chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Parakeratosis, Rash generalised, Skin discolouration, Skin oedema, Urine analysis normal
Clinical narrative: I received the pneumococcal PPV23 Merck & Co. Lot number 0556AE .5 mL VIS version 10/6/09 at the clinic on 10/16/2012. By that evening I was experiencing redness, soreness around the injection sight, headache, nausea but did not have a fever. By the next day there was a 4 inch circular raised rash at the sight and a very swollen and extremely tender lump 1 1/2 inch around anterior to the injection site. I still had the headache, nausea, and some diarrhea. I went back to the shot clinic and a doctor looked at it quickly but said the shot may have hit a lymph node and not to worry. After about the 3rd day the lump and tenderness as well as the headache had subsided. The rash, however, remained for a few more days. I had noticed some roughness on my upper back but couldn't see much. On October 29 after showering I noticed probably 20 purple oval/irregular spots on each of my lower legs. I am IN REMISSION for Wegener's Granulomatosis -6 months oral CYTOXAN and prednisone ending in Feb 2010- and knew the disease could show up on skin or in my lungs. Oct 30 In went to a local Emergi-Care and the doctor drew some bloodwork/urine sample and looked online and felt the purple spots looked like vasculitis photo and showed to me. She called my immunologist. He wanted the lab results. We were leaving town the next morning for 12 days but my doctor felt I could go. The labs came back negative over the following 12 day the rash spread to my stomach, upper and lower back, thighs and arms, and chest. During that time my immunologist was monitoring my rash via photos I had emailed. He recommended skin biopsies using immunofluorescence staining. I went to a dermatologist for the biopsies. He took three and they all came back Lichenoid Dermatitis. My immunologist felt that this indicated the rash was from a drug interaction or from the vaccine. Since there had been no changes to my medications that left the pneumococcal vaccine as the likely cause. I had bloodwork/urine sample repeated on my return Nov. 13, 2012 and they were ruling out the Wegeners.
Age: 38.0
Sex: M
Vaccine: PPV
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: Vaccination of PNEUMOVAX 23 which caused swelling at the right cervical and right axillary lymph node causing enlargement/pain - adjacent to site of injections: right deltoid.
Age: 64.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Infection, Injected limb mobility decreased, Oedema peripheral, Pain in extremity
Clinical narrative: Patient developed cellulitis following pneumococcal vaccination injection. Right arm became red, swollen and very painful. Patient states, it appears infected and I can barely move arm.
Age: 44.0
Sex: U
Vaccine: RAB
Symptoms: Dizziness, Headache, Syncope
Clinical narrative: I have been having severe headaches; dizziness since starting Rabies Vax, had to get pain medicine from urgent care due to extreme pain in head, then had a fainting spell on 19th in parking lot of a business, had to sit for over an hour before could drive. Luckily I was not driving at the time.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a physician's assistant refers to a patient of unknown age. The patient was vaccinated with her first two doses of GARDASIL (Lot # not reported) "a few years ago" and received her third dose of GARDASIL (Lot # not reported) on 19-DEC-2012. No other co-suspects were reported. No concomitant medications were reported. No adverse effect was reported. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling
Clinical narrative: Pt. had localized swelling at site.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site nodule, Injection site swelling, Injection site warmth
Clinical narrative: Pt. started with small knot at injection site day after vaccine given - 2 days later with redness, swelling, warm to touch- treated with KEFLEX 500mg BID x 10d, prednisone 10 mg BID x 3d.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Herpes zoster
Clinical narrative: Diagnosis of shingles was made 12-20-12 at Medical Center ER.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Infection
Clinical narrative: ZOSTAVAX given on 12/15/12. Patient reports infection and cellulitis was given antibiotics.
Age: 71.0
Sex: M
Vaccine: PPV
Symptoms: Blood pressure increased, Chest discomfort, Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Itching at site - then redness - hot to touch and chest discomfort. Elevated blood pressure. Pt. given 50mg oral BENADRYL and transported to hospital ER via ambulance.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Eye swelling, Oropharyngeal pain, Pharyngeal oedema, Urticaria
Clinical narrative: 12/21/12 Started developing welts bilaterally. 12/25/12 - Eyes became swollen - throat became swollen and sore - used gargle to relieve symptoms. Took Certerazine 10mg - Primary MD did not see patient.
Age: 5.0
Sex: M
Vaccine: FLU3, HEPA
Symptoms: Blood glucose normal, C-reactive protein increased, Oedema peripheral, Urine analysis normal, Urine ketone body present
Clinical narrative: Patient was seen for routine well child visit on 12/6/12. Hepatitis A#1 and Influenza vaccines were given. Patient presented to emergency room on 12/9/12 with urticaria on trunk, arms and legs. He also had swelling of hands & legs. Treated with prednisolone, BENADRYL & cetirizine. Symptoms resolved by 12/13/12. No respiratory symptoms.
Age: 5.0
Sex: M
Vaccine: FLU3, HEPA
Symptoms: Urticaria
Clinical narrative: Patient was seen for routine well child visit on 12/6/12. Hepatitis A#1 and Influenza vaccines were given. Patient presented to emergency room on 12/9/12 with urticaria on trunk, arms and legs. He also had swelling of hands & legs. Treated with prednisolone, BENADRYL & cetirizine. Symptoms resolved by 12/13/12. No respiratory symptoms.
Sex: F
Vaccine: FLU3, PPV
Symptoms: Drug administered at inappropriate site, Injection site pain, Musculoskeletal pain
Clinical narrative: This spontaneous report was received from a pharmacist refers to a female patient of unknown age who in October 2012 was vaccinated intramuscularly with a 0.5 ml dose of both AFLURIA and PNEUMOVAX23 in the same arm (in an unspecified arm) during the same visit. No concomitant medications were reported. The patient developed injection site pain and shoulder pain (October 2012). The patient recovered two weeks later. The patient sought medical attention (she called the pharmacist). The relatedness for the events and PNEUMOVAX23 and AFLURIA was unknown. Additional information has been requested.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Ear pain, Eyelid disorder, Eyelid function disorder, Neck pain, Rhinorrhoea
Clinical narrative: Bells Palsy symptoms appeared the day after the vaccine: Patient could not close her left eye, had a runny nose in her left nostril and felt aches in her left ear and the left side of her neck. The patient visited her physician who started her on Prednisone 20 mg for 10 days on Saturday, December 22. She will begin physical therapy Monday, December 31.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: VIIth nerve paralysis
Clinical narrative: Bells Palsy symptoms appeared the day after the vaccine: Patient could not close her left eye, had a runny nose in her left nostril and felt aches in her left ear and the left side of her neck. The patient visited her physician who started her on Prednisone 20 mg for 10 days on Saturday, December 22. She will begin physical therapy Monday, December 31.
Age: 60.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Patient returned to pharmacy on 12/22/12. Red spot at site of ZOSTAVAX injection & warm to the touch. (Area bout 6 inch in diameter). Patient referred to ER where she was treated with antibiotics.
Age: 61.0
Sex: M
Vaccine: TDAP
Symptoms: Asthenia, Diarrhoea, Dizziness, Dysstasia, Meningitis aseptic
Clinical narrative: Weak, barely able to stand, diarrhea, nausea and vomiting, dizzy.  Infectious disease specialist diagnosed him with aseptic meningitis related to the vaccine.  He was NOT hosptialized.
Age: 61.0
Sex: M
Vaccine: TDAP
Symptoms: Nausea, Vomiting
Clinical narrative: Weak, barely able to stand, diarrhea, nausea and vomiting, dizzy.  Infectious disease specialist diagnosed him with aseptic meningitis related to the vaccine.  He was NOT hosptialized.
Age: 74.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site haematoma, Injection site haemorrhage, Injection site reaction, Myalgia
Clinical narrative: Bleeding, myalgia & large bruise covering most of upper right arm.
Age: 48.0
Sex: M
Vaccine: TDAP
Symptoms: Rash
Clinical narrative: Rash of trunk (chest and Back) and "small area of groin".
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site nodule, Injection site pruritus, Myalgia
Clinical narrative: Large knot and itching at injection site with red spot the size of an eraser. There is also muscle pain with movment of arm.
Age: 58.0
Sex: F
Vaccine: FLU3, UNK
Symptoms: Antibody test, Arthralgia, Headache, Oedema peripheral
Clinical narrative: WOKE UP WITH HEADACHE ND GENERALIZED JOINT PAIN & MILD SWELLING TO HANDS. TOOK ALEVE FOR RELIEF.
Age: 4.0
Sex: F
Vaccine: DTAPIPVHIB, MMR
Symptoms: Abdominal pain upper, Malaise, Nausea, Vomiting
Clinical narrative: Stomach ache 8:00 pm. 7:30 am nausea, vomiting, general malaise continued 'til 10:30 am.
Age: 2.0
Sex: F
Vaccine: FLU3
Symptoms: Tic
Clinical narrative: EXPERIENCING TICS (BELOW CHEEKS) AFTER 2 HRS FROM THE FLU SHOT WITH PRESERVATIVE. THIS IS THE FIRST TIME SHE IS GETTING FLU SHOT WITH PRESERVATIVE. LAST YEAR SHE HAD FLU SHOT WITHOUT PRESERVATIVE.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: Started to develop rash around the neck and bottom of neck top of chest area small area.  Raised almost like hives.  We contacted the doctors office.  The primary physician was not avaible but the partner was at the office.  I spoke with her.  The doctor stated give Benadryl.  The patient bought liquid Benadryl and took it.  The patients wife was going to drive home and if things progressed worse then she was going to take him to Hospital.  The doctor stated her main concern is respiratory problems.  The rash was not expanding.  Nothing else was swelling up.  He was not complaining of hard time breathing.  Everyone one was in agreement to the suggestion that the wife made. We have not heard anything.
Age: 29.0
Sex: F
Vaccine: FLUX
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Three days after shot, it was still sore as can be, could not lift arm, nothing helped with the pain, stretching, Tylenol, heating pad, icy-hot, you name it, it didn't work. Now over five weeks later, its still the same song and dance.
Age: 58.0
Sex: F
Vaccine: FLUX
Symptoms: Activities of daily living impaired, Hypersensitivity, Hypertension, Injection site nerve damage, Injection site pain
Clinical narrative: Severe pain in left arm at injection site, with pain radiating down left arm, tingling in fingers, also radiating up into shoulder and neck up to base of skull. Arm seems swollen and tender to touch. Severe debilitating pain disturbs my sleep as well as my normal daily activities including work. Went to my doctor after 14 days of pain that continued to get worse. He agreed it was from the flu shot and thought that it could be some kind of an allergic reaction or nerve damage from the needle. Also my blood pressure was sky high. 180 over 100. Very unusual for me since I always read low, usually around 120 over 70. He prescribed to me a prescription of prednisone for 12 days. He also put me on a blood pressure pill. Today is the 2nd day and there a very slight decrease in pain.
Age: 58.0
Sex: F
Vaccine: FLUX
Symptoms: Oedema peripheral, Pain in extremity, Paraesthesia, Sleep disorder, Tenderness
Clinical narrative: Severe pain in left arm at injection site, with pain radiating down left arm, tingling in fingers, also radiating up into shoulder and neck up to base of skull. Arm seems swollen and tender to touch. Severe debilitating pain disturbs my sleep as well as my normal daily activities including work. Went to my doctor after 14 days of pain that continued to get worse. He agreed it was from the flu shot and thought that it could be some kind of an allergic reaction or nerve damage from the needle. Also my blood pressure was sky high. 180 over 100. Very unusual for me since I always read low, usually around 120 over 70. He prescribed to me a prescription of prednisone for 12 days. He also put me on a blood pressure pill. Today is the 2nd day and there a very slight decrease in pain.
Age: 15.0
Sex: M
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a 15 years old male patient with medical history and drug allergies not reported, who on 18-JUL-2012, was vaccinated with first GARDASIL (lot #, dose and route not provided). On 22-SEP-2012, was vaccinated with second GARDASIL (lot #, dose and route not provided). On 12-DEC-2012, was vaccinated with third GARDASIL (lot #, dose and route not provided). No other co-suspects were reported. No concomitant medications were reported. The physician reported that there not was and adverse effect. No further information is available. Additional information has been requested.
Age: 1.04
Sex: F
Vaccine: DTAP, HEPA, MMR, PER, VARCEL
Symptoms: Pyrexia, Respiratory tract infection viral
Clinical narrative: Fever 101.5 for about an hour after given Pedia Care.
Age: 32.0
Sex: M
Vaccine: FLU3
Symptoms: Pruritus, Urticaria
Clinical narrative: Urticaria Pruritus. Diphenhydramine 25 mg QID.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes ophthalmic, Ocular hyperaemia, Oral herpes
Clinical narrative: Client reported on 12/27/12 that after having ZOSTAVAX on 4/16/12 within 1 month 5/12 her (R) eye got red - she went to MD and was told it was herpes and may have been brought on by having had ZOSTAVAX IZ - she was treated with eye drop antbx and it resolved in approx 4 days. States she also had large cold sore on lip 12/1/12. Tx'd with ABBREVA - stated she has never had a cold sore in past - cleared up in several days.
Age: 50.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain, Pain
Clinical narrative: Onset of pain (L) deltoid at site of Flu immun., has continued and worsened, and spreading. Related to moving shoulder - worsening.
Age: 49.0
Sex: M
Vaccine: TDAP
Symptoms: Erythema, Feeling hot, Local swelling, Localised oedema, Pain
Clinical narrative: Adverse reaction to Tdap vaccine (local) (marked pain; swelling and warmth and erythema).
Age: 36.0
Sex: F
Vaccine: TDAP
Symptoms: Antibody test negative, Pertussis
Clinical narrative: On 11/8/2012 pt. called to report that despite Tdap in April given postpartum she was diagnosed with pertussis & lab work reveals no immunity. She and her 7 month old child on antibiotics. Vaccine given on 4/4/12 Lot #AC52B078BA Glaxo Exp. date 11/25/13.
Age: 1.27
Sex: M
Vaccine: MMR
Symptoms: Rash morbilliform
Clinical narrative: Measle like rash on torso. KENALOG 0.1% BID hydrocortisone 2.5% BID.
Age: 3.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Upper arm swelling and erythema after second half of flu vaccine (FLUZONE).
Age: 60.0
Sex: M
Vaccine: VARCEL, VARZOS
Symptoms: Pruritus, Rash
Clinical narrative: 12/11/12 - Wife reports pt. itching but BENADRYL helped. Talked with pt. - described as mosquito type bumps that come up randomly on body not just local at injection. Tx with BENADRYL. 12/13/12 Still same; contacted CDC ; prolonged reaction. 12/27/12 Reply from CDC.
Age: 11.0
Sex: M
Vaccine: FLUN3, MNQ, TDAP
Symptoms: Blepharospasm, Dyskinesia, Syncope
Clinical narrative: Patient developed brief faintng spell, eye twitching, arm jerking within 5-15 minutes of administration of vaccine.  BP before administration 109/65; after fainting 97/58; after 15 minutes of resting 112/78.
Age: 14.0
Sex: F
Vaccine: FLUX, HPV4
Symptoms: Hypoaesthesia, Pain in extremity
Clinical narrative: Foot numbness. Upper leg pain.
Age: 45.0
Sex: M
Vaccine: FLUX
Symptoms: Injected limb mobility decreased, Injection site pain, Periarthritis
Clinical narrative: Frozen shoulder, lack of mobility in left arm... can't stretch it over my head any more... when stretching, pain radiates through shoulder and down to my elbow and lasts several minutes.
Age: 73.0
Sex: M
Vaccine: FLU3
Symptoms: Blood test, Computerised tomogram, Confusional state, Disorientation, Encephalitis
Clinical narrative: Flu-like symptoms at onset. By 12/20, disorientation & confusion. Went to emergency room, suspecting stroke. After 2 hrs, ER said no stroke, but admitted to ICU to continue tests. That is last I remember - until early AM 12/24. In interim was conscious but non-responsive and apparently in acute distress and unable to bear any sensory stimulation. Diagnosis: Encephalitis of unknown origin.
Age: 73.0
Sex: M
Vaccine: FLU3
Symptoms: Influenza like illness, Intensive care, Lumbar puncture, Nuclear magnetic resonance imaging, Sensory disturbance
Clinical narrative: Flu-like symptoms at onset. By 12/20, disorientation & confusion. Went to emergency room, suspecting stroke. After 2 hrs, ER said no stroke, but admitted to ICU to continue tests. That is last I remember - until early AM 12/24. In interim was conscious but non-responsive and apparently in acute distress and unable to bear any sensory stimulation. Diagnosis: Encephalitis of unknown origin.
Age: 73.0
Sex: M
Vaccine: FLU3
Symptoms: Unresponsive to stimuli, Urine analysis
Clinical narrative: Flu-like symptoms at onset. By 12/20, disorientation & confusion. Went to emergency room, suspecting stroke. After 2 hrs, ER said no stroke, but admitted to ICU to continue tests. That is last I remember - until early AM 12/24. In interim was conscious but non-responsive and apparently in acute distress and unable to bear any sensory stimulation. Diagnosis: Encephalitis of unknown origin.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Biopsy peripheral nerve, Biopsy skin, Blood test, Burning sensation
Clinical narrative: Weakness, muscle twitches, fatigue, muscle cramps, numbness, burning and tingling sensations.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Diagnostic procedure, Electromyogram, Fatigue, Hypoaesthesia, Muscle spasms
Clinical narrative: Weakness, muscle twitches, fatigue, muscle cramps, numbness, burning and tingling sensations.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Muscle twitching, Nuclear magnetic resonance imaging, Paraesthesia
Clinical narrative: Weakness, muscle twitches, fatigue, muscle cramps, numbness, burning and tingling sensations.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Pruritus, Rash, Reaction to preservatives, Skin warm
Clinical narrative: 11 y.o. F with rashes of bilateral deltoids, pruritic, warm to touch. Dx: Prob reaction to vaccine preservatives.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Musculoskeletal stiffness, Oedema peripheral, Ultrasound scan abnormal
Clinical narrative: PPV23 0.5 ml IM given in deltoid - 11/3/12 pt called to report redness & swelling & stiffness in the arm shoulder to wrist - instructed to use cold compresses and Ibuprofen - resolved 2-3 days
Age: 1.17
Sex: M
Vaccine: DTAP, HEPA, MMR, VARCEL
Symptoms: Body temperature increased, Injection site erythema, Injection site rash, Rash vesicular
Clinical narrative: Beginning the morning of 12/17/12, mother noticed a reddened raised area (approx 1 inch in diameter) at the injection site. "chicken pox-like" lesions noted on face, ear, and torso. The client was also running a temperature (101F) on 12/1712 & 12/18/12.
Age: 28.0
Sex: F
Vaccine: PPV
Symptoms: Crying, Injection site erythema, Injection site macule, Injection site pain, Nausea
Clinical narrative: Day 1: About 5 hours after receiving a pneumonia vaccine, I woke up with excruciating pain in the injection site- left arm-. Any form of movement sent a wave of nausea over me. I could not move the arm without screaming or crying. Taking Ibuprofen was the only thing that brought a form of relief. Had to miss a whole day of work. Day 2: Arm not nearly as sore, but skin around the injection site is red and splotchy, the skin is hot to the touch, and there seem to be lumps under the skin. Day 3: Pain nearly gone in the arm, but redness has grown worse and arm is still hot to touch.
Age: 28.0
Sex: F
Vaccine: PPV
Symptoms: Screaming, Skin warm
Clinical narrative: Day 1: About 5 hours after receiving a pneumonia vaccine, I woke up with excruciating pain in the injection site- left arm-. Any form of movement sent a wave of nausea over me. I could not move the arm without screaming or crying. Taking Ibuprofen was the only thing that brought a form of relief. Had to miss a whole day of work. Day 2: Arm not nearly as sore, but skin around the injection site is red and splotchy, the skin is hot to the touch, and there seem to be lumps under the skin. Day 3: Pain nearly gone in the arm, but redness has grown worse and arm is still hot to touch.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: The patient received ZOSTAVAX injection on 11/26/12 by 12/1/12 patient began to have symptoms of facial zoster by 12/6/12 this included the right side of her face affecting all 3 trigeminal nerve branches with possible ocular and otic involvement.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Blister, Erythema, Inflammation, Oedema peripheral, Skin warm
Clinical narrative: Forty eight hours after KINRIX injection was given in upper right arm, patient's arm swelled at shoulder. Covered 1/2 of upper arm between elbow and shoulder. Very red and inflamed. Very hot to touch. Felt like a giant blister according to MOC. Saw doctor. Improved in 24 hr with BENADRYL. Now gone completely.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Severe redness / swelling at site. Very painful. Patient contacted her physician & MD stated probably hit a bld vessel. Pt being treated with prednisone.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus
Clinical narrative: Customer returned to pharmacy a few minutes after administration and stated the underside of her arm was itching. Had her remove her shirt to examine - did not seem red, no irritation at administration site. Advised to take 25mg of diphenhydramine. Was ok after that.
Age: 74.0
Sex: M
Vaccine: FLUX
Symptoms: Oedema peripheral, Urticaria
Clinical narrative: Welts and hand swelling. Diphenhydramine 25 mg QID PO.
Age: 59.0
Sex: M
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, Off label use, Syncope
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 60 years old male patient with a history of depression and allergy to sulfur, SSRI (selective serotonin re-uptake inhibitors) drug class and gluten. In September 2012, the patient was administered a first dose of GARDASIL intramuscularly dose 0.5 ml and the second dose of GARDASIL intramuscularly dose 0.5 ml (lot # 0101AE, expiration 10-OCT-2012) was given on 05-OCT-2012 for the treatment of warts. Other co-suspects were not reported. Concomitant medications were reported as none. It was reported that the patient stated that 6 to 7 days (approximately 11-OCT-2012) after receiving the second dose of GARDASIL, the patient experienced 3 fainting episodes. No treatment information was reported. Lab diagnostic studies performed were reported as none. On an unknown date in 2012, the patient was recovered from 3 fainting episodes. The relatedness of 3 fainting episodes was unknown for GARDASIL. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: Initial information has been received from a registered nurse concerning a patient with an unspecified age, gender, pertinent medical history or drug reactions/allergies, who, on an unspecified date, received CERVARIX as the first dose of the HPV vaccination series. On 19-DEC-2012, the patient was in the office, and was vaccinated with the second dose of GARDASIL (dose, indication, route and lot number were not reported). No other co-suspects were reported. No concomitant medications were reported. No adverse effect was reported. No treatment information was reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender with an medical history and drug allergies not reported who on 18-DEC-2012, was vaccinated with GARDASIL (Lot #, dose and route not provided). No other co-suspects were reported. No concomitant medications were reported. The medical assistant stated that on 18-DEC-2012, a patient may have been administered an incomplete dose of GARDASIL due to possible syringe leakage during administration. No adverse effect reported. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to a patient of unknown age who on 20-DEC-2012 (today) was vaccinated with a dose of GARDASIL (dose, route and lot # not reported) that was exposed to 30 degrees F. No other co-suspects were reported. No concomitant medications were reported. No adverse effect reported. Patient's outcome was unknown. The relatedness between the event and GARDASIL 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 as received from a Licensed Vocational Nurse refers to a patient of unknown age and gender with a medical history and drug allergies not reported, who on 15-NOV-2012, was vaccinated with dose 1 GARDASIL (lot #, dose and route not provided). On 21-DEC-2012, was vaccinated with dose 2 GARDASIL (lot #, dose and route not provided). No other co-suspects were reported. No concomitant medications were reported. The nurse, reported there not was adverse symptoms. Additional information has been requested.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Axillary pain, Injection site haematoma, Lymphadenitis, Skin reaction
Clinical narrative: Pt called into the pharmacy complaining of bruising on (L) deltoid after receiving the flu vaccine on 12-6-12. She complains that armpit was sore the next day and the following day it was swelled up all localized around the armpit.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Rash
Clinical narrative: Employee received flu vaccination on 10-31-12. On 11-2-12 she developed a rash with pruritus without respiratory symptoms. With the use of CLARITIN the symptoms resolved. Novartis FLUVIRIN Lot: 123203 Exp: 06/2013.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Hyperaesthesia, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: This spontaneous report as received from a registered nurse refers to her husband who was the 56 years old male patient with high cholesterol. The patient was vaccinated with a dose of ZOSTAVAX on the left deltoid on 03-DEC-2012. No other co-suspects were reported. Concomitant medications included: LIPITOR. His past drug history included heaviness when he had the flu vaccine. On 04-DEC-2012 the patient experienced redness, itching and swelling to baseball size at the injection site. About 2 days later (on approximately 06-DEC-2012), the redness and size resolved and itching resolved after five days later (on approximately 09-DEC-2012). On 09-DEC-2012 the patient started to have nerve sensation on his right clavicle that bothered him only when clothes touched the area. He saw his physician on an unknown date in December 2012 who stated that he nerve irritation and might or might not be related to ZOSTAVAX. No labs were performed. As of 17-DEC-2012 he did not plan to have any more ZOSTAVAX and he continued to nerve sensation on his clavicle that bothered him only when clothes touched the area. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant who administered vaccines refers to a patient of unknown age (gender unspecified). On 08-NOV-2012, the patient was vaccinated with a dose of ZOSTAVAX, (lot number, expiration date and route not provided) that was stored in the fridge at 6 degree celsius for 3 weeks (504 hours) and it was not a supported excursion. No concomitant medications were reported. The patient was not experiencing any known symptoms. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Alopecia
Clinical narrative: This spontaneous report as received from a consumer mother refers to a 15 year old female patient with no pertinent history or drug reactions/allergies who about a month and a half ago (approximately in November 2012) was vaccinated with GARDASIL (product circular: 9883616). No other co-suspects were reported. No concomitant medications were reported. Within the month (approximately in December 2012), the patient started drastically losing her hair. The patient's mother consulted the physician and subsequently scheduled appointments with a specialist (unspecified) to determine a diagnosis. At the time of reporting, the patient's condition has not improved. The relatedness for the event was unknown for GARDASIL. Additional information has been requested
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Blister, Varicella post vaccine
Clinical narrative: This spontaneous report as received from a consumer concerning his 4 years old female daughter who on an unspecified date was vaccinated with (Merck) VARIVAX (dose, route and lot # not provided). No other co-suspects were reported. No concomitant medications were reported. The consumer stated that his daughter on an unknown date had unusual side effects after her immunization with (Merck) VARIVAX follow up and shot and now had a mild case of chicken pox. However, she was still turning up new spots on her back and waist even though her first blisters showed up roughly 2.5 weeks ago. Her symptoms otherwise have been mild, roughly 20-30 spots in all. No treatment information was reported. The outcome of the events mentioned above was unknown. The relatedness for the events was unknown for (Merck) VARIVAX. Additional information has been requested.
Sex: M
Vaccine: VARCEL
Symptoms: Rash, Secondary transmission
Clinical narrative: It was reported in a published article, that a healthy adult male patient's child was vaccinated with a dose of VARIVAX (Merck) (dose #, lot # and route of administration not reported). Subsequently, the father developed a rash caused by vaccine-strain VZV after exposure to his 12 month old child. It was also reported that the 12 month old child developed disseminated VARIVAX (Merck) (MARRS # 0803USA04453). The article also discussed the experiences of two other patients after vaccination with VARIVAX (Merck) (MARRS numbers 0803USA04454 and 0803USA04484). Follow up information has been received: Information has been received from a healthcare professional. the author of the published article. It stated that the most frequently reported adverse reaction to vaccination is a mild rash that appears several weeks later in about 5 percent of healthy children, particularly after a first vaccine dose. Extensive rashes, with occasional pneumonia or neurologic symptoms have been reported rarely in immunocompromised children who were inadvertently vaccinated, such as those with undiagnosed AIDS, natural killer (NK) cell deficiency, and other immunodeficiency diseases. The author states that there is a potential for transmission of the vaccine virus if vaccines develop rash from the Oka strain, but transmission is extremely rare from healthy individuals; fewer than 10 instances of transmission have been reported since 1995, during which time as many as 60 million children were vaccinated. Additional information is not expected.
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Hyperhidrosis, Oedema peripheral, Pyrexia
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a 62 years old female patient. Patient received a dose of PNEUMOVAX23 (0.5 mL, subcutaneous in her left arm, Lot# reported as H018441, exp 28-FEB-2014) on 13-DEC-2012, and she called the practice the next day, 14-DEC-2012, reporting that she was experiencing left arm swelling, fever, and sweats. She had received a dose of PNEUMOVAX23 (Lot#, dose, route unspecified). in "November 2011." She was diagnosed as having cellulitis in her left arm and prescribed KEFLEX by the physician on-call over the weekend and she had now recovering from the events. The reporting nurse would like to request a lot check for this lot of PNEUMOVAX23, lot # H018441, exp 28-FEB-2014. This was one of several reports that received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B surface antibody negative
Clinical narrative: This spontaneous report as received from a physician refers to a couple of nurses of unknown age and sex. The physician reported that he had heard from a couple of nurses that they had completed the vaccination with RECOMBIVAX HB (lot#, expiration date and route not reported). On an unknown date, as a child. As they entered the nursing school they had their titers checked on an unspecified date and were found that the hepatitis B titer was low and they had to be re-vaccinated. No concomitant medications were reported. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B surface antibody negative, Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report was received from a 21 years old female Medical assistant reporting on herself who received all 3 doses of RECOMBIVAX HB intramuscularly between about "1993 and 1996". No other co-suspects were reported. No concomitant medications were reported. On 26-NOV-2012, a surface antibody test was performed that returned negative results for immunity to hepatitis B virus. The patient's present status was unchanged since 26-NOV-2012. No treatment was given. The relatedness for negative results to immunity to hepatitis b virus was unknown for RECOMBIVAX HB. Additional information has been requested.
Age: 0.9
Sex: U
Vaccine: HEP
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 9 months old patient of unknown gender who on 19-DEC-2012, was vaccinated with the first dose of RECOMBIVAX HB 0.5 ml intramuscularly in right thigh (lot # not reported) which expired sometime in September 2012. Nurse did not have exact expiration date. Child was not experiencing any adverse effects at that time. Additional information is not expected.
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: This spontaneous report as received from a consumer refers to herself, a female patient of unknown age. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (lot number unspecified). Route was not reported. No other co-suspects were reported. No concomitant medications were reported. On 13-Dec-2012 the patient experienced sore arm. No treatment information was reported. The outcome of sore arm was unknown. Additional information is not expected.
Age: 48.0
Sex: M
Vaccine: VARZOS
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from an unspecified reporter via TELERX refers to a 48 years old male patient, who was vaccinated with a dose of ZOSTAVAX (lot# and dose not reported) on 09-NOV-2012. No side effects were reported. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 62 years old female patient with no pertinent medical history and no drug reactions or allergies. On 18-DEC-2012 the patient was vaccinated subcutaneously with 1 vial of ZOSTAVAX (lot # reported as H019036, exp. Date: 14-JAN-2017). There were no concomitant medications taken. On 19-DEC-2012 the patient developed redness, swelling, and itchiness at the injection site after receiving a dose of ZOSTAVAX. Therapies with BENADRYL and ADVIL were given as treatment for the events. No lab diagnostic studies were performed. The patient sought medical attention through seeing the pharmacist. The outcome of events was reported as recovering. Additional information is not expected.
Age: 0.17
Sex: M
Vaccine: RV5
Symptoms: Oral administration complication
Clinical narrative: This spontaneous report was received from a registered nurse refers to a 2 month old male patient. On 20-AUG-2012, the patient was vaccinated with first dose of ROTATEQ, (lot number, expiration date not provided, route oral) and he spit up the dose. No concomitant medications were reported. On 19-OCT-2012, the patient received his second dose of ROTATEQ, (lot number, expiration date not provided and route oral) and spit it up. The third dose of ROTATEQ, (lot number, expiration date not provided and route oral) was given normally on 20-DEC-2012. The patient sought medical attention (office). additional information has been requested.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 69 years old female patient (reporting pharmacist's mother) with no drug reactions or allergies. The patient's medical history included previous case of shingles (date unspecified). On 23-AUG-2012, the patient was vaccinated with a dose of ZOSTAVAX (dose, route, lot number and exp. date were not reported). No other co-suspects were reported. No concomitant medications were reported. Pharmacist reporter that in August 2012, her mother developed injection site reaction that lasted a couple of days. It was reported that the patient's spoke to the pharmacist and no treatment was given for the patient's event. The outcome of injection site reaction was reported as recovered in an unspecified date in 2012. The relatedness for the patient's injection site reaction was not reported for ZOSTAVAX. Additional information is not expected.
Age: 1.31
Sex: M
Vaccine: PNC13
Symptoms: Pyrexia
Clinical narrative: Fever, antipyretic tonic administered around 9:45 PM.
Age: 7.0
Sex: F
Vaccine: FLUN3
Symptoms: Wheezing
Clinical narrative: Significant wheezing.
Age: 45.0
Sex: M
Vaccine: FLUX
Symptoms: Body temperature increased, Cough, Headache, Oropharyngeal pain
Clinical narrative: Elevated temperature (101.5), headache, sore throat, cough.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Rash papular, Rash pruritic
Clinical narrative: The evening of my injection I noticed a red spot on the arm of injection, by morning I had a trail of raised, itchy, patches. Right arm, forearm, right leg on lower thigh and top of knee.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site mass, Injection site reaction, Injection site warmth, Melanocytic naevus
Clinical narrative: After signs of the injection had completely disappeared a mole developed at the injection site and then a large red lump the size of a silver dollar. The lump is hot. She has no fever but looks very pale.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Pallor
Clinical narrative: After signs of the injection had completely disappeared a mole developed at the injection site and then a large red lump the size of a silver dollar. The lump is hot. She has no fever but looks very pale.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Body temperature increased, Chills, Hypoaesthesia, Pain
Clinical narrative: Temp 102.4; chills; numbness in hands; body aches. Frequent vital signs done until resolved. MD notified.
Age: 28.0
Sex: F
Vaccine: FLUX
Symptoms: Bowel movement irregularity, Brain stem syndrome, CSF immunoglobulin increased, Deafness unilateral, Heart rate increased
Clinical narrative: Severe Migraine, 2 hrs later had numbness in left hand/foot at same time, increasing over the 48 hrs to my entire left side.  felt "hungover", vertigo, nauseousness, within a week lost vision, couldn't focus and lost some hearing on left side.  Extreme, painful sensitivity to noise-left ear. Severe head pain. Culminating in a 3-week span. Rapid heart rate, irregular bowel movements. Saw neurologist who initially thought MS but then said unsure.  Had VerBaer nerve conduction test which showed damage to L ear but nothing to eyes.  No treatment other than huge course of Prednisone for probable brain stem swelling. Possible tiny brain lesion which was later determined to be gone. Few IgG cells in CSF but not enough to confirm MS test conclusive. Finally went to ER. HR/BP were up due to pain and was given painkillers.  Had a week of Vicodan and Clonazepam and slowing started to slowly recover. Whole process took almost 3 months and slowly recovered cardiovascular system/HR over next 4-5 months. I still have minor neuropathy in left hand/foot/calf and memory doesn't seem as good but overall functional.
Age: 28.0
Sex: F
Vaccine: FLUX
Symptoms: Hyperacusis, Hypoaesthesia, Migraine, Nausea, Nerve conduction studies abnormal
Clinical narrative: Severe Migraine, 2 hrs later had numbness in left hand/foot at same time, increasing over the 48 hrs to my entire left side.  felt "hungover", vertigo, nauseousness, within a week lost vision, couldn't focus and lost some hearing on left side.  Extreme, painful sensitivity to noise-left ear. Severe head pain. Culminating in a 3-week span. Rapid heart rate, irregular bowel movements. Saw neurologist who initially thought MS but then said unsure.  Had VerBaer nerve conduction test which showed damage to L ear but nothing to eyes.  No treatment other than huge course of Prednisone for probable brain stem swelling. Possible tiny brain lesion which was later determined to be gone. Few IgG cells in CSF but not enough to confirm MS test conclusive. Finally went to ER. HR/BP were up due to pain and was given painkillers.  Had a week of Vicodan and Clonazepam and slowing started to slowly recover. Whole process took almost 3 months and slowly recovered cardiovascular system/HR over next 4-5 months. I still have minor neuropathy in left hand/foot/calf and memory doesn't seem as good but overall functional.
Age: 28.0
Sex: F
Vaccine: FLUX
Symptoms: Neuropathy peripheral, Vertigo, Vision blurred, Vitamin D
Clinical narrative: Severe Migraine, 2 hrs later had numbness in left hand/foot at same time, increasing over the 48 hrs to my entire left side.  felt "hungover", vertigo, nauseousness, within a week lost vision, couldn't focus and lost some hearing on left side.  Extreme, painful sensitivity to noise-left ear. Severe head pain. Culminating in a 3-week span. Rapid heart rate, irregular bowel movements. Saw neurologist who initially thought MS but then said unsure.  Had VerBaer nerve conduction test which showed damage to L ear but nothing to eyes.  No treatment other than huge course of Prednisone for probable brain stem swelling. Possible tiny brain lesion which was later determined to be gone. Few IgG cells in CSF but not enough to confirm MS test conclusive. Finally went to ER. HR/BP were up due to pain and was given painkillers.  Had a week of Vicodan and Clonazepam and slowing started to slowly recover. Whole process took almost 3 months and slowly recovered cardiovascular system/HR over next 4-5 months. I still have minor neuropathy in left hand/foot/calf and memory doesn't seem as good but overall functional.
Age: 70.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Chills, Dizziness postural, Fatigue, Injection site pain
Clinical narrative: Severe chills and shaking of arms hands, legs feet and torso. Some nausea no vomiting.  Weak and extreme fatigue, unable to stand without dizziness.  Lasted until 11pm.  Fatigue all next day.  Soreness at site two days, pain along arm and forearm one day.
Age: 70.0
Sex: M
Vaccine: FLU3
Symptoms: Nausea, Pain in extremity, Tremor
Clinical narrative: Severe chills and shaking of arms hands, legs feet and torso. Some nausea no vomiting.  Weak and extreme fatigue, unable to stand without dizziness.  Lasted until 11pm.  Fatigue all next day.  Soreness at site two days, pain along arm and forearm one day.
Age: 57.0
Sex: M
Vaccine: FLU3
Symptoms: Insomnia, Pain in extremity
Clinical narrative: Very sore left arm. Difficult to sleep at times.
Age: 4.0
Sex: F
Vaccine: FLUX
Symptoms: Activities of daily living impaired, Influenza, Injection site movement impairment, Injection site pain, Irritability
Clinical narrative: On the first flu shot my daughter became sick a couple of hours later. She had the normal fever and crankiness but then she was full blown sick with a cold for weeks. She had to miss school and all. She normally does not get sick much but then she was sick in November 2012 and was still sick when she went in for her flu booster shot on December 2, 2012. I told the doctors before we even came how sick she was but they said it was fine. She of course became more sick and her arm hurt badly and she couldnt move it for days on both shots. My daughter started to get better and then came down with the flu on December 25, 2012. She is very sick and still is today, December 29, 2012. This is a horrible shot filled with horrible fillers and dangerous ingredients.
Age: 4.0
Sex: F
Vaccine: FLUX
Symptoms: Malaise, Nasopharyngitis, Pyrexia
Clinical narrative: On the first flu shot my daughter became sick a couple of hours later. She had the normal fever and crankiness but then she was full blown sick with a cold for weeks. She had to miss school and all. She normally does not get sick much but then she was sick in November 2012 and was still sick when she went in for her flu booster shot on December 2, 2012. I told the doctors before we even came how sick she was but they said it was fine. She of course became more sick and her arm hurt badly and she couldnt move it for days on both shots. My daughter started to get better and then came down with the flu on December 25, 2012. She is very sick and still is today, December 29, 2012. This is a horrible shot filled with horrible fillers and dangerous ingredients.
Age: 7.0
Sex: F
Vaccine: FLUX
Symptoms: Contusion, Cyanosis, Erythema, Local swelling, Malaise
Clinical narrative: Soon after the flu shot was given my daughters arm became red, which is normal, but then it started swelling up and turning bluish. The swelling got worse within the next couple of days and it started turning a little more blackish with a red bulls eye type ring around the outside. It became a large area of bad bruising and swelling. Within hours of the shot my daughter was in extreme pain and was unable to move her arm for many days and the extreme pain lasted for several days. She also became very sick that day and was sick for weeks.
Age: 7.0
Sex: F
Vaccine: FLUX
Symptoms: Mobility decreased, Oedema peripheral, Pain
Clinical narrative: Soon after the flu shot was given my daughters arm became red, which is normal, but then it started swelling up and turning bluish. The swelling got worse within the next couple of days and it started turning a little more blackish with a red bulls eye type ring around the outside. It became a large area of bad bruising and swelling. Within hours of the shot my daughter was in extreme pain and was unable to move her arm for many days and the extreme pain lasted for several days. She also became very sick that day and was sick for weeks.