chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Fall, Hypotonia, Loss of consciousness, Pallor, Syncope
Clinical narrative: Approximately 1-2 minutes post vaccine injection, pt collapsed, fell into mother's arms from standing position (? stiff ? shaking per mother), lost consciousness 2-3 seconds, I arrived in room took child (limp, pale, waking up), placed her supine on exam table -> immediate return of color & alertness BP nl (100/60) Pulse 80 neg T 97.3, remained well immediate post event minutes, observed at home - event most consistent with vasovagal syncope.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Urticarial rash.
Age: 18.0
Sex: M
Vaccine: ANTH, SMALL, SMALL, ANTH, SMALL, ANTH, SMALL
Symptoms: Blood creatine phosphokinase MB increased, Chest discomfort, Dyspnoea, Intensive care, Troponin increased
Clinical narrative: Acute myopericarditis
Age: 18.0
Sex: M
Vaccine: ANTH, SMALL, SMALL, ANTH, SMALL, ANTH, SMALL
Symptoms: Echocardiogram normal, Electrocardiogram ST segment elevation, Electrocardiogram abnormal, Myopericarditis, Nuclear magnetic resonance imaging
Clinical narrative: Acute myopericarditis
Age: 18.0
Sex: M
Vaccine: ANTH, SMALL, SMALL, ANTH, SMALL, ANTH, SMALL
Symptoms: Troponin increased
Clinical narrative: Acute myopericarditis
Age: 18.0
Sex: M
Vaccine: ANTH, SMALL, SMALL, ANTH, SMALL, ANTH, SMALL
Symptoms: Echocardiogram abnormal, Electrocardiogram abnormal, Nuclear magnetic resonance imaging normal, Pericarditis, Troponin I increased
Clinical narrative: Acute myopericarditis
Age: 19.0
Sex: F
Vaccine: ANTH
Symptoms: Arthralgia, Fatigue, Headache, Kidney infection, Myalgia
Clinical narrative: After receiving first anthrax shot symptoms were headache, fainting, kidney infection, severe joint and muscle pain. While stationed on board a ship fainted during an underway replenishment evolution. Was taken to medical and was prescribed 3 days sick in quarters for physical exhaustion and given Motrin for joint and muscle pain.
Age: 19.0
Sex: F
Vaccine: ANTH
Symptoms: Syncope
Clinical narrative: After receiving first anthrax shot symptoms were headache, fainting, kidney infection, severe joint and muscle pain. While stationed on board a ship fainted during an underway replenishment evolution. Was taken to medical and was prescribed 3 days sick in quarters for physical exhaustion and given Motrin for joint and muscle pain.
Age: 42.0
Sex: M
Vaccine: SMALL, SMALL, SMALL
Symptoms: Chest pain, Echocardiogram abnormal, Ejection fraction decreased, Electrocardiogram PR interval, Electrocardiogram ST segment elevation
Clinical narrative: Had symptoms of malaise, fever and chest pain
Age: 42.0
Sex: M
Vaccine: SMALL, SMALL, SMALL
Symptoms: Electrocardiogram abnormal, Hypokinesia, Malaise, Pyrexia
Clinical narrative: Had symptoms of malaise, fever and chest pain
Age: 42.0
Sex: M
Vaccine: SMALL, SMALL, SMALL
Symptoms: Chest pain
Clinical narrative: Had symptoms of malaise, fever and chest pain
Age: 42.0
Sex: M
Vaccine: SMALL, SMALL, SMALL
Symptoms: Electrocardiogram abnormal, Malaise, Myocarditis, Pyrexia, Troponin I increased
Clinical narrative: Had symptoms of malaise, fever and chest pain
Age: 42.0
Sex: M
Vaccine: SMALL, SMALL, SMALL
Symptoms: Chest pain, Echocardiogram abnormal, Ejection fraction decreased, Electrocardiogram PR interval, Electrocardiogram ST segment elevation
Clinical narrative: Pt presented to ED with persistent chest pain. He was admitted and medically evacuated to another Medical Center.
Age: 42.0
Sex: M
Vaccine: SMALL, SMALL, SMALL
Symptoms: Electrocardiogram abnormal, Hypokinesia, Malaise, Pyrexia
Clinical narrative: Pt presented to ED with persistent chest pain. He was admitted and medically evacuated to another Medical Center.
Age: 42.0
Sex: M
Vaccine: SMALL, SMALL, SMALL
Symptoms: Chest pain
Clinical narrative: Pt presented to ED with persistent chest pain. He was admitted and medically evacuated to another Medical Center.
Age: 42.0
Sex: M
Vaccine: SMALL, SMALL, SMALL
Symptoms: Electrocardiogram abnormal, Malaise, Myocarditis, Pyrexia, Troponin I increased
Clinical narrative: Pt presented to ED with persistent chest pain. He was admitted and medically evacuated to another Medical Center.
Age: 1.04
Sex: F
Vaccine: FLUX, HEPA, HIBV, PPV
Symptoms: Ear infection, Pyrexia, Screaming, Vomiting
Clinical narrative: Prolonged (4 hours) Vomit - screaming -low fever - resulted in double ear infection - given antibiotics.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Musculoskeletal pain, Surgery
Clinical narrative: Information has been received from a 75 year old female with no pertinent medical history and no known drug allergies who in approximately 2009 (reported as "about 2 years ago") was vaccinated subcutaneously with a 0.65ml dose of ZOSTAVAX (Merck). Concomitant therapy included simvastatin (manufacturer unknown), lisinopril (manufacturer unknown), and vitamins (unspecified). On 31-MAR-2011 the patient experienced shingles in her right buttocks one week after she had back surgery due to lots of pain in her left buttocks and her physician said it was probably caused by the stress of the surgery. The patient was treated with VICODIN for pain from the back operation, and steroid pack for 6 days, ZOVIRAX cream and pills. There was no lab diagnostics performed. At the time of the report, the patient's rash was gone but she was still in some pain. Upon internal review, pain in the left buttock, requiring back surgery, was determined to be an other important medical event. No further information is available.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: (L) deltoid region red/swollen & hot to the touch.
Age: 12.0
Sex: M
Vaccine: TDAP, VARCEL
Symptoms: Erythema, Skin warm, Swelling, Tenderness
Clinical narrative: Significant swelling, warmth, tenderness & erythema the day after receiving vaccine, improved within a few days. No specific treatment required. No fever.
Age: 0.4
Sex: F
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Computerised tomogram head, Crying, Dyskinesia, Electroencephalogram
Clinical narrative: Uncontrollable crying for seven hours followed jerking episode off and on for the next day.
Age: 76.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Cellulitis, Dizziness, Erythema, Lymphangitis, Nausea
Clinical narrative: This medically confirmed spontaneous report (initial receipt date: 27-APR-2011) concerns a 76-year old female patient, who had a medical history of chronic pruritus. She had no known allergy. Concomitant medication included hydroxyzine, hydrochlorothiazide; lisinopril combination and estrogens conjugate. On 04-NOV-2010 the patient received a flu shot (brand name unspecified) in her right arm. On the same day the patient also received PNEUMOVAX in her left arm. When a call was made to the patient on 04-DEC-2010, the patient complained of a 5 inches area on her left arm that was red, hot and swollen. The area was getting bigger. The patient 'was faint' and nauseous last night. There was no improvement since 01-DEC-2010. The patient was treated with ice packs and paracetamol. The patient subsequently presented to the clinic complaining of rash and redness on left arm with no pain or fever. She was later diagnosed with VL (very low) superficial cellulitis / lymphangitis to her left arm. The site of injection had no induration or warmth. She was prescribed with a course of cephalexin and advised to call up the clinic if symptoms persisted. The event outcome was not specified.
Age: 76.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Oedema peripheral, Rash, Skin warm
Clinical narrative: This medically confirmed spontaneous report (initial receipt date: 27-APR-2011) concerns a 76-year old female patient, who had a medical history of chronic pruritus. She had no known allergy. Concomitant medication included hydroxyzine, hydrochlorothiazide; lisinopril combination and estrogens conjugate. On 04-NOV-2010 the patient received a flu shot (brand name unspecified) in her right arm. On the same day the patient also received PNEUMOVAX in her left arm. When a call was made to the patient on 04-DEC-2010, the patient complained of a 5 inches area on her left arm that was red, hot and swollen. The area was getting bigger. The patient 'was faint' and nauseous last night. There was no improvement since 01-DEC-2010. The patient was treated with ice packs and paracetamol. The patient subsequently presented to the clinic complaining of rash and redness on left arm with no pain or fever. She was later diagnosed with VL (very low) superficial cellulitis / lymphangitis to her left arm. The site of injection had no induration or warmth. She was prescribed with a course of cephalexin and advised to call up the clinic if symptoms persisted. The event outcome was not specified.
Age: 35.0
Sex: M
Vaccine: JEV
Symptoms: Eyelid oedema, Rash
Clinical narrative: Rash on face, neck, chest, and legs. Swelling on left eye lid.
Age: 14.0
Sex: M
Vaccine: HPV4
Symptoms: Abdominal discomfort, Decreased appetite, Diarrhoea, Dizziness, Eye pain
Clinical narrative: Pain in eyes when looking left and right (Optic Neuritis), Lightheaded, Diarrhea, Malaise, Upset stomach, and decreased appetite. **Referring pt to optometrist**
Age: 14.0
Sex: M
Vaccine: HPV4
Symptoms: Malaise, Optic neuritis
Clinical narrative: Pain in eyes when looking left and right (Optic Neuritis), Lightheaded, Diarrhea, Malaise, Upset stomach, and decreased appetite. **Referring pt to optometrist**
Age: 5.0
Sex: M
Vaccine: MMRV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Mom noticed redness and swelling on Right Upper Arm the afternoon of 05/11/11. Hot to the touch. Came into office on 05/12/2011 swelling had decreased dramatically per mom warm to the touch but very mildly and no longer painful.
Age: 37.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Dry skin, Musculoskeletal stiffness, Mydriasis, Pallor, Unresponsive to stimuli
Clinical narrative: PATIENT BECAME UNRESPONSIVE, BODY STIFFENED, PUPILS DILATED, AND SKIN COLOR PALE (BUT DRY). LASTED APPPROXIMATELY 45 SECONDS. PATIENT WAS UNAWARE OF EVENT AFTER RECOVERY.  COMPLETELY ALERT AFTER EPISODE.
Age: 54.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Pain in extremity, Skin warm, Tenderness
Clinical narrative: Received PPSV23 rt arm SC 5-10-11, erythema started 5-10-2011 and became worse on 5-11-11, with complaints of pain in right arm.  Area is warm to touch.  Erythema extended from distal deltoid to proximal elbow, involving posterior surface as well.  Area is warm and tender to palpation.  Area was marked and patient instructed to follow up at office if erythema extends beyond marked area.  Was ordered Doxycycline 100mg BID for 10 days on 5-10-11 for bronchitis, but had not started it, patient was encouraged to start Doxycycline at OV 5-11-11.
Sex: U
Vaccine: TDAP
Symptoms: Cellulitis, Discomfort, Injection site erythema, Injection site swelling, Tenderness
Clinical narrative: This case is 1 of a cluster of 3 patients' who experienced similar adverse events following vaccination with ADACEL. The events for the other 2 patients' were captured in case number 2011-02656. An unidentified patient (age and sex not reported) received an intramuscular injection (site not reported) of ADACEL, sanofi pasteur lot number C3837BA, in April 2011. The patient developed redness and swelling larger than a quarter at the injection site. The redness covered the whole upper arm. The patient also experienced tenderness and discomfort. The patient had cellulitis and was treated with antibiotics. The outcome was reported as recovered. Documents held by sender: None.
Age: 13.0
Sex: M
Vaccine: HPV4, MNQ, TDAP, VARCEL
Symptoms: Infection, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Mom came to office with patient today stating that site ((R) arm subq) where VARIVAX was given on 04-19-2011 became red, hot & swollen the evening of vaccination. Mom took patient to ER on 04-21-2011 and was told patient "has an infection in the arm" and was given KEFLEX. Today area of site is red around injection site & slightly warm.
Age: 19.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Condition aggravated, Immediate post-injection reaction, Loss of consciousness, Syncope
Clinical narrative: Administered GARDASIL vaccine first and patient was fine. Immediately after administering MCV4 vaccine, patient fainted. Was unconscious for less than 5 min. When regained consciousness, war oriented to person & place, BP monitored. Gave patient juice and crackers. Patient did not eat breakfast before coming to clinic for vaccines. Patient reports that she has fainted before when getting blood drawn. Advised to follow-up with primary MD. Patient transported home by family member.
Age: 68.0
Sex: F
Vaccine: DT, HEPAB, TYP, YF
Symptoms: Coordination abnormal, Dizziness, Oedema peripheral, Pain in extremity, Pruritus generalised
Clinical narrative: 4 days after vaccine arm started aching. Shot given on 4-11-11 symptoms started on 4-15-11. On 4-17-11 arm swollen & hot. Ached clear to wrist. On 4-18-11 pt was dizzy & uncoordinated with itching over entire body. Started on steroids on 4-18-11.
Age: 68.0
Sex: F
Vaccine: DT, HEPAB, TYP, YF
Symptoms: Skin warm
Clinical narrative: 4 days after vaccine arm started aching. Shot given on 4-11-11 symptoms started on 4-15-11. On 4-17-11 arm swollen & hot. Ached clear to wrist. On 4-18-11 pt was dizzy & uncoordinated with itching over entire body. Started on steroids on 4-18-11.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis
Clinical narrative: Patient developed cellulitis after getting vaccine. AVELOX prescribed to treat.
Age: 17.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Chills, Diarrhoea, Faeces discoloured, Malaise, Mobility decreased
Clinical narrative: Vomiting and black diarrhea began evening of vaccination and continued for 2 days & chills but no temperature. Friday 4/29/11 "still feels sick", states "can't move" due to joints hurt and muscle ache. Was evaluated by Dr. Ordered LOMOTIL, PHENERGAN & encouraged fluids. Spoke to parent on Monday 5/2/11, patient is feeling well again.
Age: 17.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Myalgia, Vomiting
Clinical narrative: Vomiting and black diarrhea began evening of vaccination and continued for 2 days & chills but no temperature. Friday 4/29/11 "still feels sick", states "can't move" due to joints hurt and muscle ache. Was evaluated by Dr. Ordered LOMOTIL, PHENERGAN & encouraged fluids. Spoke to parent on Monday 5/2/11, patient is feeling well again.
Age: 3.0
Sex: F
Vaccine: PNC13
Symptoms: Chest X-ray normal, Condition aggravated, Convulsion, Electrocardiogram normal
Clinical narrative: Pt with no history of seizure had an episode I suspect as a seizure approximately 8 hours after receiving PREVNAR-13.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: No adverse event
Clinical narrative: Patient was given ZOSTAVAX vaccine and has a history of lymphoma. No adverse events have occurred.
Age: 77.0
Sex: M
Vaccine: FLU3
Symptoms: Palpable purpura, Platelet count decreased, Purpura
Clinical narrative: Sudden drop of platelets with diffuse hemorrhagic rash & palpable purpura 1 week after flu shot.
Age: 1.52
Sex: F
Vaccine: HEPA
Symptoms: Body temperature increased, Ear infection, Febrile convulsion
Clinical narrative: Child received Hep. A #2 at 9:30 AM and had a febrile seizure at 2:30 PM.  Temp. was 104.9.  Child taken to ER and diagnosed with otitis.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Hypercalcaemia
Clinical narrative: This female subject was enrolled in the prophylactic observer-blind study 106372 (FLU NG-006). On 08 October 2008, she received one dose of preservative-free FLUARIX or influenza vaccine adjuvanted with half dose of AS03 (FLU NG). This subject received FLUARIX. Medical conditions at the time of the event included hypertension and osteopenia. Concomitant medications included Hydrochlorothiazide. On 15 October 2008, seven days after the 1st dose of Blinded vaccine, 6 years after the first intake of Calcium and 9 months after the first intake of TUMS, this 73-year-old subject experienced hypercalcemia. The subject was hospitalised. The subject was treated with intravenous fluid(s) and pamidronic acid. The event resolved on 21.
Age: 8.0
Sex: M
Vaccine: HEPA
Symptoms: Diarrhoea, Headache, Neck pain, Pyrexia, Urticaria
Clinical narrative: Mother states child c/o headache, neck pain, fever & diarrhea-3 days after receiving immunization. On 5/08/11-child also developed hives head to toe and was taken to Urgent Care facility to be treated.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient complained of burning sensation at site of injection.  Claimed area had erythema and mild swelling.  Erythema and swelling has subsided but area is tender to the touch.
Age: 5.0
Sex: F
Vaccine: DTAP, MMR, VARCEL
Symptoms: Injection site urticaria
Clinical narrative: Hives (welts) on bilat arms and chin-gave Benadryl and hives disappeard by the next morning.
Age: 0.19
Sex: F
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Lethargy, Listless, Somnolence
Clinical narrative: Mother of baby reports 2 months later that approx 15-20 minutes after vaccinations, baby was lethargic, listless, and hard to awaken. This went on for 24 hours. She reported to baby's pediatrician who parent states was unconcerned. SN requested she take baby to pediatrician for 4 month vaccines but insurance won't cover. Received order from Dr. to administer 4 mo vaccines here at health dept.
Age: 13.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Cardio-respiratory arrest, Cyanosis, Resuscitation, Unresponsive to stimuli
Clinical narrative: Less than 5 minutes after vaccine given, patient became cyanotic, unresponsive cardiopulmonary arrest requiring full CPR. Transported to local ED via ambulance, required additional support including epinephrine, diphenhydramine, Solumedrol.
Age: 12.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Candidiasis, Fatigue, Full blood count normal, Lymphadenopathy, Metabolic function test
Clinical narrative: C/O NODULE TO RT SIDE OF NECK, SORE THROAT. TREATMENT REST FLUIDS AND TYLENOL. FOLLOWED UP ON 05/11/2011. TESTS DONE AND TREATED WITH DIFLUCAN 100MG TWICE A DAY X 7 DAYS, CEFTIN 500MG TWICE A DAY X 10 DAYS
Age: 12.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Mononucleosis heterophile test negative, Nodule, Oropharyngeal pain
Clinical narrative: C/O NODULE TO RT SIDE OF NECK, SORE THROAT. TREATMENT REST FLUIDS AND TYLENOL. FOLLOWED UP ON 05/11/2011. TESTS DONE AND TREATED WITH DIFLUCAN 100MG TWICE A DAY X 7 DAYS, CEFTIN 500MG TWICE A DAY X 10 DAYS
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Fatigue, Headache, Paraesthesia
Clinical narrative: Tingling of hands and feet that would come and go and lasted 5 days. I also had a headache and fatigue. I went to my PCP on the 8th. She sent me to a neurologist to rule out any serious problems such as Guillain-Barre. The symptoms subsided on their own by the 10th.
Age: 31.0
Sex: M
Vaccine: FLU3, HEPAB, MMR, MNQ, TDAP, VARCEL
Symptoms: Herpes zoster
Clinical narrative: Patient developed Shingles from vaccine.
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site cellulitis, Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: 12 hrs after vaccine was given pt c/o pain at site and warm, pink 2cm x 2cm area.  4/22 3.5cm area of redness, warm and hard to touch.  4/24 site of injection red and warm, erythema, induration; Augmentin 875mg q12hr x 7days prescribed for cellulitis at injection site.
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Dreamy state, Fall, Feeling abnormal, Tremor, Unresponsive to stimuli
Clinical narrative: Pt was waiting for discharge papers when she suddenly fell down on the floor. She was laid on her back, she was breathing, she had a pulse but she wasn't responding to questions, she appeared "dazed" for about 15-20 sec. She subseq. responded after some shaking, she said "she was dreaming". She gradually got up & went back to the room where she laid on the bed for 30 minutes. She said she "feels fine" & she was subsequently discharged.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Asthenia, Dizziness, Heart rate decreased, Hypotension, Pain in extremity
Clinical narrative: SHE FELT A BIT DIZZY AND WEAK, SHE ATE AND WENT TO SCHOOL, BUT WORSENED AND WENT TO THE NURSE TO LIE DOWN.  SHE   STABLIZED BUT CONTINUES TO FEEL THAT WAY.  YESTERDAY, SHE HAD  HER MENACTRA BOOSTER. HER LEFT ARM IS SLIGHTLY SORE. LOW B/P AND HEART RATE.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, HPV4
Symptoms: Rash generalised
Clinical narrative: 5/2/11 Phone call from mom stating "bug bite" looking rash all over body. Not ill. No fever. Probably, per mom, related to old sunscreen.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, HPV4
Symptoms: Rash generalised, Urticaria
Clinical narrative: 5/2/11 Phone call from mom stating "bug bite" looking rash all over body. Not ill. No fever. Probably, per mom, related to old sunscreen.
Age: 34.0
Sex: F
Vaccine: HEPAB, IPV, TDAP, YF
Symptoms: Fatigue, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Client first noticed this on this date; cherry red, slightly upraised 1 x 1 to 2 x 2 mm irregularly shaped rounded spot on upper right arm (the size or maybe larger than a half dollar coin), warm to the touch.  She was a little tired and by 5-12-11 it was practically gone and not red.  This was the site of the Twinrix vaccine administration.
Age: 73.0
Sex: F
Vaccine: UNK
Symptoms: Herpes zoster
Clinical narrative: Broke out in shingles on right hand and wrist.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, PPV
Symptoms: Abnormal behaviour, Aggression, Feeling abnormal
Clinical narrative: Behavior has become hostile and agressive.  Stated to me (his mother) that he feels mean in the brain.  HE WAS NOT LIKE THIS PRIOR TO HIS VACCINATIONS!!
Age: 28.0
Sex: F
Vaccine: RAB
Symptoms: Hypoaesthesia, Oedema peripheral, Paraesthesia, Skin warm
Clinical narrative: Left arm swelled, hot to touch, numbness and tingling in left hand likely due to swelling, treated at Urgent Care, given steroids, anti-inflammatories, and ice, symptoms subsided by 9 pm same day.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Oedema peripheral, Pain in extremity
Clinical narrative: Patient called the clinic and she informed me that her left arm is severely swollen and painful. She explained that the pain and swollen started only after she received the shingles vaccine.
Age: 0.3
Sex: M
Vaccine: RV1
Symptoms: Pyrexia
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of fever in a 4-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). On 25 April 2011 the subject received 2nd dose of ROTARIX which had been reconstituted with sterile water for injection (wrong solution used in drug reconstitution) and given intramuscularly in the subject's thigh (inappropriate route of vaccination). On the night of 25 April 2011, within hours of vaccination with ROTARIX, the subject experienced a slight fever (99 degrees Fahrenheit). No other reactions were reported. At the time of reporting the fever was resolved.
Age: 16.0
Sex: F
Vaccine: HEPA, HPV4, MNQ
Symptoms: Depressed level of consciousness, Loss of consciousness, Tinnitus, Tremor
Clinical narrative: About 30 seconds after administering Gardasil to the patient in her right deltoid, her right arm shook and she passed out in the chair she was sitting in. The nurse who administered the shot tried to arouse her by calling her name and lightly shaking her. The client became fully conscious after about 20 seconds. She did say that she had a ringing in her ears. Client also said that she sometimes passes out when she get shots.
Age: 0.37
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Respiratory arrest, Sudden infant death syndrome, Unresponsive to stimuli
Clinical narrative: SIDS. Was found not breathing and unresponsive in crib after nap.
Age: 1.02
Sex: F
Vaccine: FLU3, HEP, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Injection site rash, Rash, Urticaria
Clinical narrative: Hive Rash on face, head, upper and lower extremities.
Age: 0.36
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Sudden infant death syndrome
Clinical narrative: SIDS
Age: 7.0
Sex: M
Vaccine: MMR
Symptoms: Fall, Irritability
Clinical narrative: Patient felt "wimpy and whiny" (his words), then fell to the ground.  Never had loss of consciousness or eye closure.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Muscle spasms, Nausea
Clinical narrative: Cramp on l lower leg lasting for 5 seconds, on the second day, cramp lasting for 2 minutes after a run on l lower leg. Felt little nauseous this am.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Gait disturbance, Muscle spasms, Nausea
Clinical narrative: Cramp on l lower leg lasting for 5 seconds, on the second day, cramp lasting for 2 minutes after a run on l lower leg. Felt little nauseous this am.
Age: 33.0
Sex: F
Vaccine: ANTH, SMALL, TYP, ANTH, SMALL, TYP
Symptoms: Axillary pain, Injection site pain, Injection site swelling, Lymphadenopathy, Musculoskeletal chest pain
Clinical narrative: SM had a normal reaction to Smallpox vaccine, with additional chest wall pain about the pectoralis major muscle group as well as the axillary region with a single axillary node enlargement noticed on examination by myself.  I determined via Pts history that she was not experiencing cardiac related chest pain as she was tender to palpation about the Lft axilla and pectoralis major of the Lft chest.  Pts Smallpox lesion was swollen and appeared consistent with other I have seen in the past.  The Pt did have significantly more discomfort at the lesion site and surrounding tissues than anyone I have spoken to including myself.  I did not order any diagnostic testing of any kind as this is a watchful waiting type of scenario and I felt the Pts symtoms would improve over time.
Age: 33.0
Sex: F
Vaccine: ANTH, SMALL, TYP, ANTH, SMALL, TYP
Symptoms: Myalgia
Clinical narrative: SM had a normal reaction to Smallpox vaccine, with additional chest wall pain about the pectoralis major muscle group as well as the axillary region with a single axillary node enlargement noticed on examination by myself.  I determined via Pts history that she was not experiencing cardiac related chest pain as she was tender to palpation about the Lft axilla and pectoralis major of the Lft chest.  Pts Smallpox lesion was swollen and appeared consistent with other I have seen in the past.  The Pt did have significantly more discomfort at the lesion site and surrounding tissues than anyone I have spoken to including myself.  I did not order any diagnostic testing of any kind as this is a watchful waiting type of scenario and I felt the Pts symtoms would improve over time.
Age: 33.0
Sex: F
Vaccine: ANTH, SMALL, TYP, ANTH, SMALL, TYP
Symptoms: Axillary pain, Injection site discomfort, Injection site swelling, Lymph node pain, Lymphadenopathy
Clinical narrative: SM had a normal reaction to Smallpox vaccine, with additional chest wall pain about the pectoralis major muscle group as well as the axillary region with a single axillary node enlargement noticed on examination by myself.  I determined via Pts history that she was not experiencing cardiac related chest pain as she was tender to palpation about the Lft axilla and pectoralis major of the Lft chest.  Pts Smallpox lesion was swollen and appeared consistent with other I have seen in the past.  The Pt did have significantly more discomfort at the lesion site and surrounding tissues than anyone I have spoken to including myself.  I did not order any diagnostic testing of any kind as this is a watchful waiting type of scenario and I felt the Pts symtoms would improve over time.
Age: 33.0
Sex: F
Vaccine: ANTH, SMALL, TYP, ANTH, SMALL, TYP
Symptoms: Musculoskeletal chest pain, Tenderness
Clinical narrative: SM had a normal reaction to Smallpox vaccine, with additional chest wall pain about the pectoralis major muscle group as well as the axillary region with a single axillary node enlargement noticed on examination by myself.  I determined via Pts history that she was not experiencing cardiac related chest pain as she was tender to palpation about the Lft axilla and pectoralis major of the Lft chest.  Pts Smallpox lesion was swollen and appeared consistent with other I have seen in the past.  The Pt did have significantly more discomfort at the lesion site and surrounding tissues than anyone I have spoken to including myself.  I did not order any diagnostic testing of any kind as this is a watchful waiting type of scenario and I felt the Pts symtoms would improve over time.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR
Symptoms: Injection site discolouration, Injection site swelling, Pyrexia, Weight bearing difficulty
Clinical narrative: High fever. 104 degrees. 2 children. swollen injection site. Injection site turned purple. Will not bear weight on legs.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site swelling, Injection site urticaria, Injection site warmth
Clinical narrative: Pt reported a raised, warm, itchy welt at site of injection
Age: 1.02
Sex: F
Vaccine: HEPA, MMRV
Symptoms: Pyrexia, Rash
Clinical narrative: Fever Lasted 3 days, peaking at 103F on second day Used ibuprofen for 2 1/2 days Spotted rash Started 5/11/11 Still has it on hairline, chest, arms and back Called doctor 5/12/11, said normal
Age: 20.0
Sex: F
Vaccine: JEV1
Symptoms: Condition aggravated, Depression, Dizziness, Pain, Panic attack
Clinical narrative: C/O "throbbing of arms & hands", slight lightheadedness. Feels like "panic attack".
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV, PNC
Symptoms: Injection site rash
Clinical narrative: Two days after vaccines given pt started with rash at site that grew to 8 by 10 cm. Mom very concerned and had to bring child in and miss work.
Age: 9.0
Sex: M
Vaccine: HPV4
Symptoms: Erythema, Feeling hot, Pruritus
Clinical narrative: According to the ER report - woke up with itchiness about inj site. Mild erythema & warmth.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, PNC13
Symptoms: Febrile convulsion, Streptococcus test negative
Clinical narrative: Patient developed febrile convulsion at about noon on 5/10/11. Observed in emergency room and sent home.
Age: 11.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site urticaria, Injection site warmth
Clinical narrative: 10 cm x 5 cm red/warm/welpy area at injection site. Pt seen in office 5-11-11, started on BACTRIM & BENADRYL.
Age: 49.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Influenza, Pneumonia
Clinical narrative: 5/9/11 vaccines: Influenza/Pneumonia.
Age: 22.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Dyspnoea, Urticaria
Clinical narrative: Pt. went home & called health center complaining of hives & slight shortness of breath. (about 3 hours after injection) instructed to take BENADRYL and/or ZYRTEC.
Age: 22.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Anxiety, Condition aggravated, Dyspnoea, Urticaria
Clinical narrative: Pt. went home & called health center complaining of hives & slight shortness of breath. (about 3 hours after injection) instructed to take BENADRYL and/or ZYRTEC.
Age: 0.45
Sex: F
Vaccine: DTAP, PNC13
Symptoms: Irritability, Pyrexia, Wheezing
Clinical narrative: Fever, wheezing, fussiness.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Had redness at injection site the next morning - by noon Rt arm edematous from shoulder to elbow. Mom gave her TYLENOL & ice pks to arm- edema went down from below deltoid to elbow. Still has redness and some edema from shoulder to bottom of deltoid muscle. Has full ROM of arms & fingers. Mom reported it last pm.
Age: 0.3
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Injection site cellulitis, Injection site induration, Injection site warmth
Clinical narrative: (R) thigh 1 Indurated area of cellulitis. (L) thigh - 2 Indurated areas of cellulitis x 24 hours. Warm compress x po antibiotics.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Cyanosis, Hypotonia, Jaw disorder, Laboratory test normal, Musculoskeletal stiffness
Clinical narrative: Staring & generalized stiffening at about 1140pm on 5-11-11. Episode lasted 20 seconds. Episode was immediately preceded by vomiting. Unresponsive. Eyes open & staring. Jaw seemed clenched. Lips were blue. Fell asleep right after episode & seemed somewhat limp. Had received immunizations at about 3pm on 5-11-11.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Staring, Unresponsive to stimuli, Vomiting
Clinical narrative: Staring & generalized stiffening at about 1140pm on 5-11-11. Episode lasted 20 seconds. Episode was immediately preceded by vomiting. Unresponsive. Eyes open & staring. Jaw seemed clenched. Lips were blue. Fell asleep right after episode & seemed somewhat limp. Had received immunizations at about 3pm on 5-11-11.
Age: 55.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Mobility decreased, Pain in extremity
Clinical narrative: Received vaccination 4/15/11 at approx 8:45 am. By 2 pm that day, had developed severe pain at injection site. By 9 pm had very severe pain in upper arm that prevented moving arm. Slowly improved over next 48 hours.
Age: 11.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Crying, Immediate post-injection reaction, Loss of consciousness, Nausea, Pallor
Clinical narrative: Immediately after Tdap & HPV #1 given. Pt became pale & passed out in chair, recovered & passed out again a second time with nausea, was assisted to the floor & began crying. 911 was called to evaluate by paramedics & was able to go home with mother. Antiemetic given by paramedics.
Age: 1.25
Sex: F
Vaccine: DTAPIPVHIB, MMR, VARCEL
Symptoms: Diarrhoea, Rash, Rash maculo-papular, Rash morbilliform
Clinical narrative: Immunizations admin on 4/29/11. Began developing rash this AM & diarrhea x 3. No fever. Dx: confluent morbilliform maculopapular rash on upper chest, diffuse on abd.
Age: 1.07
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Papule, Pyrexia, Rash, Rash erythematous, Rash maculo-papular
Clinical narrative: Fever, rash started the next day. Rash was five maculopapular, erythematous, confluent on trunk/neck, 4-5 papules on the forearm & hands (dorsum).
Age: 27.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Feeling hot, Headache, Nodule, Pruritus
Clinical narrative: Red, hot, itching, knot, HA.
Age: 41.0
Sex: F
Vaccine: TDAP
Symptoms: Convulsion
Clinical narrative: Patient received Tdap/ADACEL 12/17/10. Had new onset of seizures 1/8/2011.
Age: 5.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMRV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Received vaccines on 5/10/11. Started to have swelling & redness to left upper arm that same evening.
Age: 15.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pte started with pain, redness and swelling of the arm where the shot was given. No fever. 24 hrs after vacc was given.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Erythema and induration of entire lateral surface of (R) upper arm; tender on palpation of erythematous area.
Age: 0.73
Sex: F
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Body temperature increased, Chest X-ray, Dyskinesia, Feeling hot, Tremor
Clinical narrative: Child woke mother at 150 am 5/12/2011 "making a noise". Temp up baby felt hot. Started to shake "very hot" mother started to sponge baby on the floor and was wiping her down when she had a jerking all over. Temp 103 at local ER.
Age: 0.73
Sex: F
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Urine analysis normal, White blood cell count normal
Clinical narrative: Child woke mother at 150 am 5/12/2011 "making a noise". Temp up baby felt hot. Started to shake "very hot" mother started to sponge baby on the floor and was wiping her down when she had a jerking all over. Temp 103 at local ER.
Age: 60.0
Sex: M
Vaccine: FLU3
Symptoms: Back pain, Guillain-Barre syndrome, Muscular weakness, Pain in extremity, Spinal laminectomy
Clinical narrative: 11/15/10 MD to discuss back pain, weak legs, pain down both legs. Pt has 30 yr history of back injury, did well until about 1/8/2011. He had L1 - 2 laminectomy on 11/23/2010 - weakness progressed rapidly. Diagnosed with Guillain-Barre Syndrome by hospital.
Age: 1.03
Sex: M
Vaccine: DTAPIPVHIB, MMR, VARCEL, HEPA, MMR, VARCEL
Symptoms: Pyrexia, Varicella
Clinical narrative: DEVELOPED FIRST PAPULES ON SKIN, THEN HAD FEVER THAT NIGHT AND NEXT DAY WITH MORE DEVELOPING PAPULES ON LIPS, CHEST, ARMS, BACK, FACE AT DIFFERENT STAGES OF HEALING.
Age: 1.03
Sex: M
Vaccine: DTAPIPVHIB, MMR, VARCEL, HEPA, MMR, VARCEL
Symptoms: Papule, Pyrexia, Varicella
Clinical narrative: DEVELOPED FIRST PAPULES ON SKIN, THEN HAD FEVER THAT NIGHT AND NEXT DAY WITH MORE DEVELOPING PAPULES ON LIPS, CHEST, ARMS, BACK, FACE AT DIFFERENT STAGES OF HEALING.
Age: 57.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Dyspnoea, Dyspnoea exertional, Electrocardiogram ambulatory, Palpitations, Ventricular extrasystoles
Clinical narrative: Almost continuous palpitations for two nights, then sporadic but decreasing frequency ever since.  Some shortness of breath with low level of exertion.  Saw cardiologist and and have Holter monitor, having multiple PVCs, cardio says benign but is doing US today to check for carditis.
Age: 57.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Dyspnoea, Electrocardiogram ambulatory abnormal, Palpitations, Respiration abnormal, Ventricular extrasystoles
Clinical narrative: Almost continuous palpitations for two nights, then sporadic but decreasing frequency ever since.  Some shortness of breath with low level of exertion.  Saw cardiologist and and have Holter monitor, having multiple PVCs, cardio says benign but is doing US today to check for carditis.
Age: 58.0
Sex: M
Vaccine: TDAP
Symptoms: Impaired work ability, Injection site pain
Clinical narrative: No pain initially after vaccination. But pain at injection site (R Deltoid) began 4 days later and has persisted until now (5/13/11) and continues to persist. Pain interferes somewhat with job duties. He is able to perform them but needs ibuprofen to complete them pain-free. He has not seen a physician yet but is considering follow-up soon if pain does not subside.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMR, VARCEL
Symptoms: Body temperature increased, Injection site erythema, Injection site swelling, Injection site warmth, Oedema peripheral
Clinical narrative: Rash on hands & feet & swelling of (L) hand 24hrs post adm. T-101.5 at highest 24 hrs post adm. Redness, swelling & warm approx. 5" diam. around Varicella adm. site LA.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMR, VARCEL
Symptoms: Rash
Clinical narrative: Rash on hands & feet & swelling of (L) hand 24hrs post adm. T-101.5 at highest 24 hrs post adm. Redness, swelling & warm approx. 5" diam. around Varicella adm. site LA.
Age: 58.0
Sex: F
Vaccine: TDAP
Symptoms: Local reaction, Pain, Pyrexia, Skin warm
Clinical narrative: 24 hours after Tdap vaccine employee ran fever, body aches & 70 x 70 cm local reaction - warm to touch & painful. Lasted 4 days after vaccine.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Inflammation, Injection site inflammation, Local reaction
Clinical narrative: Large local inflammatory reaction at left deltoid. Resolving at 72 hrs s/p immunizations.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Axillary pain, Discomfort, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Hot to touch 5" local swelling, redness, pain at site of injection. Also pain & tenderness & large swelling under rt. arm which lasted until 5-2-2011. Very uncomfortable.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Local reaction, Oedema peripheral, Tenderness
Clinical narrative: Hot to touch 5" local swelling, redness, pain at site of injection. Also pain & tenderness & large swelling under rt. arm which lasted until 5-2-2011. Very uncomfortable.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, PNC13
Symptoms: Erythema, Local reaction, Pruritus, Swelling
Clinical narrative: Local reaction redness, swelling, itching. Sought medical care 3 days after administration of vaccine. Rx'd MOTRIN, BENADRYL, icing, elevation.
Age: 41.0
Sex: F
Vaccine: TDAP
Symptoms: Asthenia, Cold sweat, Dizziness, Feeling hot, Hyperhidrosis
Clinical narrative: Pt reports day after having Tdap felt weak, slept for 2 hrs in evening which is unusual, awakened x 3 during night with drenching sweats; feels lightheaded, body aches, legs feel like "jelly", low grade fever, feels hot then clammy. Had night sweats 2nd night also.
Age: 41.0
Sex: F
Vaccine: TDAP
Symptoms: Muscular weakness, Night sweats, Pain, Pyrexia, Somnolence
Clinical narrative: Pt reports day after having Tdap felt weak, slept for 2 hrs in evening which is unusual, awakened x 3 during night with drenching sweats; feels lightheaded, body aches, legs feel like "jelly", low grade fever, feels hot then clammy. Had night sweats 2nd night also.
Age: 11.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: About 2 x 4 cm area of swelling, erythema, warmth & tenderness at area of injection ((R) upper arm). Rx - Prednisone 30 mg BID x 4d.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: 10 x 10cm round, warm, red area (L) arm. 2 x 2cm round, warm, red area (R) arm.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Incisional drainage, Injection site abscess, Wound treatment
Clinical narrative: Pt. went to med ctr on 5/7/11. Abscess had developed - site was I and D'd, then packed. IV antibiotics given, then sent home on oral Clindamycin. Abscess was to (L) upper arm.
Age: 36.0
Sex: F
Vaccine: VARCEL
Symptoms: Dizziness, Dyspnoea, Headache, Heart rate increased, Hypersensitivity
Clinical narrative: Pt reported to health department on 5/13/11 stating she had an allergic reaction to Varicella vaccine given on 5/11/2011. Pt's arm was red, swollen, and itchy at site. On the day of vaccination, pt had fast heart beat, difficult breathing, dizziness and headache. Pt called a pharmacist to discuss symptoms. Pharmacist stated to patient she was having an allergic reaction to vaccine. Pharmacist advised patient to take Ibuprofen as indicated on package. Pt did not report to a physician or ER. I suggested to apply BENADRYL cream to site. Pt stated felt better today.
Age: 36.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Pt reported to health department on 5/13/11 stating she had an allergic reaction to Varicella vaccine given on 5/11/2011. Pt's arm was red, swollen, and itchy at site. On the day of vaccination, pt had fast heart beat, difficult breathing, dizziness and headache. Pt called a pharmacist to discuss symptoms. Pharmacist stated to patient she was having an allergic reaction to vaccine. Pharmacist advised patient to take Ibuprofen as indicated on package. Pt did not report to a physician or ER. I suggested to apply BENADRYL cream to site. Pt stated felt better today.
Age: 1.28
Sex: M
Vaccine: DTAP, DTAP
Symptoms: Chest X-ray normal, Cough, Nasopharyngitis, Pertussis, Polymerase chain reaction
Clinical narrative: This is one case out of a cumulative total of 18 cases received during the surveillance period from 01 January 2010 to 03 May 2011. Enter Incident ID# 504963. Initial report received on 03 May 2011 from the Investigator participating in the above-mentioned post-marketing observation surveillance study under the reference number M5A16. A case of pertussis disease in a male subject (initials not collected), who was approximately 35 months of age, was identified by the investigator based on review of data from the system. The subject's vaccine history included one dose of DAPTACEL; lot number C3082AA received on 03 July 2009, one dose of PENTACEL, lot number C3174AA received on 08 October 2008, two dose of DAPTACEL, lot number C2956BA received on 08 August 2008 and lot number C2953AA received on 30 May 2008 (routes and sites of administration not reported). The subject developed cold-like symptoms on an unspecified date, and on 07 March 2011, approximately 20 months after the last dose, developed a cough. On 09 March 2011, the subject developed a paroxysmal cough with no whoop and no posttussive vomiting. The subject also experienced sleep disturbance. Laboratory testing included positive PCR on 07 April 2011. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of Azithromycin starting on 07 April 2011 for five days. The subject was not hospitalized. At the time of final contact on 28 April 2011, the subject's cough was still persisting. The duration of the cough was reported at that time as 52 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.
Age: 1.28
Sex: M
Vaccine: DTAP, DTAP
Symptoms: Sleep disorder
Clinical narrative: This is one case out of a cumulative total of 18 cases received during the surveillance period from 01 January 2010 to 03 May 2011. Enter Incident ID# 504963. Initial report received on 03 May 2011 from the Investigator participating in the above-mentioned post-marketing observation surveillance study under the reference number M5A16. A case of pertussis disease in a male subject (initials not collected), who was approximately 35 months of age, was identified by the investigator based on review of data from the system. The subject's vaccine history included one dose of DAPTACEL; lot number C3082AA received on 03 July 2009, one dose of PENTACEL, lot number C3174AA received on 08 October 2008, two dose of DAPTACEL, lot number C2956BA received on 08 August 2008 and lot number C2953AA received on 30 May 2008 (routes and sites of administration not reported). The subject developed cold-like symptoms on an unspecified date, and on 07 March 2011, approximately 20 months after the last dose, developed a cough. On 09 March 2011, the subject developed a paroxysmal cough with no whoop and no posttussive vomiting. The subject also experienced sleep disturbance. Laboratory testing included positive PCR on 07 April 2011. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of Azithromycin starting on 07 April 2011 for five days. The subject was not hospitalized. At the time of final contact on 28 April 2011, the subject's cough was still persisting. The duration of the cough was reported at that time as 52 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.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Extreme red, hot and swollen of Rt upper arm all the way to elbow.
Age: 64.0
Sex: F
Vaccine: HEPAB, TDAP, YF
Symptoms: Diarrhoea, Gastrointestinal disorder, Headache, Influenza like illness
Clinical narrative: 4/29-30 - Had flu-like symptoms. Denies any fever - resolved. May 2-4 - Started with GI symptoms -> diarrhea which resolved. May 7 - Started with headache. May 8 better. May 9-10 Headache - relieved with ADVIL. 5-13 - feels better.
Age: 34.0
Sex: M
Vaccine: TDAP
Symptoms: Body temperature increased, Chills, Headache, Hyperhidrosis, Injection site reaction
Clinical narrative: Patient developed baseball size welt on left deltoid, temperature of 103, severe headaches, and sweats/chills/aches. Symptoms lasted for 2 weeks. Patient reported this on 03/15/2011, after symptoms had subsided.
Age: 34.0
Sex: M
Vaccine: TDAP
Symptoms: Pain, Urticaria
Clinical narrative: Patient developed baseball size welt on left deltoid, temperature of 103, severe headaches, and sweats/chills/aches. Symptoms lasted for 2 weeks. Patient reported this on 03/15/2011, after symptoms had subsided.
Age: 3.0
Sex: M
Vaccine: PPV
Symptoms: Humoral immune defect, Injection site erythema, Injection site induration, Pyrexia
Clinical narrative: 36-48 hours after injection, mother called & reported large indurated, reddened area at injection site. (4in x 3in). Fever reported high of 103.2.