chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 17.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Dizziness, Tonic clonic movements
Clinical narrative: After administration of MENACTRA and HPV patient felt lightheaded and sat in chair. Had brief episode 10 seconds with tonic clonic motion of extremities patient stable and laid on table and given juice. Able to sit after 40 minutes. Stand after 60 minutes.
Age: 19.0
Sex: U
Vaccine: MNQ
Symptoms: Fall, Syncope
Clinical narrative: Fainting and fell 10 mins. after shot.
Age: 18.0
Sex: U
Vaccine: HEP
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from office manager refers to an 18 year old patient. On an known date the 18 year old patient was vaccianted with an adult dose of RECOMBIVAX HB), injection, 10 microgram/ml. No adverse effect reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Lip blister, Pyrexia
Clinical narrative: This spontaneous report was received from a female patient of unknown age regarding herself. On an unknown date in September 2012, the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiry date, dose and route unspecified). No concomitant medications were reported. On an unknown date in September 2012, the patient experienced fever, blisters on her lips. She used to get them (date unspecified), however she was getting more frequently since getting the ZOSTAVAX. The patient did not seek any medical attention. No treatment was given to the patient. It was unspecified if any lab tests were performed. The patient had not recovered from the events at the time of reporting. The relatedness for the events was unknown for ZOSTAVAX. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: This spontaneous report as received from a medical assistant via a company representative refers to a 15 year old female patient who was not pregnant. The patient was vaccinated with the second dose of VARIVAX (lot number, expiry, route and site not reported) about a year ago, approximately in April 2012. On an unknown date the patient experienced broke out in a case of chickenpox all over her body. The adverse event improved on an unspecified date. The outcome of the event was reported as recovered/resolved (date unspecified). It was unspecified if the patient had sought medical attention. Additional information is not expected.
Sex: M
Vaccine: VARZOS
Symptoms: Contusion, Pruritus
Clinical narrative: This spontaneous report as received from a male patient of unknown age refers to himself. On an unknown date the patient was vaccinated with ZOSTAVAX (lot# unspecified). On an unknown date the patient experienced very bad bruising and itching. The outcome of very bad bruising and itching was unknown. Additional information is not expected.
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 84 year old female patient. No medical history or concurrent conditions were reported. On 29-MAR-2013 the patient was vaccinated with ZOSTAVAX, 0.65 ml, subcutaneously. Lot number was reported as 0170AE with an expiration date on 06-MAR-2013. It was reported that the patient was administered with an expired dose of ZOSTAVAX. No adverse effect has been observed or was reported. No additional information is currently available. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a patient of unknown age. On 11-APR-2013, the patient was vaccinated with an expired dose of GARDASIL (lot number reported as 0841AA, expiry date 08-APR-2013). Concomitant medications were reported. No adverse effect was reported. Additional information has been requested.
Age: 9.0
Sex: F
Vaccine: MMRV
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report as received from a nurse refers to a 9 year old patient of unknown gender. On an unknown date in January 2013, the patient who was vaccinated with included M-M-R II (Lot number, expiry date, route and dose were not reported) and (merck) VARIVAX (Lot number, expiry date, route and dose were not reported) had returned for receiving the second dose of (merck) PROQUAD (Lot number ,expiry date were not reported)0.5 ml (milliliter) , subcutaneously on 11-APR-2013. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: This spontaneous report as received from a 65 year old female patient. The patient had no pertinent medical history and no drug reactions/allergies. On 10-APR-2013 the patient was vaccinated with one time dose of ZOSTAVAX (lot # not reported), subcutaneously into the back side of the left arm. Concomitant medications included unspecified high blood pressure medication. On 12-APR-2013, the patient experienced redness at the site of insertion on the left arm. The outcome of the event is unknown. No laboratory test was performed. The patient did not seek medical attention. Additional information has been requested.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Dizziness
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 77 year old female patient. She had no pertinent medical history. On 29-MAR-2013, the patient was vaccinated with 0.65ml ZOSTAVAX. The batch number was H019996. The patient did not take any concomitant medications. On 31-MAR-2013 the patient experienced lightheadedness and weakness. She sought medical attention for the adverse events: she visited the pharmacist. The outcome of lightheadedness and weakness was reported as not recovered/not resolved. She received no treatment for the adverse events. A causality between the adverse events and ZOSTAVAX was not provided by the reporter. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Migraine
Clinical narrative: This spontaneous report as received from a medical assistant via field representative referred to herself, who was a female patient of unknown age. Patient reported that when she received ZOSTAVAX (Lot#, dose/frequency, route and duration were unspecified) on an unknown date, she had a "terrible migraine the next morning." Patient turned the lights off and rested the day until the migraine subsided later that day. Patient did not seek medical attention, no treatment was given for the event. The outcome of terrible migraine was reported as recovered(date unspecified). Drug relationship was not provided. Additional information has been requested.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Muscle spasms
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 68 year old male patient. Medical history was not provided. On 01-APR-2013 the patient was vaccinated with ZOSTAVAX. In APR-2013, on an unspecified date after administration of ZOSTAVAX patient experienced muscle spasms. As treatment, patient was prescribed MEDROL dose pack. The outcome of muscle spasms was reported as not recovered. The relatedness for muscle spasms was not reported for ZOSTAVAX. Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Expired drug administered, Wrong drug administered
Clinical narrative: Information has been received from a gynecologist, concerning an adult male female patient of unknown age. On an unknown date, the patient was vaccinated with the wrong RECOMBIVAX HB vaccine. It was reported that the patient received a pediatric dose (5 mcg) from a RECOMBIVAX HB lot had expired on 09-NOV-2012 (lot # not reported). Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 09-APR-2013, the patient was vaccinated with a expired dose of (Merck) VARIVAX (Lot number 669193/0096AE, expiry date was 11-NOV-2012, route and dose were not reported). No adverse event reported. The reporter did not know if the expired dose was the first dose of (Merck) VARIVAX. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site rash, Pruritus, Rash, Skin irritation
Clinical narrative: 2-3 cm red, warm, raised whelp under inj. site (R) post. arm et fine rash to upper arms/neck causing itch et irritation. Tx - Dex4/BENADRYL 25 IM inj., ZYRTEC 10mg, BENADRYL prn.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin warm, Urticaria
Clinical narrative: 2-3 cm red, warm, raised whelp under inj. site (R) post. arm et fine rash to upper arms/neck causing itch et irritation. Tx - Dex4/BENADRYL 25 IM inj., ZYRTEC 10mg, BENADRYL prn.
Age: 13.0
Sex: F
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: This spontaneous report as received from a health care worker and follow up information received from a licensed practitioner nurse refers to a 13 year old female patient. On an unknown date the patient was vaccinated with a dose of (Merck) VARIVAX (lot#, dose and route was not reported). On an unknown date following vaccination of (Merck) VARIVAX the patient developed around 30 chicken pocks. And the patient was not pregnant. It was not known if the patient sought medical attention. The outcome of event was reported as not recovered/not resolved. Additional information is not expected.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a physician refers to a 70 year old female patient. The patient received ZOSTAVAX (lot# unspecified) on an unspecified date in September 2010 and developed a mild case of the shingles on her torso on an unspecified date in April 2013. The outcome of a mild case of the shingles on the torso was reported as recovering. The patient had sought medical attention via office visit. Additional information has been requested.
Sex: M
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a male physician of unknown age reporting on himself. In 2013, "a couple of weeks ago", the physician was vaccinated with a pediatric 0.5 ml dose of VAQTA (Lot # not reported) intramuscularly. No adverse effects were reported. Additional information has been requesting.
Sex: U
Vaccine: VARCEL
Symptoms: Wrong drug administered
Clinical narrative: This spontaneous report as received from a health care worker refers to a patient (unknown age and gender). On an unknown date the patient was vaccinated with (Merck) VARIVAX (Lot # not reported (dose, route and frequency not reported). No other co suspects were reported. No concomitant therapy was reported. The health care reported stated that on an unknown date an unspecified patient was accidentally vaccinated with (Merck) VARIVAX who should have received ZOSTAVAX. Additional information is not expected.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Oral herpes, Rash
Clinical narrative: This spontaneous report as received from a physician refers to a 65 year old female patient without pertinent medical history. The patient had drug reactions/ allergies to prednisone, sulfasalazine, methotrexate, hydroxyquine and meloxicam. There was no concomitant medication. On 02-DEC-2011 the patient was vacccinated with ZOSTAVAX (lot number 670816/0693AA, expiry date 11-AUG-2012) subcutaneously. The patient experienced oral herpetic lesions in January 2013 as well as a rash and cellulitis two weeks ago, approximately on 25-MAR-2013. The outcome of oral herpetic lesions, rash and cellutlits was reported as not recovered. Oral KENALOG base, CLEOCIN T anmd CIPRO were given for adverse event. No lab diagnostics studies were performed. The patient was being treated by the reporting physician. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: This spontaneous report was received from a pharmacist regarding a 66 year old female patient, with no pertinent medical history reported. On 09-APR-2013 the patient was vaccinated with ZOSTAVAX (lot number and expiration date not specified)(0.65ml subcutaneous, anatomical location not reported) for routine vaccination. It was reported that on 11-APR-2013 (reported as "today"), the patient contacted the pharmacist to report that she had a red, swollen and itchy area at the injection site that was 2-inches in size. The patient's present status was reported as not recovered. The pharmacist reported that she called a nurse of the patient's doctor, a treatment of TYLENOL and BENADRYL and not to rub was given for the event. It was reported that the patient sought medical attention by contacting the pharmacist. The pharmacist did not assess the causality between ZOSTAVAX and the red, swollen and itchy area at the injection site. Additional information is not pharmacist.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a nurse via company representative referring to a patient of unknown who on an unknown date, was vaccinated with the third dose of GARDASIL. The nurse reported that the patient had received her third dose of GARDASIL 6 weeks early. No adverse experiences were reported. Additional information
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 an unspecified number of patients received GARDASIL (Lot #, dose and route not reported) outside of the prescribed dosing schedule. No adverse events reported. No identifying patient information provided. It was not known if these patient sought for medical attention. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chest pain, Dizziness, Fatigue, Feeling cold, Hypoaesthesia
Clinical narrative: 3/26/13 10:45am Immediate dizziness, slight swollen throat, mild chest pain, lips tingling, then shaky, cold, face numb, itching. Sat in waiting room two hours; too sick to leave. Got sicker later, returned and was sent to emergency room. Nausea, sharp chest pain, pain down left arm. Sick since with chest pain, novocaine feeling in face, fatigue. 3/30/13 My son who lives with me (age 17 1/2) with swollen lymph node, progressing to severe chest pain and flattening fatigue. Both still sick, with heart irregularities, pain in chest, rapid heartbeat etc.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Immediate post-injection reaction, Nausea, Pain in extremity, Paraesthesia oral, Pharyngeal oedema
Clinical narrative: 3/26/13 10:45am Immediate dizziness, slight swollen throat, mild chest pain, lips tingling, then shaky, cold, face numb, itching. Sat in waiting room two hours; too sick to leave. Got sicker later, returned and was sent to emergency room. Nausea, sharp chest pain, pain down left arm. Sick since with chest pain, novocaine feeling in face, fatigue. 3/30/13 My son who lives with me (age 17 1/2) with swollen lymph node, progressing to severe chest pain and flattening fatigue. Both still sick, with heart irregularities, pain in chest, rapid heartbeat etc.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pruritus, Tremor
Clinical narrative: 3/26/13 10:45am Immediate dizziness, slight swollen throat, mild chest pain, lips tingling, then shaky, cold, face numb, itching. Sat in waiting room two hours; too sick to leave. Got sicker later, returned and was sent to emergency room. Nausea, sharp chest pain, pain down left arm. Sick since with chest pain, novocaine feeling in face, fatigue. 3/30/13 My son who lives with me (age 17 1/2) with swollen lymph node, progressing to severe chest pain and flattening fatigue. Both still sick, with heart irregularities, pain in chest, rapid heartbeat etc.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chest pain, Feeling abnormal, Feeling cold, Nervousness, Paraesthesia
Clinical narrative: 3/26/13 10:45am Immediate dizziness, slight swollen throat, mild chest pain, lips tingling, then shaky, cold, face numb, itching. Sat in waiting room two hours; too sick to leave. Got sicker later, returned and was sent to emergency room. Nausea, sharp chest pain, pain down left arm. Sick since with chest pain, novocaine feeling in face, fatigue. 3/30/13 My son who lives with me (age 17 1/2) with swollen lymph node, progressing to severe chest pain and flattening fatigue. Both still sick, with heart irregularities, pain in chest, rapid heartbeat etc.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pruritus, Swelling face
Clinical narrative: 3/26/13 10:45am Immediate dizziness, slight swollen throat, mild chest pain, lips tingling, then shaky, cold, face numb, itching. Sat in waiting room two hours; too sick to leave. Got sicker later, returned and was sent to emergency room. Nausea, sharp chest pain, pain down left arm. Sick since with chest pain, novocaine feeling in face, fatigue. 3/30/13 My son who lives with me (age 17 1/2) with swollen lymph node, progressing to severe chest pain and flattening fatigue. Both still sick, with heart irregularities, pain in chest, rapid heartbeat etc.
Age: 24.0
Sex: F
Vaccine: HEPA
Symptoms: Chills, Malaise, Pain, Pyrexia
Clinical narrative: C/O body aches, fever, chills, over all malaise.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Injection site pain, Swelling
Clinical narrative: Shortly after administering vaccine, I was informed by patient that he was experiencing burning at injection site. A red area approximately 3 inches in diameter and some swelling developed. Patient said burning seemed to peak, and then began to subside (as did redness and swelling). About 30 minutes after onset, pt. said he was feeling better and was able to leave.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Erythema, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient describes a transient "burning" at injection site. She reports a redness and burning the day after injection (11/13/12). Went to provider (NP) in January for redness/swelling at injection site. Prescribed KEFLEX which resolved the redness. Pt still reports burning 4/11 (no redness or knots at site).
Age: 1.05
Sex: F
Vaccine: HIBV, PNC13
Symptoms: Body temperature increased, Decreased activity, Fatigue, Full blood count, Inadequate diet
Clinical narrative: Temp up 103.7. Very fatigued, tired, laying around. Very poor diet and activity for several days.
Age: 1.05
Sex: F
Vaccine: HIBV, PNC13
Symptoms: Influenza virus test negative
Clinical narrative: Temp up 103.7. Very fatigued, tired, laying around. Very poor diet and activity for several days.
Age: 34.0
Sex: F
Vaccine: VARCEL
Symptoms: Abnormal behaviour, Injection site erythema, Injection site swelling, Mood swings, Nausea
Clinical narrative: Patient said 1 hour after vaccine given had redness and swelling at the site. 2 hours post vaccine patient said she had behavioral changes such as mood swings and a fever of 102 degrees F. She said she also had vomiting and nausea from 4/12/13-4/15/13. She said symptoms resolved on 4/16/13. Other symptoms were hives on legs/arms/face/back and resolved on 4/15/13.
Age: 34.0
Sex: F
Vaccine: VARCEL
Symptoms: Pyrexia, Urticaria, Vomiting
Clinical narrative: Patient said 1 hour after vaccine given had redness and swelling at the site. 2 hours post vaccine patient said she had behavioral changes such as mood swings and a fever of 102 degrees F. She said she also had vomiting and nausea from 4/12/13-4/15/13. She said symptoms resolved on 4/16/13. Other symptoms were hives on legs/arms/face/back and resolved on 4/15/13.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a patient of unknown age and gender. The nurse reported that a patient received an expired dose of GARDASIL (lot # 668261/1397AA, exp date 09-APR-2013) today (10-APR-2013) as the second dose. The patient received the first dose of GARDASIL on 05-FEB-2013. No adverse event reported. Additional information has been requested.
Age: 1.25
Sex: F
Vaccine: HIBV, PNC13
Symptoms: Metabolic function test, Pyrexia, Seizure like phenomena
Clinical narrative: Pt started running high fever at 4 p on 4/13/12, shortly after patient started having seizure like activity. Pt was transported to hospital by ambulance and was seen in ER.
Age: 0.59
Sex: M
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Convulsion
Clinical narrative: Seizure after receiving vaccines while at home.
Age: 0.59
Sex: M
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Convulsion
Clinical narrative: Seizure after receiving vaccine at home.
Age: 0.19
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13
Symptoms: Abnormal faeces, Diet refusal, Feeding disorder neonatal, Intestinal dilatation
Clinical narrative: C/o distended bowel, refusal of breastfeeding and issues with stooling for 3+ weeks following Rotavirus vaccination.
Age: 20.0
Sex: F
Vaccine: MMR
Symptoms: Cold sweat, Dizziness, Loss of consciousness, Nausea
Clinical narrative: Client received MMR vaccine and 5-10 seconds later blacked out for 5-10 seconds. Clammy skin, nausea, dizziness. Client monitored then after dizziness continued, client sent to hospital via EMS.
Age: 1.05
Sex: M
Vaccine: HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Oral herpes, Rash erythematous, Rash papular, Skin lesion, Varicella
Clinical narrative: Pt developed active varicella infection 3 days after vaccine was administered. Symptoms included fever, and multiple vesicular-papular erythematous lesions on scalp, face, abdomen, groin region.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Headache, Hot flush, Nausea
Clinical narrative: Headaches, nausea, dizziness, and hot flashes in her body.
Age: 3.0
Sex: F
Vaccine: VARZOS
Symptoms: Secondary transmission, Varicella
Clinical narrative: This report was received from a the authors a published literature article and refers to a 3 year old female patient. 09-NOV-2011 the patient's mother was vaccinated with a dose of zoster vaccine live (manufacturer unknown) (dose, route and lot number were not reported) (MARRS case# 1304USA005178). On approximately 23-NOV-2011 (two weeks after the mother's inoculation), the patient developed chickenpox and did not attend a preschool nor was she exposed to anyone. The patient had not been otherwise exposed to zoster vaccine live (manufacturer unknown), it was likely that the source of her viral infection was her mother's inoculation two weeks earlier. The patient's mother described appears to have transmitted VZV to her daughter after inoculation following a very short course of fingolimod. Furthermore, during the first year of fingolimod treatment, she has had 2 discrete episodes of recurrent herpes zoster. These observations suggests the possibility that zoster vaccine efficacy was attenuated in patients who had received fingolimod immediately prior Ro vaccination, event a short course, and that VZV control may be diminished during treatment with fingolimod leading to recurrent zoster in some patients. A blunted immune response to vaccination to varicella would not be surprising in the setting of the administration of immunosuppressive drugs as it has been observed with influenza and pneumococcal vaccinations. It was unlikely that either her influenza infection or the corticosteroid administration for the MS relapse occurring on its heels contributed to her bouts of shingles as there was a 6 month hiatus between them and the first onset of zoster. The zoster vaccine is a live-attenuated virus (Merck strain) that was extremely safe and highly immunogenic. It reduces the risk of developing zoster by 51.3% (95% (1=44.2-57.6). It had been proposed that vaccinated individuals may shed the attenuated virus increasing the herd immunity following vaccination efforts; however, early studies by the manufacturer failed to confirm transmission of the vaccine virus in contacts. While transmission of the live attenuated varicella virus to contacts is infrequent, it has been described. The incubation period from time of exposure to VZV to the clinical expression of varicella is typically 14-15 days, precisely the time from our patient's vaccination to the development of her daughter's varicella, and transmission may occur in the absence of the rash. As our patient's 3 year old daughter had not been otherwise exposed to VZV, it is likely that the source of her viral infection was her mother's inoculation two weeks earlier. This is one of the several reports from the same source (patient's mother case # 1304USA005178). Additional information has been requested.
Age: 62.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Rash erythematous, Rash generalised
Clinical narrative: This spontaneous report as received from a consumer refers to a 62 year old male patient. On 10-DEC-2012 the patient was vaccinated with ZOSTAVAX. Lot number, dose number, route of administration and anatomical location were not reported. Concomitant therapies included LOVASTATIN, unspecified blood pressure medication and THYROID. On 20-DEC-2012, 11 days after onset of therapy the patient experienced red itchy rash all of his entire body with the exception of face and hands. The patient contacted his dermatologist and was prescribed triamcinolone, Prednisone and Soriatane. The treatment worked for an unspecified amount of time. However, the rash returned and was persistent at the time of reporting. The outcome of red itchy rash all of his entire body with the exception of face and hands was reported as not recovered/not resolved. The relatedness of the red itchy rash all of his entire body with the exception of face and hands was not reported for ZOSTAVAX. Additional information has been assistant.
Age: 62.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Rash erythematous, Rash generalised, Rash pruritic
Clinical narrative: This spontaneous report as received from a consumer refers to a 62 year old male patient. On 10-DEC-2012 the patient was vaccinated with ZOSTAVAX. Lot number, dose number, route of administration and anatomical location were not reported. Concomitant therapies included LOVASTATIN, unspecified blood pressure medication and THYROID. On 20-DEC-2012, 11 days after onset of therapy the patient experienced red itchy rash all of his entire body with the exception of face and hands. The patient contacted his dermatologist and was prescribed triamcinolone, Prednisone and Soriatane. The treatment worked for an unspecified amount of time. However, the rash returned and was persistent at the time of reporting. The outcome of red itchy rash all of his entire body with the exception of face and hands was reported as not recovered/not resolved. The relatedness of the red itchy rash all of his entire body with the exception of face and hands was not reported for ZOSTAVAX. Additional information has been assistant.
Age: 78.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Computerised tomogram, Electroencephalogram, Extremity contracture, Gaze palsy, Muscle rigidity
Clinical narrative: This spontaneous report was received from a consumer's wife regarding her husband, a 78 years old (age at the time of the reporter) male patient with no pertinent medical history and no drug reactions or allergies. On 01-MAR-2013 the patient was vaccinated with a dose of ZOSTAVAX (lot number and expiration date not reported)(dose, route and anatomical site not reported). No other suspect therapies were reported. Concomitant therapies included PLAVIX, ZOCOR, HYZAAR, LOPRESSOR, PRILOSEC and ZYLOPRIM. The reporter stated that the patient had a seizure on 08-MAR-2013, a week after receiving ZOSTAVAX. The patient was taken to the emergency room of the hospital, and was admitted on the evening of 08-MAR-2013. The patient was released from the hospital on 09-MAR-2013. It was reported that during the seizure, the patient bit his tongue and possibly tore his rotator cuff. The patient's present status was reported as recovering. It was reported that KEPPRA was given as a treatment. The reporter stated that the following lab diagnostic studies were performed: computed axial tomography (CAT) scan (with and without contrast), electrocardiogram (EKG), electroencephalogram (EEG) and a 24 hour electroencephalogram (EEG). Dates and results were not reported for the mentioned tests. Additional information has been requested.
Age: 78.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Computerised tomogram, Convulsion, Electrocardiogram, Electroencephalogram, Rotator cuff syndrome
Clinical narrative: This spontaneous report was received from a consumer's wife regarding her husband, a 78 years old (age at the time of the reporter) male patient with no pertinent medical history and no drug reactions or allergies. On 01-MAR-2013 the patient was vaccinated with a dose of ZOSTAVAX (lot number and expiration date not reported)(dose, route and anatomical site not reported). No other suspect therapies were reported. Concomitant therapies included PLAVIX, ZOCOR, HYZAAR, LOPRESSOR, PRILOSEC and ZYLOPRIM. The reporter stated that the patient had a seizure on 08-MAR-2013, a week after receiving ZOSTAVAX. The patient was taken to the emergency room of the hospital, and was admitted on the evening of 08-MAR-2013. The patient was released from the hospital on 09-MAR-2013. It was reported that during the seizure, the patient bit his tongue and possibly tore his rotator cuff. The patient's present status was reported as recovering. It was reported that KEPPRA was given as a treatment. The reporter stated that the following lab diagnostic studies were performed: computed axial tomography (CAT) scan (with and without contrast), electrocardiogram (EKG), electroencephalogram (EEG) and a 24 hour electroencephalogram (EEG). Dates and results were not reported for the mentioned tests. Additional information has been requested.
Age: 78.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Scan with contrast, Tongue biting
Clinical narrative: This spontaneous report was received from a consumer's wife regarding her husband, a 78 years old (age at the time of the reporter) male patient with no pertinent medical history and no drug reactions or allergies. On 01-MAR-2013 the patient was vaccinated with a dose of ZOSTAVAX (lot number and expiration date not reported)(dose, route and anatomical site not reported). No other suspect therapies were reported. Concomitant therapies included PLAVIX, ZOCOR, HYZAAR, LOPRESSOR, PRILOSEC and ZYLOPRIM. The reporter stated that the patient had a seizure on 08-MAR-2013, a week after receiving ZOSTAVAX. The patient was taken to the emergency room of the hospital, and was admitted on the evening of 08-MAR-2013. The patient was released from the hospital on 09-MAR-2013. It was reported that during the seizure, the patient bit his tongue and possibly tore his rotator cuff. The patient's present status was reported as recovering. It was reported that KEPPRA was given as a treatment. The reporter stated that the following lab diagnostic studies were performed: computed axial tomography (CAT) scan (with and without contrast), electrocardiogram (EKG), electroencephalogram (EEG) and a 24 hour electroencephalogram (EEG). Dates and results were not reported for the mentioned tests. Additional information has been requested.
Age: 78.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Convulsion, Laboratory test
Clinical narrative: This spontaneous report was received from a consumer's wife regarding her husband, a 78 years old (age at the time of the reporter) male patient with no pertinent medical history and no drug reactions or allergies. On 01-MAR-2013 the patient was vaccinated with a dose of ZOSTAVAX (lot number and expiration date not reported)(dose, route and anatomical site not reported). No other suspect therapies were reported. Concomitant therapies included PLAVIX, ZOCOR, HYZAAR, LOPRESSOR, PRILOSEC and ZYLOPRIM. The reporter stated that the patient had a seizure on 08-MAR-2013, a week after receiving ZOSTAVAX. The patient was taken to the emergency room of the hospital, and was admitted on the evening of 08-MAR-2013. The patient was released from the hospital on 09-MAR-2013. It was reported that during the seizure, the patient bit his tongue and possibly tore his rotator cuff. The patient's present status was reported as recovering. It was reported that KEPPRA was given as a treatment. The reporter stated that the following lab diagnostic studies were performed: computed axial tomography (CAT) scan (with and without contrast), electrocardiogram (EKG), electroencephalogram (EEG) and a 24 hour electroencephalogram (EEG). Dates and results were not reported for the mentioned tests. Additional information has been requested.
Age: 1.3
Sex: F
Vaccine: RV5, RV5
Symptoms: Culture stool, Hypersensitivity, Laboratory test, Rotavirus infection, Swelling face
Clinical narrative: This spontaneous report was received from a physician via a field representative refers to a 15 month old female patient with allergy to lactose, egg, cheese, hemp milk. The patient was also allergic to dogs. On unspecified dates, the patient was vaccinated with the entire vaccine series of ROTATEQ (lot#, dose not reported) orally. No concomitant medications were reported. On 04-APR-2013, the patient was admitted to an unspecified hospital with a diagnosis of rotavirus. The patient was discharged from the unspecified hospital on 08-APR-2013. Diagnostic studies and treatment given while in the hospital included; an abdominal ultrasound, unspecified lab work, a stool culture, unspecified intravenous fluids and TYLENOL and MOTRIN. Patient sought medical attention. Approximately on 28-MAR-2013, the patient had experienced an unspecified allergic reaction a week before going into the hospital which included facial swelling. The patient had been prescribed prednisone for the facial swelling. On an unknown date in 2013, the patient had recovered from facial swelling and unspecified allergic reaction. The outcome of rotavirus was reported as recovered on 12-APR-2013. Therapy with ROTATEQ was not discontinued. Additional information has been requested.
Age: 1.3
Sex: F
Vaccine: RV5, RV5
Symptoms: Ultrasound abdomen
Clinical narrative: This spontaneous report was received from a physician via a field representative refers to a 15 month old female patient with allergy to lactose, egg, cheese, hemp milk. The patient was also allergic to dogs. On unspecified dates, the patient was vaccinated with the entire vaccine series of ROTATEQ (lot#, dose not reported) orally. No concomitant medications were reported. On 04-APR-2013, the patient was admitted to an unspecified hospital with a diagnosis of rotavirus. The patient was discharged from the unspecified hospital on 08-APR-2013. Diagnostic studies and treatment given while in the hospital included; an abdominal ultrasound, unspecified lab work, a stool culture, unspecified intravenous fluids and TYLENOL and MOTRIN. Patient sought medical attention. Approximately on 28-MAR-2013, the patient had experienced an unspecified allergic reaction a week before going into the hospital which included facial swelling. The patient had been prescribed prednisone for the facial swelling. On an unknown date in 2013, the patient had recovered from facial swelling and unspecified allergic reaction. The outcome of rotavirus was reported as recovered on 12-APR-2013. Therapy with ROTATEQ was not discontinued. Additional information has been requested.
Age: 1.3
Sex: F
Vaccine: RV5, RV5
Symptoms: Culture stool, Hypersensitivity, Laboratory test, Rotavirus infection, Swelling face
Clinical narrative: This spontaneous report was received from a physician via a field representative refers to a 15 month old female patient with allergy to lactose, egg, cheese, hemp milk. The patient was also allergic to dogs. On unspecified dates, the patient was vaccinated with the entire vaccine series of ROTATEQ (lot#, dose not reported). No concomitant medications were reported. On 04-APR-2013, the patient was admitted to an unspecified hospital with a diagnosis of rotavirus. The patient was discharged from the unspecified hospital on 08-APR-2013. Diagnostic studies and treatment given while in the hospital included: an abdominal ultrasound, unspecified lab work, a stool culture, unspecified intravenous fluids and TYLENOL and MOTRIN. Patient sought medical attention. Approximately on 28-MAR-2013, the patient had experienced an unspecified allergic reaction a week before going to the hospital which included facial swelling. The patient had been prescribed prednisone for the facial swelling. On an unknown date in 2013, the patient had recovered from facial swelling and unspecified allergic reaction. The outcome of rotavirus was reported as recovered on 12-APR-2013. Therapy with ROTATEQ was not discontinued. Additional information has been requested.
Age: 1.3
Sex: F
Vaccine: RV5, RV5
Symptoms: Ultrasound abdomen
Clinical narrative: This spontaneous report was received from a physician via a field representative refers to a 15 month old female patient with allergy to lactose, egg, cheese, hemp milk. The patient was also allergic to dogs. On unspecified dates, the patient was vaccinated with the entire vaccine series of ROTATEQ (lot#, dose not reported). No concomitant medications were reported. On 04-APR-2013, the patient was admitted to an unspecified hospital with a diagnosis of rotavirus. The patient was discharged from the unspecified hospital on 08-APR-2013. Diagnostic studies and treatment given while in the hospital included: an abdominal ultrasound, unspecified lab work, a stool culture, unspecified intravenous fluids and TYLENOL and MOTRIN. Patient sought medical attention. Approximately on 28-MAR-2013, the patient had experienced an unspecified allergic reaction a week before going to the hospital which included facial swelling. The patient had been prescribed prednisone for the facial swelling. On an unknown date in 2013, the patient had recovered from facial swelling and unspecified allergic reaction. The outcome of rotavirus was reported as recovered on 12-APR-2013. Therapy with ROTATEQ was not discontinued. Additional information has been requested.
Age: 10.0
Sex: F
Vaccine: FLUX
Symptoms: Abdominal pain upper, Cardiac arrest, Chest pain, Death, Dyspnoea
Clinical narrative: Initial report was received on 08 April 2013 from an electronic lay press article. A 10-year-old female patient had received an injection of INFLUENZA VACCINE (trade name, manufacturer, lot number, route, site and exact date of administration not reported) in December 2012. The patient was diagnosed with strain B flu on 20 March 2013. Three days after the patient was diagnosed with the flu, she was rushed to the hospital after complaining of stomach and chest pains and difficulty breathing. She went into cardiac arrest the following morning, and doctors revived her after performing CPR for about two hours. She was placed on a life support system to restore oxygen to her blood. Doctors also put her on a machine to do the work of her heart while waiting for a transplant. The infection morphed into a serious case of myocarditis. The patient died from flu complications at 10:45 AM on 05 April 2013. Outcome was fatal. Documents held by sender: none.
Age: 10.0
Sex: F
Vaccine: FLUX
Symptoms: Influenza, Life support, Myocarditis, Resuscitation
Clinical narrative: Initial report was received on 08 April 2013 from an electronic lay press article. A 10-year-old female patient had received an injection of INFLUENZA VACCINE (trade name, manufacturer, lot number, route, site and exact date of administration not reported) in December 2012. The patient was diagnosed with strain B flu on 20 March 2013. Three days after the patient was diagnosed with the flu, she was rushed to the hospital after complaining of stomach and chest pains and difficulty breathing. She went into cardiac arrest the following morning, and doctors revived her after performing CPR for about two hours. She was placed on a life support system to restore oxygen to her blood. Doctors also put her on a machine to do the work of her heart while waiting for a transplant. The infection morphed into a serious case of myocarditis. The patient died from flu complications at 10:45 AM on 05 April 2013. Outcome was fatal. Documents held by sender: none.
Age: 41.0
Sex: M
Vaccine: TDAP
Symptoms: Guillain-Barre syndrome, Hypoaesthesia, Immunoglobulin therapy, Lumbar puncture abnormal
Clinical narrative: On 03/21/13, Pt evaluated at urgent care and reported onset of faint numbness in fingers and toes, and numbness in lower back and buttocks x 3 days. F/U w/ PCP. On 03/23/13, patient admitted via E/R , Pt treated with IV immunoglobulin x 5 days. LP confirmed Guillain Barre Syndrome.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a physician concerning to a patient of unknown age and gender. On 27-MAR-2013 the patient was vaccinated with a dose of M-M-R II (lot number H013041, expiration date 17-JUL-2014) (dose and route not reported). The vaccine administered was improperly stored, was exposed to 66F since 21-JAN-2013. No adverse effect reported. This case is linked to the following MARRS cases: 1304USA007561, 1304USA008124, 1304USA008125, 1304USA008127, 1304USA008128. Additional information has been requested.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Ear pruritus, Eyelids pruritus, Injection site erythema, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 53 year old female patient with no pertinent medical history or drug allergies. On 05-MAR-2013 the patient was vaccinated with ZOSTAVAX lot # H021712; expiry date: 06-MAR-2014, subcutaneous with no concomitant medication. On 12-MAR-2012, "about 1 weeks after", the patient began to experience pain at her elbow and shoulder joints, extreme itching under her fingers, on eyelids, roof of mouth and inner ear (no rash present) and the insertion arm, from shoulder to elbow, were red and hot. The outcome of was reported as recovered on an unspecified date in 2013. No treatment was given. No lab tests were performed. Additional information has been requested.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Oral pruritus, Pruritus
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 53 year old female patient with no pertinent medical history or drug allergies. On 05-MAR-2013 the patient was vaccinated with ZOSTAVAX lot # H021712; expiry date: 06-MAR-2014, subcutaneous with no concomitant medication. On 12-MAR-2012, "about 1 weeks after", the patient began to experience pain at her elbow and shoulder joints, extreme itching under her fingers, on eyelids, roof of mouth and inner ear (no rash present) and the insertion arm, from shoulder to elbow, were red and hot. The outcome of was reported as recovered on an unspecified date in 2013. No treatment was given. No lab tests were performed. Additional information has been requested.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Neuralgia
Clinical narrative: This spontaneous report was received from a 78 year old female patient with no pertinent medical history and no drug reactions or allergies. Weight and height of the patient was reported as 117 (units unspecified) and 5 feet and 1 inch. On an unknown date in December 2008, the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiry date, dose and route unspecified). Concomitant therapies included valacyclovir hydrochloride, naproxen, acetaminophen and Hydroco. On 02-MAR-2013, the patient experienced burning sensation along her right breast to her back and feels nerve pain. The patient was provided with a treatment (unspecified). The outcome of both the events was was unknown. The relatedness for both the events was unknown for ZOSTAVAX. Additional information has been requested.
Age: 39.0
Sex: M
Vaccine: ANTH, HEPAB, SMALL, TYP
Symptoms: Abdominal distension, Activities of daily living impaired, Autonomic nervous system imbalance, Cardiac arrest, Cardiac pacemaker insertion
Clinical narrative: Initial VAERS file 12 Nov '06 while patient was deployed. He developed Headaches, generalized muscle pain, numbness in the legs and back, had difficulty walking. Since '06 he has developed numerous other symptoms including dizziness, GI bloating, constipation/diarrhea, urinary frequency, profuse sweating, fatigue, cognitive impairment. Unable to perform usual social and lifestyle activities due to lack of physical stamina and endurance. Unable to exercise or run due to pain in extremities. In Dec 2011 went into asystole after syncopal episode and had pacemaker inserted. Symptoms: giddiness, Flatulence/eructation/gas pain, Joint pain, Malaise and fatigue NEC, Muscle Ache, Disturbance of skin sensation, Hyperhidrosis, memory loss, Other signs and symptoms involving emotional state.
Age: 39.0
Sex: M
Vaccine: ANTH, HEPAB, SMALL, TYP
Symptoms: Cognitive disorder, Constipation, Diarrhoea, Dizziness, Fatigue
Clinical narrative: Initial VAERS file 12 Nov '06 while patient was deployed. He developed Headaches, generalized muscle pain, numbness in the legs and back, had difficulty walking. Since '06 he has developed numerous other symptoms including dizziness, GI bloating, constipation/diarrhea, urinary frequency, profuse sweating, fatigue, cognitive impairment. Unable to perform usual social and lifestyle activities due to lack of physical stamina and endurance. Unable to exercise or run due to pain in extremities. In Dec 2011 went into asystole after syncopal episode and had pacemaker inserted. Symptoms: giddiness, Flatulence/eructation/gas pain, Joint pain, Malaise and fatigue NEC, Muscle Ache, Disturbance of skin sensation, Hyperhidrosis, memory loss, Other signs and symptoms involving emotional state.
Age: 39.0
Sex: M
Vaccine: ANTH, HEPAB, SMALL, TYP
Symptoms: Gait disturbance, Headache, Hyperhidrosis, Hypoaesthesia, Laboratory test normal
Clinical narrative: Initial VAERS file 12 Nov '06 while patient was deployed. He developed Headaches, generalized muscle pain, numbness in the legs and back, had difficulty walking. Since '06 he has developed numerous other symptoms including dizziness, GI bloating, constipation/diarrhea, urinary frequency, profuse sweating, fatigue, cognitive impairment. Unable to perform usual social and lifestyle activities due to lack of physical stamina and endurance. Unable to exercise or run due to pain in extremities. In Dec 2011 went into asystole after syncopal episode and had pacemaker inserted. Symptoms: giddiness, Flatulence/eructation/gas pain, Joint pain, Malaise and fatigue NEC, Muscle Ache, Disturbance of skin sensation, Hyperhidrosis, memory loss, Other signs and symptoms involving emotional state.
Age: 39.0
Sex: M
Vaccine: ANTH, HEPAB, SMALL, TYP
Symptoms: Myalgia, Pain in extremity, Pollakiuria, Syncope
Clinical narrative: Initial VAERS file 12 Nov '06 while patient was deployed. He developed Headaches, generalized muscle pain, numbness in the legs and back, had difficulty walking. Since '06 he has developed numerous other symptoms including dizziness, GI bloating, constipation/diarrhea, urinary frequency, profuse sweating, fatigue, cognitive impairment. Unable to perform usual social and lifestyle activities due to lack of physical stamina and endurance. Unable to exercise or run due to pain in extremities. In Dec 2011 went into asystole after syncopal episode and had pacemaker inserted. Symptoms: giddiness, Flatulence/eructation/gas pain, Joint pain, Malaise and fatigue NEC, Muscle Ache, Disturbance of skin sensation, Hyperhidrosis, memory loss, Other signs and symptoms involving emotional state.