chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 12.0
Sex: F
Vaccine: MMR
Symptoms: Abdominal pain upper, Back pain, Exposure to communicable disease, Feeling abnormal, Grip strength decreased
Clinical narrative: On 3/27/13 patient presented with headache and stomach ache x 1 day. She also had a sore throat and felt bad. She had had significant exposure that week to someone who developed mumps, diagnosed on 3/24/13. Infectious disease at hospital recommended giving 3rd MMR because patient has a history of an optic glioma. No recent chemo or radiation. 3rd MMR given 3/28/13, back pain started Thursday 3/28. Continued (L) arm hurting 3/30/13. Numbness and loose grip 3/31/13. Then 4/5/13 with marked weakness (L) arm.
Age: 12.0
Sex: F
Vaccine: MMR
Symptoms: Headache, Hypoaesthesia, Mumps antibody test positive, Muscular weakness, Nuclear magnetic resonance imaging brain abnormal
Clinical narrative: On 3/27/13 patient presented with headache and stomach ache x 1 day. She also had a sore throat and felt bad. She had had significant exposure that week to someone who developed mumps, diagnosed on 3/24/13. Infectious disease at hospital recommended giving 3rd MMR because patient has a history of an optic glioma. No recent chemo or radiation. 3rd MMR given 3/28/13, back pain started Thursday 3/28. Continued (L) arm hurting 3/30/13. Numbness and loose grip 3/31/13. Then 4/5/13 with marked weakness (L) arm.
Age: 12.0
Sex: F
Vaccine: MMR
Symptoms: Nuclear magnetic resonance imaging spinal, Oropharyngeal pain, Pain in extremity
Clinical narrative: On 3/27/13 patient presented with headache and stomach ache x 1 day. She also had a sore throat and felt bad. She had had significant exposure that week to someone who developed mumps, diagnosed on 3/24/13. Infectious disease at hospital recommended giving 3rd MMR because patient has a history of an optic glioma. No recent chemo or radiation. 3rd MMR given 3/28/13, back pain started Thursday 3/28. Continued (L) arm hurting 3/30/13. Numbness and loose grip 3/31/13. Then 4/5/13 with marked weakness (L) arm.
Age: 13.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Incorrect drug dosage form administered
Clinical narrative: Client only administered liquid component of the MENVEO. Powder was not mixed in. LPN called Novartis to see if client needs to be reimmunized. They stated if she would be traveling outside the country or around a foreigner, to reimmunize. Called client's guardian and have left several messages. Will continue to try to contact client's guardian.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Chest X-ray, Febrile convulsion, Laboratory test, Pyrexia
Clinical narrative: 5/29/13 fever spiked to 102.6, febrile convulsion x 15 seconds. TYLENOL given before seizure. Taken to hospital remained over night, fever fluctuated 101-102 degrees 5/31/13 acute visit T 100.4, before and after seizure baby acted normal.
Age: 2.0
Sex: M
Vaccine: HIBV, PNC13
Symptoms: Erythema, Induration, Local swelling
Clinical narrative: Local swelling, redness, induration (8 cm of swelling).
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Abdominal discomfort, Asthenia, Chills, Dizziness, Hyperhidrosis
Clinical narrative: Pt c/o nauseated, upset stomach, cramping, dizzy, weak, sweating, chills, body aches. Took MOTRIN and laid down.
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Muscle spasms, Nausea, Pain
Clinical narrative: Pt c/o nauseated, upset stomach, cramping, dizzy, weak, sweating, chills, body aches. Took MOTRIN and laid down.
Age: 14.0
Sex: M
Vaccine: TYP, YF
Symptoms: Anaphylactic reaction, Eye swelling, Injection site pruritus, Rhinorrhoea, Sneezing
Clinical narrative: Throat tightening, sneezing, rhinorrhea, swelling around eye, hive on neck that progressed over minutes. Signs consistent with anaphylaxis. Epinephrine IM given in office within 10 minutes of symptoms onset, patient transferred to ER for further observation and treatment. (antihistamine). He also noted itching (no rash seen) at sight of yellow fever injection on left arm.
Age: 14.0
Sex: M
Vaccine: TYP, YF
Symptoms: Throat tightness, Urticaria
Clinical narrative: Throat tightening, sneezing, rhinorrhea, swelling around eye, hive on neck that progressed over minutes. Signs consistent with anaphylaxis. Epinephrine IM given in office within 10 minutes of symptoms onset, patient transferred to ER for further observation and treatment. (antihistamine). He also noted itching (no rash seen) at sight of yellow fever injection on left arm.
Age: 41.0
Sex: F
Vaccine: TD
Symptoms: Fatigue, Nasal congestion, Oropharyngeal pain, Pruritus, Pyrexia
Clinical narrative: I developed intense itching with hives, a low fever, stuffy nose and sore throat and fatigue.
Age: 41.0
Sex: F
Vaccine: TD
Symptoms: Urticaria
Clinical narrative: I developed intense itching with hives, a low fever, stuffy nose and sore throat and fatigue.
Age: 11.0
Sex: F
Vaccine: TD
Symptoms: Blister, Fatigue, Injection site pain, Injection site swelling, Lymphadenopathy
Clinical narrative: 3 days of fever, extreme exhaustion, swollen lymph nodes, and blistery rash on hands and feet. In addition to that she experienced sharp, random, radiating pain from shoulders through both hands during that time. Plus site of injection was still swollen and sore ten days later.
Age: 11.0
Sex: F
Vaccine: TD
Symptoms: Musculoskeletal pain, Pain in extremity, Pyrexia, Rash
Clinical narrative: 3 days of fever, extreme exhaustion, swollen lymph nodes, and blistery rash on hands and feet. In addition to that she experienced sharp, random, radiating pain from shoulders through both hands during that time. Plus site of injection was still swollen and sore ten days later.
Age: 39.0
Sex: F
Vaccine: TDAP
Symptoms: Axillary pain, Chills, Fatigue, Injected limb mobility decreased, Injection site pain
Clinical narrative: Severe pain, warmth @ injection site (R deltoid), 2x2cm painful palpable R axillary lymph node, fever to 100.4, inability to lift R arm, extreme fatigue, chills, muscle aches.  Treated with around the clock antiinflammatories and fever reducing meds, heat application.
Age: 39.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site warmth, Lymph node pain, Myalgia, Pyrexia
Clinical narrative: Severe pain, warmth @ injection site (R deltoid), 2x2cm painful palpable R axillary lymph node, fever to 100.4, inability to lift R arm, extreme fatigue, chills, muscle aches.  Treated with around the clock antiinflammatories and fever reducing meds, heat application.
Age: 14.0
Sex: M
Vaccine: HPV4
Symptoms: Convulsion, Electroencephalogram, Laboratory test, Nuclear magnetic resonance imaging
Clinical narrative: Generalized seizure; brought by ambulance to ER.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site cellulitis
Clinical narrative: Cellulitis of arm at site of Dtap/IPV.
Age: 0.59
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Pyrexia
Clinical narrative: High fever >105.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, C-reactive protein, Dizziness, Full blood count, Headache
Clinical narrative: Intermittent dizziness, headaches, muscle pains, abdominal pain, and nausea since administered injection.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Laboratory test, Myalgia, Nausea, Red blood cell sedimentation rate
Clinical narrative: Intermittent dizziness, headaches, muscle pains, abdominal pain, and nausea since administered injection.
Age: 37.0
Sex: F
Vaccine: PPV
Symptoms: Joint range of motion decreased, Mobility decreased, Musculoskeletal pain, Pain in extremity, Pyrexia
Clinical narrative: Developed fever later that night with inability to move arm much d/t shoulder pain, pain is to entire arm.
Age: 70.0
Sex: F
Vaccine: TDAP
Symptoms: Local reaction, Skin warm, Swelling
Clinical narrative: 2 x 3 cm, raised, warm, hot local reaction (was looked at 1 week after inj.).
Age: 44.0
Sex: M
Vaccine: TDAP
Symptoms: Chills, Decreased appetite, Fatigue, Pain in extremity, Pyrexia
Clinical narrative: Fever, chills, loss of appetite, fatigue, sore arm.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On 31-MAY-2013 the patient was vaccinated with the fourth dose of 1 ml RECOMBIVAX HB (lot# not reported) intramuscular. The first dose of RECOMBIVAX HB was administered on 02-JUL-2012, second dose of RECOMBIVAX HB was on 02-AUG-2012, the third dose of RECOMBIVAX HB was on 25-JAN-2013. No adverse effect reported. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test negative, Varicella virus test negative
Clinical narrative: This spontaneous report was received from a physician refers to a female patient of unknown age. The patient had no pertinent medical history. It was unspecified if patient had drug reactions or allergies. on 28-MAY-2013, the patient was vaccinated with 0.5ml of third dose of VARIVAX (Merck), (lot number, expiry date was not reported and route was subcutaneous). There were no concomitant medications reported. The patient had VARIVAX (Merck), series as a kid on unspecified date. The patient had titers done for admission to a university and her varicella titer came out as equivocal about a month ago. No adverse effects were reported. The patient sought medical attention. Additional information is not expected.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Injection site red, warm, swollen in an area of 7x7cm.
Age: 1.26
Sex: F
Vaccine: MNQ
Symptoms: Unevaluable event
Clinical narrative: None.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Hyperhidrosis, Injection site nodule, Injection site pruritus, Injection site reaction
Clinical narrative: Patient said that she has a red rash, itching, headache and a knot (at the injection site). She also reports sweating. I recommended diphenhydramine orally and topically for the itching and Tylenol or ibuprofen for headache and pain.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous
Clinical narrative: Patient said that she has a red rash, itching, headache and a knot (at the injection site). She also reports sweating. I recommended diphenhydramine orally and topically for the itching and Tylenol or ibuprofen for headache and pain.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Chest pain, Headache
Clinical narrative: Patient reported chest pain and headache.  She was evaluated through walk in clinic and saw a MD.  Symptoms resolved without treatment.
Age: 11.0
Sex: F
Vaccine: DTP
Symptoms: Dizziness, Syncope, Tinnitus, Visual impairment
Clinical narrative: Dizzy, fainting, vision changes and ringing in ears.
Age: 21.0
Sex: M
Vaccine: MMR
Symptoms: Arthralgia, Dyspnoea, Joint swelling, Oedema peripheral, Pain in extremity
Clinical narrative: Difficulty breathing, swollen and painful right knee, left fingers swollen and painful, right ankle painful.
Sex: U
Vaccine: HBHEPB
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a child patient of unknown age. On 29-MAY-2013 the patient was vaccinated with COMVAX (injection, lot # 1513AA, exp date as 06-MAY-2013, strength, dose number, route were unspecified). No adverse effect reported. The outcome was unknown. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Convulsion, Cyanosis, Respiratory arrest
Clinical narrative: She had a seizure then turned blue and stopped breathing. Taken by ambulance to emergency rm. Follow up with pediatrician and neurologist.
Age: 60.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: Sharp radiating pain from injection site down arm as far as back of hand, during certain movements.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy, Tuberculin test positive
Clinical narrative: This spontaneous prospective pregnancy report as received from a registered nurse refers to a 20 year old female patient with no drug reactions or allergies and with no medical history. On 01-FEB-2010 the patient was vaccinated with the first dose of GARDASIL, 0.5 ml, intramuscular (lot number was not reported). On 22-MAY-2013 the patient was vaccinated with the second dose of GARDASIL lot # H011350, esp. date February 2015, 0.5 ml, intramuscular. Concomitant therapies included albuterol. The patient became pregnant with Last Menstrual Period (LMP) in an approximately January 2013. After receiving her second dose of GARDASIL (on 22-MAY-2013), the patient reported to the nurse, that she was "14-16 weeks pregnant". On 22-MAY-2013 the patient had Purified Protein Derivative (PPD) test with positive result. There was no treatment given for the patient's events. The patient sought medical attention: saw the nurse. At the time of the report the patient outcome was not reported. The relatedness between PPD test positive and GARDASIL was not reported. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker concerning an approximately 25 year old female patient. It was reported that the patient was given the third dose of GARDASIL early. On 25-FEB-2013, the patient was vaccinated with the first dose of GARDASIL (lot number, expiry date, dose and route unspecified). On 23-APR-2013, the patient was vaccinated with the second dose of GARDASIL (lot number, expiry date, dose and route unspecified). On 21-MAY-2013, the patient was vaccinated with the third dose of GARDASIL (lot number, expiry date, dose and route unspecified). No concomitant medications were reported. No adverse effects were reported. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: VARCEL
Symptoms: Headache, Injection site induration, Rash erythematous, Rash pruritic, Rash pustular
Clinical narrative: Health care student reports (+) history of chicken pox. Varicella IgG (-) 4/9/13. Varicella #1 administered 4/26/13. Pt reports red itchy bumps extremities scab x face, back and abdomen - some vesicular and pustular. Inject site with 3 x 4 cm area of non tender induration. Pt c/o (B) maxillary and frontal headache.
Age: 22.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash vesicular, Scab
Clinical narrative: Health care student reports (+) history of chicken pox. Varicella IgG (-) 4/9/13. Varicella #1 administered 4/26/13. Pt reports red itchy bumps extremities scab x face, back and abdomen - some vesicular and pustular. Inject site with 3 x 4 cm area of non tender induration. Pt c/o (B) maxillary and frontal headache.
Age: 89.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood glucose decreased
Clinical narrative: This spontaneous report as received from a consumer refers to her 89 year old father with asthma, diabetes and emphysema and no drug/reactions and allergies. On 23-MAY-2013 the patient was vaccinated with second dose of ZOSTAVAX dose, lot # and route of administration not reported. Date of first dose was unspecified. Concomitant therapies included EFFEXOR, KLONOPIN, olanzapine, PLAVIX, aspirin, NORVASC, metoprolol tartrate and pantoprazole. On 23-MAY-2013 the patient saw a decline in his blood sugar levels after receiving a second dose of ZOSTAVAX. There were no lab diagnostics studies performed. As a treatment patient ate candy to raise his blood sugar levels. The patient did not seek medical attention. The outcome of decline in his blood sugar levels after receiving a second dose of ZOSTAVAX was unknown. The relatedness between adverse event and ZOSTAVAX was unknown. Additional information is not expected.
Age: 34.0
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B virus test positive, Malaise
Clinical narrative: This spontaneous report as received from a female approximately 34 years old patient with schizophrenia and no allergies refers to herself. On 01-JAN-2013 the patient was vaccinated with one dose of RECOMBIVAX INJECTION 10 (dose and lot # was not reported). Concomitant therapies included SAPHRIS. The patient had tested positive for HEPATITIS B after the administration of RECOMBIVAX. The patient also stated she was not feeling well and was not recovered because she was still testing positive for HEPATITIS B. The patient saw the doctor. The treatment was not given for AE. No lab diagnostics was performed. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Human papilloma virus test positive, Smear cervix abnormal
Clinical narrative: This spontaneous report was received from a nurse practitioner via field representative and refers to a female patient of unknown age, who was not in a pregnant. On an unknown date the patient was vaccinated with first, second and third dose of GARDASIL ( intramuscular, 0.5 ml, after 0, 2 and 6 months respectively). On an unknown date the patient experienced a positive pap smear that demonstrated oncogenic hpv type (unspecified number). Pap smear was performed with positive result. The patient sought medical attention and no treatment was given. The physician informed the field representative that the patient was due for her third GARDASIL injection. Physician also informed the field representative that she was uncertain as to providing the third injection. The outcome of a positive pap smear that demonstrated oncogenic hpv type was not reported. The relatedness between GARDASIL and positive pap smear that demonstrated oncogenic hpv type was not reported. It was reported that the therapy with GARDASIL was continued. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Maternal exposure before pregnancy
Clinical narrative: This spontaneous prospective pregnancy report was received from a female patient of unknown age regarding herself. On an unknown date, the patient was vaccinated with a dose of VARIVAX (Merck). The patient stated that she has discovered that she was pregnant currently after receiving VARIVAX (Merck). The patient explained that she received the vaccine during her menstrual period and believed that she conceived 2 weeks after vaccination. Additional information is not expected.
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site pain, Limb discomfort, Oedema peripheral
Clinical narrative: This spontaneous report was received from an approximately 77 year old female patient regarding herself. There was no pertinent medical history and no drug reactions or allergies. On 28-MAY-2013, the patient was vaccinated with a dose of PNEUMOVAX 23 (lot number, expiry date, dose and route unspecified) in the left arm. There were no concomitant medications. On 29-MAY-2013 (today), the patient awakened with severe pain at the injection site, red swollen arm from elbow to shoulder and discomfort with any movements with her arm. The patient sought medical attention (called the physician). No treatment was given. No lab tests were performed. The patient was not recovered from the events at the time of reporting. The relatedness for all the events was unknown for PNEUMOVAX 23. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: DTAP, HPV4, MNQ
Symptoms: Wrong drug administered
Clinical narrative: Child was given DTAP not Tdap by error.
Age: 49.0
Sex: M
Vaccine: PPV
Symptoms: Lethargy, Lip swelling, Pain, Pruritus, Rash
Clinical narrative: Swelling of lips, hives, itching, rash, achy, lethargic. Pt's reaction was several hours after vaccine.
Age: 49.0
Sex: M
Vaccine: PPV
Symptoms: Urticaria
Clinical narrative: Swelling of lips, hives, itching, rash, achy, lethargic. Pt's reaction was several hours after vaccine.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site movement impairment, Injection site pain, Weight bearing difficulty
Clinical narrative: Patient with pain in leg in area of Imm, getting worse in 48 hrs after imm, not wanting to bear wt. or bend leg with pain. Without erythema edema discharge fever or tenderness. Rx ibuprofen.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Cognitive disorder, Dysgraphia, Fall, Gait disturbance, Mental impairment
Clinical narrative: Hard time thinking, can't write well, can't spell, can't comprehend good, can't walk right (falls) per patient.
Age: 10.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Rash, Urticaria
Clinical narrative: Localized redness, swelling, pain at site of injection. Hives/rash on back as well.
Age: 14.0
Sex: M
Vaccine: HPV4
Symptoms: Cold sweat, Dizziness, Immediate post-injection reaction, Nausea
Clinical narrative: Immediately after receiving HPV number two patient became lightheaded, nauseated, dizziness, clammy. Remained so x 20 minutes, VSS 102/60, P 68. Dizziness subsided.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Fall, Gait disturbance, Hypoaesthesia, Impaired work ability, Intensive care
Clinical narrative: Onset of numbness and weakness in lower extremities. Developed unstable gait. Fell two times and presented to emergency department for evaluation due to worsening symptoms. Symptoms progressed to include paralysis of breathing functions, was admitted to intensive care, placed on vent, progressed through supportive care stage was transferred to rehabilitation facility and subsequently discharged to outpatient care. Currently in process of returning to work on part time basis in restricted position.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Mechanical ventilation, Muscular weakness, Respiratory paralysis
Clinical narrative: Onset of numbness and weakness in lower extremities. Developed unstable gait. Fell two times and presented to emergency department for evaluation due to worsening symptoms. Symptoms progressed to include paralysis of breathing functions, was admitted to intensive care, placed on vent, progressed through supportive care stage was transferred to rehabilitation facility and subsequently discharged to outpatient care. Currently in process of returning to work on part time basis in restricted position.
Age: 65.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 65 year old patient of unknown gender. On 13-MAR-2013, the patient was vaccinated with PNEUMOVAX23 (lot number H013399, expiration date: 07-MAR-2014) 0.5 ml in the arm. In March 2013, the patient experienced huge injection site reaction, swelling at least 6 inches to include the whole upper arm and redness. The patients sought medical attention (office visit) and as prescribed steroids. The nurse also reported that she had not seen this type of reaction from PNEUMOVAX23 before. The outcome of all the reported events was unknown. All telephone attempts to obtain follow-up information have been unsuccessful. This is one of several reports from the same source. Follow up information has been received from the nurse practitioner regarding a 65 year old female patient with hyperdyslipidaemia, high blood pressure (HBP), hyperglycemia and gastrooesophageal reflux disease (GERDS). Drug reactions/allergies included SINGULAIR allergy. It was reported that on 13-MAR-2013, the patient received the first dose of PNEUMOVAX23, Lot # H013399, IM. The patient had not illness at time of vaccination. On 14-MAR-2013, the patient experienced erythema, edema to the right upper arm extending to right elbow, pain and pruritus. The patient was given CELESTONE 1.5 ml for pruritus dose tapered, and ice for right arm, 1-2 times a day for pain. No relevant laboratory test was performed. At the time of the report, the patient's outcome was unknown. The nurse practitioner considered the events of erythema, edema, pain and pruritus to be medically significant events. This is one of two reports from the same patient (Case # 1306USA003520). Additional information is not expected.
Age: 65.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site erythema, Injection site oedema, Injection site swelling, Pain, Pruritus
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 65 year old patient of unknown gender. On 13-MAR-2013, the patient was vaccinated with PNEUMOVAX23 (lot number H013399, expiration date: 07-MAR-2014) 0.5 ml in the arm. In March 2013, the patient experienced huge injection site reaction, swelling at least 6 inches to include the whole upper arm and redness. The patients sought medical attention (office visit) and as prescribed steroids. The nurse also reported that she had not seen this type of reaction from PNEUMOVAX23 before. The outcome of all the reported events was unknown. All telephone attempts to obtain follow-up information have been unsuccessful. This is one of several reports from the same source. Follow up information has been received from the nurse practitioner regarding a 65 year old female patient with hyperdyslipidaemia, high blood pressure (HBP), hyperglycemia and gastrooesophageal reflux disease (GERDS). Drug reactions/allergies included SINGULAIR allergy. It was reported that on 13-MAR-2013, the patient received the first dose of PNEUMOVAX23, Lot # H013399, IM. The patient had not illness at time of vaccination. On 14-MAR-2013, the patient experienced erythema, edema to the right upper arm extending to right elbow, pain and pruritus. The patient was given CELESTONE 1.5 ml for pruritus dose tapered, and ice for right arm, 1-2 times a day for pain. No relevant laboratory test was performed. At the time of the report, the patient's outcome was unknown. The nurse practitioner considered the events of erythema, edema, pain and pruritus to be medically significant events. This is one of two reports from the same patient (Case # 1306USA003520). Additional information is not expected.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Dyspnoea, Injection site rash
Clinical narrative: This spontaneous report was received from a registered nurse concerning a 68 year old female patient with high cholesterol, allergy to ASA, reflux, osteoarthritis and fibromyalgia. On 19-APR-2013 at 11:00 the patient was vaccinated with the first dose of ZOSTAVAX (lot number H020132) dose not reported (subcutaneous route in the left arm, deltoid area). Concomitant medications were not reported. After 1 and 2 days post injection, on 20-APR-2013 at 10:00, the patient had a local injection site rash. The patient also reported shortness of breath. office nurse at medical office advised patient to visit emergency room (ER). ER doctor prescribed prednisone 40mg daily for 4 days. Relevant diagnostic test were not available. The patient recovered from adverse events on 20-APR-2013. Lot number H020132 is an invalid lot number for ZOSTAVAX. Additional information has been requested.
Age: 43.0
Sex: F
Vaccine: DTAP
Symptoms: Asthenia, Blepharospasm, Eye pain, Fatigue, Muscle twitching
Clinical narrative: Woke up to right eye & surrounding facial muscles twitching intensely. Pain was mild, but twitching was intense for several hours. Woke up again at 6:15 am. Eye twitching was gone, but I was extremely exhausted & fatigued the entire day. 22 hours later, my right eye is still sore, and I feel exhausted and weak. I haven't gone to a doctor because my husband is an RN and has kept an eye on me.
Age: 43.0
Sex: F
Vaccine: DTAP
Symptoms: Pain
Clinical narrative: Woke up to right eye & surrounding facial muscles twitching intensely. Pain was mild, but twitching was intense for several hours. Woke up again at 6:15 am. Eye twitching was gone, but I was extremely exhausted & fatigued the entire day. 22 hours later, my right eye is still sore, and I feel exhausted and weak. I haven't gone to a doctor because my husband is an RN and has kept an eye on me.
Age: 24.0
Sex: M
Vaccine: SMALL
Symptoms: Generalised vaccinia, Local reaction
Clinical narrative: Generalized vaccinia, localized reaction to bil hands, feet, elbows and knees.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site pain, Pyrexia
Clinical narrative: Fever of 101.6, injection site soreness.
Age: 1.3
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Diarrhoea, Pyrexia, Vomiting
Clinical narrative: Fever, vomiting and diarrhea started 6/6/13
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Syncope
Clinical narrative: Initial report received from a healthcare professional (nurse) on 30 May 2013. An 11 year old male patient was vaccinated on 06 May 2013 with MENACTRA intramuscularly into the right deltoid, batch # U4079AA and ADACEL intramuscularly into the left deltoid, batch C3922AA. The patient experienced a syncopal episode post vaccination at an unspecified time. The episode occurred after he left the office and was standing near the elevator. The patient did not have an acute or chronic illness or medical history. Concomitant medications and laboratory tests were not reported. The patient was observed for 15 minutes. The patient outcome was recovered at an unreported date. Documents held by sender: None.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a health care worker, via a field representative, refers to a patient of unknown age. The health care worker reported that their office administered a dose of ZOSTAVAX that had an undisclosed expiration date. She stated that the box of 10 vials was "mismatched with various expired dates". The expiration dates were not disclosed to the field representative. Field representative was not provided information on when the box of 10 ZOSTAVAX was received, or other lot/expiration information. A few days later another health care worker reported that on 14-MAY-2013 the patient was vaccinated with ZOSTAVAX (dosing information and route were not provided) Lot no. 0218AA, expiry date 16-MAY-2013 (Lot no. 0218AA is an invalid lot number for ZOSTAVAX) for prophylaxis. The patient received an expired dose of ZOSTAVAX. No adverse effect reported. PQC filed. Additional information has been requested.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Discomfort, Joint swelling
Clinical narrative: This spontaneous report as received from an 80 year old female patient with no pertinent medical history and no known drug reactions or allergies refers to herself. On 31-MAY-2013 the patient was vaccinated with a dose of ZOSTAVAX in the upper left arm for recommended vaccine from a Pharmacy. Concomitant therapies included ATENOLOL and PAXALL. On 02-JUN-2013, the patient began having joint elbow pain along with swelling. The patient contacted pharmacy to seek medical attention. The patient was treated with ALEVE (dosage unspecified). No lab diagnostics studies were performed. The patient was still feeling discomfort and was planning to contact her physician on 04-JUN-2013. The outcome of events was reported as not recovered. Additional information has been requested.
Age: 0.38
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Death
Clinical narrative: ? SIDS (death cert. not yet available).
Age: 0.16
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Death
Clinical narrative: ? SIDS (death cert. pending).
Age: 0.42
Sex: F
Vaccine: DTAPHEPBIP, FLU3, HIBV, RV5
Symptoms: Death
Clinical narrative: ? SIDS (final death cert not avail.).
Age: 0.01
Sex: M
Vaccine: HEP
Symptoms: Death
Clinical narrative: ? SIDS (death cert. not yet available).
Age: 0.64
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Blood culture, Body temperature decreased, Convulsion, Full blood count, Metabolic function test
Clinical narrative: Temp 103 degrees - 6/5/13 pm Seizure on 6/6/13 at approx 10:45 am, lasting 5 mins per mother.
Age: 88.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Anaemia, Blister, Injection site vesicles, Pain, Rash
Clinical narrative: This spontaneous report as received from a physician assistant refers to a 88 year old female patient with no drug allergies. On 08-MAY-2013, the patient was vaccinated with a dose of ZOSTAVAX (Lot number and expiry date was not reported), 0.65 millimeter (ml), subcutaneously and also received pneumococcal vaccine, polyvalent (23-Valent)(manufacturer unknown) on the same day. Approximately on an unknown date in May 2013 (reported as last week), the patient experienced significant outbreak of rash, open blisters and soreness after receiving ZOSTAVAX. The patient sought medical attention and the physician had asked the patient to use BENADRYL. The patient also presented anemia since an unknown date in MAY 2013. There have been no laboratory tests done. The reporter had not seen the patient but was told that the blisters started around the injection site the week after vaccination. The blisters had now spread to the entire body and was painful. The largest ones were the size of "half of a dime" and the other ones were smaller, "less than 3 millimeter in diameter". The blisters were on the hands, arms, face, back, and trunk. No treatment was given at this time. Physician assistant stated that the patient was not hospitalized, this was not life threatening, no significant disability, no intervention to prevent serious criteria, this was not cancer and there was no overdose. The outcome of all the reported events was not recovered/not resolved.
Age: 1.11
Sex: F
Vaccine: VARCEL
Symptoms: Rash
Clinical narrative: This spontaneous report was received from a healthcare worker refers to a 13 month old female patient. No medical history was reported. On 21-MAY-2013, the patient was vaccinated with VARIVAX lot # G007461, expiry: 02-AUG-2013 (reported as 20-AUG-2013) subcutaneously. Concomitant therapies included cetirizine hydrochloride. On 28-MAY-2013, the patient experienced rash on left arm, left chest and left flank. No treatment was given. Patient sought medical attention (seen in the physician's office). The physician documented that the rash was not a classical appearance of Varicella and had discussed appearance of rash, with department of health and was advised to report to the manufacturer of the VARIVAX. The outcome of rash on left arm, left chest and left flank was unknown. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Incomplete course of vaccination, No adverse event
Clinical narrative: This spontaneous report as received from a consumer refers to one of her two daughters, a female patient of unknown age. On 01-SEP-2012 the patient was vaccinated with the first dose of an unspecified HPV vaccine intramuscularly for prophylaxis. Since that date, neither of the patients had received subsequent doses in the series of the vaccine, which was other-than-indicated. No adverse effects were reported. This is one of two reports received from the same reporter. (other MARRS # 1306USA003399). Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse (RN) refers to an unspecified number of patients (age and gender not reported). The R.N. reported that a "sister office" on an unknown date vaccinated the patients with the first dose of VAQTA (Lot number, dose and route not reported) and in less than 6 months they received the second dose of VAQTA (Lot number, dose ans route not reported). Concomitant therapy was not reported. NO symptoms reported. Additional information has been requested.
Age: 0.24
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RVX
Symptoms: Fat tissue decreased
Clinical narrative: Loss of fat tissue on right thigh after receiving 4 months shots.
Sex: F
Vaccine: HPV4
Symptoms: Incomplete course of vaccination, No adverse event
Clinical narrative: This spontaneous report as received from a consumer refers to one of her two daughters, a female patient of unknown age. On 01-SEP-2012 the patient was vaccinated with the first dose of an unspecified HPV vaccine intramuscularly for prophylaxis. Since that date, neither of the patients had received subsequent doses in the series of the vaccine, which was other-than-indicated. No adverse effects were reported. This is one of two reports received from the same reporter. (other MARRS # 1306USA002420) Additional information has been requested.
Age: 32.0
Sex: U
Vaccine: VARCEL
Symptoms: Antibody test negative
Clinical narrative: This spontaneous report was received from a Registered Nurse refers to a 32 year old patient (unknown gender). No medical history was reported. ON 17-FEB-2006, the patient was vaccinated with a dose of VARIVAX (lot#, expiry, route, dose not reported). No concomitant medications were reported. The nurse reported that the patient has been immunized 4 times for varicella and with each immunization she has not built up a titer. The last immunization was with VARIVAX. It is unspecified whether the other 3 immunizations were with Merck product. The dates of administration of other 3 immunizations are unspecified by the reporter. No medical attention was sought. No adverse effect reported. The outcome of she has not built up a titer was unknown. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: Papule
Clinical narrative: Within 1 hour of injection pt. developed papules on back; (R) thigh-no itching.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Red and swollen at site of injection. Patient complained of itching and fever at the site.
Age: 1.28
Sex: M
Vaccine: DTAP, HIBV, PNC13
Symptoms: Injection site erythema, Injection site swelling, Injection site vesicles
Clinical narrative: 11.5 x 11.10 cm area of redness and swelling with pinpoint blisters noted at center of site.
Age: 18.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Convulsion, Syncope
Clinical narrative: This new pt fainted and then proceeded into a 30 second seizure, woke up without any further symptoms observed patient 20 minutes and no further reaction. Per parent- pt has history of fainting and seizure after immunizations.
Age: 5.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus
Clinical narrative: This spontaneous report received from a consumer refers to her 5 year old granddaughter who, on 04-JUN-2013, inadvertently received the ZOSTAVAX single dose, 0.65 ml, subcutaneously and on 04-JUN-2013 began experiencing itching at the injection site. Medical attention was not sought for the 5-year-old female and she was reported to be recovering from the event. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pyrexia, Swelling
Clinical narrative: 10 x 15 cm redness, swelling, low grade fever.
Age: 43.0
Sex: F
Vaccine: PPV
Symptoms: Injection site cellulitis, Injection site erythema, Pain in extremity, Pyrexia
Clinical narrative: States pain in arm vaccination given in.  Two areas of redness measuring 10x4 and 2x1 on same arm above axillary area.  Fever of 102 at onset time and 101 at 5:45 this am.  Took Ibuprofen.  Reported as recieved Pneumovax in Employee Health.  Reported to physician and seen in ER.  Augmentin 500mg/125mg 30 tablets to be taken twice a day for cellulitis RUE (at injection site) was prescribed in ER.
Age: 2.0
Sex: F
Vaccine: DTAP
Symptoms: Erythema, Injection site cellulitis, Local swelling, Tenderness
Clinical narrative: Patient has developed cellulitis @ the injection site. It is being treated with Septra for 7 days red swollen and tender 2 cm.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Activities of daily living impaired, Pyrexia
Clinical narrative: Fever of 103 F noted at school, client sent home; recommended acetaminophen to mom and the purchase of a thermometer to monitor temperature. Left message on 6/5/2013 to follow up but did not hear back.
Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Chills, Condition aggravated, Malaise, Musculoskeletal stiffness
Clinical narrative: That noc started with arm pain, early next morning c/o general malaise requiring Tylenol, that next night severe shaking chills and increase joint pain on 6/7 no chills but continued arm stiffness and joint pain.
Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: Pain in extremity, Tremor
Clinical narrative: That noc started with arm pain, early next morning c/o general malaise requiring Tylenol, that next night severe shaking chills and increase joint pain on 6/7 no chills but continued arm stiffness and joint pain.
Age: 12.0
Sex: F
Vaccine: HPVX
Symptoms: Activities of daily living impaired, Allergy test, Bronchitis, Dizziness, Gastric disorder
Clinical narrative: On 1/22/2009 my daughter received the Gardasil shot. She felt dizzy and had clouded vision that went away after a while. On 3/24/2009 she received her second shot and she almost passed out and had tunnel vision the rest of the day. The nurse praticioner said this was normal. I called the health department the next day and they said NO THIS IS NOT NORMAL. Since then my daughter has had only 3 periods in the past 4 years and has been sickly with respiratory infections, pneumonia, bronchitis, sinus infections, headaches and stomach problems. She has missed a lot of school due to this. she is on allergy medicine weekly allergy shots, headache and stomach medicine.
Age: 12.0
Sex: F
Vaccine: HPVX
Symptoms: Headache, Pneumonia, Presyncope, Respiratory tract infection, Sinusitis
Clinical narrative: On 1/22/2009 my daughter received the Gardasil shot. She felt dizzy and had clouded vision that went away after a while. On 3/24/2009 she received her second shot and she almost passed out and had tunnel vision the rest of the day. The nurse praticioner said this was normal. I called the health department the next day and they said NO THIS IS NOT NORMAL. Since then my daughter has had only 3 periods in the past 4 years and has been sickly with respiratory infections, pneumonia, bronchitis, sinus infections, headaches and stomach problems. She has missed a lot of school due to this. she is on allergy medicine weekly allergy shots, headache and stomach medicine.
Age: 12.0
Sex: F
Vaccine: HPVX
Symptoms: Tunnel vision, Vision blurred
Clinical narrative: On 1/22/2009 my daughter received the Gardasil shot. She felt dizzy and had clouded vision that went away after a while. On 3/24/2009 she received her second shot and she almost passed out and had tunnel vision the rest of the day. The nurse praticioner said this was normal. I called the health department the next day and they said NO THIS IS NOT NORMAL. Since then my daughter has had only 3 periods in the past 4 years and has been sickly with respiratory infections, pneumonia, bronchitis, sinus infections, headaches and stomach problems. She has missed a lot of school due to this. she is on allergy medicine weekly allergy shots, headache and stomach medicine.
Age: 24.0
Sex: F
Vaccine: DTAP
Symptoms: Urticaria
Clinical narrative: Hives on tops of feet and backs of hands.
Age: 28.0
Sex: F
Vaccine: MMR
Symptoms: Condition aggravated, Flushing, Hypersensitivity, Injection site erythema, Injection site pruritus
Clinical narrative: 28 yo female vaccinated with 0.5ml MMR II vaccine subcutaneously Rt upper arm and 15 minutes later c/o renness and itching at injection site, feeling flushed, diffuse red rash on chest and arms and felt heart was starting to race. Given history of systemic reaction to 2012 trivalent influenza vaccine was taken to ER in same facility for acute allergic reaction treatment. ED treatment consisted of Benadryl, Zantac and Prednisone. Following observation period, patient was discharged home in stable condition. Final impression: Acute allergic reaction to MMR vaccine - Resolved.
Age: 28.0
Sex: F
Vaccine: MMR
Symptoms: Palpitations, Rash erythematous
Clinical narrative: 28 yo female vaccinated with 0.5ml MMR II vaccine subcutaneously Rt upper arm and 15 minutes later c/o renness and itching at injection site, feeling flushed, diffuse red rash on chest and arms and felt heart was starting to race. Given history of systemic reaction to 2012 trivalent influenza vaccine was taken to ER in same facility for acute allergic reaction treatment. ED treatment consisted of Benadryl, Zantac and Prednisone. Following observation period, patient was discharged home in stable condition. Final impression: Acute allergic reaction to MMR vaccine - Resolved.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Lymphadenopathy
Clinical narrative: Axillary lymphadenopathy on arm that vaccine was given.
Age: 59.0
Sex: M
Vaccine: DTAP
Symptoms: Abasia, Asthenia, Muscle spasms, Pain in extremity, Paraesthesia
Clinical narrative: He started having some pain in the back of his legs bilaterally that woke him from sleep. It was a soreness and cramping. He then developed tingling in both of his legs from his thighs to his feet. He subsequently developed some tingling in his arms and hands bilaterally. Lost ability to walk due to weakness.
Age: 59.0
Sex: M
Vaccine: DTAP
Symptoms: Sleep disorder
Clinical narrative: He started having some pain in the back of his legs bilaterally that woke him from sleep. It was a soreness and cramping. He then developed tingling in both of his legs from his thighs to his feet. He subsequently developed some tingling in his arms and hands bilaterally. Lost ability to walk due to weakness.
Age: 1.02
Sex: F
Vaccine: HEPA, MMR, VARCEL, MMR, VARCEL
Symptoms: Breath sounds abnormal, Erythema, Injection site erythema, Injection site swelling, Irritability
Clinical narrative: Seen 4/25 for 12 mo WCC and vaccines.  3-4 days later developed red dots on torso, not itchy.  Spots would last 1-2 days and then fade a reappear elsewhere.  No fevers.  Mildly fussy and fighting sleep more.  3 days ago developed redness and swelling on R thigh with raised bumps on it.  Also not itching, but has grown slightly since first appeared.  Twin sister with same rashes for same time.
Age: 1.02
Sex: F
Vaccine: HEPA, MMR, VARCEL, MMR, VARCEL
Symptoms: Productive cough, Rash
Clinical narrative: Seen 4/25 for 12 mo WCC and vaccines.  3-4 days later developed red dots on torso, not itchy.  Spots would last 1-2 days and then fade a reappear elsewhere.  No fevers.  Mildly fussy and fighting sleep more.  3 days ago developed redness and swelling on R thigh with raised bumps on it.  Also not itching, but has grown slightly since first appeared.  Twin sister with same rashes for same time.
Age: 1.02
Sex: F
Vaccine: HEPA, MMR, VARCEL, MMR, VARCEL
Symptoms: Injection site erythema, Injection site rash, Injection site swelling, Insomnia, Irritability
Clinical narrative: Seen 4/25 for 12 mo WCC and vaccines.  3-4 days later developed red dots on torso, not itchy.  Spots would last 1-2 days and then fade a reappear elsewhere.  No fevers.  Mildly fussy and fighting sleep more.  3 days ago developed redness and swelling on R thigh with raised bumps on it.  Also not itching, but has grown slightly since first appeared.  Twin sister with same rashes for same time.
Age: 1.02
Sex: F
Vaccine: HEPA, MMR, VARCEL, MMR, VARCEL
Symptoms: Rash erythematous
Clinical narrative: Seen 4/25 for 12 mo WCC and vaccines.  3-4 days later developed red dots on torso, not itchy.  Spots would last 1-2 days and then fade a reappear elsewhere.  No fevers.  Mildly fussy and fighting sleep more.  3 days ago developed redness and swelling on R thigh with raised bumps on it.  Also not itching, but has grown slightly since first appeared.  Twin sister with same rashes for same time.
Age: 1.06
Sex: M
Vaccine: MMR, PPV, VARCEL
Symptoms: Cyanosis, Dyskinesia, Fall, Hypotonia, Respiratory arrest
Clinical narrative: Patient fell down and wouldn't breathe. Was turning blue and hands and feet were drawing up. Body was limp.  Lasted about 30 seconds or so. Took one small breath but was still unresponsive then started breathing again. Called pediatrician and took to hospital, was seen in ER by doctor. No treatment.
Age: 1.06
Sex: M
Vaccine: MMR, PPV, VARCEL
Symptoms: Unresponsive to stimuli
Clinical narrative: Patient fell down and wouldn't breathe. Was turning blue and hands and feet were drawing up. Body was limp.  Lasted about 30 seconds or so. Took one small breath but was still unresponsive then started breathing again. Called pediatrician and took to hospital, was seen in ER by doctor. No treatment.
Age: 5.0
Sex: M
Vaccine: VARZOS
Symptoms: Wrong drug administered
Clinical narrative: My son was given a shingles vaccine instead of a chicken pox vaccine.