chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 15.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect drug dosage form administered, No adverse event
Clinical narrative: Case number PHHY2011US69373 is an initial spontaneous report received from a health care professional on 29 Jul 2011 with a follow up physician report received on 19 Aug 2011. This report refers to an adolescent male patient. His medical history includes allergies (unspecified). He was given only the MenA powder conjugate component of MENVEO vaccine (batch number: M10053 and expiry date: Jan 2013) reconstituted with a sterile diluent instead of MenCWY liquid conjugate component, 0.5 ml intramuscularly in the right arm on 28 Jul 2011. No other adverse reaction was reported. Follow up report received on 19 August 2011: The patient demographics, suspect drug information and medical history were updated.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect drug dosage form administered, No adverse event
Clinical narrative: Case number PHHY011US69372, is an initial spontaneous report from a nurse received on 29 Jul 2011: This report refers to a patient with unknown age and gender. This patient was inadvertently received a intramuscular dose of only MenA lyophilized conjugate component of MENVEO (batch number M10059) that was reconstituted with a sterile diluent on 26 Jul 2011. The patient had not received the MenCWY-135 liquid conjugate component of MENVEO. No adverse reaction had occurred following this administration.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect drug dosage form administered, No adverse event
Clinical narrative: Case number PHHY2011US69369, is an initial spontaneous report from a physician received on 29 July 2011: This report refers to a child. This child was vaccinated with only the MenCWY liquid conjugate component of MENVEO (batch number unknown) 0.5 mL, intramuscularly without being reconstituted with the MenA conjugate component on 22 Jul 2011. No adverse events were noted following this medication error.
Age: 10.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect drug dosage form administered, No adverse event
Clinical narrative: Case number PHHY2011US68816 is an initial spontaneous report received from health care professional on 27 Jul 2011. This case refers to 10 years old male patient. He was vaccinated with MENVEO (batch number: X10031) 0.5ml intramuscularly on 25 Jul 2011. But, he was given only Men CYW-135 liquid conjugate component without reconstituting it with Men A lyophilized powder component. No adverse reaction had occurred following this drug administration error.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect drug dosage form administered, No adverse event
Clinical narrative: Case number PHHY2011US68646 is an initial spontaneous report received from health care professional on 27 Jul 2011. This case refers to 18years old male patient. He was vaccinated with MENVEO (batch number: X10031) 0.5ml intramuscularly on 25 Jul 2011. But, he was given only Men CYW-135 liquid conjugate component without reconstituting it with Men A lyophilized powder component. No adverse reaction had occurred following this drug administration error.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect drug dosage form administered, No adverse event
Clinical narrative: Case number PHHY2011US68643 is an incomplete spontaneous received from a nurse 27 Jul 2011. This report refers to eight patients of unknown age group and gender. They were given only the the CYW-135 liquid component of MENVEO  (batch number A10030, A10033, A10034, X10034) intramuscularly within the last two months. No other adverse reaction was reported.
Age: 19.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect drug dosage form administered, No adverse event
Clinical narrative: Case number PHHY2011US63525 is an initial spontaneous report received from a nurse on 13 Jul 2011. This report refers to a 19 year old male patient. He was vaccinated with MENVEO (batch number: M10034) intramuscularly on 11 Jul 2011. However, the patient received only the Men CYW-135 liquid conjugate without reconstituting it with Men A powder conjugate. No adverse event was reported following this drug administration error.
Age: 50.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Rash
Clinical narrative: Patient stated he developed "sunburn"- like rash on face, trunk & arms & upper legs. Did not itch or burn he took BENADRYL Saturday - Sunday rash resolve.
Age: 46.0
Sex: M
Vaccine: TDAP
Symptoms: Electromyogram abnormal, Hypoaesthesia, Malaise, Monoplegia, Muscular weakness
Clinical narrative: Acute pain, rear left shoulder.  Near total paralysis of left arm.  Numbness, tingling, weakness in left arm/hand.  Flu-like malaise that came and went.
Age: 46.0
Sex: M
Vaccine: TDAP
Symptoms: Musculoskeletal pain, Neuropathy peripheral, Nuclear magnetic resonance imaging normal, Paraesthesia, X-ray normal
Clinical narrative: Acute pain, rear left shoulder.  Near total paralysis of left arm.  Numbness, tingling, weakness in left arm/hand.  Flu-like malaise that came and went.
Age: 32.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site rash, Oedema peripheral, Rash
Clinical narrative: Swelling of arm and rash at site and down arm.
Age: 34.0
Sex: F
Vaccine: FLUX
Symptoms: Pain, Pain in extremity
Clinical narrative: Pain in arm when moving over a week later.  The pain is especially bad first thing in the morning and during the night but has been painful since flu shot.
Age: 39.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: RED/SWOLLEN/WARM/FIRM INJECTION SITE.  FEVERS UP TO 101.6.
Age: 10.0
Sex: F
Vaccine: FLUN3
Symptoms: Erythema, Lymph node pain, Nasal congestion, Oropharyngeal pain, Petechiae
Clinical narrative: Nasal congestion, sneezing, sore throat. Palatal petechiae, erythematous tonsils, upper cervical tenderness of lymphnodes.
Age: 10.0
Sex: F
Vaccine: FLUN3
Symptoms: Sneezing, Streptococcus test, Streptococcus test negative
Clinical narrative: Nasal congestion, sneezing, sore throat. Palatal petechiae, erythematous tonsils, upper cervical tenderness of lymphnodes.
Age: 4.0
Sex: M
Vaccine: FLUN3
Symptoms: Convulsion, Rash pruritic, Urticaria
Clinical narrative: Urticaria this AM with a 15 second seizure.  No fever.  All symptoms resolved without treatment except for the itchy urticarial rash.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site induration, Injection site mass, Injection site rash, Pruritus, Rash
Clinical narrative: Rash, hard lump at sight.  By 10/20/2011, rash around mid section, tummy area continuing through 10/22/2011 and still in existence.  No pain, slight itching.
Age: 26.0
Sex: F
Vaccine: FLUX
Symptoms: Cough, Pain, Pyrexia
Clinical narrative: Fever, cough, body pain with vaccine os H1N1.
Age: 54.0
Sex: F
Vaccine: FLUX
Symptoms: Feeling abnormal, Headache, Nausea, Vomiting
Clinical narrative: Patient complained of severe Headache, nausea, vomiting, feeling "foggy". Came into doctor office for eval.
Age: 68.0
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Dyspnoea, Immediate post-injection reaction, Respiratory rate decreased
Clinical narrative: Immediately after administering vaccine Very weak, difficulty breathing.  Respiration rate dropped to 91%. Took blood pressure, observed me.
Age: 51.0
Sex: F
Vaccine: FLUX
Symptoms: Back pain, Headache, Oropharyngeal blistering, Pain, Pulmonary congestion
Clinical narrative: Woke up with blisters in upper palate.  Later in day started experiencing backache.  On 10/17 began throwing up with low grade fever accompanied with headache.  As of today (10/22) have upper chest/sinus congestion, headache, sores in mouth, vomiting, general body aches, low grade fever.
Age: 51.0
Sex: F
Vaccine: FLUX
Symptoms: Pyrexia, Sinus congestion, Stomatitis, Vomiting
Clinical narrative: Woke up with blisters in upper palate.  Later in day started experiencing backache.  On 10/17 began throwing up with low grade fever accompanied with headache.  As of today (10/22) have upper chest/sinus congestion, headache, sores in mouth, vomiting, general body aches, low grade fever.
Age: 36.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Abortion spontaneous, Foetal heart rate abnormal, Maternal exposure during pregnancy, Ultrasound antenatal screen abnormal
Clinical narrative: I was 5 weeks pregnant when I had the mercury-free flu shot. At 7 weeks pregnant, an ultrsound found no fetal heartbeat and the fetus measured 5 weeks pregnant. Doctor confirmed miscarriage of pregnancy.
Age: 36.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Intra-uterine death, Maternal exposure during pregnancy
Clinical narrative: I was 5 weeks pregnant when I had the mercury-free flu shot. At 7 weeks pregnant, an ultrsound found no fetal heartbeat and the fetus measured 5 weeks pregnant. Doctor confirmed miscarriage of pregnancy.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Muscular weakness
Clinical narrative: Extreme weakness in legs. Dull ache in lower back. My back still hurts. I have had chiropractic treatments. But nothing really helps. It comes back.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site vesicles
Clinical narrative: Patient came by to show that she has a blister where she got a shot. The blister is now broken. She does not have any fever, chills, itchings, or anything.
Age: 7.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site inflammation, Local reaction
Clinical narrative: LOCAL INFLAMMATORY REACTION TO (R) DELTOID. APROX 2" CIRCLE.
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Fatigue, Feeling hot
Clinical narrative: Patient said around 45 minutes after receiving high-dose flu shot, he had uncontrollable chills.  The chills then came back 4 hours around 9:00 pm upon going to bed.  The chills lasted for about 3 hours, and he thinks he had a fever.  The chills were uncontrollable and he didnt know what was happening.  All pt could do was lay down in bed.  However, after the chills went away he was fine.  The next day, he just felt tired, but no other signs or symptoms of illness.
Age: 52.0
Sex: F
Vaccine: FLUX
Symptoms: Chills, Diarrhoea, Fatigue, Headache, Nausea
Clinical narrative: Woke up with fever, chills and nauseated and proceeded to throw up.  Went back to bed and woke up at 10:00 AM and had projectile diarrhea and continued to have more diarrhea throughout the day.  Also have aches, pains, headache, fatigue.  Just rested and slept.
Age: 52.0
Sex: F
Vaccine: FLUX
Symptoms: Pain, Pyrexia, Vomiting
Clinical narrative: Woke up with fever, chills and nauseated and proceeded to throw up.  Went back to bed and woke up at 10:00 AM and had projectile diarrhea and continued to have more diarrhea throughout the day.  Also have aches, pains, headache, fatigue.  Just rested and slept.
Age: 60.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Erythema, Hyperhidrosis, Injection site discolouration, Injection site erythema
Clinical narrative: Significant pain at injection site by evening.  Progressed to redness that spread down to the elbow and surrounded the entire upper arm and extended onto chest and scapula.  Fever ensured by bedtime, peaking at 102 degrees several times, alternating with chills and sweats. Fever gone after about 30 hours, redness and heat diminishing slowly by day 3, leaving hint of yellow/green coloring as if following a bruise.  Sl. tenderness remains on shoulder/chest and arm on 10/22.
Age: 60.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain, Injection site warmth, Pyrexia, Tenderness
Clinical narrative: Significant pain at injection site by evening.  Progressed to redness that spread down to the elbow and surrounded the entire upper arm and extended onto chest and scapula.  Fever ensured by bedtime, peaking at 102 degrees several times, alternating with chills and sweats. Fever gone after about 30 hours, redness and heat diminishing slowly by day 3, leaving hint of yellow/green coloring as if following a bruise.  Sl. tenderness remains on shoulder/chest and arm on 10/22.
Age: 12.0
Sex: M
Vaccine: FLU3
Symptoms: Cough, Erythema, Sneezing, Swelling face
Clinical narrative: Father reported the boy sneezing, coughing, which he stated started 45 min ago (call came in at 4:45 PM) and at the time of the call getting a red and swollen face. Pt's father was given lot number, and expiration date of vaccination and told to take pt to the emergency room.
Age: 1.0
Sex: F
Vaccine: PNC13, VARCEL
Symptoms: Insomnia, Muscle spasms, Myoclonus, Poor quality sleep, Restlessness
Clinical narrative: PATIENT WAS SHAKING WHILE SLEEPING AND CONSTANTLY BEING WOKEN FROM HER SLEEP BY RESTLESSNESS AND MYOCLONIC EPISODES. THESE CONTINUED ALMOST EVERY NIGHT FOR MULTIPLE WEEKS, CAUSING THE CHILD TO BE HIGHLY SLEEP DEPRIVED. THE ONLY WAY TO ALLOW THE CHILD TO FALL BACK INTO A DEEP SLEEP WAS TO HOLD HER DOWN AND HELP HER IGNORE THE SPASMS. THESE EPISODES ARE STILL ON GOING AND EXTREMELY CHALLENGING AS THEY EFFECT HER EACH DAY. MORE DETAIL AND VIDEO CAN BE PROVIDED. PATIENT SAW MULTIPLE NEUROLOGISTS WHO DIAGNOSED HER WITH SLEEP MYOCLONUS.
Age: 1.0
Sex: F
Vaccine: PNC13, VARCEL
Symptoms: Sleep disorder, Tremor
Clinical narrative: PATIENT WAS SHAKING WHILE SLEEPING AND CONSTANTLY BEING WOKEN FROM HER SLEEP BY RESTLESSNESS AND MYOCLONIC EPISODES. THESE CONTINUED ALMOST EVERY NIGHT FOR MULTIPLE WEEKS, CAUSING THE CHILD TO BE HIGHLY SLEEP DEPRIVED. THE ONLY WAY TO ALLOW THE CHILD TO FALL BACK INTO A DEEP SLEEP WAS TO HOLD HER DOWN AND HELP HER IGNORE THE SPASMS. THESE EPISODES ARE STILL ON GOING AND EXTREMELY CHALLENGING AS THEY EFFECT HER EACH DAY. MORE DETAIL AND VIDEO CAN BE PROVIDED. PATIENT SAW MULTIPLE NEUROLOGISTS WHO DIAGNOSED HER WITH SLEEP MYOCLONUS.
Age: 71.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Abasia, Biopsy, Blister, Burning sensation, Culture
Clinical narrative: Flu like symptoms for 4 days, severe burning on soles of feet resulting in unbearable pain could not walk. Blisters broke out over entire body, hands and fingers swollen and could not close them.
Age: 71.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Influenza like illness, Oedema peripheral, Pain in extremity, Pruritus
Clinical narrative: Flu like symptoms for 4 days, severe burning on soles of feet resulting in unbearable pain could not walk. Blisters broke out over entire body, hands and fingers swollen and could not close them.
Age: 71.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Biopsy, Burning sensation, Chills, Culture, Influenza
Clinical narrative: Flu like symptoms for 4 days, severe burning on soles of feet resulting in unbearable pain could not walk. Blisters broke out over entire body, hands and fingers swollen and could not close them.
Age: 71.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Mouth ulceration, Pruritus, Rash generalised
Clinical narrative: Flu like symptoms for 4 days, severe burning on soles of feet resulting in unbearable pain could not walk. Blisters broke out over entire body, hands and fingers swollen and could not close them.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Dyspnoea, Headache, Pyrexia
Clinical narrative: SOB, headache, fever, chilling, given oxygen.
Age: 22.0
Sex: F
Vaccine: FLU3
Symptoms: Computerised tomogram normal, Depressed level of consciousness, Hyporesponsive to stimuli
Clinical narrative: Pt had seizure symptoms. In the ER, they ruled out a seizure by CAT scan. However, the pt was exhibiting seizure symptoms with partial loss of consciousness (awake but not fully responsive).
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Headache, Wheezing
Clinical narrative: Severe headache commencing about 4 hrs after shot. Worsened & tightness in chest occured at about 6 hours. Wheezing resulted. Condition resolved itself after several hours without intervention.
Age: 74.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Paranasal sinus hypersecretion, Vaccine positive rechallenge, Vomiting
Clinical narrative: After arriving home, patient vomited 4 times, was severely chilled, had tremendous sinus drainage for 6 hours. Then recovered without incident. Had same reaction in 1954 after flu shot.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLU3, MMR, VARCEL
Symptoms: Urticaria
Clinical narrative: 4 y.o. female developed generalized urticaria several days later after immunization. Given diphenhydramine 6.25 mg 1mx1, ZANTAC 40/5 2.5 ml PO BID, and OTC BENADRYL PRN.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site induration, Swelling
Clinical narrative: 24 hours after vaccination - pt developed swelling that progressed to 6" wide oval area. Pt has thicker (hard) area around area of injection.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site haematoma, Injection site reaction, Pain in extremity
Clinical narrative: Black and blue at injection site for 1 week and pain in arm for 1 week.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Cold-stimulus headache, Cough, Fatigue, Headache
Clinical narrative: Bad headache, extreme fatigue, sinus freeze, sore throat, runny nose, chills, dry cough, aches and pain, green nasal discharge.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Nasal discharge discolouration, Oropharyngeal pain, Pain, Rhinorrhoea
Clinical narrative: Bad headache, extreme fatigue, sinus freeze, sore throat, runny nose, chills, dry cough, aches and pain, green nasal discharge.
Age: 45.0
Sex: M
Vaccine: FLU3
Symptoms: Dyspnoea, Hypoaesthesia oral, Oral pruritus, Paraesthesia oral, Pruritus
Clinical narrative: Pt reported to pharmacy today that approximately 4 hours after getting vaccination, he awoke from a nap, with itching sensation tingling/numbness in mouth and shortness of breath. Took oral BENADRYL and was completely resolved as of today per patient. Stated previously unable to tolerate "allergy shots" but unsure what specifically he was allergic to.
Age: 1.35
Sex: F
Vaccine: FLUX
Symptoms: Pyrexia, Vomiting
Clinical narrative: Child vomited. Fever 101 to 103 degrees lasting 24 hours.  Children's Tylenol 1.5 ML every 4 hours to control fever.
Age: 57.0
Sex: M
Vaccine: FLUX
Symptoms: Asthenia, Chest discomfort, Cough, Dysphonia, Dyspnoea
Clinical narrative: Coughing, wheezing, hoarseness, very difficult to breathe.  Took antihistamines and a inhaler my wife had on hand.
Age: 57.0
Sex: M
Vaccine: FLUX
Symptoms: Wheezing
Clinical narrative: Coughing, wheezing, hoarseness, very difficult to breathe.  Took antihistamines and a inhaler my wife had on hand.
Age: 61.0
Sex: M
Vaccine: FLUX
Symptoms: Mobility decreased, Muscular weakness, Tenderness
Clinical narrative: Could not raise arm over shoulder height weakness when reaching for anything in upper arm, slow motion ability after a certain distance was reached, very painful when touched, but does not seem related to muscles, can't reach behind my self, or reach up without extreme thought process before doing the deed.
Age: 58.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Back pain, Headache, Pain in extremity, Pyrexia, Renal pain
Clinical narrative: Arms horribly sore, 8:30 PM high fever, 10:30 PM shakes, 2:30 AM kidneys hurting, back hurting, headache throughout event 8:30 Am starting to decrease in symptoms.
Age: 58.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Tremor
Clinical narrative: Arms horribly sore, 8:30 PM high fever, 10:30 PM shakes, 2:30 AM kidneys hurting, back hurting, headache throughout event 8:30 Am starting to decrease in symptoms.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Blood pressure decreased, Blood test, Electrocardiogram, Feeling cold, Hypoaesthesia
Clinical narrative: I couldn't hardly lift my feet and to feel numb all over.  My neck wouldn't hold my head up and I could hardly speak. I began to heave and got sick at my stomach. Since I hadn't eaten anything, all that came up was bile.  I had the pharmacy call my daughter and she came and called the paramedics.  They took me to the ER at the hospital. They gave me something to settle my stomach and I was so cold and shaking that they piled heated blankets on me. I was told that my blood pressure went down to 35.  They said they were going to admit me to the hospital and did. There they got an IV Drip going for my blood pressure, took blood samples and did a couple of EKG tests on me.  They also put me on a liquid diet becasue of the vomiting.  I was there a day and a half.  The Dr. released me the next day.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Posture abnormal, Speech disorder, Tremor, Vomiting
Clinical narrative: I couldn't hardly lift my feet and to feel numb all over.  My neck wouldn't hold my head up and I could hardly speak. I began to heave and got sick at my stomach. Since I hadn't eaten anything, all that came up was bile.  I had the pharmacy call my daughter and she came and called the paramedics.  They took me to the ER at the hospital. They gave me something to settle my stomach and I was so cold and shaking that they piled heated blankets on me. I was told that my blood pressure went down to 35.  They said they were going to admit me to the hospital and did. There they got an IV Drip going for my blood pressure, took blood samples and did a couple of EKG tests on me.  They also put me on a liquid diet becasue of the vomiting.  I was there a day and a half.  The Dr. released me the next day.
Age: 54.0
Sex: F
Vaccine: FLUX
Symptoms: Blindness unilateral, Immune system disorder, Laboratory test, Retinal function test abnormal, Vision blurred
Clinical narrative: Acute onset blurred vision/vision loss in left eye approximately three hours after receiving flu shot. Also, severe immune response occurred with systemic symptoms. Was urgently referred to retinal specialist and then rheumatologist on 10/5/2011. Under strict monitoring and treatment currently. Had to be placed on disease-modifying agents and steroids. Vision remains impaired along with systemic symptoms.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Skin warm
Clinical narrative: Patient described the reaction as a "big red reaction, the size of a baseball/red/hot; took about a week to go away."
Age: 23.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Headache, Nausea
Clinical narrative: Headache, fatigue and nausea. Recovered with rest.
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Injection site swelling, Pain, Pyrexia
Clinical narrative: Fever - 24 hours chills - 24 hours severe swelling at injection site - 96 hours body aches - 120 hours
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR, VARCEL
Symptoms: Erythema, Induration, Pruritus, Skin warm
Clinical narrative: Large area of redness, size of grape fruit, with itchiness, hot to touch, and very, very hard to touch.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Chills, Cough, Dysphagia, Dysphonia
Clinical narrative: Started as hoarseness, red itchy eyes with pus, hacking cough, headache, fever, chills, difficult in swallowing, swollen throat. Actually vomited (foam) and no energy.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Eye infection, Eye pruritus, Headache, Ocular hyperaemia, Pharyngeal oedema
Clinical narrative: Started as hoarseness, red itchy eyes with pus, hacking cough, headache, fever, chills, difficult in swallowing, swollen throat. Actually vomited (foam) and no energy.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia, Vomiting
Clinical narrative: Started as hoarseness, red itchy eyes with pus, hacking cough, headache, fever, chills, difficult in swallowing, swollen throat. Actually vomited (foam) and no energy.
Age: 12.0
Sex: F
Vaccine: FLUX
Symptoms: Rash
Clinical narrative: Rash, no itching, here for Doctor visit only.
Age: 29.0
Sex: M
Vaccine: FLUX
Symptoms: Dizziness, Erythema, Lethargy, Pain, Paraesthesia
Clinical narrative: Large (roughly 18 cm X 8 xm, oval shaped,) progressive welt or hive with associated pain and redness. Right maxillary sinus pain, swelling, redness, and tenderness. Low grade fever, lethargy, somnolence, and paresthesia of the face, neck, and shoulder, and dizziness.
Age: 29.0
Sex: M
Vaccine: FLUX
Symptoms: Pyrexia, Sinus headache, Somnolence, Swelling, Tenderness
Clinical narrative: Large (roughly 18 cm X 8 xm, oval shaped,) progressive welt or hive with associated pain and redness. Right maxillary sinus pain, swelling, redness, and tenderness. Low grade fever, lethargy, somnolence, and paresthesia of the face, neck, and shoulder, and dizziness.
Age: 29.0
Sex: M
Vaccine: FLUX
Symptoms: Urticaria
Clinical narrative: Large (roughly 18 cm X 8 xm, oval shaped,) progressive welt or hive with associated pain and redness. Right maxillary sinus pain, swelling, redness, and tenderness. Low grade fever, lethargy, somnolence, and paresthesia of the face, neck, and shoulder, and dizziness.
Age: 0.13
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Crying, Discomfort, Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: Pt returned to clinic with mother ~4pm on day of vaccine administration.  Per mother, child had been crying >3hrs straight after vaccine administration.  On exam, baby was intermittently crying and appeared uncomfortable, but she was consolable when held.  Heart and lung exam remained unchanged from above, apart from mild tachycardia, likely 2/2 discomfort.  Temp 98.9.  B/l thighs were mildly erythematous, moderately edematous without pitting, and seemingly tender to light palpation.  Overlying skin somewhat taut.  Child remained warm and well-perfused with 2+ distal pulses b/l.   Child was given acetaminophen and diphenhydramine.
Age: 0.13
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Tachycardia
Clinical narrative: Pt returned to clinic with mother ~4pm on day of vaccine administration.  Per mother, child had been crying >3hrs straight after vaccine administration.  On exam, baby was intermittently crying and appeared uncomfortable, but she was consolable when held.  Heart and lung exam remained unchanged from above, apart from mild tachycardia, likely 2/2 discomfort.  Temp 98.9.  B/l thighs were mildly erythematous, moderately edematous without pitting, and seemingly tender to light palpation.  Overlying skin somewhat taut.  Child remained warm and well-perfused with 2+ distal pulses b/l.   Child was given acetaminophen and diphenhydramine.
Age: 59.0
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Axillary pain, Chest discomfort, Cough, Diarrhoea
Clinical narrative: Pain & swelling at injection site for about 3 hrs., applied ice pack; nausea & dizziness 2 hrs., overall itching 12 days off & on so far; coughing 12 days off & on so far; chest-tightness, wheezing, shortness of breath, accelerated heartbeat, itchy eyes, excessive urination, body aches, low fever, runny nose, swollen glands, sore throat & ears, hoarseness, lightheadedness, pain in armpit of injected arm, diarrhea, weakness for 12 days so far.
Age: 59.0
Sex: F
Vaccine: FLUX
Symptoms: Dizziness, Dysphonia, Dyspnoea, Ear pain, Eye pruritus
Clinical narrative: Pain & swelling at injection site for about 3 hrs., applied ice pack; nausea & dizziness 2 hrs., overall itching 12 days off & on so far; coughing 12 days off & on so far; chest-tightness, wheezing, shortness of breath, accelerated heartbeat, itchy eyes, excessive urination, body aches, low fever, runny nose, swollen glands, sore throat & ears, hoarseness, lightheadedness, pain in armpit of injected arm, diarrhea, weakness for 12 days so far.
Age: 59.0
Sex: F
Vaccine: FLUX
Symptoms: Heart rate increased, Injection site pain, Injection site swelling, Lymphadenopathy, Nausea
Clinical narrative: Pain & swelling at injection site for about 3 hrs., applied ice pack; nausea & dizziness 2 hrs., overall itching 12 days off & on so far; coughing 12 days off & on so far; chest-tightness, wheezing, shortness of breath, accelerated heartbeat, itchy eyes, excessive urination, body aches, low fever, runny nose, swollen glands, sore throat & ears, hoarseness, lightheadedness, pain in armpit of injected arm, diarrhea, weakness for 12 days so far.
Age: 59.0
Sex: F
Vaccine: FLUX
Symptoms: Oropharyngeal pain, Pain, Pruritus generalised, Pyrexia, Rhinorrhoea
Clinical narrative: Pain & swelling at injection site for about 3 hrs., applied ice pack; nausea & dizziness 2 hrs., overall itching 12 days off & on so far; coughing 12 days off & on so far; chest-tightness, wheezing, shortness of breath, accelerated heartbeat, itchy eyes, excessive urination, body aches, low fever, runny nose, swollen glands, sore throat & ears, hoarseness, lightheadedness, pain in armpit of injected arm, diarrhea, weakness for 12 days so far.
Age: 59.0
Sex: F
Vaccine: FLUX
Symptoms: Urine output increased, Wheezing
Clinical narrative: Pain & swelling at injection site for about 3 hrs., applied ice pack; nausea & dizziness 2 hrs., overall itching 12 days off & on so far; coughing 12 days off & on so far; chest-tightness, wheezing, shortness of breath, accelerated heartbeat, itchy eyes, excessive urination, body aches, low fever, runny nose, swollen glands, sore throat & ears, hoarseness, lightheadedness, pain in armpit of injected arm, diarrhea, weakness for 12 days so far.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Immediate post-injection reaction, Injection site pain, Pain in extremity, Tenderness
Clinical narrative: My arm started aching at the site of the injection immediately after the injection.  Two days later, after exercising my arms with weights and doing push-ups I experienced severe dizziness and my arm began hurting again.  Now, three days later my arm is still tender.  I get flu shots every year, but have not had adverse affects like this time.
Age: 26.0
Sex: M
Vaccine: FLUX
Symptoms: Dysphonia, Heart rate increased, Pain in extremity, Pyrexia
Clinical narrative: At first I felt fine, my arm was just a little sore from the shot.  However, as we began to sit down at dinner my voice became hoarse, feverish, and my heart seemed to be beating a little faster.  These feelings subsided within a few hours and I felt fine by the next morning.
Age: 40.0
Sex: M
Vaccine: FLU3
Symptoms: Bronchospasm, Dyspnoea
Clinical narrative: Hard to breathe Bronchospasm.  Took 1200mg Mucinex with lots of water throughout day.  Took 80mg prednisone at 20 mg intervals until was able to breathe enough to sleep for a few hours.  Saturday contacted ER doctor and was told I was following the correct protocol given the symptoms.  I haven't had an asthma event like this in several years.  Diagnosed in 1977.  Still hard to breath as of Sunday night 10:23 pm, but better than on Friday.
Age: 0.68
Sex: F
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Injection site discolouration
Clinical narrative: Development of an area of tan skin discoloration surrounding injection site. Exact date of onset cannot be known with certainty. The discoloration has persisted several months and appears permanent.
Age: 31.0
Sex: F
Vaccine: FLUX
Symptoms: Dizziness
Clinical narrative: Within 10 minutes of getting the flu shot, I was driving my co-workers back to the office when I felt dizzy, like I was going to faint.  I had to pull over the car and lay down for a few minutes until I felt better.  I went back to the clinic and got some juice and had my blood pressure taken.  I felt good enough by that time to go back to work.
Age: 45.0
Sex: U
Vaccine: FLU3
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Patient reported swelling, redness, warmth in area of injection. She says she had swelling with previous flu shots but not as much. She went to dr and he was not concerned said to just see ice it and take TYLENOL.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Malaise, Pain, Pain in extremity, Rhinorrhoea
Clinical narrative: Pt had body aches, sore arm, sniffles, general malaise for about 36 hrs.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Diarrhoea, Paranasal sinus hypersecretion, Rhinorrhoea
Clinical narrative: Patient said the evening after receiving her flu shot she starting coughing. She coughed for 4 days and also developed runny nose and drainage along with occasional diarrhea. List lasted for about 1 wk total.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site swelling
Clinical narrative: Patient received shot on 10/20/11 & came to pharmacy on 10/22/11 showing a swelling of 3 inches wide around the injection site. Stating it started on 10/21/11 - advised patient to use cold compress - ice.
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Back pain, Feeling cold, Neck pain, Nervousness
Clinical narrative: Pt got flu shot 11h31 on 10/22/11. Called at 16h50 to complain about being weak, shaky & aching all over. Pt was not sweating, but was cold. Arm hurts, travelling, down back from shoulder & neck, pain in lower back. Pt was already presenting with a cold at the time of administering the flu shot. Pt was advised to see MD or got to ER. MS was informed.
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Pain in extremity
Clinical narrative: Pt got flu shot 11h31 on 10/22/11. Called at 16h50 to complain about being weak, shaky & aching all over. Pt was not sweating, but was cold. Arm hurts, travelling, down back from shoulder & neck, pain in lower back. Pt was already presenting with a cold at the time of administering the flu shot. Pt was advised to see MD or got to ER. MS was informed.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient presented with 4-inch circular swollen red, hot area at injection site. Started within 24 hours of injection, subsiding within 48 hours of injection.
Age: 1.61
Sex: F
Vaccine: DTAP, FLU3, PNC, DTAP, FLU3, PNC13
Symptoms: Incorrect dose administered, Pyrexia
Clinical narrative: Patient was mistakenly given 3 doses of FLUZONE (0.5 ml) in 3 injections, 2 in (L) thigh and = in (R) thigh vaccination realized mistake immediately after administering FLUZONE. Father and neighbor given all instructions NML side effects of FLUZONE, if needed to call on-call provider/911. F/U was done, child only had low grade fever. x 3  days, no other sx.
Age: 1.61
Sex: F
Vaccine: DTAP, FLU3, PNC, DTAP, FLU3, PNC13
Symptoms: Pyrexia, Wrong drug administered
Clinical narrative: Patient was mistakenly given 3 doses of FLUZONE (0.5 ml) in 3 injections, 2 in (L) thigh and = in (R) thigh vaccination realized mistake immediately after administering FLUZONE. Father and neighbor given all instructions NML side effects of FLUZONE, if needed to call on-call provider/911. F/U was done, child only had low grade fever. x 3  days, no other sx.
Age: 49.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: Asthenia, Dysphonia, Dyspnoea, Pallor
Clinical narrative: 2 hours after vaccine admin became hoarse then throat swelled became difficult to swallow. Went to ER Hosp.-steroids, ZANTA, BENADRYL IV. Rx given for steroids x 3 days. Pt is repeating steroid dose.
Age: 49.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: Dysphagia, Dysphonia, Pharyngeal oedema
Clinical narrative: 2 hours after vaccine admin became hoarse then throat swelled became difficult to swallow. Went to ER Hosp.-steroids, ZANTA, BENADRYL IV. Rx given for steroids x 3 days. Pt is repeating steroid dose.
Age: 67.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Pain
Clinical narrative: Flu vaccine given 9-25-11. Immediately felt more pain than past flu shots. 2 days later could not lift arm because of pain. Went to see Dr. around 10/4. There was still swelling at injection site. He was told shot was given too high on the arm into the tendon. Patient was given VICODIN and some special exercises. Patient contacted us on 10/14 about the problem. Said there may be some improvement but not much. Still not able to lift anything with that arm and still in pain. Is concerned he may need physical therapy.
Age: 67.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Drug administered at inappropriate site, Immediate post-injection reaction, Injected limb mobility decreased, Injection site swelling, Pain in extremity
Clinical narrative: Flu vaccine given 9-25-11. Immediately felt more pain than past flu shots. 2 days later could not lift arm because of pain. Went to see Dr. around 10/4. There was still swelling at injection site. He was told shot was given too high on the arm into the tendon. Patient was given VICODIN and some special exercises. Patient contacted us on 10/14 about the problem. Said there may be some improvement but not much. Still not able to lift anything with that arm and still in pain. Is concerned he may need physical therapy.
Age: 86.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Musculoskeletal stiffness, Neck pain
Clinical narrative: Information has been received from a registered pharmacist concerning an 86 year old male patient who on 12-OCT-2011 was vaccinated with a dose of PNEUMOVAX 23 (lot # 671401/1158AA, expiration: 10-APR-2013) (dose and route not reported). On 13-OCT-2011 the patient's arm became sore and he could not move his neck after getting the PNEUMOVAX 23 shot. The patient sought unspecified medical attention. At the time of reporting, the patient's status was unknown. It was also reported that this was the third time that the adverse experience were reported with the same lot number. A lot check has been initiated. The patient's arm became sore and could not move his neck were considered to be disabling. This is one of several reports received from the same source. Additional information has been requested.
Age: 86.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Information has been received from a registered pharmacist concerning an 86 year old male patient who on 12-OCT-2011 was vaccinated with a dose of PNEUMOVAX 23 (lot # 671401/1158AA, expiration: 10-APR-2013) (dose and route not reported). On 13-OCT-2011 the patient's arm became sore and he could not move his neck after getting the PNEUMOVAX 23 shot. The patient sought unspecified medical attention. At the time of reporting, the patient's status was unknown. It was also reported that this was the third time that the adverse experience were reported with the same lot number. A lot check has been initiated. The patient's arm became sore and could not move his neck were considered to be disabling. This is one of several reports received from the same source. Additional information has been requested.
Age: 39.0
Sex: F
Vaccine: TD
Symptoms: Chest pain, Dyspnoea, Haematocrit decreased, Haemoglobin decreased, Injection site pain
Clinical narrative: PAIN ON INJECTION SITE. CHEST PAIN INITIALLY RIGHT SIDED BUT SPREAD TO LEFT SIDED CHEST PAIN RADIATING TOWARDS THE BACK. SHORTNESS OF BREATH.
Age: 39.0
Sex: F
Vaccine: TD
Symptoms: Mean cell haemoglobin concentration normal, Mean cell haemoglobin increased, Mean cell volume increased, Platelet count normal, Red blood cell count decreased
Clinical narrative: PAIN ON INJECTION SITE. CHEST PAIN INITIALLY RIGHT SIDED BUT SPREAD TO LEFT SIDED CHEST PAIN RADIATING TOWARDS THE BACK. SHORTNESS OF BREATH.
Age: 39.0
Sex: F
Vaccine: TD
Symptoms: Red cell distribution width normal, White blood cell count normal
Clinical narrative: PAIN ON INJECTION SITE. CHEST PAIN INITIALLY RIGHT SIDED BUT SPREAD TO LEFT SIDED CHEST PAIN RADIATING TOWARDS THE BACK. SHORTNESS OF BREATH.
Age: 29.0
Sex: M
Vaccine: FLU3, SMALL
Symptoms: Fatigue, Joint stiffness, Muscular weakness, Rash erythematous
Clinical narrative: Bilateral hand weakness, joint stiffness in the hands and elbows, fatigue, petechiae on right arm/chest.
Age: 50.0
Sex: F
Vaccine: FLUX, TDAP
Symptoms: Pain, Tenderness
Clinical narrative: Pt received immunizations on 9/12/11. Called clinic on 10/11/11 reporting arm as still tender & use of arm. Appt scheduled for 10/12/11. Eval on 10/12/11 showed not redness, swelling, or warmth, normal ROM, but tender to palpation.
Age: 6.0
Sex: M
Vaccine: FLUX
Symptoms: Erythema, Pruritus
Clinical narrative: Mom called 10-19. Face, chest, shoulders red itchy. Given BENADRYL (children's) by mom. Denied difficulty breathing swallowing & was at school.
Age: 11.0
Sex: M
Vaccine: FLU3
Symptoms: Convulsion
Clinical narrative: Patient had left office and approx. 45 min to 1 hr. after immunization patient had seizure and went to local ER. Patient has ALD & is s/p stem cell transplant approx 2 yrs ago. Patient sent home after initial ER visit, but then had another seizure at about 8pm and went to local ER then transported to medical center by ambulance.
Age: 59.0
Sex: F
Vaccine: FLUX
Symptoms: Laboratory test normal, Mass, Pain, Parvovirus B19 test negative, Polyarthritis
Clinical narrative: Pt had Sanofi Pasteur IM flu vaccine 9/18/2011. Next day developed diffuse polyarthritis with pain, swelling, MPPs, PIPs, Wnots, knees, feet.
Age: 59.0
Sex: F
Vaccine: FLUX
Symptoms: Swelling
Clinical narrative: Pt had Sanofi Pasteur IM flu vaccine 9/18/2011. Next day developed diffuse polyarthritis with pain, swelling, MPPs, PIPs, Wnots, knees, feet.
Age: 16.0
Sex: M
Vaccine: HEPA
Symptoms: Dyskinesia, Electrocardiogram normal, Electroencephalogram normal, Head injury, Posture abnormal
Clinical narrative: 5 min after receiving Hep A #2 while seated on exam table with tourniquet on arm looking for vein to draw blood. Pt slumped over, then hit (L) side of head on wall, both arms were tonic & (R) leg was shaking. Event lasted 30 sec.
Age: 16.0
Sex: M
Vaccine: HEPA
Symptoms: Tremor
Clinical narrative: 5 min after receiving Hep A #2 while seated on exam table with tourniquet on arm looking for vein to draw blood. Pt slumped over, then hit (L) side of head on wall, both arms were tonic & (R) leg was shaking. Event lasted 30 sec.
Age: 5.0
Sex: M
Vaccine: FLU3
Symptoms: Rash generalised, Rash pruritic, Urticaria
Clinical narrative: Flu vaccine given 10/21/11 approx 10 am. Pruritic, raised rash (hives) all over body started around 7 pm same day. Rash worsened over next two days (weekend). Seen by provider Mon 10/24/11 Diphenhydramine 125/5ml Q6 hr PRN for rash.
Age: 1.72
Sex: M
Vaccine: DTAP, FLUX, HEPA, HIBV
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: (Lt) thigh with erythema on upper imm. site, app. 1.5x2"; warm to touch; afebrile; non-tender; moving well; non-ill appearing. Seen by PCP on 10-22-11. Tx with ice packs & ibuprofen-PRN.
Age: 0.41
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Erythema, Flushing, Rash, Urticaria
Clinical narrative: Patient returned to office approx 45 min after immunization with red flushed face & large whelp like rash. BENADRYL 3 ml given PO. Rash resolved. Pt observed for 45 min.
Age: 30.0
Sex: F
Vaccine: FLUX
Symptoms: Dizziness, Dyspnoea, Hyperhidrosis, Paraesthesia, Vomiting
Clinical narrative: Vomited day of vaccine. Dizziness, tingling in hands & feet, SOB, sweating intermittently. 10/18-10/24/11.
Age: 61.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site nodule, Injection site pain, Injection site pruritus, Injection site rash
Clinical narrative: Localized reaction started one day after receiving injection. Redness, itching, pain at site of injection with red raised spots. Ten days later 18 cm x 20 cm red area, with central nodule: Apply cold compress, BENADRYL/TYLENOL.
Age: 61.0
Sex: F
Vaccine: TDAP
Symptoms: Local reaction
Clinical narrative: Localized reaction started one day after receiving injection. Redness, itching, pain at site of injection with red raised spots. Ten days later 18 cm x 20 cm red area, with central nodule: Apply cold compress, BENADRYL/TYLENOL.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Full blood count, Headache, Metabolic function test, Pain, Pyrexia
Clinical narrative: Fever 102.1, rash all over body (red & raised), body aches & headache. Gave pt an injection of KENALOG & pres. MEDROL Dose pack. See attached Progress Note.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Rash erythematous, Rash generalised
Clinical narrative: Fever 102.1, rash all over body (red & raised), body aches & headache. Gave pt an injection of KENALOG & pres. MEDROL Dose pack. See attached Progress Note.
Age: 0.51
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Chest X-ray normal, Cough, Laboratory test, Nasopharyngitis, Pertussis
Clinical narrative: Initial report received on 11 October 2011 from the Investigator participating in the post-marketing observational surveillance study under the reference number M5A16. A case of pertussis disease in a 20-month-old female subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance System electronic database. The subject's vaccine history included 3 doses of PENTACEL; lot number C3570AA received on 11 January 2010, lot number C3606AA received on 15 March 2010 and lot number C3608AA received on 14 May 2010 (routes and sites of administration not reported). The subject developed cold-like symptoms and a cough on 18 July 2011, approximately 14 months after the last dose. On 22 July 2011, the subject developed a paroxysmal cough without a whoop. The subject also experienced posttussive vomiting and sleep disturbance. Sleep apnea was reported as unknown. Laboratory testing included positive PCR on 23 July 2011. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of Azithromycin starting on 23 July 2011 for five days. The subject was not hospitalized. At the time of final contact on 05 August 2011, the subject's cough was still persisting. The duration of the cough was reported at that time as 18 days. Investigator causality assessment is not required as per protocol. Documents held by sender; None.
Age: 0.51
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Polymerase chain reaction, Post-tussive vomiting, Sleep apnoea syndrome, Sleep disorder
Clinical narrative: Initial report received on 11 October 2011 from the Investigator participating in the post-marketing observational surveillance study under the reference number M5A16. A case of pertussis disease in a 20-month-old female subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance System electronic database. The subject's vaccine history included 3 doses of PENTACEL; lot number C3570AA received on 11 January 2010, lot number C3606AA received on 15 March 2010 and lot number C3608AA received on 14 May 2010 (routes and sites of administration not reported). The subject developed cold-like symptoms and a cough on 18 July 2011, approximately 14 months after the last dose. On 22 July 2011, the subject developed a paroxysmal cough without a whoop. The subject also experienced posttussive vomiting and sleep disturbance. Sleep apnea was reported as unknown. Laboratory testing included positive PCR on 23 July 2011. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of Azithromycin starting on 23 July 2011 for five days. The subject was not hospitalized. At the time of final contact on 05 August 2011, the subject's cough was still persisting. The duration of the cough was reported at that time as 18 days. Investigator causality assessment is not required as per protocol. Documents held by sender; None.
Age: 0.51
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Chest X-ray normal, Cough, Laboratory test abnormal, Nasopharyngitis, Pertussis
Clinical narrative: Initial report received on 11 October 2011 from the Investigator participating in a study under the reference number M5A16. A case of pertussis disease in a 8-month-old male subject (initials not collected) was identified by the investigator based on review of data from the electronic database. The subject's vaccine history included 3 doses of PENTACEL; lot number C3613AA received on 03 February 2011, lot number C3723AA received on 07 April 2011, and lot number C3752AA received on 07 June 2011 (routes and sites of administration not reported). The subject developed cold-like symptoms and cough on 25 August 2011, 79 days after the last dose. On 02 September 2011, the subject developed a paroxysmal cough with a whoop. The subject also experienced posttussive vomiting and sleep disturbance. Laboratory testing included positive PCR on 08 September 2011. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of Azithromycin starting on 08 September 2011 for five days. The subject was not hospitalized. At the time of final contact on 21 September 2011, the subject's cough had resolved. The duration of the cough was reported at that time as 22 days. According to the investigator, this case was epidemiologically linked to a laboratory confirmed case. Investigator causality assessment is not required as per protocol. Documents held by sender: None.