chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy, Pregnancy test positive
Clinical narrative: This spontaneous prospective pregnancy report as received from a nurse refers to a 18 year old female patient. There were no pertinent medical history or drug allergies. On 18-JUL-2013, the patient was vaccinated with the first dose of GARDASIL (lot # and route not provided); and subsequently, in approximately July 2013, the patient found out she was pregnant. The patient LMP was on 03-JUN-2013 and EDD is 10-MAR-2014. Initial exposure to GARDASIL was at 6 week(s). On an unknown date, a pregnancy test was performed. There was no treatment given. The patient sought medical attention, on an unspecified date, she contacted the nurse. At the time of the report, the pregnancy outcome was unknown. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Cellulitis, Local swelling, Rash, Skin warm
Clinical narrative: This spontaneous report as received from a pharmacist referring to a 2 (of initially reported 3) patients of unknown age and gender with no pertinent medical history reported. On an unknown date these two patients were vaccinated with ZOSTAVAX (lot number and expiration date could be not provided) (dose and route not provided). The patients were not on other suspect therapies or concomitant medications at the time of the injection. On an unknown date the patients experienced large rashes in diameter, swollen and warm to touch, kind of look liked cellulitis, described as a "swollen area in their arm in the size and diameter of a softball". The pharmacist reported that these two patients did not received treatment of any kind and the swollen area resolved within ten days on its own. It was also reported that another of the initially reported patients received treatment for cellulitis (MARRS1306USA005637). Additional information has been requested.
Age: 59.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site irritation, Rash, Secretion discharge, Swelling face
Clinical narrative: This spontaneous report as received from a 59 year old female patient, with no pertinent medical history and no drug reactions/allergies, refers to herself. On 01-JUL-2013 the patient was vaccinated with a single dose of ZOSTAVAX lot # J000853; expiring 23-APR-2014 (dose and route not reported). No concomitant medication was reported. In approximately July 2013 the patient experienced a rash and extra mucus in the throat after receiving the ZOSTAVAX. The patient also stated that she suffered from a swollen face and injection site irritation after receiving the ZOSTAVAX. No treatment was given for the adverse events. No lab diagnostic studies were performed. The patient saw the doctor for medical attention. The adverse events did not improve and the patient's outcome was reported as not recovered. The causal relationship was not reported. Additional information has been requested.
Age: 59.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Angioedema, Gastrooesophageal reflux disease, Increased upper airway secretion, Injection site irritation, Pruritus
Clinical narrative: This spontaneous report as received from a 59 year old female patient, with no pertinent medical history and no drug reactions/allergies, refers to herself. On 01-JUL-2013 the patient was vaccinated with a single dose of ZOSTAVAX lot # J000853; expiring 23-APR-2014 (dose and route not reported). No concomitant medication was reported. In approximately July 2013 the patient experienced a rash and extra mucus in the throat after receiving the ZOSTAVAX. The patient also stated that she suffered from a swollen face and injection site irritation after receiving the ZOSTAVAX. No treatment was given for the adverse events. No lab diagnostic studies were performed. The patient saw the doctor for medical attention. The adverse events did not improve and the patient's outcome was reported as not recovered. The causal relationship was not reported. Additional information has been requested.
Age: 59.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash, Rash generalised, Rash maculo-papular, Swelling face, Urticaria
Clinical narrative: This spontaneous report as received from a 59 year old female patient, with no pertinent medical history and no drug reactions/allergies, refers to herself. On 01-JUL-2013 the patient was vaccinated with a single dose of ZOSTAVAX lot # J000853; expiring 23-APR-2014 (dose and route not reported). No concomitant medication was reported. In approximately July 2013 the patient experienced a rash and extra mucus in the throat after receiving the ZOSTAVAX. The patient also stated that she suffered from a swollen face and injection site irritation after receiving the ZOSTAVAX. No treatment was given for the adverse events. No lab diagnostic studies were performed. The patient saw the doctor for medical attention. The adverse events did not improve and the patient's outcome was reported as not recovered. The causal relationship was not reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age. On 10-JUL-2013 the patient was vaccinated with PROQUAD (Merck) 0.5 ml, subcutaneously, lot # unspecified. The reporter stated that the PROQUAD (merck) was stored at 46F for 10 days. The reporter also states that the PROQUAD (Merck) was put into the refrigerator on 09-JUL-2013. No adverse effect reported. The outcome of the patient was unknown. This is one of several reports received from the same source. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Culture, Erythema, Injection site erythema, Pain in extremity, Secretion discharge
Clinical narrative: 7/16/13-localized erythema at site of injection on right upper thigh. Presented to doctor clinic in late afternoon. Resolved uneventfully. Approx. 7/20, presented to ED with "sore" of left arm, no treatment.  On 7/23, presented to clinic with sores of L arm worsened, tender to touch, erythematous, "weepy".  No fever.  Culture taken.  Clindamycin initiated.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Skin ulcer, Tenderness
Clinical narrative: 7/16/13-localized erythema at site of injection on right upper thigh. Presented to doctor clinic in late afternoon. Resolved uneventfully. Approx. 7/20, presented to ED with "sore" of left arm, no treatment.  On 7/23, presented to clinic with sores of L arm worsened, tender to touch, erythematous, "weepy".  No fever.  Culture taken.  Clindamycin initiated.
Age: 9.0
Sex: M
Vaccine: HEP
Symptoms: Cough, Oropharyngeal pain, Pyrexia, Rhinitis
Clinical narrative: Sore throat, rhinitis, fever, cough.
Age: 1.1
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Convulsion, Vomiting
Clinical narrative: Violent vomiting for two days followed by two seizures on 05/04/1998.
Age: 88.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Induration, Injection site reaction, Local reaction, Swelling
Clinical narrative: Pt came to the pharmacy on 7/23/13 w/her son for ZOSTAVAX immun. Recv'd electronic Rx on 7/23/13 for cephalexin 50 mg QID x 7 d. Nurse from dr's office called 7/26/13 450 pm to reported localized site reaction. Pt had "1/2 dollar sized, red, swollen area" which was hard. Pt was given cephalexin for possible cellulitis. Nurse also mentioned could be related to diabetes.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema
Clinical narrative: Reddish circle underneath skin.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse, via company representative, refers to a patient of unknown age and gender. The patient was vaccinated with the first, the second and the third dose of GARDASIL (dose, route and lot number were not reported), on 13-JUN-2007, 01-NOV-2007, and 17-DEC-2007, respectively. The reporter stated that the patient was vaccinated with first two doses of the GARDASIL on time but then was administered the third dose in the GARDASIL series six weeks after the second dose (on 17_DEC-2007). No known adverse effect reported. Additional information has been requested.
Age: 34.0
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test negative, Induration, Injection site reaction, Pruritus, Rash erythematous
Clinical narrative: Hard, itchy, red, welt-like rash that is painful to the touch.  It seems to have increased in size since I first noticed it when I woke up in the morning. There are some raised marks within the rash.  The rash is around the injection site.
Age: 34.0
Sex: F
Vaccine: VARCEL
Symptoms: Tenderness, Urticaria
Clinical narrative: Hard, itchy, red, welt-like rash that is painful to the touch.  It seems to have increased in size since I first noticed it when I woke up in the morning. There are some raised marks within the rash.  The rash is around the injection site.
Age: 1.01
Sex: F
Vaccine: MMR, PNC13, VARCEL
Symptoms: Pruritus generalised, Rash erythematous, Rash generalised, Urticaria
Clinical narrative: Generalized hives, rashes, small bumps and red spots, itching, on neck, stomach, back, thighs.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site induration, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: 5 inch raised, hard, warm and itchy area on injection site. Patient does not complain of any systemic effects. Patient has self treated with hydrocortisone cream and Coridicin HBP Cough and Cold for its allergy component. The raised area was 3 inches and now a day later it is approximately 5 inches.
Age: 57.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Nausea, Oedema, Oedema peripheral, Pain in extremity
Clinical narrative: She reported having nausea and vomiting and pain, tenderness and mild swelling to her left arm.  During the week, her arm has continued to hurt and be swollen.  Today she presented with a warm, red, swollen arm that also has an area of edema around her elbow.
Age: 57.0
Sex: F
Vaccine: TDAP
Symptoms: Skin warm, Tenderness, Vomiting
Clinical narrative: She reported having nausea and vomiting and pain, tenderness and mild swelling to her left arm.  During the week, her arm has continued to hurt and be swollen.  Today she presented with a warm, red, swollen arm that also has an area of edema around her elbow.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Musculoskeletal stiffness, Rash
Clinical narrative: Headache, stiff neck, rash on scalp.
Age: 41.0
Sex: F
Vaccine: MMR
Symptoms: Activities of daily living impaired, Arthralgia, Chest X-ray, Chest pain, Convulsion
Clinical narrative: Short of breath. Seizures. Pain in chest. Went to hospital ER. As of 7/15/2013 severe joint pain and loss of range of motion in all joints. Can no longer do activities.
Age: 41.0
Sex: F
Vaccine: MMR
Symptoms: Dyspnoea, Joint range of motion decreased
Clinical narrative: Short of breath. Seizures. Pain in chest. Went to hospital ER. As of 7/15/2013 severe joint pain and loss of range of motion in all joints. Can no longer do activities.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site erythema, Injection site inflammation
Clinical narrative: Injection site redness and inflammation.
Age: 1.03
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, MMR, VARCEL
Symptoms: Abdominal discomfort, Decreased eye contact, Dyskinesia, Speech disorder, Wheezing
Clinical narrative: Stomach problems, wheezing, no eye contact, not talking, flapping of hands.
Age: 53.0
Sex: F
Vaccine: HEP
Symptoms: Diarrhoea, Nausea
Clinical narrative: Loose stools and nausea after eating solids the night of the vaccination and the following day, no complaints following fluid intake. No treatment necessary.
Age: 14.0
Sex: M
Vaccine: HPV4
Symptoms: Chills, Disorientation, Dizziness, Fatigue, Muscle spasms
Clinical narrative: 104 fever, chills, body ache, cramps, fatigue, dizziness, disorientation.
Age: 14.0
Sex: M
Vaccine: HPV4
Symptoms: Pain, Pyrexia
Clinical narrative: 104 fever, chills, body ache, cramps, fatigue, dizziness, disorientation.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant refers to unspecified number of patients of unknown demographics. On an unknown date the patients may have been vaccinated with VARIVAX (Merck) (lot#, expiration date and route not reported) which reached a high temperature of 28 Celsius (C). No adverse effects have been reported. This is one of the several reports from the same source. Additional information has been requested.
Age: 48.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Asthenia, Back pain, Electromyogram, Lumbar puncture, Nuclear magnetic resonance imaging
Clinical narrative: I rec'd the flu shot per hospital requirement. On 12/11/11, I was seen and admitted to the hospital for a severe backache and increasing weakness. I was hospitalized for 11 days and diagnosed with Guillain-Barre syndrome.
Age: 48.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Asthenia, Back pain, Electromyogram, Guillain-Barre syndrome, Lumbar puncture
Clinical narrative: I rec'd the flu shot per hospital requirement. On 12/11/11, I was seen and admitted to the hospital for a severe backache and increasing weakness. I was hospitalized for 11 days and diagnosed with Guillain-Barre syndrome.
Age: 48.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Nuclear magnetic resonance imaging
Clinical narrative: I rec'd the flu shot per hospital requirement. On 12/11/11, I was seen and admitted to the hospital for a severe backache and increasing weakness. I was hospitalized for 11 days and diagnosed with Guillain-Barre syndrome.
Age: 2.0
Sex: F
Vaccine: MNQ, PPV, PPV
Symptoms: Injection site cellulitis, Injection site erythema, Injection site joint swelling, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 2 year old female patient. The patient's medical history included sickle cell anemia. On 22-MAY-2013 the patient was vaccinated with PNEUMOVAX23 lot # j001180, 0.5 ml. The pharmacist reports that a patient developed swelling of the knee, pain, and "hot to touch" of the left leg on 22-MAY-2013 ("Within 24 hours") after receiving PNEUMOVAX23. The patient was admitted to on 23-MAY-2013 due to the symptoms that the patient experienced after receiving PNEUMOVAX23. During the patient's hospital stay, she received clindamycin and ceftriaxone sodium on unspecified dates. The patient was discharged from the hospital on 26-MAY-2013. The pharmacist reports that on an unspecified date during the patient's hospital stay the following studies were performed:"ESR, CRP, CBC, reticulocyte count, peripheral blood draw, and an MRI of the patient's left leg." The outcome of events was unknown. This is one of several reports received from the same source (the other two cases were: SR # 1-7875972808 and 1-7875972763). Additional information has been requested.
Age: 2.0
Sex: F
Vaccine: MNQ, PPV, PPV
Symptoms: Blood test, C-reactive protein, Full blood count, Joint swelling, Nuclear magnetic resonance imaging
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 2 year old female patient. The patient's medical history included sickle cell anemia. On 22-MAY-2013 the patient was vaccinated with PNEUMOVAX23 lot # j001180, 0.5 ml. The pharmacist reports that a patient developed swelling of the knee, pain, and "hot to touch" of the left leg on 22-MAY-2013 ("Within 24 hours") after receiving PNEUMOVAX23. The patient was admitted to on 23-MAY-2013 due to the symptoms that the patient experienced after receiving PNEUMOVAX23. During the patient's hospital stay, she received clindamycin and ceftriaxone sodium on unspecified dates. The patient was discharged from the hospital on 26-MAY-2013. The pharmacist reports that on an unspecified date during the patient's hospital stay the following studies were performed:"ESR, CRP, CBC, reticulocyte count, peripheral blood draw, and an MRI of the patient's left leg." The outcome of events was unknown. This is one of several reports received from the same source (the other two cases were: SR # 1-7875972808 and 1-7875972763). Additional information has been requested.
Age: 2.0
Sex: F
Vaccine: MNQ, PPV, PPV
Symptoms: Pain in extremity, Red blood cell sedimentation rate, Reticulocyte count, Skin warm
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 2 year old female patient. The patient's medical history included sickle cell anemia. On 22-MAY-2013 the patient was vaccinated with PNEUMOVAX23 lot # j001180, 0.5 ml. The pharmacist reports that a patient developed swelling of the knee, pain, and "hot to touch" of the left leg on 22-MAY-2013 ("Within 24 hours") after receiving PNEUMOVAX23. The patient was admitted to on 23-MAY-2013 due to the symptoms that the patient experienced after receiving PNEUMOVAX23. During the patient's hospital stay, she received clindamycin and ceftriaxone sodium on unspecified dates. The patient was discharged from the hospital on 26-MAY-2013. The pharmacist reports that on an unspecified date during the patient's hospital stay the following studies were performed:"ESR, CRP, CBC, reticulocyte count, peripheral blood draw, and an MRI of the patient's left leg." The outcome of events was unknown. This is one of several reports received from the same source (the other two cases were: SR # 1-7875972808 and 1-7875972763). Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Back pain, Chest pain, Dyspnoea, Eyelid oedema
Clinical narrative: Periorbital swelling with erythema, wheezing/chest pain and back pain.
Age: 5.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Back pain, Chest pain, Erythema, Eye swelling, Wheezing
Clinical narrative: Periorbital swelling with erythema, wheezing/chest pain and back pain.
Age: 16.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Asthenia, Injection site erythema, Injection site swelling, Injection site warmth, Nausea
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 16 year old male patient with sickle cell anemia. The patient had none drug allergies. The patient was previously discharged from the hospital on 23-JUL-2013. During that hospital stay, on 23-JUL-2013 the patient was vaccinated with a dose of PNEUMOVAX23 (lot # j004058, expiration date 22-JUN-2014) (0.5 ml, strength not specified). The vaccine was recommended due to the sickle cell (anemia). Concomitant therapies included docusate, folic acid, ibuprofen, acetaminophen, NORCO and PENICILLIN VK. It was reported that the patient developed swelling of an unspecified arm, redness, nausea, weakness, pain, and "hot to touch" skin after receiving PNEUMOVAX23. The patient was admitted to a hospital due to the symptoms that the patient experienced after receiving PNEUMOVAX23. Morphine was given as treatment. On 23-JUL-2013 the following studies were performed on the patient after he was admitted to the hospital on 23-JUL-2013: Complete Blood (cell) Count (CBC), reticulocyte count, and a blood antibody screening and no results were provided. The outcome of redness, weakness, nausea, swelling of an unspecified arm, pain and "hot to touch" skin was reported as not recovered. This is one of several reports received from the same source. Additional information has been requested.
Age: 16.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Pain
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 16 year old male patient with sickle cell anemia. The patient had none drug allergies. The patient was previously discharged from the hospital on 23-JUL-2013. During that hospital stay, on 23-JUL-2013 the patient was vaccinated with a dose of PNEUMOVAX23 (lot # j004058, expiration date 22-JUN-2014) (0.5 ml, strength not specified). The vaccine was recommended due to the sickle cell (anemia). Concomitant therapies included docusate, folic acid, ibuprofen, acetaminophen, NORCO and PENICILLIN VK. It was reported that the patient developed swelling of an unspecified arm, redness, nausea, weakness, pain, and "hot to touch" skin after receiving PNEUMOVAX23. The patient was admitted to a hospital due to the symptoms that the patient experienced after receiving PNEUMOVAX23. Morphine was given as treatment. On 23-JUL-2013 the following studies were performed on the patient after he was admitted to the hospital on 23-JUL-2013: Complete Blood (cell) Count (CBC), reticulocyte count, and a blood antibody screening and no results were provided. The outcome of redness, weakness, nausea, swelling of an unspecified arm, pain and "hot to touch" skin was reported as not recovered. This is one of several reports received from the same source. Additional information has been requested.
Age: 16.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Antibody test, Asthenia, Erythema, Full blood count, Local swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 16 year old male patient with sickle cell anemia. The patient had none drug allergies. The patient was previously discharged from the hospital on 23-JUL-2013. During that hospital stay, on 23-JUL-2013 the patient was vaccinated with a dose of PNEUMOVAX23 (lot # j004058, expiration date 22-JUN-2014) (0.5 ml, strength not specified). The vaccine was recommended due to the sickle cell (anemia). Concomitant therapies included docusate, folic acid, ibuprofen, acetaminophen, NORCO and PENICILLIN VK. It was reported that the patient developed swelling of an unspecified arm, redness, nausea, weakness, pain, and "hot to touch" skin after receiving PNEUMOVAX23. The patient was admitted to a hospital due to the symptoms that the patient experienced after receiving PNEUMOVAX23. Morphine was given as treatment. On 23-JUL-2013 the following studies were performed on the patient after he was admitted to the hospital on 23-JUL-2013: Complete Blood (cell) Count (CBC), reticulocyte count, and a blood antibody screening and no results were provided. The outcome of redness, weakness, nausea, swelling of an unspecified arm, pain and "hot to touch" skin was reported as not recovered. This is one of several reports received from the same source. Additional information has been requested.
Age: 16.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Nausea, Pain, Reticulocyte count, Skin warm
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 16 year old male patient with sickle cell anemia. The patient had none drug allergies. The patient was previously discharged from the hospital on 23-JUL-2013. During that hospital stay, on 23-JUL-2013 the patient was vaccinated with a dose of PNEUMOVAX23 (lot # j004058, expiration date 22-JUN-2014) (0.5 ml, strength not specified). The vaccine was recommended due to the sickle cell (anemia). Concomitant therapies included docusate, folic acid, ibuprofen, acetaminophen, NORCO and PENICILLIN VK. It was reported that the patient developed swelling of an unspecified arm, redness, nausea, weakness, pain, and "hot to touch" skin after receiving PNEUMOVAX23. The patient was admitted to a hospital due to the symptoms that the patient experienced after receiving PNEUMOVAX23. Morphine was given as treatment. On 23-JUL-2013 the following studies were performed on the patient after he was admitted to the hospital on 23-JUL-2013: Complete Blood (cell) Count (CBC), reticulocyte count, and a blood antibody screening and no results were provided. The outcome of redness, weakness, nausea, swelling of an unspecified arm, pain and "hot to touch" skin was reported as not recovered. This is one of several reports received from the same source. Additional information has been requested.
Age: 1.03
Sex: M
Vaccine: DTAP
Symptoms: Irritability, Pyrexia, Weight bearing difficulty
Clinical narrative: Developed very high fever: up to 103.7. Very cranky, would not bear weight on leg.
Age: 51.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Urticaria
Clinical narrative: Welts on front of arm that injection was given in-soreness in arm. Welts were 2 large ones. Started 7/25/13 only 1 welt today.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Skin warm
Clinical narrative: Patient had soreness and a little redness within day of shot. Did not pay much attention to it after that then noticed warmth 9 days after shot. At that time she had warmth with a large darker red area around original red ring.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Redness at the injection site and soreness.
Age: 29.0
Sex: F
Vaccine: RAB, TDAP, TYP, YF
Symptoms: Pruritus, Urticaria
Clinical narrative: Hives on upper chest/neck with itching a few hours after vaccines.
Age: 65.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Cellulitis, Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Left arm - site of ADACEL injection is very red, itchy, and warm to touch. Diagnosis cellulitis, treated w/doxycycline.
Age: 1.19
Sex: M
Vaccine: PNC13
Symptoms: Injection site urticaria
Clinical narrative: With 12 hours of getting PREVNAR #2, hives in area of shot.
Age: 0.09
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B surface antibody negative
Clinical narrative: This spontaneous report was received from a registered nurse refers to a currently 14 year old female patient. There was no pertinent medical history and no drug reactions/allergies. On 22-JUN-1999 the patient started a series of vaccination with hepatitis B vaccine (recombinant) (manufacturer unknown) (dose, strength, anatomical location, lot, number off doses not reported) and completed the series on an unspecified date. There was no concomitant medication. The reporter stated that the patient had serologic  testing performed by unspecified physician on an unspecified date, after the series was completed and the result was negative for anti HB antibodies. No treatment was given for the event. The outcome of negative for anti HB antibodies was reported as not recovered/not resolved. The relatedness was not reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant refers to unspecified number of patients of unknown demographics. On an unknown date the patients may have been vaccinated with (Merck) PROQUAD (lot#, expiration date and route not reported) which reached a high temperature of 28 Celsius (C). No adverse effects have been reported. This is one of the several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant refers to unspecified number of patients of unknown demographics. On an unknown date the patients may have been vaccinated with ZOSTAVAX (lot#, expiration date and route not reported) which reached a high temperature of 28 Celsius (C). No adverse effects have been reported. This is one of the several reports from the same source. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HEPA
Symptoms: Depressed level of consciousness, Presyncope
Clinical narrative: Pt had vasovagal episode, became obtunded, no loss of consciousness, BP and HR stable. Pt placed in supine position for 15 minutes, assisted to sitting position with no issues, was able to leave after 15 mins.
Age: 68.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Areflexia, Guillain-Barre syndrome, Laboratory test, Wheelchair user
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 68 year old female patient. On 13-JUN-2012 the patient was vaccinated with one shot of ZOSTAVAX (lot # 673029/0616AE, Exp: 26-JUN-2013) (route was not reported) 0.65 ml and a dose of T-DAP. The patient also received both PNEUMOVAX23 and an unspecified flu shot (manufacturer unknown) on 18-OCT-2012. According to the nurse practitioner, the patient experienced "unexplained loss of function in reflexes and lower extremity ascending paralysis" which began on an unspecified date in "July 2013". The patient was still confined to a wheelchair and was not recovered but was seeing an unspecified neurologist. The patient initially sought medical attention for this adverse experience at the emergency room of hospital, where she was afterwards admitted and hospitalized for an unspecified number of days and received unspecified treatment and lab tests. At the time of reporting, the patient was not recovered. The nurse practitioner considered "unexplained loss of function in reflexes and lower extremity ascending paralysis" to be significant disability. Upon internal review, lower extremity ascending paralysis was determined to be an other important medical event. This is one of several reports from the same reporter. Additional information has been requested.
Age: 15.0
Sex: M
Vaccine: HPV4
Symptoms: Fall, Loss of consciousness
Clinical narrative: Pt given GARDASIL injection, within 5 min pt passed out and fell forward off table onto floor. Examined by dr.
Age: 48.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: (L) deltoid red, painful, indurated swollen tender and fever tx KEFLEX 250 mg BID x2d.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Guillain-Barre syndrome, Impaired work ability, Intensive care, Lumbar puncture
Clinical narrative: 2/12/13 severe tingling from hips to feet, by the time I got to the hosp. started in my arms. Sent to ICU - symptoms reversed in 48 hrs but very weak - 5 day migraine and vomiting due to intravenous drip. In hosp. 6 days. Couldn't work for 5 wks. Could go to work end of March but only part time. My full time position let me go. Had to look for part time job. Started job beg. of May 2013. Lost 26 lbs. Very weak but grew stronger gradually. Dismissed as a patient from Dr. May 15, 2013.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Migraine, Paraesthesia, Vomiting, Weight decreased
Clinical narrative: 2/12/13 severe tingling from hips to feet, by the time I got to the hosp. started in my arms. Sent to ICU - symptoms reversed in 48 hrs but very weak - 5 day migraine and vomiting due to intravenous drip. In hosp. 6 days. Couldn't work for 5 wks. Could go to work end of March but only part time. My full time position let me go. Had to look for part time job. Started job beg. of May 2013. Lost 26 lbs. Very weak but grew stronger gradually. Dismissed as a patient from Dr. May 15, 2013.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Dyskinesia, Hypotonia
Clinical narrative: Child in for immunizations. Received Tdap, meningococcal and HPV. 1 minute post injection arms jerking and legs limp. Lowered to floor, cool cloth to forehead. Awoke child did not recall incident left ambulatory with mom. Alert and oriented 20 minutes post activity.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Abnormal behaviour, Blood test, Crying, Dehydration, Infantile spitting up
Clinical narrative: First of all let me start by saying patient was a perfectly healthy child until 7/3/13. He had experienced spit up problems that I had expressed concern about on 7/3/13. I was told he doesn't have acid reflux disease because he hasn't lost weight. On 7/3/13 he had six immunizations, that evening he started running 103-104 temperature and started frequently spitting up. He had been ZANTAC at the 7/3/13 appointment. On 7/8/13 he became sicker and continued to run fever. I called pediatric office and expressed my concern. I was told fever was normal but after I told them I wanted him checked out they said bring him in. He was examined and I was told he doesn't have an ear or throat infection so no need to give an antibiotic. That evening he started throwing up and continued to run a high fever. I called 24 hour nurse hotline because a normally non-crying child became inconsolable. They told me to take to E.R. I did Dr. did urinalysis and chest X-ray. Told me to throw away my thermometer fevers mean nothing. Babysitter called - had a friend who is Dr. On Tuesday July 9th saw doctor did blood work and ultrasound of stomach -viral infection prescribed antibiotic - dehydrated. On July 15th when picked up from babysitter was told she was concerned because he wasn't acting right - head tilted to left all day - first I had noticed on July 18 - still tilted so called Dr - looked at - saw - said no need to go further - I wasn't satisfied - called another pediatric office - saw on July 19th. On 18th I called a friend who has seen before - vaccination injury - as soon as I tell anyone he was fine until shots act like I'm crazy. Have before/after picture asked pediatric office to report - all I got is - it's not from shots - so I'm sure it wasn't reported. Everything is "oh mommy he's fine." Dr examined him - seemed concerned - can't say it is or isn't from shots but definite head tilt - possibly torticollis - sending to Pediatric neurologist to be sure. Follow up 7/26/13. As of 7/22 have already missed over 40 hours of work related to this incident. This is at a job you have to be dead or dying to miss. 7/3 - shots. 7/3 - 7/9 or 7/10 - Ran 103-104 temp, screaming, crying, dehydrated and rash on chest/stomach. 7/8 - Pediatric office. 7/8 - 9-11 pm - ER. 7/9 - Doctor. 7/15 -started or first noticed head tilting to left. 7/18 - Saw Dr. 7/19 - Another pediatric office. As of 7/22 today still tilting head.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Malaise, Posture abnormal, Pyrexia, Rash, Ultrasound abdomen
Clinical narrative: First of all let me start by saying patient was a perfectly healthy child until 7/3/13. He had experienced spit up problems that I had expressed concern about on 7/3/13. I was told he doesn't have acid reflux disease because he hasn't lost weight. On 7/3/13 he had six immunizations, that evening he started running 103-104 temperature and started frequently spitting up. He had been ZANTAC at the 7/3/13 appointment. On 7/8/13 he became sicker and continued to run fever. I called pediatric office and expressed my concern. I was told fever was normal but after I told them I wanted him checked out they said bring him in. He was examined and I was told he doesn't have an ear or throat infection so no need to give an antibiotic. That evening he started throwing up and continued to run a high fever. I called 24 hour nurse hotline because a normally non-crying child became inconsolable. They told me to take to E.R. I did Dr. did urinalysis and chest X-ray. Told me to throw away my thermometer fevers mean nothing. Babysitter called - had a friend who is Dr. On Tuesday July 9th saw doctor did blood work and ultrasound of stomach -viral infection prescribed antibiotic - dehydrated. On July 15th when picked up from babysitter was told she was concerned because he wasn't acting right - head tilted to left all day - first I had noticed on July 18 - still tilted so called Dr - looked at - saw - said no need to go further - I wasn't satisfied - called another pediatric office - saw on July 19th. On 18th I called a friend who has seen before - vaccination injury - as soon as I tell anyone he was fine until shots act like I'm crazy. Have before/after picture asked pediatric office to report - all I got is - it's not from shots - so I'm sure it wasn't reported. Everything is "oh mommy he's fine." Dr examined him - seemed concerned - can't say it is or isn't from shots but definite head tilt - possibly torticollis - sending to Pediatric neurologist to be sure. Follow up 7/26/13. As of 7/22 have already missed over 40 hours of work related to this incident. This is at a job you have to be dead or dying to miss. 7/3 - shots. 7/3 - 7/9 or 7/10 - Ran 103-104 temp, screaming, crying, dehydrated and rash on chest/stomach. 7/8 - Pediatric office. 7/8 - 9-11 pm - ER. 7/9 - Doctor. 7/15 -started or first noticed head tilting to left. 7/18 - Saw Dr. 7/19 - Another pediatric office. As of 7/22 today still tilting head.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Urine analysis, Viral infection, Vomiting, X-ray
Clinical narrative: First of all let me start by saying patient was a perfectly healthy child until 7/3/13. He had experienced spit up problems that I had expressed concern about on 7/3/13. I was told he doesn't have acid reflux disease because he hasn't lost weight. On 7/3/13 he had six immunizations, that evening he started running 103-104 temperature and started frequently spitting up. He had been ZANTAC at the 7/3/13 appointment. On 7/8/13 he became sicker and continued to run fever. I called pediatric office and expressed my concern. I was told fever was normal but after I told them I wanted him checked out they said bring him in. He was examined and I was told he doesn't have an ear or throat infection so no need to give an antibiotic. That evening he started throwing up and continued to run a high fever. I called 24 hour nurse hotline because a normally non-crying child became inconsolable. They told me to take to E.R. I did Dr. did urinalysis and chest X-ray. Told me to throw away my thermometer fevers mean nothing. Babysitter called - had a friend who is Dr. On Tuesday July 9th saw doctor did blood work and ultrasound of stomach -viral infection prescribed antibiotic - dehydrated. On July 15th when picked up from babysitter was told she was concerned because he wasn't acting right - head tilted to left all day - first I had noticed on July 18 - still tilted so called Dr - looked at - saw - said no need to go further - I wasn't satisfied - called another pediatric office - saw on July 19th. On 18th I called a friend who has seen before - vaccination injury - as soon as I tell anyone he was fine until shots act like I'm crazy. Have before/after picture asked pediatric office to report - all I got is - it's not from shots - so I'm sure it wasn't reported. Everything is "oh mommy he's fine." Dr examined him - seemed concerned - can't say it is or isn't from shots but definite head tilt - possibly torticollis - sending to Pediatric neurologist to be sure. Follow up 7/26/13. As of 7/22 have already missed over 40 hours of work related to this incident. This is at a job you have to be dead or dying to miss. 7/3 - shots. 7/3 - 7/9 or 7/10 - Ran 103-104 temp, screaming, crying, dehydrated and rash on chest/stomach. 7/8 - Pediatric office. 7/8 - 9-11 pm - ER. 7/9 - Doctor. 7/15 -started or first noticed head tilting to left. 7/18 - Saw Dr. 7/19 - Another pediatric office. As of 7/22 today still tilting head.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Aphasia, Cerebellar ataxia, Irritability, Posture abnormal, Pyrexia
Clinical narrative: First of all let me start by saying patient was a perfectly healthy child until 7/3/13. He had experienced spit up problems that I had expressed concern about on 7/3/13. I was told he doesn't have acid reflux disease because he hasn't lost weight. On 7/3/13 he had six immunizations, that evening he started running 103-104 temperature and started frequently spitting up. He had been ZANTAC at the 7/3/13 appointment. On 7/8/13 he became sicker and continued to run fever. I called pediatric office and expressed my concern. I was told fever was normal but after I told them I wanted him checked out they said bring him in. He was examined and I was told he doesn't have an ear or throat infection so no need to give an antibiotic. That evening he started throwing up and continued to run a high fever. I called 24 hour nurse hotline because a normally non-crying child became inconsolable. They told me to take to E.R. I did Dr. did urinalysis and chest X-ray. Told me to throw away my thermometer fevers mean nothing. Babysitter called - had a friend who is Dr. On Tuesday July 9th saw doctor did blood work and ultrasound of stomach -viral infection prescribed antibiotic - dehydrated. On July 15th when picked up from babysitter was told she was concerned because he wasn't acting right - head tilted to left all day - first I had noticed on July 18 - still tilted so called Dr - looked at - saw - said no need to go further - I wasn't satisfied - called another pediatric office - saw on July 19th. On 18th I called a friend who has seen before - vaccination injury - as soon as I tell anyone he was fine until shots act like I'm crazy. Have before/after picture asked pediatric office to report - all I got is - it's not from shots - so I'm sure it wasn't reported. Everything is "oh mommy he's fine." Dr examined him - seemed concerned - can't say it is or isn't from shots but definite head tilt - possibly torticollis - sending to Pediatric neurologist to be sure. Follow up 7/26/13. As of 7/22 have already missed over 40 hours of work related to this incident. This is at a job you have to be dead or dying to miss. 7/3 - shots. 7/3 - 7/9 or 7/10 - Ran 103-104 temp, screaming, crying, dehydrated and rash on chest/stomach. 7/8 - Pediatric office. 7/8 - 9-11 pm - ER. 7/9 - Doctor. 7/15 -started or first noticed head tilting to left. 7/18 - Saw Dr. 7/19 - Another pediatric office. As of 7/22 today still tilting head.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: White blood cell count decreased
Clinical narrative: First of all let me start by saying patient was a perfectly healthy child until 7/3/13. He had experienced spit up problems that I had expressed concern about on 7/3/13. I was told he doesn't have acid reflux disease because he hasn't lost weight. On 7/3/13 he had six immunizations, that evening he started running 103-104 temperature and started frequently spitting up. He had been ZANTAC at the 7/3/13 appointment. On 7/8/13 he became sicker and continued to run fever. I called pediatric office and expressed my concern. I was told fever was normal but after I told them I wanted him checked out they said bring him in. He was examined and I was told he doesn't have an ear or throat infection so no need to give an antibiotic. That evening he started throwing up and continued to run a high fever. I called 24 hour nurse hotline because a normally non-crying child became inconsolable. They told me to take to E.R. I did Dr. did urinalysis and chest X-ray. Told me to throw away my thermometer fevers mean nothing. Babysitter called - had a friend who is Dr. On Tuesday July 9th saw doctor did blood work and ultrasound of stomach -viral infection prescribed antibiotic - dehydrated. On July 15th when picked up from babysitter was told she was concerned because he wasn't acting right - head tilted to left all day - first I had noticed on July 18 - still tilted so called Dr - looked at - saw - said no need to go further - I wasn't satisfied - called another pediatric office - saw on July 19th. On 18th I called a friend who has seen before - vaccination injury - as soon as I tell anyone he was fine until shots act like I'm crazy. Have before/after picture asked pediatric office to report - all I got is - it's not from shots - so I'm sure it wasn't reported. Everything is "oh mommy he's fine." Dr examined him - seemed concerned - can't say it is or isn't from shots but definite head tilt - possibly torticollis - sending to Pediatric neurologist to be sure. Follow up 7/26/13. As of 7/22 have already missed over 40 hours of work related to this incident. This is at a job you have to be dead or dying to miss. 7/3 - shots. 7/3 - 7/9 or 7/10 - Ran 103-104 temp, screaming, crying, dehydrated and rash on chest/stomach. 7/8 - Pediatric office. 7/8 - 9-11 pm - ER. 7/9 - Doctor. 7/15 -started or first noticed head tilting to left. 7/18 - Saw Dr. 7/19 - Another pediatric office. As of 7/22 today still tilting head.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: Swelling erythema, pruritus. No pain or fever.
Age: 27.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Area of erythema and warmth at injection site - approximately 4 cm diameter persisted > 72 hours. Treatment with KEFLEX.
Age: 34.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Influenza like illness, Pain, Palpitations
Clinical narrative: Flu like symptoms, aching, dizzy heart racing sev. hr after shot. Saw dr the next AM. who sent her to ER. DECADRON, morphine and LORTABS.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site oedema, Injection site rash, Local reaction
Clinical narrative: DTaP local reaction in right thigh caused edema and rash.
Age: 15.0
Sex: M
Vaccine: HPV4
Symptoms: Computerised tomogram normal, Electroencephalogram, Hypotonia, Nuclear magnetic resonance imaging, Seizure like phenomena
Clinical narrative: Patient experienced seizure-like activity at home while playing video games with his brother. He apparently slumped over and became unresponsive. Seizure-like activity was noticed by mother. EMS was contacted; he was taken to hospital and admitted CT scan done. EEG and MRI ordered.
Age: 15.0
Sex: M
Vaccine: HPV4
Symptoms: Unresponsive to stimuli
Clinical narrative: Patient experienced seizure-like activity at home while playing video games with his brother. He apparently slumped over and became unresponsive. Seizure-like activity was noticed by mother. EMS was contacted; he was taken to hospital and admitted CT scan done. EEG and MRI ordered.
Age: 1.13
Sex: M
Vaccine: HIBV
Symptoms: Chest X-ray, Full blood count, Pyrexia
Clinical narrative: Fever to 106 within 48 hrs of HIB vaccine.
Age: 33.0
Sex: F
Vaccine: HEP
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 1.04
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Rash
Clinical narrative: 7-22-13 Patient was seen in the office CC: was a rash on the right side. Treatment ZOVIRAX 3.5.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: Pt reported 6 x 8" rash on left upper arm.
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Pyrexia
Clinical narrative: Tdap vaccine yesterday afternoon. At 2AM had fever of 101.2. Tx with ADVIL. At 10AM had fever of 103. No other symptoms.
Age: 1.0
Sex: F
Vaccine: MMRV, PNC13, VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Patient was given PROQUAD vaccine instead of MMR. At this time no side effects have occurred.
Age: 0.19
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Irritability, Screaming
Clinical narrative: Screaming episodes and marked irritability - started several hours after the vaccine and lasted for 8 days.
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Burning sensation, Chest pain, Herpes zoster, Pruritus
Clinical narrative: Pt received varicella vaccine 5/14/01 and 12/17/07. On 7/21/13 began with burning, itchy pain in dermatomal pattern (R) hemithorax. No rash erupted as of exam 7/24/13. Thought to have atypical herpes zoster and put on acyclovir x 5d and TYLENOL #3.
Age: 56.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Nausea, Pyrexia
Clinical narrative: Patient was given TDAP as part of her PE on 7/22/13. She visited our facility. Presented with fever and joint aches, nausea.
Age: 51.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Chills, Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Developed area approx 8" x 4" (R) valar aspect (R) upper arm - marked leg red, swollen and painful on day 7-17-13 evening, very painful. Did have chills and fever too last night. Will take BENADRYL and apply ice to area. Infection site clear.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Induration, Skin warm
Clinical narrative: Patient came in to pharmacy day after receiving shingles vaccination and presenting a red area, warm to touch and hard approximate 6 inches long. Followed up w/ pt on 07/27/13 and she was in contact with physician and is to follow up on 7/29/13. Area got larger, but today she stated the area is getting lighter in the red color.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Musculoskeletal pain
Clinical narrative: Shoulder pain, joint pain reported on 7/1/13.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Dyspnoea, Local swelling
Clinical narrative: Arm swelled and swelling moved up into neck area. Had trouble breathing. Emergency room gave epinephrine, antibiotic.