chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Hypersomnia, Hypoaesthesia, Laboratory test abnormal, Lactose intolerance, Lymphadenopathy
Clinical narrative: SECOND INJECTION OF GARDASIL- FATIGUE, POLYDIPSIA, COLD EXTREMITIES, CHEST DISCOMFORT, TINNITUS, HEADACHES, MUSCLE PAIN AND WEAKNESS, SEVERE ABDOMINAL PAIN, BLOATING, SLEEP TROUBLE, IMPAIRED CONCENTRATION, CHILLS, HAIR FALLING OUT IN CLUMPS.  THIRD INJECTION- SAME SYMPTOMS AS ABOVE WITH INCREASE IN INTENSITY AND DISCOMFORT.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Lymphocyte morphology abnormal, Medial tibial stress syndrome, Memory impairment, Myalgia, Nausea
Clinical narrative: SECOND INJECTION OF GARDASIL- FATIGUE, POLYDIPSIA, COLD EXTREMITIES, CHEST DISCOMFORT, TINNITUS, HEADACHES, MUSCLE PAIN AND WEAKNESS, SEVERE ABDOMINAL PAIN, BLOATING, SLEEP TROUBLE, IMPAIRED CONCENTRATION, CHILLS, HAIR FALLING OUT IN CLUMPS.  THIRD INJECTION- SAME SYMPTOMS AS ABOVE WITH INCREASE IN INTENSITY AND DISCOMFORT.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Nuclear magnetic resonance imaging abnormal, Oedema peripheral, Oropharyngeal pain, Pain, Pain in extremity
Clinical narrative: SECOND INJECTION OF GARDASIL- FATIGUE, POLYDIPSIA, COLD EXTREMITIES, CHEST DISCOMFORT, TINNITUS, HEADACHES, MUSCLE PAIN AND WEAKNESS, SEVERE ABDOMINAL PAIN, BLOATING, SLEEP TROUBLE, IMPAIRED CONCENTRATION, CHILLS, HAIR FALLING OUT IN CLUMPS.  THIRD INJECTION- SAME SYMPTOMS AS ABOVE WITH INCREASE IN INTENSITY AND DISCOMFORT.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Peripheral coldness, Pharyngitis, Polydipsia, Temperature intolerance, Thirst
Clinical narrative: SECOND INJECTION OF GARDASIL- FATIGUE, POLYDIPSIA, COLD EXTREMITIES, CHEST DISCOMFORT, TINNITUS, HEADACHES, MUSCLE PAIN AND WEAKNESS, SEVERE ABDOMINAL PAIN, BLOATING, SLEEP TROUBLE, IMPAIRED CONCENTRATION, CHILLS, HAIR FALLING OUT IN CLUMPS.  THIRD INJECTION- SAME SYMPTOMS AS ABOVE WITH INCREASE IN INTENSITY AND DISCOMFORT.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Tinnitus, Vaccine positive rechallenge, Vaginal discharge, Vaginal infection, Vulvovaginitis
Clinical narrative: SECOND INJECTION OF GARDASIL- FATIGUE, POLYDIPSIA, COLD EXTREMITIES, CHEST DISCOMFORT, TINNITUS, HEADACHES, MUSCLE PAIN AND WEAKNESS, SEVERE ABDOMINAL PAIN, BLOATING, SLEEP TROUBLE, IMPAIRED CONCENTRATION, CHILLS, HAIR FALLING OUT IN CLUMPS.  THIRD INJECTION- SAME SYMPTOMS AS ABOVE WITH INCREASE IN INTENSITY AND DISCOMFORT.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Weight increased
Clinical narrative: SECOND INJECTION OF GARDASIL- FATIGUE, POLYDIPSIA, COLD EXTREMITIES, CHEST DISCOMFORT, TINNITUS, HEADACHES, MUSCLE PAIN AND WEAKNESS, SEVERE ABDOMINAL PAIN, BLOATING, SLEEP TROUBLE, IMPAIRED CONCENTRATION, CHILLS, HAIR FALLING OUT IN CLUMPS.  THIRD INJECTION- SAME SYMPTOMS AS ABOVE WITH INCREASE IN INTENSITY AND DISCOMFORT.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Injection site irritation, Injection site pruritus
Clinical narrative: Localized irritation (1 inch diameter) with irritation at focal point of injection - itching and resembling localized shingles infection.
Age: 1.0
Sex: M
Vaccine: FLUX, HIBV, MMR, PNC
Symptoms: Blood count normal, Computerised tomogram head, Computerised tomogram normal, Convulsion, Depressed level of consciousness
Clinical narrative: convulsive seizure, lasting 2 minutes, unable to awaken, lowered consciousness for several days after event
Age: 1.0
Sex: M
Vaccine: FLUX, HIBV, MMR, PNC
Symptoms: Somnolence, Urine analysis normal
Clinical narrative: convulsive seizure, lasting 2 minutes, unable to awaken, lowered consciousness for several days after event
Age: 0.34
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Blood culture, CSF culture, CSF glucose normal, CSF protein normal, CSF white blood cell count negative
Clinical narrative: "bulging fontanelle", irritable
Age: 0.34
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Culture urine, Enterovirus test, Fontanelle bulging, Gram stain, Gram stain negative
Clinical narrative: "bulging fontanelle", irritable
Age: 0.34
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Irritability, Polymerase chain reaction, Red blood cells CSF positive, White blood cell count normal
Clinical narrative: "bulging fontanelle", irritable
Age: 23.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Injection site swelling, Nausea
Clinical narrative: Pain/swelling at and around injection site (lasting 7 days), nausea (lasting 2 days).
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: DTAP on 1/13/11 - Evening of 1/14/11 redness & swelling to left upper arm - 1/15/11 - swelling & redness to elbow.
Age: 40.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Injection site pain, Pain
Clinical narrative: Severe and constant pain in left arm at injection sight. Unable to move arm without significant pain. Also chills at 9:00PM (no fever).
Age: 5.0
Sex: F
Vaccine: FLUN3
Symptoms: Activities of daily living impaired, Antinuclear antibody positive, Biopsy muscle abnormal, Blood creatine phosphokinase increased, Dysstasia
Clinical narrative: Patient exhibited difficulty getting into the car by herself.  By the end of December of 2009, she was unable to walk up stairs quickly, could not run, could not jump, and could not stand from a seated position on the floor.
Age: 5.0
Sex: F
Vaccine: FLUN3
Symptoms: Gait disturbance, Muscular dystrophy, Polymyositis
Clinical narrative: Patient exhibited difficulty getting into the car by herself.  By the end of December of 2009, she was unable to walk up stairs quickly, could not run, could not jump, and could not stand from a seated position on the floor.
Age: 11.0
Sex: F
Vaccine: MEN, TDAP
Symptoms: Neck pain, Pain
Clinical narrative: neck pain, no fever.  Pain lessened with relation ans shoulder/neck massage.  still aches
Age: 5.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: swelling, redness, slight pain around shot site/ no medicine given
Age: 44.0
Sex: M
Vaccine: HEPA
Symptoms: Chills, Injection site erythema, Injection site inflammation, Injection site swelling, Injection site warmth
Clinical narrative: Fever, Chills and a softball size around swelling at the injection site (hot, red, and inflamed)
Age: 44.0
Sex: M
Vaccine: HEPA
Symptoms: Pyrexia
Clinical narrative: Fever, Chills and a softball size around swelling at the injection site (hot, red, and inflamed)
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Varicella virus test positive
Clinical narrative: Patient developed right V3 Shingles.  Viral culture positive for Varicella Zoster.
Age: 4.0
Sex: M
Vaccine: DTAP, MMRV, UNK
Symptoms: Febrile convulsion, Foaming at mouth, Malaise, Moaning, Multi-organ disorder
Clinical narrative: Simple Febrile Seizure; gurgling and spit coming out of mouth, open eyes but extremely "out of it", moaning and loss of most body functions, fever of 103.1 at ER at 2:50 PM, monitored fever and gave Tylenol and Motrin at the hospital, released at 5:15 PM
Age: 4.0
Sex: M
Vaccine: DTAP, MMRV, UNK
Symptoms: Pyrexia
Clinical narrative: Simple Febrile Seizure; gurgling and spit coming out of mouth, open eyes but extremely "out of it", moaning and loss of most body functions, fever of 103.1 at ER at 2:50 PM, monitored fever and gave Tylenol and Motrin at the hospital, released at 5:15 PM
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Axillary pain, C-reactive protein increased, Erythema, Injected limb mobility decreased, Injection site pain
Clinical narrative: 12/15/10: Patient was administered Pneumovax 23 vaccine by her rheumatologist.  She had a localized reaction and went home.  Patients has recieved this product before without a documented reaction.  12/17/10: Patient went to see her gynecologist for a check up and was recommended to go back to her rheumatologist to report the event. The gynecologist noted that the patient's left arm and axillary area had significant pain. There was erythema noted on the arm, but not in the axilliary area.   12/17/10: The patient went to back to her rheumatologist to have her reaction checked out.  Patient states that she experienced soreness in her arm about 8 hours after receiving the vaccination.  From the tip of her shoulder down to her elbow, was a large oval area with swelling and pain. It eventually became stiff and difficult to move.  The pain was enough for her to have difficulty sleeping for 1 to 2 nights.  Patient did not report the event, but when she went to her gynecologist, she was urged to come back to have the event recorded.  At this visit with her rheumatologist, he noted that there was an oval area of erythema (about 20 x 10 cm in diameter) with a mild to moderate swelling and mild tenderness.  There is no axillary adenopathy and no evidence of spreading infection.  Labs were take for C-reactive protein and RBS Sedimentation Rate.  She is reassured that this will likely resolve and is counseled to call if further symptoms develop or if a similar event occurs in the future.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Insomnia, Local reaction, Musculoskeletal stiffness, No reaction on previous exposure to drug
Clinical narrative: 12/15/10: Patient was administered Pneumovax 23 vaccine by her rheumatologist.  She had a localized reaction and went home.  Patients has recieved this product before without a documented reaction.  12/17/10: Patient went to see her gynecologist for a check up and was recommended to go back to her rheumatologist to report the event. The gynecologist noted that the patient's left arm and axillary area had significant pain. There was erythema noted on the arm, but not in the axilliary area.   12/17/10: The patient went to back to her rheumatologist to have her reaction checked out.  Patient states that she experienced soreness in her arm about 8 hours after receiving the vaccination.  From the tip of her shoulder down to her elbow, was a large oval area with swelling and pain. It eventually became stiff and difficult to move.  The pain was enough for her to have difficulty sleeping for 1 to 2 nights.  Patient did not report the event, but when she went to her gynecologist, she was urged to come back to have the event recorded.  At this visit with her rheumatologist, he noted that there was an oval area of erythema (about 20 x 10 cm in diameter) with a mild to moderate swelling and mild tenderness.  There is no axillary adenopathy and no evidence of spreading infection.  Labs were take for C-reactive protein and RBS Sedimentation Rate.  She is reassured that this will likely resolve and is counseled to call if further symptoms develop or if a similar event occurs in the future.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Red blood cell sedimentation rate normal, Tenderness
Clinical narrative: 12/15/10: Patient was administered Pneumovax 23 vaccine by her rheumatologist.  She had a localized reaction and went home.  Patients has recieved this product before without a documented reaction.  12/17/10: Patient went to see her gynecologist for a check up and was recommended to go back to her rheumatologist to report the event. The gynecologist noted that the patient's left arm and axillary area had significant pain. There was erythema noted on the arm, but not in the axilliary area.   12/17/10: The patient went to back to her rheumatologist to have her reaction checked out.  Patient states that she experienced soreness in her arm about 8 hours after receiving the vaccination.  From the tip of her shoulder down to her elbow, was a large oval area with swelling and pain. It eventually became stiff and difficult to move.  The pain was enough for her to have difficulty sleeping for 1 to 2 nights.  Patient did not report the event, but when she went to her gynecologist, she was urged to come back to have the event recorded.  At this visit with her rheumatologist, he noted that there was an oval area of erythema (about 20 x 10 cm in diameter) with a mild to moderate swelling and mild tenderness.  There is no axillary adenopathy and no evidence of spreading infection.  Labs were take for C-reactive protein and RBS Sedimentation Rate.  She is reassured that this will likely resolve and is counseled to call if further symptoms develop or if a similar event occurs in the future.
Age: 20.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Erythema, Injection site cellulitis, Mobility decreased, Pain, Pyrexia
Clinical narrative: Redness and swelling and severe achiness. Could not lift his arm the next day, fever. Developed cellulitis from injection point down his biceps to his elbow about 4 inches wide. Also received flu shot on the same day in the same arm.
Age: 20.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Swelling
Clinical narrative: Redness and swelling and severe achiness. Could not lift his arm the next day, fever. Developed cellulitis from injection point down his biceps to his elbow about 4 inches wide. Also received flu shot on the same day in the same arm.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood pressure increased, Headache, Oedema peripheral, Skin warm
Clinical narrative: swelling of arm, warm to touch, headache, increased blood pressure
Age: 35.0
Sex: M
Vaccine: FLU3
Symptoms: Eye pain, Headache, Insomnia, Musculoskeletal stiffness, Nasopharyngitis
Clinical narrative: Received H1N1 vaccine on 12/21/2010 on 12/23/2010 had extreme starburst effects in eyes that have not gone away. One week later had massive headaches and could not sleep and came down with a cold. Have had 2 MRI in the past week becuase one pupil has dialated larger and have haed stiff neck and eye pain.
Age: 35.0
Sex: M
Vaccine: FLU3
Symptoms: Nuclear magnetic resonance imaging normal, Pupils unequal, Visual impairment
Clinical narrative: Received H1N1 vaccine on 12/21/2010 on 12/23/2010 had extreme starburst effects in eyes that have not gone away. One week later had massive headaches and could not sleep and came down with a cold. Have had 2 MRI in the past week becuase one pupil has dialated larger and have haed stiff neck and eye pain.
Age: 4.0
Sex: F
Vaccine: DTAP, MMRV
Symptoms: Pruritus, Urticaria
Clinical narrative: Broke out in widespread, itchy hives.
Age: 69.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Biopsy bone marrow, Idiopathic thrombocytopenic purpura, Platelet count decreased, Scan spleen
Clinical narrative: On routine blood test 11/4/10 she had a platelet count of 64. She followed up with another platelet count in which they had dropped. She is now under care of hematologist with a diagnosis of ITP. She is being treated with prednisone and follows up in 3 weeks.
Age: 69.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Biopsy bone marrow normal, Blood count abnormal, Contusion, Idiopathic thrombocytopenic purpura, Platelet count decreased
Clinical narrative: On routine blood test 11/4/10 she had a platelet count of 64. She followed up with another platelet count in which they had dropped. She is now under care of hematologist with a diagnosis of ITP. She is being treated with prednisone and follows up in 3 weeks.
Age: 69.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Spleen scan normal, Thyroid function test abnormal, White blood cell count decreased
Clinical narrative: On routine blood test 11/4/10 she had a platelet count of 64. She followed up with another platelet count in which they had dropped. She is now under care of hematologist with a diagnosis of ITP. She is being treated with prednisone and follows up in 3 weeks.
Age: 69.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Blood test abnormal, Platelet count decreased
Clinical narrative: On routine blood test 11/4/10 she had a platelet count of 64. She followed up with another platelet count in which they had dropped. She is now under care of hematologist with a diagnosis of ITP. She is being treated with prednisone and follows up in 3 weeks.
Age: 4.0
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Localized pruritis, swelling, tenderness and severe erythema at injection site, >70mm in diameter lasting approximately 10 days.
Age: 39.0
Sex: F
Vaccine: TDAP
Symptoms: Back pain, Hypoaesthesia, Livedo reticularis, Myalgia, Oedema peripheral
Clinical narrative: Patient states onset of fever 1/12/11 which lasted 3 days with max 104.5 Severe muscle aches & back pain radiating down both legs, bil. upper extremity pain, bil hand swelling, numbness in left fingertips intermittently. Macular mottled looking rash entire body.
Age: 39.0
Sex: F
Vaccine: TDAP
Symptoms: Pain in extremity, Pyrexia, Rash generalised, Rash macular
Clinical narrative: Patient states onset of fever 1/12/11 which lasted 3 days with max 104.5 Severe muscle aches & back pain radiating down both legs, bil. upper extremity pain, bil hand swelling, numbness in left fingertips intermittently. Macular mottled looking rash entire body.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain upper, Full blood count, Metabolic function test, Pain, Ultrasound abdomen
Clinical narrative: C/o severe RUQ pain since receiving immunization on 1-11-11 - much more intense today 1-14-11 temp 98.6 degrees F BP 138/86.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Urine analysis
Clinical narrative: C/o severe RUQ pain since receiving immunization on 1-11-11 - much more intense today 1-14-11 temp 98.6 degrees F BP 138/86.
Age: 14.0
Sex: F
Vaccine: FLU3, MNQ, TDAP
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Red, swollen, painful.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased
Clinical narrative: Patient cannot lift arm after given flu shot 2 months ago.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Cough, Dysphonia
Clinical narrative: 1 hour after cough 2 hours after cough, hoarse, tightness chest with breathing. Took 50mg BENADRYL PO. 1 hour after BENADRYL/severe tightness relieved. Tightness x 20 hours.
Age: 35.0
Sex: M
Vaccine: FLU3
Symptoms: Chest discomfort, Dizziness, Sensation of foreign body
Clinical narrative: About 10-15 post admin of Flu vaccine pt approached the pharmacy counter stating he felt very faint w/a "knot in my throat" I instructed to sit down head btwn the legs. I brought out cold compress. Pt stated able to breathe but felt "tight". I called 911 & they instructed me to give EPIPEN shot. EPI was administered EMS arrived about 5 mins later.
Age: 48.0
Sex: U
Vaccine: FLU3, PPV
Symptoms: Nausea, Palpitations, Presyncope
Clinical narrative: C/o palpitations, nausea, & near syncope within a minute of administration (PNEUMOVAX). Started to feel better apprx. 3 min after complaint. Given 25mg BENADRYL IM.
Age: 2.0
Sex: F
Vaccine: FLU3, HIBV, PNC13
Symptoms: Urticaria
Clinical narrative: Patient developed hives after 5 minutes post immunization. No other signs of allergic reaction. Given BENADRYL 12.5 mg/5ml immediately. Hives resolved in 15 minutes approx.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Vaccination site pain
Clinical narrative: Approximately 2 hrs after receiving the vaccine she developed severe pain in the upper arm area where vaccine was given. This pain has continued and causes the patient to seek treatment from her orthopedic doctor. She is scheduled for MRI on 1/13/11.
Age: 12.0
Sex: M
Vaccine: FLUN3
Symptoms: Contraindication to vaccination
Clinical narrative: Spoke with mother, reports son is fine, that he is "perfect". States MD from clinic has advised that hx vaccine (he did not have it to give) when child arrived here. Advised to contact this facility if there are any adverse effects. Gave client FLUMIST with hx asthma (12 yrs) instead of Flu injection.
Age: 39.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Confusional state, Dizziness, Dyspnoea, Headache
Clinical narrative: Dizzy, chills, SOB, severe HA, confusion, sleepy.
Age: 39.0
Sex: M
Vaccine: FLU3
Symptoms: Somnolence
Clinical narrative: Dizzy, chills, SOB, severe HA, confusion, sleepy.
Age: 1.54
Sex: M
Vaccine: FLU3, HEPA
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: LVN reported to NP that influenza vaccine was .5mL not .25mL. Mom notified immediately & no complications reported. Mom advised to call with any c/o.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Facial pain, Headache, Hypoaesthesia, Nausea
Clinical narrative: Reported by patient 12/14/10 arm swollen "like baseball" red & numbness & facial pain. Not warm to touch. No fever. Experienced HA & nausea. Advised by Dr. on call to take BENADRYL. Overall improved just a little red & mild numbness and asked pt to call if not resolved in a few days or worsens (no - call back).
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Oedema peripheral
Clinical narrative: Reported by patient 12/14/10 arm swollen "like baseball" red & numbness & facial pain. Not warm to touch. No fever. Experienced HA & nausea. Advised by Dr. on call to take BENADRYL. Overall improved just a little red & mild numbness and asked pt to call if not resolved in a few days or worsens (no - call back).
Age: 84.0
Sex: M
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Condition aggravated, Musculoskeletal pain
Clinical narrative: Unbearable pain in right shoulder, pt went to ER and was given MEDROL dose pak and PERCOCET 5/325. Pt already has shoulder issue and gets pain meds for.
Age: 84.0
Sex: M
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Bursitis, Musculoskeletal pain
Clinical narrative: Unbearable pain in right shoulder, pt went to ER and was given MEDROL dose pak and PERCOCET 5/325. Pt already has shoulder issue and gets pain meds for.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Cellulitis, Injection site erythema, Injection site swelling
Clinical narrative: 1/14/11 swelling & redness at injection site (right deltoid). Approx. 8 cm in diameter of redness & swelling. Child treated for cellulitis 1/15/11 with BACTRIM. Symptoms resolved by 1/17/11.
Age: 61.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Axillary pain, Chills, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Red, swollen & painful at the sites of the injections, feverish, aches, chills, pain in axilla & shoulder. Pt was prescribed Naproxen sodium 220 mg, BENADRYL 25 mg.
Age: 61.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Laboratory test, Musculoskeletal pain, Pain, Pyrexia
Clinical narrative: Red, swollen & painful at the sites of the injections, feverish, aches, chills, pain in axilla & shoulder. Pt was prescribed Naproxen sodium 220 mg, BENADRYL 25 mg.
Age: 5.0
Sex: M
Vaccine: PPV
Symptoms: Injection site reaction, Local reaction
Clinical narrative: Lg local reaction (L) deltoid area 2" by 2" 2nd to PNEUMOVAX 23.
Age: 16.0
Sex: M
Vaccine: VARCEL
Symptoms: Pruritus generalised, Urticaria
Clinical narrative: Extreme itching, entire body, hives. Took Benadryl tablets, relief in 2 hours.
Age: 0.4
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Abdominal pain, Cystogram, Endoscopy, Enema administration, Intussusception
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 5 month old male with a history of meningitis due to Coxsackie virus as a neonate and no known pre-existing illness on 16-NOV-2010 was vaccinated with the third dose of ROTATEQ (Lot # 668265/0805Z) by mouth. Concomitant vaccination included PREVNAR 13 (Lot 914274, manufactured by Wyeth) IM into the left leg, third dose of PENTACEL (Lot C3656AA, manufactured by Sanofi Pasteur) IM into the right leg and the third dose of ENGERIX-B (Lot AHBVB803AB, manufactured by GlaxoSmithKline) IM into the left leg. On 19-NOV-2010 the patient experienced intussusception. Abdominal pain started afternoon of 29-NOV-2010. The patient was seen at the hospital ER, diagnosed by ultrasound, tried to reduced with air enema, but ultimately needed endoscopic reduction. The listing indicated that one or more of the events required hospitalization and were considered to be immediately life-threatening. No further information is available. The events were serious and required ER visit. The original reporting source was not reported. The VAERS ID # is 410374. A standard lot check has been finalized. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center and was released. No further information is available.
Age: 0.4
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Ultrasound abdomen abnormal, Urinary system X-ray
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 5 month old male with a history of meningitis due to Coxsackie virus as a neonate and no known pre-existing illness on 16-NOV-2010 was vaccinated with the third dose of ROTATEQ (Lot # 668265/0805Z) by mouth. Concomitant vaccination included PREVNAR 13 (Lot 914274, manufactured by Wyeth) IM into the left leg, third dose of PENTACEL (Lot C3656AA, manufactured by Sanofi Pasteur) IM into the right leg and the third dose of ENGERIX-B (Lot AHBVB803AB, manufactured by GlaxoSmithKline) IM into the left leg. On 19-NOV-2010 the patient experienced intussusception. Abdominal pain started afternoon of 29-NOV-2010. The patient was seen at the hospital ER, diagnosed by ultrasound, tried to reduced with air enema, but ultimately needed endoscopic reduction. The listing indicated that one or more of the events required hospitalization and were considered to be immediately life-threatening. No further information is available. The events were serious and required ER visit. The original reporting source was not reported. The VAERS ID # is 410374. A standard lot check has been finalized. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center and was released. No further information is available.
Age: 80.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Asthenia, Blood glucose increased, Dizziness, Erythema, Feeling hot
Clinical narrative: Lightheaded flushed pulsating pains throughout body noticed all 3 symptoms within 2-5 minutes of vaccination. Symptoms started improving upon sitting. Pt taken to hospital by paramedics - they found no apparent cause or diagnosis.
Age: 80.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Hypertension, Pain
Clinical narrative: Lightheaded flushed pulsating pains throughout body noticed all 3 symptoms within 2-5 minutes of vaccination. Symptoms started improving upon sitting. Pt taken to hospital by paramedics - they found no apparent cause or diagnosis.
Age: 80.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Dizziness, Flushing, Pain
Clinical narrative: Lightheaded flushed pulsating pains throughout body noticed all 3 symptoms within 2-5 minutes of vaccination. Symptoms started improving upon sitting. Pt taken to hospital by paramedics - they found no apparent cause or diagnosis.
Age: 56.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Asthenia, Condition aggravated, Discomfort, Hypoaesthesia, Injection site pain
Clinical narrative: Initial report was received 06 January 2010 from a consumer, who is also the patient. A 56-year-old male patient who had a past history of neuropathy in his arms and legs (since 2005), lower back disc problem, and dementia, had received a right arm injection of FLUZONE (not specified, lot number unknown) on 11 November 2010 at 3:30 pm and a few hours after vaccination, he "felt a ball in his arm". He woke up with throbbing pain in his right arm, shoulder, elbow, wrist, and fingers; per the patient, he later developed paralysis of the right arm. He went to the hospital for a check up and his blood pressure was 179/98. Three days later, he went to the hospital and was given OXYCONTIN which he took every four hours for right arm pain. He also received morphine by his treating family physician for pain. At the time of the report, the patient had not recovered and had to keep his right arm in a sling. He had no grip and was unable to pick anything up and he could not write. His last three fingers and thumb were sore and numb. The patient had not received either an H1N1 vaccine or Influenza vaccine the year prior. It was also reported that following receipt of "swine" flu vaccine in 1976, the patient experienced a fever of 105 degrees Farenheit and weakness in his legs with spasms (captured in case number 2011-00114). The reporter for this case is the same as case number 2011-00114. Documents held by sender: None.
Age: 56.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Pain in extremity
Clinical narrative: Initial report was received 06 January 2010 from a consumer, who is also the patient. A 56-year-old male patient who had a past history of neuropathy in his arms and legs (since 2005), lower back disc problem, and dementia, had received a right arm injection of FLUZONE (not specified, lot number unknown) on 11 November 2010 at 3:30 pm and a few hours after vaccination, he "felt a ball in his arm". He woke up with throbbing pain in his right arm, shoulder, elbow, wrist, and fingers; per the patient, he later developed paralysis of the right arm. He went to the hospital for a check up and his blood pressure was 179/98. Three days later, he went to the hospital and was given OXYCONTIN which he took every four hours for right arm pain. He also received morphine by his treating family physician for pain. At the time of the report, the patient had not recovered and had to keep his right arm in a sling. He had no grip and was unable to pick anything up and he could not write. His last three fingers and thumb were sore and numb. The patient had not received either an H1N1 vaccine or Influenza vaccine the year prior. It was also reported that following receipt of "swine" flu vaccine in 1976, the patient experienced a fever of 105 degrees Farenheit and weakness in his legs with spasms (captured in case number 2011-00114). The reporter for this case is the same as case number 2011-00114. Documents held by sender: None.
Age: 56.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Activities of daily living impaired, Arthralgia, Grip strength decreased, Hypoaesthesia, Monoplegia
Clinical narrative: Initial report was received 06 January 2010 from a consumer, who is also the patient. A 56-year-old male patient who had a past history of neuropathy in his arms and legs (since 2005), lower back disc problem, and dementia, had received a right arm injection of FLUZONE (not specified, lot number unknown) on 11 November 2010 at 3:30 pm and a few hours after vaccination, he "felt a ball in his arm". He woke up with throbbing pain in his right arm, shoulder, elbow, wrist, and fingers; per the patient, he later developed paralysis of the right arm. He went to the hospital for a check up and his blood pressure was 179/98. Three days later, he went to the hospital and was given OXYCONTIN which he took every four hours for right arm pain. He also received morphine by his treating family physician for pain. At the time of the report, the patient had not recovered and had to keep his right arm in a sling. He had no grip and was unable to pick anything up and he could not write. His last three fingers and thumb were sore and numb. The patient had not received either an H1N1 vaccine or Influenza vaccine the year prior. It was also reported that following receipt of "swine" flu vaccine in 1976, the patient experienced a fever of 105 degrees Farenheit and weakness in his legs with spasms (captured in case number 2011-00114). The reporter for this case is the same as case number 2011-00114. Documents held by sender: None.
Age: 56.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Musculoskeletal pain, Pain, Pain in extremity
Clinical narrative: Initial report was received 06 January 2010 from a consumer, who is also the patient. A 56-year-old male patient who had a past history of neuropathy in his arms and legs (since 2005), lower back disc problem, and dementia, had received a right arm injection of FLUZONE (not specified, lot number unknown) on 11 November 2010 at 3:30 pm and a few hours after vaccination, he "felt a ball in his arm". He woke up with throbbing pain in his right arm, shoulder, elbow, wrist, and fingers; per the patient, he later developed paralysis of the right arm. He went to the hospital for a check up and his blood pressure was 179/98. Three days later, he went to the hospital and was given OXYCONTIN which he took every four hours for right arm pain. He also received morphine by his treating family physician for pain. At the time of the report, the patient had not recovered and had to keep his right arm in a sling. He had no grip and was unable to pick anything up and he could not write. His last three fingers and thumb were sore and numb. The patient had not received either an H1N1 vaccine or Influenza vaccine the year prior. It was also reported that following receipt of "swine" flu vaccine in 1976, the patient experienced a fever of 105 degrees Farenheit and weakness in his legs with spasms (captured in case number 2011-00114). The reporter for this case is the same as case number 2011-00114. Documents held by sender: None.
Age: 20.0
Sex: M
Vaccine: SMALL, SMALL, SMALL
Symptoms: Body temperature increased, Cardiac enzymes, Chest discomfort, Chest pain, Chills
Clinical narrative: On 30 Dec 10, experienced headache, low fever and when lying flat he felt chest tightness, pain and pressure. He went to the ED and was told to return if fever exceeded 100.4 degrees F. When temp reached 101 degrees F he contacted doctor and told to go to ED. Tx MOTRIN 800 mg, given IV and blood drawn. Dx with myocarditis and instructed to schedule and echocardiogram. Results pending, will f/u with hosp and PCM.
Age: 20.0
Sex: M
Vaccine: SMALL, SMALL, SMALL
Symptoms: Dyspnoea, Echocardiogram normal, Electrocardiogram normal, Fatigue, Impaired work ability
Clinical narrative: On 30 Dec 10, experienced headache, low fever and when lying flat he felt chest tightness, pain and pressure. He went to the ED and was told to return if fever exceeded 100.4 degrees F. When temp reached 101 degrees F he contacted doctor and told to go to ED. Tx MOTRIN 800 mg, given IV and blood drawn. Dx with myocarditis and instructed to schedule and echocardiogram. Results pending, will f/u with hosp and PCM.
Age: 20.0
Sex: M
Vaccine: SMALL, SMALL, SMALL
Symptoms: Nausea, Neck pain, Pain, Painful respiration, Troponin increased
Clinical narrative: On 30 Dec 10, experienced headache, low fever and when lying flat he felt chest tightness, pain and pressure. He went to the ED and was told to return if fever exceeded 100.4 degrees F. When temp reached 101 degrees F he contacted doctor and told to go to ED. Tx MOTRIN 800 mg, given IV and blood drawn. Dx with myocarditis and instructed to schedule and echocardiogram. Results pending, will f/u with hosp and PCM.
Age: 20.0
Sex: M
Vaccine: SMALL, SMALL, SMALL
Symptoms: Vaccinia virus infection
Clinical narrative: On 30 Dec 10, experienced headache, low fever and when lying flat he felt chest tightness, pain and pressure. He went to the ED and was told to return if fever exceeded 100.4 degrees F. When temp reached 101 degrees F he contacted doctor and told to go to ED. Tx MOTRIN 800 mg, given IV and blood drawn. Dx with myocarditis and instructed to schedule and echocardiogram. Results pending, will f/u with hosp and PCM.
Age: 20.0
Sex: M
Vaccine: SMALL, SMALL, SMALL
Symptoms: Blood test, Chest discomfort, Chest pain, Headache, Myocarditis
Clinical narrative: On 30 Dec 10, experienced headache, low fever and when lying flat he felt chest tightness, pain and pressure. He went to the ED and was told to return if fever exceeded 100.4 degrees F. When temp reached 101 degrees F he contacted doctor and told to go to ED. Tx MOTRIN 800 mg, given IV and blood drawn. Dx with myocarditis and instructed to schedule and echocardiogram. Results pending, will f/u with hosp and PCM.
Age: 20.0
Sex: M
Vaccine: SMALL, SMALL, SMALL
Symptoms: Pyrexia
Clinical narrative: On 30 Dec 10, experienced headache, low fever and when lying flat he felt chest tightness, pain and pressure. He went to the ED and was told to return if fever exceeded 100.4 degrees F. When temp reached 101 degrees F he contacted doctor and told to go to ED. Tx MOTRIN 800 mg, given IV and blood drawn. Dx with myocarditis and instructed to schedule and echocardiogram. Results pending, will f/u with hosp and PCM.
Age: 20.0
Sex: M
Vaccine: SMALL, SMALL, SMALL
Symptoms: Body temperature increased, Cardiac enzymes increased, Chest discomfort, Chest pain, Chills
Clinical narrative: On 30 Dec 10, experienced headache, low fever and when lying flat he felt chest tightness, pain and pressure. He went to the ED and was told to return if fever exceeded 100.4 degrees F. When temp reached 101 degrees F he contacted doctor and told to go to ED. Tx MOTRIN 800 mg, given IV and blood drawn. Dx with myocarditis and instructed to schedule and echocardiogram. Results pending, will f/u with hosp and PCM.
Age: 20.0
Sex: M
Vaccine: SMALL, SMALL, SMALL
Symptoms: Nausea, Neck pain, Pain, Painful respiration, Pericardial disease
Clinical narrative: On 30 Dec 10, experienced headache, low fever and when lying flat he felt chest tightness, pain and pressure. He went to the ED and was told to return if fever exceeded 100.4 degrees F. When temp reached 101 degrees F he contacted doctor and told to go to ED. Tx MOTRIN 800 mg, given IV and blood drawn. Dx with myocarditis and instructed to schedule and echocardiogram. Results pending, will f/u with hosp and PCM.
Age: 20.0
Sex: M
Vaccine: SMALL, SMALL, SMALL
Symptoms: Pericarditis, Pleurisy, Skin lesion, Troponin I, Troponin increased
Clinical narrative: On 30 Dec 10, experienced headache, low fever and when lying flat he felt chest tightness, pain and pressure. He went to the ED and was told to return if fever exceeded 100.4 degrees F. When temp reached 101 degrees F he contacted doctor and told to go to ED. Tx MOTRIN 800 mg, given IV and blood drawn. Dx with myocarditis and instructed to schedule and echocardiogram. Results pending, will f/u with hosp and PCM.
Age: 12.0
Sex: M
Vaccine: HEPA, HPV4
Symptoms: Asthenia, Hypotension, Nausea, Pallor
Clinical narrative: FIVE MINUTES AFTER RECEIVING THE VACCINE THE PATIENT BEGAN HAVING NAUSEA, LOOKED PALE AND WEAK. WAS TAKEN IN A WHEELCHAIR TO ER.
Age: 36.0
Sex: M
Vaccine: HEP
Symptoms: Blood cholesterol increased, Blood glucose increased, Blood insulin increased, Blood osmolarity increased, Blood sodium decreased
Clinical narrative: Complaints of polydipsia, polyuria, weight loss with polyphagia with onset during mid-late April 2009. When patient sought evaluation in May 2009, his BGs were elevated and he was admitted to Medical Center for 3 days with insulin initiation. He is currently taking LANTUS and ASPART to control his diabetes. He was medically discharged from the military.
Age: 36.0
Sex: M
Vaccine: HEP
Symptoms: Blood triglycerides increased, Glucose urine present, Haematocrit decreased, Hyperphagia, Platelet count decreased
Clinical narrative: Complaints of polydipsia, polyuria, weight loss with polyphagia with onset during mid-late April 2009. When patient sought evaluation in May 2009, his BGs were elevated and he was admitted to Medical Center for 3 days with insulin initiation. He is currently taking LANTUS and ASPART to control his diabetes. He was medically discharged from the military.
Age: 36.0
Sex: M
Vaccine: HEP
Symptoms: Polydipsia, Polyuria, Red blood cell count decreased, Specific gravity urine increased, Urine ketone body present
Clinical narrative: Complaints of polydipsia, polyuria, weight loss with polyphagia with onset during mid-late April 2009. When patient sought evaluation in May 2009, his BGs were elevated and he was admitted to Medical Center for 3 days with insulin initiation. He is currently taking LANTUS and ASPART to control his diabetes. He was medically discharged from the military.
Age: 36.0
Sex: M
Vaccine: HEP
Symptoms: Weight decreased, White blood cell count normal
Clinical narrative: Complaints of polydipsia, polyuria, weight loss with polyphagia with onset during mid-late April 2009. When patient sought evaluation in May 2009, his BGs were elevated and he was admitted to Medical Center for 3 days with insulin initiation. He is currently taking LANTUS and ASPART to control his diabetes. He was medically discharged from the military.
Age: 51.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Pt called and spoke with the pharmacist on duty stating that she had tenderness at the injection area. The patient also had "red spots" around the injection site.  The patient did go to the ER to have the area looked at.
Age: 31.0
Sex: F
Vaccine: FLU3, TTOX
Symptoms: Chills, Headache, Hyperhidrosis, Increased upper airway secretion, Oropharyngeal pain
Clinical narrative: Woke up from a nap and had a severe headache and sore throat, chest congestion and a low grade temperature.  Took Waldryn severe cold around 8:00 PM. Around 10:00 onset chills and lowgrade fever.  Around 3:00 AM 1/16/2011 woke up in a pool of sweat, chiils and lowgrade fever still present along with other symptoms.  Around 6:30 PM monitored temperature, raised up to 100.0.  Purchased Theraflu.  Drank around 9:00PM continued to experience same symptoms as before and still fever even after consuming fluids.  Monday Morning, symptoms still present along with fever and chills. Continued to take Theraflu every 6 hours. Around 10:00PM experienced coughing up of phlegm.  Fever, and chills still present.  Tuesday Morning 01/18/2011Still experiencing the same symptoms, in addition to extreme body aches and skin soreness. Low grade fever.
Age: 31.0
Sex: F
Vaccine: FLU3, TTOX
Symptoms: Pain, Pain of skin, Productive cough, Pyrexia, Respiratory tract congestion
Clinical narrative: Woke up from a nap and had a severe headache and sore throat, chest congestion and a low grade temperature.  Took Waldryn severe cold around 8:00 PM. Around 10:00 onset chills and lowgrade fever.  Around 3:00 AM 1/16/2011 woke up in a pool of sweat, chiils and lowgrade fever still present along with other symptoms.  Around 6:30 PM monitored temperature, raised up to 100.0.  Purchased Theraflu.  Drank around 9:00PM continued to experience same symptoms as before and still fever even after consuming fluids.  Monday Morning, symptoms still present along with fever and chills. Continued to take Theraflu every 6 hours. Around 10:00PM experienced coughing up of phlegm.  Fever, and chills still present.  Tuesday Morning 01/18/2011Still experiencing the same symptoms, in addition to extreme body aches and skin soreness. Low grade fever.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injection site pain
Clinical narrative: complaint of pain at injection site at time of vaccination - pain has persisted to date
Age: 8.0
Sex: F
Vaccine: HEPA
Symptoms: Urticaria
Clinical narrative: Diffuse Urticaria
Age: 10.0
Sex: F
Vaccine: HEPA
Symptoms: Urticaria
Clinical narrative: diffuse Urticaria
Age: 59.0
Sex: F
Vaccine: FLUX
Symptoms: Activities of daily living impaired, Immediate post-injection reaction, Injected limb mobility decreased, Injection site pain, Musculoskeletal pain
Clinical narrative: Immediately upon the insertion of the needle, I had horrible shooting pain down my arm, across my shoulder and into neck and jaw.  Extreme soreness and inabiity to move arm in almost any direction has continued since and only mildly abated.  I am awakened constantly through the night and can not perform simple household chores.  Dressing is difficult.  Have had xray and sonogram but no answer to what is going on.
Age: 59.0
Sex: F
Vaccine: FLUX
Symptoms: Neck pain, Pain, Pain in extremity, Pain in jaw, Sleep disorder
Clinical narrative: Immediately upon the insertion of the needle, I had horrible shooting pain down my arm, across my shoulder and into neck and jaw.  Extreme soreness and inabiity to move arm in almost any direction has continued since and only mildly abated.  I am awakened constantly through the night and can not perform simple household chores.  Dressing is difficult.  Have had xray and sonogram but no answer to what is going on.
Age: 59.0
Sex: F
Vaccine: FLUX
Symptoms: Ultrasound scan normal, X-ray limb normal
Clinical narrative: Immediately upon the insertion of the needle, I had horrible shooting pain down my arm, across my shoulder and into neck and jaw.  Extreme soreness and inabiity to move arm in almost any direction has continued since and only mildly abated.  I am awakened constantly through the night and can not perform simple household chores.  Dressing is difficult.  Have had xray and sonogram but no answer to what is going on.
Age: 68.0
Sex: M
Vaccine: FLUX
Symptoms: Guillain-Barre syndrome, Immunoglobulin therapy, Neurological symptom, Paraesthesia
Clinical narrative: Initial report was received from a health care professional on 03 January 2011 via a search of the scientific literature. A 68-year-old male patient developed neurologic complications after he had received Influenza vaccine (manufacturer unknown, lot number and date of administration not reported). Two weeks post vaccination, the patient experienced paresthesias of the upper and lower extremities and was diagnosed with acute idiopathic demyelinating polyradiculopathy (Guillian-Barre Syndrome). He received intravenous gammaglobulin therapy as corrective treatment with marked improvement. Outcome was not reported. The reporter for this case is the same as for case number 2011-00042. Documents held by sender: None.
Sex: U
Vaccine: DTP
Symptoms: Anaphylactic reaction
Clinical narrative: Initial report was received 10 January 2011 from a health care professional. A five-year-old patient experienced an anaphylactic reaction to a vaccine (presumably a DTP vaccine) five years ago (manufacturer, lot number, route, site and date of administration not reported). The patient's age at the time of the event was not reported. At the time of the report, the physician had not yet seen the record. No additional information was provided. Documents held by sender: None.
Age: 10.0
Sex: M
Vaccine: CHOL, DT, MEN
Symptoms: Crohn's disease, Diarrhoea haemorrhagic, Dyspnoea, Foreign travel, Wheezing
Clinical narrative: Initial report received from the patient's parent on 10 January 2011. This case is not medically confirmed. A 10 year-old male patient (also reported as a 17 year-old) with unknown medical history had received on an unknown date a dose of MENOMUNE (lot not reported), and a dose of Cholera, and Tetanus Diphtheria vaccines (trade names, manufacturer names and lot numbers also not reported) in preparation for travel out of the country. Two months after receiving the vaccines while the patient was overseas, he developed bloody diarrhea and was treated with antibiotics. The patient returned home (date not reported), and a year after his return he again experienced bloody diarrhea and had wheezing and shortness of breath. It was reported that about a year after receiving the vaccinations the patient was diagnosed with Crohn's disease. Recovery status for the wheezing, shortness of breath and bloody diarrhea were unknown. The patient has not recovered from the Crohn's disease. Documents held by sender: None.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Blood pressure increased, Confusional state, Dizziness, Dyspnoea, Heart rate increased
Clinical narrative: Initial case received from a health care professional on 07 January 2011. A 68-year-old female patient received an intramuscular right deltoid injection of FLUZONE (lot number U3737AA) on 06 January 2011. Approximately 2 hours post-vaccination, the patient presented to the emergency department with shortness of breath, increased heart rate ("to the 150's"), increased blood pressure, dizziness, confusion, and diaphoresis. She was hospitalized for unspecified treatment, and remained in the hospital at the time of the report on 07 January 2011. The patient was not ill at the time of vaccination, and medical history included an allergy to penicillin. In addition, she was taking metformin, hydrochlorothiazide, amitriptyline, "clonidin", metoprolol, pravastatin, ranitidine, and gemfibrozil concomitantly; indications were not reported. Per the reporter, the patient had previously received several INFLUENZA vaccinations. Documents held by sender: None.