chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Flu shot: time of shot hurt bad. Arm where needle shot began to hurt. Can't sleep on this arm - wake up 2 to 3 times. Hurts daytime. Feel like toothache at vaccination point still hurts 3/11/13.
Age: 12.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Syncope
Clinical narrative: Syncope.
Sex: F
Vaccine: HPV4
Symptoms: Malaise
Clinical narrative: This spontaneous report as received from a consumer refers to a female patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL dose 1, intramuscular. Frequency was not provided. On an unknown date the patient was vaccinated with GARDASIL dose 2, intramuscular. On an unknown date the patient was sick and she asked if it was ok to wait for a few days to get her third dose. The outcome of sick was unknown. The action taken regarding GARDASIL was unknown. The reporter causality was unknown. Additional information is not expected.
Sex: F
Vaccine: PPV
Symptoms: Injection site cellulitis
Clinical narrative: This spontaneous report was received from a pharmacist, referring to a female patient at a nursing home facility, with no pertinent medical history reported. On an unknown date the patient was vaccinated with PNEUMOVAX23 (lot # H013581, expiration date not reported)(no dose, route or anatomical location were specified). No other co-suspects or concomitant medications were specified. On an unknown date the patient developed cellulitis at the injection site that required antibiotic therapy. The patient sought unspecified medical attention, she is in a nursing home. At the time of the report the outcome for cellulitis at the injection site was unknown. Additional information has been requested. This is one of the several reports of the same source.
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Headache, Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: 4 hrs after injection, site red, hot, itchy, swollen. C/o HA, N/V.
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Nausea, Vomiting
Clinical narrative: 4 hrs after injection, site red, hot, itchy, swollen. C/o HA, N/V.
Age: 24.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Erythema, Pruritus, Rash, Tenderness
Clinical narrative: REDNESS ITCHING TENDERNESS MILD RASH MEASURING 107MM X 75MM.
Age: 41.0
Sex: M
Vaccine: FLU3, TD
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Injection site swelling, Oedema peripheral
Clinical narrative: SEVERE SWELLING, REDNESS, PAIN AND EDEMA INVOLVING L UPPER ARM AS WELL AS PROXIMAL PART OF L FOREARM.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PPV, RVX
Symptoms: CSF protein increased, Depressed level of consciousness, Dyspnoea, Full blood count abnormal, Hypotonia
Clinical narrative: Pt. had difficulty breathing, hypotonia, and diminished level of consciousness; was taken to local ED where leukocytosis to 33.  Transferred to tertiary care, rec'd fluid resuscitation and LP.  LP showed protein to 86, otherwise nl.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PPV, RVX
Symptoms: Leukocytosis, Lumbar puncture abnormal, White blood cell count increased
Clinical narrative: Pt. had difficulty breathing, hypotonia, and diminished level of consciousness; was taken to local ED where leukocytosis to 33.  Transferred to tertiary care, rec'd fluid resuscitation and LP.  LP showed protein to 86, otherwise nl.
Age: 29.0
Sex: F
Vaccine: HEP, MMR, VARCEL
Symptoms: Chills, Joint stiffness, Pain, Pyrexia
Clinical narrative: Alternating fever and chills, body aches, stiff joints.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Mom states childs left arm turning red and swollen after injection around injection site and spreading around arm. Hot to touch and painful. Mom states child seen in ER before notifying office of reaction. States was told to take Benadryl and Tylenol advised by vaccine administrator to take ibuprofen and Benadryl and to seek MD care due to mom stating child had had cellulitis before and did not recover without meds. Mom states would call MD ASAP.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Arthrogram abnormal, Aspiration joint, Bone marrow oedema, Full blood count, Joint range of motion decreased
Clinical narrative: Left shoulder pain, limited range of motion, satus post Naproxen, Voltaren, Flexeril, Ultracet, Prednisone taper and physical therapy interventions. MRI and MRI arthrogram demonstrating bone necrosis and bone marrow edema to greater tubercle of left humerus. Still having pain 6 months later. Referrals to orthopedics, infectious disease.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Laboratory test, Musculoskeletal pain, Nuclear magnetic resonance imaging abnormal, Osteonecrosis
Clinical narrative: Left shoulder pain, limited range of motion, satus post Naproxen, Voltaren, Flexeril, Ultracet, Prednisone taper and physical therapy interventions. MRI and MRI arthrogram demonstrating bone necrosis and bone marrow edema to greater tubercle of left humerus. Still having pain 6 months later. Referrals to orthopedics, infectious disease.
Age: 5.0
Sex: F
Vaccine: DTAPHEPBIP, MMRV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Rash erythematous
Clinical narrative: Redness, pain, swelling at the site (R) deltoid area, warm, tender, also rash all over body x 2 days, flesh colored bumps, worse on face and arms, similar to what patient had with food allergies.
Age: 5.0
Sex: F
Vaccine: DTAPHEPBIP, MMRV
Symptoms: Rash generalised
Clinical narrative: Redness, pain, swelling at the site (R) deltoid area, warm, tender, also rash all over body x 2 days, flesh colored bumps, worse on face and arms, similar to what patient had with food allergies.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Neuralgia
Clinical narrative: She is complaining of pain along nerve where she had shingles disease 13 years ago.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Blood test, Injection site pain, Insomnia, Musculoskeletal pain
Clinical narrative: Soreness around injection site. Extreme pain in neck, shoulders, arms, hips and legs. Saw Doctor 01/07/2013 for blood tests. Saw Doctor again 01/17/2013 for more blood work. Saw Doctor 1/23/2013 for sedimentation rate blood work. 01/25/2013 received diagnosis of Polymyalgia Rheumatica, began 15mg Prednisone 1x/day and 800mg Ibuprofen 3x/day. Symptoms persist, extreme pain and sleeplessness despite medication.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Neck pain, Pain, Pain in extremity, Polymyalgia rheumatica, Red blood cell sedimentation rate
Clinical narrative: Soreness around injection site. Extreme pain in neck, shoulders, arms, hips and legs. Saw Doctor 01/07/2013 for blood tests. Saw Doctor again 01/17/2013 for more blood work. Saw Doctor 1/23/2013 for sedimentation rate blood work. 01/25/2013 received diagnosis of Polymyalgia Rheumatica, began 15mg Prednisone 1x/day and 800mg Ibuprofen 3x/day. Symptoms persist, extreme pain and sleeplessness despite medication.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: C-reactive protein increased, Eosinophil percentage, Haematocrit normal, Haemoglobin normal, Lymphocyte percentage increased
Clinical narrative: Pt returned to Clinic on 3/11/13 for fever, face rash, swelling of face, body rash. Pt given immunizations on 3/1/13 and doctor suspects reaction to MMR vaccine. Fever x 4 days.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Metabolic function test normal, Monocyte percentage increased, Neutrophil percentage decreased, Platelet count normal, Pyrexia
Clinical narrative: Pt returned to Clinic on 3/11/13 for fever, face rash, swelling of face, body rash. Pt given immunizations on 3/1/13 and doctor suspects reaction to MMR vaccine. Fever x 4 days.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Rash, Rash generalised, Red blood cell sedimentation rate normal, Swelling face, Urine analysis normal
Clinical narrative: Pt returned to Clinic on 3/11/13 for fever, face rash, swelling of face, body rash. Pt given immunizations on 3/1/13 and doctor suspects reaction to MMR vaccine. Fever x 4 days.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Vaccination complication, White blood cell count normal
Clinical narrative: Pt returned to Clinic on 3/11/13 for fever, face rash, swelling of face, body rash. Pt given immunizations on 3/1/13 and doctor suspects reaction to MMR vaccine. Fever x 4 days.
Age: 0.62
Sex: F
Vaccine: DTAPHEPBIP, FLU3, HIBV, PNC13
Symptoms: Laboratory test normal, Pyrexia
Clinical narrative: Developed fever to over 106F, taken to ER and admitted. Workup completely negative. No prior reactions to vaccines. First time receiving flu vaccine.
Age: 14.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Concussion, Contusion, Face and mouth X-ray, Fall, Injury
Clinical narrative: The patient presented to the office, under the accompanyment of her mother, for administration of the third Gardasil vaccine. They denied any previous reactions to the vaccine and reviewed the VIS sheet. The patient was administer Gardasil IM in her left deltoid and the Havrix IM in her right deltoid while sitting on the exam table by LPN. While she turned around to dispose of the used needles, the patient fell face first off of the table onto a laminate tile floor. LPN immediately alerted myself, and MD to the patient falling. We came into the room and found the patient lying on the floor with her head turned to the side. LPN reported that the patient had been unconscious for a few seconds prior to us coming into the room. The patient was turned to a supine position and allowed to rest on the floor for a few minutes, then helped onto the table to lie down. She was then examined by myself and found to have normal vitals, contusions to her nose and forehead, and slight bleeding of the upper gum. LPN stayed in the room with the patient to monitor her until about 3:15. Then I checked on the patient periodically (approx Q5-10 minitues) for the next hour. The patient was discharged from the office in the care of her mother and father, and was advised to get a facial xray done that day to rule out facial fractures and to follow up with a concussion specialist and a dentist the next day to rule out concussion and any dental damage. The patient was found to have a concussion and is being followed by MD. One of her teeth was found to be loose and she is being followed by her private dentist.
Age: 14.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Loose tooth, Loss of consciousness
Clinical narrative: The patient presented to the office, under the accompanyment of her mother, for administration of the third Gardasil vaccine. They denied any previous reactions to the vaccine and reviewed the VIS sheet. The patient was administer Gardasil IM in her left deltoid and the Havrix IM in her right deltoid while sitting on the exam table by LPN. While she turned around to dispose of the used needles, the patient fell face first off of the table onto a laminate tile floor. LPN immediately alerted myself, and MD to the patient falling. We came into the room and found the patient lying on the floor with her head turned to the side. LPN reported that the patient had been unconscious for a few seconds prior to us coming into the room. The patient was turned to a supine position and allowed to rest on the floor for a few minutes, then helped onto the table to lie down. She was then examined by myself and found to have normal vitals, contusions to her nose and forehead, and slight bleeding of the upper gum. LPN stayed in the room with the patient to monitor her until about 3:15. Then I checked on the patient periodically (approx Q5-10 minitues) for the next hour. The patient was discharged from the office in the care of her mother and father, and was advised to get a facial xray done that day to rule out facial fractures and to follow up with a concussion specialist and a dentist the next day to rule out concussion and any dental damage. The patient was found to have a concussion and is being followed by MD. One of her teeth was found to be loose and she is being followed by her private dentist.
Age: 1.02
Sex: M
Vaccine: HIBV, PNC13
Symptoms: Pyrexia
Clinical narrative: Fever up to 105.5.
Age: 58.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site joint pain, Injection site pain, Injection site swelling
Clinical narrative: Patient complains of pain at injection site, shoulder joint, states "feels like it's in the bone".  Complained of "bump" at injection site.
Age: 35.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site joint pain
Clinical narrative: PT describe gradual onset of severe right shoulder pain (injection arm) without evidence of cellulitis or allergic response. Injection given in Right Posterior Aspect of Deltoid.
Age: 1.51
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Crying, Decreased appetite, Hyperhidrosis, Insomnia, Irritability
Clinical narrative: Extreme irritability/fussiness, fever, sweats, crying in his sleep, inability to sleep, loss of appetite. Alternated Tylenol & Motrin every 3-4 hours for fever, and fever remained around 100.1 for over 24 hours.
Age: 1.51
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Pyrexia
Clinical narrative: Extreme irritability/fussiness, fever, sweats, crying in his sleep, inability to sleep, loss of appetite. Alternated Tylenol & Motrin every 3-4 hours for fever, and fever remained around 100.1 for over 24 hours.
Age: 21.0
Sex: M
Vaccine: TTOX
Symptoms: Dizziness, Hyperhidrosis, Nausea, Pallor
Clinical narrative: DONOR RECEIVED SHOT, WENT TO LOBBY TO WAIT 15 MINS. WAITED APPROX. 10 MINS. AND CAME TO OFFICE STATING HE FELT LIGHTHEADED AND SLIGHTLY NAUSEOUS, DONOR APPEARED PALE AND SLIGHTLY DIAPHORETIC. HAD DONOR SIT DOWN IN CHAIR, ICE PACK APPLIED TO BACK OF DONOR'S NECK, ASSISTED DONOR TO LIE DOWN ON BED. WHEN NAUSEA SUBSIDED OFFERED 8OZ JUICE AND CRACKERS TO DONOR DONOR FULLY RECOVERED IN APPROX 5-10 MINS. STATED FELT WELL AND HEALTHY, VS STABLE AND WAS RELEASED.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLU3, MMR, VARCEL
Symptoms: Pain, Skin lesion, Skin warm
Clinical narrative: Painful hot lesion 4x4. Antibiotics and warm compress ordered by MD.
Age: 1.01
Sex: M
Vaccine: HIBV, MMR, PNC13, VARCEL
Symptoms: Decreased activity, Lethargy, Pyrexia
Clinical narrative: Mom states patient had high fever and was lathargic/inactive. Physician called, Motrin given. On 3/13/2013 follow up phone call to mom she states pt is feeling better and fever is 99.8 degrees. No Motrin has been given since 03/12/2013 PM dose.
Age: 28.0
Sex: M
Vaccine: MMR, TDAP
Symptoms: Tenderness
Clinical narrative: Exquisitely tender testicles. Treatment: Naprosyn 500mg BID. Referred to urologist.
Age: 1.29
Sex: F
Vaccine: HIBV, MMR
Symptoms: Escherichia test negative, Listless, Pyrexia, Vomiting
Clinical narrative: Fever, vomiting/emesis, listlessness.
Age: 1.57
Sex: F
Vaccine: DTAP
Symptoms: Cold sweat, Cyanosis, Grand mal convulsion, Haematoma, Lethargy
Clinical narrative: Within 24-48hrs. patient spiked a fever which escalated to 107 degrees 02/12/1996 during which time Grand-Mal seizures surfaced, administered Tylenol, alternating with ibuprofen as directed, due to seizures- physician was contacted by the time patient arrived fever was 104 degrees. Child was clammy, blueish tone, lethargic and appeared to be in febrile shock.
Age: 1.57
Sex: F
Vaccine: DTAP
Symptoms: Lumbar puncture, Pain, Pyrexia, Screaming, Shock
Clinical narrative: Within 24-48hrs. patient spiked a fever which escalated to 107 degrees 02/12/1996 during which time Grand-Mal seizures surfaced, administered Tylenol, alternating with ibuprofen as directed, due to seizures- physician was contacted by the time patient arrived fever was 104 degrees. Child was clammy, blueish tone, lethargic and appeared to be in febrile shock.
Age: 4.0
Sex: M
Vaccine: DTAP, FLU3, IPV, MMR, VARCEL
Symptoms: Abscess, Cellulitis
Clinical narrative: Cellulitis and abscess. Clindamycin.
Age: 67.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Pain, Pruritus
Clinical narrative: Redness, a little sore, itchy, redness size of tennis ball.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Unresponsive to stimuli
Clinical narrative: After ZOSTAVAX vaccination, patient felt dizzy, became unresponsive, was breathing on her own, we lowered her to the floor, raised her legs and she regained consciousness, felt better and afterwards. EMTs came took her vitals, vitals good. She declined further treatment.
Age: 1.47
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Injection site swelling
Clinical narrative: Presents to PCP 3/13/13 at 1614. Large swollen area to right & left thigh lateral to injection site. Treated with AUGMENTIN. Swelling >10 cm on both legs. HIB >15 cm, DTaP >10 cm.
Age: 25.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Oedema peripheral, Pyrexia
Clinical narrative: Pt stated her arm was red, swollen, and got fever. Went to ER for tx. was given antibiotic.
Age: 0.59
Sex: M
Vaccine: DTAPIPV, HIBV
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: This spontaneous as received from a 81 year old male physician with no drug reactions or allergies reporting on himself. The patient's medical history included bilateral hip replacement, retinal surgery and Guillain-Barre syndrome in 1999. On 09-JUL-2010, the patient was vaccinated with a dose of ZOSTAVAX (Lot # not reported). Concomitant therapies included FLOMAX and LUMIGAN. The physician reported that on approximately 18-FEB-2013, "three weeks ago", he developed shingles. The physician reported that he had a rash on the mid-back dermatome. He reported that there was no blistering, he had a little bit of sensory change, but not painful. The physician reported that the diagnosis of shingles was confirmed by his physician. There were no Lab diagnosis or studies performed. The patient did not receive treatment for the adverse event. The outcome of shingles was unknown. Additional information has been requested.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia
Clinical narrative: This spontaneous report as received from a physician concerning a 78 year old female patient with sulfonamide allergy who on an unknown date in 2011 was vaccinated with a 0.65ml dose of ZOSTAVAX, subcutaneous (lot number not provided). The physician started that on an unknown date approximately three months later after ZOSTAVAX vaccination (no dates provided) the patient developed a severe case of shingles. The unspecified patient experienced severe post herpetic neuralgia as well as classic shingles symptoms according to the physician. The outcome of severe case of shingles was reported as fully recovered. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse concerning an unknown number of patients who on an unknown date were vaccinated with a dose of LIQUID PEDVAXHIB exposed to -1 degrees C for 24 hours (dose, route and lot number not provided). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse concerning an unknown number of patients who on an unknown date were vaccinated with a dose of GARDASIL exposed to -1 degrees C for 24 hours (dose, route and lot number not provided). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HEP, RV5
Symptoms: Expired drug administered
Clinical narrative: This spontaneous report as received from a consumer refers to an infant of unknown age. In 2012 the infant was vaccinated with a dose of RECOMBIVAX HB (lot # reported as 0809Y, expiration date unspecified). Concomitant therapies included oral ROTATEQ (lot # 664076/0768Y, expiration date 26-JAN-2011). The consumer inquired into the expiration dates for RECOMBIVAX lot 0809Y, expiration date unspecified, and ROTATEQ lot 0768Y expiration date unspecified. She stated that they were "administered to an infant in 2010" and now the consumer was concerned that they were expired (in fact, the oral ROTATEQ was not expired; expiration date was 26-JAN-2011). The consumer stated "I don't feel comfortable discussing it, but I am concerned that they were expired at the time," and "I don't want to jump the gun until I know if they were expired or not." At the time of the report, the outcome of the event was unknown. Additional information is not expected.
Age: 88.0
Sex: M
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: Information has been received from a doctor of pharmacy concerning a patient who on 21-JUN-2012 was vaccinated with a dose of ZOSTAVAX (Merck) (lot number 669406/1358Z) (dose and route not reported) that was expired. The vaccine expired on 15-JAN-2012. No symptoms were reported. Follow up information has been received from a healthcare professional concerning the patient, an 88 year old male (now 89 years old) who on 21-JUN-2012 (10:25 AM) was vaccinated with a first does of ZOSTAVAX (Merck) (lot number 669406/1358Z) subcutaneously at right arm. The vaccine has expired. Per patient, there were adverse events. Additional information is not expected.
Age: 42.0
Sex: F
Vaccine: FLU3, MNQ, PPV
Symptoms: Cellulitis, Pyrexia
Clinical narrative: Case number PHHY2013US012162 is an initial spontaneous report from a pharmacist via Vaccine Adverse Event Reporting System (VAERS reference 475163) received on 08 Feb 2013, and with a follow up received from QA department on 12 Mar 2013. This report refers to a 42-year-old female patient. Her medical history included drug hypersensitivity to soy isoflavone and rubber latex sensitivity. Her previous vaccinations included PNEUMOVAX with which she had cellulitis and fever which were milder. Her healthcare providers had urged her to get PNEUMOVAX every 5-10 years. She was vaccinated with FLUVIRIN (batch number: not reported) in her right arm, MENACTRA (other manufacturer, batch number not reported) in her right arm and PNEUMOVAX (other manufacturer, batch number H010661, expiry 02 Feb 2014) intramuscularly in her left arm on 13 Oct 2012. On an unknown date after vaccination, she experienced cellulitis which was described as "very large" and fever described as greater than 102 degree Fahrenheit. The patient was sought for unspecified medical attention. She was treated with antibiotics and oral steroids. There were no lab tests performed. The outcome of the events was reported as complete recovery as of 26 Nov 2012. The seriousness and causality of the events was not reported. Batch number was not available therefore batch specific review cannot be carried out. The review was based on a general review of the quality requirements of FLUVIRIN. All FLUVIRIN batches were released into the market by a qualified person, who confirmed that the batch complies with the quality and regulatory requirements, including confirmation that deviations will not adversely effect the quality, safety or efficacy of the batch. The stability data indicates that the batch had complied with the product specification at the time of vaccination. Follow up report received from QA department on 12 Mar 2013. QA investigational summary was provided.
Age: 19.0
Sex: F
Vaccine: FLU3, HPV4, FLU3, HPV4, MNQ
Symptoms: Convulsion, Diplopia, Headache, Nuclear magnetic resonance imaging brain abnormal, Paraesthesia
Clinical narrative: This spontaneous report was received from a medical assistant concerning a 20 year old female patient. On 25-JUN-2012, the patient was vaccinated with dose 1 of GARDASIL (lot number and expiry date reported as 0754AE and 17-JAN-2015 respectively) (dose and route unspecified). On 24-AUG-2012, the patient was vaccinated with dose 2 of GARDASIL (lot number and expiry date reported as 0518AE and 21-NOV-2014 respectively) (dose and route unspecified). No concomitant medications were reported. On 15-NOV-2012, the patient experienced a seizure. On an unknown date, the patient experienced numbness, loss of motor skills, migraines and the patient was passing out. On an unknown date, the patient was seen in the emergency room of medical center, (also reported as unspecified if the patient sought medical attention). On an unknown date, magnetic resonance imaging (MRI) was performed which showed demyelinating of the white matter of the brain. On an unknown date, electrocardiogram (EKG) and unspecified blood tests were performed and the results were unknown. The patient was not vaccinated with the subsequent dose of GARDASIL. The outcomes all the events were reported as not resolved. The relatedness for all the events was unknown for GARDASIL. Upon internal review, a seizure and passing out were considered as medically significant. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: FLU3, HPV4, FLU3, HPV4, MNQ
Symptoms: White matter lesion
Clinical narrative: This spontaneous report was received from a medical assistant concerning a 20 year old female patient. On 25-JUN-2012, the patient was vaccinated with dose 1 of GARDASIL (lot number and expiry date reported as 0754AE and 17-JAN-2015 respectively) (dose and route unspecified). On 24-AUG-2012, the patient was vaccinated with dose 2 of GARDASIL (lot number and expiry date reported as 0518AE and 21-NOV-2014 respectively) (dose and route unspecified). No concomitant medications were reported. On 15-NOV-2012, the patient experienced a seizure. On an unknown date, the patient experienced numbness, loss of motor skills, migraines and the patient was passing out. On an unknown date, the patient was seen in the emergency room of medical center, (also reported as unspecified if the patient sought medical attention). On an unknown date, magnetic resonance imaging (MRI) was performed which showed demyelinating of the white matter of the brain. On an unknown date, electrocardiogram (EKG) and unspecified blood tests were performed and the results were unknown. The patient was not vaccinated with the subsequent dose of GARDASIL. The outcomes all the events were reported as not resolved. The relatedness for all the events was unknown for GARDASIL. Upon internal review, a seizure and passing out were considered as medically significant. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: FLU3, HPV4, FLU3, HPV4, MNQ
Symptoms: Blood test, Convulsion, Demyelination, Electrocardiogram, Hypoaesthesia
Clinical narrative: This spontaneous report was received from a medical assistant concerning a 20 year old female patient. On 25-JUN-2012, the patient was vaccinated with dose 1 of GARDASIL (lot number and expiry date reported as 0754AE and 17-JAN-2015 respectively) (dose and route unspecified). On 24-AUG-2012, the patient was vaccinated with dose 2 of GARDASIL (lot number and expiry date reported as 0518AE and 21-NOV-2014 respectively) (dose and route unspecified). No concomitant medications were reported. On 15-NOV-2012, the patient experienced a seizure. On an unknown date, the patient experienced numbness, loss of motor skills, migraines and the patient was passing out. On an unknown date, the patient was seen in the emergency room of medical center, (also reported as unspecified if the patient sought medical attention). On an unknown date, magnetic resonance imaging (MRI) was performed which showed demyelinating of the white matter of the brain. On an unknown date, electrocardiogram (EKG) and unspecified blood tests were performed and the results were unknown. The patient was not vaccinated with the subsequent dose of GARDASIL. The outcomes all the events were reported as not resolved. The relatedness for all the events was unknown for GARDASIL. Upon internal review, a seizure and passing out were considered as medically significant. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: FLU3, HPV4, FLU3, HPV4, MNQ
Symptoms: Loss of consciousness, Migraine, Nuclear magnetic resonance imaging brain abnormal, Psychomotor skills impaired
Clinical narrative: This spontaneous report was received from a medical assistant concerning a 20 year old female patient. On 25-JUN-2012, the patient was vaccinated with dose 1 of GARDASIL (lot number and expiry date reported as 0754AE and 17-JAN-2015 respectively) (dose and route unspecified). On 24-AUG-2012, the patient was vaccinated with dose 2 of GARDASIL (lot number and expiry date reported as 0518AE and 21-NOV-2014 respectively) (dose and route unspecified). No concomitant medications were reported. On 15-NOV-2012, the patient experienced a seizure. On an unknown date, the patient experienced numbness, loss of motor skills, migraines and the patient was passing out. On an unknown date, the patient was seen in the emergency room of medical center, (also reported as unspecified if the patient sought medical attention). On an unknown date, magnetic resonance imaging (MRI) was performed which showed demyelinating of the white matter of the brain. On an unknown date, electrocardiogram (EKG) and unspecified blood tests were performed and the results were unknown. The patient was not vaccinated with the subsequent dose of GARDASIL. The outcomes all the events were reported as not resolved. The relatedness for all the events was unknown for GARDASIL. Upon internal review, a seizure and passing out were considered as medically significant. Additional information has been requested.
Age: 62.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Arthralgia, Injection site pain, Muscle tightness, Musculoskeletal pain, Myalgia
Clinical narrative: Arthalgia and myalgia starting 2 days after receiving vaccination continuing to present day.
Age: 62.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Pain
Clinical narrative: Arthalgia and myalgia starting 2 days after receiving vaccination continuing to present day.
Age: 62.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Arthralgia, Myalgia
Clinical narrative: Arthalgia and myalgia starting 2 days after receiving vaccination continuing to present day.
Age: 62.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Arthralgia
Clinical narrative: Arthalgia and myalgia starting 2 days after receiving vaccination continuing to present day.
Age: 41.0
Sex: F
Vaccine: VARCEL, VARCEL, VARCEL
Symptoms: Dizziness, Fatigue, Headache, Oedema peripheral, Pain in extremity
Clinical narrative: Patient came in to our clinic 2/4/13 requesting Varicella Vaccine. Varicella was given to the client that day. 3/12/13 Phone call from patient niece re: vaccines she was given here. Called back and talked with patient with MA interpreting. Client was given Varicella vaccine 2/4/2013. She waited the recommended 15 minutes after the vaccine was given, then went back to work. 1 hour after the vaccine was given she noticed a burning sensation at the site of injection. The following day she had a headache and people at her work noted that the skin on her face looked yellow. She also states that she had dizziness and arms and legs seemed to be weak. She did not seek medical assistance until 2 weeks later 3/18/2013, when she went to Dr office and was given an antibiotic for a sinus infection. She states that she did not mention to them that she had the vaccine at that visit or had any problems with the vaccine. On 2/23/13 she went into the Immediate Care with a rash that looked like chicken pox. She states that the doctor told her it was a normal reaction to the varicella vaccine. They did blood work and told her to follow up with Dr for results of the blood work. They also told her that she was dehydrated and needed to increase her fluids. On 2/26/13 she followed up with Dr about the lab work and the rash. Dr told her that the rash was a normal reaction to the varicella vaccine and there was nothing that they could give her at that time. 3/5/13 she came here stating that she was feeling ill since she had the vaccine. She did not say anything about a reaction at the time of the vaccine, only that she had felt bad since the vaccines and we offered to call an ambulance. She opted to go to the ER with the friend she was with, rather than go by ambulance. There she was examined there, lab work was done, which was normal, and she sent her home. Later that day she started trembling and she went to the ER at the hospital. They put her on a short course of steroids to take until 3/10/2013. They told her that the CBC was abnormal and she could follow up with Dr. 3/11/13 she followed up with Dr who referred her to a Neurologist. She is awaiting the appointment with this doctor.
Age: 41.0
Sex: F
Vaccine: VARCEL, VARCEL, VARCEL
Symptoms: Yellow skin
Clinical narrative: Patient came in to our clinic 2/4/13 requesting Varicella Vaccine. Varicella was given to the client that day. 3/12/13 Phone call from patient niece re: vaccines she was given here. Called back and talked with patient with MA interpreting. Client was given Varicella vaccine 2/4/2013. She waited the recommended 15 minutes after the vaccine was given, then went back to work. 1 hour after the vaccine was given she noticed a burning sensation at the site of injection. The following day she had a headache and people at her work noted that the skin on her face looked yellow. She also states that she had dizziness and arms and legs seemed to be weak. She did not seek medical assistance until 2 weeks later 3/18/2013, when she went to Dr office and was given an antibiotic for a sinus infection. She states that she did not mention to them that she had the vaccine at that visit or had any problems with the vaccine. On 2/23/13 she went into the Immediate Care with a rash that looked like chicken pox. She states that the doctor told her it was a normal reaction to the varicella vaccine. They did blood work and told her to follow up with Dr for results of the blood work. They also told her that she was dehydrated and needed to increase her fluids. On 2/26/13 she followed up with Dr about the lab work and the rash. Dr told her that the rash was a normal reaction to the varicella vaccine and there was nothing that they could give her at that time. 3/5/13 she came here stating that she was feeling ill since she had the vaccine. She did not say anything about a reaction at the time of the vaccine, only that she had felt bad since the vaccines and we offered to call an ambulance. She opted to go to the ER with the friend she was with, rather than go by ambulance. There she was examined there, lab work was done, which was normal, and she sent her home. Later that day she started trembling and she went to the ER at the hospital. They put her on a short course of steroids to take until 3/10/2013. They told her that the CBC was abnormal and she could follow up with Dr. 3/11/13 she followed up with Dr who referred her to a Neurologist. She is awaiting the appointment with this doctor.
Age: 41.0
Sex: F
Vaccine: VARCEL, VARCEL, VARCEL
Symptoms: White blood cell count increased, Yellow skin
Clinical narrative: Patient came in to our clinic 2/4/13 requesting Varicella Vaccine. Varicella was given to the client that day. 3/12/13 Phone call from patient niece re: vaccines she was given here. Called back and talked with patient with MA interpreting. Client was given Varicella vaccine 2/4/2013. She waited the recommended 15 minutes after the vaccine was given, then went back to work. 1 hour after the vaccine was given she noticed a burning sensation at the site of injection. The following day she had a headache and people at her work noted that the skin on her face looked yellow. She also states that she had dizziness and arms and legs seemed to be weak. She did not seek medical assistance until 2 weeks later 3/18/2013, when she went to Dr office and was given an antibiotic for a sinus infection. She states that she did not mention to them that she had the vaccine at that visit or had any problems with the vaccine. On 2/23/13 she went into the Immediate Care with a rash that looked like chicken pox. She states that the doctor told her it was a normal reaction to the varicella vaccine. They did blood work and told her to follow up with Dr for results of the blood work. They also told her that she was dehydrated and needed to increase her fluids. On 2/26/13 she followed up with Dr about the lab work and the rash. Dr told her that the rash was a normal reaction to the varicella vaccine and there was nothing that they could give her at that time. 3/5/13 she came here stating that she was feeling ill since she had the vaccine. She did not say anything about a reaction at the time of the vaccine, only that she had felt bad since the vaccines and we offered to call an ambulance. She opted to go to the ER with the friend she was with, rather than go by ambulance. There she was examined there, lab work was done, which was normal, and she sent her home. Later that day she started trembling and she went to the ER at the hospital. They put her on a short course of steroids to take until 3/10/2013. They told her that the CBC was abnormal and she could follow up with Dr. 3/11/13 she followed up with Dr who referred her to a Neurologist. She is awaiting the appointment with this doctor.
Age: 41.0
Sex: F
Vaccine: VARCEL, VARCEL, VARCEL
Symptoms: Dizziness, Full blood count abnormal, Headache, Injection site pain, Laboratory test
Clinical narrative: Patient came in to our clinic 2/4/13 requesting Varicella Vaccine. Varicella was given to the client that day. 3/12/13 Phone call from patient niece re: vaccines she was given here. Called back and talked with patient with MA interpreting. Client was given Varicella vaccine 2/4/2013. She waited the recommended 15 minutes after the vaccine was given, then went back to work. 1 hour after the vaccine was given she noticed a burning sensation at the site of injection. The following day she had a headache and people at her work noted that the skin on her face looked yellow. She also states that she had dizziness and arms and legs seemed to be weak. She did not seek medical assistance until 2 weeks later 3/18/2013, when she went to Dr office and was given an antibiotic for a sinus infection. She states that she did not mention to them that she had the vaccine at that visit or had any problems with the vaccine. On 2/23/13 she went into the Immediate Care with a rash that looked like chicken pox. She states that the doctor told her it was a normal reaction to the varicella vaccine. They did blood work and told her to follow up with Dr for results of the blood work. They also told her that she was dehydrated and needed to increase her fluids. On 2/26/13 she followed up with Dr about the lab work and the rash. Dr told her that the rash was a normal reaction to the varicella vaccine and there was nothing that they could give her at that time. 3/5/13 she came here stating that she was feeling ill since she had the vaccine. She did not say anything about a reaction at the time of the vaccine, only that she had felt bad since the vaccines and we offered to call an ambulance. She opted to go to the ER with the friend she was with, rather than go by ambulance. There she was examined there, lab work was done, which was normal, and she sent her home. Later that day she started trembling and she went to the ER at the hospital. They put her on a short course of steroids to take until 3/10/2013. They told her that the CBC was abnormal and she could follow up with Dr. 3/11/13 she followed up with Dr who referred her to a Neurologist. She is awaiting the appointment with this doctor.
Age: 41.0
Sex: F
Vaccine: VARCEL, VARCEL, VARCEL
Symptoms: Muscular weakness, Rash vesicular, Sinusitis, Tremor, Yellow skin
Clinical narrative: Patient came in to our clinic 2/4/13 requesting Varicella Vaccine. Varicella was given to the client that day. 3/12/13 Phone call from patient niece re: vaccines she was given here. Called back and talked with patient with MA interpreting. Client was given Varicella vaccine 2/4/2013. She waited the recommended 15 minutes after the vaccine was given, then went back to work. 1 hour after the vaccine was given she noticed a burning sensation at the site of injection. The following day she had a headache and people at her work noted that the skin on her face looked yellow. She also states that she had dizziness and arms and legs seemed to be weak. She did not seek medical assistance until 2 weeks later 3/18/2013, when she went to Dr office and was given an antibiotic for a sinus infection. She states that she did not mention to them that she had the vaccine at that visit or had any problems with the vaccine. On 2/23/13 she went into the Immediate Care with a rash that looked like chicken pox. She states that the doctor told her it was a normal reaction to the varicella vaccine. They did blood work and told her to follow up with Dr for results of the blood work. They also told her that she was dehydrated and needed to increase her fluids. On 2/26/13 she followed up with Dr about the lab work and the rash. Dr told her that the rash was a normal reaction to the varicella vaccine and there was nothing that they could give her at that time. 3/5/13 she came here stating that she was feeling ill since she had the vaccine. She did not say anything about a reaction at the time of the vaccine, only that she had felt bad since the vaccines and we offered to call an ambulance. She opted to go to the ER with the friend she was with, rather than go by ambulance. There she was examined there, lab work was done, which was normal, and she sent her home. Later that day she started trembling and she went to the ER at the hospital. They put her on a short course of steroids to take until 3/10/2013. They told her that the CBC was abnormal and she could follow up with Dr. 3/11/13 she followed up with Dr who referred her to a Neurologist. She is awaiting the appointment with this doctor.
Age: 0.26
Sex: F
Vaccine: PPV, RVX, PNC, RV1
Symptoms: Abdominal pain upper, Asthenia, Haematochezia, Irritability, Pyrexia
Clinical narrative: Apparent cramping pain, blood and mucous in stool x 1. No further blood or pain. Stool now guaiac negative.
Age: 0.26
Sex: F
Vaccine: PPV, RVX, PNC, RV1
Symptoms: Abdominal pain, Haematochezia, Mucous stools, Occult blood negative
Clinical narrative: Apparent cramping pain, blood and mucous in stool x 1. No further blood or pain. Stool now guaiac negative.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Arthralgia, Muscle tightness, Musculoskeletal pain, Tenderness
Clinical narrative: Arthalgia and myalgia starting 2 days after receiving vaccination and continuing to present day.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Arthralgia, Myalgia
Clinical narrative: Arthalgia and myalgia starting 2 days after receiving vaccination and continuing to present day.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Arthralgia
Clinical narrative: Arthalgia and myalgia starting 2 days after receiving vaccination and continuing to present day.
Age: 13.0
Sex: F
Vaccine: TYP, TYP
Symptoms: Chest discomfort, Lip swelling, Throat irritation
Clinical narrative: Swollen upper lip, sensation of swollen throat without stridor or dyspnea. Throat was not itchy. Upon review of systems, no nausea/vomiting/diarrhea, wheezing, dysphagia, acute nasal congestion or scleral injection, angioedema, presyncope/syncope or other anaphylactic symptoms developed. She took Benadryl 50mg aggregate and visited the PCP's office. She was advised to stop the course of antihistamines. The following evening, she developed a rash on her back and hives on her lower abdomen which became itchy, for which she was treated with 50mg Benadryl with resolution.  She had a few doses of cetirizine or Benadryl subsequently, then no recurrences. + antecedent URI 1 month prior.
Age: 13.0
Sex: F
Vaccine: TYP, TYP
Symptoms: Lip swelling, Pharyngeal oedema, Rash, Skin test negative, Urticaria
Clinical narrative: Swollen upper lip, sensation of swollen throat without stridor or dyspnea. Throat was not itchy. Upon review of systems, no nausea/vomiting/diarrhea, wheezing, dysphagia, acute nasal congestion or scleral injection, angioedema, presyncope/syncope or other anaphylactic symptoms developed. She took Benadryl 50mg aggregate and visited the PCP's office. She was advised to stop the course of antihistamines. The following evening, she developed a rash on her back and hives on her lower abdomen which became itchy, for which she was treated with 50mg Benadryl with resolution.  She had a few doses of cetirizine or Benadryl subsequently, then no recurrences. + antecedent URI 1 month prior.
Age: 4.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site vesicles, Injection site warmth, Lethargy
Clinical narrative: Large, red, hot, painful blister the size of a softball at injection site accompanied by medium grade fever of 102 and lethargy.
Age: 4.0
Sex: M
Vaccine: TDAP
Symptoms: Pyrexia
Clinical narrative: Large, red, hot, painful blister the size of a softball at injection site accompanied by medium grade fever of 102 and lethargy.
Age: 12.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Blood glucose decreased, Contusion, Fall, Head injury, Syncope
Clinical narrative: Fainted, fell and hit head on ground. Contusion to lip. EMS responded on scene.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Guillain-Barre syndrome
Clinical narrative: Guillain-Barre syndrome following one week after flu vaccine.
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a consumer refers to herself, a female patient of unknown age and no reported medical history. On an unknown date the patient was vaccinated with ZOSTAVAX (route, dose and lot number unknown). No other suspect therapies or concomitant medications were reported. On an unknown date the patient experienced may have been improperly stored. Noted that she received ZOSTAVAX withiout any proper storage instructions but was not administered the dose but that these other doses of ZOSTAVAX dispensed by this pharmarcy may have been improperly stored and administered to other unspecified patients on unspecified dates. Consumer requested AE follow up report be sent to the owner of the pharmacy. Please note the consumer did not want AE follow up report sent to her physician. No adverse effect reported. Please note that PQC filed on possible missing prescribing information for ZOSTAVAX packaging. The primary reporter, reports that she has not received the improperly stored dose of ZOSTAVAX. She is reporting an improper practice which may affect unspecified numbers of unspecified patients. Additional information has been requested.
Age: 41.0
Sex: F
Vaccine: TD
Symptoms: Erythema, Induration, Injected limb mobility decreased, Oedema peripheral, Skin warm
Clinical narrative: Td given in ER on Sunday 3/10/13 to Health Dept today arm is red, swollen, hot to touch, hard - area where shot is given is toward back of arm. Pt states could barely move/raise arm has been using TYLENOL the entire time.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site rash, Injection site warmth
Clinical narrative: This spontaneous report as received from a 64 year old female technician pharmacist reporting on herself. On an unknown date the patient was vaccinated with ZOSTAVAX (lot # unspecified by reporter), subcutaneous (dose and site unspecified). On an unknown date immediately after getting ZOSTAVAX, the patient experienced flat, grainy rash as large as her hand at the injection site. The patient reported that had no fever but reported that rash was warm to touch and also the patient was tired. The outcome of she also was tired, rash was warm to touch and injection site rash was reported as recovered/resolved 10 days after injection. The patient did not seek medical attention. Additional information is not expected.
Age: 5.0
Sex: U
Vaccine: MMR, MMRV
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a 5 year old patient. On 08-MAR-2013 the patient was vaccinated with a dose of M-M-R II (lot# not reported) and PROQUAD (merck) (lot# not reported), subcutaneously. No adverse effect reported. It was unknown if the patient sought medical attention. Additional information has been requested.