chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 11.0
Sex: M
Vaccine: HPV4
Symptoms: Pain, Respiratory disorder, Sinus disorder, Streptococcus test
Clinical narrative: Within a day or so if getting the injection.  Patient began to experience numerous abnormal symptoms.  These included, dizziness, body aches, joint pain, headache, fatigue, brain fog, trouble sleeping, weakness especially in legs, ongoing sinus and upper respiratory problems.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus generalised, Rash generalised, Rash maculo-papular
Clinical narrative: Generalized itching, generalized maculopapular rash, no fever.
Age: 41.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Feeling hot, Headache, Hyperhidrosis, Nausea
Clinical narrative: Sweaty, hot, headache, nausea, lightheaded, dizzy.
Age: 34.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain, Pruritus generalised
Clinical narrative: VERY VERY SORE IN RIGHT ARM WHERE SHOT WAS GIVEN.. SIGNIFICANTLY MORE SORENESS THAN USUAL.. AND ITCHING ALL OVER.. IT HAS BEEN COMING AND GOING AT RANDOM PLACES. MAINLY ARMS, CHEST, AND LEGS.. NO TREATMENT YET FOR IT. I GOT THE SHOT LAST NIGHT SO WILL GIVE IT A FEW DAYS. I HAVE NEVER HAD IT ITCH BEFORE UNTIL THIS TIME. I AM POSITIVE THAT IS WHAT IT IS COMING FROM THOUGH AS IT STARTED AN HOUR AFTER THE SHOT AND IS CONTINUING STILL AND I HAVE NOT DONE ANYTHING DIFFERENT..
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Joint range of motion decreased, Mobility decreased, Musculoskeletal pain, Periarthritis, X-ray limb
Clinical narrative: Extreme pain in shoulder. Unable to move arm. Saw doctor. Was told by the doctor that the placement of the flu shot had caused my shoulder to freeze. Had x-rays to eliminate any other causes. Prescribed prednisone and therapy.  After a month and a half, it is still very painful. Range of motion is markedly reduced.
Age: 32.0
Sex: M
Vaccine: ANTH, TYP
Symptoms: Injection site bruising, Injection site erythema, Injection site warmth
Clinical narrative: Bruising at the site (L arm) redness down and warm to the touch about 4 inches around injection site.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 03-OCT-2013, the patient was vaccinated with a dose of VARIVAX (Merck) (dose, route and lot number not provided) that was stored in improper temperature. This is one of several reports from the same source. Additional information is not expected.
Age: 10.0
Sex: F
Vaccine: HPV4, PPV
Symptoms: Chest pain, Dyspnoea, Erythema, Pallor, Wheezing
Clinical narrative: Post administration of PNV23 (PNEUMOVAX) pt. got red, pale, chest pain, SOB, wheezing. Dr. gave the pt 0.3mg AUVI-Q on lat. (R) thigh.
Age: 1.02
Sex: F
Vaccine: FLU3, MMR, PNC13, VARCEL
Symptoms: Irritability, Pyrexia
Clinical narrative: Fever of 102.3 and fussiness.
Age: 1.32
Sex: M
Vaccine: DTAP
Symptoms: Injection site bruising, Injection site haemorrhage, Injection site nodule
Clinical narrative: Pt bled and developed 1 inch knot w/ 1 cm bruise after DTaP in (R) upper thigh.
Age: 0.51
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13
Symptoms: Pyrexia, Upper respiratory tract infection
Clinical narrative: Child had vaccines on 12/16/13, developed fever following day bwt. 102 degrees-104 degrees F. Was seen in ER 12/20/13 and dx with URI and discharged with MOTRIN and phenylephrine 0.125 drops. Fever cont. 2 more days. Doctor feels the fever was d/t respiratory illness rather than vaccine.
Age: 0.38
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC13, RV5
Symptoms: Body temperature increased, Febrile convulsion
Clinical narrative: Febrile seizure in afternoon - mom called paramedics - taken to hospital where temp was 102.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Lip discolouration, Lip swelling, Swelling face
Clinical narrative: Vaccine given 9-30-13. C/o 3 days after face and lip swelled up. Black spot on lip remains. "Couldn't handle breathe so took a breathing tx" went to center for eval.
Age: 1.01
Sex: F
Vaccine: FLU3, HEPA, MMR, PNC13, VARCEL
Symptoms: Erythema, Injection site swelling, Injection site warmth, Macule, Pruritus
Clinical narrative: Swollen area in left upper thigh, scant papular rash on trunk and arms with red macule on left axilla x 3 - 4 days. Left thigh swollen and warm to touch. Advised to use calamine lotion prn pruritis. Seen on 1/10/14.
Age: 1.01
Sex: F
Vaccine: FLU3, HEPA, MMR, PNC13, VARCEL
Symptoms: Rash papular
Clinical narrative: Swollen area in left upper thigh, scant papular rash on trunk and arms with red macule on left axilla x 3 - 4 days. Left thigh swollen and warm to touch. Advised to use calamine lotion prn pruritis. Seen on 1/10/14.
Sex: U
Vaccine: MMR
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to an university student patient of unknown age and gender. On 23-DEC-2013 the patient received a dose of M-M-R II (dose, route, and lot number not provided) and on 09-JAN-2013 was inadvertently given a second dose of M-M-R II (dose, route, and lot number not provided). No adverse effects were reported. Additional information has been requested.
Age: 73.0
Sex: M
Vaccine: FLU3
Symptoms: Cough, Injection site bruising, Respiratory tract congestion
Clinical narrative: Patient states he developed a cough on 1/1/14 that progressively worsened into severe chest congestion. On 1/7/14 he received azithromycin and felt better on 1/9. Still coughing on 1/16 and plans to go back to his MD for recheck. Also small bruise at injection site.
Age: 60.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Persistent, daily, aching pain at left upper arm with tenderness at biceps muscle and biceps tendon. No bruising, mass, erythema or swelling. Normal neuro/vascular.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Urticaria, Vaccination complication
Clinical narrative: Redness and swelling of upper left arm near injection site. Currently a large whelp at the site. Dr. examined the injection site 10:30 A.M. on 1/16/2014: a reaction to the shingles vaccine.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unknown number of patients of unknown age and gender. From February 2013 to April 2013, the patients were vaccinated with doses of VARIVAX (merck) (dose and lot # were not reported) that were exposed to multiple excursions and stability information was undetermined. Concomitant therapy was not reported. Doses of VARIVAX (merck) were exposed to temperatures of 12F for 5.5 hours, 11F for 5.5 hours, 10.5F for 5 hours, 11F for 3 hours, 11.5F for 2 hours, 11.5F for 2.5 hours, 11F for 2.5 hours, 11F for 2.5 hours, 10.5F for 2.5 hours, 10.5F for 3 hours, 10.5F for 2.5 hours, 10.5F for 2.5 hours, 10.5F for 3 hours, 10.5F for 3 hours, 10.5F for 2 hours, 11.5F for 2.5 hours, 10.5F for 2.5 hours, 7.5F for 2 hours, 10F for 2.5 hours, 8.5F for 1.5 hours, 9.5F for 1.5 hours, 9.5F for 2 hours, 10F for 1.5 hours, 10F for 2 hours, 10.5F for 2 hours, 10.5F for 2.5 hours, 11.5F for 2.5 hours, 11.5F for 2 hours, 11F for 2 hours, 11.5F for 2.5 hours, 11.5F for 2 hours, 9F for 2 hours, 8F for 1.5 hours, 9F for 2 hours, 9.5F for 1.5 hours, 12F for 1.5 hours, 9F for 2 hours, 11.5F for 2.5 hours, 9.5F for 1.5 hours, 9.5F for 2 hours, 11.5F for 2 hours, 12F for 2 hours, 11.5F for 2 hours, 12.5F for 2 hours, 11.5F for 5 hours, 11.5F for 2 hours, 12.5F for 2 hours, 12.5F for 5 hours, 12F for 5 hours, 11.5F for 2 hours, 11.5F for 4 hours, 11F for 1.5 hours, 10.5F for 2 hours, 15.5F for 3 hours, 9.5F for 2 hours, 10.5F for 2 hours, 11.5F for 3 hours, 12.5F for 2 hours, then 12F for 1.5 hours. No adverse effects was reported. This case is linked to MARRS# 1401USA006142 by the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unknown number of patients of unknown age and gender. From February 2013 to April 2013, the patients were vaccinated with doses of PROQUAD (merck) (dose and lot # were not reported) that were exposed to multiple excursions and stability information was undetermined. Concomitant therapy was not reported. Doses of PROQUAD (merck) were exposed to temperatures of 12F for 5.5 hours, 11F for 5.5 hours, 10.5F for 5 hours, 11F for 3 hours, 11.5F for 2 hours, 11.5F for 2.5 hours, 11F for 2.5 hours, 11F for 2.5 hours, 10.5F for 2.5 hours, 10.5F for 3 hours, 10.5F for 2.5 hours, 10.5F for 2.5 hours, 10.5F for 3 hours, 10.5F for 3 hours, 10.5F for 2 hours, 11.5F for 2.5 hours, 10.5F for 2.5 hours, 7.5F for 2 hours, 10F for 2.5 hours, 8.5F for 1.5 hours, 9.5F for 1.5 hours, 9.5F for 2 hours, 10F for 1.5 hours, 10F for 2 hours, 10.5F for 2 hours, 10.5F for 2.5 hours, 11.5F for 2.5 hours, 11.5F for 2 hours, 11F for 2 hours, 11.5F for 2.5 hours, 11.5F for 2 hours, 9F for 2 hours, 8F for 1.5 hours, 9F for 2 hours, 9.5F for 1.5 hours, 12F for 1.5 hours, 9F for 2 hours, 11.5F for 2.5 hours, 9.5F for 1.5 hours, 9.5F for 2 hours, 11.5F for 2 hours, 12F for 2 hours, 11.5F for 2 hours, 12.5F for 2 hours, 11.5F for 5 hours, 11.5F for 2 hours, 12.5F for 2 hours, 12.5F for 5 hours, 12F for 5 hours, 11.5F for 2 hours, 11.5F for 4 hours, 11F for 1.5 hours, 10.5F for 2 hours, 15.5F for 3 hours, 9.5F for 2 hours, 10.5F for 2 hours, 11.5F for 3 hours, 12.5F for 2 hours, then 12F for 1.5 hours. No adverse effects were reported. This case is linked to MARRS# 1401USA007112 by the same reporter. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Rash macular
Clinical narrative: Blotchy erythema upper (L) arm with swelling from (L) shoulder to elbow eval and tx ice to area BENADRYL P.O.
Age: 6.0
Sex: F
Vaccine: FLUN4
Symptoms: Expired drug administered
Clinical narrative: FLUMIST was given to patient 8 days after expired. Vaccine was still in refrigerator and had been stored under proper conditions.
Age: 15.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Injection site erythema, Injection site urticaria, Local reaction
Clinical narrative: Next day after VAX pt presented with 4.5cm (R) deltoid erythematic wheal. Took BENADRYL 125mg po. Recheck with NP 1/16/14. Pt stated redness down. No angioedema, SOB, or neuro sx. Erythema 6cm, slight wheal. Pt stated "its better"
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Oedema mouth, Swelling face, Swollen tongue
Clinical narrative: Patient states she had swelling tongue, mouth, chin and cheeks. Took BENADRYL next morning had minimal swelling chin other sx resolved. No other treatment necessary.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Rash, Skin lesion, Swelling face
Clinical narrative: 11/19/13 pt came to Dr. c/o chin swelling/blister and rash. Pt had shingles injection in July 2013 and October 2013. 1/15/14 office visit at clinic - pt states new lesions on hands and wrists in Nov. No active lesions currently. Pt states facial outbreak approx. 3 wks after 10/13 vaccine.
Age: 76.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Inflammation
Clinical narrative: Pharmacist gave flu and pneumonia vaccine on same arm and arm is inflamed.
Age: 75.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Cellulitis, Infection, Inflammation
Clinical narrative: Pharmacist gave flu and pneumonia vaccine on same arm and got infected, inflamed (cellulitis). Got admitted in hospital.
Age: 39.0
Sex: F
Vaccine: FLUC3
Symptoms: Pain, Pain in extremity
Clinical narrative: Pt states that following vaccine administration her arm/shoulder became very sore and has remained sore since. She states it is very painful to move her shoulder.
Age: 60.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Blindness unilateral, C-reactive protein increased, Differential white blood cell count, Full blood count, Optic neuritis
Clinical narrative: Sudden vision loss (L) eye 1/2/14 (10 wks after flu vaccine) optic neuritis/papillitis (L) eye.
Age: 60.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Papillitis, Red blood cell sedimentation rate normal, Sudden visual loss, Visual acuity tests
Clinical narrative: Sudden vision loss (L) eye 1/2/14 (10 wks after flu vaccine) optic neuritis/papillitis (L) eye.
Age: 60.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: C-reactive protein increased, Differential white blood cell count, Full blood count, Optic neuritis, Red blood cell sedimentation rate normal
Clinical narrative: Sudden vision loss (L) eye 1/2/14 (10 wks after flu vaccine) optic neuritis/papillitis (L) eye.
Age: 60.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Sudden visual loss, Visual acuity tests
Clinical narrative: Sudden vision loss (L) eye 1/2/14 (10 wks after flu vaccine) optic neuritis/papillitis (L) eye.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Injection site erythema, Injection site pain, Injection site rash
Clinical narrative: On 01/14/14, 70 yo F was seen in clinic for evaluation. During visit, pt was ordered to receive vaccination with pneumococcal polysaccharide vaccine 23-valent (PNEUMOVAX-23) [IMM53] (Order 169086882). Per immunization records, pt received 0.5 mL IM in right deltoid (lot #J009689, NDC #0006-4943-01). On 01/15, pt called clinic & reported a large, painful (8/10) rash at the injection site. Pt reported chills, but no fever, SOB or any other sytemic symptoms. Pt returned to clinic. By time of arrival, pt reported improvement in pain to 6/10. Exam found an oval area of erythema over the right deltoid, ~5 cm x 6 cm. No fluctuance. MD characterized the symptoms as an injection site reaction rather than a cellulitis, given no fever & good response to ibuprofen. Pt with multiple allergies & past drug reactions. The area of erythema was marked with a pen & pt was instructed to monitor for spread of the redness, fever, increasing pain, etc.
Age: 60.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Axillary pain, Back pain, Breast pain, Rash
Clinical narrative: Pain and rash on right side of upper back, axilla, and lateral right breast.
Age: 43.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient aquired a red, swollen, hot area, somewhat painful to touch, the size slightly smaller than a baseball on her upper arm surrounding the injection site, within 24 hours after pneumonia vaccine injection. Patient was treated with Benedryl and cold compress on localized area. 48 hours after injection the pain and swelling was decreased.  96 hours after injection all symptoms had resolved.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site nodule
Clinical narrative: Patient states there is a knot on her arm in the injection location and that she had been told by the doctor that a nerve had possibly been hit.
Age: 65.0
Sex: F
Vaccine: TDAP
Symptoms: Diarrhoea, Dizziness, Fatigue, Headache, Nausea
Clinical narrative: Head ache, dizziness, tiredness, nausea, & diarrhea.
Age: 0.35
Sex: M
Vaccine: RV5
Symptoms: Diarrhoea, Salmonella test positive
Clinical narrative: Loose stools and watery diarrhea.
Age: 18.0
Sex: F
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: Rash.
Age: 46.0
Sex: F
Vaccine: TD
Symptoms: Erythema, Skin warm
Clinical narrative: Came in 1/16/2014 to report redness and warm to touch on upper part of arm, advised to see provider.
Age: 14.0
Sex: M
Vaccine: FLUC3
Symptoms: No adverse event
Clinical narrative: There were no adverse events.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Rash macular
Clinical narrative: Red raised blotches on both legs on the shin and calf.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Pyrexia, Rash, Vomiting
Clinical narrative: Rash, fever, vomiting.
Age: 36.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Incorrect dose administered
Clinical narrative: Patient was given a state purchased pediatric dose of Hepatitis B vaccine, instead of an adult dose.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Bursal fluid accumulation, Motor dysfunction, Muscle atrophy, Musculoskeletal pain, Nuclear magnetic resonance imaging abnormal
Clinical narrative: Shoulder pain and motor deficit later definitively diagnosed as a rotator cuff tear--complete supraspinatus tear on 1/10/2014, with subacromial bursa fluid and muscle atrophy.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Rotator cuff syndrome
Clinical narrative: Shoulder pain and motor deficit later definitively diagnosed as a rotator cuff tear--complete supraspinatus tear on 1/10/2014, with subacromial bursa fluid and muscle atrophy.
Age: 71.0
Sex: M
Vaccine: FLU3
Symptoms: Acute disseminated encephalomyelitis
Clinical narrative: On 1/15/14 patient's daughter informed me that patient was diagnosed with ADEM (acute disseminated encephalomyelitis) secondary to Fluzone HD. He was admitted on 12/1/13 and now is in a hospital.
Age: 1.0
Sex: F
Vaccine: DTAPHEPBIP, HEPA, HIBV, PNC
Symptoms: Staring, Unresponsive to stimuli
Clinical narrative: Not responsive for about 40 sec or so, she was looking glazed and was not responsive to verbal stimulus.
Age: 3.0
Sex: F
Vaccine: FLUN4
Symptoms: Pyrexia, Vomiting
Clinical narrative: Vomiting and low grade fever.
Age: 51.0
Sex: M
Vaccine: TDAP
Symptoms: Disturbance in attention, Dizziness, Headache, Myalgia, Pyrexia
Clinical narrative: Fever, myalgia, headache, dizziness, difficulty concentrating.
Age: 71.0
Sex: M
Vaccine: FLUX
Symptoms: Dizziness, Dysstasia, Eye movement disorder, Hyperhidrosis, Nausea
Clinical narrative: Vertigo:  room spinning, dizzy, eye movement, nausea, perspiration, unable to stand.
Age: 71.0
Sex: M
Vaccine: FLUX
Symptoms: Vertigo
Clinical narrative: Vertigo:  room spinning, dizzy, eye movement, nausea, perspiration, unable to stand.
Age: 16.0
Sex: F
Vaccine: FLU3
Symptoms: Bursitis, Ultrasound joint
Clinical narrative: Patient has developed gradual subacromial bursitis following the injection over the last two months.  She is currently prescribed physical therapy and is still symptomatic.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Bursitis, Skeletal survey abnormal
Clinical narrative: Patient developed gradual onset of subacromial bursitis in the shoulder.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age and gender. On 14-MAY-2007 the patient was vaccinated with the first dose of GARDASIL (lot#, dose unspecified), intramuscularly. On 13-MAY-2009 and 20-DEC-2013, the patient received the second dose and third dose of GARDASIL (lot# and dose unspecified) intramuscularly, in respectively. No adverse event reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Breast cancer female, Herpes zoster, Pain, Skin lesion
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a female patient in her early 70's. On an unknown date the patient was vaccinated with ZOSTAVAX (lot#, expiration date, route not reported). On an unknown date (reported "about a year" after her ZOSTAVAX dose, the patient developed shingles that were "very severe". The patient had lesions on her trunk which were on her chest and on her back. An unspecified amount of time after the patient received ZOSTAVAX, the patient was diagnosed with breast cancer. The physician did not have information as to whether the patient had a medical history of any cancers or information as to the patient's cancer treatment. The patient was prescribe unspecified pain medications for severe shingles related pain and treated with VALTREX. The physician stated that he "believed the patient had recovered, but he had not seen her for follow up in a couple months". The outcome of breast cancer was unknown. Upon internal review, breast cancer was considered as medically significant. This is one of the two reports from the same source. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from an office manager refers to a patient of unknown age. On an unknown date over one year ago the patient was vaccinated with GARDASIL (lot#, expiration date, dose, route, indication not reported). The patient might have received the 2nd dose of GARDASIL late. No adverse effects reported. Additional information has been requested.
Age: 0.36
Sex: F
Vaccine: RV5
Symptoms: Barium enema normal, Culture stool, Decreased appetite, Intussusception, Laboratory test
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 4 month old female patient. Pertinent medical history, drug reaction or allergies were denied. On 04-OCT-2013, the patient was vaccinated with ROTATEQ dose 1 (concentration, route and lot # were not reported). On 02-JAN-2014, the patient was vaccinated with ROTATEQ dose 2, 2 ml, oral, lot# J008383, expiration date: 28-NOV-2014. None concomitant medication reported. On 08-JAN-2014, six days after receiving the second dose, the patient experienced intussusception. On 08-JAN-2014, the patient was admitted to a hospital. The nurse stated that the patient had an ultrasound, stool culture and unspecified labs during her hospital stay (results were not reported). On 09-JAN-2014, the patient was given a barium study and the results showed "no reoccurrence". 48 hours after admission, the patient was discharged from the hospital. On 10-JAN-2014, the patient was seen in the doctor's office and the nurse stated that the patient's stool were back to normal and that she was back to eating. On 10-JAN-2014, the patient recovered from intussusception. Causality was not reported. Additional information has been requested.
Age: 0.36
Sex: F
Vaccine: RV5
Symptoms: Ultrasound scan
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 4 month old female patient. Pertinent medical history, drug reaction or allergies were denied. On 04-OCT-2013, the patient was vaccinated with ROTATEQ dose 1 (concentration, route and lot # were not reported). On 02-JAN-2014, the patient was vaccinated with ROTATEQ dose 2, 2 ml, oral, lot# J008383, expiration date: 28-NOV-2014. None concomitant medication reported. On 08-JAN-2014, six days after receiving the second dose, the patient experienced intussusception. On 08-JAN-2014, the patient was admitted to a hospital. The nurse stated that the patient had an ultrasound, stool culture and unspecified labs during her hospital stay (results were not reported). On 09-JAN-2014, the patient was given a barium study and the results showed "no reoccurrence". 48 hours after admission, the patient was discharged from the hospital. On 10-JAN-2014, the patient was seen in the doctor's office and the nurse stated that the patient's stool were back to normal and that she was back to eating. On 10-JAN-2014, the patient recovered from intussusception. Causality was not reported. Additional information has been requested.
Age: 81.0
Sex: M
Vaccine: VARZOS
Symptoms: Musculoskeletal disorder, Musculoskeletal pain, Pain in extremity
Clinical narrative: This spontaneous report as received from an 81 year old male consumer refers to himself. The patient's medical history included colon bleeding after using aspirin 4 years ago. Current condition includes "blood pressure". On an unknown date in July 2013 the patient was vaccinated with ZOSTAVAX (dose, units, route, lot # unknown). Concomitant therapies included unspecified "blood pressure" drug. On the next day after receiving ZOSTAVAX, the patient felt pain and soreness in the injection arm. The pain had continued, and progressed into the patient's shoulder about 3 months ago. The patient went to health care professional (HCP) to seek medical attention. The patient's HCP prescribed unspecified pain reliever pills that only relieve some of the pain "but not all of it." The patient stated that this pain was constant and getting worse. The patient said he "can't use" the affected arm. No lab test was performed. Outcome of "can't use the affected arm" was unknown. Additional information has been requested.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a physician refers to a 54 year old female patient. In March 2012 the patient was vaccinated with a dose of ZOSTAVAX (lot#, expiration date, dose, route not reported). In November 2012 the patient developed a case of shingles, it was a mild case that was not painful and manifested as "two spots right on her bra strap, on her ribs." The patient sought medical attention. She received VALTREX as treatment and had fully recovered. This is one of the two cases from the same source. Additional information is not expected.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Ear discomfort, Feeling abnormal, Feeling hot, Immediate post-injection reaction
Clinical narrative: This spontaneous report as received from a nurse refers to a 23 year old female patient with no pertinent medical history and no drug reactions/allergies. On 25-JUN-2013 the patient was vaccinated with the first dose of 0.5 ml GARDASIL (lot #, expiration date unspecified), intramuscular with no adverse effects. On 26-AUG-2013 the patient was vaccinated with the second dose of 0.5 ml GARDASIL (lot #, expiration date unspecified), intramuscular. On 26-AUG-2013 immediately after the injection, the patient seeing black spots in vision and her ears felt clogged and felt like they were "stuffed with cotton", a feeling of being hot, dizzy, light headed and wanting to pass out. The nurse stated that the patient did not lose consciousness. The patient had no additional symptoms until reporting day, 13-NOV-2013 the patient was vaccinated with the third dose of 0.5 ml GARDASIL (lot #, expiration date unspecified), intramuscular. No concomitant medication was reported. On 13-NOV-2013 the patient experienced the same symptoms. The nurse stated that the symptoms were transient and resolved while the patient was kept in the office for observation after the injection. The nurse stated that the patient reported that she experienced no symptoms between doses. No lab diagnostics studies performed. No treatment was given. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Loss of consciousness, Melanoderma
Clinical narrative: This spontaneous report as received from a nurse refers to a 23 year old female patient with no pertinent medical history and no drug reactions/allergies. On 25-JUN-2013 the patient was vaccinated with the first dose of 0.5 ml GARDASIL (lot #, expiration date unspecified), intramuscular with no adverse effects. On 26-AUG-2013 the patient was vaccinated with the second dose of 0.5 ml GARDASIL (lot #, expiration date unspecified), intramuscular. On 26-AUG-2013 immediately after the injection, the patient seeing black spots in vision and her ears felt clogged and felt like they were "stuffed with cotton", a feeling of being hot, dizzy, light headed and wanting to pass out. The nurse stated that the patient did not lose consciousness. The patient had no additional symptoms until reporting day, 13-NOV-2013 the patient was vaccinated with the third dose of 0.5 ml GARDASIL (lot #, expiration date unspecified), intramuscular. No concomitant medication was reported. On 13-NOV-2013 the patient experienced the same symptoms. The nurse stated that the symptoms were transient and resolved while the patient was kept in the office for observation after the injection. The nurse stated that the patient reported that she experienced no symptoms between doses. No lab diagnostics studies performed. No treatment was given. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: DTAP, FLUN4, IPV, MMR, VARCEL
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Vomiting and diarrhea.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: This spontaneous report as received from a pharmacist via a company representative refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX, (lot #, expiration date, dose and route not reported) for shingles prevention. Pharmacist stated the patient experienced redness and tenderness at injection site on an unspecified date. It was unspecified if the patient had sought medical attention. The outcome of the events was unknown. This is one of several reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site reaction
Clinical narrative: This spontaneous report as received from a pharmacist via a company representative refers to a female patient under 50 years old (the pharmacist's wife). On an unknown date the patient was vaccinated with a dose of ZOSTAVAX, (lot #, expiration date, dose and route not reported) for shingles prevention. Pharmacist stated that his wife had received ZOSTAVAX on an unspecified date, at an unspecified pharmacy. The pharmacist's wife who was under 50 years old at the time of administration had an injection site reaction, on an unspecified date, involving redness and tenderness at the injection site. The outcome of the events was unknown. It was unspecified if the patient had sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HEPA, MNQ
Symptoms: Erythema, Feeling hot, Local swelling, Pruritus
Clinical narrative: Localized redness, swelling, itching, warmth. Cold compress, BENADRYL, MOTRIN.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Injection site swelling
Clinical narrative: This spontaneous report as received from a patient's mother refers to a 14 year old patient with no pertinent medical history and no drug reactions/allergies. On 09-AUG-2013 and 11-OCT-2013 the patient was vaccinated with two doses of recalled lot of GARDASIL (lot # J007354, expiration date 20-FEB-2016), dose unspecified, intramuscular for prevention of HPV respectively. No concomitant medication was reported. On 11-OCT-2013, the patient experienced headache and swelling around the injection site after receiving the recalled GARDASIL. No lab diagnostics studies performed. The patient had no sought medical attention. Ibuprofen was given for headache, cold packs and heat were provided for swelling. Headache and swelling resolved within 48 hours. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Erythema, Inflammation, Pain
Clinical narrative: Pain, inflammation, redness very sore.
Age: 66.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Pt says she developed a case of shingles after receiving the ZOSTAVAX injection. A rash developed. She went to her doctor who prescribed acyclovir 5% topical.
Age: 27.0
Sex: F
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 27 years patient of unknown gender. The healthcare worker reported that a 27 years old patient received the first dose of GARDASIL (lot # unspecified) (dose, route and location unspecified) for vaccination on 10/03/2013. No adverse event reported. Additional information is not expected.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Body temperature increased, Clostridium test positive, Diarrhoea, Feeling hot, Flushing
Clinical narrative: Patient became flushed several minutes following vaccine and said she felt hot. After sitting for a few minutes it went away. Pt. left store with husband. That night felt nauseated, vomiting, diarrhea and temp of approximately 101. Was advised by RPh on duty to go to ER. Given Rx of FLAGYL. Instructed to follow up with PCP or Gastroenterologist. Stool culture was positive for C. Diff.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea, Vomiting
Clinical narrative: Patient became flushed several minutes following vaccine and said she felt hot. After sitting for a few minutes it went away. Pt. left store with husband. That night felt nauseated, vomiting, diarrhea and temp of approximately 101. Was advised by RPh on duty to go to ER. Given Rx of FLAGYL. Instructed to follow up with PCP or Gastroenterologist. Stool culture was positive for C. Diff.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Syringe issue, Underdose
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gener. On 27-DEC-2013 the patient was vaccinated with less than a full dose of ZOSTAVAX (lot #, expiration date, dose, indication, route not reported). No adverse effects reported. Follow up information was received from an other pharmacist. The pharmacist reported that on 18-DEC-2013 (previously reported as 27-DEC-2013) the patient was vaccinated with ZOSTAVAX (lot #, expiration date, dose and route were not reported). The pharmacist also reported that "half the dose leaked out of the syringe and ran down the patients arm during administration". Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Chest discomfort, Electrocardiogram
Clinical narrative: Tight feeling in chest "elephant sitting on chest". Not complaining of difficulty of breathing or signs of anaphylaxis, no rash. Pharmacist and ER Dr. did not feel epinephrine was indicated.
Age: 61.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Vaccination complication
Clinical narrative: Tight feeling in chest "elephant sitting on chest". Not complaining of difficulty of breathing or signs of anaphylaxis, no rash. Pharmacist and ER Dr. did not feel epinephrine was indicated.
Age: 52.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Skin warm
Clinical narrative: Arm red, warm.
Age: 21.0
Sex: M
Vaccine: HEP, HEPA, HPV4, TDAP
Symptoms: Convulsion, Laboratory test, Leukocytosis, Vaccination complication
Clinical narrative: At 1448 on 11/26/2013 this pt. received Tdap, HPV, Hep A and Hep B at this clinic. He has been receiving immunization since 1992 without any adverse reaction. At 1508 on 11/26/2013 seen by a medical provider at this clinic for genital warts, penis. While at the clinic the pt. did not show any signs/symptoms of an adverse reaction to the vaccines. At 1959 on 11/26/2013 the pt. was seen at the Medical Center. The ER physician noted that the pt. had received vaccines 11/26/2013. Several tests were completed which are attached. The pt. was discharged from the ER 11/27/2013 at 00:27. "Impression: Seizure, leukocytosis - unspecified" pt was prescribed KEPPRA at that time. This pt. has been under neuro. care since his TBI 6/10/2012. On 1/13/2014 the pt. returned to this clinic for a refill on the KEPPRA. On that day he was seen by one of our providers. On that date Dr. dx the seizure of 11/26/2013 as "related to adverse effect of immunization". I am not aware that the ER physician or Dr. had attributed the seizure of 11/26/2013 to the vaccines. Since Dr. has related the seizure to the vaccines we are notifying VAERS today 1/16/2014. Please let me know if you need any additional information.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Dermatitis herpetiformis, Eczema, Nasopharyngitis, Pain
Clinical narrative: Fever, aches, cold-like symptoms. A few weeks later developed eczema patches on shoulder, lower back, both outer thighs. Later developed itchy bumps and painful blisters on face and neck area. Diagnosed by dermatologist in October 2011 by biopsy as dermatitis Herpetiformis. Have since deleted Gluten from my diet and skin care products. Still have occasional flare-ups.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Rash pruritic
Clinical narrative: Fever, aches, cold-like symptoms. A few weeks later developed eczema patches on shoulder, lower back, both outer thighs. Later developed itchy bumps and painful blisters on face and neck area. Diagnosed by dermatologist in October 2011 by biopsy as dermatitis Herpetiformis. Have since deleted Gluten from my diet and skin care products. Still have occasional flare-ups.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Hypotension, Loss of consciousness
Clinical narrative: Case number PHHY2013US140165 is an initial spontaneous report received via vaccine adverse event reporting system (VAERS reference number: 504148) on 03 Dec 2013 and a follow-up information was received from Quality Assurance Department (reference number: 269007) on 09 Dec 2013 and another follow up received from QA department on 15 Jan 2014. This report refers to a 75 years-old female patient. Her medical history included hypothyroidism, hypertension and osteoporosis. Her concomitant medications were LUNESTA, levothyroxine, liothyronine, pravastatin, amlodipine and PREMARIN. She was vaccinated with FLUVIRIN (batch number: 1307901) intramuscularly in the left arm on 24 Sep 2013. On 24 Sep 2013, one to two minutes after immunization, she lost consciousness for approximately 10-15 seconds. She regained consciousness and her vital signs were monitored until EMTS arrived. She was given intravenous fluids and had a low blood pressure of approximately 80/50 and was taken to a local emergency room. The outcome was reported as complete recovery. Batch review report (reference number: 269007) received from quality assurance department on 15 Jan 2014. Based on the batch review performed, it was concluded that FLUVIRIN (batch number: 1307901) was manufactured in accordance with approved internal procedures and it is in compliance with the current good manufacturing practices (cGMP) requirements. Non-significant follow-up received from Quality Assurance Department (reference number: 269007) on 09 Dec 2013: Updated QA reference number only. Significant follow up received from Quality Assurance Department on 15 Jan 2014: Updated Batch review report.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Aphasia, Crying, Dizziness, Dyskinesia, Feeling hot
Clinical narrative: Case number PHHY2014US000836 is an initial spontaneous report received from a consumer via the Vaccine Adverse Event Reporting System (VAERS reference number: 507311) website on 06 Jan 2014 and a follow up information received from the quality assurance department on 15 Jan 2014. This report refers to a 44-year-old female patient. Her medical history included allergies, asthma, rhinitis, and sinusitis. She was currently suffering from fall allergy symptoms and a little motion vertigo. Her concomitant medications included ZYRTEC, evening primrose oil for cyst , fish oil, probiotic, and women's daily multivitamin. On 14 Oct 2013, she was vaccinated with FLUVIRIN (batch number: not reported) intramuscularly in the left arm. On the same day, after vaccination, she experienced pain in left arm, muscle weakness, dizziness, and seizure-like activity with staring spell along with inability to speak or move for a few minutes. She experienced the same events again on 15 Oct 2013, at about 9 am. She also reported that she was also feeling hot and light-headed, following which she fainted. She had also cried and reported that her body felt like it was jerking. She visited a nurse who described it as "looking like a seizure" and referred her to a neurologist. The outcome of the events was reported as condition unchanged as of 15 Oct 2013. The seriousness and causality of the events were not reported. The quality assurance department has confirmed that the initially reported batch number: 66521011610 was invalid and therefore, a QA investigation could not be performed. Follow up information received from quality assurance department on 15 Jan 2014: The quality assurance department has confirmed that the initially reported batch number: 66521011610 was invalid and therefore, a QA investigation could not be performed.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Hypokinesia, Muscular weakness, Pain in extremity, Seizure like phenomena, Staring
Clinical narrative: Case number PHHY2014US000836 is an initial spontaneous report received from a consumer via the Vaccine Adverse Event Reporting System (VAERS reference number: 507311) website on 06 Jan 2014 and a follow up information received from the quality assurance department on 15 Jan 2014. This report refers to a 44-year-old female patient. Her medical history included allergies, asthma, rhinitis, and sinusitis. She was currently suffering from fall allergy symptoms and a little motion vertigo. Her concomitant medications included ZYRTEC, evening primrose oil for cyst , fish oil, probiotic, and women's daily multivitamin. On 14 Oct 2013, she was vaccinated with FLUVIRIN (batch number: not reported) intramuscularly in the left arm. On the same day, after vaccination, she experienced pain in left arm, muscle weakness, dizziness, and seizure-like activity with staring spell along with inability to speak or move for a few minutes. She experienced the same events again on 15 Oct 2013, at about 9 am. She also reported that she was also feeling hot and light-headed, following which she fainted. She had also cried and reported that her body felt like it was jerking. She visited a nurse who described it as "looking like a seizure" and referred her to a neurologist. The outcome of the events was reported as condition unchanged as of 15 Oct 2013. The seriousness and causality of the events were not reported. The quality assurance department has confirmed that the initially reported batch number: 66521011610 was invalid and therefore, a QA investigation could not be performed. Follow up information received from quality assurance department on 15 Jan 2014: The quality assurance department has confirmed that the initially reported batch number: 66521011610 was invalid and therefore, a QA investigation could not be performed.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Syncope
Clinical narrative: Case number PHHY2014US000836 is an initial spontaneous report received from a consumer via the Vaccine Adverse Event Reporting System (VAERS reference number: 507311) website on 06 Jan 2014 and a follow up information received from the quality assurance department on 15 Jan 2014. This report refers to a 44-year-old female patient. Her medical history included allergies, asthma, rhinitis, and sinusitis. She was currently suffering from fall allergy symptoms and a little motion vertigo. Her concomitant medications included ZYRTEC, evening primrose oil for cyst , fish oil, probiotic, and women's daily multivitamin. On 14 Oct 2013, she was vaccinated with FLUVIRIN (batch number: not reported) intramuscularly in the left arm. On the same day, after vaccination, she experienced pain in left arm, muscle weakness, dizziness, and seizure-like activity with staring spell along with inability to speak or move for a few minutes. She experienced the same events again on 15 Oct 2013, at about 9 am. She also reported that she was also feeling hot and light-headed, following which she fainted. She had also cried and reported that her body felt like it was jerking. She visited a nurse who described it as "looking like a seizure" and referred her to a neurologist. The outcome of the events was reported as condition unchanged as of 15 Oct 2013. The seriousness and causality of the events were not reported. The quality assurance department has confirmed that the initially reported batch number: 66521011610 was invalid and therefore, a QA investigation could not be performed. Follow up information received from quality assurance department on 15 Jan 2014: The quality assurance department has confirmed that the initially reported batch number: 66521011610 was invalid and therefore, a QA investigation could not be performed.
Age: 76.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Dizziness, Dyspnoea
Clinical narrative: Case number PHHY2014US000890 is an initial spontaneous report received from health care professional via Vaccine Adverse Event Reporting System (VAERS reference number: 507908) website on 06 Jan 2014 and a follow up received from Quality Assurance Department (QA, reference number: 273839) on 16 Jan 2014. This case refers to 76-year-old female patient. The patient was vaccinated with FLUVIRIN (batch number: 1308601) intramuscularly in left arm and ZOSTAVAX (other manufacturer, batch number: J007856) subcutaneously in right arm both on 24 Sep 2013. On 24 Sep 2013, the patient developed lightheadedness and shortness of breath. She was given two 25 mg capsules of diphenhydramine. Paramedics also administered oxygen and patient was taken to hospital for observation. She was released two hours later. The outcome of events was reported as complete recovery. The seriousness and causality of events was not reported. Based on the batch review performed, the QA department conclude that the FLUVIRIN (batch number: 1308601) was manufactured in accordance with the approved internal procedures and it is compliance with the cGMP requirements. Follow-up received from Quality Assurance Department (reference number: 273839) on 16 Jan 2014: Updated batch review report.
Age: 49.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Asthenia, Barium swallow abnormal, Dysarthria, Dysphagia, Dysphonia
Clinical narrative: Case number PHHY2014US000805, is an initial report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 508952) website on 06 Jan 2014, with the follow-up received from PTC department on 16 Jan 2014. This report refers to 49-year-old male patient. His medical history included alcoholism and his current conditions included bilateral avascular necrosis and right hip fracture for which he underwent a surgery right hip arthroplasty. On the second and third day after surgery, he was having difficulty in getting out of bed, but was still able to ambulate. His concomitant medications included chlordiazepoxide at a dose of 25 mg orally thrice daily, docusate at a dose of 100 mg twice daily, enoxaparin at a dose of 40 mg once daily, folic acid at 1 mg orally daily, metaprolol at a dose of 25 mg twice daily orally, multivitamin daily, pantoprazole at a dose of 40 mg orally daily, MIRALAX twice daily. Four days after undergoing surgery, he was vacciated with FLUVIRIN (batch number: 13413P) intramuscularly in the right arm and PNEUMOVAX (other manufacturer, batch number: J007786) intramuscularly in the left arm on 05 Oct 2013. On 09 Oct 2013, he felt diffusely weak on his legs which progressed to a point where he had complete loss of strength in his legs. His speech became dysarthic, hoarse and was unable to swallow well. Lab test like modified barium swallow study was done which showed severe pharyngeal dysphagia. The event outcome was completely recovered. The seriousness was not reported. The causality was reported as not-suspected to the vaccination with FLUVIRIN but other issues related to admission diagnosis and condition. Follow-up received from PTC department on 16 Jan 2014: It was reported that, reported batch number (13413P) belongs to FLUVIRIN and AGRIFLU. Hence product recoded from AGRIFLU to FLUVIRIN.