chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.31
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a health care professional concerning a 1 year old patient of unknown gender. On 02-JUL-2013, the patient was vaccinated with a expired dose of M-M-R II HSA first dose, 0.5 ml, subcutaneously (lot # 1025AA exp 30-JUN-2013). No adverse effects were reported. Additional informations has been requested. This is one case of several cases reported by the same reporter.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a consumer's husband refers to his 81 year old wife with high blood pressure and cholesterol. The patient's medical history included ulcer and thyroid disorder (unspecified reported as thyroidn). No drug reactions/allergies were reported. On an unknown date in August 2008 (reported as five years ago), the patient was vaccinated with a dose of ZOSTAVAX (lot #, expiry not reported) in the left arm. No concomitant medications were reported (reporter did not known names of the medication). On an unknown date in April 2013, the patient came down with shingles. Shingles came around from the back to the left breast. The reporter stated he was not aware you could get shingles after taking the vaccine. No laboratory test were performed. The outcome of shingles was unknown. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse concerning a patient of unknown age and gender. On an unknown dates, the patient received the 3 doses of GARDASIL (lot number, expiry date, dose and route unspecified) vaccination series approximately one year apart. No concomitant therapy was reported. No adverse effects were reported. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse (L.P.N.) refers to a female patient of unknown age. On 13-AUG-2010 the patient was vaccinated with GARDASIL (lot # not reported) (dose 1, strength and total daily dose not reported). On 05-SEP-2012 the patient was vaccinated with GARDASIL (lot # not reported) (dose 2, strength and total daily dose not reported). On 01-AUG-2013 the patient would receive GARDASIL (lot # not reported) (dose 3, strength and total daily dose not reported). No adverse effect was reported. It was unspecified whether the patient sought for medical attention. The outcome was unknown. Additional information has been requested.
Age: 0.1
Sex: U
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 1 month old patient. On 31-JUL-2013 the patient was vaccinated with a dose of VAQTA (Lot # J000366, exp. 22-AUG-2015, also reported as "22-AUG-2105") intramuscularly. No adverse effects were reported. It was not known if the patient sought medical attention. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a health worker (nurse) refers to unspecified patients of unknown age and gender. On an unknown date the patients were vaccinated with a dose of measles, mumps and rubella (Wistar Ra 27-3) virus vaccine, live (manufacturer unknown), lot # 1375Aa expiration date 26-AUG-2013 (dose, route not reported). It was reported that measles, mumps and rubella (Wistar Ra 27-3) virus vaccine (manufacturer unknown) underwent temperature excursion from 29-JUN-2012 to 30-JUN-2012. Measles, mumps and rubella (Wistar Ra 27-3) virus vaccine, live (manufacturer unknown) was unsupported based on stability information however it was administered after excursion. There were unspecified patients that were administered. The outcome of event was unknown. This is one of several cases reporting from same source. Additional information has been requested.
Age: 21.0
Sex: M
Vaccine: ANTH, FLUX, SMALL, ANTH, FLUN3, SMALL
Symptoms: Echocardiogram normal, Electrocardiogram normal, Myocarditis, Troponin I increased
Clinical narrative: Initial report was received 26 July 2013 from the investigator for the trial. A 21-year-old male subject had received the following vaccinations on 27 September 2012: ACAM2000 in the right arm, FLUMIST and anthrax vaccines (lot numbers not reported; routes and sites of administration for FLUMIST and anthrax vaccines were not reported). From 05-09 October 2012, the subject experienced a swollen a right axillary lymph node of mild intensity. On 10 October 2012, testing revealed positive rapid Troponin I, elevated Troponin I (3.06 ng/mL - high critical) and an EKG showed normal sinus rhythm with sinus arrhythmia. Subject denied chest pain, chest pressure, shortness of breath and chest discomfort. He was evaluated by cardiology on 11-12 October 2012; ECHO was normal. He was diagnosed with asymptomatic myocarditis, placed on activity restriction and made non-deployable. The subject had no new symptoms and no evidence of NSAID Rx. On 15 October 2012, Troponin I was "O.K." and the subject recovered. According to the investigator, the event of subclinical myocarditis was probably related to the study vaccine. Documents held by sender: Visit notes, EKG, lab report.
Age: 21.0
Sex: M
Vaccine: ANTH, FLUX, SMALL, ANTH, FLUN3, SMALL
Symptoms: Echocardiogram normal, Electrocardiogram normal, Lymphadenopathy, Myocarditis, Troponin I increased
Clinical narrative: Initial report was received 26 July 2013 from the investigator for the trial. A 21-year-old male subject had received the following vaccinations on 27 September 2012: ACAM2000 in the right arm, FLUMIST and anthrax vaccines (lot numbers not reported; routes and sites of administration for FLUMIST and anthrax vaccines were not reported). From 05-09 October 2012, the subject experienced a swollen a right axillary lymph node of mild intensity. On 10 October 2012, testing revealed positive rapid Troponin I, elevated Troponin I (3.06 ng/mL - high critical) and an EKG showed normal sinus rhythm with sinus arrhythmia. Subject denied chest pain, chest pressure, shortness of breath and chest discomfort. He was evaluated by cardiology on 11-12 October 2012; ECHO was normal. He was diagnosed with asymptomatic myocarditis, placed on activity restriction and made non-deployable. The subject had no new symptoms and no evidence of NSAID Rx. On 15 October 2012, Troponin I was "O.K." and the subject recovered. According to the investigator, the event of subclinical myocarditis was probably related to the study vaccine. Documents held by sender: Visit notes, EKG, lab report.
Age: 20.0
Sex: F
Vaccine: TYP, YF, TYP, YF
Symptoms: Oral administration complication, Vomiting
Clinical narrative: Pt. vomited 20 minutes after taking 4th dose of oral typhoid vaccine.
Age: 20.0
Sex: F
Vaccine: TYP, YF, TYP, YF
Symptoms: Vomiting
Clinical narrative: Pt. vomited 20 minutes after taking 4th dose of oral typhoid vaccine.
Age: 59.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site irritation, Rash, Secretion discharge, Swelling face
Clinical narrative: This spontaneous report as received from a 59 year old female patient, with no pertinent medical history and no drug reactions/allergies, refers to herself. On 01-JUL-2013 the patient was vaccinated with a single dose of ZOSTAVAX lot # J000853; expiring 23-APR-2014 (dose and route not reported). No concomitant medication was reported. In approximately July 2013 the patient experienced a rash and extra mucus in the throat after receiving the ZOSTAVAX vaccine. The patient also stated that she suffered from a swollen face and injection site irritation after receiving the ZOSTAVAX vaccine. No treatment was given for the adverse events. No lab diagnostic studies were performed. The patient saw the doctor for medical attention. The adverse events did not improve and the patient outcome was reported as not recovered. The causal relationship was not reported. Follow up information has been received on 30-JUL-2013 from a physician. It was reported that the patient experienced a generalized macular-papular, urticarial rash with angioedema and itching, approximately 3 weeks (approximately 22-JUL-2013) after receiving ZOSTAVAX on 01-JUL-2013. The patient had started DEXILANT for gastroesophageal reflux disease (GERD) approximately on 11-JUL-2013 to 12-JUL-2013. The patient was seen by the physician on 18-JUL-2013 and was treated with Epinephrine, oral H1 and H2 blockers, Leukotriene inhibitor and DEPO-MEDROL. Physician accepted VZV IP packet. At the time of the report, the patient's outcome was reported as not recovered. Upon internal review the macular papular rash, urticarial rash, angioedema and itching were considered other important medical events, since these were treated with epinephrine. Additional information has been requested.
Age: 59.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Angioedema, Gastrooesophageal reflux disease, Increased upper airway secretion, Injection site irritation, Pruritus
Clinical narrative: This spontaneous report as received from a 59 year old female patient, with no pertinent medical history and no drug reactions/allergies, refers to herself. On 01-JUL-2013 the patient was vaccinated with a single dose of ZOSTAVAX lot # J000853; expiring 23-APR-2014 (dose and route not reported). No concomitant medication was reported. In approximately July 2013 the patient experienced a rash and extra mucus in the throat after receiving the ZOSTAVAX vaccine. The patient also stated that she suffered from a swollen face and injection site irritation after receiving the ZOSTAVAX vaccine. No treatment was given for the adverse events. No lab diagnostic studies were performed. The patient saw the doctor for medical attention. The adverse events did not improve and the patient outcome was reported as not recovered. The causal relationship was not reported. Follow up information has been received on 30-JUL-2013 from a physician. It was reported that the patient experienced a generalized macular-papular, urticarial rash with angioedema and itching, approximately 3 weeks (approximately 22-JUL-2013) after receiving ZOSTAVAX on 01-JUL-2013. The patient had started DEXILANT for gastroesophageal reflux disease (GERD) approximately on 11-JUL-2013 to 12-JUL-2013. The patient was seen by the physician on 18-JUL-2013 and was treated with Epinephrine, oral H1 and H2 blockers, Leukotriene inhibitor and DEPO-MEDROL. Physician accepted VZV IP packet. At the time of the report, the patient's outcome was reported as not recovered. Upon internal review the macular papular rash, urticarial rash, angioedema and itching were considered other important medical events, since these were treated with epinephrine. Additional information has been requested.
Age: 59.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash, Rash generalised, Rash maculo-papular, Swelling face, Urticaria
Clinical narrative: This spontaneous report as received from a 59 year old female patient, with no pertinent medical history and no drug reactions/allergies, refers to herself. On 01-JUL-2013 the patient was vaccinated with a single dose of ZOSTAVAX lot # J000853; expiring 23-APR-2014 (dose and route not reported). No concomitant medication was reported. In approximately July 2013 the patient experienced a rash and extra mucus in the throat after receiving the ZOSTAVAX vaccine. The patient also stated that she suffered from a swollen face and injection site irritation after receiving the ZOSTAVAX vaccine. No treatment was given for the adverse events. No lab diagnostic studies were performed. The patient saw the doctor for medical attention. The adverse events did not improve and the patient outcome was reported as not recovered. The causal relationship was not reported. Follow up information has been received on 30-JUL-2013 from a physician. It was reported that the patient experienced a generalized macular-papular, urticarial rash with angioedema and itching, approximately 3 weeks (approximately 22-JUL-2013) after receiving ZOSTAVAX on 01-JUL-2013. The patient had started DEXILANT for gastroesophageal reflux disease (GERD) approximately on 11-JUL-2013 to 12-JUL-2013. The patient was seen by the physician on 18-JUL-2013 and was treated with Epinephrine, oral H1 and H2 blockers, Leukotriene inhibitor and DEPO-MEDROL. Physician accepted VZV IP packet. At the time of the report, the patient's outcome was reported as not recovered. Upon internal review the macular papular rash, urticarial rash, angioedema and itching were considered other important medical events, since these were treated with epinephrine. Additional information has been requested.
Age: 33.0
Sex: M
Vaccine: FLUX
Symptoms: Asthenia, Blindness, Chest pain, Neck pain, Paralysis
Clinical narrative: Paralyzation, blindness, pain in chest, weakness, neck pain.
Age: 33.0
Sex: M
Vaccine: FLUX
Symptoms: Post vaccination syndrome
Clinical narrative: Paralyzation, blindness, pain in chest, weakness, neck pain.
Age: 62.0
Sex: M
Vaccine: TDAP
Symptoms: Activities of daily living impaired, Arthralgia, Dysphagia, Dysstasia, Fatigue
Clinical narrative: People, can not call facility - throat so painful can not speak clearly. Day one, August 6th 2013, no symptoms. Day two, August 7th 2013 - difficult to walk or stand - tiredness making it difficult to attend a meeting, drive, etc. Day three August 8th 2013 - ambulatory faculties returning. Have strong headache and tiredness - lapse into brief periods of sleep often and involuntarily. Vaccine area very sore - throat so sore can hardly swallow or speak - strong joint pain in knees - shoulders and wrists. Can not monitor body temp as I have no equipment for this procedure. Need guidance from your office as to what action if any to take. Please e-mail or text because I can not speak clearly.
Age: 62.0
Sex: M
Vaccine: TDAP
Symptoms: Gait disturbance, Headache, Impaired driving ability, Injection site pain, Oropharyngeal pain
Clinical narrative: People, can not call facility - throat so painful can not speak clearly. Day one, August 6th 2013, no symptoms. Day two, August 7th 2013 - difficult to walk or stand - tiredness making it difficult to attend a meeting, drive, etc. Day three August 8th 2013 - ambulatory faculties returning. Have strong headache and tiredness - lapse into brief periods of sleep often and involuntarily. Vaccine area very sore - throat so sore can hardly swallow or speak - strong joint pain in knees - shoulders and wrists. Can not monitor body temp as I have no equipment for this procedure. Need guidance from your office as to what action if any to take. Please e-mail or text because I can not speak clearly.
Age: 62.0
Sex: M
Vaccine: TDAP
Symptoms: Speech disorder, Sudden onset of sleep
Clinical narrative: People, can not call facility - throat so painful can not speak clearly. Day one, August 6th 2013, no symptoms. Day two, August 7th 2013 - difficult to walk or stand - tiredness making it difficult to attend a meeting, drive, etc. Day three August 8th 2013 - ambulatory faculties returning. Have strong headache and tiredness - lapse into brief periods of sleep often and involuntarily. Vaccine area very sore - throat so sore can hardly swallow or speak - strong joint pain in knees - shoulders and wrists. Can not monitor body temp as I have no equipment for this procedure. Need guidance from your office as to what action if any to take. Please e-mail or text because I can not speak clearly.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Intussusception, Laparoscopy abnormal
Clinical narrative: Patient developed ileocolic intussusception 4 days after receiving 4 month vaccines (PENTACEL, PCV-13, Rotavirus).
Sex: M
Vaccine: HPV4
Symptoms: Loss of consciousness
Clinical narrative: This spontaneous report as received from a registered nurse refers to a male adolescent patient (age not specified). Medical history was not provided. On 05-AUG-2013 the patient was vaccinated with GARDASIL dose 1, 0.5 ml, intramuscular (lot number not provided). Concomitant medication was not provided. On 05-AUG-2013, within 5 minutes of administration patient passed out while sitting. The outcome of the SAE was not provided. Passed out while sitting was determined as medically significant upon internal review. Additional information has been requested.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Dysphagia, Eyelid ptosis, Injected limb mobility decreased, Mobility decreased
Clinical narrative: Case number PHEH2013US016340 is an initial spontaneous report received from a consumer (who is a pharmacist) on 31 Jul 2013. This report refers to a 39-years-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 111772P1) intramuscularly on an unknown date. It was mentioned that one month after receiving FLUVIRIN, on 01 Oct 2010, she experienced significant neurological issues that progressively worsened. The events first started with a drooping eyelid and later she had trouble swallowing due to swelling in her throat followed by hip,leg and arm pain. She also noticed in pictures that one month after her flu shot, her eyelid drooped compared to the pictures taken before the flu shot. The reporter stated that she could not lift her arms for months after injection and had a torn tendon. It was reported that it had been one event after another since then (unspecified). The outcome was reported that she had been in extreme pain, muscle weakness and lots of unspecified neurological symptoms since the FLUVIRIN administration, three years ago. The outcome of the other events was not reported.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Muscular weakness, Neurological symptom, Pain in extremity, Pharyngeal oedema, Tendon rupture
Clinical narrative: Case number PHEH2013US016340 is an initial spontaneous report received from a consumer (who is a pharmacist) on 31 Jul 2013. This report refers to a 39-years-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 111772P1) intramuscularly on an unknown date. It was mentioned that one month after receiving FLUVIRIN, on 01 Oct 2010, she experienced significant neurological issues that progressively worsened. The events first started with a drooping eyelid and later she had trouble swallowing due to swelling in her throat followed by hip,leg and arm pain. She also noticed in pictures that one month after her flu shot, her eyelid drooped compared to the pictures taken before the flu shot. The reporter stated that she could not lift her arms for months after injection and had a torn tendon. It was reported that it had been one event after another since then (unspecified). The outcome was reported that she had been in extreme pain, muscle weakness and lots of unspecified neurological symptoms since the FLUVIRIN administration, three years ago. The outcome of the other events was not reported.
Sex: U
Vaccine: MNQ
Symptoms: Cellulitis
Clinical narrative: Case number PHEH2013US016359, is an initial spontaneous report received from a nurse on 30 Jul 2013. This report refers to a patient of unknown age and gender. The patient's medical history and concomitant medications were not reported. The patient was vaccinated with MENVEO (batch number: not reported) on an unspecified date. On an unspecified date after vaccination, the patient experienced cellulitis. The outcome was reported as unknown. The seriousness and causality of the event were not reported.
Age: 0.93
Sex: M
Vaccine: DTAPHEPBIP, PNC13
Symptoms: Convulsion, Injection site mass, Laboratory test normal, Pyrexia, Skin warm
Clinical narrative: Patient received vaccine (Fri) 8/2/13 at 1642. Sat morning 8/3/13 patient had low grade fever, lumps on legs where vaccines were given. Treated w/ warm baths. Monday morning 8/5/13 at 0700 patient was warm to touch, temp was 100.4. Mother nursed child, when he finish he started to have a seizure. Called EMS. Went to ER. 1 day stay. Labs, treated with TYLENOL and MOTRIN.
Age: 34.0
Sex: F
Vaccine: UNK
Symptoms: Dehydration, Renal failure acute, Vomiting
Clinical narrative: Vomiting, dehydration, Acute Kidney Disease.
Age: 64.0
Sex: F
Vaccine: VARCEL
Symptoms: Diarrhoea, Flank pain, Rash
Clinical narrative: Diarrhea, severe pain on right side and a rash outbreak one day later.
Age: 11.0
Sex: M
Vaccine: HEPA, MNQ, TDAP
Symptoms: Joint swelling, Pyrexia
Clinical narrative: Daily fevers. Increased swelling of knee.
Age: 25.0
Sex: M
Vaccine: ANTH
Symptoms: Urticaria
Clinical narrative: Patient reports developing hives across forehead and bilateral upper lateral arms.
Age: 0.16
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Blood test normal, CSF test normal, Haematochezia, Intussusception, Nuclear magnetic resonance imaging abdominal normal
Clinical narrative: Intermittent bloody stools and fever for 48 hours. He was pale and septic appearing on 7/24 and was admitted to the hospital. Sepsis evaluation was negative and bloody stools resolved. Suspected intussusception.
Age: 0.16
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Pallor, Pyrexia, Urine analysis normal
Clinical narrative: Intermittent bloody stools and fever for 48 hours. He was pale and septic appearing on 7/24 and was admitted to the hospital. Sepsis evaluation was negative and bloody stools resolved. Suspected intussusception.
Age: 55.0
Sex: M
Vaccine: PPV
Symptoms: Lip swelling, Pruritus
Clinical narrative: Patient called later in the day, stating he had lip swelling and itching 1 hour after getting pneumonia shot. Started taking BENADRYL every 4-6 hrs. which seems to help symptoms.
Age: 13.0
Sex: M
Vaccine: VARCEL
Symptoms: Headache, Pyrexia
Clinical narrative: NO SWELLING OR REDNESS NOTED AT INJECTION SITE ON LEFT ARM. LOW GRADE TEMP OF 100. CHILD COMPLAINED OF A MILD HEADACHE. NO PHYSICAL IMPAIRMENT NOTED.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Vomiting
Clinical narrative: Mom called stated child woke up at 3:15 AM vomiting one time. Child alert and talkative. Child vomited again at 8:30 AM. Mom stated does not act like he feels bad. No complaints of pain in arms from immunizations and shed call MD if no better.
Age: 22.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Local swelling, Pruritus, Skin warm
Clinical narrative: RA swelling and red, itching and warm.
Age: 1.51
Sex: M
Vaccine: DTAP, HEPA, HIBV
Symptoms: Pyrexia, Rash macular
Clinical narrative: 6 hrs after vaccination he developed a fever of 100.4 degrees F and erythematous macular rash on the cheeks.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13
Symptoms: Ocular hyperaemia, Rash, Urticaria
Clinical narrative: He received his 6 month vaccine on 7/23/12 the rash developed 7/25. He developed generalized hives including head, face, back, chest. His eyes were slightly erythematous as well. No wheezing. Oral steroids and antihistamine provided. Referred to allergist.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site vesicles, Malaise
Clinical narrative: Pt developed multiple fluid filled blisters surrounding injection site 1 day after injection. She denied fever, redness, swelling. She did report general malaise. She was advised to take CLARITIN and use BENADRYL or OTC cortisone cream.
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Abdominal pain upper, Decreased appetite, Pyrexia, Rash
Clinical narrative: High fever x 4 days, stomach pains, rash on legs, stomach, buttocks. Fever reached 103-104 x 2 days. Rash remained after fever "broke". No appetite for many days.
Age: 0.53
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Acne, Injection site erythema, Pyrexia, Rash generalised
Clinical narrative: Vaccinated on 7/29/13. Started having fever that evening. 2 days later on 7/31/13 in AM woke up with a raised rash all over body. Mom described it as "looks like little pimples". Child continues to have a low grade fever and redness at inj. site.
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Body temperature increased, Chills, Headache, Injection site erythema, Injection site pain
Clinical narrative: 7/19/13 Tdap. 7/20/13 chills, 101 degrees, severe headache. 7/21/13 T 100 degrees. 7/22/13 afebrile - cont to complain of painful site, redness, pruritus.
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pruritus
Clinical narrative: 7/19/13 Tdap. 7/20/13 chills, 101 degrees, severe headache. 7/21/13 T 100 degrees. 7/22/13 afebrile - cont to complain of painful site, redness, pruritus.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature increased, Chills, Diarrhoea, Myalgia, Nausea
Clinical narrative: 1 hr after injection developed chills. Several hrs later temperature 101 degrees F, nausea, body myalgia, diarrhea.
Age: 19.0
Sex: M
Vaccine: MNQ
Symptoms: Expired drug administered
Clinical narrative: Patient was given expired MENVEO. Expired on 12/2012. Called manufacturer and they couldn't give advice on whether to reimmunize or not. Made Drs. office aware as well.
Age: 4.0
Sex: F
Vaccine: IPV, MMR, TDAP, VARCEL
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Warmth, swelling, tenderness (L) thigh no fever.
Age: 14.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Rec'd MENVEO vaccine on 8/05/13. Seen for reaction in office 8/7/13. S/S equal LT deltoid, upper arm with edema, 12cm x 10cm warm, red area. No induration; non-tender; denies pain, afebrile Tx; ibuprofen, ice packs. Pt. to call back  if pain, fever occur.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age or gender. The patient received the first dose of GARDASIL (dose, frequency, route and lot# not reported) on an unspecified date in 2012. On 05-AUG-2013 the patient was currently in the office and receiving the second dose of GARDASIL (dose, frequency, route and lot# not reported). No adverse effects reported. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Alopecia
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a female patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL dose 2, (lot number, exp.date not reported). Concomitant therapies included DEPO-PROVERA, dose 150 mg every 3 months. On an unknown date the patient experienced extreme hair loss after receiving the second shot of vaccinated with GARDASIL. The patient sought medical attention and saw the doctor. It was unknown at this time if the patient received the third shot of vaccine. The outcome of event was reported as recovering/resolving. Relatedness between therapy with GARDASIL and event was not reported. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a 72 year old female consumer with high blood pressure, reporting on herself. The patient had no pertinent drug reactions/allergies. On 17-JAN-2012 the patient was vaccinated with ZOSTAVAX (lot number 671452/1124AA, exp. date 12-OCT-2012) (Dose and route were not reported) in the left arm for shingles prevention. Concomitant therapies included hydrochlorothiazide (manufacturer unknown), meloxicam (manufacturer unknown), lisinopril (manufacturer unknown) and levothyroxine sodium (manufacturer unknown). On 22-JUL-2013, patient experienced shingles after received ZOSTAVAX vaccine. Patient was treated with bacitracin ointment (manufacturer unknown) (dosage unspecified), methylprednisolone (manufacturer unknown 4mg/(dosage varies), valaciclovir (manufacturer unknown) 1 gram/Every 8 hours. No lab diagnostics studies were performed. Patient sought medical attention, went to the eye doctor. The outcome of shingles was reported as not recovered/not resolved. The relationship between ZOSTAVAX and the events was not reported. Additional information has been requested.
Age: 38.0
Sex: U
Vaccine: VARCEL
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to a 38 year old patient. On 06-AUG-2013, the patient was vaccinated with an expired dose of 0.5 ml VARIVAX (Merck) (lot number reported as G00758, expiry date 04-AUG-2013, route not reported). Concomitant medications were not reported. No adverse effects reported. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Chest X-ray, Face and mouth X-ray, Fatigue, Hypothyroidism, Influenza like illness
Clinical narrative: This spontaneous report as received from a 60 year old female consumer reporting on herself with no pertinent medical history, drug reactions or allergies. On 19-JUN-2013 the patient was vaccinated with ZOSTAVAX (strength, route and dose were not reported) (lot number not provided) injection for shingles prevention. Concomitant therapies included methotrexate (manufacturer unknown) shot once a week, folic acid (manufacturer unknown) and an unspecified "thyroid pill". Consumer reported that on 20-JUN-2013 "by 24 hours after", receiving ZOSTAVAX, she began to feel sick with "flu-like symptoms." Consumer also had a fever, a respiratory infection, and sinus problems including nasal inflammation. She also said she fainted 2 days after the shot, on 21-JUN-2013. Consumer went to an unspecified clinic "3 times" to seek medical attention (dates unspecified). On her visits, she had tests performed which included a chest x-ray and a sinus x-ray. On an unspecified date in 2013, patient was treated with an unspecified antibiotic shot, a cyanocobalamin B12 shot for "exhaustion" an unspecified oral antibiotic. Consumer also reported that, after receiving ZOSTAVAX, her "thyroid was low" so her physician "had to change her thyroid medicine (unspecified)." The patient is now fully recovered. She recovered on an unspecified date "at least 2 weeks" after receiving ZOSTAVAX, on approximately 03-JUL-2013. The relationship between ZOSTAVAX and the events was not reported. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Nasal inflammation, Pyrexia, Respiratory tract infection, Sinus disorder
Clinical narrative: This spontaneous report as received from a 60 year old female consumer reporting on herself with no pertinent medical history, drug reactions or allergies. On 19-JUN-2013 the patient was vaccinated with ZOSTAVAX (strength, route and dose were not reported) (lot number not provided) injection for shingles prevention. Concomitant therapies included methotrexate (manufacturer unknown) shot once a week, folic acid (manufacturer unknown) and an unspecified "thyroid pill". Consumer reported that on 20-JUN-2013 "by 24 hours after", receiving ZOSTAVAX, she began to feel sick with "flu-like symptoms." Consumer also had a fever, a respiratory infection, and sinus problems including nasal inflammation. She also said she fainted 2 days after the shot, on 21-JUN-2013. Consumer went to an unspecified clinic "3 times" to seek medical attention (dates unspecified). On her visits, she had tests performed which included a chest x-ray and a sinus x-ray. On an unspecified date in 2013, patient was treated with an unspecified antibiotic shot, a cyanocobalamin B12 shot for "exhaustion" an unspecified oral antibiotic. Consumer also reported that, after receiving ZOSTAVAX, her "thyroid was low" so her physician "had to change her thyroid medicine (unspecified)." The patient is now fully recovered. She recovered on an unspecified date "at least 2 weeks" after receiving ZOSTAVAX, on approximately 03-JUL-2013. The relationship between ZOSTAVAX and the events was not reported. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Syncope, Thyroid function test abnormal
Clinical narrative: This spontaneous report as received from a 60 year old female consumer reporting on herself with no pertinent medical history, drug reactions or allergies. On 19-JUN-2013 the patient was vaccinated with ZOSTAVAX (strength, route and dose were not reported) (lot number not provided) injection for shingles prevention. Concomitant therapies included methotrexate (manufacturer unknown) shot once a week, folic acid (manufacturer unknown) and an unspecified "thyroid pill". Consumer reported that on 20-JUN-2013 "by 24 hours after", receiving ZOSTAVAX, she began to feel sick with "flu-like symptoms." Consumer also had a fever, a respiratory infection, and sinus problems including nasal inflammation. She also said she fainted 2 days after the shot, on 21-JUN-2013. Consumer went to an unspecified clinic "3 times" to seek medical attention (dates unspecified). On her visits, she had tests performed which included a chest x-ray and a sinus x-ray. On an unspecified date in 2013, patient was treated with an unspecified antibiotic shot, a cyanocobalamin B12 shot for "exhaustion" an unspecified oral antibiotic. Consumer also reported that, after receiving ZOSTAVAX, her "thyroid was low" so her physician "had to change her thyroid medicine (unspecified)." The patient is now fully recovered. She recovered on an unspecified date "at least 2 weeks" after receiving ZOSTAVAX, on approximately 03-JUL-2013. The relationship between ZOSTAVAX and the events was not reported. Additional information has been requested.
Age: 37.0
Sex: U
Vaccine: HEP, TDAP
Symptoms: Electromyogram normal, Pain in extremity, Paraesthesia, Sensory disturbance, Ulnar neuritis
Clinical narrative: Initially just tingling in fingers but as this went away a new sensation appeared in palm of my left hand. Sensation was sometimes minimal but also at times was rather painful and was felt up into the forearm. Sensation/pain persisted and led me to see my doctor (Jul 26). Hand also X-rayed that same day but no breaks of fractures identified. Referred to neurologist.
Age: 37.0
Sex: U
Vaccine: HEP, TDAP
Symptoms: X-ray limb normal
Clinical narrative: Initially just tingling in fingers but as this went away a new sensation appeared in palm of my left hand. Sensation was sometimes minimal but also at times was rather painful and was felt up into the forearm. Sensation/pain persisted and led me to see my doctor (Jul 26). Hand also X-rayed that same day but no breaks of fractures identified. Referred to neurologist.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received, refers to a 72 year old male patient reporting on himself. On an unknown date the patient was vaccinated with ZOSTAVAX dose, route and lot # not reported. On an unknown date the patient experienced shingles in spite of having received the ZOSTAVAX. Patient stated that he had have already received a vaccine for shingles and there was no booster. The outcome of adverse event was unknown. The relatedness between adverse event and ZOSTAVAX was not reported. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse, concerning a patient of unknown age and gender. Patient's pertinent medical history, drug reactions/allergies were not provided. On 10-APR-2013, the patient received a first dose of GARDASIL, (route, lot number and expiration date were not provided). Co-suspect therapy and concomitant medications were not provided. It was reported that the patient received a second dose of GARDASIL (route, lot number and expiration date were not provided) on 18-JUN-2013, and the third dose of GARDASIL (route, lot number and expiration date were not provided) on 31-JUL-2013. No adverse effects were reported. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Product quality issue, Syringe issue, Underdose
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 71 year old female patient. The patient's medical history included allergy to latex. On an unspecified date the patient was vaccinated with a dose of ZOSTAVAX VIAL 19400 PFU subcutaneously, lot # and dose unspecified. As the reporter pushed the plunger to give the injection, ZOSTAVAX began to leak out of the syringe onto the patient's skin. Reporter stated that he then tightened the needle and administered the remaining volume. On an unknown date the patient experienced a reddened area "the size of a sardine" surrounding her injection site where she received ZOSTAVAX. The reporter stated that he placed a small bandage over her injection site when she received the dose of ZOSTAVAX. The reporter also stated that when he was initially administering the dose of ZOSTAVAX to the patient, she moved slightly causing the slip-tip hub of the needle to dislodge from the syringe tip. He believed that was the reason that some of the solution from the dose was "lost" during the administration procedure. The outcome of the patient was unknown. PQC filed. Reporter stated that the patient would come into the pharmacy to be examined, and if she developed a rash, he would follow the procedure in the VZVIP. VZVIP faxed to the pharmacist. Additional information has been requested.
Age: 14.0
Sex: M
Vaccine: VARCEL, VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from an office manager (clinic manager) refers to a 14 year old male patient. On 24-JUL-2013 the patient inadvertently received 0.65 ml ZOSTAVAX (lot # J001690, expiry date 08-MAY-2013), instead of VARIVAX (Merck), as her first dose of varicella vaccine. No adverse effect reported. The patient did not seek medical attention. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Ovarian cyst
Clinical narrative: This spontaneous report as received from a nurse via a representative refers to a female patient of unknown age. On 25-JUL-2012 the patient was vaccinated with the first dose of GARDASIL (lot # 672232/1495AA, exp date 22-AUG-2014). The nurse reported to representative that the patient developed an ovarian cyst at an unspecified date. The patient saw an unspecified OB/GYN physician. Therapy was reported as discontinued. At the time of the report, the outcome of the event was unknown. Additional information is not expected.
Age: 1.3
Sex: F
Vaccine: VARCEL
Symptoms: Blister, Rash, Varicella post vaccine
Clinical narrative: This spontaneous report as received from a physician via a doctor of pharmacy refers to a 15 month old female patient. On an unknown date in several months ago the patient was vaccinated with a dose of VARIVAX (Merck) (lot #, expiration date and route not reported). On 01-AUG-2013 the patient presented to the physician's office with a rash that the physician suspected was chickenpox and rash had an unusual presentation in that the blisters were not open or crusted over but were still spreading. Treatment was not rendered for the events. It was unspecified whether lab diagnostic studies were performed for the event. The outcome of the reported events were not recovered/not resolved. Causality was not reported. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Dyspnoea, Erythema, Local swelling, Skin warm
Clinical narrative: Pt's left arm became red, swollen and hot to the touch the next day at 1700. Pt went to the ER c/o difficulty breathing. She was given epinephrine Methylprednisolone ranitidine, albuterol, diphenhydramine. Pt was monitored overnight and released the next morning.
Sex: M
Vaccine: FLU3
Symptoms: Foetal exposure during pregnancy, Premature baby
Clinical narrative: This prospective pregnancy case was reported by a healthcare professional and described the occurrence of hospitalization in a male neonate exposed to FLUARIX (GlaxoSmithKline) transplacentally when his mother was treated during pregnancy. On 10 October 2012 the 32 year old mother of the subject received unspecified dose of FLUARIX (unknown) and experienced maternal vaccine exposure. The mother's last menstrual period was on 27 July 2012 and estimated date of delivery was 16 April 2013. The neonate was exposed to FLUARIX at approximately 10 weeks gestation during the first trimester. On 14 February 2013, at 31 weeks gestation, the neonate was delivered prematurely by normal vaginal delivery and weighed 4.75 pounds. The neonate had no apparent congenital anomaly. The neonate experienced hospitalization since the nurse reported that a "(illegible) team here for delivery and assumed care for the infant at the time of birth" and the neonate was transferred to another location "due to being 31 weeks." The nurse did not attribute any problems to the suspect vaccine. The nurse requested that GSK not "send anymore correspondence on this case"; therefore, this case was closed. Please see report A0998075A for details regarding the mother case.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Burning sensation, Pruritus generalised
Clinical narrative: Day of vaccine around 18:00 pt. started experiencing itching/burning sensation over whole body. Pt. described as "stinging". Pt. developed pin head size dots on body, received BENADRYL at 19:00.
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Infection, Pain, Rash erythematous, Skin warm, Swelling
Clinical narrative: TDAP ADMINISTERED 1 AUG. ON 6 AUGUST, PT NOTICED 2 RED SPOTS ON ARM ABOUT 4 INCHES APART FROM INJECTION SITE. THE NEXT DAY (7 AUG), SWELLING, SPOTS WERE WARM TO THE TOUCH, AND PAIN NOTICED. PT AND HUSBAND WENT TO URGENT CARE ON 7 AUGUST 2013 PER RECOMMENDATIONS FROM IMMUNIZATIONS CLINIC. PT PRESCRIBED ANTIBIOTIC TO AID IN INFECTION.
Sex: F
Vaccine: HEP
Symptoms: Blood test, Convulsion, Eczema, Electroencephalogram, Nuclear magnetic resonance imaging
Clinical narrative: She developed severe eczema and on 10/05/2008 she had convulsions. She may had convulsions before but they went unnoticed.
Age: 18.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Dizziness, Hyperhidrosis, Pallor, Syncope
Clinical narrative: Patient became dizzy, pale, diaphoretic, and fainted.
Age: 12.0
Sex: M
Vaccine: HEPA, HPV4, MNQ, TDAP, VARCEL
Symptoms: Dizziness, Hyperhidrosis, Pallor, Syncope
Clinical narrative: Patient became pale, dizzy, and diaphoretic after receiving vaccines.  Patient fainted.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Erythema, Skin warm
Clinical narrative: Reported a large red warm area to right deltoid measuring 3 in by 3 in.
Age: 14.0
Sex: M
Vaccine: MNQ, VARZOS
Symptoms: Injection site rash
Clinical narrative: Pt c/o rash at site.
Age: 16.0
Sex: M
Vaccine: TDAP
Symptoms: Head injury, Laceration, Loss of consciousness, Syncope
Clinical narrative: Pt was leaving the clinic walking out of store, his stepdad asked him "how was the shot" and pt immediately passed out. Was unconscious for just seconds, VS were stable, EMS was called and pt hit his head on the side of a metal shelf. Stepmother then admitted pt has history of extreme sensitivity to any medical procedures. He once threw up from an eye exam. They did not want to tell me before his shot as his father died 2 weeks before and "we didn't want any drama". I asked that in the future, they inform any provider of the possibility of his reaction to shots. He did require surgical glue at the local ER to close the 2 inch laceration above his right eye. No signs of head injury. No reaction at site of injection. Called 2 days later and was told by stepmother he was having no issues at all.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: When Pt woke up today he was having a low grade fever. Said his arm was sore. Mother looked at the arms and noticed that the right arm was swollen. She measured them there is a 1/2 in difference between the left and right arm. Pt temp was 101.0 at that time. Mother is giving Tylenol and Motrin for the fever. She is to watch the area and use cool compress.
Age: 25.0
Sex: M
Vaccine: ANTH, TYP
Symptoms: Balance disorder, Nausea, Visual impairment
Clinical narrative: Nausea, coning down of vision, loss of balance.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Dizziness
Clinical narrative: Patient received vaccinations and felt lightheaded he explained. Patient laid down on exam table BP 102/62. Patient had to lay down for 15-20 minutes and he felt good enough to sit up BP 106/52. Patient stated he felt he could stand up BP 102/55. Someone walked patient to car.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Neck pain
Clinical narrative: Neck pain.
Age: 1.28
Sex: F
Vaccine: DTAPIPVHIB, HEP
Symptoms: Pyrexia, Rash, Urticaria
Clinical narrative: Patient received on 6/17/13 PENTACEL (R) arm Hep B (L) arm, she developed a rash the next day on face then progressed w/ welts to arms and legs w/ fever 103.
Age: 1.05
Sex: M
Vaccine: HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Blister, Decreased appetite, Injection site erythema, Injection site swelling, Injection site vesicles
Clinical narrative: Report of swelling / redness with warmth to (Rt) thigh within 2 hours or less of receiving immunizations on 07/23/13. Area gradually within 48 hours returned to "normal". Ct. with increased fussiness, decreased appetite and low grade fever. 08-08-13 fluid filled vesicles in linear pattern on (R) thigh/forehead/face.
Age: 1.05
Sex: M
Vaccine: HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Irritability, Pyrexia
Clinical narrative: Report of swelling / redness with warmth to (Rt) thigh within 2 hours or less of receiving immunizations on 07/23/13. Area gradually within 48 hours returned to "normal". Ct. with increased fussiness, decreased appetite and low grade fever. 08-08-13 fluid filled vesicles in linear pattern on (R) thigh/forehead/face.
Age: 7.0
Sex: M
Vaccine: MNQ, PPV
Symptoms: Oedema peripheral, Pain in extremity
Clinical narrative: Lt arm swelling and painful.
Age: 1.03
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Polymerase chain reaction, Varicella post vaccine, Varicella virus test positive
Clinical narrative: Diagnosed with varicella 17 days after receiving varicella vaccine.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema
Clinical narrative: 5 cm area of erythema at injection site.
Age: 2.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Pruritus, Rash generalised
Clinical narrative: Rash, redness axillary, thighs, face, torso, soles of feet, palms of hands, inside of ears, itching ? Allergic reaction, doesn't look like varicella or measles. Denies any hx of anything new. Non toxic, looks happy, no other symptoms besides rash. Went to ER.
Age: 3.0
Sex: M
Vaccine: HEPA
Symptoms: Urticaria
Clinical narrative: Within 2 hours of vaccine administration, developed several hives around left arm and armpit no local reaction at injection site. No other symptoms. Rash went away after approx 2 hrs post x 1 dose (p.o.) of BENADRYL Pt w/ Hx of strawberry (past) and cat allergy.
Sex: M
Vaccine: MMR
Symptoms: Injection site pain, Underdose
Clinical narrative: This spontaneous report as received from registered nurse refers to a male, child patient (age not further specified). Information on medical history was not reported. On 24-JUL-2013 the patient was vaccinated with M-M-R II (lot # not reported) injection shot, 0.5 ml (dose number, route, indication not reported). The nurse stated that as she was giving injection of M-M-R II to a patient, the patient flicked his arm and very last drops of injection shot out of needle and landed on patient's mom's forehead. It was also reported that patient probably moved the arm due to some pain or stinging. The outcome of the events was unknown. The reporter did not assessed the relationship between the therapy with M-M-R II and the adverse events. Product Quality Compliant (PQC) was not involved. This is one of the reports from the same source. Additional information has been requested.