chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 30.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Fatigue, Nausea, Retching, Urine analysis, Vaccination complication
Clinical narrative: Case number PHEH2013US008408 is an initial spontaneous report received froma nurse on 10 Apr 2013. This report refers to a female patient of an unspecified age. Her medical history and concomitant medications was not reported. She was vaccinated with MENVEO (batch number not reported) on 09 Apr 2013 at 12:30 pm At approximately 1:30 pm, she experienced vomiting and diarrhea. Between 1:30 pm and 6:30 pm, she called her primary care physician and he recommended her to go to the emergency room due to the symptoms she was experiencing. At 7:30pm, she visited emergency room. She was examined for stomach illness, CT was performed to check any bowel obstruction (if any) and urine sample was collected for testing. No results were provided. She was given 2 bags of saline, ZOFRAN, PROTONIX, ZANTAC, BENADRYL, COMPAZINE, IV contrast, THORAZINE, VALIUM, SOLUMEDROL. It was reported that the doses for the treatment medication was not known. Vomiting stopped after taking VALIUM. At the time of discharge at 12:30pm on 10 Apr 2013, the physician diagnosed with an adverse reaction to meningococcal vaccine. The outcome, seriousness and causality were not reported.
Age: 30.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Vomiting
Clinical narrative: Case number PHEH2013US008408 is an initial spontaneous report received froma nurse on 10 Apr 2013. This report refers to a female patient of an unspecified age. Her medical history and concomitant medications was not reported. She was vaccinated with MENVEO (batch number not reported) on 09 Apr 2013 at 12:30 pm At approximately 1:30 pm, she experienced vomiting and diarrhea. Between 1:30 pm and 6:30 pm, she called her primary care physician and he recommended her to go to the emergency room due to the symptoms she was experiencing. At 7:30pm, she visited emergency room. She was examined for stomach illness, CT was performed to check any bowel obstruction (if any) and urine sample was collected for testing. No results were provided. She was given 2 bags of saline, ZOFRAN, PROTONIX, ZANTAC, BENADRYL, COMPAZINE, IV contrast, THORAZINE, VALIUM, SOLUMEDROL. It was reported that the doses for the treatment medication was not known. Vomiting stopped after taking VALIUM. At the time of discharge at 12:30pm on 10 Apr 2013, the physician diagnosed with an adverse reaction to meningococcal vaccine. The outcome, seriousness and causality were not reported.
Age: 30.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Computerised tomogram, Diarrhoea, Urine analysis, Vaccination complication, Vomiting
Clinical narrative: Case number PHEH2013US008408 is an initial spontaneous report received froma nurse on 10 Apr 2013. This report refers to a female patient of an unspecified age. Her medical history and concomitant medications was not reported. She was vaccinated with MENVEO (batch number not reported) on 09 Apr 2013 at 12:30 pm At approximately 1:30 pm, she experienced vomiting and diarrhea. Between 1:30 pm and 6:30 pm, she called her primary care physician and he recommended her to go to the emergency room due to the symptoms she was experiencing. At 7:30pm, she visited emergency room. She was examined for stomach illness, CT was performed to check any bowel obstruction (if any) and urine sample was collected for testing. No results were provided. She was given 2 bags of saline, ZOFRAN, PROTONIX, ZANTAC, BENADRYL, COMPAZINE, IV contrast, THORAZINE, VALIUM, SOLUMEDROL. It was reported that the doses for the treatment medication was not known. Vomiting stopped after taking VALIUM. At the time of discharge at 12:30pm on 10 Apr 2013, the physician diagnosed with an adverse reaction to meningococcal vaccine. The outcome, seriousness and causality were not reported.
Age: 52.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain, Pain in extremity, Swelling
Clinical narrative: Arm started to hurt, noticed swelling redness. Reaction got bigger and more painful.
Age: 0.55
Sex: F
Vaccine: DTAPH, FLUX, OPV, PPV
Symptoms: Crying, Gaze palsy, Hypotonia, Irritability, Musculoskeletal stiffness
Clinical narrative: Patient received vaccine total 5, DTaP, HiB, PCV-13, IPV, Influenza at the MD clinic. At home patient fell asleep for 2hrs, then woke up crying, irritable, mother noticed patient became stiff and limp after, eyes wanting to roll back.
Sex: F
Vaccine: FLUX, PPV, FLUX, PPV
Symptoms: Influenza, Pneumonia
Clinical narrative: This spontaneous report as received from a female consumer refers to herself with a history of a sinus surgery in 1993 and with no drug reactions/allergies. Approximately in April 2010 (reported as "off and on for last 2 to 3 years), the patient started therapy with NASONEX (nasal spray, 50 mcg, frequency not reported) for sinus allergies. Other suspect therapies included flu shot (manufacturer unknown) and pneumonia shot (manufacturer unknown). Consumer stated that NASONEX gave her a headache and made her eyes bloodshot and weak. Her doctor told her to spray it into the side of her nose, so she had not been getting a proper dose. These symptoms with the spray started on 01-APR-2013. She used RESTASIS, but said it didn't help. Her primary care, a physician prescribed MUCINEX, which "doesn't help". Consumer also had an unspecified flu shot last year in 2012, and an unspecified pneumonia shot at an unspecified time. She had pneumonia in January 2013, February 2013 and March 2013 and the flu in February 2013. She went to the ER and was admitted at an unspecified hospital for pneumonia and flu in February 2013, and also admitted at an unspecified hospital for pneumonia from 01-MAR-2013 to 08-MAR-2013. She had been on unspecified antibiotics from January 2013 to April 2013 and was on prednisone (manufacturer unknown), which gave her side effects, saying it "blows you up". Lab test included X-Ray (results unknown). At the time of reporting, the outcome was unknown. The relatedness for the events was unknown for NASONEX, flu shot (manufacturer unknown) and pneumonia shot (manufacturer unknown). Additional information has been requested.
Sex: F
Vaccine: FLUX, PPV, FLUX, PPV
Symptoms: Influenza, Pneumonia, X-ray
Clinical narrative: This spontaneous report as received from a female consumer refers to herself with a history of a sinus surgery in 1993 and with no drug reactions/allergies. Approximately in April 2010 (reported as "off and on for last 2 to 3 years), the patient started therapy with NASONEX (nasal spray, 50 mcg, frequency not reported) for sinus allergies. Other suspect therapies included flu shot (manufacturer unknown) and pneumonia shot (manufacturer unknown). Consumer stated that NASONEX gave her a headache and made her eyes bloodshot and weak. Her doctor told her to spray it into the side of her nose, so she had not been getting a proper dose. These symptoms with the spray started on 01-APR-2013. She used RESTASIS, but said it didn't help. Her primary care, a physician prescribed MUCINEX, which "doesn't help". Consumer also had an unspecified flu shot last year in 2012, and an unspecified pneumonia shot at an unspecified time. She had pneumonia in January 2013, February 2013 and March 2013 and the flu in February 2013. She went to the ER and was admitted at an unspecified hospital for pneumonia and flu in February 2013, and also admitted at an unspecified hospital for pneumonia from 01-MAR-2013 to 08-MAR-2013. She had been on unspecified antibiotics from January 2013 to April 2013 and was on prednisone (manufacturer unknown), which gave her side effects, saying it "blows you up". Lab test included X-Ray (results unknown). At the time of reporting, the outcome was unknown. The relatedness for the events was unknown for NASONEX, flu shot (manufacturer unknown) and pneumonia shot (manufacturer unknown). Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Crying, Gaze palsy, Immediate post-injection reaction, Seizure like phenomena, Smear cervix abnormal
Clinical narrative: This spontaneous report was received from an office manager (also reported as a healthcare worker) concerning an approximately 26 year old female patient with no drug reactions or allergies. On 11-APR-2013, the patient was vaccinated with dose 1 of, 0.5 milliliter (ml) of GARDASIL (lot number and expiry date reported as H015863 and 24-FEB-2015 respectively) intramuscularly. There were no concomitant medications. On 11-APR-2013, the patient fainted and possibly had a seizure immediately after receiving the vaccination. Initially the eyes of the patient rolled back, fainted and woke up crying. The patient had not eaten any food on the day of reporting. The patient sought medical attention (patient was still in the office at the time of reporting). No treatment was provided. On an unknown date, a pap test was was performed and the result was found to be abnormal, (also reported as no lab tests were performed). At the time of reporting, the patient was recovering from all the events (also reported as the entire episode lasted for 30 seconds). The relatedness for all the events was unknown for GARDASIL. Upon internal review, seizure was considered as medically significant. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Syncope
Clinical narrative: This spontaneous report was received from an office manager (also reported as a healthcare worker) concerning an approximately 26 year old female patient with no drug reactions or allergies. On 11-APR-2013, the patient was vaccinated with dose 1 of, 0.5 milliliter (ml) of GARDASIL (lot number and expiry date reported as H015863 and 24-FEB-2015 respectively) intramuscularly. There were no concomitant medications. On 11-APR-2013, the patient fainted and possibly had a seizure immediately after receiving the vaccination. Initially the eyes of the patient rolled back, fainted and woke up crying. The patient had not eaten any food on the day of reporting. The patient sought medical attention (patient was still in the office at the time of reporting). No treatment was provided. On an unknown date, a pap test was was performed and the result was found to be abnormal, (also reported as no lab tests were performed). At the time of reporting, the patient was recovering from all the events (also reported as the entire episode lasted for 30 seconds). The relatedness for all the events was unknown for GARDASIL. Upon internal review, seizure was considered as medically significant. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Crying, Gaze palsy, Immediate post-injection reaction, Smear cervix abnormal, Syncope
Clinical narrative: This spontaneous report was received from an office manager (also reported as a healthcare worker) concerning an approximately 26 year old female patient with no drug reactions or allergies. On 11-APR-2013, the patient was vaccinated with dose 1 of, 0.5 milliliter (ml) of GARDASIL (lot number and expiry date reported as H015863 and 24-FEB-2015 respectively) intramuscularly. There were no concomitant medications. On 11-APR-2013, the patient fainted and possibly had a seizure immediately after receiving the vaccination. Initially the eyes of the patient rolled back, fainted and woke up crying. The patient had not eaten any food on the day of reporting. The patient sought medical attention (patient was still in the office at the time of reporting). No treatment was provided. On an unknown date, a pap test was was performed and the result was found to be abnormal, (also reported as no lab tests were performed). At the time of reporting, the patient was recovering from all the events (also reported as the entire episode lasted for 30 seconds). The relatedness for all the events was unknown for GARDASIL. Upon internal review, seizure was considered as medically significant. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Crying, Gaze palsy, Immediate post-injection reaction, Seizure like phenomena, Smear cervix abnormal
Clinical narrative: This spontaneous report was received from an office manager (also reported as a healthcare worker) concerning an approximately 26 year old female patient with no drug reactions or allergies. On 11-APR-2013, the patient was vaccinated with dose 1 of, 0.5 milliliter (ml) of GARDASIL (lot number and expiry date reported as H015863 and 24-FEB-2015 respectively) intramuscularly. There were no concomitant medications. On 11-APR-2013, the patient fainted and possibly had a seizure immediately after receiving the vaccination. Initially the eyes of the patient rolled back, fainted and woke up crying. The patient had not eaten any food on the day of reporting. The patient sought medical attention (patient was still in the office at the time of reporting). No treatment was provided. On an unknown date, a pap test was performed and the result was found to be abnormal. (also reported as no lab tests were performed). At the time of reporting, the patient was recovering from all the events (also reported as the entire episode lasted for for 30 seconds). The relatedness for all the events was unknown for GARDASIL. Upon internal review, seizure was considered as medically significant. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Syncope
Clinical narrative: This spontaneous report was received from an office manager (also reported as a healthcare worker) concerning an approximately 26 year old female patient with no drug reactions or allergies. On 11-APR-2013, the patient was vaccinated with dose 1 of, 0.5 milliliter (ml) of GARDASIL (lot number and expiry date reported as H015863 and 24-FEB-2015 respectively) intramuscularly. There were no concomitant medications. On 11-APR-2013, the patient fainted and possibly had a seizure immediately after receiving the vaccination. Initially the eyes of the patient rolled back, fainted and woke up crying. The patient had not eaten any food on the day of reporting. The patient sought medical attention (patient was still in the office at the time of reporting). No treatment was provided. On an unknown date, a pap test was performed and the result was found to be abnormal. (also reported as no lab tests were performed). At the time of reporting, the patient was recovering from all the events (also reported as the entire episode lasted for for 30 seconds). The relatedness for all the events was unknown for GARDASIL. Upon internal review, seizure was considered as medically significant. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Crying, Gaze palsy, Immediate post-injection reaction, Smear cervix abnormal, Syncope
Clinical narrative: This spontaneous report was received from an office manager (also reported as a healthcare worker) concerning an approximately 26 year old female patient with no drug reactions or allergies. On 11-APR-2013, the patient was vaccinated with dose 1 of, 0.5 milliliter (ml) of GARDASIL (lot number and expiry date reported as H015863 and 24-FEB-2015 respectively) intramuscularly. There were no concomitant medications. On 11-APR-2013, the patient fainted and possibly had a seizure immediately after receiving the vaccination. Initially the eyes of the patient rolled back, fainted and woke up crying. The patient had not eaten any food on the day of reporting. The patient sought medical attention (patient was still in the office at the time of reporting). No treatment was provided. On an unknown date, a pap test was performed and the result was found to be abnormal. (also reported as no lab tests were performed). At the time of reporting, the patient was recovering from all the events (also reported as the entire episode lasted for for 30 seconds). The relatedness for all the events was unknown for GARDASIL. Upon internal review, seizure was considered as medically significant. Additional information has been requested.
Age: 0.53
Sex: M
Vaccine: FLU3, RV5
Symptoms: Intussusception
Clinical narrative: This spontaneous report was received from a physician via a company representative concerning a male patient of unknown age. On 10-DEC-2012, the patient was vaccinated with dose 3 of ROTATEQ (lot number, expiry date, dose and route unspecified). No concomitant medications were reported. On 29-JAN-2013, the patient went to an emergency room of the hospital and was diagnosed with intussusception. The patient sought medical attention (visited hospital). The patient received treatment during hospitalization. It was unspecified if any lab tests were performed. The outcome of intussusception was unknown. The relatedness for intussusception was unknown for ROTATEQ. Additional information has been requested.
Age: 91.0
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 91 year old patient. Pharmacist reported that on 10-APR-2013 or 11-APR-2013 the patient was vaccinated with an expired 0.65 ml dose ZOSTAVAX (lot # 672606/1655AA, Exp date 21-JAN-2013) subcutaneously. It was unknown if the patient sought medical attention. At the time of reporting, the status of patient was unknown. Additional information is not expected.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Blood glucose normal, Excessive eye blinking, Feeling abnormal, Pallor, Syncope
Clinical narrative: HPV#2 given -> pt fainted & unresponsive x about 1 min. Remained pale & sl dazed - unable to answer basic questions for 45 min in spite of positioning, juice, cool compresses. Eye fluttering again at 45 min mark so sent to ER via ambulance - there got IVF, ZOFRAN & had nl EKG & sent home by 12 noon. (Was lying down when shot given & had eaten b'fast_.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Unresponsive to stimuli
Clinical narrative: HPV#2 given -> pt fainted & unresponsive x about 1 min. Remained pale & sl dazed - unable to answer basic questions for 45 min in spite of positioning, juice, cool compresses. Eye fluttering again at 45 min mark so sent to ER via ambulance - there got IVF, ZOFRAN & had nl EKG & sent home by 12 noon. (Was lying down when shot given & had eaten b'fast_.
Age: 2.0
Sex: M
Vaccine: HEPA
Symptoms: Blood lead, Haematocrit increased, Haemoglobin increased, Mean cell volume normal, Pruritus
Clinical narrative: Hives of large size, small size, raised, itchy come and go, at different changing locations, first on trunk, legs, face left jaw. No new food items. As of 4/15/2013 still present.
Age: 2.0
Sex: M
Vaccine: HEPA
Symptoms: Urticaria
Clinical narrative: Hives of large size, small size, raised, itchy come and go, at different changing locations, first on trunk, legs, face left jaw. No new food items. As of 4/15/2013 still present.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: PROQUAD given left thigh subcutaneous has reddened, raised, warm touch area 6x5cm diameter to right of injection site.
Age: 0.21
Sex: F
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Culture stool, Diarrhoea, Rotavirus test
Clinical narrative: Pt was given ROTATEQ and developed diarrhea the following day.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Fall, Muscular weakness, Walking aid user
Clinical narrative: This spontaneous report was received from an approximately 65 year old female patient with type 2 diabetes and high blood pressure. The medical history of the patient included shingles. On 24-MAR-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiry date, dose and route unspecified) in the left arm. Concomitant therapy included meloxicam of 15 milligrams (mg). On 28-MAR-2013, she noticed that she was not able to use her left leg as normal. She thought it was her shoe or heel that was broken. She stated that in the next few days her symptoms became progressively worse. On 28-MAR-2013, she started to feel weakness in her thigh muscles in both legs. Approximately since an unknown date in April 2013 (reported as now), she was reduced to using two canes for walking. Approximately on 10-APR-2013 (yesterday), she took a fall due to the weakness in her legs, just buckled on her and caused her to fall on her face. She was going to be seeing a specialist (spinal Specialist). It was enquired if her if symptoms could be attributed to ZOSTAVAX according to the prescribing information. The patient did not seek any medical attention. She was treated with hydro/acetaminophen for the pain. On 01-APR-2013, magnetic resonance imaging (MRI) was performed and the result was unknown. Outcome of reduced to using two canes for walking was reported as not resolved. Outcome of weakness in her thigh muscles in both legs and fall due to the weakness in her legs was unknown. The relatedness for all the events was unknown for ZOSTAVAX. Additional information has been requested.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Influenza
Clinical narrative: Initial report was received from a healthcare professional, who was also the patient, on 05 April 2013. This case has the same reporter as case number 2013-04711. A 78-year-old female patient had received an injection of FLUZONE (lot number, route and site not reported) in August of 2012 and experienced the flu in March of 2013. The reporter did not have any information regarding the strain and substrain of flu the patient experienced since they did not do any testing. The patient had no illness at the time of vaccination. Outcome was recovered. Documents held by sender: None.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Cough, Middle insomnia, Oropharyngeal pain, Throat irritation
Clinical narrative: Pt. woke up early AM c/o severe burning in her throat w/ sporadic coughing. Had also taken 1/2 AMBIEN (2nd time she had that med ever.) No SOB. Went back to sleep propped on pillows. Rest of that day no burning, and sore throat, cough resolved.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Influenza
Clinical narrative: Initial report was received from a healthcare professional, who was also the patient, on 05 April 2013. This case has the same reporter as case number 2013-04712. A 74-year-old female patient had received an injection of FLUZONE (lot number, route and site not reported) on August of 2012 and experienced the flu in March of 2013. The reporter did not have any information regarding the strain and substrain of flu she experienced since she did not do any testing. The patient had no illness at the time of vaccination. Outcome was recovered. Documents held by sender: None.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Feeling hot, Induration, Local reaction, Oedema
Clinical narrative: Pt received vaccine on 3/25/13 seen on 03/26/13 with c/o edema, induration, erythema, warmth, and pruritus. Tx with BENADRYL. Ice to area and OTC steroid cream. F/U on 04/10/13 local reaction resolved, back to normal.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Pruritus
Clinical narrative: Pt received vaccine on 3/25/13 seen on 03/26/13 with c/o edema, induration, erythema, warmth, and pruritus. Tx with BENADRYL. Ice to area and OTC steroid cream. F/U on 04/10/13 local reaction resolved, back to normal.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site joint movement impairment, Injection site pain, Injection site swelling, Limb discomfort
Clinical narrative: Initial report received from a healthcare professional on 21 December 2012. A 39-year-old female patient, had received an intradermal dose of FLUZONE ID (Lot number: UT4470BA, dose number, side and site of administration were not reported) on 20 December 2012. The patient's medical history included allergy to Penicillin (PCN). The patient's concomitant medications were not reported. The patient had no illness at time of vaccination. On 20 December 2012, about 20 minutes after vaccination, the patient developed redness around injection site. Through the night, the site became swollen to the size of a softball and redness had increased. The patient also had pain from the site to her shoulder and had ROM (range of motion) in the arm with little discomfort. Corrective treatment details were not reported. Relevant diagnostic tests/laboratory data were none. At the time of this report, the patient had not recovered from the events. Follow-up information was received from a healthcare professional on 08 April 2013. Based upon the new information, this case has been upgraded to serious. FLUZONE INTRADERMAL was given in the right arm. Treatments included cephalexin 500mg one pill three times a day and Prednisone 10mg two tablets two times a day. Concomitant medication included fluocinonide 0.05% cream. Outcome was recovered. Documents held by sender: None.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin lesion
Clinical narrative: This spontaneous report as received from a pharmacist via a company representative refers to a 64 year old female patient. On an unspecified day in January 2012 (year confirmed to be 2012) the patient was vaccinated with a dose of ZOSTAVAX (lot# not reported). On an unspecified day in April 2013 the patient developed recurring sores on her head that look like ringworm. Pharmacist reported that patient had been referred to an unspecified dermatologist for treatment. Patient sought medical attention by contacting the pharmacist. At the time of report, the outcome of event was reported as not recovered/not resolved. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Local reaction, Malaise, Pyrexia
Clinical narrative: On 4/1/13, pt received PPSV23 in (R) deltoid. Tuesday pt developed fever 103 degrees with malaise and 3+, large localized reaction. No respiratory effects.
Age: 0.21
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Emotional distress, Injection site erythema, Injection site swelling, Irritability
Clinical narrative: 2 hours after injections in left leg Hib/PREVNAR family reported leg swelling and redness past knee. TYLENOL given swelling resolved. Fussy and hard to console. On recheck exam some swelling at injection site. Outline of band-aid adhesive could be seen.
Age: 65.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Blister, Rash pruritic, Scar
Clinical narrative: Case number PHEH2013US008321 is an initial spontaneous report received from a consumer on 09 Apr 2013. This case refers to a 66-year-old male patient. His medical history and concomitant medications were not reported. His vaccination history included of flu vaccinations in previous years without any reactions. He was vaccinated with FLUVIRIN (batch number: 123023) in his right arm on an unspecified date in Oct 2012. On the same day he was also vaccinated with ZOSTAVAX (batch number: 8012576, expiration date: Sep [year:unknown]). Three to four days after vaccination, he experienced a rash with itchy blisters on his right arm, right shoulder, back and few on his left arm. He had scars at places where he had blisters. He still had some blisters but the reaction seems to be tapering off. The patient saw his primary care physician initially and a dermatologist three times. His primary care physician gave him 4 to 5 different ointments/lotions but nothing helped. He also tried over the counter allergy medicine. He was also suggested light therapy by his doctor. The final outcome was reported as ongoing at the time of this report. The seriousness and causality were not reported.
Age: 24.0
Sex: F
Vaccine: ANTH
Symptoms: Rash generalised
Clinical narrative: 48 hrs post vaccine patient developed rash on body, reported to ER and dismissed 3 hrs later with ZYRTEC and hydrocortisone.
Age: 29.0
Sex: M
Vaccine: ANTH, HEPA, SMALL, TYP
Symptoms: Bundle branch block right, Cardiac electrophysiologic study, Cytogenetic analysis normal, Echocardiogram, Electrocardiogram
Clinical narrative: While taking a Physical Fitness Test I had a syncopal episode. A ECG taken that day showed prolonged QT interval and right bundle branch block. I have been evaluated and a ICD was implanted in December 2006. I have symptoms of Long QT Syndrome and Brugada Syndrome but genetic testing is negative for both. There is no family history of syncope, Long QT Syndrome, Brugada Syndrome or sudden unexplained death.
Age: 29.0
Sex: M
Vaccine: ANTH, HEPA, SMALL, TYP
Symptoms: Electrocardiogram QT prolonged, Implantable defibrillator insertion, Syncope
Clinical narrative: While taking a Physical Fitness Test I had a syncopal episode. A ECG taken that day showed prolonged QT interval and right bundle branch block. I have been evaluated and a ICD was implanted in December 2006. I have symptoms of Long QT Syndrome and Brugada Syndrome but genetic testing is negative for both. There is no family history of syncope, Long QT Syndrome, Brugada Syndrome or sudden unexplained death.
Age: 23.0
Sex: F
Vaccine: ANTH
Symptoms: Chest pain, Dizziness, Throat tightness
Clinical narrative: 10 min after 2nd dose of anthrax, had dizziness, throat tightness, chest pain that worsened over the next 20-40 min.  Pt was brought to the ER and given IV Solumedrol, Benadryl, Zantac with complete resolution of symptoms within 15 min of onset of IV.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Blood glucose normal, Face injury, Syncope
Clinical narrative: Fainted & hit the floor face first.
Age: 1.28
Sex: F
Vaccine: DTAP
Symptoms: Injection site discolouration, Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Patient received only one immunization at well-child visit:  Infanrix.  (Most recent previous immunization for these diseases had been 9 months prior, via Pediarix.)  Immunization on left thigh.  Patient developed a large red swollen area on left thigh, offset from immunization site.  Zone was hot to the touch for 3 days.  Indurations were worst at 24 hours post-immunization.  Swollen zone continued to spread for 3 days post-immunization.  Maximum size of swollen zone was greater than 5 inches long and about 2.5 inches wide.  No fever observed.  Swelling gradually faded after 3 days, leaving purple zone and eventually returning to normal skin coloration.
Age: 44.0
Sex: F
Vaccine: HEP
Symptoms: Pain
Clinical narrative: Started a week after injection with soreness. Two weeks after injection had pain of 6 on a scale of 1-10. Pain gradually increased to 8. Pain would get better then worse.  Takes Aleve for pain.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL, DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Pt has redness locally @ injection site of right arm where Kinrix was given and right arm where varicella was given with slight swelling and warmth.  Mother provided child with Tylenol and Benadryl and ice pack. Child had no fever, nausea, vomiting, or any other adverse signs.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, VARZOS
Symptoms: No adverse event
Clinical narrative: No reported adverse.
Age: 16.0
Sex: M
Vaccine: FLUN3, HPV4, MNQ
Symptoms: Blood glucose decreased, Dizziness, Hyperhidrosis
Clinical narrative: Five minutes after recieving Gardasil, Menactra and Flumist, patient started becoming diaphoretic and very light headed. Patient moved to shot area given 15lt of O2 and evaluated by doctor and given apple juice due to not eating all day.
Age: 10.0
Sex: M
Vaccine: TDAP
Symptoms: Axillary pain, Swelling
Clinical narrative: Pain and swelling in right armpit.
Age: 26.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Caesarean section, Exposure during pregnancy
Clinical narrative: Information has been received from a registered nurse, for GARDASIL, a Pregnancy Registry product, concerning a 26 year old female patient with insulin-dependent diabetes and no drug reactions/allergies who on 02-APR-2012, was vaccinated IM with the first 0.5 mL dose of GARDASIL (lot # not provided) and on 14-MAY-2012 was vaccinated IM with the second dose 0.5 mL dose of GARDASIL (lot # 666163/0664Z, expiration date on 18-SEP-2012). Concomitant therapy included insulin. The nurse reported that the patient was pregnant. The last menstrual period (LMP) was unknown and her estimated delivery date (EDD) was on 22-DEC-2012. Method of confirmation was unknown. The patient sought medical attention at the physician's office and she did not receive any treatment for the event. Follow up information has been received from a registered nurse, for GARDASIL, a Pregnancy Registry product, concerning the 26 year old female with diabetes, high cholesterol and a history of 2 pregnancies and 2 live births (at the week of 38 and 37 weeks) who on 02-APR-2012, was vaccinated first dose of GARDASIL (lot # 666118/1539Y) and on 14-APR-2012 was vaccinated with the second dose of GARDASIL (lot # 666163/0664Z). Concomitant therapy also included LIPITOR, LEVEMIR, metformin and vitamins (unspecified). The last menstrual period (LMP) was 17-MAR-2012 and her estimated delivery date (EDD) was on 22-DEC-2012. Estimated conception date was 30-MAR-2012. No birth defects in previous pregnancies and no infant complication in previous pregnancies. Follow up information has been received from a registered nurse, for GARDASIL, a Pregnancy Registry product, concerning the 26 year old female with diabetes, smoking of 1/2 pack per day, and a history of 2 pregnancies and 2 male babies (one at the week of 38 weeks (on 17-FEB-2009) with weight of 6 lbs 8ozs and 36 weeks (on 13-JAN-2012) with weight of 5 lbs 13ozs) who on 14-MAY-2012 was vaccinated with the second dose of GARDASIL (lot # reported as M0664Z). On 08-DEC-2012, the patient delivered a live birth via cesarean section. The mother and infant experience no complications during the delivery. The male infant was normal, no congenital anomalies, with weight of 6 lbs 7ozs and length of 19 1/2. Upon internal review, cesarean section was considered as a medically significant event. Additional information is not expected.
Age: 26.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Caesarean section, Exposure during pregnancy, Live birth
Clinical narrative: Information has been received from a registered nurse, for GARDASIL, a Pregnancy Registry product, concerning a 26 year old female patient with insulin-dependent diabetes and no drug reactions/allergies who on 02-APR-2012, was vaccinated IM with the first 0.5 mL dose of GARDASIL (lot # not provided) and on 14-MAY-2012 was vaccinated IM with the second dose 0.5 mL dose of GARDASIL (lot # 666163/0664Z, expiration date on 18-SEP-2012). Concomitant therapy included insulin. The nurse reported that the patient was pregnant. The last menstrual period (LMP) was unknown and her estimated delivery date (EDD) was on 22-DEC-2012. Method of confirmation was unknown. The patient sought medical attention at the physician's office and she did not receive any treatment for the event. Follow up information has been received from a registered nurse, for GARDASIL, a Pregnancy Registry product, concerning the 26 year old female with diabetes, high cholesterol and a history of 2 pregnancies and 2 live births (at the week of 38 and 37 weeks) who on 02-APR-2012, was vaccinated first dose of GARDASIL (lot # 666118/1539Y) and on 14-APR-2012 was vaccinated with the second dose of GARDASIL (lot # 666163/0664Z). Concomitant therapy also included LIPITOR, LEVEMIR, metformin and vitamins (unspecified). The last menstrual period (LMP) was 17-MAR-2012 and her estimated delivery date (EDD) was on 22-DEC-2012. Estimated conception date was 30-MAR-2012. No birth defects in previous pregnancies and no infant complication in previous pregnancies. Follow up information has been received from a registered nurse, for GARDASIL, a Pregnancy Registry product, concerning the 26 year old female with diabetes, smoking of 1/2 pack per day, and a history of 2 pregnancies and 2 male babies (one at the week of 38 weeks (on 17-FEB-2009) with weight of 6 lbs 8ozs and 36 weeks (on 13-JAN-2012) with weight of 5 lbs 13ozs) who on 14-MAY-2012 was vaccinated with the second dose of GARDASIL (lot # reported as M0664Z). On 08-DEC-2012, the patient delivered a live birth via cesarean section. The mother and infant experience no complications during the delivery. The male infant was normal, no congenital anomalies, with weight of 6 lbs 7ozs and length of 19 1/2. Upon internal review, cesarean section was considered as a medically significant event. Additional information is not expected.
Age: 26.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Caesarean section, Exposure during pregnancy
Clinical narrative: Information has been received from a registered nurse, for GARDASIL, a Pregnancy Registry product, concerning a 26 year old female patient with insulin-dependent diabetes and no drug reactions/allergies who on 02-APR-2012, was vaccinated IM with the first 0.5 mL dose of GARDASIL (lot # not provided) and on 14-MAY-2012 was vaccinated IM with the second 0.5 mL dose of GARDASIL (lot # 666163/0664Z, expiration date on 18-SEP-2012). Concomitant therapy included insulin. The nurse reported that the patient was pregnant. The last menstrual period (LMP) was unknown and her estimated delivery date (EDD) was on 22-DEC-2012. Method of confirmation was unknown. The patient sought medical attention at the physician's office and she did not receive any treatment for the event. Follow up information has been received from a registered nurse, for GARDASIL, a Pregnancy Registry product, concerning a 26 year old female with diabetes, high cholesterol and a history of 2 pregnancies and 2 live births (at the week of 38 and 37 weeks) who on 02-APR-2012, was vaccinated first dose of GARDASIL (lot # 666118/1539Y) and on 14-MAY-2012 was vaccinated with the second dose of GARDASIL (lot # 666163/0664Z). Concomitant therapy also included LIPITOR, LEVEMIR, metformin and vitamins (unspecified). The last menstrual period (LMP) was 17-MAR-2012 and her estimated delivery date (EDD) was on 22-DEC-2012. Estimated conception date was 30-MAR-2012. No birth defects in previous pregnancies and no infant complication in previous pregnancies. Follow up information has been received from a registered nurse, for GARDASIL, a Pregnancy Registry product, concerning the 26 year old female with diabetes, smoking of 1/2 pack per day, and a history of 2 pregnancies and 2 male babies (one at the week of 38 weeks (on 17-FEB-2009) with weight of 6 lbs 8ozs and 36 weeks (on 13-JAN-2012) with weight of 5 lbs 13ozs) who on 14-MAY-2012 was vaccinated with the second dose of GARDASIL (lot # reported as M0664Z). On 08-DEC-2012, the patient delivered a live birth via cesarean section. The mother and infant experience no complications during the delivery. The male infant was normal, no congenital anomalies, with weight of 6 lbs 7ozs and length of 19 1/2. Upon internal review, cesarean section was considered as a medically significant event. Additional information is not expected.
Age: 26.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Caesarean section, Exposure during pregnancy, Live birth
Clinical narrative: Information has been received from a registered nurse, for GARDASIL, a Pregnancy Registry product, concerning a 26 year old female patient with insulin-dependent diabetes and no drug reactions/allergies who on 02-APR-2012, was vaccinated IM with the first 0.5 mL dose of GARDASIL (lot # not provided) and on 14-MAY-2012 was vaccinated IM with the second 0.5 mL dose of GARDASIL (lot # 666163/0664Z, expiration date on 18-SEP-2012). Concomitant therapy included insulin. The nurse reported that the patient was pregnant. The last menstrual period (LMP) was unknown and her estimated delivery date (EDD) was on 22-DEC-2012. Method of confirmation was unknown. The patient sought medical attention at the physician's office and she did not receive any treatment for the event. Follow up information has been received from a registered nurse, for GARDASIL, a Pregnancy Registry product, concerning a 26 year old female with diabetes, high cholesterol and a history of 2 pregnancies and 2 live births (at the week of 38 and 37 weeks) who on 02-APR-2012, was vaccinated first dose of GARDASIL (lot # 666118/1539Y) and on 14-MAY-2012 was vaccinated with the second dose of GARDASIL (lot # 666163/0664Z). Concomitant therapy also included LIPITOR, LEVEMIR, metformin and vitamins (unspecified). The last menstrual period (LMP) was 17-MAR-2012 and her estimated delivery date (EDD) was on 22-DEC-2012. Estimated conception date was 30-MAR-2012. No birth defects in previous pregnancies and no infant complication in previous pregnancies. Follow up information has been received from a registered nurse, for GARDASIL, a Pregnancy Registry product, concerning the 26 year old female with diabetes, smoking of 1/2 pack per day, and a history of 2 pregnancies and 2 male babies (one at the week of 38 weeks (on 17-FEB-2009) with weight of 6 lbs 8ozs and 36 weeks (on 13-JAN-2012) with weight of 5 lbs 13ozs) who on 14-MAY-2012 was vaccinated with the second dose of GARDASIL (lot # reported as M0664Z). On 08-DEC-2012, the patient delivered a live birth via cesarean section. The mother and infant experience no complications during the delivery. The male infant was normal, no congenital anomalies, with weight of 6 lbs 7ozs and length of 19 1/2. Upon internal review, cesarean section was considered as a medically significant event. Additional information is not expected.
Age: 0.99
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Injection site mass, Injection site pain, Injection site warmth
Clinical narrative: Egg-sized lump developed at site of Pediarix, warm and mildly tender to touch.
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Hypersensitivity, Migraine, Oedema peripheral, Pain in extremity, Skin warm
Clinical narrative: Pt called health dept and spoke with RN on 4/15/13.  Pt reported migraine and vomiting the night of 4/10/13.  Pt stated the next day her right arm was puffy, warm, and sore.  Pt states soreness has gotten worse over time.  Pt referred to PHP for eval of complaints.  Pt went to PHP on 4/15/13 and reports to health dept that PHP thinks it was an allergic reaction and she is being treated with clindamycin, prednisone, and ibuprofen prn.
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Vomiting
Clinical narrative: Pt called health dept and spoke with RN on 4/15/13.  Pt reported migraine and vomiting the night of 4/10/13.  Pt stated the next day her right arm was puffy, warm, and sore.  Pt states soreness has gotten worse over time.  Pt referred to PHP for eval of complaints.  Pt went to PHP on 4/15/13 and reports to health dept that PHP thinks it was an allergic reaction and she is being treated with clindamycin, prednisone, and ibuprofen prn.
Age: 33.0
Sex: F
Vaccine: SMALL
Symptoms: Hypertrophic scar, Injection site nodule, Injection site pruritus, Keloid scar
Clinical narrative: The ensuing weeks after smallpox immunization patient noted typical pustule and scab formation; however, the next month a hypertrophic scar occurred.  Patient reports intensely pruritic nodule, measuring one centimeter diameter, at the immunization site (left upper arm) frustrating pruritic lesion has persisted since April 2011 smallpox immunization.
Age: 0.18
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Abdominal pain, Abdominal tenderness, Diarrhoea, Eating disorder, Faeces discoloured
Clinical narrative: Had irritability and low grade fever up to 101 for 2 days, then developed lethargy, poor eating, diarrhea with orange stool, vomiting, abdominal pain, episodic pallor. On exam had significant abdominal tenderness but by the time patient saw me he had already improved and the severe lethargy and orange stools resolved.
Age: 0.18
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Irritability, Lethargy, Pallor, Pyrexia, Vomiting
Clinical narrative: Had irritability and low grade fever up to 101 for 2 days, then developed lethargy, poor eating, diarrhea with orange stool, vomiting, abdominal pain, episodic pallor. On exam had significant abdominal tenderness but by the time patient saw me he had already improved and the severe lethargy and orange stools resolved.
Age: 0.17
Sex: M
Vaccine: DTP, OPV
Symptoms: Blood aluminium increased, Blood mercury abnormal, Emotional distress, Pyrexia, Screaming
Clinical narrative: Very upset screaming unconsolable feverish. Tylenol was given.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Blood test, Bone scan, Burning sensation, Complex regional pain syndrome, Hypoaesthesia
Clinical narrative: SYMPTOMS: Soreness at injection site (left deltoid) progressing to intense burning pain, loss of ROM of motion in left shoulder; spasms, burning sensations, constriction sensations, tingling, numbness in left arm and hand. DIAGNOSIS: RSD/CRPS (no known cure). TREATMENT: Nerve Block, PT, medications to help relieve symptoms.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site joint movement impairment, Injection site pain, Muscle spasms, Nerve block, Nuclear magnetic resonance imaging
Clinical narrative: SYMPTOMS: Soreness at injection site (left deltoid) progressing to intense burning pain, loss of ROM of motion in left shoulder; spasms, burning sensations, constriction sensations, tingling, numbness in left arm and hand. DIAGNOSIS: RSD/CRPS (no known cure). TREATMENT: Nerve Block, PT, medications to help relieve symptoms.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Paraesthesia, X-ray
Clinical narrative: SYMPTOMS: Soreness at injection site (left deltoid) progressing to intense burning pain, loss of ROM of motion in left shoulder; spasms, burning sensations, constriction sensations, tingling, numbness in left arm and hand. DIAGNOSIS: RSD/CRPS (no known cure). TREATMENT: Nerve Block, PT, medications to help relieve symptoms.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Large red, swollen, feverish circle at injection site.  Diameter of about 1 1/2 inches.
Age: 33.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Abortion spontaneous, Feeling hot, Hypoaesthesia oral, Muscle twitching, Muscular weakness
Clinical narrative: Extreme heat in bilateral feet that ascended to pelvic region over a two week period.  Paresthia over entire body.  Biateral hand, arm weakness and muscle tremors.  Numb lips, needle and pricking sensation all over body.  Tongue tremors, tongue spasms.  Muscle twitches.
Age: 33.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Paraesthesia, Tongue spasm, Tremor
Clinical narrative: Extreme heat in bilateral feet that ascended to pelvic region over a two week period.  Paresthia over entire body.  Biateral hand, arm weakness and muscle tremors.  Numb lips, needle and pricking sensation all over body.  Tongue tremors, tongue spasms.  Muscle twitches.
Age: 33.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Abortion spontaneous, Anxiety, Balance disorder, Disease progression, Exposure during pregnancy
Clinical narrative: Extreme heat in bilateral feet that ascended to pelvic region over a two week period.  Paresthia over entire body.  Biateral hand, arm weakness and muscle tremors.  Numb lips, needle and pricking sensation all over body.  Tongue tremors, tongue spasms.  Muscle twitches.
Age: 33.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Feeling hot, Formication, Hereditary spastic paraplegia, Hypoaesthesia, Hypoaesthesia oral
Clinical narrative: Extreme heat in bilateral feet that ascended to pelvic region over a two week period.  Paresthia over entire body.  Biateral hand, arm weakness and muscle tremors.  Numb lips, needle and pricking sensation all over body.  Tongue tremors, tongue spasms.  Muscle twitches.
Age: 33.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Muscle spasticity, Muscle twitching, Muscular weakness, Paraesthesia, Sensory disturbance
Clinical narrative: Extreme heat in bilateral feet that ascended to pelvic region over a two week period.  Paresthia over entire body.  Biateral hand, arm weakness and muscle tremors.  Numb lips, needle and pricking sensation all over body.  Tongue tremors, tongue spasms.  Muscle twitches.
Age: 33.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Tremor
Clinical narrative: Extreme heat in bilateral feet that ascended to pelvic region over a two week period.  Paresthia over entire body.  Biateral hand, arm weakness and muscle tremors.  Numb lips, needle and pricking sensation all over body.  Tongue tremors, tongue spasms.  Muscle twitches.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Antibody test positive, Varicella post vaccine, Varicella virus test positive
Clinical narrative: Patient developed a rash consistent with varicella disease despite immunization with vaccine 2 times and had positive varicella IgM titers.