chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 50.0
Sex: M
Vaccine: DTAP
Symptoms: Staphylococcal infection, White blood cell count increased
Clinical narrative: This case was reported in a literature article and described the occurrence of renal infarction in a 50-year-old male subject who was vaccinated with DTPa ((with small D + P), manufacturer unspecified). Concurrent medical conditions included Hodgkin's lymphoma, hyperlipidemia, hypothyroidism; migraine, prostatic hypertrophy, pulmonary fibrosis, pulmonary sarcoidosis and splenectomy. Historic vaccination included Hib; manufacturer unspecified; unknown given on an unspecified date; meningitis vaccine, strain not specified; manufacturer unspecified; unknown given on an unspecified date, SYNFLORIX; manufacturer unspecified, unknown given on an unspecified date. Historic medications included Doxorubicin, Bleomycin, Vinblastine and Dacarbazine. Concurrent medications included Calcium citrate, Enteric-coated aspirin, Simvastatin, Levothyroxine and Ergocalciferol. 21 months before vaccination, a stress echocardiogram showed normal left ventricular function at rest, mild aortic-root dilatation and trivial regurgitation of the other valves. The stress echocardiogram was negative for ischemia. The subject maintained a high-fiber low-fat diet, exercised, drank alcohol in moderation and didn't smoke. His mother had had breast cancer and she and a maternal aunt had had coronary artery disease. On an unspecified date, the subject received an unspecified dose of DTPa (with small D + P) (administration site and route unknown, batch number not provided). During the following 4 nights, the subject experienced mild nausea and fever (38.1 deg.C) without chills. 4 days after vaccination with DTPa (with small D + P), the subject experienced flank pain which was diagnosed as a thromboembolic renal infarction due to endocarditis. The subject was hospitalised. During hospitalisation, the subject had a methicillin-resistant Staphylococcus aureus. The subject was treated with Penicillin, ceftriaxone, vancomycin, Gentamicin, Ondansetron, Levothyroxine and simvastatin. At the time of reporting, the outcome of the events was unspecified. The authors considered that fever and nausea were almost certainly related to vaccination with DTPa (with small D + P).
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash
Clinical narrative: Sx : Pt left arm (vaccinated arm) shows red rash an back of arm from elbow to shoulder. 2" radius around injection site is dark red. Rash area is itchy. Tx: Topical Hydrocortisone.
Age: 63.0
Sex: F
Vaccine: TDAP
Symptoms: Aphagia, Erythema, Malaise, Migraine, Nausea
Clinical narrative: Pain to left arm. Redness from shoulder to elbow. Migraine headache. Fever to 101.4. Nausea. Unable to eat. General body ache. Started 24 hours after receiving vaccine. Fever treated with ibuprofen. Obtain relief for about 4 hrs, then fever returns. Been three days now still sick.
Age: 63.0
Sex: F
Vaccine: TDAP
Symptoms: Pain, Pain in extremity, Pyrexia
Clinical narrative: Pain to left arm. Redness from shoulder to elbow. Migraine headache. Fever to 101.4. Nausea. Unable to eat. General body ache. Started 24 hours after receiving vaccine. Fever treated with ibuprofen. Obtain relief for about 4 hrs, then fever returns. Been three days now still sick.
Age: 36.0
Sex: F
Vaccine: HEP, PPV
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Pt presents on 2/21/13 with c/o redness and tenderness at site of (L) deltoid immunization. She first noticed redness in the morning. Somewhat irregularly shaped though well circumscribed erythematous macule on (L) anterior deltoid roughly 10 cm x 8 cm no increase temp or drainage. She is instructed to use Cephalexin 500 mg TID x 10 days if redness spread.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP, HPV4
Symptoms: Amnesia, Convulsion, Epilepsy, Fear, Personality change
Clinical narrative: Seizures started 2 weeks after the shot. Personality changed. Patient felt scared. Loss of memory. Taking zonisamide 6 pills a day to control seizures.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP, HPV4
Symptoms: Activities of daily living impaired, Amnesia, Anger, Convulsion, Disturbance in social behaviour
Clinical narrative: Seizures started 2 weeks after the shot. Personality changed. Patient felt scared. Loss of memory. Taking zonisamide 6 pills a day to control seizures.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP, HPV4
Symptoms: Palpitations, Personality change, School refusal
Clinical narrative: Seizures started 2 weeks after the shot. Personality changed. Patient felt scared. Loss of memory. Taking zonisamide 6 pills a day to control seizures.
Age: 49.0
Sex: F
Vaccine: HEP, MMR
Symptoms: Dyspnoea, Headache
Clinical narrative: Severe dyspnea/headache went to local clinic and was prescribed Prednisone / Z PACK. S/S started 3-4 days after MMR #1 & resolved 3 weeks later.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: This spontaneous report was received from a 68-year-old female patient regarding herself, with no drug reactions or allergies. Current conditions included lactose intolerance. Approximately on an unknown date in February 2010 the patient was vaccinated with a dose of live ZOSTAVAX (lot# and expiration date not reported) subcutaneously. On 14-FEB-2013, she began to develop a rash on her left leg and back that developed into blisters. She showed them to her doctor and he told her she had shingles. The patient stated the blisters were healing and she considered herself recovering. Patient was treated with acyclovir and CLOBET cream. No lab diagnostic studies were performed. Patient sought medical attention for the event. Causality was not reported. Additional information is not expected.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Nausea
Clinical narrative: This spontaneous report as received from a physician via field employee referred to a 25 year old female patient. On 19-FEB-2013 the patient was vaccinated with GARDASIL (lot # H010915, exp date as 13-FEB-2015, dose/frequency and route were unspecified). Patient felt "queasy" following the vaccination on 19-FEB-2013. It was not known which dose in the schedule the patient received today's vaccine. Patient did not seek medical attention. No treatment was given for the event. The outcome of felt "queasy" following the vaccination was unknown. The relationship was not provided. 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. On an unknown date, the patient was vaccinated with the first dose of GARDASIL (injection) (lot#, dose and route not reported). On an unknown date, the patient was vaccinated with the second dose of GARDASIL (injection) (lot#, dose and route not reported) 1 year after the the first. No adverse effect reported. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: VARCEL
Symptoms: Varicella post vaccine, Viral titre decreased
Clinical narrative: Information has been received from a medical assistant, who did not administer vaccines, concerning a 12 year old female patient. The patient had no pertinent medical history, and no known drug allergies or reactions. On 10-JAN-2002, the patient was vaccinated with a dose of live (Merck) VARIVAX (dose and route were not reported) (Lot # and expiration date were not reported). On an unknown date, the patient developed chickenpox. The patient sought medical attention through office visit. No treatment was given for the event. The medical assistant reported that in approximately February 2013 last week some "titers test" was drawn with negative results. At the time of the report, the patient had recovered from chickenpox. The relatedness for live (Merck) VARIVAX and chickenpox was unknown. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a physician refers to a female patient (age unknown). In approximately February 2012, about a year ago, the patient was vaccinated with first two doses of GARDASIL (120 micrograms) (lot number, dose and route were not reported) as prophylaxis. On approximately 13-FEB-2013, the patient was vaccinated with third dose of GARDASIL (120 micrograms) as prophylaxis (lot number and route were not reported). No adverse effects 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 pharmacy student refers to a patient of unknown age. This case was linked to case 1302USA011365 (same reporter). On 11-FEB-2013 the patient was vaccinated with live ZOSTAVAX (lot # 671455/1256AA, expiration date 11-JAN-2012). On 11-FEB-2013 the patient received expired live ZOSTAVAX. No adverse event was reported. Additional information has been requested.
Age: 43.0
Sex: F
Vaccine: PPV
Symptoms: Blood immunoglobulin G decreased, Blood immunoglobulin M decreased, Immunodeficiency common variable, Immunoglobulin therapy, No therapeutic response
Clinical narrative: It was reported in a published article title as stated above that a female patient with Crohn's disease, diagnosed at age of 31, on an unknown date was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unspecified). The patient was treated with Prednisone and Mesalamine. 12 years later (at 43 year old) immune studies revealed low IgG and IgM with absent antibody response to pneumococcal vaccine. On Intravenous immunoglobulin (IVIG) the severity of her inflammatory bowel disease (IBD) symptoms decreased. The patient failed treatment with steroids but responded to IVIG. The article concluded that intestinal symptoms suggestive of IBD were common in Common variable immunodeficiency (CIVD), but did not respond well to classical IBD regimen. Additional information is not expected.
Age: 54.0
Sex: F
Vaccine: MMRV
Symptoms: Erythema, Injection site swelling, Rash
Clinical narrative: This spontaneous report was received from a physician refers to a 54 year old female patient. In December 2012, the patient was vaccinated with PROQUAD (Merck) (lot # H015642; exp date; 06-JAN-2014) o0.5 ml, intramuscular injection as immunization. On an unknown date, the patient received PROQUAD (Merck), and after had swelling at the injection site "the size of a golf-ball" and a rash across the torso that was red, but did not itch or hurt. She reports both adverse reactions went away after three days. She did not seek medical treatment for adverse effects. Laboratories were not performed. At the time of the report, the outcome of swelling at the injection site and rash was recovering. The events of swelling at the injection site and rash were unknown related to PROQUAD (Merck). Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered pharmacist concerning a patient of unknown age who on 12-FEB-2013 was vaccinated with a dose of ZOSTAVAX (dose, route and lot number not provided) that was exposed to an unsupported temperature excursion. No adverse effect reported. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: DTAPIPVHIB, MMR
Symptoms: Decreased appetite, Lethargy, Pain, Pain in extremity, Pruritus generalised
Clinical narrative: Common vaccine reations: sore limb, lethargic, lack of appetite, low grade fever, runny nose. Head started itching. 12.5mg of Benadryl administered. 8:00 PM itching reappeared but was proceded by full body itching. 12.5mg of Benadryl readministered after contacting Urgent Care. Child was very restless, achy, and only mildly comforted by Benadryl.
Age: 4.0
Sex: F
Vaccine: DTAPIPVHIB, MMR
Symptoms: Pyrexia, Restlessness, Rhinorrhoea
Clinical narrative: Common vaccine reations: sore limb, lethargic, lack of appetite, low grade fever, runny nose. Head started itching. 12.5mg of Benadryl administered. 8:00 PM itching reappeared but was proceded by full body itching. 12.5mg of Benadryl readministered after contacting Urgent Care. Child was very restless, achy, and only mildly comforted by Benadryl.
Age: 21.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Vaccination site rash
Clinical narrative: Rash on shoulder near vaccine site. Patient seen in clinic on 2/25/13 and prescribed Keflex.
Age: 5.0
Sex: M
Vaccine: DTAP, DTAPHEPBIP, MMRV
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: 5 year old child given Pediarix and DTAP.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Pain, Pyrexia
Clinical narrative: First 3 days after vaccination patient had a fever of 103,severe pain at injection site and general body aches.  There was no redness at injection site and there was no other signs/symptoms except the above stated.
Age: 0.34
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Blood test, Body temperature increased, Chorea, Computerised tomogram, Cytogenetic analysis
Clinical narrative: At 12:00 PM on Thursday February 7, 2013, I checked patient's temperature and it was 100.8 degrees Fahrenheit. I gave her 2.5 ml of Children's Tylenol. I started to notice her right arm was flailing like she was having an spasms. Around 3:30 PM I called facility and made an appointment to see Dr. that same day at 4:30 PM. At 4:00 PM I rechecked patient's temperature and it was 99.1 Degrees Fahrenheit. I brought her to see Dr. who was unsure why her arm was flailing like that. I was then advised to give it a couple of days to see if it would subside and if it did not stop come Monday February 11, 2013 to contact the Neurology Department of Hospital. She continued to flail her arm the rest of the day. The next day Friday, February 8, 2013 after patient was still having this problem I contacted the Neurology department and spoke with a nurse who said to be on the safe side bring her in to be seen. I immediately brought her in and was seen by several doctors including neurologists and specialists. Tests were performed and we were admitted at 7 PM for further testing.  On Saturday February 9, 2013 after further testing we were discharged and waiting for pending results. Was diagnosed with Acute Chorea of February 14, 2013 with additional bloodwork ordered.
Age: 0.34
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Electroencephalogram, Muscle spasms, Nuclear magnetic resonance imaging
Clinical narrative: At 12:00 PM on Thursday February 7, 2013, I checked patient's temperature and it was 100.8 degrees Fahrenheit. I gave her 2.5 ml of Children's Tylenol. I started to notice her right arm was flailing like she was having an spasms. Around 3:30 PM I called facility and made an appointment to see Dr. that same day at 4:30 PM. At 4:00 PM I rechecked patient's temperature and it was 99.1 Degrees Fahrenheit. I brought her to see Dr. who was unsure why her arm was flailing like that. I was then advised to give it a couple of days to see if it would subside and if it did not stop come Monday February 11, 2013 to contact the Neurology Department of Hospital. She continued to flail her arm the rest of the day. The next day Friday, February 8, 2013 after patient was still having this problem I contacted the Neurology department and spoke with a nurse who said to be on the safe side bring her in to be seen. I immediately brought her in and was seen by several doctors including neurologists and specialists. Tests were performed and we were admitted at 7 PM for further testing.  On Saturday February 9, 2013 after further testing we were discharged and waiting for pending results. Was diagnosed with Acute Chorea of February 14, 2013 with additional bloodwork ordered.
Age: 42.0
Sex: F
Vaccine: HEP
Symptoms: Contusion, Limb discomfort, Myalgia
Clinical narrative: Injection site was upper left bicep. Started with slight discomfort in left inner forearm as if bruised. Later, gradually became worse as a muscular ache that spread out in a larger area.  Eventually pain subsided by the afternoon of 02/23/2013 when small burst of body aches set in for about 2-3 hours and then stopped.
Age: 47.0
Sex: F
Vaccine: HEP, MMR
Symptoms: Choking, Facial pain, Injection site erythema, Injection site pain, Muscle contractions involuntary
Clinical narrative: Site of vaccination swollen, red and hot size 2 inches x 1 inch, pain in right shoulder right neck and face with muscle in right cheek involuntarily contracting, next day site swelling doubled, face swelling, some choking.
Age: 47.0
Sex: F
Vaccine: HEP, MMR
Symptoms: Neck pain, Swelling face, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Site of vaccination swollen, red and hot size 2 inches x 1 inch, pain in right shoulder right neck and face with muscle in right cheek involuntarily contracting, next day site swelling doubled, face swelling, some choking.
Age: 24.0
Sex: F
Vaccine: FLUX
Symptoms: Diarrhoea, Food aversion, Rash erythematous, Rash pruritic
Clinical narrative: Short term: diarrhea. long term: red itchy bumps on top of hands, looks like rash. Aversion to milk now (did not have any issue with it prior to vaccination).
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Hypersensitivity, Pain, Paraesthesia oral
Clinical narrative: This spontaneous report as received from the consumer's husband refers to a female patient of unknown age. On an unspecified date, the patient was vaccinated with ZOSTAVAX (Lot #, dose, route not reported). No concomitant Medications reported. The patient's husband reported that 6 to 7 days after his wife had received the ZOSTAVAX shot she had an allergic reaction (onset date unknown). The patient's lips tingled, throbbed, and started to blister (onset date unknown). Reporter refused to provide physician in formation. Patient's outcome was unknown. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Patient had complained about pain at the site of injection.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Immediate post-injection reaction, Presyncope, Syncope
Clinical narrative: Pt was given 3 vaccines today: MENACTRA, ADACEL and GARDASIL given in that order. Immediately after GARDASIL was given. Pt had a vasovagal reaction with syncope. Pt was lowered to a laying position (from sitting). Episode lasted approx. 30 sec. Pt came to and began to cry. No treatment was needed. Pt stayed in clinic to be observed for 30 mins.
Age: 12.0
Sex: F
Vaccine: TDAP
Symptoms: Fall, Head injury, Immediate post-injection reaction
Clinical narrative: After administering Tdap within seconds pt after pt got/stood up, feel & hit her head on the wall. I examined the head no lump or laceration noted. Pt regain total concents within seconds & didn't complain of anything. RN in charge notified. After close observation. Pt was released at 335.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus
Clinical narrative: Red, itchy, hard patch at sight of injection.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Crying, Diarrhoea, Haematochezia, Irritability, Vomiting
Clinical narrative: Within 3 1/2 hours of vaccines, vomited, crying. blood in stools, diarrhea x 2 weeks. Irritability lasted x 2 months.
Age: 24.0
Sex: F
Vaccine: TYP
Symptoms: Urticaria
Clinical narrative: Patient reports hives on trunk & arms, which appeared within 15 minutes of taking first dose. Pt. reported this to provider on 2-25-13.
Age: 26.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a 26 year old female pharmacist refers to herself. The patient had none pertinent medical history. On 12-FEB-2013, the patient was vaccinated with ZOSTAVAX (lot # not reported) at the age of 26 years. Concomitant therapies included contraceptives and vitamins. Soon after vaccination, on 12-FEB-2013, the injection site became red, itchy, warm and raised. The patient reported that she developed a slight injection reaction to all vaccines including unspecified flu vaccine (manufacturer unknown) (related ID: 1302USA011802). The patient did not seek medical attention. No treatment was given. The outcome of injection site became red, itchy, warm and raised was reported as not recovered/not resolved. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Immediate post-injection reaction, Injection site anaesthesia
Clinical narrative: This spontaneous report was received from a a registered nurse refers to a 13 year old female patient with penicillin allergy and amoxicillin allergy and no pertinent medical history. On 30-NOV-2009, the patient was vaccinated with the first dose of GARDASIL (Lot # 0672Y, Exp date: 19-SEP-2011). On 29-NOV-2010, the patient was vaccinated with the second dose of GARDASIL (Lot # 0992Z, Exp date: 14-OCT-2012). The patient had no concomitant medications. The nurse reported that the patient developed numbness in the arm (injection site arm) immediately following the first and second dose of GARDASIL. No treatment was given. No laboratories were performed. The numbness resolved after an unspecified time period after each dose of GARDASIL. The patient sought medical attention, contacted office. The nurse had no other information about the numbness at the time of the call. Additional information has been requested.
Age: 39.0
Sex: M
Vaccine: HPV4
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a doctor of pharmacy concerning a patient of unknown age and gender. On 20-FEB-2013, the patient was vaccinated with a dose of GARDASIL (lot number reported as 667194/1271Z, dose and route unspecified) that had expired on 11-DEC-2012. No adverse effect was reported. This is one of the two reports from the same reporter. Additional information has been requested.
Age: 0.2
Sex: M
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 2 month old patient. On an unknown date the patient was inadvertently vaccinated with a dose of VAQTA (Lot# and route were not reported). No adverse effect was reported. It was unknown if the patient sought medical attention. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a physician assistant referred to a patient of unknown age. Physician assistant mentioned that patient received the 2nd dose of GARDASIL (Lot#, dose/frequency, route were unspecified) on 12-APR-2012 and was in the office today, 13-FEB-2013 for the 3rd dose of GARDASIL (Lot#, dose/frequency, route were unspecified). The patient was not experiencing any known symptoms. The outcome and relationship were not provided. Additional information has been requested.
Age: 17.0
Sex: M
Vaccine: HPV4
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a doctor of pharmacy concerning a patient of unknown age and gender. On 29-DEC-2012, the patient was vaccinated with a dose of GARDASIL (lot number reported as 667194/1271Z, dose and route unspecified) that had expired on 11-DEC-2012. No adverse effect was reported. This is one of the two reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (Lot # not reported). The pharmacist reported that on an unknown date the patient experienced a rash. The outcome of rash was unknown. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Initial information has been received from a nurse practitioner via field representative concerning a patient with an unspecified age, gender, pertinent medical history or drug reactions/allergies. On an unknown date, the patient was vaccinated with an inappropriate stored second dose of GARDASIL for prophylaxis (dose, duration, frequency and lot number were not reported). No co-suspect medications were reported. No concomitant medications were reported. No adverse effect reported. The patient's outcome was unknown. No treatment information was reported. No laboratory studies were reported. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Dry eye, Dry mouth, Injection site erythema, Injection site mass, Injection site reaction
Clinical narrative: This spontaneous report as received from a Doctor of pharmacist concerning a 70 year old female patient with some unspecified pre-existing eye problem and allergic to sulfa drugs who on 11-FEB-2013 was vaccinated with a dose of ZOSTAVAX (dose route and lot # not provided). Concomitant therapies included ALPHAGAN P, prednisolone (manufacturer unspecified) and cyclobenazapine hydrochloride (manufacturer unspecified). The pharmacist stated that after the ZOSTAVAX was given the patient developed an injection site reaction and dry eyes and dry mouth. The injection site reaction developed late yesterday on 12-FEB-2013 or today 13-FEB-2013 and was described as a 2 inch diameter red bump at the injection site. The pharmacist was unsure when the dry eyes and mouth occurred in relation to the administration of the ZOSTAVAX, but stated that the patient reported drink two large glasses of water, just this morning on 13-FEB-2013. TYLENOL was given as a treatment for the events. There were no labs performed. The patient contacted the pharmacist. The outcome of dry mouth, injection site reaction, 2 inch in diameter red bump at the injection site and dry eyes was reported as not recovered. Additional information has been requested.
Age: 75.0
Sex: F
Vaccine: TD, VARZOS
Symptoms: Expired drug administered
Clinical narrative: Administration of expired vaccine ZOSTAVAX expiration date 05 October 2012.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Discomfort, Immediate post-injection reaction, Injection site discolouration, Injection site mass, Injection site pain
Clinical narrative: This spontaneous report as received from a 66 year old female patient without any pertinent medical history or drug reactions/allergies. On 25-NOV-2012 the patient was vaccinated with ZOSTAVAX (dose and lot # not reported). "The vaccine was given approximately 1 inch above the elbow". There was no concomitant medication. On 25-NOV-2012 the patient developed immediately pain at the injection site that continued throughout the next day (26-NOV-2012). On 27-NOV-2012 the area became very itchy, and had a considerable burning sensation. The reaction continued to spread towards her upper and mid arm in either direction. The area had become very swollen and the patient had developed fluid in her elbow. The whole affected area was fiery hot and swollen. The patient went to her physician who put her on unspecified antibiotics, BENADRYL to address the itching, and ADVIL for the discomfort. The area had now reduced to a 1 cm, sensitive, blue lump. There was no lab diagnostics studies performed. At the time of reporting, the outcome of the events was unknown. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site swelling, Injection site warmth, Joint effusion
Clinical narrative: This spontaneous report as received from a 66 year old female patient without any pertinent medical history or drug reactions/allergies. On 25-NOV-2012 the patient was vaccinated with ZOSTAVAX (dose and lot # not reported). "The vaccine was given approximately 1 inch above the elbow". There was no concomitant medication. On 25-NOV-2012 the patient developed immediately pain at the injection site that continued throughout the next day (26-NOV-2012). On 27-NOV-2012 the area became very itchy, and had a considerable burning sensation. The reaction continued to spread towards her upper and mid arm in either direction. The area had become very swollen and the patient had developed fluid in her elbow. The whole affected area was fiery hot and swollen. The patient went to her physician who put her on unspecified antibiotics, BENADRYL to address the itching, and ADVIL for the discomfort. The area had now reduced to a 1 cm, sensitive, blue lump. There was no lab diagnostics studies performed. At the time of reporting, the outcome of the events was unknown. Additional information has been requested.
Age: 19.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Echocardiogram normal, Electrocardiogram abnormal, Myocarditis, Troponin I increased
Clinical narrative: This study case was received from the investigator on 18 February 2013. A 19-year-old male subject had received ACAM2000 on 03 December 2012 and 14 days later, he was diagnosed with "other and unspecified acute myocarditis" (ICD-9 422.9). The subject had previously received an injection of Typhoid, ViCPs and Anthrax vaccines on 03 December 2012, and an injection of Influenza seasonal vaccine on 14 November 2012 (lot numbers, routes and sites of administration not reported). On 14 December 2012, the subject had abnormal troponin I results (6.68 ng/mL) and an abnormal ECG. The subject was diagnosed with Other and unspecified acute myocarditis on 17 December 2012. On 18 December 2012, echocardiogram results were normal. Lumbar puncture and MRI of the brain, spinal cord and heart were not performed. The subject has no significant medical history. Outcome was not reported. Additional information will be requested from the investigator. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: None.
Age: 87.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Injection site erythema
Clinical narrative: A red streak appeared down the injection site it was approx 4" long & 3/4" wide. Pt said did not hurt or itch. Maybe slightly warmer to the touch than surrounding skin.
Age: 87.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site streaking, Injection site warmth
Clinical narrative: A red streak appeared down the injection site it was approx 4" long & 3/4" wide. Pt said did not hurt or itch. Maybe slightly warmer to the touch than surrounding skin.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL, DTAP, IPV, MMR, VARCEL, DTAP, IPV, MMR, VARCEL
Symptoms: Hypersensitivity, Wheezing
Clinical narrative: Initial information was received on 19 February 2013 from a consumer with additional information received the same day from a healthcare professional (HCP). A 4-year-old male patient with a medical history of asthma and bee sting allergy received 4 vaccines on 18 February 2013: intramuscular DAPTACEL in the left arm (lot number C4310BA, sanofi pasteur), intramuscular IPOL vaccine in the left arm (lot number H1605-2, sanofi pasteur), subcutaneous MMR vaccine in right arm (lot number H012140/G004488, other manufacturer), and subcutaneous VARICELLA vaccine in right arm (lot H016911/G004488, other manufacturer). On 18 February 2013, within 5 minutes of administration of the 4 vaccines and Ibuprofen, the patient experienced symptoms of allergic reaction, began wheezing, and required supplemental oxygen, albuterol, and epinephrine. The patient was transferred to the emergency room. Patient had 4 previous doses of DTaP vaccine, 3 previous doses of polio virus vaccine, 1 previous dose of MMR vaccine, and 1 previous dose of varicella vaccine. Patient had no illness at time of vaccination. The HCP reported the adverse events were life threatening and required hospitalization. The patient's outcome was reported as recovered by the HCP. Documents held by sender: none.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL, DTAP, IPV, MMR, VARCEL, DTAP, IPV, MMR, VARCEL
Symptoms: Anaphylactic reaction, Hypersensitivity, Wheezing
Clinical narrative: Initial information was received on 19 February 2013 from a consumer with additional information received the same day from a healthcare professional (HCP). A 4-year-old male patient with a medical history of asthma and bee sting allergy received 4 vaccines on 18 February 2013: intramuscular DAPTACEL in the left arm (lot number C4310BA, sanofi pasteur), intramuscular IPOL vaccine in the left arm (lot number H1605-2, sanofi pasteur), subcutaneous MMR vaccine in right arm (lot number H012140/G004488, other manufacturer), and subcutaneous VARICELLA vaccine in right arm (lot H016911/G004488, other manufacturer). On 18 February 2013, within 5 minutes of administration of the 4 vaccines and Ibuprofen, the patient experienced symptoms of allergic reaction, began wheezing, and required supplemental oxygen, albuterol, and epinephrine. The patient was transferred to the emergency room. Patient had 4 previous doses of DTaP vaccine, 3 previous doses of polio virus vaccine, 1 previous dose of MMR vaccine, and 1 previous dose of varicella vaccine. Patient had no illness at time of vaccination. The HCP reported the adverse events were life threatening and required hospitalization. The patient's outcome was reported as recovered by the HCP. Documents held by sender: none.
Age: 1.45
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL, MMR, VARCEL, DTAP, IPV, MMR, VARCEL
Symptoms: Convulsion, Gaze palsy, Pyrexia, Skin warm, Tremor
Clinical narrative: This spontaneous report as received from an office manager refers to a 17 month old male patient with asthma and 29 week gestation age and no drug reactions or allergies. The patient's medical history included periodic fever syndrome. On 07-APR-2010 the patient was vaccinated with the first dose of M-M-R II (lot# not reported) and the first dose of VARIVAX (Merck) (lot# not reported). On 18-FEB-2013 the patient was vaccinated subcutaneously on the right arm with the second 0.5mL dose of M-M-R II (lot # reported as H012140, exp. date 29-JUN-2014) and was vaccinated subcutaneously on the right arm with the second 0.5mL dose of VARIVAX (Merck) (lot # reported as H016911, exp. date 10-SEP-2014). The patient was receiving the second doses of M-M-R II and VARIVAX (Merck) because of 4 year vaccinations. Concomitant therapies included IPOL (manufactured by Sanofi Pasteur) and DAPTACEL (manufactured by Sanofi Pasteur). There was no other concomitant therapies. On 12-APR-2010, the patient experienced seizure febrile. On 19-FEB-2013 at 03:00 am the patient was warm with a fever. On 19-FEB-2013 at 12:45am the patient had 2 episodes of legs shaking and eyes looking up. The patient was fine by the morning of 19-FEB-2013 when the patient's mother contacted the office at around 09:00. The patient was given unspecified fever reducer medication. No lab diagnostics studies were performed. The patient had a phone call and office visit on 19-FEB-2013. At the time of report, the outcome of the events was recovered. Upon internal review, seizure febrile was considered to be an medically significant event. Additional information has been requested.
Age: 1.45
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL, MMR, VARCEL, DTAP, IPV, MMR, VARCEL
Symptoms: Febrile convulsion, Gaze palsy, Pyrexia, Skin warm, Tremor
Clinical narrative: This spontaneous report as received from an office manager refers to a 17 month old male patient with asthma and 29 week gestation age and no drug reactions or allergies. The patient's medical history included periodic fever syndrome. On 07-APR-2010 the patient was vaccinated with the first dose of M-M-R II (lot# not reported) and the first dose of VARIVAX (Merck) (lot# not reported). On 18-FEB-2013 the patient was vaccinated subcutaneously on the right arm with the second 0.5mL dose of M-M-R II (lot # reported as H012140, exp. date 29-JUN-2014) and was vaccinated subcutaneously on the right arm with the second 0.5mL dose of VARIVAX (Merck) (lot # reported as H016911, exp. date 10-SEP-2014). The patient was receiving the second doses of M-M-R II and VARIVAX (Merck) because of 4 year vaccinations. Concomitant therapies included IPOL (manufactured by Sanofi Pasteur) and DAPTACEL (manufactured by Sanofi Pasteur). There was no other concomitant therapies. On 12-APR-2010, the patient experienced seizure febrile. On 19-FEB-2013 at 03:00 am the patient was warm with a fever. On 19-FEB-2013 at 12:45am the patient had 2 episodes of legs shaking and eyes looking up. The patient was fine by the morning of 19-FEB-2013 when the patient's mother contacted the office at around 09:00. The patient was given unspecified fever reducer medication. No lab diagnostics studies were performed. The patient had a phone call and office visit on 19-FEB-2013. At the time of report, the outcome of the events was recovered. Upon internal review, seizure febrile was considered to be an medically significant event. Additional information has been requested.
Age: 1.45
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL, MMR, VARCEL, DTAP, IPV, MMR, VARCEL
Symptoms: Gaze palsy, Pyrexia, Tremor
Clinical narrative: This spontaneous report as received from an office manager refers to a 17 month old male patient with asthma and 29 week gestation age and no drug reactions or allergies. The patient's medical history included periodic fever syndrome. On 07-APR-2010 the patient was vaccinated with the first dose of M-M-R II (lot# not reported) and the first dose of VARIVAX (Merck) (lot# not reported). On 18-FEB-2013 the patient was vaccinated subcutaneously on the right arm with the second 0.5mL dose of M-M-R II (lot # reported as H012140, exp. date 29-JUN-2014) and was vaccinated subcutaneously on the right arm with the second 0.5mL dose of VARIVAX (Merck) (lot # reported as H016911, exp. date 10-SEP-2014). The patient was receiving the second doses of M-M-R II and VARIVAX (Merck) because of 4 year vaccinations. Concomitant therapies included IPOL (manufactured by Sanofi Pasteur) and DAPTACEL (manufactured by Sanofi Pasteur). There was no other concomitant therapies. On 12-APR-2010, the patient experienced seizure febrile. On 19-FEB-2013 at 03:00 am the patient was warm with a fever. On 19-FEB-2013 at 12:45am the patient had 2 episodes of legs shaking and eyes looking up. The patient was fine by the morning of 19-FEB-2013 when the patient's mother contacted the office at around 09:00. The patient was given unspecified fever reducer medication. No lab diagnostics studies were performed. The patient had a phone call and office visit on 19-FEB-2013. At the time of report, the outcome of the events was recovered. Upon internal review, seizure febrile was considered to be an medically significant event. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL, MMR, VARCEL, DTAP, IPV, MMR, VARCEL
Symptoms: Convulsion, Gaze palsy, Pyrexia, Skin warm, Tremor
Clinical narrative: Initial case was received from a healthcare professional on 20 February 2013. A four-year-old male patient received the following vaccines on 18 February 2013 at 2:10pm: dose five of an intramuscular left arm injection of DAPTACEL, sanofi pasteur Ltd., lot number C4310BA; dose four of an intramuscular left arm injection of IPOL, sanofi pasteur SA, lot number H1605-2; dose two of right arm subcutaneous injection of MMR vaccine, MERCK, lot number H012140; and dose two of right arm subcutaneous injection of VARIVAX, MERCK, lot number H016911. Overnight, on 19 February 2013 at 03:00AM, the patient was seen to have two episodes with legs shaking and eyes looking up. The second time, the mom noticed the patient was very warm with fever. He was "fine by AM" morning. The only other time the patient had a seizure was after MMR and VARIVAX, at 17 months old, given on 07 April 2010 and he had febrile seizure on 12 April 2010. His two siblings had no adverse events following prior vaccination. The patient had no illness at time of vaccination. The patient had a past medical history of preterm birth at 29 weeks gestational age with birth weight of two pounds, 14 ounces, periodic fever syndrome and asthma. No laboratory or diagnostic tests were performed. Treatments were not reported. The patient was reported as recovered "fine by morning" on 19 February 2013. Documents held by sender: None.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL, MMR, VARCEL, DTAP, IPV, MMR, VARCEL
Symptoms: Febrile convulsion, Gaze palsy, Pyrexia, Skin warm, Tremor
Clinical narrative: Initial case was received from a healthcare professional on 20 February 2013. A four-year-old male patient received the following vaccines on 18 February 2013 at 2:10pm: dose five of an intramuscular left arm injection of DAPTACEL, sanofi pasteur Ltd., lot number C4310BA; dose four of an intramuscular left arm injection of IPOL, sanofi pasteur SA, lot number H1605-2; dose two of right arm subcutaneous injection of MMR vaccine, MERCK, lot number H012140; and dose two of right arm subcutaneous injection of VARIVAX, MERCK, lot number H016911. Overnight, on 19 February 2013 at 03:00AM, the patient was seen to have two episodes with legs shaking and eyes looking up. The second time, the mom noticed the patient was very warm with fever. He was "fine by AM" morning. The only other time the patient had a seizure was after MMR and VARIVAX, at 17 months old, given on 07 April 2010 and he had febrile seizure on 12 April 2010. His two siblings had no adverse events following prior vaccination. The patient had no illness at time of vaccination. The patient had a past medical history of preterm birth at 29 weeks gestational age with birth weight of two pounds, 14 ounces, periodic fever syndrome and asthma. No laboratory or diagnostic tests were performed. Treatments were not reported. The patient was reported as recovered "fine by morning" on 19 February 2013. Documents held by sender: None.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL, MMR, VARCEL, DTAP, IPV, MMR, VARCEL
Symptoms: Gaze palsy, Pyrexia, Tremor
Clinical narrative: Initial case was received from a healthcare professional on 20 February 2013. A four-year-old male patient received the following vaccines on 18 February 2013 at 2:10pm: dose five of an intramuscular left arm injection of DAPTACEL, sanofi pasteur Ltd., lot number C4310BA; dose four of an intramuscular left arm injection of IPOL, sanofi pasteur SA, lot number H1605-2; dose two of right arm subcutaneous injection of MMR vaccine, MERCK, lot number H012140; and dose two of right arm subcutaneous injection of VARIVAX, MERCK, lot number H016911. Overnight, on 19 February 2013 at 03:00AM, the patient was seen to have two episodes with legs shaking and eyes looking up. The second time, the mom noticed the patient was very warm with fever. He was "fine by AM" morning. The only other time the patient had a seizure was after MMR and VARIVAX, at 17 months old, given on 07 April 2010 and he had febrile seizure on 12 April 2010. His two siblings had no adverse events following prior vaccination. The patient had no illness at time of vaccination. The patient had a past medical history of preterm birth at 29 weeks gestational age with birth weight of two pounds, 14 ounces, periodic fever syndrome and asthma. No laboratory or diagnostic tests were performed. Treatments were not reported. The patient was reported as recovered "fine by morning" on 19 February 2013. Documents held by sender: None.
Age: 40.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Back pain, Guillain-Barre syndrome, Hypoaesthesia, Hypoaesthesia oral, Immunoglobulin therapy
Clinical narrative: Numbing/cramping on my right toes & foot. Becoming evident on my right hand-spreading through my right side of my body. Woke up 02/02/2013 with a lock-jaw sensation & cramping spreading through my left side off my body. 02/05/2013, back pains occurred - progressing the following day. 02/08/2013, facial paralysis. 02/09//2013, Tongue & throat numbness (bar). I was diagnosed with GBS on 02/09//20133 -confirmed through a spinal lumbar puncture. 02/10/2013 at 2:00 am Immunoglobulin was administered (3 times daily, for 5 days). So far, recovering nicely.
Age: 40.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Lumbar puncture abnormal, Muscle spasms, Pharyngeal hypoaesthesia, Trismus, VIIth nerve paralysis
Clinical narrative: Numbing/cramping on my right toes & foot. Becoming evident on my right hand-spreading through my right side of my body. Woke up 02/02/2013 with a lock-jaw sensation & cramping spreading through my left side off my body. 02/05/2013, back pains occurred - progressing the following day. 02/08/2013, facial paralysis. 02/09//2013, Tongue & throat numbness (bar). I was diagnosed with GBS on 02/09//20133 -confirmed through a spinal lumbar puncture. 02/10/2013 at 2:00 am Immunoglobulin was administered (3 times daily, for 5 days). So far, recovering nicely.
Age: 40.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Inappropriate schedule of drug administration, Musculoskeletal pain, Pain
Clinical narrative: This spontaneous report was received from a physician 40-year-old female patient. The patient's medical history included shingles and post herpetic neuralgia. Approximately on an unknown date (reported as a year ago) in February 2012, the patient was vaccinated with a dose of live ZOSTAVAX (lot#, expiration date and route not reported), subcutaneously after recovering from a case of shingles. The physician added that the patient's post-herpetic neuralgia resolved after she received live ZOSTAVAX. The patient was experiencing intense burning pain in left scapula region approximately on an unknown date in February 2013 (reported as 'now') which the physician had diagnosed as possible shingles. There were no lesions. The reported event had not resolved. The patient sought medical attention by office visit. Causality was not reported. 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 licensed practical nurse refers to a patient of unknown age (gender unspecified). On 12-APR-2012, the patient was vaccinated with first dose of GARDASIL (lot number, expiry date and route was not reported). On 30-NOV-2012, the patient was vaccinated with second dose of GARDASIL (lot number, expiry date and route was not reported). Concomitant medications were not reported. No adverse effect was reported. Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a patient of unknown age. On 09-FEB-2013, the patient was vaccinated with a dose of 0.65ml ZOSTAVAX (lot number reported as 0364AE, expiry date 16-MAR-2013, route was subcutaneous) that had been previously exposed to 71 degrees Fahrenheit for possibly 16 to 24 hours. Concomitant medications were not reported. No adverse effect was reported. Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Adverse drug reaction, Fatigue, Influenza like illness, Pyrexia, Reaction to preservatives
Clinical narrative: This spontaneous report was received from a 73-year-old female patient regarding herself. Current conditions included thimerosal allergy. Approximately on an unknown date in February 2003 (reported as 10 years ago) the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (lot#, expiration date and route not reported). Upon receiving pneumococcal vaccine polyvalent (23-valent) (manufacturer unknown), approximately on an unknown date in February 2003 she had a severe drug reaction and interaction due to thimerosal and preservatives contained within the vaccine. The patient had flu-like symptoms fever, vomiting and extreme fatigue. She went to physician and was given antibiotics. Patient fully recovered from the events after several weeks. It was unspecified whether lab diagnostic studies were performed. The patient sought medical attention by office visit. Additional information is not expected.