patient of unknown age who on 07-AUG-2012, was inadvertently vaccinated subcutaneously with a single dose of ZOSTAVAX (lot number 670547/0659AA) that was expired. The vaccine expired on 04-AUG-2012. No adverse effects were reported. This is one of several reports from the same source. Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. The patient was vaccinated with lot # (670617/0618AA) ZOSTAVAX (dose, and route not reported) on 30-JUL-2012. The pharmacist reported that on 30-JUL-2012, the patient received an expired ZOSTAVAX. No adverse events reported. The relatedness for no adverse events and patient received expired ZOSTAVAX (lot#0618AA, expiration date 26-JUL-2012). Additional information has been requested. This is one of several reports from the same source.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site induration, Injection site swelling
Clinical narrative: This spontaneous report as received from a 51 years old female medical assistant who is the patient with a lot of unspecified allergies. In July 2012, about two weeks ago, the patient was vaccinated with a 0.65 ml dose of ZOSTAVAX. No other co-suspects were reported. No concomitant medications were reported. The patient told the representative that she was given ZOSTAVAX and later that day the arm she got the vaccine in became "hard and swollen" from her shoulder to her elbow. The patient verified that there was no rash. The patient also told this representative that she had the same reaction to an unspecified flu vaccine about 10 years ago. No treatment was given. The patient recovered from the arm she got the vaccine in became hard and swollen" from her shoulder to her elbow 5 days after the vaccination. No additional information was provided. Additional information has been requested.
Age: 28.0
Sex: M
Vaccine: ANTH
Symptoms: Depression, Pain
Clinical narrative: Severe depression and body ache.
Age: 7.0
Sex: F
Vaccine: FLUN3
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: Complaint of body aches and headache, on 8/24/2012 complaint of severe headache, 8/25/2012 complaint of severe headache and slight fever.
Age: 63.0
Sex: M
Vaccine: PPV
Symptoms: Angioedema, Injection site discomfort, Injection site erythema, Injection site induration, Injection site reaction
Clinical narrative: Outpatient adult male who spiked fever 101.5 on 08/23/2012 after receiving flu vaccine in left deltoid IM and Pneumovax vaccine SQ in the left upper lateral brachus on 8/22/2012; Noted discomfort, swelling and redness in left upper arm on 08/24/12 and progressive worsening of symptoms.  Arrived afebrile on 8/25/2012 in clinic at approx 09:45 AM with an erythemic region on left upper arm on the lateroposterior aspect of the upper arm measuring 18 X 19 CM of erythema and angioedema with induration.  Demonstated moderaterate tenderness with tactile stimulation.
Age: 63.0
Sex: M
Vaccine: PPV
Symptoms: Injection site swelling, Pyrexia
Clinical narrative: Outpatient adult male who spiked fever 101.5 on 08/23/2012 after receiving flu vaccine in left deltoid IM and Pneumovax vaccine SQ in the left upper lateral brachus on 8/22/2012; Noted discomfort, swelling and redness in left upper arm on 08/24/12 and progressive worsening of symptoms.  Arrived afebrile on 8/25/2012 in clinic at approx 09:45 AM with an erythemic region on left upper arm on the lateroposterior aspect of the upper arm measuring 18 X 19 CM of erythema and angioedema with induration.  Demonstated moderaterate tenderness with tactile stimulation.
Age: 16.0
Sex: F
Vaccine: HEP, TDAP, VARCEL
Symptoms: Dizziness, Fall, Head injury, Headache, Immediate post-injection reaction
Clinical narrative: Patient fainted immediately following administration of 3 immunizations (Tdap, pediatric Hepatitis B, and Varicella).  When patient fainted, she fell from a seated position to the floor, hitting her head.  She initially complained of dizziness and pain at the site of injury; VS WNL.  Within 1 hour, pt complained of frontal headache and nausea; referred to local emergency room for evaluation.
Age: 16.0
Sex: F
Vaccine: HEP, TDAP, VARCEL
Symptoms: Nausea, Pain, Syncope
Clinical narrative: Patient fainted immediately following administration of 3 immunizations (Tdap, pediatric Hepatitis B, and Varicella).  When patient fainted, she fell from a seated position to the floor, hitting her head.  She initially complained of dizziness and pain at the site of injury; VS WNL.  Within 1 hour, pt complained of frontal headache and nausea; referred to local emergency room for evaluation.
Age: 5.0
Sex: M
Vaccine: PNC13
Symptoms: Pyrexia
Clinical narrative: Fever.
Age: 12.0
Sex: M
Vaccine: FLUN3
Symptoms: Decreased appetite, Eye discharge, Fatigue, Nausea, Pyrexia
Clinical narrative: He had high fever, nasal discharge, eye discharge slightly, anorexia, exhaustion, nausea for one day. After that day he still had mild to moderate fever for almost a week with complete loss of appetite with exhaustion. I offered him Tylenol for two days.
Age: 12.0
Sex: M
Vaccine: FLUN3
Symptoms: Rhinorrhoea
Clinical narrative: He had high fever, nasal discharge, eye discharge slightly, anorexia, exhaustion, nausea for one day. After that day he still had mild to moderate fever for almost a week with complete loss of appetite with exhaustion. I offered him Tylenol for two days.
Age: 1.28
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Pyrexia
Clinical narrative: Fever started 8/13/12.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Activities of daily living impaired, Headache, Myalgia, Nausea, Pyrexia
Clinical narrative: Pt in office for routine 15 yr old physical. Not ill, felt great. Has had 2 previous GARDASIL vaccines. About 2 hrs after vaccine, pt felt nauseous, febrile, severe  myalgias, headache. Could not attend school or cross country practice. Sx resolved in 24 hrs.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Oedema peripheral
Clinical narrative: Pt said liquid hurt when it went in her arm. Swollen in 2 days - MD said to treat w/ heat called RpH on 8/24/12 & we told her to ice the area.
Age: 82.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Oedema peripheral
Clinical narrative: Redness and swelling in left arm. Pt. took 2 doses of BENADRYL. Completely resolved by next day.
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Anxiety, Condition aggravated, Hypopnoea, Palpitations, Tachycardia
Clinical narrative: Pt. had anxiety attack. Tachycardia, palpitations, shallow breathing. EMS was called upon pt. request and was taken to ER upon her request.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Red, warm, swelling at injection site injection on 8/21/12, she said site reaction seemed to get worse thru 8/24/12, better 8/25/12 when she came in to see me at pharmacy.
Age: 22.0
Sex: F
Vaccine: MMR
Symptoms: Rubella antibody negative
Clinical narrative: This spontaneous report as received from a medical assistant refers to a currently 22 years old female patient with attention deficit disorder. The patient was vaccinated with MMR II (lot number, Albumin status of rHa or HAS were not reported) (dose, route and injection site were not known) on an unknown date. No other co-suspects were reported. Concomitant medication was ADDERALL tablets. On an unknown date the patient had a negative titer for rubella. The reporter thought the patient had received at least one dose of MMR II sometime in the past, but she did not have the vaccination records available at the time of report. There was no treatment given for the adverse event. Laboratory diagnostics rubella titers were performed and the results was negative. The present status of patient was reported as "rubella titer is negative". The patient had sought unspecified medical attention. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age. It was reported that an expired dose of 0.5 ml PNEUMOVAX 23 (lot # 667914/1067Z, expired on 28-FEB-2012) was intramuscularly administered to a patient on 10-AUG-2012. No adverse effect was reported. The outcome of patient was unknown. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age. The patient was vaccinated with first dose GARDASIL on 16-JUN-2008 (lot # and route were unspecified). It was reported that the patient received the second dose of GARDASIL late on 13-AUG-2012 (lot # and route were unspecified). The patient was not experiencing any known symptoms. No other information were provided. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: FLUX
Symptoms: Cold sweat, Dizziness, Dysstasia, Flushing, Nausea
Clinical narrative: About 15 minutes after receiving a flu shot, I suddenly felt all the blood drain from my face and my skin go clammy even though I was walking around. I felt dizzy, very lightheaded and nauseous and my visual surroundings became grainy and out of focus. I sat down and vomited and could not stand up for the next half hour.
Age: 19.0
Sex: F
Vaccine: FLUX
Symptoms: Vision blurred, Visual impairment, Vomiting
Clinical narrative: About 15 minutes after receiving a flu shot, I suddenly felt all the blood drain from my face and my skin go clammy even though I was walking around. I felt dizzy, very lightheaded and nauseous and my visual surroundings became grainy and out of focus. I sat down and vomited and could not stand up for the next half hour.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain upper, Activities of daily living impaired, Fatigue, Influenza like illness
Clinical narrative: Friday, day after 1st injection. Flu-like symptoms, stomach ache, fatigue. Sent home from school, went to bed. Called Dr. told to bring her in if still feeling bad on Monday.
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Dyspnoea, Productive cough, Wheezing
Clinical narrative: On 8/21/2012 at 3:05 PM pt received influenza vaccine Fluzone and PPD/TB skin test few minutes apart, same day. Well tolerated at the clinic. When she gets home she developed SOB, chest tightness, wheezing, and wet cough. Treated at home by parents who are nurses with steroids and albuterol orally. Shortly after symptoms resolved. Pt returned to HC on 8/24/2012 at 12:15 PM for PPD/TB skin test results and reported the event at that time. Now pt is doing well, no complains at this moment.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Contusion, Pain in extremity, Paraesthesia, Skin warm
Clinical narrative: Arm hot to the touch, painful. Localized bruising. Tingle, sore.
Age: 19.0
Sex: M
Vaccine: FLUN3, HPV4
Symptoms: Arthralgia, Fatigue, Lymphadenopathy, Malaise, Pyrexia
Clinical narrative: Began with hives, progressed to fever, joint paint, fatigue, ill feeling, swollen lymph nodes. Saw healthcare provider on 22nd but hives were gone at this point. Didn't prescribe anything. Went to ER the evening of the 22nd. Labs drawn and prednisone and antibiotic given. Saw primary doctor on 23rd. Hives gone at this point and fever gone. Continue on meds. Started getting more hives on 24th and had tongue swollen on 25th. Continues to break out even while on 40mg prednisone and taking antihistamines. Very scared for him once the steroids are completed. Trying to get in to a specialist.
Age: 19.0
Sex: M
Vaccine: FLUN3, HPV4
Symptoms: Swollen tongue, Urticaria
Clinical narrative: Began with hives, progressed to fever, joint paint, fatigue, ill feeling, swollen lymph nodes. Saw healthcare provider on 22nd but hives were gone at this point. Didn't prescribe anything. Went to ER the evening of the 22nd. Labs drawn and prednisone and antibiotic given. Saw primary doctor on 23rd. Hives gone at this point and fever gone. Continue on meds. Started getting more hives on 24th and had tongue swollen on 25th. Continues to break out even while on 40mg prednisone and taking antihistamines. Very scared for him once the steroids are completed. Trying to get in to a specialist.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Back pain, Bacterial test positive, Blood test, Decreased appetite, Headache
Clinical narrative: High fevers (104.5), swollen and a red rash where injections were given. The right thigh has a large welt in the center of the rash. Headaches, back aches, tingly fingers, swollen tonsils, so much so they almost touched, high white blood counts, lack of appetite, wouldn't/won't drink, mild rash on is back and shoulders, sores in his mouth and nose, throwing up....I have pictures of the injection sites.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site rash, Injection site swelling, Injection site urticaria, Mononucleosis heterophile test negative
Clinical narrative: High fevers (104.5), swollen and a red rash where injections were given. The right thigh has a large welt in the center of the rash. Headaches, back aches, tingly fingers, swollen tonsils, so much so they almost touched, high white blood counts, lack of appetite, wouldn't/won't drink, mild rash on is back and shoulders, sores in his mouth and nose, throwing up....I have pictures of the injection sites.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Paraesthesia, Pyrexia, Rash, Stomatitis, Tonsillitis
Clinical narrative: High fevers (104.5), swollen and a red rash where injections were given. The right thigh has a large welt in the center of the rash. Headaches, back aches, tingly fingers, swollen tonsils, so much so they almost touched, high white blood counts, lack of appetite, wouldn't/won't drink, mild rash on is back and shoulders, sores in his mouth and nose, throwing up....I have pictures of the injection sites.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Vomiting, West Nile virus test negative, White blood cell count increased
Clinical narrative: High fevers (104.5), swollen and a red rash where injections were given. The right thigh has a large welt in the center of the rash. Headaches, back aches, tingly fingers, swollen tonsils, so much so they almost touched, high white blood counts, lack of appetite, wouldn't/won't drink, mild rash on is back and shoulders, sores in his mouth and nose, throwing up....I have pictures of the injection sites.
Age: 46.0
Sex: F
Vaccine: DTP
Symptoms: Mobility decreased, Pain, Rash erythematous
Clinical narrative: Severe pain that woke me up in the middle of the night and could not move arm.  The next day I had a large red rash on the arm bicep area.
Sex: F
Vaccine: FLU3
Symptoms: Injection site haematoma, Mobility decreased, Pain in extremity
Clinical narrative: Patient states her whole forearm has been hurt since the vaccination. She has some difficulty moving her arm, bruise at injection site.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Facial pain, Herpes zoster, Rash, Speech disorder
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 83 years old female patient with asthma, hyperthyroidism and allergies to sulfa. The patient was vaccinated with ZOSTAVAX (0.65 ml, lot # not reported) on 28-NOV-2007. Since the administration of the product, the patient has had two cases of shingles on her face. The first incidence was in "May of 2008" where she developed pain and a rash on her face. She also was having trouble speaking at that time. "A couple of weeks ago " the patient was hospitalized for "pain in her face". Pharmacist was unsure of the diagnosis made in the hospital but knew the patient was prescribed gabapentin at that time. The patient thought that this was a new case of shingles developing and was going to follow up with her primary care physician, today on 20-AUG-2012. Pharmacist adamant since patient was not presenting with rash at present time. No other co-suspects were reported. Concomitant medications included FLOVENT, albuterol, gabapentin and prednisone. At the time of report the outcome was reported as not recovered/not resolved. Treatment of OXYCONTIN was given for adverse event. The patient sought medical attention via office visiting. The events were reported as disabling by the pharmacist. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Blood test, Dizziness, Echocardiogram, Electrocardiogram, Encephalopathy
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 15 years old female patient with no pertinent medical history and drug allergy. The patient was vaccinated with the first, second and third dose of GARDASIL (Lot# unspecified) intramuscularly on 17-AUG-2009, 11-NOV-2009 and 06-MAY-2010 respectively with no concomitant medication. No other co-suspects were reported. On 09-MAY-2010 the patient developed neck pain, dizziness, headache, unspecified "vision problems," shoulder pain, and "trouble sleeping." The patient went to an unspecified emergency room where she was diagnosed with post vaccine encephalopathy and hypothyroidism. She was given levothyroxine sodium and amitriptyline hydrochloride. She was then discharged from the emergency room. She was still recovering at time of the report. Magnetic Resonance Imaging, blood tests, electrocardiogram, echocardiogram, x-ray and spinal tap were performed (no results reported). Upon internal review, post vaccine encephalopathy was considered to be an other medically significant event. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Hypothyroidism, Insomnia, Lumbar puncture, Musculoskeletal pain
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 15 years old female patient with no pertinent medical history and drug allergy. The patient was vaccinated with the first, second and third dose of GARDASIL (Lot# unspecified) intramuscularly on 17-AUG-2009, 11-NOV-2009 and 06-MAY-2010 respectively with no concomitant medication. No other co-suspects were reported. On 09-MAY-2010 the patient developed neck pain, dizziness, headache, unspecified "vision problems," shoulder pain, and "trouble sleeping." The patient went to an unspecified emergency room where she was diagnosed with post vaccine encephalopathy and hypothyroidism. She was given levothyroxine sodium and amitriptyline hydrochloride. She was then discharged from the emergency room. She was still recovering at time of the report. Magnetic Resonance Imaging, blood tests, electrocardiogram, echocardiogram, x-ray and spinal tap were performed (no results reported). Upon internal review, post vaccine encephalopathy was considered to be an other medically significant event. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Neck pain, Nuclear magnetic resonance imaging, Visual impairment, X-ray
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 15 years old female patient with no pertinent medical history and drug allergy. The patient was vaccinated with the first, second and third dose of GARDASIL (Lot# unspecified) intramuscularly on 17-AUG-2009, 11-NOV-2009 and 06-MAY-2010 respectively with no concomitant medication. No other co-suspects were reported. On 09-MAY-2010 the patient developed neck pain, dizziness, headache, unspecified "vision problems," shoulder pain, and "trouble sleeping." The patient went to an unspecified emergency room where she was diagnosed with post vaccine encephalopathy and hypothyroidism. She was given levothyroxine sodium and amitriptyline hydrochloride. She was then discharged from the emergency room. She was still recovering at time of the report. Magnetic Resonance Imaging, blood tests, electrocardiogram, echocardiogram, x-ray and spinal tap were performed (no results reported). Upon internal review, post vaccine encephalopathy was considered to be an other medically significant event. Additional information has been requested.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Confusional state, Dizziness, Ear discomfort, Nasal congestion
Clinical narrative: Via phone, pt stated about 45 min after vaccination to experienced nasal congestion, plugged ears, dizziness, increased confusion shortly after all these symptoms. Pt declined seeing MD/ER at this time.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site haematoma, Injection site swelling
Clinical narrative: Pt returned to the Pharmacy on 8-24-12 with a swollen bruised area at the site of vaccine injection. Length 3.5 inches and width of approximately 1.2 to 1.6 inches.
Sex: M
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant refers to a male patient of unknown age. The patient was vaccinated intramuscularly with a first, second and third 0.5 ml doses of GARDASIL on 28-MAY-2012, 18-JUL-2012 and 25-JUL-2012, respectively. No adverse effect reported. Additional information is not expected.
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Maternal exposure during pregnancy, No adverse event, Pregnancy test urine positive
Clinical narrative: Information has been received from a physician, for GARDASIL, a Pregnancy Registry product, concerning a 16 years old female patient patient. The patient's history of previous pregnancies and live births is not known. The patient was vaccinated with the first dose of GARDASIL (dose and lot # not unknown) on 29-JUL-2001. The second dose of GARDASIL (0.5 ml, intramuscular right deltoid, lot #:672233/1561AA, expiration date 26-AUG-2014) on 04-MAY-2012, the patient got MENACTRA on that day too. The patient's mother brought her to the doctor office on 18-JUL-2012 and urine pregnancy test performed and was positive. The patient was sent to ob/gyn specialist her for the follow up. No adverse effects reported. The patient became pregnant with an LMP of 06-JAN-2012 and an EDD of 12-OCT-12. Initial exposure to GARDASIL was at 17 week(s). The patient was exposed to GARDASIL during trimester 2 and 3. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. The patient was vaccinated with an expired ZOSTAVAX (lot #670980/0731AA, expire date 17-AUG-2012) (vaccination site unknown) on 20-AUG-2012. No other co-suspects were reported. No concomitant medications were reported. No treatment information was reported. No adverse effect reported. It was unspecified if the patient had sought medical attention. Additional information has been requested.
Age: 32.0
Sex: F
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a health worker refers to a 32 years old female patient. The patient was vaccinated with GARDASIL (dose, route and lot # not reported) immunization series at another facility "years ago". The patient had just received a letter advising her that one or more of the doses of GARDASIL administered had been stored at improper temperatures. No adverse effect reported. No other co-suspects were reported. No concomitant medications were reported. The physician exists in SR contacts to receive medical information in connection with this case, but was not the treating provider when the GARDASIL was administered. Patient sought medical attention not reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a patient of unknown age. The patient was vaccinated with ZOSTAVAX (lot # 670816/0693AA) on 13-AUG-2012 that expired on 11-AUG-2012. No other co-suspects were reported. No concomitant medications were reported. The patient was not experiencing any known symptoms. It was unspecified if the patient had sought medical attention. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B surface antibody negative
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unknown number of patients. The patients were vaccinated with RECOMBIVAX HB series (route, dose, lot number not reported). No other co-suspects or concomitant medications were reported. The patients had low or negative Hepatitis B titers. No treatment information was reported. The outcome was unknown. Attempts are being made to obtain identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available.
Age: 0.24
Sex: M
Vaccine: RV5
Symptoms: Infrequent bowel movements
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 96 days old male patient. The patient was vaccinated orally with 2 ml ROTATEQ (Lot# unspecified) on 07-AUG-2012. No other co-suspects were reported. No concomitant medications were reported. The reporter did not know if the patient had an adverse effect or not. However, mother of the patient called their office in the morning of 16-AUG-2012 and left message stating her son had had "3 bowel movements." The reported stated she would call the mother to obtain more details. The outcome of "3 bowel movements" was unknown. Additional information is not expected.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to unknown number patients of unknown age. The nurse reported that unknown number of patients had been vaccinated with improperly stored VARIVAX (lot# was unknown). The vaccines were stored between 10F and 24F for the past several months. No adverse effect reported. Additional information has been requested. 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: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report as received from a consumer refers to her daughter of a 18 years old female patient. The reporter mentioned that her daughter was due for the third dose of GARDASIL (lot # was unknown) in 2008. The reporter wanted to know if her daughter could take the remaining dose or if her daughter needed to start the treatment again. The caller mentioned she would contact her HCP. Additional information has been requested.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood test, Condition aggravated, Herpes zoster, Vaccination failure
Clinical narrative: This spontaneous report as received from a 71 years old male patient with diabetes and no drug reaction/allergy. The patient stated after having shingles, he received ZOSTAVAX on 07-JUN-2011 (lot# and route were unspecified) to prevent shingles a second time, and it did not work, the shingles came again sometime in February-2012. Concomitant medications included metformin and glyburide (reported as glybride). Valacyclovir and acyclovir were given for the events. Lab diagnostic study included blood work, and no result was reported. The patient was not recovered. The patient sought medical attention via office visit. Additional information has been requested.
Age: 0.34
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1, RV1, RV1
Symptoms: Intestinal obstruction, Intussusception
Clinical narrative: Intussusception.
Age: 0.34
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1, RV1, RV1
Symptoms: Crying, Gastritis, Haematochezia, Intestinal obstruction, Intussusception
Clinical narrative: Intussusception.
Age: 0.34
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1, RV1, RV1
Symptoms: Irritability, Surgery, Vomiting, X-ray abnormal
Clinical narrative: Intussusception.
Age: 0.34
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1, RV1, RV1
Symptoms: Intussusception
Clinical narrative: Intussusception.
Age: 18.0
Sex: F
Vaccine: DTAP, TDAP
Symptoms: Dysphonia, Headache, Injection site pain, Malaise, Oropharyngeal pain
Clinical narrative: 24 hours after injection Pt had sore, tight scratchy throat. Swollen uvula and upper lip. Pt felt feverish, but temp not taken. Headache, body aches, general malaise. Pt took BENADRYL 50 mg and swelling resolved in 24 hours. Unusual tenderness at injection site.
Age: 18.0
Sex: F
Vaccine: DTAP, TDAP
Symptoms: Pain, Pharyngeal oedema, Pyrexia, Swollen tongue, Throat irritation
Clinical narrative: 24 hours after injection Pt had sore, tight scratchy throat. Swollen uvula and upper lip. Pt felt feverish, but temp not taken. Headache, body aches, general malaise. Pt took BENADRYL 50 mg and swelling resolved in 24 hours. Unusual tenderness at injection site.
Age: 18.0
Sex: F
Vaccine: DTAP, TDAP
Symptoms: Headache, Injection site pain, Lip swelling, Malaise, Oropharyngeal pain
Clinical narrative: 24 hours after injection Pt had sore, tight scratchy throat. Swollen uvula and upper lip. Pt felt feverish, but temp not taken. Headache, body aches, general malaise. Pt took BENADRYL 50 mg and swelling resolved in 24 hours. Unusual tenderness at injection site.
Age: 18.0
Sex: F
Vaccine: DTAP, TDAP
Symptoms: Pain, Palatal oedema, Pyrexia, Throat irritation, Throat tightness
Clinical narrative: 24 hours after injection Pt had sore, tight scratchy throat. Swollen uvula and upper lip. Pt felt feverish, but temp not taken. Headache, body aches, general malaise. Pt took BENADRYL 50 mg and swelling resolved in 24 hours. Unusual tenderness at injection site.
Sex: M
Vaccine: HEP
Symptoms: Feeding disorder neonatal, Immediate post-injection reaction, Oxygen saturation decreased, Pneumonia aspiration
Clinical narrative: Before given vaccination baby breastfeed with no difficulites. Immediately after vaccinations childs O2 stats would drop when feeding and would no longer accept the breast. Also for the next 2 years had aspiration pneumonia.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Death
Clinical narrative: DEATH
Age: 0.39
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Cardiac arrest, Intensive care, Respiratory failure
Clinical narrative: 8/15/12 05:51 - presented to ER in full arrest - brought by EMS. Admitted to the PICU with diagnosis of cardiac arrest, respiratory failure.
Age: 41.0
Sex: F
Vaccine: TDAP
Symptoms: Herpes zoster, Pain in extremity, Rash generalised
Clinical narrative: Initial report was received from a health care professional on 22 August 2012. A 41-year-old female patient had received a dose one intramuscular injection in the left deltoid of ADACEL, lot number C4137AA, on 09 August 2012. Forty-eight hours later on 11 August 2012, the patient developed a sore left arm then a rash on the arm and body. The patient was seen in the physician's office on 21 August 2012 and diagnosed with shingles. Treatment was unknown. The patient had no illness at the time of vaccination and an unknown past medical history. The patient's outcome was not recovered. Documents held by sender: None.
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Unevaluable event
Clinical narrative: Initial report was retrieved on 14 August 2012 from the scientific literature. Verbatim from the report: "PURPOSE: In studying the safety of vaccine for H1N1 given during pregnancy, spontaneous abortion (SAB) is one of the important points to consider. Because women may receive the vaccine any time during their pregnancy, evaluation of the effect of the vaccine on SAB should only take place after vaccination and in the risk window for SAB, that is, the first 20 weeks of gestation. In addition, when such studies are conducted through pregnancy registries where recruitment occurs after pregnancy recognition, the accrued subjects are left truncated in the sense that they are not followed from the start of pregnancy. METHODS: As previously reported, left truncation needs to be properly handled using survival analysis methods to avoid bias. In the context of time-dependent vaccine exposure, a time-dependent covariate Cox model can be used to simultaneously take into account the left truncation and the vaccine exposure timing. RESULTS: In this communication, we illustrate the approach using the Vaccine and Medication in Pregnancy Surveillance System data. We explain in details how the model is fitted using different software. CONCLUSIONS: We recommend survival analysis methods together with collection of necessary data to study the effects of vaccine on SAB." This report utilized preliminary data from the Vaccine and Medication in Pregnancy Surveillance System H1N1 vaccine which included 677 pregnancies. The report focused on 198 women who were enrolled in the study before 20 weeks gestation. Of the 198 women, 158 were exposed to the H1N1 at different stages of their pregnancies and an unspecified amount of time after vaccination five of the patients had spontaneous abortions. Of these patients, one patient was exposed to the vaccine during the period from their last menstrual period to date of conception and four were exposed during the first trimester. No further information was provided at the time of the report. The patient's outcomes were not reported. Documents held by sender: none.
Age: 37.0
Sex: M
Vaccine: TDAP
Symptoms: Bone marrow myelogram abnormal, Full blood count abnormal, Immunoglobulin therapy, Petechiae, Platelet count decreased
Clinical narrative: Initial report was received from a health care professional on 17 August 2012. A 37-year-old male patient had received a dose one intramuscular injection of ADACEL, Sanofi Pasteur Ltd. (lot number and site not reported) on 28 June 2012. On 07 July 2012, the patient was seen in the emergency room (ER) with a petechial rash. A complete blood count (CBC) was done and the patient's platelet count was 2. On the day of vaccination, the patient's platelet count was normal at 186. The patient was hospitalized from 07 July 2012 to 12 July 2012 and treated with high doses of steroids and intravenous immunoglobulin (IVIG). The patient had a bone marrow analysis post hospitalization which indicated low cellularity. The patient improved but was still being treated. The patient had no illness at the time of vaccination and had a past medical history of high cholesterol. Outcome was reported as recovered. Documents held by sender: None.
Age: 31.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Hyporeflexia, Muscle contracture, Muscular weakness
Clinical narrative: Initial report was received from a health care professional on 17 August 2012. A 31-year-old male patient had received an injection in the left arm of FLUZONE, Sanofi Pasteur Inc. (lot number, route and site not reported) on 07 August 2012. On 09 August 2012, the patient experienced right wrist pain which got better then left wrist pain. The patient ran and experienced ankle pain. The patient got better and experienced muscle contractions, difficulty holding dental instruments and reduced reflex action which "leveled off on 20 August 2012" (future date). The physician first thought it was GBS but "then didn't really think so." The patient's outcome was not recovered. Documents held by sender: None.
Age: 0.51
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Apnoea, Chest X-ray normal, Cough, Laboratory test abnormal, Nasopharyngitis
Clinical narrative: Initial report received on 16 August 2012 from the Investigator participating in a post-marketing study under the reference number M5A16. A case of pertussis disease in a nine-month-old male subject was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received 3 doses of PENTACEL; lot number C3923AA received on 05 December 2011, lot number C4143AA received on 13 February 2012 and lot number C4204AA received on 17 April 2012 (routes and sites of administration not reported). The subject developed cold-like symptoms and paroxysmal cough without a whoop on 16 July 2012, approximately three months after the last dose. The subject also experienced posttussive vomiting, sleep disturbance and apnea. Laboratory testing included positive PCR on 30 July 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 01 August 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 09 August 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 24 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 0.51
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Pertussis, Polymerase chain reaction, Post-tussive vomiting, Sleep disorder
Clinical narrative: Initial report received on 16 August 2012 from the Investigator participating in a post-marketing study under the reference number M5A16. A case of pertussis disease in a nine-month-old male subject was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received 3 doses of PENTACEL; lot number C3923AA received on 05 December 2011, lot number C4143AA received on 13 February 2012 and lot number C4204AA received on 17 April 2012 (routes and sites of administration not reported). The subject developed cold-like symptoms and paroxysmal cough without a whoop on 16 July 2012, approximately three months after the last dose. The subject also experienced posttussive vomiting, sleep disturbance and apnea. Laboratory testing included positive PCR on 30 July 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 01 August 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 09 August 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 24 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 42.0
Sex: F
Vaccine: RAB
Symptoms: Abdominal pain, Chills, Diarrhoea, Haematochezia, Injection site pain
Clinical narrative: Initial report was received from a consumer, who was also the patient, on 15 August 2012. A 42-year-old female patient had received a dose one intramuscular injection in the left deltoid of IMOVAX Rabies, Sanofi Pasteur SA (lot number not reported) on 13 August 2012 for pre exposure. Right after the vaccination, the patient felt soreness at arm at the injection site. On 14 August 2012 at 3:00AM, the patient experienced severe abdominal pain, diarrhea, blood in stool, fever and chills. Corrective treatments included rest and fluids. The patient was to return to the physician if symptoms continued. The patient had no illness at the time of vaccination and an allergy to sulfa. The patient's outcome was unknown. Documents held by sender: None.
Age: 42.0
Sex: F
Vaccine: RAB
Symptoms: Pyrexia
Clinical narrative: Initial report was received from a consumer, who was also the patient, on 15 August 2012. A 42-year-old female patient had received a dose one intramuscular injection in the left deltoid of IMOVAX Rabies, Sanofi Pasteur SA (lot number not reported) on 13 August 2012 for pre exposure. Right after the vaccination, the patient felt soreness at arm at the injection site. On 14 August 2012 at 3:00AM, the patient experienced severe abdominal pain, diarrhea, blood in stool, fever and chills. Corrective treatments included rest and fluids. The patient was to return to the physician if symptoms continued. The patient had no illness at the time of vaccination and an allergy to sulfa. The patient's outcome was unknown. Documents held by sender: None.
Age: 1.38
Sex: F
Vaccine: DTAP
Symptoms: Chest X-ray normal, Cough, Laboratory test abnormal, Pertussis, Polymerase chain reaction
Clinical narrative: Initial report received on 15 August 2012 from the Investigator participating in a post-marketing study under the reference number M5A16. A case of pertussis disease in a 4-year-old female subject was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received 4 doses of DAPTACEL; lot number C2651AA received on 31 October 2007, lot number C2797AA received pm 18 January 2008, lot number C2798AA received on 01 April 2008 and lot number C2957AA received on 15 January 2009 (routes and sites of administration not reported). The subject developed a paroxysmal cough without a whoop on 28 July 2012, approximately 42 months after the last dose. The subject also experienced posttussive vomiting and sleep disturbance. Laboratory testing included positive PCR on 29 July 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of Azithromycin starting on 01 August 2012 for five days. The subject was not hospitalized. At the time of final contact on 13 August 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 16 days. According to the reporter, the event was outbreak-related. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 1.38
Sex: F
Vaccine: DTAP
Symptoms: Post-tussive vomiting, Sleep disorder
Clinical narrative: Initial report received on 15 August 2012 from the Investigator participating in a post-marketing study under the reference number M5A16. A case of pertussis disease in a 4-year-old female subject was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received 4 doses of DAPTACEL; lot number C2651AA received on 31 October 2007, lot number C2797AA received pm 18 January 2008, lot number C2798AA received on 01 April 2008 and lot number C2957AA received on 15 January 2009 (routes and sites of administration not reported). The subject developed a paroxysmal cough without a whoop on 28 July 2012, approximately 42 months after the last dose. The subject also experienced posttussive vomiting and sleep disturbance. Laboratory testing included positive PCR on 29 July 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of Azithromycin starting on 01 August 2012 for five days. The subject was not hospitalized. At the time of final contact on 13 August 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 16 days. According to the reporter, the event was outbreak-related. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 0.9
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Apnoea, Chest X-ray normal, Cough, Laboratory test abnormal, Pertussis
Clinical narrative: Initial report received on 15 August 2012 from the Investigator participating in a post-marketing study under the reference number of M5A16. A case of pertussis disease in an 11-month-old female subject was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received 3 doses of PENTACEL; lot number C3801AA received on 13 June 2011, lot number C3930AA received on 15 August 2011 and lot number C4001AB received on 17 October 2011 (routes and sites of administration not reported). The subject developed a cough on 28 March 2012, approximately five months after the last dose. On 01 April 2012, the subject developed a paroxysmal cough without a whoop. The subject also experienced apnea and sleep disturbance. Laboratory testing included positive PCR on 09 April 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of Azithromycin starting on 09 April 2012 for five days. The subject was not hospitalized. At the time of final contact on 17 April 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 20 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 0.9
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Polymerase chain reaction, Sleep disorder
Clinical narrative: Initial report received on 15 August 2012 from the Investigator participating in a post-marketing study under the reference number of M5A16. A case of pertussis disease in an 11-month-old female subject was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received 3 doses of PENTACEL; lot number C3801AA received on 13 June 2011, lot number C3930AA received on 15 August 2011 and lot number C4001AB received on 17 October 2011 (routes and sites of administration not reported). The subject developed a cough on 28 March 2012, approximately five months after the last dose. On 01 April 2012, the subject developed a paroxysmal cough without a whoop. The subject also experienced apnea and sleep disturbance. Laboratory testing included positive PCR on 09 April 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of Azithromycin starting on 09 April 2012 for five days. The subject was not hospitalized. At the time of final contact on 17 April 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 20 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.