chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 25.0
Sex: F
Vaccine: PPV, PPV, PPV
Symptoms: Culture wound, Injection site pain, Injection site swelling, Nuclear magnetic resonance imaging, Pyrexia
Clinical narrative: The patient (pt) had pain, redness and swelling over injection site. Pt developed fever over the following 24 hrs. She was admitted to the hospital for cellulitis. She was place on IV antibiotics. The pain and swelling increased with persistent fever. She had a surgical consult due to a MRI of her arm showing a fluid collection in the muscle with substantial edema. The patient had an incision and drainage in the operating room which showed purulent fluid (suspicious for infection)without abscess. There was no sign of necrotizing fasciitis or necrosis of the muscle. Pt is recovering in the hospital on IV antibiotics.
Age: 25.0
Sex: F
Vaccine: PPV, PPV, PPV
Symptoms: Surgery, Ultrasound scan
Clinical narrative: The patient (pt) had pain, redness and swelling over injection site. Pt developed fever over the following 24 hrs. She was admitted to the hospital for cellulitis. She was place on IV antibiotics. The pain and swelling increased with persistent fever. She had a surgical consult due to a MRI of her arm showing a fluid collection in the muscle with substantial edema. The patient had an incision and drainage in the operating room which showed purulent fluid (suspicious for infection)without abscess. There was no sign of necrotizing fasciitis or necrosis of the muscle. Pt is recovering in the hospital on IV antibiotics.
Age: 19.0
Sex: F
Vaccine: HIBV, PPV
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient states unable to move arm after injection, c/o severe pain left deltoid since day before, area tender to touch, hurts to move arm, states pain radiates to left scapular area. Reddess, warmth and swelling at injection site.
Age: 19.0
Sex: F
Vaccine: HIBV, PPV
Symptoms: Musculoskeletal pain, Nuclear magnetic resonance imaging, Pain, Ultrasound scan
Clinical narrative: Patient states unable to move arm after injection, c/o severe pain left deltoid since day before, area tender to touch, hurts to move arm, states pain radiates to left scapular area. Reddess, warmth and swelling at injection site.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Muscular weakness, Nerve injury, Pyrexia
Clinical narrative: Fever accompanied by leg and arm weakness.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Chest pain, Depressed mood, Ear pain, Fatigue, Oropharyngeal pain
Clinical narrative: c/o mid-day fever, yellow exudate out of sinus', sore throat, ears hurt "By Saturday night, c/o 'it was into my chest', and I was down."
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Pharyngitis, Pyrexia, Tonsillitis
Clinical narrative: c/o mid-day fever, yellow exudate out of sinus', sore throat, ears hurt "By Saturday night, c/o 'it was into my chest', and I was down."
Age: 63.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Arthralgia, Headache, Myalgia
Clinical narrative: Headache, joint pain, muscle aches. None responded to aspirin or Aleve. Persists today.
Age: 1.59
Sex: F
Vaccine: MMR
Symptoms: Abnormal behaviour, Crying, Discomfort, Gait disturbance, Hypotonia
Clinical narrative: Extra whiny, walking less than usual, slight limp, crying when falling (more than usual, actual pain cry).  As of this morning, it has significantly worsened, she will not walk, stand, and is just limp.  If picked up she will slump over the shoulder and not want to move.  In obvious discomfort/pain, fever is evident.  Overall not her normal joyous self.
Age: 1.59
Sex: F
Vaccine: MMR
Symptoms: Irritability, Pain, Pyrexia
Clinical narrative: Extra whiny, walking less than usual, slight limp, crying when falling (more than usual, actual pain cry).  As of this morning, it has significantly worsened, she will not walk, stand, and is just limp.  If picked up she will slump over the shoulder and not want to move.  In obvious discomfort/pain, fever is evident.  Overall not her normal joyous self.
Age: 21.0
Sex: F
Vaccine: FLUX
Symptoms: Chills, Erythema, Headache, Induration, Nausea
Clinical narrative: Headache, chills/shakiness, nausea, vomiting, itchiness all over, very red sore and hard lump on arm.
Age: 21.0
Sex: F
Vaccine: FLUX
Symptoms: Pain in extremity, Pruritus generalised, Tremor, Upper extremity mass, Vomiting
Clinical narrative: Headache, chills/shakiness, nausea, vomiting, itchiness all over, very red sore and hard lump on arm.
Age: 5.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Pyrexia, Rash erythematous, Rash generalised, Rash macular
Clinical narrative: Full body rash - small bumps the size of goosebumps, red. 12/2/12. Fever reaching 103.0 F December 4-6, 2012. Second Full body rash, this time blotchy red bumps 12/8/12.
Age: 10.0
Sex: M
Vaccine: FLUN3
Symptoms: Dyskinesia, VIIth nerve paralysis
Clinical narrative: On 10/2/12 patient received a live flu vaccine (Flumist). On 10/10/12 he presented for care due to abnormal facial movements.  He was diagnosed with Bells Palsy on the R side and treated appropriately.  He was again seen on 10/25/12 with some resolution.
Age: 1.26
Sex: M
Vaccine: DTAP, MMR, PNC
Symptoms: Autism, Pyrexia, Speech disorder developmental
Clinical narrative: Family says that child developed a high fever (104) after the vaccines.  Family stated that child was speaking prior to vaccines and not speaking after vaccines.
Age: 0.39
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Rash generalised
Clinical narrative: Parent called on 12/4/12 to report child had rash on face and other parts of her body (left message for nurse).  No further information received.  Three attempts to contact parent for further information/follow-up were unsuccessful.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Hives over entire body treated with Benadryl for 2 days then Zyrtec.
Age: 0.42
Sex: F
Vaccine: RV5
Symptoms: Rash
Clinical narrative: Rash noted on chest and neck.
Age: 6.0
Sex: M
Vaccine: FLUN3
Symptoms: Tic
Clinical narrative: Eye & face tics less than 24 hours after the Flumist. Now you have a record of an event. I have been told that there is no record of this happening even though I can find it all over the internet by other concerned parents.
Age: 16.0
Sex: M
Vaccine: HPV4
Symptoms: Chills, Laboratory test normal, Myalgia, Pyrexia
Clinical narrative: My son received the HPV vaccination and a little while after he started getting a fever, chills, muscle aches.
Age: 23.0
Sex: M
Vaccine: SMALL
Symptoms: Blood test, Infection, Knee operation, Skin lesion
Clinical narrative: Lesions on stomach and knee area that are infected. He is concerned about the infection spreading from his smallpox vaccination.
Age: 64.0
Sex: F
Vaccine: TDAP
Symptoms: Arthritis, Body temperature increased, Chills, Condition aggravated, Injection site induration
Clinical narrative: Severe chills x 4 days. Temp for 2 1/2 days ranging from 99.1 to 102.0. Hot/hard lump on arm where recieved shot that was "size of a baseball. Flared up her arthritis.
Age: 64.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site mass, Injection site warmth
Clinical narrative: Severe chills x 4 days. Temp for 2 1/2 days ranging from 99.1 to 102.0. Hot/hard lump on arm where recieved shot that was "size of a baseball. Flared up her arthritis.
Age: 69.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Hypoaesthesia, Injection site anaesthesia, Muscle contractions involuntary, Muscle twitching
Clinical narrative: Muscle twitching and numb feelings in left arm (site of vaccine); eventually in left thumb. Has had intermittent fasciculations in arms, legs since then. Usually not while active.
Age: 18.0
Sex: M
Vaccine: FLU3
Symptoms: Anxiety, Asthenia, Chest pain, Dizziness, Dyspnoea
Clinical narrative: Difficulty breathing, severe chest pain, fast severe chest pain, increasing and fast heart beat, shortness of breath, weakening of entire body, feel of fainting, shaking, trembling, severely high fever, skin tone changes to red/violet or veins showing through skin, nausea, vomiting, feeling heart will stop or explode.
Age: 18.0
Sex: M
Vaccine: FLU3
Symptoms: Feeling abnormal, Heart rate increased, Nausea, Palpitations, Panic attack
Clinical narrative: Difficulty breathing, severe chest pain, fast severe chest pain, increasing and fast heart beat, shortness of breath, weakening of entire body, feel of fainting, shaking, trembling, severely high fever, skin tone changes to red/violet or veins showing through skin, nausea, vomiting, feeling heart will stop or explode.
Age: 18.0
Sex: M
Vaccine: FLU3
Symptoms: Pyrexia, Tremor, Vomiting
Clinical narrative: Difficulty breathing, severe chest pain, fast severe chest pain, increasing and fast heart beat, shortness of breath, weakening of entire body, feel of fainting, shaking, trembling, severely high fever, skin tone changes to red/violet or veins showing through skin, nausea, vomiting, feeling heart will stop or explode.
Age: 21.0
Sex: M
Vaccine: MNQ
Symptoms: Balance disorder, Dyspnoea, Fall, Guillain-Barre syndrome, Muscle twitching
Clinical narrative: Tingling and pins and needles effect in lower extremities.  Spread to hands and fingers.  Neuropathy was accompanied by paresthesia.  Nerve Twitches, complications breathing, falling when walking or getting up from sitting or laying down.
Age: 21.0
Sex: M
Vaccine: MNQ
Symptoms: Nerve conduction studies abnormal, Neuropathy peripheral, Nuclear magnetic resonance imaging, Paraesthesia
Clinical narrative: Tingling and pins and needles effect in lower extremities.  Spread to hands and fingers.  Neuropathy was accompanied by paresthesia.  Nerve Twitches, complications breathing, falling when walking or getting up from sitting or laying down.
Age: 44.0
Sex: F
Vaccine: FLUX
Symptoms: Blood test, Cardiac function test, Computerised tomogram head, Feeling jittery, Hypoaesthesia
Clinical narrative: Numbness, legs and arms feeling heavy, trouble seaking, jittery, mobility issues.
Age: 44.0
Sex: F
Vaccine: FLUX
Symptoms: Mobility decreased, Nuclear magnetic resonance imaging, Sensation of heaviness, Speech disorder
Clinical narrative: Numbness, legs and arms feeling heavy, trouble seaking, jittery, mobility issues.
Age: 0.35
Sex: F
Vaccine: RVX
Symptoms: Bowel movement irregularity, Diarrhoea
Clinical narrative: Patient has had a massive change in bowel frequency since her vaccine. She used to have at least 2-3 poopy diapers a day and since the vaccine she only has one explosive diarrhea a day or every other day.
Age: 17.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Dysarthria, Fatigue, Flank pain, Headache, Hypoaesthesia
Clinical narrative: Pain in side and pelvic area at around 5:00 p.m.   Eventually she got a bad headache and was very fatigued.  By 10 p.m. that night she had numbness in her hands and feet.  The next day at school she fell asleep and now 29 hours after the shot she is so tired she is slurring her words and still has numbness.
Age: 17.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Pelvic pain, Somnolence
Clinical narrative: Pain in side and pelvic area at around 5:00 p.m.   Eventually she got a bad headache and was very fatigued.  By 10 p.m. that night she had numbness in her hands and feet.  The next day at school she fell asleep and now 29 hours after the shot she is so tired she is slurring her words and still has numbness.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Hip arthroplasty, Incorrect route of drug administration
Clinical narrative: This spontaneous report as received from a doctor of pharmacy refers to a male patient of unknown age. The patient was vaccinated intramuscularly (IM) with a 0.65 ml dose of ZOSTAVAX (lot # and expiration not reported) on an unspecified date. No other co-suspects were reported. No concomitant medications were reported. The pharmacist reported that her husband was given ZOSTAVAX administered IM instead of subcutaneously (SC). After an unspecified amount of time (date unspecified) he needed hip replacement surgery and later developed shingles. No treatment information was reported. The patient sought unspecified medical attention. The outcome of hip replacement surgery and shingles was unknown. The relatedness for hip replacement surgery and shingles was not provided for ZOSTAVAX. Upon internal review hip replacement surgery was considered to be medically significant. Additional information has been requested.
Age: 79.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Injection site erythema
Clinical narrative: Rt upper arm increased redness at site area marked, Dr notified. Heat applied.
Age: 12.0
Sex: M
Vaccine: MMR, TD
Symptoms: Dizziness, Nausea, Pyrexia, Vomiting
Clinical narrative: Fever (Tmax - 101.8). Nausea & vomiting. Lightheadedness. Treated with p.o. Ibuprofen.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HEPA, HIBV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Misadministration of vaccine HAVRIX. Pt. was vaccinated with PEDIARIX and ACTHIB on 12-10-12. HAVRIX given instead of PREVNAR 13. Parents notified on 12-11-12. No adverse effects reported at this time.
Age: 73.0
Sex: M
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Patient received the high dose FLUZONE and it has been one month and patient still has pain all up & down his arm.
Age: 35.0
Sex: M
Vaccine: TDAP
Symptoms: Discomfort, Hypoaesthesia, Paraesthesia
Clinical narrative: Discomfort, tingling, numbness in a patch of skin w/ the right upper lateral thigh 2 days after ADACEL. (Lateral/femoral nerve distribution)
Age: 15.0
Sex: M
Vaccine: FLU3, HPV4
Symptoms: Headache, Pyrexia, Rash, Rash erythematous
Clinical narrative: Rash - "red bumps" down both arms and on his chest - per mom headache and mild fever.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Mobility decreased, Musculoskeletal pain, Pain, Pain in extremity
Clinical narrative: Received flu shot on 11/30/12, immediately experienced pain. 2 weeks later still in pain with limited mobility. Arm and shoulder affected.
Age: 88.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Musculoskeletal pain, Neck pain, Pain in extremity, Periarthritis
Clinical narrative: Pt complained of increasing arm pain & shoulder & neck pain to daughter. Daughter took pt to see MD, who diagnosed pt with "frozen shoulder syndrome as a result of vaccine".
Age: 88.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Pain, Pain in extremity, Periarthritis
Clinical narrative: Pt complained of increasing arm pain & shoulder & neck pain to daughter. Daughter took pt to see MD, who diagnosed pt with "frozen shoulder syndrome as a result of vaccine".
Age: 63.0
Sex: F
Vaccine: UNK
Symptoms: Injection site pain, Myalgia, Pain in extremity
Clinical narrative: Pt c/o very sore arm/muscle after the vaccine and it has continued, only hurts at the injection site.
Age: 90.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Feeling cold, Nausea, Vomiting
Clinical narrative: Within 5 minutes of getting his flu shot the patient started complaining of being cold, he started shivering, given TYLENOL and blankets. After about 30min the patient again began to shiver and c/o of being cold after having some relief, he was without fever or perspiration, did not vomit. Symptoms: NauseaVomiting & chills. Treatment: Acetaminophen 500 MG other.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling
Clinical narrative: Injection site reaction with softball size swelling and redness. Not painful and no difficulty in breathing. No other symptoms.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Induration, Infection, Mass, Skin warm
Clinical narrative: Patient described 4 inch hard, hot, lump. And symptoms of fever. She was seen by physician who stated that she must have been sensitive to something in vaccine and her arm was infected. She was given antibiotics.
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Injection site pain
Clinical narrative: This spontaneous report as received from a pharmacist refers to a male patient of unknown age. The patient did not have pertinent medical history or drug reaction/allergies. The patient was vaccinated in an arm with 0.65 ml ZOSTAVAX (lot number not provided) subcutaneously on 15-OCT-2012. No other co-suspects were reported. The patient received AFLURIA in the opposite arm during the same visit that he received ZOSTAVAX. Subsequently the patient had injection site pain at the site where he received ZOSTAVAX (there was no rash, just pain at the injection site). The patient contacted pharmacist for seeking medical attention. No treatment was given for adverse event. No lab diagnostics studies were performed. The outcome of adverse event was reported as not recovered. Additional information is not expected.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Feeling hot, Immediate post-injection reaction, Swelling
Clinical narrative: Redness, warmth, swelling immediately after injection on 11-30 seen by PCP 12.3 given ROCEPHIN injection along with oral AUGMENTIN.
Age: 25.0
Sex: F
Vaccine: FLU3, HEP, HEPA
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site reaction, Paraesthesia
Clinical narrative: Patient called 5 days after given Hep B & A vaccines. Patient reported red welt below Hep B injection site on left arm. Pt also reported some itching, pain at injection site and tingling sensation in left hand.
Age: 25.0
Sex: F
Vaccine: FLU3, HEP, HEPA
Symptoms: Urticaria
Clinical narrative: Patient called 5 days after given Hep B & A vaccines. Patient reported red welt below Hep B injection site on left arm. Pt also reported some itching, pain at injection site and tingling sensation in left hand.
Age: 4.0
Sex: M
Vaccine: DTAP, FLU3, MMR, TYP, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Oedema peripheral, Pain, Pyrexia
Clinical narrative: 2 days after injections (L) thigh increased erythema & swelling without fevers. Pt with pain but ambulates with ease (L) thigh 60 % erythema & edematous warm & TTP nonfluctuant.
Age: 4.0
Sex: M
Vaccine: DTAP, FLU3, MMR, TYP, VARCEL
Symptoms: Tenderness
Clinical narrative: 2 days after injections (L) thigh increased erythema & swelling without fevers. Pt with pain but ambulates with ease (L) thigh 60 % erythema & edematous warm & TTP nonfluctuant.
Age: 66.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Influenza like illness, Injection site pain, Injection site rash, Injection site swelling, Pyrexia
Clinical narrative: 48 hrs after vaccine admin - reaction at (LD) admin. site swollen rash & painful 2" x 3" - fevers up to 102- (+) flu like symptoms-pt believes worst is over now (12/11) but is not 100% well yet - using ibuprofen.
Age: 15.0
Sex: F
Vaccine: MNQ
Symptoms: Vomiting
Clinical narrative: Vomiting, can not keep anything down, "mom said vomiting up bile".
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Redness and raised approximately 3 inch in diameter around injection site slightly itchy, painful if lays on it. Does not feel feverish. Patient called for follow up w/MD.
Age: 34.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Pyrexia, Rash
Clinical narrative: The evening of the same day the pt received the shot she noticed a rash. The next day the rash was worse and she had a fever, the following day she went in for treatment, MD suspected cellulitis.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Mobility decreased, Nausea, Neck pain, X-ray
Clinical narrative: Pt complained of pain up neck, in excruciating pain, nausea, couldn't move arm - went to ER and got x-rays taken, pain meds & a sling .
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site inflammation, Rash generalised
Clinical narrative: Pt. came in with a rash all over his body. The injection site was red and big. Very flared up. No temperature or swelling. The rash started about 6 days after injection.
Sex: F
Vaccine: HPV4
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant (C.M.A.) refers to a female patient of unknown age. On 03-DEC-2012, the patient was vaccinated intramuscularly with her third dose of 0.5 ml GARDASIL (lot # 666598/0786Z) that had expired on 18-OCT-2012. No adverse effects were reported. It was unspecified whether the patient sought for medical attention. The outcome was unknown. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a multiple number of unspecified patients of unknown age and gender, who might have received a dose on an unknown date of GARDASIL (dose and lot # not reported), that was possibly exposed to 31 F for an unknown period of time. The medical assistant reported that she has 2 thermometers in her refrigerator where GARDASIL was stored. She mentioned that her mercury thermometer was reading 3 C and her digital thermometer was reading 31 F. The medical assistant did not know which thermometer reading was accurate. No other co-suspects were reported. No concomitant medications were reported. No adverse symptoms reported. No treatment information was reported. Additional information has been requested.
Sex: U
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 patient of unknown gender and age. The patient was vaccinated with dose first GARDASIL 0.5 ml, intramuscularly on 22-SEP-2009. No other co-suspects were reported. No concomitant medications were reported. On 30-NOV-2012 the patient was in the office to receive the second dose of GARDASIL. No adverse effects were reported. No treatment information was reported. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant who administers vaccines, refers to two patients of unknown age and gender. Information regarding medical history was not provided. on 05-DEC-2012 the two patients were vaccinated with dose 2 of expired GARDASIL intramuscularly. Lot number was reported as 0766Z with expiry date of 15-OCT-2012. No adverse events were reported. The date the first dose was administered was unknown for each patient. No other co-suspects were reported. No concomitant medications were reported. No outcome was reported. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Hypoaesthesia, Muscular weakness
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 19 years old female patient. The patient was vaccinated IM with the first dose of 0.5 GARDASIL on 24-OCT-2012 (lot # and exp date unknown). On 26-NOV-2012, the patient was vaccinated with the second dose of 0.5 ml GARDASIL (lot # H015863, expiration date 24-FEB-2020). No other co-suspects were reported. No concomitant medications were reported. After her second dose, on 26 NOV-2012, the patient came back to urgent care unit after several hours with complaints of numbness in her left arm, hand and left foot and muscle weakness. No treatment information was reported. Neurological assessment was performed on an unknown date (results not provided). The patient seem medical attention via office visit. The outcome of numbness in her left arm, hand and left foot and muscle weakness were unknown at the time of the report. The relatedness for muscle weakness and numbness in her left arm, hand and left foot was unknown for GARDASIL. No additional information was provided. Additional information has been requested.
Age: 3.0
Sex: M
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age, Medication error
Clinical narrative: This spontaneous report as received from a consumer refers to her 3 years old male grandson. The patient was vaccinated in error with a dose of GARDASIL (Lot # not reported) on an unspecified date. Any adverse effects were reported. Additional information has been requested.
Age: 1.5
Sex: M
Vaccine: MMRV, VARCEL
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Initial information has been received from a medical assistant refers to a 18 months old male patient (pertinent medical history or drug reactions / allergies were not reported). On 04-DEC-2012, the patient was inadvertently vaccinated subcutaneously with a 0.5 ml dose of VARIVAX (Merck) (lot number was not reported). Other suspect vaccine included a 0.5 ml dose PROQUAD (Merck) (lot number was not reported), subcutaneously (04-DEC-2012). No concomitant medications were reported. No adverse effects were reported. No treatment information was reported. The patient's outcome was unknown. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Pyrexia
Clinical narrative: Father reported today (12-10-12) that his son had fever of 104 degrees on Thursday night (12-6-12). Fever resolved without treatment and temperature was normal on 12-8-12.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender who on 06-DEC-2012, was vaccinated with an expired dose of PNEUMOVAX 23 (dose and route not reported) (lot # 667274/083Z, Exp: 12-DEC-2011). No symptoms reported. Additional information is not expected.
Sex: U
Vaccine: RV5
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age. On 03-NOV-202, the patient was vaccinated with an expired dose of ROTATEQ (lot # 670000/0885AA, expiration date 21-NOV-2012) (dose, route not reported). Nurse reported that another nurse in the office administered an expired dose of ROTATEQ to a patient. No other co-suspects were reported. No concomitant medications were reported. No symptoms reported. Additional information has been requested.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 76 years old female patient, with none drug reactions/allergies, who was vaccinated with 0.65 ml ZOSTAVAX (lot# not reported) SQ, on 18-MAY-2012. No other concomitant medications. Pharmacist reported that a patient stated "ZOSTAVAX didn't work" and recently in the past month, in approximately November 2012, on an unspecified date, patient developed shingles. As a treatment VALTREX was given. The outcome of patient was reported as recovering/resolving. The relatedness for ZOSTAVAX didn't work and shingles were not reported for ZOSTAVAX by reporting pharmacist. Additional information is not expected.
Age: 29.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a registered pharmacist via company representative refers to a 29 years old female patient. Current conditions included Crohn's disease and bronchospasms. On an unspecified date, the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiry date and dose were unspecified) subcutaneously. Other suspect therapies included PNEUMOVAX 23 (lot number, expiry date, route and dose were unspecified0. Concomitant medications included: INTRACORT. On an unknown date, the patient did not eat for several days while on ZOSTAVAX and experienced shingles. It was unspecified if the patient sought medical attention. Treatment information was unspecified. It was unspecified if lab studies were performed. The outcome of all the reported events was unknown. Additional information has been requested.
Age: 65.0
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 65 years old patient (gender unknown). The patient was vaccinated with a dose of ZOSTAVAX on approximately  27-NOV-2012 ("about 2 days ago") (lot #, route and dose not reported). No other co-suspects were reported. No concomitant medications were reported. In November 2012, the patient developed 'heat and redness' at the injection site after receiving a dose of ZOSTAVAX. It was unknown if the patient had sought medical attention. No treatment information was reported. The outcome of heat and redness at the injection site is unknown. The relatedness for patient's 'heat and redness' at the injection site was unknown for ZOSTAVAX. Additional information is not expected.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 69 years old female patient. The patient was vaccinated with ZOSTAVAX on 24-OCT-2012 (dose/frequency, route, lot #/Exp. Date were unspecified by reported). No other co-suspects were reported. No concomitant medications were reported. After day or two later post vaccination, approximately on 25-OCT-2012, the patient got shingles. No treatment information was reported. The patient seeks medical attention. The outcome of shingles was unknown. The relatedness for shingles was unknown for ZOSTAVAX. Additional information has been requested.
Age: 44.0
Sex: U
Vaccine: PPV
Symptoms: Pneumonia
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 44 (now was 54 year old as reported) years old patient. The patient started therapy with an unspecified pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) on an unspecified date 10 years ago and later developed pneumonia (date also unspecified). No concomitant medications were reported. It did not report the patient if sought medical attention. No treatment information was reported. The outcome of pneumonia was unknown. Follow-up information received reported that the 44 years old (at the time she received the vaccinated) did not know the manufacturer or trade name of the pneumococcal vaccine, polyvalent (23-valent) she received. Additional information is not expected.
Sex: U
Vaccine: VARZOS
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. The patient was vaccinated with a dose of ZOSTAVAX (route, dose, lot # and exp date not reported) on an unknown date. No other co-suspects were reported. No concomitant medications were reported. On an unknown date the physician noted that a patient may have been administered a dose of ZOSTAVAX that was stored improperly. The physician noted that no specific storage condition for the ZOSTAVAX were available. No adverse effect was reported. No patient specific information is available so most appropriate fields in the adverse experience screen were NA. No further information is available. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: The primary reporter is RN. The nurse is reporting the patient, who was intended to receive ZOSTAVAX, was inadvertently administered VARIVAX on 11/26/2012. The patient was then administered a single subcutaneous dose of ZOSTAVAX on 12/03/2012. No adverse effects reported. No further information provided.
Sex: M
Vaccine: VARZOS
Symptoms: Rash, Rash macular
Clinical narrative: This spontaneous report as received from a physician refers to a male patient of unknown age. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (dose, route, lot number not reported). No other co-suspects were reported. No concomitant medications were reported. On an unknown date, after administering ZOSTAVAX, the patient developed a rash and several spots on different areas of the body the patient complained about. No treatment information was reported. At the time of the report the patient's outcome was unknown. The patient sought medical attention, came back for a doctor visit. The relatedness for adverse events was not reported for ZOSTAVAX. Additional information is not expected.
Age: 40.0
Sex: U
Vaccine: VARZOS
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient in her "forties" with allergic. The patient was vaccinated with ZOSTAVAX on DEC-2011. No adverse effect reported. No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient experienced 40s received ZOSTAVAX. No treatment information was reported. The outcome of 40s received ZOSTAVAX is unknown. The pharmacist also stated that the patient told her that she "couldn't tolerate VALTREX", and was "very allergic to it". No other information is available at this time. Additional information is expected.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 76 years old male patient with vaccination. This is the second of two reports from this reporter; see SR # 1-5796715254 for the first report. The pharmacist reported that a patient developed an injection site reaction following vaccination with 1 DF ZOSTAVAX on 28-NOV-2012. On 30-NOV-2012 the patient experienced injection site reaction which was described as a small red area (exact size unspecified, but described as a small spot) 3 days after onset of therapy. No other co-suspects were reported. No concomitant medications were reported. No treatment information was reported. The outcome of injection site reaction was described as a small red area was reported as not recovered/not resolved. The relatedness for injection site reaction was described as a small red area is unknown for ZOSTAVAX. No other information to report.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash generalised
Clinical narrative: This spontaneous report as received from a 71 years old male consumer reporting on himself, with no drug reactions or allergies and no pertinent medical history. The patient was vaccinated with a dose of ZOSTAVAX (dose, route, lot number not reported) on 05-NOV-2012. No other co-suspects were reported. Concomitant medications included desonide (reported as "defonide"), triamcinolone acetonide and generic ZOCOR. On 29-NOV-2012, the patient had a rash all over his body. He noticed it a few weeks after receiving the vaccine. No treatment information was reported. No laboratory tests were performed. At the time of the report the patient's outcome was unknown. The relatedness for adverse event was not reported for ZOSTAVAX. The patient sought unspecified medical attention. Additional information is not expected.
Age: 10.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Dehydration, Dizziness, Hypophagia, Immediate post-injection reaction, Palpitations
Clinical narrative: Pharmacist led my daughter to a chair while I was filling out paperwork. Within a minute she called for me and said patient wasn't feeling good. I ran towards my daughter and she was barely able to speak, her breathing was heavy, her eyes were closed and when she tried to see her eyes were crossing and then rolling back in her head. She could barely speak, she said her heart hurt, she was crying and within 2 minutes began vomiting. Her complexion wash pale/flushed. She could not stand up. She was in excruciating pain! Paramedics arrived, her blood pressure was very low. Other vitals seemed to be stabilized. They said it was a possibility she had not drank enough water or had eaten dinner. They eventually laid her down so that the room could stop spinning. She eventually came to.
Age: 10.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Vomiting
Clinical narrative: Pharmacist led my daughter to a chair while I was filling out paperwork. Within a minute she called for me and said patient wasn't feeling good. I ran towards my daughter and she was barely able to speak, her breathing was heavy, her eyes were closed and when she tried to see her eyes were crossing and then rolling back in her head. She could barely speak, she said her heart hurt, she was crying and within 2 minutes began vomiting. Her complexion wash pale/flushed. She could not stand up. She was in excruciating pain! Paramedics arrived, her blood pressure was very low. Other vitals seemed to be stabilized. They said it was a possibility she had not drank enough water or had eaten dinner. They eventually laid her down so that the room could stop spinning. She eventually came to.
Age: 10.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Angina pectoris, Crying, Dyspnoea, Dysstasia, Eye movement disorder
Clinical narrative: Pharmacist led my daughter to a chair while I was filling out paperwork. Within a minute she called for me and said patient wasn't feeling good. I ran towards my daughter and she was barely able to speak, her breathing was heavy, her eyes were closed and when she tried to see her eyes were crossing and then rolling back in her head. She could barely speak, she said her heart hurt, she was crying and within 2 minutes began vomiting. Her complexion wash pale/flushed. She could not stand up. She was in excruciating pain! Paramedics arrived, her blood pressure was very low. Other vitals seemed to be stabilized. They said it was a possibility she had not drank enough water or had eaten dinner. They eventually laid her down so that the room could stop spinning. She eventually came to.
Age: 10.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Feeling abnormal, Flushing, Gaze palsy, Hypotension, Pain
Clinical narrative: Pharmacist led my daughter to a chair while I was filling out paperwork. Within a minute she called for me and said patient wasn't feeling good. I ran towards my daughter and she was barely able to speak, her breathing was heavy, her eyes were closed and when she tried to see her eyes were crossing and then rolling back in her head. She could barely speak, she said her heart hurt, she was crying and within 2 minutes began vomiting. Her complexion wash pale/flushed. She could not stand up. She was in excruciating pain! Paramedics arrived, her blood pressure was very low. Other vitals seemed to be stabilized. They said it was a possibility she had not drank enough water or had eaten dinner. They eventually laid her down so that the room could stop spinning. She eventually came to.
Age: 10.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Pallor, Speech disorder, Vertigo, Vomiting
Clinical narrative: Pharmacist led my daughter to a chair while I was filling out paperwork. Within a minute she called for me and said patient wasn't feeling good. I ran towards my daughter and she was barely able to speak, her breathing was heavy, her eyes were closed and when she tried to see her eyes were crossing and then rolling back in her head. She could barely speak, she said her heart hurt, she was crying and within 2 minutes began vomiting. Her complexion wash pale/flushed. She could not stand up. She was in excruciating pain! Paramedics arrived, her blood pressure was very low. Other vitals seemed to be stabilized. They said it was a possibility she had not drank enough water or had eaten dinner. They eventually laid her down so that the room could stop spinning. She eventually came to.
Age: 2.0
Sex: M
Vaccine: DTAP, HIBV, MMR, PNC13, DTAP, HIBV, MMR, PNC13
Symptoms: Abnormal behaviour, Aggression, Balance disorder, Coordination abnormal, Crying
Clinical narrative: Patient was warm to the touch and when set down on the floor his walk was very unstable, he walked into furniture, he fell several times for no apparent reason. When he was picked back up to prevent him from being hurt, twice for brief periods he stared off and I and his mother could not get his attention during these episodes. He became less unstable in an hour or two, but he became very irritable and hyperactive. It was difficult to get him to sleep for the next 4 days and several times he started to cry unconsolably for almost an hour. His walk is now more of a shuffle and not the high energy athelete style he exhibited before the shots. He also exhibited aggressive behavior that he has never shown before. Dr was informed of the adverse reaction(s) but has stated that none of them are associated with the 4 shots he was given. We obtained the manafacturer's inserts and find that is not correct.
Age: 2.0
Sex: M
Vaccine: DTAP, HIBV, MMR, PNC13, DTAP, HIBV, MMR, PNC13
Symptoms: Dizziness, Gait disturbance, Irritability, Middle insomnia, Psychomotor skills impaired
Clinical narrative: Patient was warm to the touch and when set down on the floor his walk was very unstable, he walked into furniture, he fell several times for no apparent reason. When he was picked back up to prevent him from being hurt, twice for brief periods he stared off and I and his mother could not get his attention during these episodes. He became less unstable in an hour or two, but he became very irritable and hyperactive. It was difficult to get him to sleep for the next 4 days and several times he started to cry unconsolably for almost an hour. His walk is now more of a shuffle and not the high energy athelete style he exhibited before the shots. He also exhibited aggressive behavior that he has never shown before. Dr was informed of the adverse reaction(s) but has stated that none of them are associated with the 4 shots he was given. We obtained the manafacturer's inserts and find that is not correct.
Age: 2.0
Sex: M
Vaccine: DTAP, HIBV, MMR, PNC13, DTAP, HIBV, MMR, PNC13
Symptoms: Sleep disorder, Staring, Unresponsive to stimuli
Clinical narrative: Patient was warm to the touch and when set down on the floor his walk was very unstable, he walked into furniture, he fell several times for no apparent reason. When he was picked back up to prevent him from being hurt, twice for brief periods he stared off and I and his mother could not get his attention during these episodes. He became less unstable in an hour or two, but he became very irritable and hyperactive. It was difficult to get him to sleep for the next 4 days and several times he started to cry unconsolably for almost an hour. His walk is now more of a shuffle and not the high energy athelete style he exhibited before the shots. He also exhibited aggressive behavior that he has never shown before. Dr was informed of the adverse reaction(s) but has stated that none of them are associated with the 4 shots he was given. We obtained the manafacturer's inserts and find that is not correct.
Age: 2.0
Sex: M
Vaccine: DTAP, HIBV, MMR, PNC13, DTAP, HIBV, MMR, PNC13
Symptoms: Aggression, Crying, Fall, Gait disturbance, Insomnia
Clinical narrative: Patient was warm to the touch and when set down on the floor his walk was very unstable, he walked into furniture, he fell several times for no apparent reason. When he was picked back up to prevent him from being hurt, twice for brief periods he stared off and I and his mother could not get his attention during these episodes. He became less unstable in an hour or two, but he became very irritable and hyperactive. It was difficult to get him to sleep for the next 4 days and several times he started to cry unconsolably for almost an hour. His walk is now more of a shuffle and not the high energy athelete style he exhibited before the shots. He also exhibited aggressive behavior that he has never shown before. Dr was informed of the adverse reaction(s) but has stated that none of them are associated with the 4 shots he was given. We obtained the manafacturer's inserts and find that is not correct.
Age: 2.0
Sex: M
Vaccine: DTAP, HIBV, MMR, PNC13, DTAP, HIBV, MMR, PNC13
Symptoms: Irritability, Psychomotor hyperactivity, Skin warm, Staring, Unresponsive to stimuli
Clinical narrative: Patient was warm to the touch and when set down on the floor his walk was very unstable, he walked into furniture, he fell several times for no apparent reason. When he was picked back up to prevent him from being hurt, twice for brief periods he stared off and I and his mother could not get his attention during these episodes. He became less unstable in an hour or two, but he became very irritable and hyperactive. It was difficult to get him to sleep for the next 4 days and several times he started to cry unconsolably for almost an hour. His walk is now more of a shuffle and not the high energy athelete style he exhibited before the shots. He also exhibited aggressive behavior that he has never shown before. Dr was informed of the adverse reaction(s) but has stated that none of them are associated with the 4 shots he was given. We obtained the manafacturer's inserts and find that is not correct.
Age: 31.0
Sex: F
Vaccine: HEP
Symptoms: Aphagia, Disorientation, Fatigue, Gingival pain, Pain in jaw
Clinical narrative: Extreme tiredness and disorientation. Went to sleep early and slept for 15 hours. On the night of 11/14/2012 I woke up at 2:00 AM in extreme pain in my jaw and gums and teeth. It hurt to eat, drink or talk. I made an emergency appt with a dentist who sent me to another specialist to get a root canal. The specialist said that I didn't show any need for a root canal. He gave me a prescription for Aspirin and sent me away. The pain did not respond to the Aspirin. I was unable to eat for 3 days. I saw my doctor on 11/17/2012 who noticed that I had the HEP B vaccine the day before the symptoms appeared. My doctor prescribed pain medications and recommended that I report my adverse experience.
Age: 31.0
Sex: F
Vaccine: HEP
Symptoms: Toothache
Clinical narrative: Extreme tiredness and disorientation. Went to sleep early and slept for 15 hours. On the night of 11/14/2012 I woke up at 2:00 AM in extreme pain in my jaw and gums and teeth. It hurt to eat, drink or talk. I made an emergency appt with a dentist who sent me to another specialist to get a root canal. The specialist said that I didn't show any need for a root canal. He gave me a prescription for Aspirin and sent me away. The pain did not respond to the Aspirin. I was unable to eat for 3 days. I saw my doctor on 11/17/2012 who noticed that I had the HEP B vaccine the day before the symptoms appeared. My doctor prescribed pain medications and recommended that I report my adverse experience.
Age: 0.27
Sex: M
Vaccine: DTAP, RVX
Symptoms: Faeces discoloured
Clinical narrative: Poop became dark green, stringy, and came in very little amounts.
Age: 41.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Dizziness, Fatigue, Headache, Nausea
Clinical narrative: Dizzy, chills, headache, fatigue....for the first 2 days then nausea and lightheadedness for added for next three.
Age: 47.0
Sex: M
Vaccine: FLU3
Symptoms: Guillain-Barre syndrome
Clinical narrative: Patient states he got Guillain Barre syndrome after receiving the vaccine and was hospitalized for 10 days.
Age: 53.0
Sex: F
Vaccine: TYP
Symptoms: Pruritus, Rash, Skin ulcer
Clinical narrative: Initial report was received from a consumer, who was also the patient, on 30 November 2012. A 53-year-old female patient had received a dose of TYPHIM VI (lot number, route and site not reported) and an injection of gammaglobulin on 03 October 1990. The patient wasn't sure but thought she may have received oral typhoid vaccine. The same day, the patient developed severe itching and broke out in a rash. To this day, 22 years later, the patient continues to get episodes of severe itching and "breaks out". From all the scratching, the patient developed sores on her body. The patient had no illness at the time of vaccination. The patient's outcome was not recovered. Documents held by sender: None.
Age: 69.0
Sex: F
Vaccine: FLUX
Symptoms: Culture, Herpes zoster, Pain in extremity, Skin lesion
Clinical narrative: This consumer report (initial receipt 27-Nov-2012) concerns a 69-year-old female patient, who had a medical history of ovarian cancer. Concomitant medication included bevacizumab. On 10-Oct-2012, the patient received influenza vaccine (also reported as H1N1 [conflicting information] manufacturer and batch # were not provided). She also received CIPRO (batch no. not specified) on an unspecified date. On 11-Oct-2012 the patient developed pain in her calf. On 12-Oct-2012 the patient broke out in a lesion in her groin area and towards her lower back area. The patient sought medical attention and a culture was done on the lesions. She was later diagnosed with shingles. She was treated with CIPRO. The events improved. Reporter's comment: The consumer stated that she was unsure if the influenza vaccine or the CIPRO medication brought on the onset of shingles. She did not want to provide any additional information.