chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Heart sounds abnormal, Inflammation, Menstruation irregular, Mood swings
Clinical narrative: This spontaneous report as received from patient's mother on 17-APR-2014 refers to her daughter, 16 year old female patient of unknown demographics. Patient pertinent medical history was not reported. On an unspecified date in year 2013 the patient was vaccinated with GARDASIL injections intramuscularly (lot#, expiration date unspecified date). There was no concomitant medications reported. On ana unspecified date in year 2013 the patient experienced irregular bleeding patterns sinus infections, mood swings, and joint pain after receiving the first shot of GARDASIL. On an unspecified date Nuclear magnetic resonance imaging (MRI) was conducted by an orthopedic physician which revealed that the patient's heart no longer sounds the same and that there was significant inflammation in patient back. The outcome of the events was reported as not recovered. The causality of events regarding GARDASIL was unspecified by the reporter. Additional information is not expected.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Nuclear magnetic resonance imaging abnormal, Sinusitis
Clinical narrative: This spontaneous report as received from patient's mother on 17-APR-2014 refers to her daughter, 16 year old female patient of unknown demographics. Patient pertinent medical history was not reported. On an unspecified date in year 2013 the patient was vaccinated with GARDASIL injections intramuscularly (lot#, expiration date unspecified date). There was no concomitant medications reported. On ana unspecified date in year 2013 the patient experienced irregular bleeding patterns sinus infections, mood swings, and joint pain after receiving the first shot of GARDASIL. On an unspecified date Nuclear magnetic resonance imaging (MRI) was conducted by an orthopedic physician which revealed that the patient's heart no longer sounds the same and that there was significant inflammation in patient back. The outcome of the events was reported as not recovered. The causality of events regarding GARDASIL was unspecified by the reporter. Additional information is not expected.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Local swelling, Pain in extremity, Stevens-Johnson syndrome
Clinical narrative: This spontaneous report as received from a physician via a field representative refers to a 65 year old female patient. On 21-OCT-2013, the patient was vaccinated with a dose of PNEUMOVAX23, lot # J004747, expiration date 20-JUL-2014, intramuscular (IM) in the left deltoid (dose not reported). Concomitant therapies included simvastatin (manufacturer unknown) and baby aspirin. The physician reported within the course of 7 days (approximately on 28-OCT-2013), the patient experienced a swollen and painful arm. The patient went to the hospital where she was admitted for 6 days (hospital and location were unspecified). The patient was diagnosed (date unspecified) with Stevens-Johnson Syndrome. The patient sought medication attention. No treatment detail were provided. The outcome of the event was unknown. Upon internal review, Stevens-Johnson Syndrome was considered as medically significant. Additional information has been requested.
Age: 3.0
Sex: M
Vaccine: FLUN4, HEPA
Symptoms: Abscess, Incisional drainage, Injection site erythema, Injection site swelling
Clinical narrative: Patient had redness and swelling near injection site, was taken to a pediatric orthopedist who diagnosed him with a abscess, where they performed an incision and drainage. The orthopedist also consulted the local infectious disease department.
Age: 45.0
Sex: M
Vaccine: TDAP
Symptoms: Formication, Headache
Clinical narrative: Patient complained of feeling like "tiny spiders were crawling all over his arms, face and some of his leg" and complained of headache.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Rash generalised, Rash pruritic
Clinical narrative: Widespread, itching rash, stared <24 hours after administration of vaccines.
Age: 62.0
Sex: M
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from an other health professional refers to a 62 year old male patient. Pertinent medical history, concomitant medication, drug reactions and allergies were not provided. On 07-APR-2014 the patient was vaccinated with the expired 0.5 ml dose of PNEUMOVAX 23 in the left upper deltoid (lot # H014196, expiration date 19-MAR-2014) intramuscularly. No adverse effects reported. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Abasia, Cystitis, Death, Dysstasia, Wheelchair user
Clinical narrative: Took Flu shot in January 2013 - the next day could not walk. Went to hospital was told had bladder infection - Live about 13 months. Could never walk again. Had flu shot in January 2013 - could not walk or stand the next day - was in a wheelchair until her death 1-2-14.
Age: 70.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Abasia, Cystitis, Death, Dysstasia
Clinical narrative: Took Flu shot in January 2013 - the next day could not walk. Went to hospital was told had bladder infection - Live about 13 months. Could never walk again. Had flu shot in January 2013 - could not walk or stand the next day - was in a wheelchair until her death 1-2-14.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Per grandmother the patient presented pain to touch, red and warm to touch in the right arm after the KINRIX vaccine was administered.
Age: 56.0
Sex: M
Vaccine: PNC13
Symptoms: Computerised tomogram head abnormal, Demyelinating polyneuropathy, Dysstasia, Electromyogram abnormal, Nuclear magnetic resonance imaging spinal abnormal
Clinical narrative: Patient states symptoms started Saturday (04/05/14) AM when he attempted to get out of bed he noted that he was unable to stand. This has progressed to requiring 2 person assist down stairs to car and wheelchair to get to clinic.
Age: 56.0
Sex: M
Vaccine: PNC13
Symptoms: Wheelchair user
Clinical narrative: Patient states symptoms started Saturday (04/05/14) AM when he attempted to get out of bed he noted that he was unable to stand. This has progressed to requiring 2 person assist down stairs to car and wheelchair to get to clinic.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Asthenia, Fatigue, Injection site joint pain, Insomnia
Clinical narrative: Fever and tiredness evolving into serious joint pain in shoulders and hips which is painful enough to affect sleeping.  Continuing fever and low energy.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Fever and tiredness evolving into serious joint pain in shoulders and hips which is painful enough to affect sleeping.  Continuing fever and low energy.
Age: 36.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Pain at T-dap injection site, warm and tender to touch, erythematous and afebrile.  Treated with Keflex.
Age: 23.0
Sex: F
Vaccine: FLU3, VARCEL
Symptoms: Unevaluable event
Clinical narrative: Mild breakthrough dx.
Age: 1.51
Sex: F
Vaccine: DTAP
Symptoms: Erythema multiforme, Skin lesion
Clinical narrative: Erythema multiforme. Had WCC and DTAP 04/21/12. A couple of annular lesions noted on face last night (4/21/12). Spread all over this A.M. (4/22/12). No meds given prior to rash. 4/22/12 started BENADRYL 4ml prn for every 6 hrs, ORAPRED 9ml once a day x 7 days if having mouth ulcers. Triamcinolone apply to affected area BID 14 days. Use wet compresses and oral antihistamine if itching.
Sex: U
Vaccine: VARCEL
Symptoms: Drug label confusion, 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 03-APR-2014 the patient was vaccinated with VARIVAX (lot# 0945AA, exp 14-JUN-2014). Route, dose and dose number were not reported. The dose of VARIVAX was expired. No adverse symptoms reported. The pharmacist mentioned "The expiration date on the label says '14 JUN 13', which is very confusing, because the person who administered the vaccine interpreted that as the product expired on June 13, 2014, not on June 14, 2013. The outcome of received an expired dose of VARIVAX and no adverse symptoms was unknown. Reporter causality assessment was not reported. Additional information has been requested.
Age: 0.18
Sex: F
Vaccine: HIBV, PNC13, RV1
Symptoms: Pyrexia
Clinical narrative: Fever 101.6; visit to emergency room day of vaccines.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information was received from a medical assistant who stated that multiple temperature excursions involving GARDASIL took place from 20-FEB-2014 through 06-MAR-2014. Improperly stored vaccines of GARDASIL were administered to unspecified patients on unspecified dates (dosages and routes of administration were not provided). Lot numbers of the impacted vaccines are as follows: J011272, expiration date 21-APR-2016 (reported as 16-APR-2016); J010396, expiration date 16-FEB-2015; J013277, expiration date 06-AUG-2015: J006850, expiration date 31-MAR-2016 (reported as 10-JUL-2015); J006850, expiration date 31-MAR-2016 (reported as 06-AUG-2015); and J009788, expiration date 17-MAR-2016. No adverse effects reported. Lot number J010396 is an invalid lot number for GARDASIL. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 13 years old female patient. On 02-OCT-2012, patient received first dose, of GARDASIL, 0.5 ml (milliliter), intramuscularly. No concomitant medications were reported. On 09-OCT-2013, the patient was vaccinated with the second dose GARDASIL, dose (unknown) and route of administration (unknown). On 30-DEC-2013, patient received third dose, GARDASIL, dose (unknown) and route of administration (unknown). No adverse effects reported. No product quality complaint was involved. The outcome of events was unknown. Causality was not provided. Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site induration, Pyrexia
Clinical narrative: This spontaneous report as received from a Nurse practitioner refers to a 60 year old male patient with paronychia and no known drug allergies. On 09-APR-2014 the patient was vaccinated with a dose of ZOSTAVAX (lot # J013135, expiration date 17-JAN-2015) (dose and route of administration were not reported) in the arm. Concomitant therapies included KEFLEX and LOVAZA. On 10-APR-2014, the patient experienced indurated area around the injection site and fever. Nurse practitioner stated that the fever had resolved on an unspecified date however "there was still a little bit of induration on the arm". The patient was told to use warm soaks on the indurated area around injection site. The relatedness between events and ZOSTAVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a pharmacist via company representative to two patients of unspecified demographics. Patients medical history was unspecified. On an unknown date, the patients were vaccinated with ZOSTAVAX (dose, frequency, lot number and expiry date were unspecified). Concomitant therapy was unspecified. On an unknown date (after receipt of ZOSTAVAX at a later, unspecified date), the patients developed herpes zoster. The representative reported that the pharmacist could not remember who the patients were at the time of this report. It was reported that VZV not offered to the pharmacist because these occurrences of herpes zoster occurred an unspecified period of time ago. No product quality complaint was involved. The outcome of event herpes zoster was reported as fully recovered (also reported as patients present status as unspecified). The reporters causality assessment for the event of herpes zoster with the therapy of ZOSTAVAX was not reported. No further information was available. Additional information has been requested.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Back pain, Computerised tomogram normal, Discomfort, Pain, Paraesthesia
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 69 year old male patient. The patient's pertinent medical history included benign prostatic hypertrophy, high cholesterol and hypertension. No known drug reactions/allergies. On 15-MAR-2014 the patient was vaccinated with ZOSTAVAX, 0.65 ml, subcutaneous in the right rear deltoid. Lot number J014851. Concomitant therapies included JALYN, pravastatin sodium, and ZIAC. On 16-MAR-2014 the patient stated to pharmacist that he experienced back pain that moved around to his kidney area. On unspecified dated the patient contacted his physician. It was reported that the patient declined pain medication on unspecified date. The physician prescribed a CAT Scan on an unspecified body area. The result of the CAT Scan, received on 24-MAR-2014, was negative. The patient also reported to the pharmacist that pain shifted from spine to kidney area. "Around 23-MAR-2014 or 24-MAR-2014" the patient noticed that his spine was tingling. On 24-MAR-2014 the patient's wife noticed a rash on the patient's back. On 26-MAR-2014 the patient reported to pharmacist that the rash was coming around one side of his body (side of body was unspecified) in the same spots where pain originated in kidney area since an unspecified date. On an unspecified date the patient was prescribed an unspecified antiviral medication. On 26-MAR-2014 the patient stated to pharmacist that he still has the rash, the rash is incredibly painful and uncomfortable. The outcome of experienced back pain that moved around to his kidney area and his spine was tingling is unknown. The outcome of rash on the patient's back in the same spots where pain originated in kidney area was reported as not recovered/not resolved. The causal relationship was not provided. Additional information has been requested.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash, Renal pain
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 69 year old male patient. The patient's pertinent medical history included benign prostatic hypertrophy, high cholesterol and hypertension. No known drug reactions/allergies. On 15-MAR-2014 the patient was vaccinated with ZOSTAVAX, 0.65 ml, subcutaneous in the right rear deltoid. Lot number J014851. Concomitant therapies included JALYN, pravastatin sodium, and ZIAC. On 16-MAR-2014 the patient stated to pharmacist that he experienced back pain that moved around to his kidney area. On unspecified dated the patient contacted his physician. It was reported that the patient declined pain medication on unspecified date. The physician prescribed a CAT Scan on an unspecified body area. The result of the CAT Scan, received on 24-MAR-2014, was negative. The patient also reported to the pharmacist that pain shifted from spine to kidney area. "Around 23-MAR-2014 or 24-MAR-2014" the patient noticed that his spine was tingling. On 24-MAR-2014 the patient's wife noticed a rash on the patient's back. On 26-MAR-2014 the patient reported to pharmacist that the rash was coming around one side of his body (side of body was unspecified) in the same spots where pain originated in kidney area since an unspecified date. On an unspecified date the patient was prescribed an unspecified antiviral medication. On 26-MAR-2014 the patient stated to pharmacist that he still has the rash, the rash is incredibly painful and uncomfortable. The outcome of experienced back pain that moved around to his kidney area and his spine was tingling is unknown. The outcome of rash on the patient's back in the same spots where pain originated in kidney area was reported as not recovered/not resolved. The causal relationship was not provided. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site discomfort, Injection site pain, Injection site swelling
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. On an unknown date the patient experienced an adverse event. The patient stated that after receiving the ZOSTAVAX they had an injection site reaction on an unspecified date that created pain, discomfort and swelling. "The discomfort was worse when coming into contact with clothing". It was unknown if the patient sought medical attention. The outcome of adverse events was unknown. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Vaccination complication
Clinical narrative: This spontaneous report was received from a health care worker (medical assistant) and refers to a patient of unknown age and gender. On an unspecified date the patient was vaccinated with a dose of Hepatitis B (manufacturer unknown) and on an unspecified date experienced an unspecified reaction to Hepatitis B vaccine (manufacturer unknown). Additional information has been requested.
Sex: U
Vaccine: MMR, VARCEL, DTAP, IPV, MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a physician refers to a patient of unknown demography. On 14-APR-2014, the patient was vaccinated with VARIVAX (Merck) Lot # J009729 (Expiry: 29-OCT-2014) (dose, route and frequency were not reported) and M-M-R II Lot # J003787 (Expiry: 07-JUN-2015) which were exposed to 13C for 68 hours. No adverse effects were reported. No further information was provided. This case is linked to the case 1404USA010752 and 1404USA010753 (same reporter link). Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Malaise, Tachycardia, Urticaria
Clinical narrative: Within 5 mins. of injection, developed hives and tachycardia, pain at site. Took ALLEGRA 180 mg and symptoms resolved in 20" except for approximately 24h generalized not feeling well and 2 wks. soreness at site.
Sex: U
Vaccine: MMR, VARCEL, PNC13, VARCEL, PNC13, VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a physician refers to a patient of unknown demography. On 14-APR-2014, the patient was vaccinated with VARIVAX (Merck) Lot # J009729 (Expiry: 29-OCT-2014) (dose, route and frequency were not reported) and M-M-R II Lot # J003787 (Expiry: 07-JUN-2015) which were exposed to 13C for 68 hours. No adverse effects were reported. No further information was provided. This case is linked to the case 1404USA008994 and 1404USA010752 (same reproter link). Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information was received from a medical assistant who stated that multiple temperature excursions involving M-M-R II, took place from 20-FEB-2014 through 06-MAR-2014. Improperly stored vaccines of M-M-R II (batch #H017436, lot #0480AE, expiration date 29-AUG-2015; reported as expiration date of 20-SEP-2014), albumin status rHA, were administered to unspecified patients on unspecified dates (dosages and routes of administration were not provided). No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: MMR, VARCEL, DTAP, IPV, VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a physician refers to a patient of unknown demography. On 14-APR-2014, the patient was vaccinated with VARIVAX Lot # J009729 (Expiry: 29-OCT-2014) (dose, route and frequency were not reported) and M-M-R II Lot # J003787 (Expiry: 07-JUN-2015) which were exposed to 13C for 68 hours. No adverse effects were reported. No further information was provided. This case is linked to the case 1404USA008994 and 1404USA010753 (same reporter link). Additional information has been requested.
Age: 1.03
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 37.0
Sex: F
Vaccine: TDAP
Symptoms: Eye injury, Head injury, Headache, Muscular weakness, Nuclear magnetic resonance imaging brain normal
Clinical narrative: C/O right arm weakness, paralysis, headache, fever, body aches on 4-17-14.
Age: 37.0
Sex: F
Vaccine: TDAP
Symptoms: Pain, Paralysis, Pyrexia
Clinical narrative: C/O right arm weakness, paralysis, headache, fever, body aches on 4-17-14.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Pt developed shingles (rash on left hip) one week post vaccination. MD visit required tx w/VALTREX and doxycycline.
Age: 20.0
Sex: F
Vaccine: HEPA, TYP
Symptoms: Dysgeusia, Immediate post-injection reaction
Clinical narrative: Immediately after receiving injections pt. states "I have a metallic taste in my mouth".
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Pain in extremity
Clinical narrative: Pt. complains of very painful arm, very sore to move. Taking aspirin for the pain tried heat/cold on site heat helps the most. Advised to call Dr. Dr. saw her and dx her w/ a local significant vaccine reaction he also stated she had injured the same arm last week. Put her on steroids.
Age: 6.0
Sex: M
Vaccine: MMR
Symptoms: Headache, Rash, Rash erythematous, Rash morbilliform, Rhinorrhoea
Clinical narrative: Red spots/rash x 2 days on trunk. HA & vomiting x 1, runny nose on 4/17/14. Mom gave Zyretc & Tylenol. Pt received MMR on 4/10/14.   Skin: ABNORMAL inspection: 2-3 mm erythematous morbilliform rash on trunk mostly, including back.    Assessment  MMR vaccine reaction - with morbilliform rash  DX 1: 057.9 VIRAL EXANTHEM   Plan  Discussed with mom, rash self resolving.  Symptomatic treatment.  OTC meds prn.  F/U if sx's persist/worsen.
Age: 6.0
Sex: M
Vaccine: MMR
Symptoms: Vaccination complication, Vomiting
Clinical narrative: Red spots/rash x 2 days on trunk. HA & vomiting x 1, runny nose on 4/17/14. Mom gave Zyretc & Tylenol. Pt received MMR on 4/10/14.   Skin: ABNORMAL inspection: 2-3 mm erythematous morbilliform rash on trunk mostly, including back.    Assessment  MMR vaccine reaction - with morbilliform rash  DX 1: 057.9 VIRAL EXANTHEM   Plan  Discussed with mom, rash self resolving.  Symptomatic treatment.  OTC meds prn.  F/U if sx's persist/worsen.
Age: 1.44
Sex: F
Vaccine: HEPA, HIBV, MMR, VARCEL
Symptoms: Injection site bruising, Injection site urticaria, Urticaria
Clinical narrative: Child received Hep A #1 left thigh in late AM 4/9/14. Mom called about 3 hrs later stated that child had hives over left thigh extending over buttocks. No difficulty breathing. Exam confirmed above, no wheezing. Slight bruising at site. Hives appeared around the Hep A site.
Sex: U
Vaccine: RV5
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age. On 09-APR-2014 the patient was vaccinated with an expired dose of ROTATEQ (lot # H017721, exp. date: 01-APR-2014, 2 ml, route of administration-oral). No adverse effects reported. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site bruising, Injection site erythema, Injection site pruritus, Injection site rash
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 67 year old female patient. On 08-APR-2014 the patient was vaccinated with one dose of ZOSTAVAX (lot number# J013449, expiry date: 24-JAN-2015), once, subcutaneously into the back of left upper arm. The patient's past medical history, past drug history, and concomitant medications were unknown. On 09-APR-2014 (reported as 'next day') the patient reported that injection site became itchy and red. Over the next several days the redness progressed and moved up her left upper arm towards her left neck under left ear and her left neck gland became swollen and painful to the touch, and painful with talking and chewing. On 12-APR-2014 the consumer went back in to the pharmacy and told the pharmacist that she was taking ibuprofen (manufacturer unknown) for pain and wanted to know what else she could take for the pain because the pain was bothering her. Pharmacist also noticed that a purple and red bruise around the injection site that is a couple of inches in diameter and a raised rash around the injection site. The patient did not have a fever, was not having trouble breathing and was fully alert. The pharmacist contacted the physician who were concerned that it could be some cellulitis and advised the pharmacist to go to the emergency room. It was unknown if any relevant laboratory testing was performed. As of 12-APR-2014 it was unknown if the patient would receive another dose of ZOSTAVAX. The outcome of the events was unknown. The relatedness of the ZOSTAVAX and the events was unknown. Additional information is not expected.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 67 year old female patient. On 08-APR-2014 the patient was vaccinated with one dose of ZOSTAVAX (lot number# J013449, expiry date: 24-JAN-2015), once, subcutaneously into the back of left upper arm. The patient's past medical history, past drug history, and concomitant medications were unknown. On 09-APR-2014 (reported as 'next day') the patient reported that injection site became itchy and red. Over the next several days the redness progressed and moved up her left upper arm towards her left neck under left ear and her left neck gland became swollen and painful to the touch, and painful with talking and chewing. On 12-APR-2014 the consumer went back in to the pharmacy and told the pharmacist that she was taking ibuprofen (manufacturer unknown) for pain and wanted to know what else she could take for the pain because the pain was bothering her. Pharmacist also noticed that a purple and red bruise around the injection site that is a couple of inches in diameter and a raised rash around the injection site. The patient did not have a fever, was not having trouble breathing and was fully alert. The pharmacist contacted the physician who were concerned that it could be some cellulitis and advised the pharmacist to go to the emergency room. It was unknown if any relevant laboratory testing was performed. As of 12-APR-2014 it was unknown if the patient would receive another dose of ZOSTAVAX. The outcome of the events was unknown. The relatedness of the ZOSTAVAX and the events was unknown. Additional information is not expected.
Age: 29.0
Sex: F
Vaccine: MMR
Symptoms: Measles antibody negative, Mumps antibody test negative, Rubella antibody negative
Clinical narrative: This spontaneous report as received from a medical assistant refers to a currently 30 year old female patient with drug reaction or allergy to codeine. There was no concomitant medication. On an unknown date, in the patient's childhood, she was probably vaccinated with a dose of M-M-R II (dose, lot number and route not reported). It was reported that a patient, who probably had M-M-R II vaccines in childhood, recently came to the office and reported that she had labs drawn for her job (date unspecified) and her MMR titers came back negative. As treatment, on 25-FEB-2014 the patient was vaccinated with a dose of M-M-R II (dose, lot number and route not reported). At the time of the report, the patient's outcome was unknown. Relatedness between the therapy and the event was not reported. Additional information has been requested.
Age: 57.0
Sex: M
Vaccine: FLU3, TDAP, FLUC3, TDAP
Symptoms: Angiogram abnormal, Arrhythmia, Atrioventricular block second degree, Blood creatine phosphokinase MB increased, Borrelia test negative
Clinical narrative: 57 year-old male retiree with 5-year history of HTN, history of OSA, allergic rhinitis, and 1st degree heart block noted in 2010 who was in his usual state of health on 5 FEB 2014 when he received Tdap and Influenza vaccines on 5 FEB following a routine physical. When patient returned for a blood pressure check on 7 FEB, an irregular heart rate was noted. At the time, patient was asymptomatic and an ECG completed did not show significant changes from a 2010 ECG. Patient was referred for a 24-hour Holter which was completed on 19 FEB. During the course of the Holter, cessation of ventricular activity up to 6 seconds was noted and tracings were consistent with high degree AV block/Type 2 Mobitz. During these episodes of ventricular cessation, patient continued to be asymptomatic. After interpretation of Holter monitor recordings, patient was contacted and admitted to hospital. He was placed on telemetry where several non-conducted p-waves with ventricular pauses were observed, but patient remained asymptomatic. During his 6-day hospitalization, patient had normal echocardiogram and CT, Cardiac Angiography (except for dilation of the ascending aorta and minimal bilateral hilar and mediastinal lymphadenopathy), but had positive cardiac enzymes and cardiac MRI (see results below). During hospitalization, Infectious Disease was consulted for recommendations for viral myocarditis and recommended numerous viral serologies (see results below). Patient reported vague history of URI symptoms during the previous month). On 24 FEB, a pacemaker was implanted. When patient was discharged on 25 FEB, his discharge diagnosis included Arrhythmia likely related to myocarditis of unknown etiology. Patient has a history of vertigo during the past 3 years thought to be consistent with BPV. He denies history of syncope or loss of consciousness. He reports a history of lightheadedness and fogginess with standing up too quickly or after eating.
Age: 57.0
Sex: M
Vaccine: FLU3, TDAP, FLUC3, TDAP
Symptoms: Cardiac enzymes increased, Cardiac pacemaker insertion, Cardiac telemetry abnormal, Computerised tomogram abnormal, Coxsackie virus test negative
Clinical narrative: 57 year-old male retiree with 5-year history of HTN, history of OSA, allergic rhinitis, and 1st degree heart block noted in 2010 who was in his usual state of health on 5 FEB 2014 when he received Tdap and Influenza vaccines on 5 FEB following a routine physical. When patient returned for a blood pressure check on 7 FEB, an irregular heart rate was noted. At the time, patient was asymptomatic and an ECG completed did not show significant changes from a 2010 ECG. Patient was referred for a 24-hour Holter which was completed on 19 FEB. During the course of the Holter, cessation of ventricular activity up to 6 seconds was noted and tracings were consistent with high degree AV block/Type 2 Mobitz. During these episodes of ventricular cessation, patient continued to be asymptomatic. After interpretation of Holter monitor recordings, patient was contacted and admitted to hospital. He was placed on telemetry where several non-conducted p-waves with ventricular pauses were observed, but patient remained asymptomatic. During his 6-day hospitalization, patient had normal echocardiogram and CT, Cardiac Angiography (except for dilation of the ascending aorta and minimal bilateral hilar and mediastinal lymphadenopathy), but had positive cardiac enzymes and cardiac MRI (see results below). During hospitalization, Infectious Disease was consulted for recommendations for viral myocarditis and recommended numerous viral serologies (see results below). Patient reported vague history of URI symptoms during the previous month). On 24 FEB, a pacemaker was implanted. When patient was discharged on 25 FEB, his discharge diagnosis included Arrhythmia likely related to myocarditis of unknown etiology. Patient has a history of vertigo during the past 3 years thought to be consistent with BPV. He denies history of syncope or loss of consciousness. He reports a history of lightheadedness and fogginess with standing up too quickly or after eating.
Age: 57.0
Sex: M
Vaccine: FLU3, TDAP, FLUC3, TDAP
Symptoms: Cytomegalovirus test, Cytomegalovirus test negative, Echocardiogram normal, Electrocardiogram P wave abnormal, Electrocardiogram ambulatory abnormal
Clinical narrative: 57 year-old male retiree with 5-year history of HTN, history of OSA, allergic rhinitis, and 1st degree heart block noted in 2010 who was in his usual state of health on 5 FEB 2014 when he received Tdap and Influenza vaccines on 5 FEB following a routine physical. When patient returned for a blood pressure check on 7 FEB, an irregular heart rate was noted. At the time, patient was asymptomatic and an ECG completed did not show significant changes from a 2010 ECG. Patient was referred for a 24-hour Holter which was completed on 19 FEB. During the course of the Holter, cessation of ventricular activity up to 6 seconds was noted and tracings were consistent with high degree AV block/Type 2 Mobitz. During these episodes of ventricular cessation, patient continued to be asymptomatic. After interpretation of Holter monitor recordings, patient was contacted and admitted to hospital. He was placed on telemetry where several non-conducted p-waves with ventricular pauses were observed, but patient remained asymptomatic. During his 6-day hospitalization, patient had normal echocardiogram and CT, Cardiac Angiography (except for dilation of the ascending aorta and minimal bilateral hilar and mediastinal lymphadenopathy), but had positive cardiac enzymes and cardiac MRI (see results below). During hospitalization, Infectious Disease was consulted for recommendations for viral myocarditis and recommended numerous viral serologies (see results below). Patient reported vague history of URI symptoms during the previous month). On 24 FEB, a pacemaker was implanted. When patient was discharged on 25 FEB, his discharge diagnosis included Arrhythmia likely related to myocarditis of unknown etiology. Patient has a history of vertigo during the past 3 years thought to be consistent with BPV. He denies history of syncope or loss of consciousness. He reports a history of lightheadedness and fogginess with standing up too quickly or after eating.
Age: 57.0
Sex: M
Vaccine: FLU3, TDAP, FLUC3, TDAP
Symptoms: Electrocardiogram normal, Enterovirus test negative, Epstein-Barr virus antibody negative, Epstein-Barr virus antibody positive, Heart rate irregular
Clinical narrative: 57 year-old male retiree with 5-year history of HTN, history of OSA, allergic rhinitis, and 1st degree heart block noted in 2010 who was in his usual state of health on 5 FEB 2014 when he received Tdap and Influenza vaccines on 5 FEB following a routine physical. When patient returned for a blood pressure check on 7 FEB, an irregular heart rate was noted. At the time, patient was asymptomatic and an ECG completed did not show significant changes from a 2010 ECG. Patient was referred for a 24-hour Holter which was completed on 19 FEB. During the course of the Holter, cessation of ventricular activity up to 6 seconds was noted and tracings were consistent with high degree AV block/Type 2 Mobitz. During these episodes of ventricular cessation, patient continued to be asymptomatic. After interpretation of Holter monitor recordings, patient was contacted and admitted to hospital. He was placed on telemetry where several non-conducted p-waves with ventricular pauses were observed, but patient remained asymptomatic. During his 6-day hospitalization, patient had normal echocardiogram and CT, Cardiac Angiography (except for dilation of the ascending aorta and minimal bilateral hilar and mediastinal lymphadenopathy), but had positive cardiac enzymes and cardiac MRI (see results below). During hospitalization, Infectious Disease was consulted for recommendations for viral myocarditis and recommended numerous viral serologies (see results below). Patient reported vague history of URI symptoms during the previous month). On 24 FEB, a pacemaker was implanted. When patient was discharged on 25 FEB, his discharge diagnosis included Arrhythmia likely related to myocarditis of unknown etiology. Patient has a history of vertigo during the past 3 years thought to be consistent with BPV. He denies history of syncope or loss of consciousness. He reports a history of lightheadedness and fogginess with standing up too quickly or after eating.
Age: 57.0
Sex: M
Vaccine: FLU3, TDAP, FLUC3, TDAP
Symptoms: Hepatitis A antibody negative, Hepatitis B DNA assay negative, Hepatitis B core antibody positive, Hepatitis B surface antibody negative, Hepatitis B surface antigen negative
Clinical narrative: 57 year-old male retiree with 5-year history of HTN, history of OSA, allergic rhinitis, and 1st degree heart block noted in 2010 who was in his usual state of health on 5 FEB 2014 when he received Tdap and Influenza vaccines on 5 FEB following a routine physical. When patient returned for a blood pressure check on 7 FEB, an irregular heart rate was noted. At the time, patient was asymptomatic and an ECG completed did not show significant changes from a 2010 ECG. Patient was referred for a 24-hour Holter which was completed on 19 FEB. During the course of the Holter, cessation of ventricular activity up to 6 seconds was noted and tracings were consistent with high degree AV block/Type 2 Mobitz. During these episodes of ventricular cessation, patient continued to be asymptomatic. After interpretation of Holter monitor recordings, patient was contacted and admitted to hospital. He was placed on telemetry where several non-conducted p-waves with ventricular pauses were observed, but patient remained asymptomatic. During his 6-day hospitalization, patient had normal echocardiogram and CT, Cardiac Angiography (except for dilation of the ascending aorta and minimal bilateral hilar and mediastinal lymphadenopathy), but had positive cardiac enzymes and cardiac MRI (see results below). During hospitalization, Infectious Disease was consulted for recommendations for viral myocarditis and recommended numerous viral serologies (see results below). Patient reported vague history of URI symptoms during the previous month). On 24 FEB, a pacemaker was implanted. When patient was discharged on 25 FEB, his discharge diagnosis included Arrhythmia likely related to myocarditis of unknown etiology. Patient has a history of vertigo during the past 3 years thought to be consistent with BPV. He denies history of syncope or loss of consciousness. He reports a history of lightheadedness and fogginess with standing up too quickly or after eating.
Age: 57.0
Sex: M
Vaccine: FLU3, TDAP, FLUC3, TDAP
Symptoms: Hepatitis C antibody negative, Herpes simplex serology negative, Human herpes virus 6 serology negative, Influenza A virus test negative, Influenza virus test negative
Clinical narrative: 57 year-old male retiree with 5-year history of HTN, history of OSA, allergic rhinitis, and 1st degree heart block noted in 2010 who was in his usual state of health on 5 FEB 2014 when he received Tdap and Influenza vaccines on 5 FEB following a routine physical. When patient returned for a blood pressure check on 7 FEB, an irregular heart rate was noted. At the time, patient was asymptomatic and an ECG completed did not show significant changes from a 2010 ECG. Patient was referred for a 24-hour Holter which was completed on 19 FEB. During the course of the Holter, cessation of ventricular activity up to 6 seconds was noted and tracings were consistent with high degree AV block/Type 2 Mobitz. During these episodes of ventricular cessation, patient continued to be asymptomatic. After interpretation of Holter monitor recordings, patient was contacted and admitted to hospital. He was placed on telemetry where several non-conducted p-waves with ventricular pauses were observed, but patient remained asymptomatic. During his 6-day hospitalization, patient had normal echocardiogram and CT, Cardiac Angiography (except for dilation of the ascending aorta and minimal bilateral hilar and mediastinal lymphadenopathy), but had positive cardiac enzymes and cardiac MRI (see results below). During hospitalization, Infectious Disease was consulted for recommendations for viral myocarditis and recommended numerous viral serologies (see results below). Patient reported vague history of URI symptoms during the previous month). On 24 FEB, a pacemaker was implanted. When patient was discharged on 25 FEB, his discharge diagnosis included Arrhythmia likely related to myocarditis of unknown etiology. Patient has a history of vertigo during the past 3 years thought to be consistent with BPV. He denies history of syncope or loss of consciousness. He reports a history of lightheadedness and fogginess with standing up too quickly or after eating.
Age: 57.0
Sex: M
Vaccine: FLU3, TDAP, FLUC3, TDAP
Symptoms: Lymphadenopathy mediastinal, Myocardial oedema, Myocarditis, Parvovirus B19 test positive, Polymerase chain reaction
Clinical narrative: 57 year-old male retiree with 5-year history of HTN, history of OSA, allergic rhinitis, and 1st degree heart block noted in 2010 who was in his usual state of health on 5 FEB 2014 when he received Tdap and Influenza vaccines on 5 FEB following a routine physical. When patient returned for a blood pressure check on 7 FEB, an irregular heart rate was noted. At the time, patient was asymptomatic and an ECG completed did not show significant changes from a 2010 ECG. Patient was referred for a 24-hour Holter which was completed on 19 FEB. During the course of the Holter, cessation of ventricular activity up to 6 seconds was noted and tracings were consistent with high degree AV block/Type 2 Mobitz. During these episodes of ventricular cessation, patient continued to be asymptomatic. After interpretation of Holter monitor recordings, patient was contacted and admitted to hospital. He was placed on telemetry where several non-conducted p-waves with ventricular pauses were observed, but patient remained asymptomatic. During his 6-day hospitalization, patient had normal echocardiogram and CT, Cardiac Angiography (except for dilation of the ascending aorta and minimal bilateral hilar and mediastinal lymphadenopathy), but had positive cardiac enzymes and cardiac MRI (see results below). During hospitalization, Infectious Disease was consulted for recommendations for viral myocarditis and recommended numerous viral serologies (see results below). Patient reported vague history of URI symptoms during the previous month). On 24 FEB, a pacemaker was implanted. When patient was discharged on 25 FEB, his discharge diagnosis included Arrhythmia likely related to myocarditis of unknown etiology. Patient has a history of vertigo during the past 3 years thought to be consistent with BPV. He denies history of syncope or loss of consciousness. He reports a history of lightheadedness and fogginess with standing up too quickly or after eating.
Age: 57.0
Sex: M
Vaccine: FLU3, TDAP, FLUC3, TDAP
Symptoms: Systolic dysfunction, Troponin T increased, Viral myocarditis, Viral test
Clinical narrative: 57 year-old male retiree with 5-year history of HTN, history of OSA, allergic rhinitis, and 1st degree heart block noted in 2010 who was in his usual state of health on 5 FEB 2014 when he received Tdap and Influenza vaccines on 5 FEB following a routine physical. When patient returned for a blood pressure check on 7 FEB, an irregular heart rate was noted. At the time, patient was asymptomatic and an ECG completed did not show significant changes from a 2010 ECG. Patient was referred for a 24-hour Holter which was completed on 19 FEB. During the course of the Holter, cessation of ventricular activity up to 6 seconds was noted and tracings were consistent with high degree AV block/Type 2 Mobitz. During these episodes of ventricular cessation, patient continued to be asymptomatic. After interpretation of Holter monitor recordings, patient was contacted and admitted to hospital. He was placed on telemetry where several non-conducted p-waves with ventricular pauses were observed, but patient remained asymptomatic. During his 6-day hospitalization, patient had normal echocardiogram and CT, Cardiac Angiography (except for dilation of the ascending aorta and minimal bilateral hilar and mediastinal lymphadenopathy), but had positive cardiac enzymes and cardiac MRI (see results below). During hospitalization, Infectious Disease was consulted for recommendations for viral myocarditis and recommended numerous viral serologies (see results below). Patient reported vague history of URI symptoms during the previous month). On 24 FEB, a pacemaker was implanted. When patient was discharged on 25 FEB, his discharge diagnosis included Arrhythmia likely related to myocarditis of unknown etiology. Patient has a history of vertigo during the past 3 years thought to be consistent with BPV. He denies history of syncope or loss of consciousness. He reports a history of lightheadedness and fogginess with standing up too quickly or after eating.
Age: 57.0
Sex: M
Vaccine: FLU3, TDAP, FLUC3, TDAP
Symptoms: Angiogram abnormal, Aortic dilatation, Arrhythmia, Atrioventricular block second degree, Cardiac enzymes increased
Clinical narrative: 57 year-old male retiree with 5-year history of HTN, history of OSA, allergic rhinitis, and 1st degree heart block noted in 2010 who was in his usual state of health on 5 FEB 2014 when he received Tdap and Influenza vaccines on 5 FEB following a routine physical. When patient returned for a blood pressure check on 7 FEB, an irregular heart rate was noted. At the time, patient was asymptomatic and an ECG completed did not show significant changes from a 2010 ECG. Patient was referred for a 24-hour Holter which was completed on 19 FEB. During the course of the Holter, cessation of ventricular activity up to 6 seconds was noted and tracings were consistent with high degree AV block/Type 2 Mobitz. During these episodes of ventricular cessation, patient continued to be asymptomatic. After interpretation of Holter monitor recordings, patient was contacted and admitted to hospital. He was placed on telemetry where several non-conducted p-waves with ventricular pauses were observed, but patient remained asymptomatic. During his 6-day hospitalization, patient had normal echocardiogram and CT, Cardiac Angiography (except for dilation of the ascending aorta and minimal bilateral hilar and mediastinal lymphadenopathy), but had positive cardiac enzymes and cardiac MRI (see results below). During hospitalization, Infectious Disease was consulted for recommendations for viral myocarditis and recommended numerous viral serologies (see results below). Patient reported vague history of URI symptoms during the previous month). On 24 FEB, a pacemaker was implanted. When patient was discharged on 25 FEB, his discharge diagnosis included Arrhythmia likely related to myocarditis of unknown etiology. Patient has a history of vertigo during the past 3 years thought to be consistent with BPV. He denies history of syncope or loss of consciousness. He reports a history of lightheadedness and fogginess with standing up too quickly or after eating.