chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 20.0
Sex: F
Vaccine: VARCEL
Symptoms: Pyrexia
Clinical narrative: Patient's mother reports a trip to the ER within 24 hours of vaccination due to soft ball like bump at the injection site. This bump is swollen, red, and hot to the touch. Pt also had fever. She was given antibiotics, and MD said it was infection secondary to the immunization. Culture still pending. What type of infection not known.
Age: 10.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth, Pyrexia
Clinical narrative: Rec'd 0.5 Quad. flu injection at office 1/22/14. S/S began 1/23/14; seen in office for (+) light pink erythema area 12-15 cm and (+) pruritus at site. Afebrile. ((+) warmth to touch). Tx with ice packs, BENADRYL and to c/ office if fever or other s/s occur.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Electromyogram abnormal, Hypoaesthesia, Injection site pain, Muscular weakness, Musculoskeletal pain
Clinical narrative: Prior to vaccination I had a prolonged viral infection lasting about a month. Because the infection was improving and I was afebrile, I received my annual Flu vaccine. Just over a month later I woke one night with severe (L) scapular pain - with resulting (L) deltoid pain and (L) thumb numbness the symptoms progressed to (L) arm pain and onset of (L) hand weakness. (L) hand weakness improved after 2 courses of steroids - but persists after one year now. EMG's showed severe radial nerve damage. My neurologist felt based on her research the Brachial Neuritis was caused from a virus or vaccine. My question was - Did the combination of a persistent viral illness a long with the influenza vaccine contribute to the development of the Brachial Neuritis.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Nuclear magnetic resonance imaging spinal, Pain in extremity, Radial nerve injury, Radiculitis brachial, Spinal X-ray
Clinical narrative: Prior to vaccination I had a prolonged viral infection lasting about a month. Because the infection was improving and I was afebrile, I received my annual Flu vaccine. Just over a month later I woke one night with severe (L) scapular pain - with resulting (L) deltoid pain and (L) thumb numbness the symptoms progressed to (L) arm pain and onset of (L) hand weakness. (L) hand weakness improved after 2 courses of steroids - but persists after one year now. EMG's showed severe radial nerve damage. My neurologist felt based on her research the Brachial Neuritis was caused from a virus or vaccine. My question was - Did the combination of a persistent viral illness a long with the influenza vaccine contribute to the development of the Brachial Neuritis.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Viral infection
Clinical narrative: Prior to vaccination I had a prolonged viral infection lasting about a month. Because the infection was improving and I was afebrile, I received my annual Flu vaccine. Just over a month later I woke one night with severe (L) scapular pain - with resulting (L) deltoid pain and (L) thumb numbness the symptoms progressed to (L) arm pain and onset of (L) hand weakness. (L) hand weakness improved after 2 courses of steroids - but persists after one year now. EMG's showed severe radial nerve damage. My neurologist felt based on her research the Brachial Neuritis was caused from a virus or vaccine. My question was - Did the combination of a persistent viral illness a long with the influenza vaccine contribute to the development of the Brachial Neuritis.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site mass, Injection site paraesthesia, Injection site pruritus, Injection site reaction
Clinical narrative: Injection site reaction. Egg size lump. Very sensitive to touch. Red spot with little ones around it on the side. Both lesions were itchy. Took about a day to develop.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin lesion
Clinical narrative: Injection site reaction. Egg size lump. Very sensitive to touch. Red spot with little ones around it on the side. Both lesions were itchy. Took about a day to develop.
Age: 60.0
Sex: F
Vaccine: FLUC3
Symptoms: Pain in extremity
Clinical narrative: Pain when laying on left arm.
Age: 44.0
Sex: M
Vaccine: FLU3, RAB
Symptoms: Injection site pain
Clinical narrative: Employee states after injection he felt "burning and soreness" at injection site. Employee states the burning and soreness have continued since.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Next day site turned red and swollen making a circle - The entire area red and swollen. Site was hot - as if fever in it.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Echocardiogram, Electrocardiogram, Electrocardiogram ambulatory, Syncope, Ultrasound Doppler
Clinical narrative: 2 episodes of syncope.
Age: 40.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site pain
Clinical narrative: Patient experienced immobility of the arm where vaccine was injected. The site of injection was tender, sore and red. Symptom lasted for over (1) week - pt went to walk in clinic to seek medical advice - was given antibiotics just in case of abscess.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Breath sounds abnormal, Fatigue, Loss of consciousness, Posture abnormal, Tremor
Clinical narrative: After vaccine continues sitting in waiting rm - observed by father and mother. Losing consciousness for approx 30 seconds, mild shaking, gurgling. I observed pt slumped in chair and incontinent of urine, helped assist pt to floor, once on floor pt conscious, no injuries apparent, once on floor orient x 3 BP 112/68 P 60 R 18, c/o fatigue monitored x 15 min, ambulating out of clinic seen by PCP immediately after.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Urinary incontinence
Clinical narrative: After vaccine continues sitting in waiting rm - observed by father and mother. Losing consciousness for approx 30 seconds, mild shaking, gurgling. I observed pt slumped in chair and incontinent of urine, helped assist pt to floor, once on floor pt conscious, no injuries apparent, once on floor orient x 3 BP 112/68 P 60 R 18, c/o fatigue monitored x 15 min, ambulating out of clinic seen by PCP immediately after.
Age: 31.0
Sex: M
Vaccine: ANTH, PPV, SMALL, TYP
Symptoms: Cardiomyopathy, Echocardiogram, Electrocardiogram abnormal, Troponin I
Clinical narrative: Note: Any requests for follow-up information on this case should be sent directly to the sponsor of this study, Sanofi Pasteur. This study case was received from the investigator in a trial on 14 January 2014. A 31 year-old male subject whose past medical history included high blood pressure, abnormal ECG, shortness of breath and headaches was found to have secondary cardiomyopathy, unspecified one day after the subject had received the following vaccines on 01 October 2013: an injection of ACAM2000 (lot number, route and site of administration not reported), TYPHIM VI (lot number, route and site of administration not reported), Pneumococcal vaccine (manufacturer, lot number, route and site of administration not reported) and Anthrax 8 (manufacturer, lot number, route and site of administration not reported). An abnormal ECG on 02 October 2013, Troponin I and echocardiogram results were not available. Lumbar puncture and MRI of the brain, spinal cord and heart were not performed. Treatments were not reported. Additional information will be requested from the investigator. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: none.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Crying, Injection site induration, Injection site movement impairment, Injection site swelling, Pain
Clinical narrative: (L) upper thigh swollen - hard area at inj. site. Infant cries when (L) leg extended and limits her own movement of the limb.
Age: 13.0
Sex: M
Vaccine: FLUN4, HEPA
Symptoms: Pruritus, Rash
Clinical narrative: Approximately 30 min after Hep A/FLUMIST administered patient broke out with a rash - itchy on trunk 25 mg BENADRYL given at 11:50AM.
Age: 17.0
Sex: M
Vaccine: FLU3, HEP, MNQ
Symptoms: Dyspnoea, Fall, Nausea, Salivary hypersecretion
Clinical narrative: Initial report was received on 22 January 2014 from a health care professional. A 17 year-old male patient with no known allergies and no medical history had received the following vaccines on 21 January 2014: a dose two intramuscular left deltoid injection of MENACTRA, lot number U4657AA, an intramuscular left deltoid injection of FLUZONE, lot number UH900AE (number of previous doses for FLUZONE was reported as several) and dose three right arm injection of Hepatitis B, lot number J006511 (manufacturer not reported) and an unspecified amount of time later after the patient received MENACTRA vaccination "slumped over but caught by nurse and returned to position". The patient was observed for 15 minutes and no other symptoms were noted and the patient left facility for home. The next day patient reported experiencing nausea, increased salivation and shortness of breath. The patient was to be evaluated by a physician assistant. Outcome was not recovered. Documents held by sender: none.
Sex: U
Vaccine: FLU3
Symptoms: Influenza, Influenza A virus test positive
Clinical narrative: This initial case was received from a nurse on 22 January 2014. It represents a cluster of "five or six" unidentified patients reported by the same reporter who each experienced H1N1 influenza following administration of FLUZONE (lot number unknown). Five or six patients, ranging in age from 18 to 62 years old, received FLUZONE (lot numbers not reported) in September 2013. In January 2014, approximately four months post-vaccination, the reporter was contacted by the local hospital and informed that the patients had tested positive for H1N1 influenza virus. One patient was briefly hospitalized due to the event. Additional information, including medical history, treatment, and outcome, was not reported. Additional information has been requested.
Age: 18.0
Sex: M
Vaccine: HEPA, MNQ
Symptoms: Convulsion, Excoriation, Fall, Loss of consciousness, Swelling face
Clinical narrative: After giving the Hepatitis A vaccine to patient, he convulsed and lost consciousness. While falling, he hit his forehead on the desk and ended up with a small abrasion with swelling.  After laying him flat on the floor, patient regained consciousness in 10 seconds or less.  I applied ice to his forehead and a bandaid although there was no apparent bleeding from the site.
Age: 69.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Malaise, Muscular weakness, Pain in extremity, Pyrexia
Clinical narrative: Severe muscle weakness/malaise. Fever > 102. Arm soreness/redness.
Age: 38.0
Sex: M
Vaccine: FLU3
Symptoms: Hypoaesthesia, Injection site reaction, Muscle spasms, Musculoskeletal discomfort, X-ray normal
Clinical narrative: Severe Charlie horse feeling at injection site occasional numbness at fingers muscle always has discomfort NSAID for 2 weeks, no results physical therapy no results.
Age: 3.0
Sex: F
Vaccine: FLU3
Symptoms: Body temperature increased, Erythema, Injection site rash, Rash, Rash macular
Clinical narrative: Rash to (B) legs day of vaccine and following day - T. 100 - red - not dark red or purple. No itchy - blotchy - warm to touch - resolved without intervention.
Age: 3.0
Sex: F
Vaccine: FLU3
Symptoms: Skin warm
Clinical narrative: Rash to (B) legs day of vaccine and following day - T. 100 - red - not dark red or purple. No itchy - blotchy - warm to touch - resolved without intervention.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Asthma, Dyspnoea, Hypersensitivity, Rhinorrhoea, Wheezing
Clinical narrative: "Very serious allergic rxn - wheezing, asthma symptoms, runny nose, difficulty breathing" 1 hr after flu shot.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Blood culture, Cellulitis, Full blood count, Injection site erythema, Injection site pruritus
Clinical narrative: Received vaccines 1/23/14. 1/24 - called office arm (left upper) warm swollen itchy. 1/25 seen in office redness Left arm getting worse Diag - cellulitis - given ROCEPHIN and oral antibiotic.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Received vaccines 1/23/14. 1/24 - called office arm (left upper) warm swollen itchy. 1/25 seen in office redness Left arm getting worse Diag - cellulitis - given ROCEPHIN and oral antibiotic.
Age: 35.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Erythema, Injection site pain, Pain, Skin warm
Clinical narrative: Received Flu and Pneumonia vaccines 1/16/14. On 1/17 pt c/o (R) upper arm pain, tender deltoid area. On 1/18 pt continue to c/o pain, tenderness, redness, warm to touch. MD aware. KEFLEX ordered. 1/19 continue to c/o pain, using cold compress, keeping elevated. TORADOL 30 mg IM x1 for pain. Diagnosis cellulitis.
Age: 35.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Tenderness
Clinical narrative: Received Flu and Pneumonia vaccines 1/16/14. On 1/17 pt c/o (R) upper arm pain, tender deltoid area. On 1/18 pt continue to c/o pain, tenderness, redness, warm to touch. MD aware. KEFLEX ordered. 1/19 continue to c/o pain, using cold compress, keeping elevated. TORADOL 30 mg IM x1 for pain. Diagnosis cellulitis.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Expired drug administered
Clinical narrative: This spontaneous  report as received from a nurse refers to a 22 year old female patient with headaches and migraines. Per reporter the patient had no pertinent medical history and no history of drug reactions/allergies. On 27-JAN-2014 the patient was vaccinated with an expired dose of GARDASIL (lot # 0849AA; expiry date 23-JUN-2013), 0.5 ml, intramuscularly. This was the patient's third dose of GARDASIL. Concomitant therapies included EXCEDRIN, ibuprofen, IMITREX and an unspecified birth control. After the patient received the third dose of GARDASIL, the patient became dizzy. The nurse reported that the patient sat and rested "for a second" after becoming dizzy and then "felt better". The patient outcome was reported as recovered. Additional information has been requested.
Age: 14.0
Sex: M
Vaccine: HPV4
Symptoms: Convulsion, Syncope
Clinical narrative: Fainted working on a farm. Rushed to Hospital was diagnosed with a seizure.
Age: 38.0
Sex: M
Vaccine: TDAP
Symptoms: Dysphagia, Pharyngeal oedema
Clinical narrative: Swelling of throat and difficulty swallowing.
Age: 64.0
Sex: M
Vaccine: TDAP, VARZOS
Symptoms: Vision blurred, Xanthopsia
Clinical narrative: Blurry vision in left eye, yellow vision in right eye.
Age: 7.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Body temperature increased, Headache, Heart rate increased, Lethargy, Pallor
Clinical narrative: Elevated Temp. Increased Heart Rate. Pale. Lethargic. Headache.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Antinuclear antibody negative, Arthralgia, Borrelia test negative, C-reactive protein normal
Clinical narrative: Abdominal pain went to ED to rule out surgical abdomen, work up normal.  Had dysmenorrhea, 2 weeks later, diagnosed with strep over 1 month later and developed bilateral hip pain/arthralgias a few weeks later and in Dec 2013-Jan 2014 has increased fatigue.  Parent attributes these findings to possibly the vaccine.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Dysmenorrhoea, Epstein-Barr virus test negative, Fatigue, Full blood count normal, Metabolic function test
Clinical narrative: Abdominal pain went to ED to rule out surgical abdomen, work up normal.  Had dysmenorrhea, 2 weeks later, diagnosed with strep over 1 month later and developed bilateral hip pain/arthralgias a few weeks later and in Dec 2013-Jan 2014 has increased fatigue.  Parent attributes these findings to possibly the vaccine.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Red blood cell sedimentation rate normal, Rheumatoid factor negative, Streptococcal infection, Streptococcus test negative, Thyroid function test normal
Clinical narrative: Abdominal pain went to ED to rule out surgical abdomen, work up normal.  Had dysmenorrhea, 2 weeks later, diagnosed with strep over 1 month later and developed bilateral hip pain/arthralgias a few weeks later and in Dec 2013-Jan 2014 has increased fatigue.  Parent attributes these findings to possibly the vaccine.
Age: 11.0
Sex: M
Vaccine: VARCEL
Symptoms: Dizziness, Pallor
Clinical narrative: Patient was reclined when vaccine given and remained that way for 15 minutes post vaccination without complaints of dizziness.  Upon walking out of the clinic, he became pale and dizzy.  Patient sat on the floor, was laid flat with feet elevated and cold compress applied to back of neck for relief.  Remained in that position for 10 minutes after which patient felt fully recovered.  Sat up, stood up, and ambulated out of office without further problems.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Joint range of motion decreased, Musculoskeletal pain, Pain in extremity
Clinical narrative: Pain in entire arm from shoulder to wrist.  Limited motion of arm. Went to private physician on 11-08-13 and was told to take naproxen and apply heat. In January went to another doctor who told me the pain was caused by the shot and to exercise and apply cold. No improvement and would like to know prognosis.
Age: 43.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Fever 101, evening of vaccine. Then redness, swellling and pain left deltoid - wife said 3"x4" in diameter. Pt has maintained fever of 100-101.0 since last with PCP. Fever for 3 days although not febrile at follow-up visit.
Age: 2.0
Sex: F
Vaccine: FLU3
Symptoms: Acute disseminated encephalomyelitis, Decreased appetite, Lethargy, Mental status changes, Nuclear magnetic resonance imaging abnormal
Clinical narrative: Patient developed vomiting and decrease in appetite followed by altered mental status and lethargy.  She was admitted to hospital then was transferred to another hospital where she was diagnosed with acute disseminated encephalomyelitis.
Age: 2.0
Sex: F
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: Patient developed vomiting and decrease in appetite followed by altered mental status and lethargy.  She was admitted to hospital then was transferred to another hospital where she was diagnosed with acute disseminated encephalomyelitis.
Age: 0.35
Sex: M
Vaccine: DTAP, HEPA, HIBV, IPV, PNC13
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: No adverse events associated with Hep A given at 4 months age.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Blood test normal, Hypoaesthesia, Nodule, Pain, Pain in extremity
Clinical narrative: Went to facility 1/14 was given NAPROSYN and hydrocodone. No fever. Arm is throbbing, fingers numb. A knot in back of arm. On 1/18 went to Dr urgent care. Got steroid for 5 days and is now on MOBIC.
Age: 1.02
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Injection site cellulitis, Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Child seen 1/17/14 and received Varicella vaccine (L) thigh. Developed warm, red, indurated injection site yesterday. Today cellulitis noted 3 x 1.5 cm on thigh.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: The patient called at 5:15pm on 01/27/2014 about a possible reaction to the Zostavax vaccination she received on 01/25/2014. She stated that the area was red and raised.  We recommended that she contact her doctor to have it evaluated.  We called notified the Dr and she had already called the Dr and set up an appointment to have it evaluated.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Muscular weakness
Clinical narrative: Stabbing pain in arm at location of injection, in muscle, muscle and arm weakness.
Age: 19.0
Sex: M
Vaccine: HPV4, TDAP
Symptoms: Injected limb mobility decreased, Injection site pain, Neurological examination normal
Clinical narrative: Severe pain in left upper arm and shoulder with decreased ROM. Normal strength and neuorological exam at 2 weeks. Starting to resolve. ?Brachial neuritis? Treated with NSAIDs and arm/shoulder strengthening exercise. If not continuing to improve or if new/worsening symptoms, pt will see his PCP. Consider MRI and physical therapy.
Age: 69.0
Sex: F
Vaccine: FLUX
Symptoms: Amylase normal, Back pain, Bronchitis, Culture stool negative, Diarrhoea
Clinical narrative: Chest Congestion/Bronchitis lasting 5 wks treated with antibiotic. 2 wks after onset of above symptoms. Experienced dizziness, tingling/pins and needles sensation in base of neck. Severe pain in upper back between shoulder blades and lower back sending prickling sensation down lower extremities.  Treatment: Xray of neck. Rx Voltaren 75mg BID for inflammation. Awaiting MRI presently. Beginning of January. Onset of gastrointestinal problems including: Nausea, severe cramping, diarrhea, dizziness. Treatment: Upper Quadrant left and right Ultra sound-Normal, Labs: Comprehensive panel-Normal, CBC-normal, Amalyse/Lypase-normal, Stool Culture-Normal.
Age: 69.0
Sex: F
Vaccine: FLUX
Symptoms: Dizziness, Full blood count normal, Gastrointestinal pain, Metabolic function test normal, Muscle spasms
Clinical narrative: Chest Congestion/Bronchitis lasting 5 wks treated with antibiotic. 2 wks after onset of above symptoms. Experienced dizziness, tingling/pins and needles sensation in base of neck. Severe pain in upper back between shoulder blades and lower back sending prickling sensation down lower extremities.  Treatment: Xray of neck. Rx Voltaren 75mg BID for inflammation. Awaiting MRI presently. Beginning of January. Onset of gastrointestinal problems including: Nausea, severe cramping, diarrhea, dizziness. Treatment: Upper Quadrant left and right Ultra sound-Normal, Labs: Comprehensive panel-Normal, CBC-normal, Amalyse/Lypase-normal, Stool Culture-Normal.
Age: 69.0
Sex: F
Vaccine: FLUX
Symptoms: Nausea, Paraesthesia, Pulmonary congestion, Spinal X-ray, Ultrasound scan normal
Clinical narrative: Chest Congestion/Bronchitis lasting 5 wks treated with antibiotic. 2 wks after onset of above symptoms. Experienced dizziness, tingling/pins and needles sensation in base of neck. Severe pain in upper back between shoulder blades and lower back sending prickling sensation down lower extremities.  Treatment: Xray of neck. Rx Voltaren 75mg BID for inflammation. Awaiting MRI presently. Beginning of January. Onset of gastrointestinal problems including: Nausea, severe cramping, diarrhea, dizziness. Treatment: Upper Quadrant left and right Ultra sound-Normal, Labs: Comprehensive panel-Normal, CBC-normal, Amalyse/Lypase-normal, Stool Culture-Normal.
Age: 0.47
Sex: M
Vaccine: DTAPIPVHIB, IPV
Symptoms: Incorrect dose administered
Clinical narrative: Patient was given Pentacel and IPV vaccine in same visit.  This is a double dose of IPV.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Hypoaesthesia, Mobility decreased, Muscular weakness
Clinical narrative: Body numbness, feeling limb in arms, decrease strength and motionless. Symptoms come and go.
Age: 0.22
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Irritability
Clinical narrative: 7 x 5 cm red, tender, indurated right thigh and extremely fussy.  After applying ice and administering Tylenol, induration 4x 4 cm and less fussy.
Age: 20.0
Sex: F
Vaccine: VARCEL
Symptoms: Chills, Discomfort, Pruritus, Rash
Clinical narrative: Patient received routine varicella vaccine, intramuscularly in the left deltoid, at a Pharmacy.  Shortly afterwards, the patient noticed a rash that developed near the injection site.  There was about a 6-9 inch diameter of a rash that resulted in some itchiness and discomfort.  The patient also developed chills.  The patient self treated with Tylenol and Benadryl and recovered after several days.
Age: 11.0
Sex: M
Vaccine: MEN
Symptoms: Bed rest, Dizziness, Headache, Pyrexia, Vomiting
Clinical narrative: Headaches, fever, vomiting, dizzy. Treated mostly with bed rest, limited ibuprofen for headache.
Age: 3.0
Sex: M
Vaccine: DTAP, FLU3, HEPA, HIBV
Symptoms: Erythema, Rash, Rash pruritic, Skin warm, Urticaria
Clinical narrative: Patient returned for a rash that developed on his ears, trunk, and extremities. Occurred 30 min. after leaving office. Rash was itchy. 3PM - he had diffuse erythema and warmth of ears bilaterally. He has several variable size urticarial lesion on the inner thigh and proximal arms. Gave pt 1 1/2 teaspoon of BENADRYL and 1 1/2 teaspoon ORAPRED. O2 sat 99%. See attached for additional records.
Age: 22.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Anxiety, Asthenia, Convulsion, Dizziness, Hypotension
Clinical narrative: Pallor, weakness, hypotension, syncope, seizure, anxiety, nausea, dizziness, pain at the injection site.
Age: 22.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Injection site pain, Nausea, Pallor, Syncope
Clinical narrative: Pallor, weakness, hypotension, syncope, seizure, anxiety, nausea, dizziness, pain at the injection site.
Age: 58.0
Sex: M
Vaccine: PPV
Symptoms: Axillary pain, Erythema, Injection site pain
Clinical narrative: Pain in (L) armpit with mild pain at inj. site. Non indurated red patches of 2cm x 2" in anterior shoulder with 1 1/2 cm x 1 and 8x4cm x 1 in anterior axillary leve.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: This spontaneous reported as received from a physician via company representative refers to a 62 year old female patient with no drug reactions/allergies. Medical history was not reported. On 14-JAN-2014, the patient was vaccinated with ZOSTAVAX 19400 plaque-formin units (PFU), for to prevent shingles. Dose, route and lot number were not reported. No co-suspect and concurrent therapies were reported. The physician reported that patient, who failed to report she had a rash on the day she received ZOSTAVAX (on 14-JAN-2014), developed shingles the day after receiving ZOSTAVAX (on 15-JAN-2014). The physician stated the patient's rash was worse and more painful the next day and the rash was confirmed to be shingles. At the time of this report the outcome was not recovered. The patient sought medical attention, office visit. No lab diagnostics studies was performed. "Unspecified antiviral medication" was given to treat the adverse event. The causality was not reported. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a Practitioner Nurse refers to a 62 year old female patient. The patient's current conditions or medical history were not reported. On 09-JAN-2014, the patient received her first dose of PNEUMOVAX 23 (route was not reported) lot J005071 expiration date 19-JAN-2015. On 15-JAN-2014, the patient received a second dose of PNEUMOVAX 23 from the same lot as the first dose (lot J005071 expiration 19-JAN-2015), the patient has not reported or demonstrated any adverse effects. At the time of the report the outcome was unknown. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of an unknown age and gender. On 27-AUG-2013, the patient was vaccinated with an out of range dose of ZOSTAVAX (dose and route administration were not provided) (Lot number J003360, Exp. Date: 21-JUN-2014). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of an unknown age and gender. On 18-OCT-2013, the patient was vaccinated with an out of range dose of ZOSTAVAX (dose and route administration were not provided) (Lot number J004268, Exp. Date: 12-JUL-2014). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of an unknown age and gender. On 27-JUN-2013, the patient was vaccinated with an out of range dose of ZOSTAVAX (dose and route administration were not provided) (Lot number J001005, Exp. Date: 24-APR-2014). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of an unknown age and gender. On 23-AUG-2013, the patient was vaccinated with an out of range dose of ZOSTAVAX (dose and route administration were not reported) (Lot number J003360, Exp. Date: 21-JUN-2014). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of an unknown age and gender. On 26-AUG-2013, the patient was vaccinated with an out of range dose of ZOSTAVAX (dose and route administration were not provided) (Lot number J003360, Exp. Date: 21-JUN-2014). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.
Age: 41.0
Sex: M
Vaccine: FLU3, TD
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Injection site swelling
Clinical narrative: A 41 year old male patient experienced severe swelling, redness, pain and edema at the injection site of his left arm after receiving a Td vaccination on 03/11/13; symptoms were experienced extending down to the patient's left forearm (almost to the wrist). The patient also received an influenza vaccination on 03/11/13 and experienced a small amount of swelling at the injection site on his right arm. The patient returned to the physician's office on 03/12/13; the patient was advised to go to the emergency room by the physician. Follow-up: the physician indicated that the patient went to the ER on 03/12/13 and was admitted to the hospital same day. Dr contacted the hospital attending resident on 03/13/2013 and learned that patient was receiving cefazolin for possible infection and a steroid treatment for possible allergic reaction. Patient was discharged to home on 03/14/2013 after the patient had a remarkable decrease in swelling. The patient followed-up with dr on 03/18/2013, at which time dr noted that the patient's swelling was almost subsided. At this visit, dr learned that the patient was prescribed an oral steroid and cephalexin at time of discharge.
Age: 33.0
Sex: M
Vaccine: MMR, TD
Symptoms: Headache, Injection site pain, Injection site swelling, Pyrexia, Tuberculin test
Clinical narrative: Patient received Td, MMR and a PPD skin test on 04/09/13. Patient returned to the provider 2 days later for a reading of the PPD test, at which time he reported that he experienced swelling and pain at the MMR vaccine injection site, light fever and a slight headache the day after the vaccinations. He was prescribed ibuprofen 600 mg BID for pain. Patient recovered by 04/15/13.
Age: 21.0
Sex: M
Vaccine: ANTH, PPV, SMALL, TYP, ANTH, PPV, SMALL
Symptoms: Arteriogram coronary normal, Blood creatine phosphokinase MB decreased, Blood creatine phosphokinase increased, Brain natriuretic peptide decreased, Cardiac enzymes increased
Clinical narrative: Note: Any requests for follow-up information on this case should be sent directly to the sponsor of this study, Sanofi Pasteur. This study case was received from the investigator in a trial on 21 January 2014. An 21 year-old male subject with no significant past medical history was found to have "other and unspecified acute pericarditis" 12 days after the subject had received the following vaccines on 22 November 2013: an injection of ACAM2000 (lot number, route and site of administration not reported), Pneumococcal PPV23 vaccine (manufacturer, lot number, route and site of administration not reported) and Anthrax 1 (manufacturer, lot number, route and site of administration not reported). On 04 November 2013, the subject received Influenza seasonal injectable vaccine (manufacturer, lot number, route and site of administration not reported). Relevant laboratory data on 04 December 2013 included: an abnormal Troponin I recorded highest value of 03.52 ng/ml and an abnormal ECG. An Echocardiogram and MRI of the heart were not available. Lumbar puncture and MRI of the brain and spinal cord were not performed. Treatments were not reported. Additional information will be requested from the investigator. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: none.
Age: 21.0
Sex: M
Vaccine: ANTH, PPV, SMALL, TYP, ANTH, PPV, SMALL
Symptoms: Cardiac imaging procedure normal, Chest X-ray normal, Chest discomfort, Chest pain, Dyspnoea
Clinical narrative: Note: Any requests for follow-up information on this case should be sent directly to the sponsor of this study, Sanofi Pasteur. This study case was received from the investigator in a trial on 21 January 2014. An 21 year-old male subject with no significant past medical history was found to have "other and unspecified acute pericarditis" 12 days after the subject had received the following vaccines on 22 November 2013: an injection of ACAM2000 (lot number, route and site of administration not reported), Pneumococcal PPV23 vaccine (manufacturer, lot number, route and site of administration not reported) and Anthrax 1 (manufacturer, lot number, route and site of administration not reported). On 04 November 2013, the subject received Influenza seasonal injectable vaccine (manufacturer, lot number, route and site of administration not reported). Relevant laboratory data on 04 December 2013 included: an abnormal Troponin I recorded highest value of 03.52 ng/ml and an abnormal ECG. An Echocardiogram and MRI of the heart were not available. Lumbar puncture and MRI of the brain and spinal cord were not performed. Treatments were not reported. Additional information will be requested from the investigator. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: none.
Age: 21.0
Sex: M
Vaccine: ANTH, PPV, SMALL, TYP, ANTH, PPV, SMALL
Symptoms: Echocardiogram, Echocardiogram normal, Electrocardiogram PR interval, Electrocardiogram ST segment elevation, Electrocardiogram abnormal
Clinical narrative: Note: Any requests for follow-up information on this case should be sent directly to the sponsor of this study, Sanofi Pasteur. This study case was received from the investigator in a trial on 21 January 2014. An 21 year-old male subject with no significant past medical history was found to have "other and unspecified acute pericarditis" 12 days after the subject had received the following vaccines on 22 November 2013: an injection of ACAM2000 (lot number, route and site of administration not reported), Pneumococcal PPV23 vaccine (manufacturer, lot number, route and site of administration not reported) and Anthrax 1 (manufacturer, lot number, route and site of administration not reported). On 04 November 2013, the subject received Influenza seasonal injectable vaccine (manufacturer, lot number, route and site of administration not reported). Relevant laboratory data on 04 December 2013 included: an abnormal Troponin I recorded highest value of 03.52 ng/ml and an abnormal ECG. An Echocardiogram and MRI of the heart were not available. Lumbar puncture and MRI of the brain and spinal cord were not performed. Treatments were not reported. Additional information will be requested from the investigator. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: none.
Age: 21.0
Sex: M
Vaccine: ANTH, PPV, SMALL, TYP, ANTH, PPV, SMALL
Symptoms: Haematocrit decreased, Haemoglobin normal, Insomnia, Platelet count decreased, Troponin I increased
Clinical narrative: Note: Any requests for follow-up information on this case should be sent directly to the sponsor of this study, Sanofi Pasteur. This study case was received from the investigator in a trial on 21 January 2014. An 21 year-old male subject with no significant past medical history was found to have "other and unspecified acute pericarditis" 12 days after the subject had received the following vaccines on 22 November 2013: an injection of ACAM2000 (lot number, route and site of administration not reported), Pneumococcal PPV23 vaccine (manufacturer, lot number, route and site of administration not reported) and Anthrax 1 (manufacturer, lot number, route and site of administration not reported). On 04 November 2013, the subject received Influenza seasonal injectable vaccine (manufacturer, lot number, route and site of administration not reported). Relevant laboratory data on 04 December 2013 included: an abnormal Troponin I recorded highest value of 03.52 ng/ml and an abnormal ECG. An Echocardiogram and MRI of the heart were not available. Lumbar puncture and MRI of the brain and spinal cord were not performed. Treatments were not reported. Additional information will be requested from the investigator. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: none.
Age: 21.0
Sex: M
Vaccine: ANTH, PPV, SMALL, TYP, ANTH, PPV, SMALL
Symptoms: White blood cell count normal
Clinical narrative: Note: Any requests for follow-up information on this case should be sent directly to the sponsor of this study, Sanofi Pasteur. This study case was received from the investigator in a trial on 21 January 2014. An 21 year-old male subject with no significant past medical history was found to have "other and unspecified acute pericarditis" 12 days after the subject had received the following vaccines on 22 November 2013: an injection of ACAM2000 (lot number, route and site of administration not reported), Pneumococcal PPV23 vaccine (manufacturer, lot number, route and site of administration not reported) and Anthrax 1 (manufacturer, lot number, route and site of administration not reported). On 04 November 2013, the subject received Influenza seasonal injectable vaccine (manufacturer, lot number, route and site of administration not reported). Relevant laboratory data on 04 December 2013 included: an abnormal Troponin I recorded highest value of 03.52 ng/ml and an abnormal ECG. An Echocardiogram and MRI of the heart were not available. Lumbar puncture and MRI of the brain and spinal cord were not performed. Treatments were not reported. Additional information will be requested from the investigator. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: none.
Age: 21.0
Sex: M
Vaccine: ANTH, PPV, SMALL, TYP, ANTH, PPV, SMALL
Symptoms: Cardiac imaging procedure, Echocardiogram, Electrocardiogram abnormal, Nuclear magnetic resonance imaging, Pericarditis
Clinical narrative: Note: Any requests for follow-up information on this case should be sent directly to the sponsor of this study, Sanofi Pasteur. This study case was received from the investigator in a trial on 21 January 2014. An 21 year-old male subject with no significant past medical history was found to have "other and unspecified acute pericarditis" 12 days after the subject had received the following vaccines on 22 November 2013: an injection of ACAM2000 (lot number, route and site of administration not reported), Pneumococcal PPV23 vaccine (manufacturer, lot number, route and site of administration not reported) and Anthrax 1 (manufacturer, lot number, route and site of administration not reported). On 04 November 2013, the subject received Influenza seasonal injectable vaccine (manufacturer, lot number, route and site of administration not reported). Relevant laboratory data on 04 December 2013 included: an abnormal Troponin I recorded highest value of 03.52 ng/ml and an abnormal ECG. An Echocardiogram and MRI of the heart were not available. Lumbar puncture and MRI of the brain and spinal cord were not performed. Treatments were not reported. Additional information will be requested from the investigator. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: none.
Age: 21.0
Sex: M
Vaccine: ANTH, PPV, SMALL, TYP, ANTH, PPV, SMALL
Symptoms: Troponin I increased
Clinical narrative: Note: Any requests for follow-up information on this case should be sent directly to the sponsor of this study, Sanofi Pasteur. This study case was received from the investigator in a trial on 21 January 2014. An 21 year-old male subject with no significant past medical history was found to have "other and unspecified acute pericarditis" 12 days after the subject had received the following vaccines on 22 November 2013: an injection of ACAM2000 (lot number, route and site of administration not reported), Pneumococcal PPV23 vaccine (manufacturer, lot number, route and site of administration not reported) and Anthrax 1 (manufacturer, lot number, route and site of administration not reported). On 04 November 2013, the subject received Influenza seasonal injectable vaccine (manufacturer, lot number, route and site of administration not reported). Relevant laboratory data on 04 December 2013 included: an abnormal Troponin I recorded highest value of 03.52 ng/ml and an abnormal ECG. An Echocardiogram and MRI of the heart were not available. Lumbar puncture and MRI of the brain and spinal cord were not performed. Treatments were not reported. Additional information will be requested from the investigator. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: none.
Age: 71.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Chills, Confusional state, Fall, Gait disturbance, Injection site reaction
Clinical narrative: Pt is a 71 yo male who went to urgent care, on 4/18/13, due to conjunctivitis. Pt was prescribed ciprofloxacin ophthalmic. He was also given a pneumococcal vaccine. Per report from his family, approximately 2-3 hours after the vaccine, he developed confusion, chills, feverishness, and started mumbling, had an unsteady gait and multiple falls, and developed urinary incontinence. He had a localized reaction at the injection site. This was an acute change. Pt's family brought him back to urgent care on 4/19/13 and they were directed to take him to the emergency department. Pt was admitted, neurology was consulted and thought that the patient had encephalopathy due to a systemic reaction to the vaccine or due to pneumonitis. The patient had a 4 day stay for delirium suspected to be related to immunization. He was discharged on 4/23/13 still sundowning but improved enough to go home with family care.
Age: 71.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Local reaction, Pyrexia, Speech disorder, Urinary incontinence
Clinical narrative: Pt is a 71 yo male who went to urgent care, on 4/18/13, due to conjunctivitis. Pt was prescribed ciprofloxacin ophthalmic. He was also given a pneumococcal vaccine. Per report from his family, approximately 2-3 hours after the vaccine, he developed confusion, chills, feverishness, and started mumbling, had an unsteady gait and multiple falls, and developed urinary incontinence. He had a localized reaction at the injection site. This was an acute change. Pt's family brought him back to urgent care on 4/19/13 and they were directed to take him to the emergency department. Pt was admitted, neurology was consulted and thought that the patient had encephalopathy due to a systemic reaction to the vaccine or due to pneumonitis. The patient had a 4 day stay for delirium suspected to be related to immunization. He was discharged on 4/23/13 still sundowning but improved enough to go home with family care.
Age: 71.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Chills, Confusional state, Conjunctivitis, Delirium, Encephalopathy
Clinical narrative: Pt is a 71 yo male who went to urgent care, on 4/18/13, due to conjunctivitis. Pt was prescribed ciprofloxacin ophthalmic. He was also given a pneumococcal vaccine. Per report from his family, approximately 2-3 hours after the vaccine, he developed confusion, chills, feverishness, and started mumbling, had an unsteady gait and multiple falls, and developed urinary incontinence. He had a localized reaction at the injection site. This was an acute change. Pt's family brought him back to urgent care on 4/19/13 and they were directed to take him to the emergency department. Pt was admitted, neurology was consulted and thought that the patient had encephalopathy due to a systemic reaction to the vaccine or due to pneumonitis. The patient had a 4 day stay for delirium suspected to be related to immunization. He was discharged on 4/23/13 still sundowning but improved enough to go home with family care.
Age: 71.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Fall, Gait disturbance, Injection site reaction, Local reaction, Pneumonitis
Clinical narrative: Pt is a 71 yo male who went to urgent care, on 4/18/13, due to conjunctivitis. Pt was prescribed ciprofloxacin ophthalmic. He was also given a pneumococcal vaccine. Per report from his family, approximately 2-3 hours after the vaccine, he developed confusion, chills, feverishness, and started mumbling, had an unsteady gait and multiple falls, and developed urinary incontinence. He had a localized reaction at the injection site. This was an acute change. Pt's family brought him back to urgent care on 4/19/13 and they were directed to take him to the emergency department. Pt was admitted, neurology was consulted and thought that the patient had encephalopathy due to a systemic reaction to the vaccine or due to pneumonitis. The patient had a 4 day stay for delirium suspected to be related to immunization. He was discharged on 4/23/13 still sundowning but improved enough to go home with family care.
Age: 71.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Pyrexia, Speech disorder, Urinary incontinence, Vaccination complication
Clinical narrative: Pt is a 71 yo male who went to urgent care, on 4/18/13, due to conjunctivitis. Pt was prescribed ciprofloxacin ophthalmic. He was also given a pneumococcal vaccine. Per report from his family, approximately 2-3 hours after the vaccine, he developed confusion, chills, feverishness, and started mumbling, had an unsteady gait and multiple falls, and developed urinary incontinence. He had a localized reaction at the injection site. This was an acute change. Pt's family brought him back to urgent care on 4/19/13 and they were directed to take him to the emergency department. Pt was admitted, neurology was consulted and thought that the patient had encephalopathy due to a systemic reaction to the vaccine or due to pneumonitis. The patient had a 4 day stay for delirium suspected to be related to immunization. He was discharged on 4/23/13 still sundowning but improved enough to go home with family care.