chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Local swelling, Skin warm
Clinical narrative: Patient described swelling and redness in the arm. Also fever in the arm, but no systemic fever.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Patient noticed redness, pain and heat at sight of injection. At routine dr's appointment, showed dr who prescribed Dicloxacillin for cellulitis.
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Skin lesion
Clinical narrative: Pt reports waking up with 4 lesions on her back 3-4" long.  Nothing at injection site or on arm.  Went to ER.  Reported to Dr and will follow up with her.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Hypersomnia, Migraine, Nausea
Clinical narrative: HEADACHE (MIGRAINE TYPE) AND SEVERE NAUSEA.  SYMPTOMS CONTINUING TO PRESENT (10/20/14 8:00pm).  Have been taking migraine (fioricete and relpax) and Mylanta.  Sleeping quite a bit which helps to calm my stomach.  Received the high dose vaccine by injection.
Age: 41.0
Sex: F
Vaccine: FLUX
Symptoms: Cough, Eye irritation, Eye swelling, Ocular hyperaemia, Swelling face
Clinical narrative: Swollen face, swollen red burning eyes, throat itching, cough.
Age: 41.0
Sex: F
Vaccine: FLUX
Symptoms: Throat irritation
Clinical narrative: Swollen face, swollen red burning eyes, throat itching, cough.
Age: 20.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Headache, Nausea, Pyrexia, Vomiting
Clinical narrative: PT GOT SHOT AFTER 5 TO 10 MIN WENT HOME, ATE, THEN GOT NAUSEA, VOMITED, HEADACHE, CHILLS.  WENT TO CLASS NEXT DAY. FELT NO BETTER. WENT TO STUDENT HEALTH HAD 104 FEVER. THEY SENT HIM TO HOSPITAL.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema
Clinical narrative: Mild skin redness at site of injection. 1 cm circle. Nontender. As of 10/20/2014 the redness has remained constantly without any changes.
Age: 57.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain, Insomnia, Muscular weakness, Neck pain, Pain in extremity
Clinical narrative: Stabbing pain in upper arm that radiates down to fingers and up into the neck causing left arm weakness. Unable to sleep on left side due to left arm pain. Warm packs, ice packs, NSAIDS and OTC topical gels are not helpful. Pain continues with no relief.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Diarrhoea, Nausea, Pain, Pain in extremity
Clinical narrative: Patient stated painful arm, then body aches started and also nausea and diarrhea.  Patient said symptoms continued all weekend but feels better today, arm still hurts.
Age: 1.86
Sex: M
Vaccine: IPV
Symptoms: Abdominal pain, Constipation, Decreased appetite, Grunting, Hyperhidrosis
Clinical narrative: He woke up, irritable, sweaty with a fever of 103.5 and abdominal pain.  He did not sleep that night until about 9 am the next day. He continues to have fever.  During the first two days, he would grunt slightly while breathing.  When he sleeps, he sleeps on his stomach with his legs pulled up under him, including tonight.  Prior to this incident, he would sleep on his back.  We have been treating him with fever reducers as necessary.  We went to the emergency room Sunday where they did not find any sign of infection.  He was constipated and was given glycerin suppositories which caused him to have a large bowel movement.  He was prescribed glycerin suppositories and Miralax for the next few days.  Since the onset of the fever, he has eaten almost nothing.  He does drink milk and fluids.
Age: 1.86
Sex: M
Vaccine: IPV
Symptoms: Insomnia, Irritability, Pyrexia, Urine analysis normal
Clinical narrative: He woke up, irritable, sweaty with a fever of 103.5 and abdominal pain.  He did not sleep that night until about 9 am the next day. He continues to have fever.  During the first two days, he would grunt slightly while breathing.  When he sleeps, he sleeps on his stomach with his legs pulled up under him, including tonight.  Prior to this incident, he would sleep on his back.  We have been treating him with fever reducers as necessary.  We went to the emergency room Sunday where they did not find any sign of infection.  He was constipated and was given glycerin suppositories which caused him to have a large bowel movement.  He was prescribed glycerin suppositories and Miralax for the next few days.  Since the onset of the fever, he has eaten almost nothing.  He does drink milk and fluids.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Altered state of consciousness, Cold sweat, Dizziness, Fatigue, Headache
Clinical narrative: Severe aching; cold clammy skin; profuse sweating; headache; dizziness; nausea; almost passed out; severe fatigue.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Hyperhidrosis, Nausea, Pain
Clinical narrative: Severe aching; cold clammy skin; profuse sweating; headache; dizziness; nausea; almost passed out; severe fatigue.
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Pain, Pain in extremity
Clinical narrative: The patient stated that her arm went numb and then she developed shooting pains down the limb.
Age: 54.0
Sex: M
Vaccine: FLUX
Symptoms: Electromyogram, Haematology test, Laboratory test, Muscular weakness, Musculoskeletal pain
Clinical narrative: Left acute brachial plexus neuritis. Severe left-sided neck, shoulder and arm pain for about 6 days, progressing to left hand, arm, and shoulder muscle weakness.
Age: 54.0
Sex: M
Vaccine: FLUX
Symptoms: Neck pain, Neuralgic amyotrophy, Nuclear magnetic resonance imaging, Pain in extremity, Serology test
Clinical narrative: Left acute brachial plexus neuritis. Severe left-sided neck, shoulder and arm pain for about 6 days, progressing to left hand, arm, and shoulder muscle weakness.
Age: 90.0
Sex: F
Vaccine: FLU3
Symptoms: Aspiration pleural cavity, Atrial fibrillation, Blood test, Chest X-ray, Dyspnoea
Clinical narrative: Fever of 101, shortness of breath, treated on 09/15/2014 for a UTI. Condition worse, admitted to hospital with atrial fib, developed pneumonia, pleural effusion, and pericardial effusion. In hosp. 12 days.
Age: 90.0
Sex: F
Vaccine: FLU3
Symptoms: Echocardiogram, Electrocardiogram, Pericardial effusion, Pleural effusion, Pneumonia
Clinical narrative: Fever of 101, shortness of breath, treated on 09/15/2014 for a UTI. Condition worse, admitted to hospital with atrial fib, developed pneumonia, pleural effusion, and pericardial effusion. In hosp. 12 days.
Age: 90.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia, Urinary tract infection
Clinical narrative: Fever of 101, shortness of breath, treated on 09/15/2014 for a UTI. Condition worse, admitted to hospital with atrial fib, developed pneumonia, pleural effusion, and pericardial effusion. In hosp. 12 days.
Age: 63.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Right deltoid: redness, swollen, itchy and pain. Benadryl 25mg po PRN prescribed.
Age: 14.0
Sex: M
Vaccine: HPV4
Symptoms: Asthenia, Fatigue, Gait disturbance, Hypersomnia, Incoherent
Clinical narrative: Uncontrollable vomitting on the way to school, extreme fatigue after, slept for 10 days with no energy.
Age: 14.0
Sex: M
Vaccine: HPV4
Symptoms: Mononucleosis heterophile test negative, Neurological symptom, Vomiting
Clinical narrative: Uncontrollable vomitting on the way to school, extreme fatigue after, slept for 10 days with no energy.
Age: 33.0
Sex: M
Vaccine: FLU4
Symptoms: Myalgia, Pain
Clinical narrative: Sharp pain within 48 hours of injection. Pain subsided, but after 1 week patient started to notice more muscle pain during overhead movement or reaching behind. Pain getting worse until this day.
Age: 54.0
Sex: F
Vaccine: FLUX, FLU4
Symptoms: Hypoaesthesia, Injection site atrophy, Pain in extremity, Paraesthesia, Ultrasound scan
Clinical narrative: Deep indention in left upper arm with muscle wasting.  Numbness, tingling to arm and fingers.  Achy pain to arm.
Age: 54.0
Sex: F
Vaccine: FLUX, FLU4
Symptoms: Asthenia, Haematoma, Hypoaesthesia, Injection site reaction, Pain in extremity
Clinical narrative: Deep indention in left upper arm with muscle wasting.  Numbness, tingling to arm and fingers.  Achy pain to arm.
Age: 54.0
Sex: F
Vaccine: FLUX, FLU4
Symptoms: Skin warm, Ultrasound scan abnormal
Clinical narrative: Deep indention in left upper arm with muscle wasting.  Numbness, tingling to arm and fingers.  Achy pain to arm.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Induration, Local swelling, Pain in extremity
Clinical narrative: (R) arm - swollen and hard to touch and painful.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Convulsion, Feeling hot, Local swelling, Loss of consciousness, Pharyngeal oedema
Clinical narrative: Itchy, swollen throat and neck at 1 am on 10/18/14. Pt took BENADRYL -> didn't help -> hands swelled up. Internal hives -> went to hospital -> they gave her steroids -> she had a seizure, got hot then passed out. Was discharged 10/20/14.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Throat irritation, Urticaria
Clinical narrative: Itchy, swollen throat and neck at 1 am on 10/18/14. Pt took BENADRYL -> didn't help -> hands swelled up. Internal hives -> went to hospital -> they gave her steroids -> she had a seizure, got hot then passed out. Was discharged 10/20/14.
Sex: U
Vaccine: FLU4
Symptoms: Cellulitis
Clinical narrative: Initial information received on 10 October 2014 from a consumer. The reporter for this case also reported another event which is captured in case 2014SA140898. An unidentified patient was administered on an unspecified date a dose of FLUZONE QIV, (batch number: UI192AA) route and site of vaccination not reported. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced cellulitis. The patient required an ER/doctor visit on an unreported date. Corrective treatment and laboratory investigations were not reported. The reporter considered the event life threatening. At the time of this report, the outcome of the event was reported as unknown. No further details were available at the time of this report. Documents held by sender: none.
Age: 35.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site pain, Injection site swelling, Local swelling, Pain in extremity
Clinical narrative: Swelling and pain in right arm/hand and deltoid.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Local swelling, Pain, Pain in extremity, Poisoning, Rash macular
Clinical narrative: Painful to lay on right arm and painful to touch it got worse, it became swollen, red blotches went down arm and into lymph nodes underneath. 10/17 went to doctor. Doctor diagnosed blood poisoning and prescribed clindamycin. At doctor office temp was normal and BP 107/78. Currently in bed applying heat on arm until tomorrow to see if it improves otherwise doctor advised to go to ER. Just took medicine so has not started to see improvements yet.
Age: 58.0
Sex: U
Vaccine: FLU3, PPV
Symptoms: Staphylococcal infection
Clinical narrative: Staph infection per PCP
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Nausea
Clinical narrative: Pt. called with complaint of feeling lightheaded, dizzy and nausea. Pt. called on call MD who instructed him to take BP, 111/72. 10/1/14 follow up call pt. still not 100% will see MD. Instructed pt. to call us if any symptoms worsen.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Ocular hyperaemia, Pain in extremity, Skin discolouration
Clinical narrative: Had flu shot Friday - next morning I woke up to my arm hurting and black and blue - also - my right eye was real red on outside and above my right eyebrow.
Age: 82.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Pt notified us that left arm, in deltoid region, became red and warm to touch day after administration. Pt advised to take 24mg Diphenhydramine and 400 mg Ibuprofen every 6 hours. Called pt back 24 hours later and he reported arm was not as red anymore, getting better.
Age: 79.0
Sex: U
Vaccine: FLUC3
Symptoms: Eye swelling, Gait disturbance, Headache, Muscular weakness, Musculoskeletal pain
Clinical narrative: Severe pain in my shoulders, arms and weakness in my legs, had difficulty walking - red swollen eyes, visual disturbance and headache. (I will not get another flu vaccine again!)
Age: 79.0
Sex: U
Vaccine: FLUC3
Symptoms: Ocular hyperaemia, Pain in extremity, Visual impairment
Clinical narrative: Severe pain in my shoulders, arms and weakness in my legs, had difficulty walking - red swollen eyes, visual disturbance and headache. (I will not get another flu vaccine again!)
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site scab
Clinical narrative: Patient has redness/tenderness/scab around the injection site. Has not resolved within 9 days so was concerned. Looks like it may have been skin allergy/rxn to bandage adhesive, but pt states it's at actual injection site.
Age: 71.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Headache
Clinical narrative: Persistent headache. Taking acetaminophen with no relief. Advised to continued acetaminophen and try caffeine.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Red, hot itch at site of injection. Apply Benadryl and oral Ibuprofen.
Age: 73.0
Sex: U
Vaccine: FLU3
Symptoms: Erythema, Rash, Skin warm, Swelling
Clinical narrative: Area red, swollen and warm.  Rash in the forearm.
Age: 11.0
Sex: M
Vaccine: FLU4
Symptoms: Cyanosis, Dizziness, Dyskinesia, Loss of consciousness, Musculoskeletal stiffness
Clinical narrative: After receiving injection patient stated "I feel dizzy" lost consciousness for 30 seconds had seizure like movements stiffening of arms and legs and jerking motion, color pale, blue around lips transported to hospital.
Age: 11.0
Sex: M
Vaccine: FLU4
Symptoms: Pallor, Seizure like phenomena
Clinical narrative: After receiving injection patient stated "I feel dizzy" lost consciousness for 30 seconds had seizure like movements stiffening of arms and legs and jerking motion, color pale, blue around lips transported to hospital.
Age: 43.0
Sex: F
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Received FLUZONE vaccination on 10/9/2014. Developed hives to left arm approximately 12 hours post vaccine. Resolved spontaneously by 10/13/2014.
Age: 47.0
Sex: F
Vaccine: FLUC3
Symptoms: Immediate post-injection reaction, Injection site erythema
Clinical narrative: Immediately at onset of giving the influenza vaccie the recipient developed large area of redness on site of injection. Ice pack applied immediately. Offered to have her take BENADRYL but she did not want to.
Age: 34.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Axillary pain, Tenderness
Clinical narrative: Pain and tenderness of left axillary region (left armpit). No swelling or nodules noticed by patient.
Age: 53.0
Sex: F
Vaccine: FLU4, TDAP, VARZOS
Symptoms: Dyspnoea, Injection site erythema, Injection site swelling
Clinical narrative: On 10/6 patient reported redness and swelling at ZOSTAVAX site. We followed up with the patient on 10/10 when she said she was feeling better but did have trouble breathing after injection. She also mentioned that she has "a lot of allergies" that she didn't report at time of vaccination.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Rash, Vaccination complication
Clinical narrative: Patient had rash on backs of hands, forearms and face with itching. Claims reaction due to shot. Reported reaction on 10-13-14. Says reaction started evening of 10/9. Recommended BENADRYL and hydrocortisone cream.
Age: 43.0
Sex: F
Vaccine: FLU4
Symptoms: Dyspnoea, Erythema, Pruritus
Clinical narrative: 10 minutes after receiving vaccine, had diffuse itchiness, sensation of dyspnea, diffuse erythema. Treated at ED with BENADRYL, SOLU-MEDROL, ZANTAC, d/c'd home with BENADRYL and prednisone x 3 days.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Joint range of motion decreased
Clinical narrative: Pain in (L) shoulder, loss of ROM for 1 wk.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site irritation, Injection site scab, Mass, Rash erythematous
Clinical narrative: Lump formed right away. Skin rash is red, irritated, and scabbed over from shoulder to elbow on left arm.
Age: 28.0
Sex: F
Vaccine: FLUX
Symptoms: Bed rest, Chills, Cough, Headache, Influenza like illness
Clinical narrative: Fever of 102.4 for two days, cough, runny nose, headache, chills, flu-like symptoms for three days. Two days in bed with bed rest.
Age: 28.0
Sex: F
Vaccine: FLUX
Symptoms: Pyrexia, Rhinorrhoea
Clinical narrative: Fever of 102.4 for two days, cough, runny nose, headache, chills, flu-like symptoms for three days. Two days in bed with bed rest.
Age: 1.04
Sex: F
Vaccine: FLU4, HEPA
Symptoms: Pyrexia, Vomiting
Clinical narrative: Fever and vomiting started the next day from when vaccine was given.
Age: 28.0
Sex: M
Vaccine: FLU3
Symptoms: Hyperhidrosis, Hypoaesthesia, Pyrexia, VIIth nerve paralysis
Clinical narrative: On Oct 8, 2014 noticed increasing numbness left side of face which progressed to left facial paralysis; transient fever and sweating, went to ED. On Wed night 10/8/14 - diagnosed Bell's palsy; will f/u with PCP on 10/13/14.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Rash generalised
Clinical narrative: Diffuse rash -- looks like pruritus.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Heart rate increased, Hyperhidrosis, Local swelling, Mobility decreased
Clinical narrative: Severe pain, heart beating very fast. Shaking, sweating, fever. Unable to raise arm. Rgt arm swollen and very lg. Red band on arm.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pain, Pyrexia, Tremor
Clinical narrative: Severe pain, heart beating very fast. Shaking, sweating, fever. Unable to raise arm. Rgt arm swollen and very lg. Red band on arm.
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pruritus
Clinical narrative: 1.5 hours post vaccination, developed reddened appearance of arms and face and started to feel "itchy". Has history of receiving FLUZONE in past without reaction.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea, Dyspepsia, Dyspnoea, Hyperventilation
Clinical narrative: 3 hours post vaccination, patient experienced major shortness of breath and hyperventilation. She also had bad diarrhea and heart burn. She visited the doctor the following day and has been dispensed albuterol HFA.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Dysgeusia
Clinical narrative: Day after immunization, reports metallic taste in mouth that persists.
Age: 22.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site inflammation
Clinical narrative: Patient had a red, inflamed 1 1/2 inch diameter circular area around the injection site that was.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Burning sensation, Dizziness, Hyperhidrosis, Nausea
Clinical narrative: Dizziness, burning sensation (whole body), nausea, sweating -> symptoms lasted 45 min-1 hour.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Rash erythematous, Rash pruritic, Skin warm
Clinical narrative: Patients arm has a large, red, itchy rash below where vaccine was administered. Warm to touch and showed up day after vaccine administered.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia
Clinical narrative: 15 min after receiving the Influenza vaccine she developed numbness to her (L) forearm, thumb and index finger.
Age: 14.0
Sex: F
Vaccine: FLU3, HEPA, HPV4
Symptoms: Rash
Clinical narrative: Rash, MD does not think rash is a result of vaccinations, but according to product insert it must be reported.
Age: 76.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Erythema, Fatigue, Headache, Injection site reaction, Pain
Clinical narrative: Pain, redness, swelling, fever, headache, fatigue. Shoulder to elbow.
Age: 76.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Pyrexia, Swelling
Clinical narrative: Pain, redness, swelling, fever, headache, fatigue. Shoulder to elbow.
Age: 82.0
Sex: F
Vaccine: FLU4
Symptoms: Erysipelas, Erythema, Rash
Clinical narrative: Patient had redness/rash beginning the morning after injection. Patient was seen by Dr. and there was concern for erysipelas. Patient was treated conservatively with Amoxicillin 500mg TID x 7 days.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Joint range of motion decreased, Pain in extremity
Clinical narrative: Patient states cannot rotate arm above shoulder, pain down arm into fingers.
Age: 18.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain upper, Dizziness, Nausea, Vomiting
Clinical narrative: Patient developed nausea, vomiting, stomach ache, dizziness 1 or 2 hours after vaccinated. Patient reports vomiting 8 to 12 times daily for 3 days and lessening in dizziness. Patient was advised to contact her doctor or go to local health center and push fluids.
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Pain in arm of injection site, difficult to lift arm.
Age: 40.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Injection site reaction, Local reaction, Rash
Clinical narrative: Skin eruption in neck (left side) - (10/20/2014). Day after immunization presented arthralgia local reaction in injection site. (10/04/2014).
Age: 11.0
Sex: M
Vaccine: FLU3, HPV4
Symptoms: Erythema, Injection site cellulitis, Local reaction
Clinical narrative: Severe local reaction and cellulitis of injection site - fared and spread x 3 days requiring treatment with oral steroid (Prednisone), oral antihistamine, oral antibiotics (Keflex) and Ibuprofen. Maximum spread 10 inches x 7 inches of erythemia.
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Cheilitis, Rash
Clinical narrative: Rash behind knees, upper lip, in between eyes, on neck and inner arms.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Local swelling, Vaccination complication
Clinical narrative: Patient received influenza vaccine 10.2.14. on 10.3.14 at 0800. patient noticed (R) neck swelling above right clavicle, measuring 6cm x 4cm in diameter. Was seen at Health Services and referred to PCP who dx as influenza vaccine reaction. Today reports 90% resolved.
Age: 1.08
Sex: F
Vaccine: FLUN4
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: None stated.
Age: 4.0
Sex: M
Vaccine: FLU4
Symptoms: Unevaluable event
Clinical narrative: See attached physician note.
Age: 50.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Local swelling, Pain, Pyrexia
Clinical narrative: Swelled upr arm turned red past elbow, fever, pain. ER doc treated with antibiotics.
Age: 66.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Erythema, Incorrect dose administered, Pain in extremity, Pyrexia
Clinical narrative: Fever and very red/sore arm (per nurse). Patient did not return phone call to pharmacy. Nurse said patient already had pneumonia vaccine in 2012 but patient wasn't aware.
Age: 65.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site erythema, Injection site rash, Injection site swelling
Clinical narrative: Injection site reaction red, slightly swollen, raised rash at injection site about the size of a tennis ball.
Age: 58.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Cellulitis, Chills, Flushing, Immediate post-injection reaction, Injection site erythema
Clinical narrative: Developed swelling/redness and itching at injection site (R) arm immediately by that evening, the area was hot and each morning since then the area of redness/warmth/pain and itching has increased. Yesterday, developed tingling sensation (R) med-thoracic dermatomal distribution and continues to have achiness, flushing/chills now has cellulitis of (R) arm.
Age: 58.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth, Pain
Clinical narrative: Developed swelling/redness and itching at injection site (R) arm immediately by that evening, the area was hot and each morning since then the area of redness/warmth/pain and itching has increased. Yesterday, developed tingling sensation (R) med-thoracic dermatomal distribution and continues to have achiness, flushing/chills now has cellulitis of (R) arm.
Age: 58.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Paraesthesia
Clinical narrative: Developed swelling/redness and itching at injection site (R) arm immediately by that evening, the area was hot and each morning since then the area of redness/warmth/pain and itching has increased. Yesterday, developed tingling sensation (R) med-thoracic dermatomal distribution and continues to have achiness, flushing/chills now has cellulitis of (R) arm.
Age: 59.0
Sex: U
Vaccine: FLU4
Symptoms: Chills, Headache, Nasopharyngitis, Oropharyngeal pain, Pyrexia
Clinical narrative: Had fever, chills (temp 99.9 degrees F) 5 hours after getting vaccine. Had a splitting headache, sore throat. 3 days later, has symptoms of a cold (congestion, running nose). Other symptoms reduced significantly.
Age: 59.0
Sex: U
Vaccine: FLU4
Symptoms: Respiratory tract congestion, Rhinorrhoea
Clinical narrative: Had fever, chills (temp 99.9 degrees F) 5 hours after getting vaccine. Had a splitting headache, sore throat. 3 days later, has symptoms of a cold (congestion, running nose). Other symptoms reduced significantly.
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Rash
Clinical narrative: Rash beginning on arm starting below injection site spreading to other arm.
Age: 69.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Pt c/o (L) arm pain. Unable to raise arm x 4 days. Pt notified doc office on 10/20/14 of reaction. Pt stated able to raise arm enough to put on deodorant today.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Aphonia, Ear swelling, Laryngeal oedema, Nodule, Pharyngeal oedema
Clinical narrative: 10/7/14  AM - Vaccine (flu). Rash on back of neck by afternoon. By evening, rash spread to back, pruritic, hot, welts (hives) on throat. 10/8 Earlobes swollen, raised knots below ea. ear at jaw line. Rash spread to chest and flanks. 10/9 - Raised hot swelling throat, vocal cords swollen w/some loss of voice. Occ Health appt - course of prednisolone rx.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Rash, Skin warm, Urticaria
Clinical narrative: 10/7/14  AM - Vaccine (flu). Rash on back of neck by afternoon. By evening, rash spread to back, pruritic, hot, welts (hives) on throat. 10/8 Earlobes swollen, raised knots below ea. ear at jaw line. Rash spread to chest and flanks. 10/9 - Raised hot swelling throat, vocal cords swollen w/some loss of voice. Occ Health appt - course of prednisolone rx.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pruritus, Injection site rash, Pruritus, Rash
Clinical narrative: Rash with itching: bl upper arm and thighs
Sex: U
Vaccine: FLU3
Symptoms: Asthenia, Body temperature increased, Disorientation, Dysstasia
Clinical narrative: Received flu shot on Oct 12, 2014 about 2pm. At 5:30pm I was suddenly weak and disoriented. Had to go to bed and could not stand up until 12 hours later - also temp of 100 degrees.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Headache, Pyrexia
Clinical narrative: Chest discomfort -pressure. Slight headache. Feverish - symptoms lasted about 2 hrs.
Age: 59.0
Sex: F
Vaccine: FLUC3
Symptoms: Pruritus generalised, Rash generalised
Clinical narrative: Flu shot 10-2-14 between 12 -1 pm. By 10/3 5:30 AM developed full body itching and rash. Treated with OTC ZYRTEC during day then BENADRYL OTC that night. Denies pain or any loss of function.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Joint swelling, Laboratory test, Local swelling, Pain in extremity
Clinical narrative: Pain and swelling in elbow and lower arm and fingers.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Ultrasound scan, X-ray
Clinical narrative: Pain and swelling in elbow and lower arm and fingers.
Age: 3.0
Sex: F
Vaccine: FLU4, HEPA
Symptoms: Cellulitis, Injection site erythema, Injection site irritation, Injection site swelling
Clinical narrative: Child had a flu vaccination on 10/15/2014 and leg became red, swollen and irritated. Child was diagnosed with cellulitis and put on AUGMENTIN for 10 days. Left thigh was flu shot.
Age: 0.17
Sex: F
Vaccine: DTAPIPV, HIBV, PNC13, RV5
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Pt was given KINRIX. This vaccine is not for a 2 month old. Manufacturer was called. No harm to child.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Joint range of motion decreased, Pain, Pain in extremity
Clinical narrative: Over a week, range of motion, throbbing pain relieved by ADVIL. No redness. Shoulder to wrist still experiencing pain 10/20/14.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV, FLUX, PPV
Symptoms: Ear pain, Influenza like illness, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: After receiving FLUZONE HD and PNEUMOVAX 23 shot on same day, same arm, patient had inject site swelling, redness, heat, ear pain in same side, flu like symptoms for 3 days.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV, FLUX, PPV
Symptoms: Chills, Ear pain, Fatigue, Headache, Injection site urticaria
Clinical narrative: After receiving FLUZONE HD and PNEUMOVAX 23 shot on same day, same arm, patient had inject site swelling, redness, heat, ear pain in same side, flu like symptoms for 3 days.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV, FLUX, PPV
Symptoms: Pain, Pain in extremity
Clinical narrative: After receiving FLUZONE HD and PNEUMOVAX 23 shot on same day, same arm, patient had inject site swelling, redness, heat, ear pain in same side, flu like symptoms for 3 days.
Age: 86.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Mobility decreased, Pain in extremity
Clinical narrative: Arm was sore and hard to move. 2 weeks later, with some pain and numbness.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Local swelling, Skin warm
Clinical narrative: Large area of patients arm became red, swollen and warm - right arm. More than a normal reaction. MD put on antibiotics.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Pruritus, Urticaria
Clinical narrative: Received Flu vaccine around 930am and has been itchy on and off. Recently developed a facial hive and chest "not feeling right". Received BENADRYL with relief in ED.
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Drug administered at inappropriate site, Joint range of motion decreased, Myalgia
Clinical narrative: Patient called at 6pm stating her flu shot given earlier today is giving her extreme muscle pain and radiating towards her neck, limiting her range of motion. We talked about how VIS -> rare but a serious reaction. I will call her PCP and she will as well and monitor. She thinks it may be b/c her shot was given higher on her arm (near shoulder) than she's used to.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Pruritus, Pyrexia
Clinical narrative: Pt had a 99.5 degrees F fever and started feeling itchy and achy all over.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Cough, Dysphagia, Dyspnoea, Paraesthesia oral
Clinical narrative: 3 hrs after receiving vaccine, pt developed itching on her body, her tongue swelled up, had trouble breathing/swallowing and started coughing. She took BENADRY immediately. At bed time had fever/chills. Next day felt much better, tongue still felt "a little strange, hard."
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Pyrexia, Swollen tongue
Clinical narrative: 3 hrs after receiving vaccine, pt developed itching on her body, her tongue swelled up, had trouble breathing/swallowing and started coughing. She took BENADRY immediately. At bed time had fever/chills. Next day felt much better, tongue still felt "a little strange, hard."
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Local swelling, Pain in extremity
Clinical narrative: Patient stated arm got swollen and hurts. I instructed patient to take BENADRYL, as soon as possible.
Age: 63.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Activities of daily living impaired, Pain in extremity
Clinical narrative: Patient complained of severe arm pain, could not remove her work smock, high tolerance to pain (stated by patient), "but this really hurts", left arm.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pruritus, Rash, Skin irritation, Urticaria
Clinical narrative: Hives, itchiness, rash, red and irritated and spreading
Age: 15.0
Sex: M
Vaccine: FLUN4
Symptoms: Drug administration error
Clinical narrative: Administration error. Pt received dose in nostril. RPH did remove clip and gave full dose in the nostril.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Injection site erythema, Mobility decreased, Pain in extremity
Clinical narrative: Patient said arm was very sore, could not move or lift, was red at injeciton site and down below elbow.
Age: 87.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Erythema, Injection site erythema, Injection site pain, Pain in extremity
Clinical narrative: Patient reported arm very sore, red, painful at injection site and moved down past elbow. Advised to take acetaminophen and antihistamine.
Age: 72.0
Sex: F
Vaccine: FLUX
Symptoms: Feeling abnormal, Off label use, Oropharyngeal pain
Clinical narrative: This spontaneous case from a consumer was received from a Consumer Company (Mfr.control no: US0JNJFOC-20140916023) along with additional information received from another Agency on 16-Sep-2014 and was forwarded to another Agency on 11-Oct-2014. This case involves an off label use for population (72-year-old) for ZYRTEC Children's Dissolve Tabs 10 mg Citrus as per the local labeling. The patient initiated treatment with cetirizine hydrochloride dissolve tablet (batch no: 42602815 and expiry date: Nov-2016) orally at a dose of 10 mg daily for seasonal allergies. Non-company suspect drug included "Flu shot" (Flu vaccine (influenza vaccine)). The patient had been feeling out of it. She reported that she had flu shot "last week (Sept-2014)" and had a sore throat since then. At the time of this report, it was unknown if the patient continued treatment with cetirizine hydrochloride and influenza vaccine. The outcome of the events feeling out of it and sore throat was unknown. The reporter assessed the events as related to cetirizine hydrochloride. Consumer report: A 72-year-old patient on cetirizine hydrochloride Children's Dissolve Tabs (off label use for population as per the local labeling) experienced the events after an unknown period of initiation of treatment. Co suspect medication included influenza vaccine. It was unknown if the patient continued treatment with cetirizine hydrochloride and influenza vaccine. the outcome of the events was unknown. The reporter assessed the events as related to cetirizine hydrochloride. The Case Company Causality is determined as Related.
Age: 95.0
Sex: F
Vaccine: FLU4
Symptoms: Contusion, Feeling hot, Local swelling
Clinical narrative: Patient received her flu shot and after 10 minutes she felt warmth and swelling in (R) arm (lump walnut size). She applied ice PRN. The next day there was bruising and on Thurs the bruise continued to her elbow. Bruise is resolving and no medical treatment was required.
Age: 66.0
Sex: U
Vaccine: FLU3
Symptoms: Incorrect dose administered
Clinical narrative: None stated
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Influenza like illness, Injection site erythema, Injection site pruritus, Injection site reaction, Injection site swelling
Clinical narrative: This spontaneous report as received from a patient's husband refers to his wife of unknown age. On approximately 04-OCT-2014 the patient was vaccinated with a dose of ZOSTAVAX (lot#, dosage and route not reported). The consumer reported that approximately on 06-OCT-2014 "earlier this week" his wife developed an injection-site reaction that includes swelling, redness, and itchiness 48 hours after receiving ZOSTAVAX. The same day she received ZOSTAVAX, she received an unspecified flu shot, and with 24 hours of that vaccination, she had flu-like symptoms. The outcome was unknown. It was unspecified by reporter if the patient sought medical attention or not. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a female patient of unknown age via company representative refers to herself. The patient pertinent medical history was not provided. On an unspecified date in 2009 (also reported as sometime in 2009), the patient was vaccinated with ZOSTAVAX (dose, route of administration, lot # and expiration date were not reported). On an unknown date, when the patient went to get her annual influenza virus vaccine inactivated (unspecified) (also reported as flu shot) from her pharmacist, she was also given the ZOSTAVAX (dose, route of administration, lot # and expiration date were not reported), despite she had already been given ZOSTAVAX. The patient was not experiencing an adverse reactions. There was no treatment given for adverse event. The patient did not sought medical attention. Additional information has been requested.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Bad swollen on injection site, severe pain, and tenderness.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant and from a healthcare worker refers to a patient of unknown age and gender. ON 20-AUG-2014 the patient was vaccinated with (Oka/Merck) VARIVAX (dose, units, route of administration, anatomical location were not reported) which had been exposed to a supported temperature excursion on 15-AUG-2014. No adverse events were observed or reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant and from a healthcare worker refers to a patient of unknown age and gender. On 22-AUG-2014 the patient was vaccinated with (Oka/Merck) VARIVAX (dose, units, route of administration, anatomical location were not reported) which had been exposed to a supported temperature excursion on 15-AUG-2014. No adverse events were observed or reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant and from a healthcare worker refers to a patient of unknown age and gender. On 21-AUG-2014 the patient was vaccinated with (Oka/Merck) VARIVAX (dose, units, route of administration, anatomical location were not reported) which had been exposed to a supported temperature excursion on 15-AUG-2014. No adverse events were observed or reported. This is one of several reports from the same reporter. Additional information has been requested.
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 unspecified number of patient of unknown age and gender.. In September 2014 (reported as "within the last month") unspecified number of patients (reported as "about 1-2 patients") were vaccinated with a d ose of improperly stored (Oka/Merck) VARIVAX (lot number, expiration date, dose and route were not reported). No concomitant medications were reported. No adverse  effects were reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report refers received from pharmacist refers to a female patient of unknown age. The patient's drug reactions/allergies were reported for azithromycin, KEFLEX and penicillin. On an unknown date the patient was vaccinated with ZOSTAVX (strength, route not reported). Concomitant therapies included lidocaine, oxycodone, lorazepam, pantoprazole, sertraline hydrochloride, zolpidem tartrate (manufacturer unknown), naproxen and zinc (unspecified). The reporter stated that the patient has had shingles 3 times since receiving the vaccine. The patient was treated with VALTREX for the event. The outcome of shingles is unknown. The patient sought medical attention. Varicella Zoster Virus Identification Program (VZVIP) packet faxed. No product quality complaint was involved. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Oedema, Pain
Clinical narrative: This spontaneous report was received from a pharmacist refers to a female patient of unknown age. Medical history and concurrent conditions were not reported. On 14-OCT-2014 at 07:00 hours, the patient was vaccinated with PNEUMOVAX 23 injection in the left arm (dose, frequency, route, lot number unknown) for unknown indication from an unspecified provider. Concomitant therapies included MOBIC. On 14-OCT-2014, 20:00 hours the patient experienced fluid build-up between her left shoulder and neck. The area was sore and the size of an egg. It was reported that the patient had never received PNEUMOVAX 23 in the past. On an unknown date (reported as compared to yesterday) the patient reported that the fluid buildup had reduced. Patient sought medical attention as she spoke to pharmacist. The outcome of the events was unknown. Causality of the events were unknown. No product quality complaint (PQC) was involved. Additional information is not expected because patient was not a patient at the pharmacy.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 17-OCT-2014 the patient was inadvertently vaccinated with a dose of (Merck) VARIVAX (lot # K001389, expiration date: 29-JAN-2016), 0.5 ml, subcutaneous instead of ZOSTAVAX (lot number, expiration date, dose, route were not reported). No concomitant medications were reported. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. On an unknown date those patients were vaccinated with GARDASIL (dose, units, route of administration, anatomical location, lot number were not reported) which were given a year or more past the scheduled interval for administration. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a patient of unknown age and gender. On 25-AUG-2014 the patient was vaccinated with a dose of (Merck) VARIVAX (dose, units, route of administration, lot# and expiration date were not reported) which was exposed to a supported temperature excursion on 15-AUG-2014. No adverse events had been observed or reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 14.0
Sex: M
Vaccine: VARCEL
Symptoms: Herpes zoster, Incomplete course of vaccination
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a 14 year old male patient. In 2001 (date unspecified, reported also when the patient was one year old) the patient was vaccinated with (Merck) VARIVAX (subcutaneously, dose, units, anatomical location, lot number were not reported). In 2014 (date unspecified, reported as thirteen years after vaccination) the patient experienced herpes zoster. The reporter stated that the patient never received his second injection of (Merck) VARIVAX at the age of one year old. The patient sought medical attention via visiting the physician. The outcome of event was reported as not recovered. The relatedness between event and VARIVAX was not reported. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an 18 year old female patient. No concurrent conditions or medical history were provided. The patient was vaccinated with doses of GARDASIL (strength, dose, route of administration, indication, lot# and expiry date unspecified for all), on the following dates, approximately: "mid summer 2013, around 02-JUL-2013", 31-JAN-2014 and 09-AUG-2014. The patient was told by her gynecologist, that she should receive a fourth dose of GARDASIL. The nurse nor the patient, who was present with the nurse at the time of this report, could not specify physician's contact information. The nurse had not administered a fourth dose of GARDASIL to this patient. The patient had not experienced any adverse effects. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report as received from an office manager (who is also a female patient of unknown age) via a company representative, refers to herself. No concurrent conditions or medical history were provided. On 04-SEP-2014 (reported as "six weeks ago"), the patient was vaccinated with a dose of ZOSTAVAX injection administered in the arm (strength, dose, route of administration, indication, lot# and expiry date unspecified), in an unspecified pharmacy. No concomitant medications were reported. The consumer developed a large swollen area on the back of her arm at the site of injection on an unspecified date in 2014. She described the injection site as a large, 3 to 4 inch swelling that was hard to the touch at the back of her arm and it was very painful. She stated that it took two weeks to resolve on an unspecified date in 2014. The relatedness between the event and ZOSTAVAX was not reported. Additional information is not expected as the physician did not grant permission to contact him.
Age: 16.0
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a 16 year old patient of unknown gender. In 2008 the patient was vaccinated with the first dose of GARDASIL (lot #, dose and route unspecified). In 2013 the patient was vaccinated with the second dose of GARDASIL (lot#, dose and route unspecified). In 2014 the patient was vaccinated with the third dose of GARDASIL (lot#, dose and route unspecified). No adverse effects were noted. Additional information has been requested.
Age: 0.72
Sex: F
Vaccine: IPV, RV5
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from nurse practitioner via company representative and refers to a 36 week old female patient. On 09-SEP-2014, the patient was vaccinated with the first dose of ROTATEQ series (dose, lot and expiration date not reported). On the same day (09-SEP-2014), the patient was concomitantly vaccinated with poliovirus vaccine inactivated (unspecified) (dose, route, lot and expiration date were not reported). There was no adverse effect reported. Additional information has been requested.
Sex: M
Vaccine: HPV4
Symptoms: Dizziness, Incorrect storage of drug
Clinical narrative: This spontaneous report was received from a other health professional refers to a male patient of unknown age. On 07-OCT-2014 the patient was vaccinated with GARDASIL lot # H021862, expiry: 09-OCT-2015 (dose, dose # and route unspecified). No concomitant medications were reported. On 07-OCT-2014 (also reported as shortly after), patient received a dose of GARDASIL and felt dizzy shortly after but they believe it was because the patient did not eat and also he saw blood. Healthcare worker reports that the patient recovered within a half an hour on 07-OCT-2014. The outcome of saw blood and patient received a dose of the GARDASIL on 10/07/2014 and felt dizzy shortly after was reported as recovered/resolved. The outcome of patient received doses that were exposed to temperatures outside of the proper storage was unknown. Causality assessment was not provided for the events. There was no product quality complaint (PQC) involved. Additional information has been requested.