chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Lupus-like syndrome, Myalgia, Pleuritic pain, Ultrasound scan normal, Ventilation/perfusion scan normal
Clinical narrative: 1 week after shot lupus like reaction with myalgias, SOB, CP, pleuritic CP, headaches.
Age: 15.0
Sex: U
Vaccine: FLU3
Symptoms: Dizziness, Hyperhidrosis, Nausea
Clinical narrative: Patient experienced nausea, lightheaded, and sweating after vaccine. After waiting 10-15 mins & propping feet up patient felt better. Left pharmacy.
Age: 11.0
Sex: F
Vaccine: FLUN3, HEPA, HPV4, MNQ, TDAP
Symptoms: Erythema, Skin reaction, Swelling
Clinical narrative: Site: (L) arm upper & lower shot given Tdap left upper arm MENACTRA (L) lower arm - redness/swollen. Localized reaction.
Age: 5.0
Sex: M
Vaccine: MMR
Symptoms: Eyelid disorder, Hypotonia, Pyrexia
Clinical narrative: MMR given 2/20/13. Phone call from mom 2/25/13. Fever of 103.7 on Saturday 2/23/13 no other symptoms per mom but dad wondering if he saw a seizure for a few seconds while he had the fever, eyes were open, flailed his arms/legs no problems since. No rash.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Skin lesion
Clinical narrative: Painful lesion left eye, redness. Treatment acyclovir. Pt. saw ophthalmology 2-25-13, no ocular findings.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Rash
Clinical narrative: Patient states on 2/27/13 that she developed a rash on her (L) arm at the injection site, and (R) side of abdomen. Pt did not seek or receive treatment.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Skin warm
Clinical narrative: 2 1/2 x 1 in lateral raised rash on tricep found 5 days after shingles injection. Warm to touch but no pain associated.
Age: 0.53
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Body temperature increased, Convulsion, Culture urine, Dyskinesia, Hypotonia
Clinical narrative: Pt noted with jerky of arm of leg approx 13 hr post vaccination. Pt seizure lasted 3-4 min. Pt limp then irritable Temp 102 in hospital ER Rx with MOTRIN & after 1 hr became playful.
Age: 0.53
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Irritability, Urine analysis normal
Clinical narrative: Pt noted with jerky of arm of leg approx 13 hr post vaccination. Pt seizure lasted 3-4 min. Pt limp then irritable Temp 102 in hospital ER Rx with MOTRIN & after 1 hr became playful.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Pt has on (R) thigh 2.25"X 1.75" raised red area on (L) thigh 1.75"X1.5" raised red area was seen by Dr given rx for AUGMENTIN.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: Edema, redness, hot at touch on right thigh (cellulitis). Tx AUGMENTIN 200/5ml q 12h. CLARINEX 2.5 po.
Age: 1.6
Sex: M
Vaccine: DTAP, PNC13
Symptoms: Convulsion, Gaze palsy, Musculoskeletal stiffness, Pyrexia, Upper respiratory tract infection
Clinical narrative: Seen for minor URI, temp 100.4 in office noted to have vaccines not up to date. Given DtaP, PREVNAR at approximately noon. Noted to have fever, stiffening, eyes rolling back. EMS called, temp 100.6. EMS checked child who had stopped seizure by then. Parents brought him to ER, temp 40.1 observed for 3 hrs. Exam looked good. No further episodes.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. In September 2012, the patient was vaccinated with the first dose of RECOMBIVAX HB (dose, route and lot not reported) and on 20-DEC-2012 the patient received the second dose of RECOMBIVAX HB late. The patient was not experiencing any known symptoms. The outcome of the event was unknown. The reporter considered the event to be not related to RECOMBIVAX HB. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus
Clinical narrative: This spontaneous report as received from a female consumer of unknown age reporting on herself. On an unknown date, the consumer was vaccinated with a dose of ZOSTAVAX (Lot # not reported). The consumer reported that on an unknown date, she experienced injection site itching. The outcome of injection site itching was unknown. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. The pharmacist reported that on an unknown date, the patient was vaccinated with the first dose of GARDASIL (dose, route and lot not reported). The patient received the second dose of GARDASIL (dose, route and lot not reported) too early. The patient was not experienced any known symptoms. The outcome of the event was unknown. The reporter considered the event to be not related to GARDASIL. Additional information has been requested.
Age: 17.0
Sex: M
Vaccine: VARCEL
Symptoms: Antibody test negative
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 18 year old male patient with penicillin allergy and not pertinent medical history. On 18-JUL-2000 and on 30-APR-2007, the patient was vaccinated with the first and second dose of VARIVAX (route, Lot # and dose not reported) due to he was exposed to a person that had shingles. No concomitant medications taken. On 27-DEC-2012, the patient showed "equivocal" titers. The healthcare worker mentioned the patient received an additional dose of VARIVAX (route, Lot # and dose not reported) on 02-JAN-2013. The patient did not receive treatment. No lab tests were performed. The patient sought medical attention (unspecified). Patient's outcome was unknown. Additional information has been requested.
Age: 1.31
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Full blood count abnormal, Lymphadenopathy, Lymphocyte count decreased, Neutrophil count increased
Clinical narrative: This spontaneous report as received from a physician refers to a currently 16 months old female patient with eczema and none Drug reactions/allergies. On 15-FEB-2013, the patient was vaccinated subcutaneously (SQ) with a 0.5 ml dose of M-M-R II lot# H01013, expire date: 17-MAY-2014 and a dose of VARIVAX (Merck), lot# H018015 expire date: 01-OCT-2014 (dose and route not reported). No concomitant medications taken. The physician reported that the patient developed diffuse lymphadenopathy (approximately in February 2013) after administration of M-M-R II and VARIVAX (Merck). On 25-FEB-2013, the patient was evaluated in the office and was found to have post-auricular, anterior cervical, axillary, and inguinal lymphadenopathy. On 25-FEB-2013, complete blood count showed slightly increased neutrophils and decreased lymphocytes. There was no hepatomegaly or splenomegaly. The patient did not receive Treatment. The outcome of outcome of the event was reported as not recovered. Causality assessment was not provided. Additional information is not expected.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a registered nurse via a company representative refers to a female patient of unknown age. On an unknown date in 2008 the patient was vaccinated with a dose of ZOSTAVAX (route and lot# unspecified). On18-FEB-2013 ("today") the patient came into the nurse's office with shingles around the eye area. The outcome of event was unknown. Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Body temperature increased, Pneumonia
Clinical narrative: This spontaneous report as received from a male consumer of unknown age refers to himself. The patient stated that he has "just received" a booster for an unspecified pneumonia vaccine that protected against 23 or 24 serotypes of the virus (manufacturer unknown) (lot # not reported). The patient mentioned that he had had a 102 temperature at an unspecified time that resulted in him developing pneumonia. The patient did not confirm if he received the booster dose of this vaccine before or after he developed the pneumonia, nor did he explain when his initial dosing with the vaccine series began. It was unspecified whether the patient sought for medical attention. The outcome was unknown. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Hypersensitivity, Urticaria
Clinical narrative: This spontaneous report as received from a pharmacist refers to a male patient (unknown age) with medical history and drug allergies unspecified by the reporter. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (Lot # and exp date not reported) (dose, frequency, route and indication unknown). No other co-suspects were reported. Concomitant medication was not reported. The pharmacist was informed by the physician that an unspecified patient experienced an allergic reaction, hives to an unspecified product. The patient had received ZOSTAVAX three weeks prior to developing the allergic reaction. The patient sought unspecified medical attention. The outcome of the patient experienced an allergic reaction was unknown. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pt seen for shots on 2/20/13. Mother noticed that left arm red and swollen and tender to touch on 2/22/13. Patient was seen by provider on 2/22/13. No fever, child able to move arm and no problem. KEFLEX 150 mg po tid x 7 days prescribed. Patient reassessed on 2/26/13. Doing well. Area of left arm, no swelling, no redness, no warmth, no fever. From of shoulder and arm.
Age: 5.0
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Wrong drug administered
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 5 year old patient. On 20-FEB-2013 the patient was vaccinated with a dose of ZOSTAVAX instead of VARIVAX (Merck) due to a human error. No adverse effect reported. Additional information has been requested.
Age: 5.0
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 5 year old patient. On 20-FEB-2013 the patient was vaccinated with a dose of ZOSTAVAX instead of VARIVAX (Merck) due to a human error. No adverse effect reported. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAP, HEP, PPV
Symptoms: Cough, Pertussis, Pyrexia, Retching
Clinical narrative: Patient got the DTP vaccine on 2/12/13 and coughed a dry cough for 2 weeks after.  When it turned into gagging and fever, he was finally diagnosed with whooping cough.  The P in DTP is Pertussis, otherwise known as whooping cough... which he got FROM the vaccine.
Age: 49.0
Sex: F
Vaccine: HEPA, TDAP
Symptoms: Joint range of motion decreased, Pain, X-ray limb normal
Clinical narrative: Developed pain 4 days after injection.  States pain 7/10 with limited ROM and pain with lifting light weight.
Sex: M
Vaccine: MMR
Symptoms: Deafness, Ear infection
Clinical narrative: This spontaneous report was received from a consumer concerning his grandson of unknown age. On an unknown date, the patient was vaccinated with a dose of M-M-R II (lot number, expiry date, dose and route unspecified). No concomitant medications were reported. On an unknown date, the patient experienced ear infections and hearing loss. It was unspecified if the patient sought any medical attention. The outcome of hearing loss and ear infections was unknown. The consumer did not provide the name and demographics of the healthcare professional. Legal issue was involved. Adverse event was sent to legal department. The relatedness for ear infections and hearing loss was unknown for M-M-R II. Upon internal review, the event, hearing loss was considered as medically significant. This is one of the two reports from the same source. Additional information has been requested.
Sex: M
Vaccine: MMR
Symptoms: Deafness, Ear infection
Clinical narrative: This spontaneous report was received from a consumer concerning his grandson of unknown age. On an unknown date, the patient was vaccinated with a dose of MMR II (lot number, expiry date, dose and route unspecified). No concomitant medications were reported. On an unknown date, the patient experienced ear infections and hearing loss. It was unspecified if the patient sought any medical attention. The outcome of hearing loss and ear infections was unknown. The consumer did not provide the name and demographics of the healthcare professional. Legal issue was involved. Adverse event was sent to legal department. The relatedness for ear infections and hearing loss was unknown for MMR II. Upon internal review, the event, hearing loss was considered as medically significant. This is one of the two reports from the same source. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HEPA, HPV4, MNQ
Symptoms: Pharyngeal oedema, Pruritus, Vomiting
Clinical narrative: Developed itching with throat swelling & vomiting. Resolved with 2 doses BENADRYL.
Sex: F
Vaccine: PPV
Symptoms: Lymphadenopathy, Pain in jaw
Clinical narrative: This spontaneous report was received from a physician refers to a female patient of unknown age. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX23 (lot#, dose and route not reported). No concomitant medications were reported. On an unknown date, the patient experienced pain in her jaw after receiving PNEUMOVAX23. She also had a questionable enlarged lymph node in the throat area. No treatment was received. The patient sought medical attention(contacted the HCP). No laboratory diagnostics studies were performed. The outcome of pain in her jaw and enlarged lymph node in the throat area was reported as recovered. Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site discolouration, Injection site erythema, Injection site warmth
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 50 year old female patient. No drug reactions or medical history was reported. On 22-FEB-2013, the patient was vaccinated subcutaneously with a dose of ZOSTAVAX (lot # reported as H021292, expiry: 20-FEB-2014, dose not reported) in the arm for shingles prophylaxis. No concomitant medications were reported. On 25-FEB-2013, the patient noted "her arm looked like it got hit by softball". There was no rash but her arm was purple at the injection site and the area around that was red, raised, and warm. No treatment was received. The patient sought medical attention (patient presented at the pharmacy). No laboratory diagnostics studies were performed. The outcome of her arm was purple at the injection site, area around that was red, raised and warm was reported as not recovered. 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 certified medical assistant refers to an unknown number of patients. Medical assistant reported that the office improperly stored GARDASIL (lot #, route and dose were not provided) and she did not known if any patients received any of the improperly stored doses. No symptoms were reported. Additional information is not expected.
Age: 67.0
Sex: U
Vaccine: PPV
Symptoms: Blister, Cough, Decreased appetite, Dizziness, Dyspnoea
Clinical narrative: Redness & pain where shots were given. Muscles aches. High fever for days & sweating heavily at night. Severe dry cough with difficulty of breathing, fast heart beat, wheezing, dizziness. Blisters, paleness. Lost of appetite. Sleeplessness. Still have chest congestion with very tick.
Age: 67.0
Sex: U
Vaccine: PPV
Symptoms: Heart rate increased, Injection site erythema, Injection site pain, Insomnia, Myalgia
Clinical narrative: Redness & pain where shots were given. Muscles aches. High fever for days & sweating heavily at night. Severe dry cough with difficulty of breathing, fast heart beat, wheezing, dizziness. Blisters, paleness. Lost of appetite. Sleeplessness. Still have chest congestion with very tick.
Age: 67.0
Sex: U
Vaccine: PPV
Symptoms: Night sweats, Pallor, Pyrexia, Respiratory tract congestion, Wheezing
Clinical narrative: Redness & pain where shots were given. Muscles aches. High fever for days & sweating heavily at night. Severe dry cough with difficulty of breathing, fast heart beat, wheezing, dizziness. Blisters, paleness. Lost of appetite. Sleeplessness. Still have chest congestion with very tick.
Age: 11.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP
Symptoms: Cardiac arrest, Crying, Death, Endotracheal intubation, Respiratory arrest
Clinical narrative: 2/19/13 23:24 Pt brought in by ambulance in cardiac arrest, "mother states pt has been having cough & URI symptoms since 5 days - seen by doctor 2/19/13 & given 4 vaccines. Pt sleeping & crying - suddenly pt turned white & was not breathing - 911 called & intubated. Doctor states he was not aware of any illness & child's DILANTIN level was 1.0. No lab found in medical record child revived & transfer to another hospital where child died on 2/20/13.
Age: 11.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP
Symptoms: Skin discolouration
Clinical narrative: 2/19/13 23:24 Pt brought in by ambulance in cardiac arrest, "mother states pt has been having cough & URI symptoms since 5 days - seen by doctor 2/19/13 & given 4 vaccines. Pt sleeping & crying - suddenly pt turned white & was not breathing - 911 called & intubated. Doctor states he was not aware of any illness & child's DILANTIN level was 1.0. No lab found in medical record child revived & transfer to another hospital where child died on 2/20/13.
Age: 1.05
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: Fever, rash about 10 days after MMR given.
Sex: U
Vaccine: PNC13
Symptoms: Death, Meningitis, Pneumonia streptococcal
Clinical narrative: This is a spontaneous report from a contactable physician through Pfizer Vaccine Representative. This physician reported for a 8 year old (unknown gender) patient who received a dose of PREVNAR 13 on unknown date. Relevant medical history and concomitant medication were unknown. It was reported that on an unknown date the patient had streptococcus pneumonia and meningitis. Therapeutic measures taken, if any, were unknown. The patient had not recovered from the reported events and passed away on an unknown date in Feb2013 due to streptococcus pneumonia and meningitis. At the time of reporting, it was unknown if autopsy was performed.
Age: 60.0
Sex: M
Vaccine: FLU3
Symptoms: Anxiety, Chills, Dyspnoea, Pyrexia
Clinical narrative: Fever, anxiety, chills, in bed for few days after rapid breathing.
Age: 7.0
Sex: M
Vaccine: DTAPIPV, HEPA, MMR, VARZOS
Symptoms: Body temperature increased, Injection site erythema, Injection site pain, Pain in extremity, Wrong drug administered
Clinical narrative: Received ZOSTAVAX accidentally instead of VARIVAX. Noted error on 2/21/13. Per mom, T 100 range on 2/21/13 & complaints of arm pain after vaccines given. 2/23/13 erythema & tenderness at site only 1 x 2 cm.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Allodynia, Pain of skin, Rash macular
Clinical narrative: This spontaneous report as received from a physician refers to a 73 year old male patient with no pertinent medical history and no drug reactions/allergies. On 06-FEB-2013 the patient was vaccinated with ZOSTAVAX (subcutaneous, lot#, dose/frequency and dose number were unspecified). There was no concomitant medications. On 11-FEB-2013, "5 days after administration of ZOSTAVAX", patient began to experience "dermatomal pain, allodynia and blotchy skin with no rash present". Patient had sought medical attention via office visit. No lab diagnostics studies performed and no treatment was given for the events. The outcome of dermatomal pain, blotchy skin with no rash present and allodynia were reported as not recovered. Additional information has been requested,.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Migraine
Clinical narrative: This spontaneous report was received from a 55 year old female patient with food allergies and migraines and no drug allergies/reactions. On 15-FEB-2013 the patient was vaccinated with a dose of ZOSTAVAX (lot # reported as 998115, dose and route not reported). Concomitant therapies included progesterone. On 16-FEB-2013 (the day after the vaccine), the patient had a migraine for 2 days. The patient saw the allergist for medical attention. No treatment was given for migraine. No lab diagnostics studies were performed. As of 17-FEB-2013, the patient recovered from migraine. The patient stated she was all better now. The patient was trying to figure out if something else she ate might have brought on her recent migraine and would like to know what foods used (corn or egg perhaps) in the production of shingles vaccine. Additional information has been requested.
Sex: F
Vaccine: MMR
Symptoms: Rubella antibody negative
Clinical narrative: This spontaneous report was received from a registered nurse refers to a female patient of unknown age. On 06-APR-1972, the patient was vaccinated with a dose of M-M-R II, (lot number, expiry date and route was not reported). No concomitant medications were reported. The nurse reported that within the last 6 months (since starting a new job requiring employee testing for rubella). She had a blood test titer for rubella and it was reported to be equivocal. As a child she had mumps. The nurse reported that a few years ago when she was last pregnant her titer to rubella was acceptable. No adverse event reported other than equivocal to rubella. 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 healthcare worker refers to a patient of unknown age. The reporter reported that a patient received GARDASIL (lot# was not reported) on 12-APR-2012 and the patient  was  in the office to receive the second dose on 25-FEB-2013. No adverse effect reported. Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a male patient in his 60. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (dose, route and lot # not reported). On an unknown date the patient developed a case of shingles after having ZOSTAVAX administered. The outcome of shingles was unknown. The patient saw a physician for medical attention. Additional information is not expected.
Age: 0.7
Sex: U
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse refers to a 9 month old patient. On 25-FEB-2013, the patient was vaccinated with 0.5 ml dos eof VAQTA (lot number and expiry date was not reported, route was intramuscular). Concomitant medications were not reported. No adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Syringe issue
Clinical narrative: This spontaneous report was received from a doctor of pharmacy refers to a patient of unknown age who on 26-FEB-2013, was vaccinated with a dose of ZOSTAVAX (dose, route and lot number not reported). The pharmacist reported that the patient received less than the required dose of ZOSTAVAX (due to syringe or needle leakage). It was stated that during administration of the ZOSTAVAX a couple of drops came out of the syringe and ran down the needle. No adverse events were reported. Additional information is not expected.
Age: 8.0
Sex: M
Vaccine: DTAP, HEP, MMR, VARZOS
Symptoms: Lethargy, Pain in extremity, Wrong drug administered
Clinical narrative: Received ZOSTAVAX vaccine accidentally (instead of VARIVAX) noted error on 2/21/13. T = 102 degrees & pt lethargic with complaints (R) arm pain per mom on 2/21/13.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 22 year old female patient, who on 25-JAN-2010, was vaccinated with the first dose of GARDASIL (0.5 ml, intramuscularly) (lot number was not reported) and on 11-NOV-2011 was vaccinated with the second dose of GARDASIL (0.5 ml, intramuscularly) (lot number was not reported). No other co-suspects were reported. No concomitant medications were reported. The nurse reported that the third dose of GARDASIL would be administered on 23-FEB-2013. No adverse effect reported. At the time of the report, the patient's outcome for the adverse event was unknown. Additional information has been requested.,
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site inflammation, Injection site rash
Clinical narrative: Pt had a rash and inflammation of the injection site.
Age: 1.71
Sex: M
Vaccine: DT
Symptoms: Complement factor, Full blood count normal, Metabolic function test normal, Pyrexia, Rash
Clinical narrative: Patient developed a rash and swelling of face 3 days after vaccine administered. Rash and swelling progressed over 2 days and fever up to 104.7 developed. Diagnosed with serum sickness and was started on prednisone and BENADRYL and then ZYRTEC.
Age: 1.71
Sex: M
Vaccine: DT
Symptoms: Red blood cell sedimentation rate increased, Serum sickness, Swelling face, Urine analysis normal
Clinical narrative: Patient developed a rash and swelling of face 3 days after vaccine administered. Rash and swelling progressed over 2 days and fever up to 104.7 developed. Diagnosed with serum sickness and was started on prednisone and BENADRYL and then ZYRTEC.
Age: 21.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Injection site pain, Musculoskeletal pain, Neck pain, Pain
Clinical narrative: Continued aching - 3 weeks after TDAP injection. Pain at (L) arm injection site radiates to (L) neck down to (L) wrist. Warm to touch. Pain in (L) shoulder joint & (L) elbow. Afebrile.
Age: 21.0
Sex: F
Vaccine: TDAP
Symptoms: Pain in extremity, Skin warm
Clinical narrative: Continued aching - 3 weeks after TDAP injection. Pain at (L) arm injection site radiates to (L) neck down to (L) wrist. Warm to touch. Pain in (L) shoulder joint & (L) elbow. Afebrile.
Age: 65.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Rash
Clinical narrative: Received Tdap & PNEUMOVAX on 2/6/13 RT arm flat rash appeared approximately 2/11/13 given BACTRIM and took x 4 days to resolve.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Injection site induration, Injection site warmth
Clinical narrative: Warm induration 16 x 10 cm (L) upper arm reaction. Treated with antibiotic/MOTRIN. Had to go to ER 2-27-13.
Age: 34.0
Sex: F
Vaccine: TYP
Symptoms: Cough, Nasopharyngitis, Throat tightness, Upper respiratory tract infection
Clinical narrative: Pt was given Tdap 1/18/13; Hepatitis A #2 & Influenza 2/19/13; started 1st VIVOTIF 2/20/13 in morning et that day developed cough & tightness in throat - no sore throat or fever. Saw Dr here 2/21/13 & was given BENADRYL 25 mg po qid & stop VIVOTIF. Symptoms subsided. A few days later developed same other cold symptoms - ? upper respiratory infection? No fever.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site bruising, Injection site pain, Injection site pruritus, Musculoskeletal pain
Clinical narrative: Injection site reaction; bruised for 2 weeks itching for few days (no rash); pain that radiates to shoulder (constant).
Age: 56.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Severe body aches and pains, fever, chills.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: Pt states that itching, swelling, and redness began on 02/26/2013.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Impaired driving ability, Mobility decreased, Pain in extremity
Clinical narrative: Very sore arm. Patient reports that she can't drive or lift her arm.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Incorrect dose administered
Clinical narrative: 4th dose of HPV given in error.
Age: 38.0
Sex: F
Vaccine: MMR
Symptoms: Asthenia, Dyspnoea, Fatigue, Hypoaesthesia, Insomnia
Clinical narrative: Very tired, generalized weakness, no strength, fatigue, short of breath, insomnia, numbness/tingling to left hand & both feet.
Age: 38.0
Sex: F
Vaccine: MMR
Symptoms: Paraesthesia
Clinical narrative: Very tired, generalized weakness, no strength, fatigue, short of breath, insomnia, numbness/tingling to left hand & both feet.
Age: 56.0
Sex: F
Vaccine: FLU3, TYP, YF
Symptoms: Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: 4cm area of tenderness, warmness and itching at site of Yellow Fever immunization on left upper arm.
Age: 40.0
Sex: M
Vaccine: SMALL
Symptoms: Pain, Pyrexia, Rash, Vomiting
Clinical narrative: Rash on Back, Legs, Face, Soreness, Fever, Vomiting.
Age: 11.0
Sex: M
Vaccine: HPV4
Symptoms: Feeling cold, Heart rate decreased, Immediate post-injection reaction, Nausea, Pallor
Clinical narrative: AT THE TIME OF INJECTION, PT BECOME COOL, PALE, STATED HE FELT NAUSEOUS, PT HEART RATE DECREASED WITH A RATE IN THE 50'S, APPEARS TO HAVE HAD A VAGAL RESPONSE. 10 MINUTES POST INJECTION PATIENT'S HEART RATE IN THE 70'S, NO COMPLAINTS, STATED HE FELT FINE.
Age: 11.0
Sex: M
Vaccine: HPV4
Symptoms: Presyncope
Clinical narrative: AT THE TIME OF INJECTION, PT BECOME COOL, PALE, STATED HE FELT NAUSEOUS, PT HEART RATE DECREASED WITH A RATE IN THE 50'S, APPEARS TO HAVE HAD A VAGAL RESPONSE. 10 MINUTES POST INJECTION PATIENT'S HEART RATE IN THE 70'S, NO COMPLAINTS, STATED HE FELT FINE.
Age: 0.37
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Vomiting
Clinical narrative: CHILD VOMITED AFTER 7 A.M. FEEDING THEN AGAIN AFTER 11 A.M. FEEDING ON 2/28/13.
Age: 12.0
Sex: M
Vaccine: HPVX
Symptoms: Drug screen, Dysarthria, Headache, Hypertension, Nausea
Clinical narrative: Headache, sore throat, body aches, blurred vision, slurred/slow speech, nausea, hypertension.
Age: 12.0
Sex: M
Vaccine: HPVX
Symptoms: Oropharyngeal pain, Pain, Urine analysis, Vision blurred
Clinical narrative: Headache, sore throat, body aches, blurred vision, slurred/slow speech, nausea, hypertension.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Dizziness, Injection site pain, Injection site swelling
Clinical narrative: Pt called the day after receiving PN injection. Pt reported pain and moderate swelling at injection site and approximately 8 hrs of chills and intermittent dizziness. Reported reaction to PCP and pharmacy.
Age: 64.0
Sex: M
Vaccine: PPV
Symptoms: Body temperature increased, Injected limb mobility decreased, Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: Patient reported new onset redness, pain, and decreased range of motion in his right upper extremity after receiving Pneumococcal vaccine at 0801 on 1/24/2013. On 01/25/13, the medical team was notified and they started oral Clindamycin due to redness, edema and erythema in the RUE.
Age: 64.0
Sex: M
Vaccine: PPV
Symptoms: Joint range of motion decreased, White blood cell count decreased
Clinical narrative: Patient reported new onset redness, pain, and decreased range of motion in his right upper extremity after receiving Pneumococcal vaccine at 0801 on 1/24/2013. On 01/25/13, the medical team was notified and they started oral Clindamycin due to redness, edema and erythema in the RUE.
Age: 79.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Oedema peripheral, Pain
Clinical narrative: Pt returned to clinic the day after receiving PN injection. Left arm was red and swollen with severe edema down to and including elbow. Pt reported 7/10 pain. Was seen and treated as per provider.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to an unknown number of patients (unknown age and genders). The pharmacist reported that the patients at another clinic were vaccinated with ZOSTAVAX (lot#, exp date,dose and route not reported) stored at temperature of about 19F for an unknown period of time up for 6 months. No adverse effect reported. Additional information has been requested.
Age: 53.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Chills, Headache, Myalgia, Nausea
Clinical narrative: FEVER, SHAKING CHILLS, MYALGIA, JOINT PAIN, NAUSEA, SEVERE HEADACHE.
Age: 53.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia, Tremor
Clinical narrative: FEVER, SHAKING CHILLS, MYALGIA, JOINT PAIN, NAUSEA, SEVERE HEADACHE.
Age: 11.0
Sex: M
Vaccine: FLU3, HPV4, MNQ, TDAP
Symptoms: Body temperature increased, Vomiting
Clinical narrative: According to pt's mother he awoke at 7:30 am vomiting. Pt's mother reports that pt's temperature was 102.8 orally at 8:00 am. Pt's mother gave pt Tylenol (dose based on pt's weight) at 8:00 am. pt was taken to family doctor later the same day. According to pt's mother "PCP stated that it was a normal reaction and that the pt was possibly coming down with a cold".
Age: 24.0
Sex: F
Vaccine: ANTH, SMALL, TYP, ANTH, SMALL, TYP
Symptoms: Chest X-ray, Chest pain, Electrocardiogram, Laboratory test
Clinical narrative: Patient went to ER complaining of chest pain x 2 days, this was 10 days after smallpox vaccination.
Age: 24.0
Sex: F
Vaccine: ANTH, SMALL, TYP, ANTH, SMALL, TYP
Symptoms: Electrocardiogram normal, Pericarditis, Troponin I increased
Clinical narrative: Patient went to ER complaining of chest pain x 2 days, this was 10 days after smallpox vaccination.
Age: 0.98
Sex: M
Vaccine: HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Granuloma annulare
Clinical narrative: Granuloma Annulare.
Age: 45.0
Sex: F
Vaccine: MMR
Symptoms: Injection site swelling
Clinical narrative: Developed large swelling at injection site.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site induration, Injection site mass, Pain
Clinical narrative: Egg-sized lump at injection site - very hard. Also aches/headaches for week following injection.
Age: 36.0
Sex: F
Vaccine: PPV
Symptoms: Abdominal discomfort, Cellulitis, Chills, Fatigue, Nausea
Clinical narrative: Had fevers/chills, generalized fatigue, nausea (no vomiting), abdominal upset, cellulitis.
Age: 36.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: Had fevers/chills, generalized fatigue, nausea (no vomiting), abdominal upset, cellulitis.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Local swelling, Pain in extremity
Clinical narrative: Developed pain ("mild") in L arm, which pt initially discounted as a normal reaction to a vaccination. Noticed that area was red, swollen. Cellulitis measured diameter, 11 inches (compared to 10 inches on right).
Age: 64.0
Sex: M
Vaccine: FLU3, TDAP
Symptoms: Headache, Hypoaesthesia, Paraesthesia
Clinical narrative: Patient does describe beginning this a.m. a tingling/numbness sensation in both his upper extremities as well as lower extremities. Patient also describes a slight headache at the base of his skull and posterior.
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Activities of daily living impaired, Mobility decreased, Musculoskeletal stiffness, Pain, Rash
Clinical narrative: Extreme stiff neck on same side as shot in arm was given. Could not turn head at all-he had his head facing the right side upon waking and could not move it or the pain was very intense. I put heating pads on neck as well as put a soft collar around his neck so he could function. Missed two days of school. Shortly after a rash on skin on neck appeared and lasted for about two days.
Age: 19.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Pain, Pyrexia, Vomiting
Clinical narrative: States received Flu vaccine at Ashe Tuesday and then few hours after exp whole body soreness, vomiting, fever.
Age: 29.0
Sex: F
Vaccine: HEPA, TDAP
Symptoms: Dyspnoea, Throat tightness, Wheezing
Clinical narrative: Difficulty breathing, wheezing, tightness in throat. Treated with inhaler and Benadryl.
Age: 0.12
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Cough, Cyanosis, Dyspnoea, Increased bronchial secretion, Pallor
Clinical narrative: Patient slept from 1PM - 4:20PM and was woken by mother. Mother went to change diaper and baby began gagging and reguritating. She spit copious amounts of mucous out her mouth and nose and could not catch her breath. She became pale then cyanotic. EMS was called. When EMS arrived patient was still cyanotic. She coughed, spit out "a ton of mucous" and then began to breathe and improve. Patient was taken to hospital where she was evaluated and admitted for observation. She was back to baseline by her arrival in the ER and had no further episodes while admitted.
Age: 0.12
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Regurgitation, Retching
Clinical narrative: Patient slept from 1PM - 4:20PM and was woken by mother. Mother went to change diaper and baby began gagging and reguritating. She spit copious amounts of mucous out her mouth and nose and could not catch her breath. She became pale then cyanotic. EMS was called. When EMS arrived patient was still cyanotic. She coughed, spit out "a ton of mucous" and then began to breathe and improve. Patient was taken to hospital where she was evaluated and admitted for observation. She was back to baseline by her arrival in the ER and had no further episodes while admitted.
Age: 53.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Myalgia
Clinical narrative: Extremely sore muscle in upper arm lasting to present (6 weeks). seemed to be a semi-paralyzed muscle. It is just now easing.
Age: 53.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Pain in extremity
Clinical narrative: Extremely sore muscle in upper arm lasting to present (6 weeks). seemed to be a semi-paralyzed muscle. It is just now easing.
Age: 19.0
Sex: F
Vaccine: HEPA, PPV, TD
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness 10 cm, swelling, mild pain, mild tenderness at injection site of right arm. Left arm - normal.
Sex: U
Vaccine: HEP
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Initial information has been received from a physician concerning a several adult patients with an unspecified age, gender, pertinent medical history or drug reactions / allergies. On an unspecified date, the patients was vaccinated with a 1.3 ml or 1.5 dose of RECOMBIVAX HB, obtained from 2 pediatric doses of RECOMBIVAX HB (lot number was not reported). No other co-suspect medications were reported. No concomitant medications were reported. No adverse effect were reported. No treatment information was reported. The patient's outcome was unknown. This is one of several reports from the same source. Additional information is not expected.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: This spontaneous report was received from a physician via a company representative concerning a 11 year old female patient. On 22-FEB-2013 the patient was vaccinated with a dose of GARDASIL (lot number, expiry date, dose and route unspecified). No concomitant medications were reported. On 22-FEB-2013, the patient fainted in the lobby of the office after the administration of GARDASIL. Outcome of the event was unknown. The relatedness for the event was unknown for GARDASIL. Additional information is not expected.
Age: 1.05
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Rash, Rash papular
Clinical narrative: Pt. presents to clinic with a rash on his trunk that started in AM of 2/26/13 Pt has an erythematous papular rash on the abdomen, back & proximal extremities. Rash is not urticarial in nature mother denies itchiness or fevers noted. Mother instructed to continue Amoxicillin mother instructed to observe for rash worsens or becomes urticarial in nature or has swelling. Pt to be re-evaluated.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a Healthcare worker refers to two unspecified patients. The patients were vaccinated with the first dose of RECOMBIVAX HB (route, dose and lot # were unknown) on an unspecified date in November 2012 and the second dose on 20-FEB-2013. No adverse effect reported. The outcome of event was unknown. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Rash vesicular, Secondary transmission
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. On an unknown date, the patient was vaccinated with ZOSTAVAX (lot #, dose and route not reported) sometime in the past from an unspecified healthcare provider and she developed a shingles-like rash. The patient's husband then developed shingles himself because he was exposed to the patient's rash. The patient's husband and the patient have both recovered. The relatedness of the event with ZOSTAVAX was not provided. Additional information is not expected.
Age: 4.0
Sex: M
Vaccine: IPV, VARCEL
Symptoms: Cold sweat, Immediate post-injection reaction, Malaise, Pallor, Vomiting
Clinical narrative: Immediately following vaccines PT c/o "not feeling well". Vomited small amount of emesis. Pt became pale and clammy. Dr. notified vs taken. BP 93/57 R 24 HR 100 O2 Sat 98%. Pt quickly started feeling better. Sipping water. Pt released home. Pt denies any SOB or difficulty breathing.
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to a patient (age and gender unknown). On 29-DEC-2011, the patient was vaccinated with first dose of VAQTA (25/0.5 U/ml) (dose, route and lot number not reported). On 06-JUN-2012, the patient was vaccinated with second dose of VAQTA (dose, route and lot number not reported). No adverse symptoms were reported. Additional information has been requested.
Age: 15.0
Sex: M
Vaccine: HPV4
Symptoms: Headache
Clinical narrative: 2 hrs after immz HPV #1 pt c/o HA, no fever, pt stated he is feeling better today.
Sex: U
Vaccine: BCG
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a doctor of pharmacy refers to a patient of unknown age who on an unknown date, was administered intravesicularly with one dose of BCG USP instead of TICE. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Age: 34.0
Sex: F
Vaccine: HEP
Symptoms: Laboratory test normal, Urticaria
Clinical narrative: Hives - generalized developed one day after vaccine of hep B. Received Prednisone - two 20 mg tabs daily 7 days with resolution of hives.
Age: 7.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Injection site red, swollen, hot. Redness area has increased.
Sex: U
Vaccine: BCG
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a doctor of pharmacy refers to a patient of unknown age who on an unknown date, was administered intravesicularly with six doses of BCG USP over the course of six weeks instead of TICE. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Age: 0.48
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Erythema, Oedema peripheral
Clinical narrative: Both legs swollen & red.
Age: 38.0
Sex: F
Vaccine: HEP, MMR
Symptoms: Erythema, Oedema peripheral, Skin warm
Clinical narrative: Client reported back to clinic with red swollen area on Lt. arm. States that she had shots yesterday and just wanted someone to check area. Arm warm to touch, red, denies any SOB or any other reactions. Informed client to seek medical help for any SOB or if.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a medical assistant reporting that a patient (age and gender unknown) was in the office to receive Dose 2 of GARDASIL (lot # and route of administration not reported) which will be late. Dose 1 was administered sometime in April 2012. No symptoms reported. No other details. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Headache
Clinical narrative: Information has been received from a pharmacist regarding a patient of unknown age and gender. The patient's medical history or concurrent conditions were not provided. On 21-DEC-2012, the patient was vaccinated with a dose of (Merck) VARIVAX, dose, route and lot number were not provided. On an unknown date, the patient experienced headaches. The outcome of headache was unknown. This was originally reported by a pharmacist. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a medical assistant concerning a female patient who in September 2010, was vaccinated with a first dose of HPV rL1 6 11 18 VLP vaccine (yeast) (dose, route and lot # not reported), in January 2011 was vaccinated with a second dose of HPV rL1 6 11 18 VLP vaccine (yeast) (dose, route and lot # not reported) and on 25-JAN-2012 was vaccinated with a third dose of HPV rL1 6 11 18 VLP vaccine (yeast) (dose, route and lot # not reported). No adverse effect was reported. Additional information has been requested.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Auricular swelling, Chest pain, Lip swelling, Rash
Clinical narrative: Pt. rep called 2/23 reported rash - pt. was advised to cover rash, take BENADRYL, report to Dr. if condition worsened. 2/25/12 - Pt. rep called - pt. went to ER on 2/24/13 - with chest pain, rash and swelling of lips and ears.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Confusional state, Headache, Migraine
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 68 year old female patient with diabetes and has not been eating well routinely. On 09-FEB-2013 the patient was vaccinated subcutaneously with a single dose of ZOSTAVAX (lot # H017447, exp. date: 20-DEC-2013). The patient had experienced intermittent migraine headaches, chills, and intermittent confusion since having receiving ZOSTAVAX at the pharmacy on 09-FEB-2013. No treatment was given for the events. None lab diagnostics studies were performed. The outcome of the events was reported as not recovered. The relatedness for the events with the therapy was unknown. Additional information is not expected.
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This spontaneous report as received from a physician refers to a female patient of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX (lot# was not reported,Standard dose). On an unknown date the patient experienced mild rash on her breast after receiving ZOSTAVAX. The patient sought unspecified medical attention. The outcome of mild rash on her breast was unknown. This the 3rd patient from the building that had developed a rash after receiving the ZOSTAVAX vaccine. The other events had been reported previously. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age. The reporter reported that the patient received the first dose of GARDASIL (lot# was not reported) about 4 years ago in February 2009, the 2nd dose 1 month ago in January 2013 and the 3rd dose on 26-FEB-2013. No adverse effect reported. Additional information has been requested.
Age: 1.11
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Body temperature increased, Discomfort, Irritability, Lymph node pain, Lymphadenopathy
Clinical narrative: Pt seen 2/5/13 by me, having been to ER previous night, dx with viral infx in ER. In office T 102.1, very uncomfortable with neck tilted to (L), multiple enlarged tender (L) post ax LN, sl enlg (R) post ax LN. Normal neck flexion, but child irritable. Diffuse somewhat lacy M-Prash sib had had a sore throat. Patient did not have red throat but (+) throat culture.