chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Ankle fracture, Blood creatine phosphokinase decreased, Burning sensation, Dysstasia, Fall
Clinical narrative: 10/26/12 received Flu Vaccine. 10/27/12 Awoke in AM unable to stand, legs numb from knees down, stabbing pains, burning in feet. Father carried her to car and transported her to ER. After six hours diagnosed her with paresthesia and sent her to Hospital for MRI which showed no injury to spine. Sent her home to follow up with doctor who gave flu shot. She became wheelchair bound. 10/31/12 Returned to Dr.'s office where flu shot was given. He did blood work and became suspect of Guillain Barre since she showed low levels of Creatine Kinase. Referred her to a neurologist for testing. Two weeks later Neurologist ruled out Guillain Barre "since she was not on a ventilator". Frustrated her family made appt. with a clinic in another state for further treatment. 11/5/12 Dr. at pain management ordered physical therapy, fentanyl patch and cream for burning, stabbing pain in feet. He would later put her on the drug GRALISE. 11/8/12 Physical Rehabilitation began physical therapy two to three times a week. By this time she had regained use of right leg and could stand on right leg with help to enter shower and bed. She was able to interchange between the wheel chair and a walker for short distances with a high stepping gait to clear her left foot. Without the walker she needs assistance to keep her balance. Goes up and down stairs by using her arms crawling on her bottom. She also has PT exercises to perform at home. Nov 12-Dec 12 Clinic in another state, under the care of Neurologists, she had numerous testing which included a lumbar puncture which ruled out MS, MD and Guillain Barre. In final notes which are included, they state that there is a possibility that this represented some kind of reaction to the flu vaccine. Suggested that she remain there for further treatment or return home for physical therapy under her doctor's care at home. 12/20/12 Returned home for further treatment. Her leg was extremely unstable and she fell fracturing her left ankle. Delayed PT until Jan 29th. Presently still under care of Pain Management for pain and Physical therapy. Making small steps of gaining use of legs.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Gait disturbance, Hypoaesthesia, Lumbar puncture normal, Pain, Paraesthesia
Clinical narrative: 10/26/12 received Flu Vaccine. 10/27/12 Awoke in AM unable to stand, legs numb from knees down, stabbing pains, burning in feet. Father carried her to car and transported her to ER. After six hours diagnosed her with paresthesia and sent her to Hospital for MRI which showed no injury to spine. Sent her home to follow up with doctor who gave flu shot. She became wheelchair bound. 10/31/12 Returned to Dr.'s office where flu shot was given. He did blood work and became suspect of Guillain Barre since she showed low levels of Creatine Kinase. Referred her to a neurologist for testing. Two weeks later Neurologist ruled out Guillain Barre "since she was not on a ventilator". Frustrated her family made appt. with a clinic in another state for further treatment. 11/5/12 Dr. at pain management ordered physical therapy, fentanyl patch and cream for burning, stabbing pain in feet. He would later put her on the drug GRALISE. 11/8/12 Physical Rehabilitation began physical therapy two to three times a week. By this time she had regained use of right leg and could stand on right leg with help to enter shower and bed. She was able to interchange between the wheel chair and a walker for short distances with a high stepping gait to clear her left foot. Without the walker she needs assistance to keep her balance. Goes up and down stairs by using her arms crawling on her bottom. She also has PT exercises to perform at home. Nov 12-Dec 12 Clinic in another state, under the care of Neurologists, she had numerous testing which included a lumbar puncture which ruled out MS, MD and Guillain Barre. In final notes which are included, they state that there is a possibility that this represented some kind of reaction to the flu vaccine. Suggested that she remain there for further treatment or return home for physical therapy under her doctor's care at home. 12/20/12 Returned home for further treatment. Her leg was extremely unstable and she fell fracturing her left ankle. Delayed PT until Jan 29th. Presently still under care of Pain Management for pain and Physical therapy. Making small steps of gaining use of legs.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Walking aid user
Clinical narrative: 10/26/12 received Flu Vaccine. 10/27/12 Awoke in AM unable to stand, legs numb from knees down, stabbing pains, burning in feet. Father carried her to car and transported her to ER. After six hours diagnosed her with paresthesia and sent her to Hospital for MRI which showed no injury to spine. Sent her home to follow up with doctor who gave flu shot. She became wheelchair bound. 10/31/12 Returned to Dr.'s office where flu shot was given. He did blood work and became suspect of Guillain Barre since she showed low levels of Creatine Kinase. Referred her to a neurologist for testing. Two weeks later Neurologist ruled out Guillain Barre "since she was not on a ventilator". Frustrated her family made appt. with a clinic in another state for further treatment. 11/5/12 Dr. at pain management ordered physical therapy, fentanyl patch and cream for burning, stabbing pain in feet. He would later put her on the drug GRALISE. 11/8/12 Physical Rehabilitation began physical therapy two to three times a week. By this time she had regained use of right leg and could stand on right leg with help to enter shower and bed. She was able to interchange between the wheel chair and a walker for short distances with a high stepping gait to clear her left foot. Without the walker she needs assistance to keep her balance. Goes up and down stairs by using her arms crawling on her bottom. She also has PT exercises to perform at home. Nov 12-Dec 12 Clinic in another state, under the care of Neurologists, she had numerous testing which included a lumbar puncture which ruled out MS, MD and Guillain Barre. In final notes which are included, they state that there is a possibility that this represented some kind of reaction to the flu vaccine. Suggested that she remain there for further treatment or return home for physical therapy under her doctor's care at home. 12/20/12 Returned home for further treatment. Her leg was extremely unstable and she fell fracturing her left ankle. Delayed PT until Jan 29th. Presently still under care of Pain Management for pain and Physical therapy. Making small steps of gaining use of legs.
Sex: F
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: This spontaneous report was received from a nurse via company representative refers to a female patient of unknown age. On an unknown date in 1999, the patient was vaccinated with the first dose of VARIVAX (merck), (lot number, expiry date and route was not reported). On an unknown date in 2012, the patient was vaccinated with the second dose of VARIVAX (merck), (lot number, expiry date and route was not reported). On an unknown date, the patient was diagnosed with chickenpox "a couple of months ago". The outcome of the reporter event was reported event was reported as recovered. This is one of the two reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report as received from a clinical medical assistant refers to a female patient of unknown age. The patient received their second dose of GARDASIL (lot number unspecified) in June 2008 and was in the office today, on 08-APR-2013, to receive their third dose of GARDASIL (lot number unspecified). The outcome of the patient was unknown. It was unknown if the patient had sought medical attention. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a register nurse concerning who stated a product confusion due to similar packing of PROQUAD (Merck) (lot number H020850, expiration date 26-MAY-2013) and M-M-R. The nurse stated that the PROQUAD (Merck) and M-M-R packing looked similar that the staff inadvertently stored the of PROQUAD (Merck) in the refrigerator. The improperly stored of PROQUAD (Merck) was not administered to any patients. No adverse events were reported. Additional information is not expected.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a Medical Assistant refers to a 60 year old female patient. On 05-APR-2013 the patient was vaccinated with an expired dose of ZOSTAVAX (lot # was reported as H009779, expiry date 27-MAR-2013). No adverse effects reported. Additional information has been requested.
Age: 20.0
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a registered pharmacist concerning a 20 year old patient of unknown gender. On 10-APR-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiry date, dose and route unspecified) instead of VARIVAX (Merck). No concomitant medications were reported. The patient was not experiencing any symptoms at the time of reporting. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Oedema peripheral, Pyrexia
Clinical narrative: This spontaneous report was received from a registered pharmacist via a company representative concerning an approximately 63 year old female patient. Approximately on an unknown date in April 2013 (reported as within the last week), the patient was vaccinated with 0.65 milliliter (ml) of ZOSTAVAX (lot number and expiry date unspecified), subcutaneously. No concomitant medications were reported. Around 06-APR-2013, arm of the patient swelled up, she had pain in her elbow after receiving the vaccination and she had a fever. The patient sought medical attention (spoke with pharmacist). The patient was treated with pain or anti-inflammatory medicine (unspecified). It was unspecified if any lab tests were performed. The patient was recovering from all the events at the time of reporting. The relatedness for all the events was unknown for ZOSTAVAX. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age and gender. On 13-MAR-2013 at 09:20 am, the patient was vaccinated with RECOMBIVAX HB (lot # H018689 and expiration date 07-NOV-2014) (dose, therapy route and anatomical location unspecified). The physician reported that on an unknown date, RECOMBIVAX HB was exposed to multiple low temperature excursions. The excursion time at -1 was 124.50 hours (also reported as 17 hours -1, then 291, 2 admin). The patient was not experiencing any known symptoms. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age and gender. On 15-MAR-2013 at 04:20 pm, the patient was vaccinated with RECOMBIVAX HB (lot # H018689 and expiration date 07-NOV-2014) (dose, therapy route and anatomical location unspecified). The physician reported that on an unknown date, RECOMBIVAX HB was exposed to multiple low temperature excursions. The excursion time at-1 was 130.50 hours (also reported 17 hours -1, 337, 2 admin). The patient was not experiencing any known symptoms. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age and gender. On 18-MAR-2013 at 11:20 am, the patient was vaccinated with RECOMBIVAX HB (lot # H018689 and expiration date 07-NOV-2014) (dose, therapy route and anatomical location unspecified). The physician reported that on an unknown date, RECOMBIVAX HB was exposed to multiple low temperature excursions. The excursion time at -1 was 130.50 hours (also reported 17-1, 404, 2 admin). The patient was not experiencing any known symptoms. This is one of several reports from the same source. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Arm red and swollen around injection site.
Age: 1.01
Sex: M
Vaccine: HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Erythema, Macule, Pallor
Clinical narrative: Received shots (see above) on 4/2/13. Began with blanching erythematous macules with halo on 4/11, worse 4/12, seen in clinic. Possible post varicella rash. VAERS report ordered. HC consulted.
Age: 50.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Induration, Pain, Skin warm
Clinical narrative: A HARD RED AREA THE SIZE OF A SMALL APPLE WHICH WAS WARM, RED AND PAINFUL TO TOUCH. CALLED MD SAID TO APPLY ICE. REDNESS CONTINUED TO EXPAND UP LOWER ARM. SEEN ON 4/12/12.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Influenza like illness, Pruritus, Rash
Clinical narrative: Itching around RUE under shoulder with mild rash and fatigue. Flu like symptoms w/o sore throat.
Age: 40.0
Sex: F
Vaccine: TTOX
Symptoms: Arthralgia, Chills, Diarrhoea, Dizziness, Fatigue
Clinical narrative: 04/12/13 - Donor called at 10:27 AM to report sx. Onset of aching started 4/11/13 @ 6PM to joints, wrist, elbows, shoulder, and neck and hasn't resolved. Weakness to hands w/onset starting 3:30 AM, low grade fever 99.5 at 03:30 AM, woke up at 01:00 AM with nausea, cold/chills & diarrhea off/on since. States, feels exhausted and dizziness off/on when sitting or standing since 01:00 AM and that she received the Tetanus shot 04/11/13. Husband w/her and has been assisting her d/t sx.
Age: 40.0
Sex: F
Vaccine: TTOX
Symptoms: Muscular weakness, Nasopharyngitis, Nausea, Neck pain, Pyrexia
Clinical narrative: 04/12/13 - Donor called at 10:27 AM to report sx. Onset of aching started 4/11/13 @ 6PM to joints, wrist, elbows, shoulder, and neck and hasn't resolved. Weakness to hands w/onset starting 3:30 AM, low grade fever 99.5 at 03:30 AM, woke up at 01:00 AM with nausea, cold/chills & diarrhea off/on since. States, feels exhausted and dizziness off/on when sitting or standing since 01:00 AM and that she received the Tetanus shot 04/11/13. Husband w/her and has been assisting her d/t sx.
Age: 12.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Injection site inflammation, Injection site swelling
Clinical narrative: Nurse reported large inflamed raised area on left upper arm.
Age: 1.51
Sex: F
Vaccine: HEPA
Symptoms: Rash erythematous, Skin warm, Streptococcus test negative, Vaccination complication
Clinical narrative: Woke up in the middle of the night.  In the morning a rash appeared on back.  By the evening of 4/10/2013 entire back and chest was covered in a rash that was red and very hot to the touch.  Had to take to back the Dr to figure out what is going on.  Got checked for strep and all was negative.  Most likely thought to be a reaction to vaccination.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Erythema, Headache, Injection site mass, Musculoskeletal stiffness
Clinical narrative: Within 20 hours he developed a lump where shot given.  Headache, chills--down spine and across shoulders.  Neck stiff.  Extreme pain.  Within 2 days had an open sore with extreme redness, radiating around arm.  The next day redness had spread even after starting antibiotics.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Ulcer
Clinical narrative: Within 20 hours he developed a lump where shot given.  Headache, chills--down spine and across shoulders.  Neck stiff.  Extreme pain.  Within 2 days had an open sore with extreme redness, radiating around arm.  The next day redness had spread even after starting antibiotics.
Age: 47.0
Sex: F
Vaccine: TDAP
Symptoms: Diarrhoea, Influenza like illness, Pain in extremity, Pyrexia
Clinical narrative: Severe arm pain, fever 101, diarrhea, flu like symptoms.
Age: 16.0
Sex: F
Vaccine: FLU3
Symptoms: Arthrogram, Electromyogram, Mobility decreased, Nerve conduction studies, Neuralgic amyotrophy
Clinical narrative: Parsonage Turner syndrome.... Limited movement of right arm.. Currently undergoing rehabilitation for the last month.
Age: 16.0
Sex: F
Vaccine: FLU3
Symptoms: Nuclear magnetic resonance imaging
Clinical narrative: Parsonage Turner syndrome.... Limited movement of right arm.. Currently undergoing rehabilitation for the last month.
Age: 40.0
Sex: M
Vaccine: TTOX
Symptoms: Glassy eyes, Loss of consciousness, Pallor
Clinical narrative: AFTER RECEIVING INJECTION, DONOR BECAME PALE, AND GLASSY EYED, HAD LOSS OF CONSCIOUSNESS FOR APPROX. 30 SECONDS. THIS WRITER HELD DONOR IN CHIN THRUST POSTION UNTIL RESPONSIVE, THEN HEAD WAS PLACED BELOW AND BETWEEN KNEES WATER WAS GIVEN WHEN DONOR WAS STEADY, HE WAS TRANSFERRED TO BED WHILE VITALS WERE TAKEN ALL THIS TOOK PLACE FROM 12:27 TO 12:30.
Age: 49.0
Sex: M
Vaccine: HEP
Symptoms: Pruritus generalised, Vaccination complication
Clinical narrative: Skin itching all over. Started after applying hair permanent on 4/2/13 in afternoon and showered to remove hair permanent. Itching continued daily. On 4/11/13, client called clinic to report symptoms. Client was sent to seek medical advice at his primary doctor. Was prescribed Benadryl 25mg by mouth twice a day for 10 days. On 4/12/13, client reported itching continued and he had to call his doctor's office again on 4/12/13.
Age: 35.0
Sex: F
Vaccine: DTAP
Symptoms: Chest discomfort, Cough, Injection site erythema, Injection site pruritus, Injection site urticaria
Clinical narrative: Itchiness at vaccination site (left arm) spread rapidly across to chest and throat. Throat constriction followed, accompanied by coughing.  Treated with Benadryl and Albuterol. Following day (04/12/2013) itchiness at vaccination site reoccurred accompanied by redness and swelling and hives on left shoulder, throat & chest tightness and coughing.
Age: 35.0
Sex: F
Vaccine: DTAP
Symptoms: Pruritus, Throat tightness, Vaccination site swelling
Clinical narrative: Itchiness at vaccination site (left arm) spread rapidly across to chest and throat. Throat constriction followed, accompanied by coughing.  Treated with Benadryl and Albuterol. Following day (04/12/2013) itchiness at vaccination site reoccurred accompanied by redness and swelling and hives on left shoulder, throat & chest tightness and coughing.
Age: 10.0
Sex: M
Vaccine: FLU3, TDAP
Symptoms: Injection site erosion, Injection site erythema, Injection site nodule, Injection site pruritus, Injection site swelling
Clinical narrative: Injectiosn site red, raised, itchy, non tender, with some excoriation about 3.5x4 cm with central hard nodule about 1/2 cm. No pustule.
Age: 8.0
Sex: M
Vaccine: MMR
Symptoms: Cardiac monitoring, Enuresis, Heart rate abnormal, Heart rate decreased, Heart rate increased
Clinical narrative: Same Day: wet bed for first time in years. Next day: complained of irregular heartbeat, but it went away after a couple of minutes. 2nd day: complained of irregular heart beat, fast then stopping then slow, for over 10-15 minutes. We went to the ER and did a followup appointment the next day and came home with a heart monitor for the next 30 days to track it. When I looked online, the correlation for arrhythmia and MMR was grim but no doctors were interested or took it seriously. He seems to be doing fine now but tracking it closely.
Age: 8.0
Sex: M
Vaccine: MMR
Symptoms: Heart rate irregular
Clinical narrative: Same Day: wet bed for first time in years. Next day: complained of irregular heartbeat, but it went away after a couple of minutes. 2nd day: complained of irregular heart beat, fast then stopping then slow, for over 10-15 minutes. We went to the ER and did a followup appointment the next day and came home with a heart monitor for the next 30 days to track it. When I looked online, the correlation for arrhythmia and MMR was grim but no doctors were interested or took it seriously. He seems to be doing fine now but tracking it closely.
Age: 63.0
Sex: M
Vaccine: TDAP
Symptoms: Pain in extremity
Clinical narrative: Got tetanus shot 3-19-12 on 3-21-12 called doc because arm was sore from the shot. They said it is common. On 3-29-12 said it still hurt no anger and other doc's would not say anything it's been over a yr it still hurts.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pruritus, Injection site swelling, Urticaria
Clinical narrative: 2 days after recovering vaccine pt. developed wheals on (R) wrist - 10 days after receiving vaccine pt. developed itching & swelling both upper arms.
Age: 5.0
Sex: M
Vaccine: DTAPHEPBIP, MMR
Symptoms: Erythema, Injection site swelling, Pain, Skin lesion
Clinical narrative: (R) erythematous raised area measuring 4.2 x 4.3 cm over upper left thigh. Started as a dime sized lesion. 1 day after injection which was place 4/10/2013. No SOB no itching mild pain.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Injection site swelling, Neck pain
Clinical narrative: Pain in (R) deltoid radiating up into (R) neck area with noted swelling of 5 inches in (R) upper arm.
Age: 1.28
Sex: U
Vaccine: IPV, PNC
Symptoms: Erythema
Clinical narrative: 35 mm erythema -no inguinal adenopathy. Amoxicillin 250 mg/5 mL - take 6.2 mLs po BID.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Swelling
Clinical narrative: 6 x 3 area of redness, swelling doctor suggested cold compresses and BENADRYL.
Age: 1.84
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Injection site erythema
Clinical narrative: Developed a red area around injection vaccine site 2 cm x 2 cm on (R) thigh after varicella.
Age: 1.65
Sex: M
Vaccine: DTAPIPVHIB, HEPA, PNC13, VARCEL
Symptoms: Injection site erythema, Injection site mass, Injection site vesicles, Pruritus
Clinical narrative: Firm lump with redness & 2-3 tiny vesicles over lying it on (L) thigh developed 9 days after vaccine (same thigh as received varicella). Area involved about 2 cm. No fever; mildly itchy.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Cellulitis, Injection site erythema, Injection site swelling
Clinical narrative: Cellulitis - Rt deltoid swelling and redness had imm on Wed 4/10/13 gave KEFLEX 250mg/5mL 4mL po tid advised BENADRYL to help with swelling.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a female patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL (lot# and expiration date unspecified) (dose, route and anatomical location unspecified). The medical assistant reported that years ago (unknown dates) the patient was administered the second dose of GARDASIL 1 year after the first dose of GARDASIL. No adverse effects reported. At the time of report the action taken with GARDASIL was unknown. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age and gender. On 06-MAR-2013 at 10:20 am, the patient was vaccinated with RECOMBIVAX HB (lot # H018689 and expiration date 07-NOV-2014) (dose, therapy route and anatomical location unspecified). The physician reported that on an unknown date, RECOMBIVAX HB was exposed to multiple low temperature excursions. The excursion time at -1 was 50.50 hours (also reported 17 hours -1, then 130, 2 admin). The patient was not experiencing any known symptoms. This is one of several report from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age and gender. On 06-MAR-2013 at 11:20 am, the patient was vaccinated with RECOMBIVAX HB (lot # H018689 and expiration date 07-NOV-2014) (dose, therapy route and anatomical location unspecified). The physician reported that on an unknown date, RECOMBIVAX HB was exposed to multiple low temperature excursions. The excursion time at -1 was 51.50 hours (also reported as 17 hours -1, then 131 normal 2 admin). The patient was not experiencing any known symptoms. This is one of several reports from the same source. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: ZOSTAVAX vaccination given in error when varicella was ordered by provider. Given at 2:00 pm 4/8/13 with no evident adverse reaction followed up with patient by phone and still no reaction.
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Incorrect dose administered, Product label issue
Clinical narrative: Physician clinic staff gave a child the adult dose of HAVRIX - Hepatitis A vaccine-instead of the pediatric dose. This has happened several times at our associated clinics so I think there is lack of appropriate labeling on the products from the manufacturer.
Age: 1.3
Sex: M
Vaccine: HIBV
Symptoms: Bacterial test positive, Body temperature increased, Conjunctivitis infective, Full blood count, Haemophilus infection
Clinical narrative: This literature marketed report was received from a physician concerning a 16 month old male patient. On an unknown date, the patient received PREVNAR 13 on an unknown date. On an unknown date, the patient was vaccinated with LIQUID PEDVAXHIB (lot number, expiry date, dose and route unspecified). On an unknown date, the patient presented with symptoms of mild preseptal cellulitis (PC) of the right lower eyelid, purulent rhinorrhea, mild peri-oral facial rash, acute otitis media (AOM), purulent conjunctivitis for several days and upper respiratory infection (URI) for 2 weeks. The patient was treated with amoxicillin, twice daily for acute otitis media (AOM). Body temperature of the patient was 100 degrees Fahrenheit. The physical examination of the patient was unremarkable. Routine bacterial culture of the right eye discharge and complete blood count (CBC) showed a leukocyte count of 12550 cells per cubic millimeter. The patient was afebrile and non toxic, his leucocyte count was within normal range and he has an infection which highly suggest non typeable H. influenza. Patient received treatment with cefdinir and amoxicillin clavulanate twice daily. Three days later, his eye grew beta lactamase-negative H. influenzae. Upon follow up the next day, the preseptal cellulitis (PC) of the patient was much improved and his demeanor was much better. Additional information has been requested.
Age: 1.3
Sex: M
Vaccine: HIBV
Symptoms: Influenza virus test negative, Otitis media acute, Periorbital cellulitis, Rash, Rhinitis
Clinical narrative: This literature marketed report was received from a physician concerning a 16 month old male patient. On an unknown date, the patient received PREVNAR 13 on an unknown date. On an unknown date, the patient was vaccinated with LIQUID PEDVAXHIB (lot number, expiry date, dose and route unspecified). On an unknown date, the patient presented with symptoms of mild preseptal cellulitis (PC) of the right lower eyelid, purulent rhinorrhea, mild peri-oral facial rash, acute otitis media (AOM), purulent conjunctivitis for several days and upper respiratory infection (URI) for 2 weeks. The patient was treated with amoxicillin, twice daily for acute otitis media (AOM). Body temperature of the patient was 100 degrees Fahrenheit. The physical examination of the patient was unremarkable. Routine bacterial culture of the right eye discharge and complete blood count (CBC) showed a leukocyte count of 12550 cells per cubic millimeter. The patient was afebrile and non toxic, his leucocyte count was within normal range and he has an infection which highly suggest non typeable H. influenza. Patient received treatment with cefdinir and amoxicillin clavulanate twice daily. Three days later, his eye grew beta lactamase-negative H. influenzae. Upon follow up the next day, the preseptal cellulitis (PC) of the patient was much improved and his demeanor was much better. Additional information has been requested.
Age: 1.3
Sex: M
Vaccine: HIBV
Symptoms: Upper respiratory tract infection, White blood cell count normal
Clinical narrative: This literature marketed report was received from a physician concerning a 16 month old male patient. On an unknown date, the patient received PREVNAR 13 on an unknown date. On an unknown date, the patient was vaccinated with LIQUID PEDVAXHIB (lot number, expiry date, dose and route unspecified). On an unknown date, the patient presented with symptoms of mild preseptal cellulitis (PC) of the right lower eyelid, purulent rhinorrhea, mild peri-oral facial rash, acute otitis media (AOM), purulent conjunctivitis for several days and upper respiratory infection (URI) for 2 weeks. The patient was treated with amoxicillin, twice daily for acute otitis media (AOM). Body temperature of the patient was 100 degrees Fahrenheit. The physical examination of the patient was unremarkable. Routine bacterial culture of the right eye discharge and complete blood count (CBC) showed a leukocyte count of 12550 cells per cubic millimeter. The patient was afebrile and non toxic, his leucocyte count was within normal range and he has an infection which highly suggest non typeable H. influenza. Patient received treatment with cefdinir and amoxicillin clavulanate twice daily. Three days later, his eye grew beta lactamase-negative H. influenzae. Upon follow up the next day, the preseptal cellulitis (PC) of the patient was much improved and his demeanor was much better. Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age and gender. On 18-MAR-2013 at 9:20 am, the patient was vaccinated with RECOMBIVAX HB (lot # H018689 and expiration date 07-NOV-2014) (dose, therapy route and anatomical location unspecified). The physician reported that on an unknown date, RECOMBIVAX HB was exposed to multiple low temperature excursions. The excursion time at -1 was 154.50 hours (also reported as -1, 442, 2, -54 hours, 58, 2 -admin). The patient was not experiencing any known symptoms. This is one of several reports from the same source. Additional information has been requested.
Age: 0.07
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Patient was given his 2 mo, vaccines at 3wk 5d old. No adverse event occurred.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Dizziness, Nausea
Clinical narrative: Patient felt faint & nauseated after vaccine.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema
Clinical narrative: Redness around injection site.
Age: 18.0
Sex: M
Vaccine: SMALL
Symptoms: Cardiac enzymes normal, Electrocardiogram abnormal, Pericarditis, Vaccination complication
Clinical narrative: Adverse reaction to smallpox Pericarditis.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age and gender. On 27-MAR-2013 at 2:20 pm, the patient was vaccinated with RECOMBIVAX HB (lot # H018689 and expiration date 07-NOV-2014) (dose, therapy route and anatomical location unspecified). The physician reported that on an unknown date, RECOMBIVAX HB was exposed to multiple low temperature excursions. The excursion time at -1 was 226.50 hours (also reported as 17 hours -1, 447, 2, -54 hours, 178, 2 admin). The patient was not experiencing any known symptoms. This is one of several reports from the same source. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a nurse refers to a male patient of unknown age. On an unknown date 2 to 3 years ago, the patient was vaccinated with ZOSTAVAX 19400PFU (Lot# and exp date not reported) 0.5 ml, subcutaneous. No other co suspects were reported. No concomitant therapy was reported. The nurse reported that 10 days ago (31-MAR-2013) the patient developed herpes zoster. The patient sought medical attention at physician office. Unspecified treatment was given for the events. The outcome of 10 days ago developed herpes zoster was unknown. Additional information has been requested.
Age: 1.02
Sex: M
Vaccine: MMRV
Symptoms: Rash morbilliform
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 12 month old male patient with ear infection. Drug Reactions/Allergies were not reported. On 27-MAR-2013 the patient was vaccinated with a dose of (merck) PROQUAD (lot # H020134, expiration date 07-MAY-2014), 0.5 ml, subcutaneously. Concomitant therapies included amoxicillin started on 27-MAR-2013. The healthcare worker reported that the patient developed a measles like rash following vaccination with (merck) PROQUAD on 27-MAR-2013. The measles like rash developed yesterday (07-APR-2013) on the face, neck and upper chest and this morning (08-APR-2013) the measles like rash has spread to the arms, abdomen and back. Patient sought medical attention. No treatment was given for adverse event. Patient's outcome was unknown. Additional information is not expected.
Age: 2.0
Sex: M
Vaccine: DTAPHEPBIP, HIBV, MMR, VARCEL
Symptoms: Chest X-ray, Febrile infection, Full blood count, Metabolic function test, Pyrexia
Clinical narrative: Generalized rash 6-8 hrs after shots. Fever. Had been ill with febrile illness, but was better, when he got shots. Seen ER, where he received ROCEPHIN and BENADRYL.
Age: 2.0
Sex: M
Vaccine: DTAPHEPBIP, HIBV, MMR, VARCEL
Symptoms: Rash generalised, Red blood cell sedimentation rate
Clinical narrative: Generalized rash 6-8 hrs after shots. Fever. Had been ill with febrile illness, but was better, when he got shots. Seen ER, where he received ROCEPHIN and BENADRYL.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: (L) arm was hot and red. Mother stated no fever. Instructed to put cold compressions and TYLENOL if she likes to give to help for pain or any other brand she wants over the counter, instructed orders per doctor.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Posterior to (Rt) deltoid red, hot, tender, size of softball area.
Age: 1.54
Sex: M
Vaccine: DTAP, HEPA, DTAP, HEPA
Symptoms: Abasia, Angiogram normal, Basal ganglia infarction, Central nervous system lesion, Ear infection
Clinical narrative: 12/30/12 dad noticed when he woke up he couldn't use his left arm to push himself up in crib. when he would sit he would fall over. He was unable to walk and was irritable.  He was seen at a Walk in Care and dx with an ear infection and started on Amoxicillin. 12/31/12 he developed decreased use of left arm and maintained it in flexed position with fisting of the hand.  He was able to walk at this point. 1/1/13 he was seen in Walk in care again and had a negative arm xray and had a nursemaid's elbow reduction with no improvement. 1/3/13 he showed increased use of his left arm. 1/4/13 he had episodic left arm and leg tremors. No alterations in consciousness or postictal state. Also had squinting of left eye with pinpoint pupils and episodic giggling.  He was admitted to hospital and noted to have hemiparesis. Tremors resolved the next day. 1/4/13 he had a normal EEG. 1/5/13 he had a brain MRI that demonstrated a lesion in his right basal ganglia (putamen) that was associated with restricted diffusion and subtle enhasement, he was dx with a subacute infarct. 1/6/13 had a normal MRA. Hematology was consulted. He was placed on Aspirin. He was seen at hospital on 4/5/13 by Dr.
Age: 1.54
Sex: M
Vaccine: DTAP, HEPA, DTAP, HEPA
Symptoms: Electroencephalogram normal, Hemiparesis, Inappropriate affect, Injection site movement impairment, Irritability
Clinical narrative: 12/30/12 dad noticed when he woke up he couldn't use his left arm to push himself up in crib. when he would sit he would fall over. He was unable to walk and was irritable.  He was seen at a Walk in Care and dx with an ear infection and started on Amoxicillin. 12/31/12 he developed decreased use of left arm and maintained it in flexed position with fisting of the hand.  He was able to walk at this point. 1/1/13 he was seen in Walk in care again and had a negative arm xray and had a nursemaid's elbow reduction with no improvement. 1/3/13 he showed increased use of his left arm. 1/4/13 he had episodic left arm and leg tremors. No alterations in consciousness or postictal state. Also had squinting of left eye with pinpoint pupils and episodic giggling.  He was admitted to hospital and noted to have hemiparesis. Tremors resolved the next day. 1/4/13 he had a normal EEG. 1/5/13 he had a brain MRI that demonstrated a lesion in his right basal ganglia (putamen) that was associated with restricted diffusion and subtle enhasement, he was dx with a subacute infarct. 1/6/13 had a normal MRA. Hematology was consulted. He was placed on Aspirin. He was seen at hospital on 4/5/13 by Dr.
Age: 1.54
Sex: M
Vaccine: DTAP, HEPA, DTAP, HEPA
Symptoms: Miosis, Nuclear magnetic resonance imaging brain abnormal, Orthopaedic procedure, Posture abnormal, Tremor
Clinical narrative: 12/30/12 dad noticed when he woke up he couldn't use his left arm to push himself up in crib. when he would sit he would fall over. He was unable to walk and was irritable.  He was seen at a Walk in Care and dx with an ear infection and started on Amoxicillin. 12/31/12 he developed decreased use of left arm and maintained it in flexed position with fisting of the hand.  He was able to walk at this point. 1/1/13 he was seen in Walk in care again and had a negative arm xray and had a nursemaid's elbow reduction with no improvement. 1/3/13 he showed increased use of his left arm. 1/4/13 he had episodic left arm and leg tremors. No alterations in consciousness or postictal state. Also had squinting of left eye with pinpoint pupils and episodic giggling.  He was admitted to hospital and noted to have hemiparesis. Tremors resolved the next day. 1/4/13 he had a normal EEG. 1/5/13 he had a brain MRI that demonstrated a lesion in his right basal ganglia (putamen) that was associated with restricted diffusion and subtle enhasement, he was dx with a subacute infarct. 1/6/13 had a normal MRA. Hematology was consulted. He was placed on Aspirin. He was seen at hospital on 4/5/13 by Dr.
Age: 1.54
Sex: M
Vaccine: DTAP, HEPA, DTAP, HEPA
Symptoms: X-ray limb normal
Clinical narrative: 12/30/12 dad noticed when he woke up he couldn't use his left arm to push himself up in crib. when he would sit he would fall over. He was unable to walk and was irritable.  He was seen at a Walk in Care and dx with an ear infection and started on Amoxicillin. 12/31/12 he developed decreased use of left arm and maintained it in flexed position with fisting of the hand.  He was able to walk at this point. 1/1/13 he was seen in Walk in care again and had a negative arm xray and had a nursemaid's elbow reduction with no improvement. 1/3/13 he showed increased use of his left arm. 1/4/13 he had episodic left arm and leg tremors. No alterations in consciousness or postictal state. Also had squinting of left eye with pinpoint pupils and episodic giggling.  He was admitted to hospital and noted to have hemiparesis. Tremors resolved the next day. 1/4/13 he had a normal EEG. 1/5/13 he had a brain MRI that demonstrated a lesion in his right basal ganglia (putamen) that was associated with restricted diffusion and subtle enhasement, he was dx with a subacute infarct. 1/6/13 had a normal MRA. Hematology was consulted. He was placed on Aspirin. He was seen at hospital on 4/5/13 by Dr.
Age: 1.54
Sex: M
Vaccine: DTAP, HEPA, DTAP, HEPA
Symptoms: Basal ganglia stroke, Computerised tomogram abnormal, Crying, Echocardiogram abnormal, Electroencephalogram abnormal
Clinical narrative: 12/30/12 dad noticed when he woke up he couldn't use his left arm to push himself up in crib. when he would sit he would fall over. He was unable to walk and was irritable.  He was seen at a Walk in Care and dx with an ear infection and started on Amoxicillin. 12/31/12 he developed decreased use of left arm and maintained it in flexed position with fisting of the hand.  He was able to walk at this point. 1/1/13 he was seen in Walk in care again and had a negative arm xray and had a nursemaid's elbow reduction with no improvement. 1/3/13 he showed increased use of his left arm. 1/4/13 he had episodic left arm and leg tremors. No alterations in consciousness or postictal state. Also had squinting of left eye with pinpoint pupils and episodic giggling.  He was admitted to hospital and noted to have hemiparesis. Tremors resolved the next day. 1/4/13 he had a normal EEG. 1/5/13 he had a brain MRI that demonstrated a lesion in his right basal ganglia (putamen) that was associated with restricted diffusion and subtle enhasement, he was dx with a subacute infarct. 1/6/13 had a normal MRA. Hematology was consulted. He was placed on Aspirin. He was seen at hospital on 4/5/13 by Dr.
Age: 1.54
Sex: M
Vaccine: DTAP, HEPA, DTAP, HEPA
Symptoms: Emotional distress, Injection site movement impairment, Mobility decreased, Nuclear magnetic resonance imaging abnormal, Nuclear magnetic resonance imaging brain abnormal
Clinical narrative: 12/30/12 dad noticed when he woke up he couldn't use his left arm to push himself up in crib. when he would sit he would fall over. He was unable to walk and was irritable.  He was seen at a Walk in Care and dx with an ear infection and started on Amoxicillin. 12/31/12 he developed decreased use of left arm and maintained it in flexed position with fisting of the hand.  He was able to walk at this point. 1/1/13 he was seen in Walk in care again and had a negative arm xray and had a nursemaid's elbow reduction with no improvement. 1/3/13 he showed increased use of his left arm. 1/4/13 he had episodic left arm and leg tremors. No alterations in consciousness or postictal state. Also had squinting of left eye with pinpoint pupils and episodic giggling.  He was admitted to hospital and noted to have hemiparesis. Tremors resolved the next day. 1/4/13 he had a normal EEG. 1/5/13 he had a brain MRI that demonstrated a lesion in his right basal ganglia (putamen) that was associated with restricted diffusion and subtle enhasement, he was dx with a subacute infarct. 1/6/13 had a normal MRA. Hematology was consulted. He was placed on Aspirin. He was seen at hospital on 4/5/13 by Dr.
Age: 1.54
Sex: M
Vaccine: DTAP, HEPA, DTAP, HEPA
Symptoms: Pyrexia, VIIth nerve paralysis
Clinical narrative: 12/30/12 dad noticed when he woke up he couldn't use his left arm to push himself up in crib. when he would sit he would fall over. He was unable to walk and was irritable.  He was seen at a Walk in Care and dx with an ear infection and started on Amoxicillin. 12/31/12 he developed decreased use of left arm and maintained it in flexed position with fisting of the hand.  He was able to walk at this point. 1/1/13 he was seen in Walk in care again and had a negative arm xray and had a nursemaid's elbow reduction with no improvement. 1/3/13 he showed increased use of his left arm. 1/4/13 he had episodic left arm and leg tremors. No alterations in consciousness or postictal state. Also had squinting of left eye with pinpoint pupils and episodic giggling.  He was admitted to hospital and noted to have hemiparesis. Tremors resolved the next day. 1/4/13 he had a normal EEG. 1/5/13 he had a brain MRI that demonstrated a lesion in his right basal ganglia (putamen) that was associated with restricted diffusion and subtle enhasement, he was dx with a subacute infarct. 1/6/13 had a normal MRA. Hematology was consulted. He was placed on Aspirin. He was seen at hospital on 4/5/13 by Dr.
Age: 51.0
Sex: F
Vaccine: PNC13, TDAP
Symptoms: Cellulitis, Erythema, Oedema peripheral, Pain in extremity, Skin warm
Clinical narrative: L arm swelling, pain, redness, and warmth.  Symptoms worsen and patient went to ER on 4/9/2013.  Patient was diagnosed with cellulitis and started on 10-day course of Clindamycin.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Hypoaesthesia, Immediate post-injection reaction, Muscle twitching, Neurological symptom, Paraesthesia
Clinical narrative: Immediately after the vaccine was administered, The muscle in my forearm began to twitch and the ring finger and last finger began tingling and neurological reaction.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Decreased appetite, Fatigue, Sleep disorder
Clinical narrative: Swelling after 1 day led to extremely pain (no rash) for 7 days. Also fatigued loss of appetite, thought of suicide, disrupted sleep.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Injection site abscess, Injection site cellulitis, Oedema peripheral
Clinical narrative: On 4-12-13 pt. went to Ugent Care diagnosed with cellulitis, abscess at inj. site and her arm is swollen past elbow will follow up with her MD. Also pt. reported numbness in fingers.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling
Clinical narrative: This spontaneous report was received from a registered pharmacist concerning an approximately 54 year old female patient with penicillin allergy and DURICEF allergy. On 02-APR-2013, the patient vaccinated with a dose of ZOSTAVAX (lot number and expiry date reported as H019999 and 02-FEB-2014 respectively, dose and route unspecified). No concomitant medications were reported. Approximately on an unknown date in April 2013, the patient experienced swelling around injection site. The patient sought medical attention (spoke to pharmacist). The patient was treated with BENADRYL. The outcome of swelling around injection site was unknown. The relatedness for swelling around injection site was unknown for ZOSTAVAX. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a patient of unknown age. Nurse practitioner called regarding a delay in the patient receiving the second dose of GARDASIL. The patient received the first dose of GARDASIL (0.5ml, intramuscular, lot#, unspecified) on an unspecified date in 2008. The second dose(lot#, dose, route were unspecified) was just administered today, 09-APR-2013. The outcome was unknown. Additional information is not expected.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Injection site erythema, Injection site swelling, Oedema peripheral
Clinical narrative: Light fever, chills, headache, red, raised injection site swelling and general swelling of entire arm (predominantly upper arm down to elbow. Adverse effect lasted 2 weeks.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Light fever, chills, headache, red, raised injection site swelling and general swelling of entire arm (predominantly upper arm down to elbow. Adverse effect lasted 2 weeks.
Age: 22.0
Sex: M
Vaccine: TTOX
Symptoms: Chills, Dizziness, Feeling hot, Hyperhidrosis, Immediate post-injection reaction
Clinical narrative: Immediately, post tetanus immunization, donor report seeing "stars." Within less than 1 min, donor complained of nausea, thirst, and lightheadedness. Donor also presented with sweating, pallor, and warmth/chills. No emesis, LOC or respiratory problems at any point. Donor sat bent forward in chair and given 8 oz water per donor's request. Donor moved from original seated position to side-lying position on exam table and given wrapped ice packs on chest and back of neck. VS taken at 11:21 (57BPM, 95/47), 11:29 (58BPM, 108/60), 11:39 (57BPM, 124/69). Donor was 100% recovered by 11:45. Donor ate cookies and fluids at this time w/o complaint/nausea and ambulated w/o dizziness. Donor states feels "100%" prior to departure.